81 FR 8221 - Hatem M. Ataya, M.D.; Decision and Order; Introduction and Procedural History
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 32 (February 18, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 32 (February 18, 2016)
| Page Range | 8221-8245 | |
| FR Document | 2016-03359 |
[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)] [Notices] [Pages 8221-8245] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03359] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 14-20] Hatem M. Ataya, M.D.; Decision and Order; Introduction and Procedural History On July 23, 2014, the Deputy Assistant Administrator, Office of Diversion Control, issued an Order to Show Cause to Hatem M. Ataya (Respondent), of Lapeer, Michigan. ALJ Ex. 1, at 1. The Show Cause Order proposed the revocation of Respondent's DEA Certificates of Registration, pursuant to which he is authorized to dispense controlled substances in schedules II through V, as a practitioner, at the registered address of 971 Baldwin Road, Lapeer, Michigan (FA2278201), and at the registered address of 3217 W. M-55 Suite B, West Branch, Michigan (BA7776353), on the ground that he has committed acts which render his registration inconsistent with the public interest.\1\ Id. (citing 21 U.S.C. 824(a)(4)). The Order also proposed the denial of Respondent's applications for two additional registrations,\2\ on the ground that ``it is not consistent with the public interest . . . for [him] to be registered with the [Agency] to handle controlled substances.'' Id. (citing 21 U.S.C. 823(f)). --------------------------------------------------------------------------- \1\ The Order alleged that Respondent's registration number FA2278201 expires on June 30, 2016, and that his registration number BA7776353 expires on June 30, 2017. ALJ Ex. 1, at 1. \2\ The applications are for proposed registered locations in Davidson and Flint, Michigan. ALJ Ex. 1, at 1. --------------------------------------------------------------------------- The Show Cause Order alleged that from 2010 through 2013, Respondent ``repeatedly violated [his] obligation under federal law by prescribing controlled substances to [his] patients outside of the normal course of professional medical practice.'' Id. at 2 (citing 21 CFR 1306.04(a)). Continuing, the Order specifically alleged that Respondent's ``practice of regularly prescribing controlled substances to five patients [who were identified by the initials R.E.H., J.W., R.K., R.J.H., and J.H.] despite numerous and repeated red flags of drug abuse and diversion, [his] repeated failures to take appropriate steps to monitor [his] patients' use of controlled substances, and numerous other actions [he] took in the course of treating these patients all indicate that [he] violated [his] obligations under federal law by `prescribing [controlled substances] as much and as frequently as the patient demanded' so that `[in] practical effect, [he] acted as a large-scale ``pusher'' not as a physician.' '' Id. [[Page 8222]] (quoting U.S. v. Moore, 423 U.S. 122, 143 (1975)). The Show Cause Order then set forth detailed allegations regarding Respondent's prescribing to each of these patients.\3\ See id. at 2-6. --------------------------------------------------------------------------- \3\ The patient-specific allegations will be set forth in discussing the evidence pertinent to each patient. --------------------------------------------------------------------------- In addition, the Show Cause Order alleged that on March 26, 2013, Respondent was interviewed by a DEA Diversion Investigator and a local Detective. Id. at 6. The Show Cause Order further alleged that during the interview, Respondent made multiple false statements regarding his controlled substance prescribing practices.\4\ Id. at 6-7. --------------------------------------------------------------------------- \4\ The Show Cause Order specifically alleged that Respondent attempted to mislead investigators in an interview on March 26, 2013, when he told a DEA Diversion Investigator and a Lapeer City Detective that he was not aware of any prescription pads being stolen, that patient R.E.H.'s fraudulent practices were in the past and he was no longer a patient, that no controlled substance prescriptions are phoned in, that he attempted to taper patients off of methadone over time, that chronic pain patients must have some diagnostic finding to support their pain and are required to see a specific psychiatrist and attend physical therapy, that each chronic pain patient must sign and annually renew a pain management contract, that MAPS searches are usually run for chronic pain patients on every visit, and that he was unaware of any of his patients dying. Id. at 6-7. The Government alleged that Respondent's patient files and its investigation indicated that these statements and others were false. Id. at 7. --------------------------------------------------------------------------- Following service of the Show Cause Order, Respondent timely requested a hearing on the allegations. ALJ Ex. 2. The matter was placed on the docket of the Office of Administrative Law Judges and assigned to Administrative Law Judge (ALJ) Christopher B. McNeil, who commenced to conduct pre-hearing procedures and ordered the parties to submit their respective pre-hearing statements. GX 3. Thereafter, the parties submitted their pre-hearing and supplemental pre-hearing statements. The parties also filed various motions, the most significant of these being (given the issues raised by the Parties in their Exceptions), the Government's Motion to Exclude Respondent's Witnesses (ALJ Ex. 41). Also, on September 29, 2014, the ALJ conducted an on-the-record conference with the Parties at which he set the initial date for the evidentiary phase of the proceeding. Tr. 1, 16-17 (Sept. 29, 2014). During the conference, the ALJ authorized the taking of testimony at either the Agency's Arlington, Virginia hearing facility or ``by video- teleconferencing in the Detroit DEA Office.'' Id. at 19. The ALJ also authorized Respondent and his counsel to appear at either the Arlington hearing facility or the ``video-teleconferencing site'' and ``direct[ed] the Government to make available its DEA District or Field Office for this purpose.'' Id. at 19-20. On November 3, 2014, the ALJ conducted a further on-the-record conference during which he reviewed the parties' proposed stipulations and ruled on the Government's Motion to Exclude Respondent's Witnesses. See generally Tr. (Nov. 3, 2014). The ALJ granted the Government's motion with respect to twelve of Respondent's proposed fact witnesses on the ground that Respondent had not identified with sufficient particularity their proposed testimony because his pre-hearing statements did ``not clearly indicate each and every matter Respondent intend[ed] to introduce in opposition to the allegations.'' Id. at 35- 36; see also id. at 37-38. The ALJ also granted the Government's motion to exclude the testimony of Respondent's six witnesses who were to ``either testify or provide testimonials . . . as to [his] character, reputation, and qualifications as a physician,'' ALJ Ex. 39, at 3; stating his agreement with the Government's contention that their testimony was irrelevant and that Respondent did not proffer that ``any of these witnesses plan to testify about his treatment of'' the five patients. Id.; see also Tr. 38 (Nov. 3, 2014). The Government also sought to exclude the testimony of Ms. Michelle Ann Richards, who, according to Respondent, would ``testify that she is certified in healthcare compliance consulting, coding, and office management,'' and ``that she was retained by Respondent to do risk assessment audit and risk mitigation for his practice.'' ALJ Ex. 39, at 3. Respondent also stated that Ms. Richards would testify that she had ``provided compliance training to Respondent's staff [and] that she is continuing to monitor and implement changes to ensure [his] medical practice with all State and Federal laws.'' Tr. 39. In addition to the ground that Respondent had not adequately summarized Ms. Richards' testimony, the Government also argued that the testimony should be barred because Respondent had represented that he ``intend[ed] to testify that he has never been out of compliance with such laws,'' and that his `` `care and treatment [of the five patients] at all times comported with reasonable and minimally accepted standards and that all prescriptions were issued for a legitimate medical purpose by a registered physician within the course of professional practice.' '' ALJ Ex. 42, at 4-5 (Gov. Mot.) (quoting Resp. Pre-Hearing Statement, at 3-4 (Sept. 15, 2014)). Continuing, the Government reasoned that under agency precedent, `` `mitigation' evidence is not admissible unless and until the registrant fully and unequivocally accepts responsibility for the wrongful or unlawful conduct on which registration consequences are sought.'' Id. at 5. The ALJ granted the Government's motion, agreeing with both of the Government's arguments. Specifically, the ALJ agreed that Respondent had failed to describe Ms. Richards' testimony ``with sufficient particularity'' and thus had not complied with his prehearing order. Tr. 39 (Nov. 3, 2014). Also, the ALJ explained that because Respondent intended to testify that in prescribing to the five patients he had ``at all times comported with reasonable and minimally accepted standards'' and that all of the prescriptions were issued within the usual course of professional practice and for a legitimate medical purpose, this ``compels the conclusion that Respondent does not accept responsibility for any failure to conform to the requirements of the'' CSA. Id. at 40-41. The ALJ thus concluded that there was ``no need to address whether the remedial measures that [Respondent] claims to have instituted are adequate to protect the public interest.'' Id. at 41. Notably, during the conference, the ALJ did not address Respondent's contention that the ALJ had misinterpreted the Agency's precedents, and that if the case law actually required him to admit to misconduct which he did not engage in, ``then that precedent is inconsistent with procedural due process.'' ALJ Ex. 45, at 1 (Resp.'s Response in Opposition to Govt's Mot. to Exclude Resp.'s Witnesses). Nor did the ALJ address Respondent's suggestion that he ``defer'' his ruling ``until the hearing itself,'' at which time the ALJ and the parties would be in ``a better position to determine whether'' he ``ha[d] sufficiently titrated his contrition to permit the introduction of such testimony.'' Id. Finally, the Government moved to exclude the testimony of two physicians who Respondent proposed would testify on his behalf as experts. While Respondent identified some eight areas on which he ``anticipated'' that the experts would testify, ALJ Ex. 39, at 3-5; the Government argued that the disclosure was inadequate because ``Respondent has not disclosed any conclusions that the witnesses have actually reached regarding the prescribing conduct at issue.'' ALJ Ex. 42, at 6. The Government further argued that ``[i]t remains a mystery if these doctors have actually reached any [[Page 8223]] opinions, to which they will subscribe under oath, to support Respondent's view that his prescribing was entirely legitimate.'' Id. The ALJ granted the Government's motion, reasoning that he could not ``tell from the supplemental prehearing statement which witness will espouse each of the opinions presented in the supplemental prehearing statement'' and ``whether either of the witnesses has a sufficient foundation, obtained through the review of patient records, or otherwise, to express the opinions presented in the supplemental prehearing statement.'' Tr. 42. The ALJ also explained that he could not tell which professional standards the witnesses were relying on to reach their opinions. Id. at 42-43. Finally, while the ALJ noted that Respondent proposed that one of the doctors (who was also from Flint, Michigan) would testify that this area ``is infested with drug-seeking addicts, who employ sophisticated tricks to deceive and frustrate the most vigilant anti-diversion efforts of healthcare providers,'' the ALJ reasoned that this evidence was irrelevant because Respondent ``intends to establish that his prescription practice complied fully with the requirements of the'' CSA. Id. at 43. Subsequently, the ALJ issued a Journal Entry and Order memorializing his various rulings as well as the various stipulations agreed to by the parties. On November 17-18, 2015, the ALJ presided over the evidentiary phase of the proceeding, conducting a video-teleconference with he and the reporter being present in Arlington, Virginia, and the witnesses (including Respondent) and the parties' counsels present at the DEA Detroit, Michigan Field Division Office. Id. at 73-74; id. at 423. Notably, from the outset, the proceeding was marked by telephonic interference and interruptions of the transmission, with interruptions occurring nearly 60 times over the course of a day and half of testimony. See id. at 72 et seq. At the hearing, the Government called four witnesses to testify, including Dr. Eugene O. Mitchell, who was accepted as an expert in pain medicine. The Government also submitted for the record an extensive amount of documentary evidence including, inter alia, the medical records of the five patients identified in the Show Cause Order, copies of various prescriptions issued to the patients, and copies of reports obtained from the Michigan Automated Prescription System (MAPS) showing the controlled substance prescriptions obtained and filled by each of the five patients. Respondent testified on his own behalf. He also submitted several exhibits for the record. After the hearing, both parties submitted briefs containing their proposed findings of fact and conclusions of law.\5\ --------------------------------------------------------------------------- \5\ These briefs will be referred to as Post-hearing Briefs. --------------------------------------------------------------------------- Thereafter, the ALJ issued his Recommended Decision (hereinafter cited as R.D.). Therein, the ALJ found that the Government's evidence with respect to Factors Two (Respondent's experience in dispensing controlled substances) and Four (compliance with applicable laws related to controlled substances) supported the conclusion that ``Respondent's continued registration would be inconsistent with the public interest.'' R.D. 66-68. More specifically, with respect to Factor Two, the ALJ found that ``Respondent demonstrated a material lack of . . . experience regarding a prescribing source's responsibilities to resolve red flags when prescribing controlled substances for persons presenting with symptoms of chronic pain and terminate from his practice patients whose drug- seeking behavior indicates the potential for abuse or diversion (or both) of controlled substances.'' Id. at 67. And with respect to Factor Four, the ALJ found that ``[a] preponderance of the evidence establishes that Respondent issued controlled substance prescriptions for the five patients identified [in the Show Cause Order], in a manner that was not in the ordinary course of professional medical practice and was not based upon legitimate medical justification.'' Id. (citing 21 CFR 1306.04(a)). The ALJ also found that Respondent violated Michigan law by post-dating controlled substance prescriptions and failing to include ``the patient's full name and address'' on the prescription. Id. at 67-68 (citing Mich. Comp. Laws Sec. Sec. 333.7333(7), 338.3161(1)(a)); see also id. at 64 (Finding of Fact (FoF) # 3). Finally, the ALJ found that Respondent violated state and federal law by issuing prescriptions for schedule IV controlled substances which authorized more than five refills. Id. at 68 (citing 21 U.S.C. 829(b); Mich. Comp. Laws Sec. 333.7333(4)); see also id. at 64-65 (FoF#s 3, 5).\6\ --------------------------------------------------------------------------- \6\ Noting that ``the record is silent with respect to the recommendation of the . . . state licensing board,'' the ALJ found that this factor ``neither supports nor contradicts a finding that Respondent's continued . . . registration is inconsistent with the public interest.'' R.D. 66. The ALJ also found that the Government had neither alleged nor provided evidence that Respondent was convicted of a federal or state offense related to the manufacture, distribution, or dispensing of controlled substances, and thus, Factor Three does not support the revocation of his registrations and denial of his pending applications. Id. at 67. As for Factor Five--such other conduct which may threaten public health or safety--the ALJ found that the Government had not proved the allegation that Respondent made various false statements to the Diversion Investigator and Detective. Id. at 68. The ALJ based his conclusion on the fact that ``the written record of that interview was not present'' and ``the questions presented and answers given were not sufficiently established in the record so as to permit a determination of Respondent's candor during [the] interview.'' Id. Because the Government did not take exception to the ALJ's findings on the issue of Respondent's candor during the interview, I deem it unnecessary to make any findings related to the allegation. --------------------------------------------------------------------------- The ALJ thus concluded that ``the Government has established its prima facie case by at least a preponderance of the evidence.'' Id. at 69. The ALJ explained that ``[w]hen responding to the Government's prima facie case . . . Respondent has the opportunity to demonstrate that he recognizes any noncompliance with controlled substance laws and has taken steps to ensure against future noncompliance.'' Id. at 68-69. The ALJ then reasoned that under the Agency's case law, ``in the absence of evidence of `sincere[ ] remorse[ ],' a `generalized acceptance of responsibility to the allegations' is not enough to open the hearing so as to permit evidence of remediation.'' Id. (citing Govt's Post-Hrng. Br. 48). Finding that ``Respondent has not provided substantial evidence meeting this standard,'' the ALJ concluded that he ``failed to establish a basis that would permit him to rebut the Government's prima facie case.'' Id. The ALJ thus recommended that I revoke Respondent registrations and deny his pending applications. Id. Both parties filed Exceptions to the ALJ's Recommended Decision. Thereafter, the record was forwarded to my Office for Final Agency Action. On review of the record, I noted that it contained no evidence as to whether Respondent is currently authorized under Michigan law to dispense controlled substances. Order at 1 (Nov. 10, 2015). Accordingly, I directed the parties to address whether Respondent currently possesses authority under Michigan law to dispense controlled substances and if Respondent does not possess such authority, to address what consequence attaches for this proceeding. Id. On November 17, 2015, the Government submitted its Response. Therein, the Government noted that on July 6, 2015, the Michigan Department of Licensing and Regulatory Affairs had filed an Administrative Complaint with the Board of Medicine Disciplinary Subcommittee. Govt's. Resp., at 7-8; Govt's Resp. Ex. 3, at 8-14 [[Page 8224]] (Administrative Complaint, In re Ataya, No. 43-15-137995 (Mich. Bd. of Med. July 6, 2015)). When Respondent failed to respond to the allegations of the complaint, the allegations were deemed admitted, and on October 30, 2015, the Board revoked his medical license. Gov. Resp. Ex. 3, at 2-3, 5. In his Response to my Order, Respondent states that he does not dispute that the Board has revoked his medical license and that he ``no longer has any legal authority to dispense controlled substances, which, as a practical matter, he could not accomplish from the jail cell he has occupied for the past several months anyway.'' Respondent's Resp., at 1. Having considered the record in its entirety, including the parties' Exceptions, as well as the recent action taken by the Michigan Board of Medicine, I issue this Decision and Final Order. I agree with the ALJ that the record supports findings that Respondent ignored multiple red flags of abuse and/or diversion with respect to each of the five patients (FoF #2). I also agree that the record supports the ALJ's factual findings specific to Respondent's prescribing of controlled substances to each of the five patients (FOF#s 3, 4, 5, 6, and 7), as well as his legal conclusions that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in prescribing controlled substances to each of the five patients in violation of 21 CFR 1306.04(a). See R.D. at 66-67. I further agree with the ALJ that Respondent violated federal and state law when he issued prescriptions authorizing more than five refills of schedule IV controlled substances, as well as when he post-dated a prescription and failed to include the patients' names and addresses on numerous prescriptions. Finally, I agree with the ALJ's conclusion that the Government made out a prima facie case that Respondent's registration is inconsistent with the public interest. With respect to Respondent's rebuttal case, for reasons explained below, I find troubling the ALJ's handling of the issue of whether Respondent has adequately accepted responsibility for his misconduct. And as for the ALJ's ruling barring Respondent from presenting evidence of his remedial measures, I agree with the ALJ that Respondent did not sufficiently disclose the scope of the proposed testimony. While this alone is sufficient reason to reject Respondent's exception, the ALJ further reasoned that under the Agency's precedent, Respondent is barred from introducing evidence of his remedial measures absent his admission to the allegations before the Government was even required to put on its evidence. Contrary to the ALJ's understanding, while a respondent's failure to acknowledge his misconduct renders evidence of his remedial measures irrelevant, the Agency has never held that a respondent must admit to his misconduct prior to even being able to test the Government's evidence at the hearing. I reject, however, Respondent's contention that a remand is warranted for multiple reasons. First, as explained above, I agree with the ALJ's conclusion that Respondent did not adequately disclose the scope of the proposed testimony on the adequacy of his remedial measures. Second, even were I to credit Respondent's admissions at the hearing and give weight to his testimony regarding the remedial measures he has undertaken, I would nonetheless find that his conduct was so egregious that the protection of the public interest warrants the revocation of his registrations and the denial of his pending applications. Finally, because of the recent action of the Michigan Board of Medicine, Respondent is precluded from being registered because he no longer holds authority under state law to dispense controlled substances, and thus evidence of his acceptance of responsibility and remedial measures is irrelevant. See 21 U.S.C. 802(21), 823(f). Findings of Fact Respondent's Licensure and Registration Status Respondent was formerly licensed as a physician by the Michigan Board of Medicine. However, on July 6, 2015, the Bureau of Professional Licensing, acting on behalf of the Michigan Department of Professional Licensing and Regulatory Affairs, filed a complaint against Respondent. Administrative Complaint, In re Ataya, No. 43-15-137995 (Mich. Bd. of Med. July 6, 2015). The Department also ordered that Respondent's medical license be summarily suspended. Order of Summary Suspension, In re Ataya. Thereafter, on October 30, 2015, the Board of Medicine revoked Respondent's medical license. Final Order, In re Ataya. Respondent currently holds two DEA practitioner's registrations, pursuant to which he is authorized to dispense controlled substances in schedules II through V. GX 4, at 1-2. The first of these (BA7776353) is for the registered location of 5097 Miller Road, Flint, Michigan and does not expire until June 30, 2017. Id. at 1. The second (FA2278201) is for the registered location of 971 Baldwin Road, Lapeer, Michigan and does not expire until June 30, 2016. GX 3, at 1. Respondent has also applied for two additional registrations: One at the address of 3390 N. State Road, Davison, Michigan; the other at the address of 3400 Fleckenstein, Flint, Michigan. The Investigation of Respondent Respondent first came to the attention of law enforcement on January 5, 2012, when a Detective with the City of Lapeer Police Department responded to the death of R.J.H., one of the patients identified in the Show Cause Order. Tr. 90; ALJ Ex. 1, at 1-2. According to the Detective, he knew R.J.H. from his experience in law enforcement and knew him to be an abuser of both ``prescription drugs [and] illegal drugs.'' Tr. 93. The Detective testified that R.J.H. bore no signs of external injuries and there was no evidence that injuries had led to his death. Id. The police did, however, find three empty prescription vials, including a vial bearing a label for 120 methadone 10 \7\ and clonazepam (Klonopin), as well as a syringe, on a nightstand in R.J.H.'s bedroom. Id. The Detective subsequently obtained a report from the Michigan Automated Prescription System (MAPS) and found that both the methadone and Klonopin had been prescribed to R.J.H. by Respondent on January 3, 2012. Id. According to the detective, toxicology testing led to the conclusion that R.J.H. had died of an overdose. Id. at 95. The Detective also learned that R.J.H. had overdosed on heroin two days before and was taken to the hospital. Id. at 107; GX 5, at 1. --------------------------------------------------------------------------- \7\ All numbers which follow the name of a drug refer to the dose per pill in milligrams. --------------------------------------------------------------------------- On January 22, 2012, the Detective responded to the death of J.W. Tr. 95. The authorities found two pill bottles in J.W.'s coat, as well as marijuana. Id. at 96, 108. One vial, which bore a label for 120 methadone, contained only nine methadone pills; however, the vial also included four Klonopin pills and two diazepam. Id. The second vial, which bore a label for 120 Klonopin, contained only 91 pills. Id. According to the Detective, J.W.'s body bore possible needle marks. Id. at 112. During his investigation, the Detective determined that on January 19 (three days earlier), J.W. had obtained prescriptions from Respondent for 120 methadone 10 and 120 clonazepam 1. Id. at 96. According to the Detective, the investigation and toxicology test results led to the conclusion that J.W. had died of an overdose. Id. at 96-97. [[Page 8225]] During the course of his investigation, the Detective spoke with both J.W.'s mother and niece. The Detective testified that J.W.'s mother said that J.W. did not like methadone and usually sold it to buy other drugs. Id. at 112. According to the Detective, J.S. (J.W.'s niece) told him that J.W. had been released from jail only ``a week or two prior to his death.'' Id. at 98. J.S.'s niece also told the Detective that she had contacted Respondent's office and told him that her uncle ``had a problem'' with controlled substances ``and asked him not to prescribe any controlled substances'' to her uncle. Id. J.S. subsequently testified that her uncle's drug problem ``was obvious'' and that ``[e]verybody knew.'' Id. at 125. She testified that she spoke with Respondent on the phone a couple of weeks before her uncle was released and told Respondent that her uncle ``was sick and he didn't need the medications because he wasn't taking them'' and ``was selling them.'' Id. at 128-29. According to J.S., Respondent initially ``blew [her] off.'' Id. at 129. However, when J.S. told Respondent that the police ``wanted to know why [J.W.] had two prescriptions for Methadone'' which he had not filled, Respondent asked for J.W.'s name, address and date of birth. Id. J.S. also told Respondent that J.W. had ``nearly died from withdrawal'' and asked Respondent not to ``give him these strong medications.'' Id. While Respondent said that ``he wouldn't do it anymore,'' id. at 130, as found above, Respondent subsequently issued the methadone and clonazepam prescriptions to J.W.\8\ Id. at 96. --------------------------------------------------------------------------- \8\ Respondent testified that he does not recall the phone conversation about which J.S. testified, explaining that he would not remember what patient the conversation involved because he has 7,500 patients. Tr. 485. He also testified that if someone calls and wants to speak to him about a patient, his assistants ask the person ``to come with the patient and discuss the matter.'' Id. The ALJ did not make a finding as to whether J.S.'s testimony was credible. R.D. at 9-10. I find her testimony credible, noting that while it may be that Respondent would not recall the conversation given the large number of patients he treated, one would recall a conversation she had with a doctor about a family member. --------------------------------------------------------------------------- The Detective also testified regarding an investigation conducted by a subordinate into the death of R.K. on or about July 21, 2012. Id. at 98-100. According to the Detective, there was no evidence that R.K. had died of injuries and upon arriving at the scene, the police found a prescription vial which, according to the label, had been issued by Respondent four days earlier for 90 Xanax. Id. at 100. However, the vial was empty. Id. The Detective also obtained a MAPS report for R.K. Id. The MAPS report shows that on July 17, Respondent issued to R.K. a prescription for 90 tablets of methadone 10, which R.K. filled the next day. GX 22, at 16. The cause of R.K.'s death was a drug overdose. Id. at 101. According to a police report, a person with Community Mental Health stated that R.K. was known to abuse heroin, Tramadol, and other prescription medications. GX 5, at 17. The Detective testified that because his agency did not have a lot of experience in prescription drug investigations, after R.K.'s death, he sought the assistance of DEA, and on August 13, 2012, met with a DEA Diversion Investigator (DI). Tr. 102. Two days after the meeting, the mother of another of Respondent's patients (J.L.H.) contacted the Lapeer Police and reported that she had taken her daughter to see Respondent the day before and that he had issued her prescriptions for methadone, tramadol and clonazepam. Id. at 102-03. However, the day after J.L.H. saw Respondent, her mother reported that she was unable to contact J.L.H. at her residence and could not get her to answer the door; she thus requested the assistance of the police. Id. at 103. The Detective testified that ``[a] neighbor had climbed up on the roof and looked through a second story window and observed [J.L.H.] on the couch unresponsive.'' Id. A police officer entered J.L.H.'s home and found her ``blue in color and unresponsive.'' Id. J.L.H. was taken to the hospital. Id. Several months later, the Detective obtained a warrant to search Respondent's Lapeer office for several patient charts, and on March 26, 2013, the Lapeer Police Department, DEA, and members of the Thumb Narcotics Unit (a local multijurisdictional task force) executed the warrant. Id. at 104. However, the Detective and the DI decided to interview Respondent, who was at his Davidson office, prior to searching his Lapeer office. Id. During the search of the Lapeer office, the Detective determined that several of the patient files that were being sought under the warrant were not at that office. Id. at 105. Accordingly, the Detective obtained an amended warrant, which authorized searches of Respondent's Flint and Davidson offices. Id. The records were subsequently seized and provided to the DI, who had them scanned. Id. The Government also called the DI who worked with the Detective on the investigation. The DI testified that she obtained MAPS reports for Respondent and found that they showed that he prescribed ``a lot of combinations of prescriptions for [m]ethadone, [h]ydrocodone, and . . . [a]lprazolam'' and that the patients were ``getting them on a regular basis.'' Id. at 146. The DI also testified that when alprazolam is taken with methadone or hydrocodone, ``it enhances the effect of the narcotic causing somewhat of a heroin-type high.'' Id. at 147. The DI further testified that she participated in the execution of the search warrant and that she assisted in the seizure of patient charts and conducted employee interviews. Id. at 149. According to the DI, she determined what charts to seize by reviewing MAPS data and conducting ``criminal history searches to determine what patients were known to be drug seekers or had a positive criminal history.'' Id. The DI testified that ``many of the charts contained information that [showed] that the patients were not taking the controlled substances as they had been prescribed, or that they had drug addiction issues, or they were narcotic dependent, or any of a number of red flags that were indicated in the charts, and then we sent the patient charts out for expert review.'' Id. at 156-57. The DI explained that there were ``instances where the patient was coming [back] before the 30-day[s] had expired, and were [sic] obtaining additional prescriptions for the same medication or,'' the patients were ``obtaining refills of a prescription that had refills written on [it] prior to the time [that] they should have used [ ] the medication up if they were taking it as directed.'' Id. at 157. The DI testified that the patient records included evidence that pharmacies had called Respondent raising issues of whether the patients ``were doctor shopping or obtaining refills early.'' Id. at 158. The DI also testified that the files contained ``reports from the State alerting [Respondent] about medication issues that they wanted him to be aware of'' regarding ``his prescribing of certain drugs,'' as well as ``police reports'' and ``hospital reports on several patients indicating that they had a history of drug abuse or they had been admitted for a drug-related issue.'' Id. The DI testified that she provided Dr. Eugene Mitchell, Jr., with the files of the five patients at issue in this proceeding and asked him to review the files and identify examples of Respondent's issuance of controlled substance prescriptions outside of ``the usual course of medical practice'' and which lacked a legitimate medical purpose. Id. at 160. According to the DI, these specific charts were selected for review by Dr. Mitchell because ``the findings in these files . . . were [[Page 8226]] egregious'' and four of the five patients were deceased. Id. at 160- 61.\9\ --------------------------------------------------------------------------- \9\ In addition to obtaining each patient's medical file, the DI used the MAPS data to obtain copies of the original prescriptions from the various pharmacies. --------------------------------------------------------------------------- The DI further testified that in reviewing the patient files she found evidence of other violations of the Controlled Substance Act and DEA regulations. Tr. 172-73. These included instances in which Respondent authorized more than five refills on a prescription; instances in which he issued early refills; instances in which he failed to include a patient's address, which is required information on a prescription; and instances in which Respondent post-dated prescriptions. Id. at 173-74. The DI then testified as to the following examples: (1) A Xanax prescription dated Feb. 9, 2013 issued to R.E.H. authorizing six refills (GX 8, at 23); (2) a Klonopin prescription dated August 14, 2012 issued to J.H. authorizing six refills (GX 19, at 117); and (3) a Xanax prescription dated April 10, 2012 issued to R.K. authorizing six refills (GX 17, at 49). Tr. 184-86.\10\ The DI also discussed two examples of prescriptions which Respondent issued to Patient R.E.H. without including his address, and did so even after Respondent had received information that R.E.H., who shared the same first name as his father, had attempted to fill a methadone prescription using his father's name and date of birth. Tr. 182-84; see also GX 8, at 42 (methadone and Xanax prescriptions dated April 19, 2012 with patient's address left blank). --------------------------------------------------------------------------- \10\ The DI also testified regarding two methadone prescriptions Respondent issued to R.E.H. in October 2012, including one which was issued notwithstanding that R.E.H. was a week early, and on which the date of the copy in R.E.H.'s file appears to have been altered. Tr. 175-80. These prescriptions are discussed more fully in the findings regarding Respondent's prescribing to R.E.H. --------------------------------------------------------------------------- The Government Expert's Testimony The Government called Dr. Eugene O. Mitchell, Jr., who testified as an expert on pain management. Dr. Mitchell received a Bachelor of Science in Biochemistry in 1975 from the University of Florida and a Bachelor of Science in Medicine in 1979 from the University of Florida's Physician's Assistant Program. GX 25, at 1. Dr. Mitchell subsequently obtained a Doctor of Medicine in 1985 from the Wayne State University School of Medicine. Id. His post-doctoral training includes an internship in internal medicine and a residency in anesthesiology (both at the University of Illinois), and a fellowship in pain medicine at the University of Michigan. Id. Dr. Mitchell holds a medical license issued by the State of Michigan and is board certified in both anesthesiology and pain medicine. Id. at 2. He is also a member of numerous professional societies including the American Academy of Pain Medicine and the American Society of Regional Anesthesia and Pain Medicine. Id. Since February 2001, Dr. Mitchell has held the position of Clinical Assistant Professor in the Department of Anesthesiology, Division of Interventional Pain Medicine, at the University of Michigan Medical Center. Id. In this position, he lectures medical students on pain medicine and trains fellows in pain medicine as well as residents, interns, and nursing staff. Id. at 3, Tr. 234. He also is active in practice. Id. Dr. Mitchell was qualified as an expert. Id. at 239. Dr. Mitchell testified ``all controlled substances have the risk of significant morbidities including death from overdose,'' ``withdrawal from their use,'' and ``addiction.\11\ '' Id. He testified that to reduce the risks associated with the abuse and diversion of controlled substances, a physician must ``be familiar with the patient's medical history'' and review the patient's records so that the physician has ``a clear understanding'' of the patient's diagnosis. Id. at 240. Also, the physician must review the patient's ``history of abuse'' and ``[a]ny issue of addictive illness,'' whether it involves tobacco, alcohol, and both ``licit'' and ``illicit'' drugs. Id. --------------------------------------------------------------------------- \11\ He also testified that the use of controlled substances presents a risk of developing both renal and hepatic disease. Tr. 239. --------------------------------------------------------------------------- Dr. Mitchell further testified that there are various compliance tools that he uses to determine whether patients are abusing or diverting controlled substances. The first of these is a ``medication agreement'' between the physician and the patient which sets forth the ``criteria that [the patient] will adhere to'' while ``being prescribed controlled substances.'' Id. Dr. Mitchell testified that an essential part of the agreement is ``a clause that allows the physician to ask the patient'' to provide ``a random body fluid sample,'' whether of blood or urine, ``on demand to verify what is or isn't present in'' the patient's body. Id. at 241. Dr. Mitchell explained that a further compliance tool is to use the MAPS, Michigan's controlled substance prescription monitoring program, which allows a physician to obtain a list of the controlled substance prescriptions filled by a patient in the State. Id. Dr. Mitchell also testified that in Michigan, a task force of physicians developed Guidelines for the ``appropriate prescribing'' of controlled substances for the treatment of pain. Id. at 243; GX 26. These Guidelines have been issued by both the Board of Medicine and the Board of Osteopathic Medicine & Surgery. GX 26, at 1. The Guidelines ``recognize that controlled substances, including opioid analgesics, may be essential in the treatment of acute pain due to trauma or surgery and chronic pain, whether due to cancer or non-cancer origins.'' Id. However, the Guidelines caution ``that inappropriate prescribing of controlled substances, including opioid analgesics, may lead to drug diversion and abuse by individuals who seek them for other than legitimate medical use'' and that ``[p]hysicians should be diligent in preventing the diversion of drugs for illegitimate purposes.'' Id. According to the Guidelines, they ``are not intended to define complete or best practice, but rather to communicate what the Board considers to be within the boundaries of professional practice.'' Id. at 2. Dr. Mitchell then testified regarding the ``typical steps taken by doctors in treating patients who suffer from chronic pain.'' Tr. 247. Dr. Mitchell testified that when a new patient seeks treatment, a physician ``take[s] a detailed history'' and asks the patient ``to bring [his/her] records'' including imaging findings. Tr. 247; see also GX 26, at 3-4. Dr. Mitchell explained that a physician ``document[s] what [his/her] chief complaint is'' and why the patient is seeking ``to begin care.'' Tr. 247. Dr. Mitchell testified that the ``standard medical doctoring for a new patient encounter'' includes a ``review of [the patient's] systems'' and ``[a]n appropriately detailed physical examination.'' Id. The physician then makes a diagnosis and creates a treatment plan. Id. The physician also ``modulates the treatment plan'' in accordance with the patient's disease process.\12\ Id. at 248. --------------------------------------------------------------------------- \12\ With respect to the initial evaluation of the patient, the Michigan Guidelines state: A complete medical history and physical examination must be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance. GX 26, at 3. With respect to the creation of a treatment plan, the Guidelines state: The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment. Id. --------------------------------------------------------------------------- [[Page 8227]] Re-emphasizing his earlier testimony, Dr. Mitchell testified that as part of the process of formulating a plan involving the long term prescribing of controlled substances, the physician reviews the medication agreement/opioid contract with the patient and explains that if the patient violates the agreement, the patient will be discharged from the practice.\13\ Id. at 249. Dr. Mitchell further explained that the first time a patient presents with a red flag, regardless of whether the patient has a history of addiction, the red flag should be documented and the patient should be brought in and given the ``opportunity to explain what's going on.'' Id. at 249-50. Dr. Mitchell explained that there is a spectrum of red flags which runs from such incidents as a patient claiming to have lost a prescription but having ``no other infractions,'' to a patient whose ``urine screens are inappropriate'' or whose MAPS report shows they are ``multi sourcing. '' Id. at 250. --------------------------------------------------------------------------- \13\ Relevant to this testimony, the Guidelines state that: [i]f the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the physician may employ the use of a written agreement between physician and patient outlining patient responsibilities, including . . . urine/serum medication levels screening when requested; . . . number and frequency of all prescriptions, refills; and . . . reasons for which drug therapy may be discontinued (i.e., violation of agreement). GX 26, at 3. The Guidelines further advise physicians to periodically ``monitor patient compliance in medication usage and related treatment plans.'' Id. at 4. --------------------------------------------------------------------------- Regarding the five patients identified in the Show Cause Order, Dr. Mitchell testified that he reviewed the patient files including the visit notes, MAPS reports, and copies of the prescriptions which included the pharmacy labels. Id. at 251. Dr. Mitchell testified that he had identified specific prescriptions which he believed were issued outside of the usual course of professional medical practice. Id. at 252. Dr. Mitchell further explained that he has been ``practicing medicine for nearly 30 years,'' and that he is ``familiar with what constitutes general[ly] appropriate behavior regarding prescribing controlled substances.'' Id. The Patient Specific Evidence R.E.H. The Allegations With respect to R.E.H., the Government alleged that from August 5, 2010 through at least March 13, 2013, Respondent repeatedly prescribed controlled substances to the patient even after Respondent knew that R.E.H. ``was engaged in the abuse and/or diversion of controlled substances, as well as prescription fraud.'' ALJ Ex. 1, at 2. Specifically, the Government alleged that Respondent repeatedly prescribed methadone, a schedule II narcotic controlled substance, and other controlled substances to R.E.H., notwithstanding that he presented ``numerous red flags of diversion and/or abuse.'' Id. The allegations included that:R.E.H. repeatedly sought early refills; R.E.H. repeatedly claimed that his prescriptions were lost or stolen; pharmacists repeatedly contacted Respondent's office to report suspicious behavior by R.E.H.; MAPS reports in R.E.H.'s file corroborated reports that R.E.H. and his wife were committing prescription fraud; R.E.H. had been recently released from jail; and hospital records in his file showed that R.E.H. was using illegal drugs. Id. at 2. The Show Cause Order also alleged that R.E.H.'s patient file and the prescriptions issued to him show that Respondent prescribed methadone on R.E.H.'s ``first visit without undertaking other actions typical of medical professionals[,] such as conducting and documenting a complete medical history and physical examination, requiring that R.E.H. (a self-identified addict) sign a pain management contract or undergo a drug test, running a MAPS search on R.E.H., or creating a written treatment plan.'' Id. at 2-3. The Show Cause Order then alleged that Respondent: Never subsequently required R.E.H. to sign a pain management contract; ``repeatedly issued prescriptions to [him] with instructions to take his methadone `PRN'--thus directing that this self-identified addict should take this powerful opioid analgesic (properly used in scheduled dosages) on an `as needed' basis''; issued at least one prescription on a date when R.E.H.'s patient file indicates that he did not have an appointment; notwithstanding that he knew that R.E.H. was attempting to fill the prescriptions using his father's birthdate to avoid being detected, Respondent did not take the minimal preventative step of including R.E.H's address on his methadone prescriptions as required by state and federal law; issued a prescription for Xanax to be refilled six times, in violation of state and federal law; and falsified records to post-date a methadone prescription in order to provide R.E.H. with an early refill in violation of state and federal law, circumventing the efforts by his staff noting that an early refill should not be issued. Id. at 3. The Evidence On August 5, 2010, R.E.H. made his first visit to Respondent. Tr. 254; GX 8, at 143. According to his medical record, R.E.H.'s chief complaint was back pain. Tr. 256; GX 8, at 143. R.E.H. also reported a history of abusing heroin, which is a ``significant addictive illness history,'' Tr. 257, as well as tobacco abuse and that he was taking methadone; however, there is no indication that Respondent determined how much methadone R.E.H. was taking, which according to Dr. Mitchell was ``a critical bit of information . . . because methadone . . . is approximately five times as potent as morphine.'' Id. at 256. Dr. Mitchell also explained that Respondent did not determine if R.E.H.'s heroin abuse, which he characterized as a ``significant addictive illness history'' was ``currently active'' and whether he had gone (or was going to rehabilitation) for it. Id. at 257. Dr. Mitchell further found that Respondent's physical examination was ``very cursory for a new patient'' as he did not conduct neurological and spinal examinations. Id. at 256. He also did not require that R.E.H. sign a medication contract, id. at 257-58, even though he prescribed 30 tablets of methadone 10, with a dosing instruction of TID or one tablet, to be taken three times per day. Id. at 255. Dr. Mitchell opined that this prescription was not issued in the usual course of medical practice. Id. I agree. Even though the prescription should have lasted for ten days, R.E.H. returned to Respondent only six days later and obtained a new prescription, which was for 90 tablets of methadone, TID (three times a day). Id. at 258-59. Dr. Mitchell testified that this was an early refill and thus required that Respondent ask R.E.H. why he needed to refill his prescription four days early and document the reason he needed the early refill. Tr. 259-60. Dr. Mitchell thus found that the prescription was not [[Page 8228]] issued in the usual course of medical practice. Id. at 259. He further explained that R.E.H.'s seeking of the refill was a matter of concern because of R.E.H.'s history of drug abuse.\14\ Id. at 260. --------------------------------------------------------------------------- \14\ The transcript includes a question by Government's counsel which suggests that R.E.H.'s second visit occurred on October 11, 2010. See Tr. 260, at Ls 5-6. However, R.E.H.'s medical record includes a progress note for August 11, 2010 and contains no note for an October 11, 2010 visit. See GX 8, at 140-42 (progress notes for visits of Aug. 11, Sept., 21, and Oct. 13, 2010). --------------------------------------------------------------------------- R.E.H.'s third visit occurred on September 21, 2010. Tr. 262. The progress note documents, however, that R.E.H. was ``just release [sic] from jail'' and that he had been in jail ``15 days.'' GX 8, at 141; Tr. 262. The note further states that R.E.H.'s methadone dose was increased to 10 mg five times a day for two weeks, suggesting that this had occurred when he was in jail. Id. The note also states: ``methadone x 6 months Heroin addiction.'' GX 8, at 141. Respondent issued R.E.H. a prescription for 90 pills of methadone 10, TID. Id. While this should have provided a 30-day supply and thus lasted until October 21, R.E.H. returned to Respondent on October 13, eight days early, and obtained a new prescription for 90 tablets of methadone 10. Tr. 263-64. Dr. Mitchell testified that R.E.H. was manifesting a pattern of seeking early refills and Respondent's issuance of the prescriptions was not within the usual course of medical practice because there was ``no documentation'' that Respondent engaged R.E.H. ``as to why this is going on.'' Id. at 265. Moreover, Respondent did not attempt to determine if R.E.H. was ``even taking the medication'' by demanding that he provide ``a urine sample.'' Id. He also did not obtain a MAPS report. Id. R.E.H. returned to Respondent on November 1, 2010. GX 8, at 139. While R.E.H. was 11 days early, Respondent issued him another prescription for 90 tablets of methadone 10 with the same dosing instruction. GX 8, at 139; Tr. 266. While R.E.H. was not early at his next visit (November 30), when he again obtained a prescription for 90 methadone 10 (one tablet TID, or three times per day), he returned to Respondent on December 23, and obtained a new prescription, which he increased to 120 tablets (TID) even though he was a week early. Tr. 266-67; GX 8, at 137-38; GX 15, at 15-16. According to Dr. Mitchell, none of the prescriptions Respondent issued in November-December 2010 were issued in the usual course of professional practice. Tr. 268. However, Respondent did not require that R.E.H. sign a pain contract until apparently December 23, 2010.\15\ Tr. 270-71; GX 8, at 242. --------------------------------------------------------------------------- \15\ The date does not, however, include the year. GX 8, at 242. --------------------------------------------------------------------------- R.E.H. returned on January 4, 2011. GX 8, at 136; GX 15, at 17. Even though R.E.H. was 18 days early, and notwithstanding that the pain contract required him to use his ``medicine at a rate no greater than the prescribed rate'' and stated that if he used it at a greater rate, he would be ``without medication for a period of time,'' GX 8, at 242; Respondent issued him another prescription for 90 tablets of methadone 10 with a dosing instruction of TID and PRN (take as needed). GX 8, at 136; GX 15, at 17. Dr. Mitchell testified that this prescription was not issued in the usual course of professional practice and that the usual course of professional practice would be to discharge a patient seeking a prescription two weeks early. Tr. 269. He also testified that it is not in the usual course of medical practice to prescribe methadone with a dosing instruction of PRN because the drug ``has [a] very long half-life'' and ``takes a while . . . to enter the blood'' stream, and the reason the drug is used for pain is to provide ``a stable blood level'' of medication. Id. at 274. Respondent did not, however, discharge R.E.H., who returned on January 26, 2011. GX 8, at 135. Notwithstanding that R.E.H. was eight days early, Respondent issued him a new prescription and increased the quantity to 120 pills and the dosing to four tablets per day. GX 15, at 19-20. Dr. Mitchell testified that this prescription was also not issued within the usual course of medical practice. Tr. 270. An entry in R.E.H.'s medical record documents that on February 15, 2011, a pharmacy called and reported that R.E.H. had tried to fill three prescriptions for 120 tablets of methadone in less than one month. GX 8, at 18. The note documented that on January 26, 2011, R.E.H. had filled one such prescription at a different pharmacy using insurance, and that on February 1, 2011, he had filled the second prescription at a second pharmacy paying cash. Id. Moreover, on February 15, R.E.H. had attempted to fill a third prescription at still another pharmacy but was denied, after which he took it to the pharmacy that called Respondent's office. Id. Dr. Mitchell testified that ``this is obviously very concerning behavior'' and that a doctor acting the usual course of medical practice would summon the patient and ask for an explanation. Tr. 276- 77. He further testified that it would ``[a]bsolutely not'' be within the usual course of professional practice to issue a new prescription for a controlled substance in these circumstances. Id. at 277. R.E.H.'s file includes a MAPS report which was obtained on the morning of February 17, 2011, two days after the Respondent's office was notified that R.E.H. had filled two prescriptions since January 26 and had attempted to fill a third. GX 8, 236. The MAPS report corroborated the pharmacy's report and showed that R.E.H. had managed to fill Respondent's January 26 prescription on both that date and on February 1, 2011 at two different pharmacies. Id. Of further note, various entries for these two dispensings are circled, thus indicating that someone reviewed them. Id. Dr. Mitchell testified that this raised ``another obvious problem with [R.E.H.'s] compliance,'' and that given his ``known history of heroin abuse . . . appropriate medical care would dictate engaging the patient in this behavior,'' followed by ``discharging'' him and urging him ``to go to rehabilitation.'' Tr. 279. While R.E.H. saw Respondent on both February 17 and 22, 2011, there is no evidence that Respondent even addressed R.E.H.'s drug-seeking behavior, let alone discharged him. Id. at 280-81; see GX 8, at 132-33. While Respondent did not prescribe methadone to R.E.H. at any of his three visits in February 2011, Tr. 281, on March 2, he issued R.E.H. a new prescription for 120 methadone 10, a 30-day supply based on the dosing instruction (QID and PRN). GX 8, at 131; GX 15, at 25. Yet only 21 days later on March 23, Respondent issued to R.E.H. another prescription for 120 methadone 10 (also QID and PRN), and only six days later on March 29, Respondent issued him a prescription for 90 more methadone 10 (TID). Tr. 282; GX 15, at 27-30. Dr. Mitchell testified that there was no justification in R.E.H.'s chart for Respondent's issuance of prescriptions, which authorized the dispensing of a three-month supply of the drug. Tr. 283. He also testified that these prescriptions were not issued in the usual course of professional practice. Id. The evidence further shows that on June 2, 2011,\16\ Respondent issued to [[Page 8229]] R.E.H. a prescription for 100 tablets of methadone 10 QID. GX 15, at 37-38. This was followed by additional prescriptions for 120 tablets of methadone 10 QID on June 16, July 12, July 14, August 9, and August 23, 2011. Id. at 41-42, 45-46, 47-48, 51-52, 53-54. The June 16 prescription was 11 days early, and while the July 12 prescription was only four days early, as Dr. Mitchell testified, the July 14 prescription was 28 days early. Tr. 284-85. Moreover, the August 9 prescription was also early, and the August 23 prescription was 16 days early. Id. at 286. Yet there is no progress note for the August 23 prescription and no entry in the log used to document various activities. GX 8, at 15-20 (log entries); id. at 120-21 (progress notes for Aug. 9 and Sept. 13, 2011, but not Aug. 23). Dr. Mitchell testified that Respondent's issuance of the early methadone refills during the June through August period was not within the usual course of professional practice. Id. at 287. --------------------------------------------------------------------------- \16\ While the Government did not ask Dr. Mitchell about the methadone prescriptions issued in April and May 2011, the pattern of early refills continued, as on April 20, 2011, Respondent issued R.E.H. a new prescription for 90 methadone 10 TID, this being eight days early (ignoring that R.E.H. had also obtained methadone on March 23). GX 15, at 31-32. Thereafter, on May 10, 2011, Respondent issued R.E.H. a prescription for 120 methadone QID, this being 10 days early. Id. at 33-34. Thus, the June 2 prescription was one week early. --------------------------------------------------------------------------- R.E.H.'s patient file also includes copies of two prescriptions for 120 Vicodin ES (QID), which were dated November 17 and 22, 2011. GX 8, at 191-92. The document bearing the November 17 prescription includes the notation: ``Please verify--just filled this RX on 11/17 for 30 day supply--then the follow[ing] RX was brought in 11/23/11.'' Id. at 192. The document further asked: ``please call Walmart'' and included the notation of ``suspicious RX.'' Id. Dr. Mitchell testified that ``as a stand-alone incident it's very concerning'' because ``[i]t smacks of prescription forgery.'' Tr. 288. However, in R.E.H.'s case, it was ``just another incident . . . in his history that just masked a horrible addictive illness, diversion or both.'' Id. at 288-89. Dr. Mitchell then explained that a physician's ``primary concern'' is the welfare of his/her patients, and a physician ``need[s] to protect them from their addictive illness and document it and refer them to a'' detoxification facility and not just ``feed'' their addiction ``by continuing to write medications.'' Id. at 289. R.E.H.'s patient file also includes a MAPS report which Respondent obtained on December 9, 2011. GX 8, at 185-90. The report showed that during the months of October and November 2011, R.E.H. had filled six prescriptions for 120 methadone 10 (with four of the prescriptions having been filled between Nov. 10 and 29) and that R.E.H. had used four different pharmacies. Id. at 185-86. However, R.E.H.'s patient file includes progress notes only for visits on October 10 and November 11. Id. at 116-119. Notably, each of the prescriptions listed on the first page of the report has check marks and Respondent's initial/ signature \17\ is on the page, thus establishing that Respondent reviewed the document. Id. at 185. --------------------------------------------------------------------------- \17\ This initial/signature is the same as that used on the numerous prescriptions contained in the record. --------------------------------------------------------------------------- Dr. Mitchell testified that the report would indicate ``[g]reat concern for what's going on'' to a doctor acting in the usual course of medical practice as it showed that R.E.H. was ``[o]btaining hundreds of tablets of methadone.'' Tr. 291. The report also showed that R.E.H. had obtained other controlled substances (alprazolam and hydrocodone) from two additional pharmacies during these two months. GX 8, at 185-86. Thus, R.E.H. had used a total of six pharmacies. Id.; Tr. 291-92. The evidence also showed that Respondent was prescribing methadone and other controlled substances (alprazolam and hydrocodone) to R.S.H., who was R.E.H.'s wife, and that he obtained a MAPS report on her only minutes after obtaining the MAPS report on R.E.H. GX 13, at 161-68. The MAPS report showed that between October 11, 2011 and November 28, 2011, R.S.H. filled seven prescriptions for 120 methadone 10, four prescriptions for 90 alprazolam (in either .5 or 1 mg dose), and prescriptions for 90 and 120 hydrocodone 7.5. Id. at 161-63. Notably, the MAPS reports listed the same address for R.S.H. and R.E.H. Compare GX 13, at 161; with GX 8, at 185. Regarding this information, Dr. Mitchell testified that ``the concerns speak[ ] for itself [sic]. There's something very troublesome and potentially life threatening going on here with multitudes of refills, repeated incidents,'' given ``there's some indication that they're cohabiting together and have the same last name.'' Tr. 294-95. Dr. Mitchell then testified that it was not within the usual course of professional practice to continue writing methadone and other controlled substance prescriptions given these circumstances. Id. at 295. However, Respondent did not stop issuing methadone and other controlled substance prescriptions to R.E.H. after he learned of this. Id. at 295. Instead, on both December 21 and 22, 2011, Respondent issued R.E.H. two more prescriptions for 120 methadone 10, and he continued issuing methadone prescriptions to R.E.H. for another 15 months. GX 15, at 87-90, 155-56. Moreover, on February 29, 2012, Respondent's office received a phone call from a pharmacy, which reported that R.E.H. was using his father's birthdate to fill the prescriptions. GX 8, at 43. The pharmacy also reported that it had called R.E.H.'s father who stated that ``he doesn't receive [sic] this script.'' Id. As Dr. Mitchell testified, this was evidence that R.E.H. was forging prescriptions. Tr. 296; see also 21 U.S.C. 843(a)(3) (rendering it unlawful to ``knowingly or intentionally . . . acquire . . . a controlled substance by misrepresentation, fraud, forgery, deception, or subterfuge''). Asked whether it was appropriate for Respondent to continue to issue controlled substance prescriptions to R.E.H., Dr. Mitchell answered: ``[a]bsolutely no.'' Tr. 297. Yet, on March 6, 2012, Respondent issued another prescription to R.E.H. for 120 methadone 10.\18\ GX 15, at 107. --------------------------------------------------------------------------- \18\ There is, however, no progress note for this visit. See GX 8, at 113-14 (notes for visits of Mar. 22 and Feb. 28, 2012 but not for Mar. 6). --------------------------------------------------------------------------- On July 12, 2012 (in the interim, Respondent had continued issuing prescriptions for 120 methadone 10 to R.E.H., several of which were early \19\), Respondent obtained another MAPS report showing the controlled substance prescriptions filled by R.E.H. GX 8, at 204-12. The report includes the handwritten notation of ``was not seen on this day'' in 14 separate entries for methadone prescriptions which list Respondent as the authorizing practitioner.\20\ See id. at 204-09. The report also bears Respondent's signature on the first page. Id. at 204. Dr. Mitchell explained that these entries ``typically mean[ ]'' either that Respondent was issuing the prescriptions without seeing R.E.H. or that R.E.H. had stolen a prescription pad. Tr. 299. Yet Respondent issued R.E.H. still more prescriptions for 120 methadone 10 on July 24, August 15, September 18, and October 8, 2012, as well as a prescription for 60 methadone 10 on September 4; each of the last four prescriptions was early. GX 15, at 125-36. --------------------------------------------------------------------------- \19\ The prescriptions were issued on March 22, April 19, May 15, June 6, and June 26. GX 15, at 109-24. Each of the prescriptions was for a 30-day supply, and thus the March 22, June 6, and June 26 prescriptions were early. \20\ The ``was not seen on this day'' notations are also written in entries for an alprazolam prescription (filled on 1/3/12) and for two hydrocodone prescriptions (filled on 12/30/11 and 11/19/11). GX 8, at 207, 209. --------------------------------------------------------------------------- The evidence further shows that even when Respondent's nurse noted in R.E.H.'s file that R.E.H. was seeking an early refill, Respondent nonetheless issued a post-dated prescription to him. As found above, the evidence shows that on October 8, 2012, Respondent [[Page 8230]] issued R.E.H. a prescription for 120 methadone 10.\21\ GX 8, at 32. However, a progress note for an October 29, 2012 visit includes a nurse's note stating: ``med refills--Ibuprophen--asked for methadone, last refill 10/8/12.'' Id. at 100. Also, a note in a log dated October 30, 2012 states: ``Pt requests a refill on methadone--and last refill was 10/8/12--not time yet.'' Id. at 15. A MAPS report obtained by the Government shows that R.E.H. filled two methadone prescriptions with an issue date of October 8, 2012--one on October 8th, the other on October 30th. GX 20, at 14; see also GX 15, at 135-36 (Rx filled on Oct. 8); id. at 137-38 (Rx filled on Oct. 30). Not only was the second prescription post-dated--a violation of 21 CFR 1306.05(a) which requires that ``[a]ll prescriptions for controlled substances shall be dated as of, and signed on, the day when issued''--it was also another early refill which should not have been filled. Tr. 301 (testimony of Dr. Mitchell). --------------------------------------------------------------------------- \21\ Here again, there is no progress note for this visit. See GX 8, at 100-101 (progress noted for visits on Oct. 3 and 29, 2012). However, a copy of the prescription is in R.E.H.'s patient file. --------------------------------------------------------------------------- On December 12, 2012, R.E.H. was admitted to a hospital after he overdosed on Seroquel. GX 8, at 158. While in the hospital, R.E.H. provided a urine drug test which was positive for cocaine. Id. He also was diagnosed as ``polysubstance dependen[t].'' Id. at 159. A copy of the hospital report was provided to Respondent and bears his signature. Id. at 158. Dr. Mitchell testified that upon learning that R.E.H. was using cocaine, the appropriate response was to refer him to inpatient drug rehabilitation as R.E.H. ``obviously'' had ``a life threatening illness manifested by his addicting behavior'' as well as to cease prescribing controlled substances to him. Tr. 303. Asked by the Government whether there ever was a point at which Respondent should have stopped writing controlled substance prescriptions to R.E.H., Dr. Mitchell testified: The short answer is yes. But the whole format of the care is so appalling that he never had a drug contract in the beginning and it's just one infraction after another. So if you had started from the very beginning, the patient already told you that he has a history of heroin abuse. So if you were to make the decision to treat his . . . back pain . . . there has to be documentation. Discussing with the patient about concerns regarding his illness, contract agreed upon and . . . random urine samples as well as MAPS surveys being pulled. In my opinion, in this case, after the second early refill, he'd be discharged from the practice. With the option to go to rehabilitation. You can't just let him go off and not have some kind of aftercare. I mean--he's a very sick individual . . . regarding his addictive illness. Id. at 303-04. Yet even after the December 12, 2012 hospitalization, Respondent continued to issue more methadone prescriptions to R.E.H. See GX 15, at 143 (Rx of 12/27/12); 145 (Rx of 1/22/13); 149 (Rx 2/19/ 13); 155 (Rx 3/13/13). Moreover, on February 19, 2013, Respondent issued R.E.H. a prescription for 90 Xanax with six refills.\22\ GX 15, at 151. --------------------------------------------------------------------------- \22\ However, the pharmacy apparently caught the fact that Respondent had provided too many refills, and noted that only five refills were authorized. GX 15, at 152. Following Dr. Mitchell's testimony, Respondent testified on his own behalf. After acknowledging that he had listened to all of Dr. Mitchell's testimony, Respondent was asked by his counsel if Dr. Mitchell is ``right or wrong about you ignoring the red flags about patients who are or could be abusing or diverting drugs?'' Tr. 484. Respondent answered: ``He's right.'' Id. Subsequently, the ALJ asked Respondent if he (the ALJ) was ``correct in understanding that you've read the order to show cause?'' Id. 535. Respondent answered: ``I did.'' Id. The ALJ then asked Respondent: ``Do you agree that the facts that they allege there are all true?'' Respondent answered: ``I did.'' Id. The ALJ followed up by asking: ``Your answer was yes you do?'' Id. Respondent answered: ``Yes.'' Id. I find (as did the ALJ) that Dr. Mitchell provided credible testimony that Respondent ignored multiple red flags that R.E.H. was abusing and diverting controlled substances and that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice when he continued to prescribe methadone and other drugs in the face of the red flags. While this alone constitutes substantial evidence to support a finding that Respondent violated 21 CFR 1306.04(a) and 21 U.S.C. 841(a)(1) in prescribing to J.E.H., this conclusion is buttressed by Respondent's testimony that Dr. Mitchell was ``right'' when he testified that Respondent ignored multiple red flags. J.W. The Allegations The Show Cause Order alleged that from December 23, 2010 through January 4, 2012, Respondent ``repeatedly prescribed controlled substances after [he] came to know that J.W. was engaged in the abuse and/or diversion of controlled substances.'' ALJ Ex. 1, at 3. Specifically, the Show Cause Order alleged that Respondent repeatedly prescribed controlled substances to J.W. notwithstanding numerous red flags of diversion and/or abuse. Id. These included that: J.W. repeatedly sought early refills; the Michigan Medicaid program notified Respondent that J.W. was doctor-shopping; a pharmacy also notified Respondent that J.W. was doctor- shopping; J.W. was incarcerated; J.W. exhibited withdrawal symptoms; and a MAPS report obtained by Respondent in October of 2011 showed that J.W. was engaged in a persistent pattern of doctor and pharmacy shopping. Id. The Show Cause Order also alleged that J.W.'s patient file and the prescriptions issued to him show that Respondent: Prescribed Adderall, a schedule II stimulant, to J.W. on his first visit without diagnosing him with Attention Deficit Disorder (ADD), and that he prescribed other controlled substances without taking actions typical of medical professionals such as conducting and documenting a complete medical history and physical examination, or creating a written treatment plan; prescribed numerous controlled substances to J.W. without conducting a MAPS search ``that a typical Michigan doctor would have conducted,'' and that such a search would have shown that J.W. was engaged in ``a dangerous pattern of doctor and pharmacy shopping (through which J.W. obtained 11 monthly prescriptions for Adderall within the first six months of 2011)''; prescribed methadone to J.W. with a PRN (take as needed) dosing instruction ``within a week of meeting him and repeatedly thereafter''; ``never subjected J.W. to any drug tests''; and ``took no action to enforce the pain management contract that J.W. signed on his first visit, in which [J.W.] committed (among other things) to obtain controlled medications from only one provider (Respondent), fill them at one pharmacy, and take them at the prescribed dosages.'' Id. at 3-4. The Evidence J.W. first saw Respondent on December 23, 2010. GX 9, at 42. [[Page 8231]] According to a nurse's notation on the progress note, J.W. was seeking treatment for pain. Id. Respondent prescribed to J.W. 60 tablets of Adderall 20, with a dosing instruction of BID or one tablet to be taken twice a day. GX 16, at 1. One week later, J.W. returned to Respondent, who wrote him a prescription for 90 tablets of methadone 5, with a dosing of TID and PRN. Id. at 3. Dr. Mitchell testified that neither prescription was issued in the usual course of professional practice. Tr. 308. As for the Adderall prescription, Dr. Mitchell explained that the drug is ``typically'' prescribed to treat ADD (Attention Deficit Disorder) or ADHD (Attention Deficit Hyperactivity Disorder). Id. Dr. Mitchell explained that neither J.W.'s chief complaint nor history ``would indicate an appropriate diagnosis for the prescribing of Adderall.'' Id. Dr. Mitchell also observed that Respondent's assessment and plan also contained ``no indication of any appropriate diagnosis for'' Adderall. Id. Reviewing the notes for the first visit, Dr. Mitchell also questioned whether Respondent had performed a physical exam, as in the space on the progress note for listing the exam findings, Respondent had scribbled ``an S.'' GX 9, at 42. Regarding the notation, Dr. Mitchell testified that ``I don't know what that signifies.'' Id. at 309. While Dr. Mitchell also noted that the margin of the progress note included a listing of various areas with boxes in which Respondent wrote either plus or minus signs, he further testified that he was ``not sure what they're trying to communicate.'' Id. Dr. Mitchell testified that it was inappropriate for Respondent to issue the methadone prescription at J.W.'s second visit. Id. Asked to explain why, Dr. Mitchell testified that: There's no documentation that the patient is having any findings based on physical examination that would serve as a foundation for prescribing [me]thadone. Even though the records are reviewed, I don't see any documentation where it states the patient had previously taken [m]ethadone or was on any analgesics whatsoever. And then there's some notation that's very hard to make out, it says something Vicodin. I can't really read it, but it's in the middle of the HPI box. I'm not really sure what it's trying to communicate. Whether it's regarding prior Vicodin prescription or what. So it's really not legible. Id. at 309-10. As he testified regarding Respondent's prescribing to R.E.H., Dr. Mitchell re-iterated that it was not appropriate to prescribe methadone for pain on a PRN basis. Id. J.W.'s file includes a fax of a ``Notice of Prior Authorization Determination,'' which Respondent received from the Michigan Medicaid program on or about January 21, 2011. GX 9, at 69. The form noted that a prior authorization request had been received and provided the name of another physician (Dr. M.) who had prescribed Adderall to J.W.; it also listed a pharmacy other than the one which J.W. had listed on the Pain Management Agreement he entered into at his first visit with Respondent. Compare GX 9, at 69; with id. at 70. As Dr. Mitchell explained, this is ``evidence that . . . J.W. [wa]s multi-sourcing for amphetamine from another physician.'' Tr. 311. However, in the Pain Management Agreement, J.W. had agreed that he would ``not attempt to obtain controlled medicine, including . . . stimulants . . . from any other doctor, provider or facility.'' GX 9, at 70; see also Tr. 312. While the Pain Management Agreement also stated that if J.W. broke the agreement, Respondent would stop prescribing controlled substances and discharge him, Respondent did not do so. See GX 9, at 70. Dr. Mitchell further explained that upon learning that J.W. was obtaining Adderall from another doctor, Respondent should have engaged J.W. and obtained an explanation for why he was obtaining prescriptions from two different doctors and documented the encounter. Tr. 313. Respondent, however, did not do this. Id. at 314 (GX 9, at 39). Instead, he issued J.W. another prescription for 60 Adderall. Tr. 314; ALJ Ex. 50, at 2; GX 16, at 7-8. Asked whether Respondent's issuance of the prescription was within the usual course of professional practice, Dr. Mitchell answered ``no'' and added that ``[t]he whole beginning for the prescriptions of Adderall were not issued in the course of legitimate methods of practice.'' Tr. 314-15. On February 16, 2011 (22 days later), J.W. again saw Respondent. GX 9, at 38. Respondent wrote J.W. a new prescription for 60 Adderall even though he was eight days early. Tr. 315. Respondent also wrote J.W. a prescription for 120 methadone 10. GX 16, at 11. However, only two days later (Feb. 18), Respondent's office received a phone call from a pharmacy reporting that insurance would not cover J.W.'s methadone prescriptions and that he was seeing Dr. M. who was prescribing Suboxone to him--Dr. M. being the same doctor listed as the medical provider on the prior authorization request form Respondent had received from the Michigan Medicaid program. Compare GX 9, at 4; with id. at 69. Thus, J.W. was simultaneously obtaining prescriptions for both methadone and Suboxone, which according to Dr. Mitchell ``is not done.'' Tr. 316. Dr. Mitchell testified that in response to this information, the appropriate course would be to discharge the patient and recommend that he go to inpatient drug rehabilitation. Id. at 316. Dr. Mitchell testified that he would ``have called the other physician'' to tell him/her that J.W. was engaged in ``potentially . . . life threatening'' behavior. Id. Yet there is no evidence in J.W.'s file that Respondent did this. Id. On both March 16 and April 6, 2011, Respondent wrote J.W. additional prescriptions for 60 Adderall. GX 16, at 21-22; id.at 25-26. According to Dr. Mitchell, J.W. was a week early when he received the April 6 prescription.\23\ Tr. 317. Dr. Mitchell explained that J.W.'s early refills and doctor shopping was ``a continued obvious flag to the physician that there's something going on here that can potentially put the patient's life at risk.'' Id. --------------------------------------------------------------------------- \23\ Actually, he was nine days early. --------------------------------------------------------------------------- The evidence also shows that in the first six months of 2011, Respondent wrote J.W. six prescriptions for 60 Adderall.\24\ GX 21, at 19-25. Dr. Mitchell testified that these prescriptions were not issued in the usual course of professional practice. Tr. 317-18. --------------------------------------------------------------------------- \24\ While Dr. Mitchell testified that 10 prescriptions were issued to J.W. in this period, three of them were issued by Dr. M., the other by a Dr. R. GX 21, at 19-25. --------------------------------------------------------------------------- The evidence further shows that Respondent issued to J.W. prescriptions for 60 Adderall 30 (BID) and 120 Klonopin (QID) on both July 6 and 26. GX 16, at 41-52. According to Dr. Mitchell, both of the July 26 prescriptions were ``approximately a week early'' (actually, they were 10 days early), and there was no justification in the patient file for issuing the prescription when Respondent did. Tr. 318. On October 25, 2011, Respondent received a fax from the Medical Department of the Lapeer County Jail. The fax stated that J.W. was an inmate and requested information as to his prescriptions and diagnosis. GX 9, at 47. Respondent reported that J.W. was on methadone for chronic pain and Adderall for EDS and ADD. Id. at 47. The same day, Respondent obtained a MAPS report on J.W. GX 9, at 48-51; 79-83. The report showed that J.W. was still obtaining controlled substance prescriptions for Suboxone and Adderall from Dr. M., while also [[Page 8232]] obtaining prescriptions for methadone, hydrocodone and Adderall from Respondent. See id. As found above, while J.W. was incarcerated, his niece contacted Respondent and told him that J.W. had ``nearly died from withdrawal'' and that he was selling his medications; she also asked him to stop prescribing controlled substances to J.W. Tr. 128-29. Dr. Mitchell explained that under these circumstances, he would confront the patient regarding whatever the family reported and ``let the patient react and respond.'' Tr. 323. J.W. did not see Respondent again until December 21, 2011. GX 9, at 25. Regarding the progress note for the visit, Dr. Mitchell testified that ``the physical exam is really nothing, it says awake and stable.'' Tr. 324. As for J.W.'s chief complaint, Dr. Mitchell testified that Respondent's writing was illegible. Id.; see also GX 9, at 25. Respondent did not issue any prescriptions to J.W. on this day.\25\ ALJ Ex 50, at 3. --------------------------------------------------------------------------- \25\ However, on October 18, 2011, J.W. had filled an Adderall prescription which Respondent had written for him on the same day. GX 16, at 57-58. --------------------------------------------------------------------------- J.W. returned on January 4, 2012. On the progress note, Respondent lined through a box next to the words stating ``substance abuse +, reviewed w/patie[nt].'' GX 9, at 24. However, the progress note is otherwise illegible. See id. Also, Respondent resumed prescribing controlled substances to J.W., issuing him prescriptions for 30 tablets of Valium 10 mg and 120 tablets of Tylenol with Codeine No. 4. ALJ Ex 50, at 3. On January 19, 2012, J.W. made his final visit to Respondent and obtained a prescription for 120 tablets of methadone 10 with a dosing instruction of QID and PRN. Tr. 325; GX 16, at 59-60. Asked whether the prescription was issued in the usual course of professional practice, Dr. Mitchell answered ``no.'' Tr. 325. Asked ``why not,'' Dr. Mitchell explained: ``[w]ell again, the same basis. Where is the justification, based on the patient['s] clinical complaints, a detailed examination, a clear diagnosis that [m]ethadone was justified.'' Id. As for at what point during his treatment of J.W. Respondent should have refused to prescribe controlled substance and discharged him, Dr. Mitchell answered: Again, it would be early on with the early refills. The behavior that is an obvious flag by the patient for addiction illness. Which he has a history of. History of drug abuse is documented in the chart. Id. at 326. As found above, Respondent testified that he had listened to all of Dr. Mitchell's testimony. Respondent was then asked by his counsel if Dr. Mitchell is ``right or wrong about you ignoring the red flags about patients who are or could be abusing or diverting drugs?'' Tr. 484. Respondent answered: ``He's right.'' Id. Based on Dr. Mitchell's credible testimony, I find that the controlled substance prescriptions Respondent provided to J.W. lacked a legitimate medical purpose and were issued outside of the usual course of professional practice and violated the CSA. 21 CFR 1306.04(a); 21 U.S.C. 841(a)(1). This finding is buttressed by Respondent's admission that Dr. Mitchell was correct in his criticism that he ignored red flags. R.K. The Allegations The Show Cause Order alleged that from January 27, 2011 through July 17, 2012, Respondent repeatedly prescribed controlled substances to R.K. after Respondent knew that R.K. was engaged in the abuse and/or diversion of controlled substances. ALJ Ex. 1, at 4. The Show Cause Order specifically alleged that Respondent repeatedly prescribed to R.K. controlled substances despite the numerous red flags of diversion and/or abuse R.K. presented. Id. These included that: R.K. repeatedly sought early refills; Respondent was notified by the Michigan Department of Community Health Drug Utilization Review that R.K. was doctor shopping; a pharmacist contacted [his] office reporting suspicious conduct by R.K.; and two consecutive drug tests on April 10, 2012 and May 8, 2012 showed that R.K. was not taking the methadone that Respondent had prescribed to him. Id. The Show Cause Order also alleged that R.K.'s patient file and the prescriptions issued to him show that Respondent: Prescribed controlled substances to R.K. on his first visit without taking actions typical of medical professionals, such as conducting and documenting a complete medical history and physical examination, or creating a written treatment plan; never required R.K. to sign a pain management contract or ran a MAPS report on him; engaged in a pattern of issuing Xanax prescriptions to R.K. on a near monthly basis that authorized multiple refills, and that while the dosing instructions directed R.K. to take 690 tablets in the 10-month period preceding his death, the prescriptions allowed R.K. to obtain up to 2,250 tablets of Xanax; issued a prescription for Xanax to be refilled six times, in violation of state and federal law; and stopped testing R.K. to determine if he was taking the methadone Respondent prescribed after R.K. tested negative on two consecutive monthly drug tests. Id. at 4-5. The Evidence At the beginning of the Government's examination of Dr. Mitchell about Respondent's prescribing to R.K., the ALJ raised his ``concern about evidence that becomes cumulative at some point in a preceding [sic].'' \26\ Tr. 326. The Government thus did not ask Dr. Mitchell about the prescriptions Respondent issued to R.K. from his first visit (January 27, 2011), through and [[Page 8233]] including R.K.'s visit of October 4, 2011. See id. at 330-36; GX 10, at 52-65. --------------------------------------------------------------------------- \26\ According to the ALJ, ``[t]hat can happen in two ways in this particular preceding [sic]. And one way is that you [the Government] present evidence of many patients and the other way is to present evidence of many forms of failure to treat in a manner that's required in the ordinary course of medical practice.'' Tr. 326-27. Continuing, the ALJ explained that: So far I've heard more than one instance. In fact, multiple instances of prescribing [m]ethadone on a PRN basis, which the witness has told me is inconsistent with medical practice. Not having a complete medical history, not having a physical examination noted in the file, not writing a treatment plan, diagnosing controlled substances without sufficient support in the medical record through objected[sic] testing, imagining [sic] or other data, prescribing controlled substances prematurely before the expiration of the prior prescription, concurrent prescriptions from more than one prescribing source, filling those prescriptions in more than one pharmacy, failure to properly utilize the MAPS data in the record, failure to discharge and failure to enforce the pain medication treatment plan and contract. Id. The ALJ then announced that ``[t]o the extent that proposed testimony is redundant in these fields, I will be sensitive to an objection that the evidence does not have an informative role and becomes less useful to me as it is cumulative at that point.'' Id. The ALJ thus directed the Government to ``tailor your questions appropriately'' and advised Respondent's counsel that ``I will be listening to you for your concern as well.'' Id. at 328. Contrary to the ALJ's understanding, the Government was entitled to put on evidence regarding each and every allegation it had raised in the Order to Show Cause and its pre-hearing statements. That the Government had previously shown that Respondent failed to obtain a complete history and conduct an adequate physical exam, or that he failed to address red flags such as repeated early refill requests or ignored evidence of doctor shopping and the use of multiple pharmacies, etc., with respect to patients R.E.H. and J.W., does not render evidence as to whether he acted in the same manner with respect to the other three patients redundant. Furthermore, notwithstanding that evidence of a single act of diversion can, in appropriate circumstances, support an order of revocation, it is for the Government to decide, in the exercise of its prosecutorial discretion, on the number of patients (and prescriptions) that are necessary to prove its case. --------------------------------------------------------------------------- On October 20, 2011, Respondent issued R.K. a prescription for 60 tablets of Xanax .5 mg, with a dosing instruction of BID or PRN. ALJ Ex. 50, at 3; Tr. 330. The prescription authorized three refills, ALJ Ex. 50, at 3; and based on the dosing instruction, the prescription provided R.K. with a four-month supply of the drug. However, Dr. Mitchell testified that there was nothing in the progress note for this visit which justified providing R.K. with a four-month supply of the drug. Tr. 330. Yet, not even six weeks later on November 29, 2011, Respondent issued R.K. an additional prescription for 60 Xanax .5 mg (BID or PRN), with three refills. ALJ Ex. 50, at 3; Tr. 330. Here again, Dr. Mitchell testified that there was no medical justification in the visit's progress note for providing R.K. with another four-month supply of Xanax. Tr. 330-31. On January 17, 2012, Respondent provided R.K. with another prescription for 60 Xanax (BID and PRN), with three refills. ALJ Ex. 50, at 3. Moreover, Respondent increased the strength of the drug to 1 mg. Id. While this prescription alone again provided R.K. with a four- month supply, on February 15, 2012, Respondent provided R.K. with another prescription for 60 Xanax 1(BID and PRN) with three refills. Id. On April 10, 2012, Respondent provided R.K. with another prescription for Xanax 1, increasing the quantity to 90 tablets and the dosing to TID (and PRN). Id. Moreover, Respondent authorized six refills, this being a separate violation of the Controlled Substances Act, which, with respect to a schedule IV drug, prohibits refilling a prescription ``more than five times'' unless the practitioner renews the prescription. See 21 U.S.C. 829(b). Notwithstanding the numerous refills R.K. had remaining on both the February 15 and April 10 prescriptions (not to mention the supply R.K. had likely obtained from the earlier prescriptions), Respondent provided him with new prescriptions for 90 Xanax 1 (TID or PRN) on May 8 and May 30, 2012. ALJ Ex. 50, at 4. While these two prescriptions did not authorize any refills, on June 21, 2012, Respondent provided R.K. with another prescription for 90 Xanax 1(TID or PRN), which authorized three refills. Id. Finally, at R.K.'s last visit, Respondent provided him with another prescription for 90 Xanax 1 (TID or PRN). Id. According to Dr. Mitchell, from October 20, 2011 through July 17, 2012, R.K. ``obtained 1950 tablets of alprazolam,'' an amount far in excess (by more than 1,000 pills) of what was necessary based on Respondent's dosing instructions.\27\ Tr. 331. Dr. Mitchell further testified that Respondent pattern of issuing multi-month prescriptions on top of one another is ``not a customary, legitimate medical practice behavior.'' Id. at 332. --------------------------------------------------------------------------- \27\ A review of the MAPS data suggests that the actual figure was 1890 tablets, as one dispensing which occurred on January 15, 2012 is listed twice. GX 22, at 11. Either way, the amount of alprazolam R.K. was able to obtain based on Respondent's prescriptions far exceeded what was necessary based on the dosing instructions. --------------------------------------------------------------------------- The Government also questioned Dr. Mitchell about Respondent's prescribing of methadone to R.K. On March 13, 2012, Respondent first prescribed 90 methadone 5 mg (TID + PRN), a 30-day supply, to R.K. GX 17, at 45-46. However, on April 10, 2012, R.K. tested negative for methadone. GX 10, at 31. A note in the entry states: ``ran out week ago.'' Id. Regarding this incident, Dr. Mitchell testified that ``[i]f a patient was truly taking [m]ethadone . . . and they abruptly ran out, they would go through significant medical withdrawal.'' Tr. 333. Dr. Mitchell further explained that a physician ``would engage the patient, are you taking, what's the problem here? Find out why the chaotic pattern in your lab results, when you are prescribing the medication for them and give them a chance to respond.'' Id. Dr. Mitchell also stated that even if he believed in giving the benefit of the doubt to the patient he would still ask the patient why the patient ``never bothered to contact'' him and would also express his ``concern[ ] about what's going on with [the patient's] behavior.'' Id. at 334. At the April 10 visit, Respondent issued R.K. a new prescription for 90 methadone 10 mg (TID), which was double the strength of what he had previously prescribed. GX 17, at 47-48. Moreover, while Respondent subjected R.K. to another drug test during his next visit (May 8, 2012), R.K. again tested negative for methadone claiming that he had run out several days earlier.\28\ GX 10, at 31. Yet here again, Respondent issued R.K. a new prescription for 90 methadone 10 TID. GX 17, at 51-52. --------------------------------------------------------------------------- \28\ The actual notation in R.K. drug screening record states: ``last pill Saturday.'' GX 10, at 31. In May 2012, May 8 was a Tuesday. --------------------------------------------------------------------------- Dr. Mitchell testified that ``[t]here is no legitimate foundation for'' the prescription. Tr. 335. And when asked what the appropriate response was to R.K.'s having provided a second negative urine test for methadone, Dr. Mitchell answered: ``[d]ischarge.'' Id. On May 30, 2012, R.K. again saw Respondent, who provided him with a new prescription for 90 methadone 10. GX 10, at 6, 43; GX 17, at 55-56. Notwithstanding that R.K. had provided negative urine samples on his two previous visits, there is no evidence that Respondent required R.K. to provide a new urine sample. Tr. 335. And while Respondent put a slash mark through the box next to the entry ``Substance Abuse +, reviewed w/patient,'' GX 10, at 43; as Dr. Mitchell explained: ``There's no detail, it's just merely a swipe of the pen.'' Tr. 336. Continuing, Dr. Mitchell noted that there is ``[n]o documentation of, I discussed with the patient two negative urines samples, so forth and so . . . my plan was so forth and so on.'' Id. Asked by the Government whether there was ever a point when Respondent should have discharged R.K., Dr. Mitchell answered ``[y]es.'' Id. While Dr. Mitchell explained that he would give the patient the benefit of the doubt, after the second negative urine test, ``he would definitely be discharged.'' Id. Dr. Mitchell further agreed that every controlled substance prescription Respondent issued to R.K.'s after the second negative urine test was issued outside of the usual course of professional practice. Id. at 336-37. During cross examination, Dr. Mitchell agreed that by referring R.K. to a physical therapist to treat the patient's back pain, Respondent was employing a multifaceted treatment plan. Id. at 446. However, Dr. Mitchell found that there was no medical evidence to support Respondent's prescribing of methadone, and there was no evidence that Respondent ever tested R.K. to determine if he was using the medication as prescribed. Id. at 335. Based on the above, I find that all of the controlled substance prescriptions issued by Respondent to R.K. on and after October 20, 2011 lacked a legitimate medical purpose and were issued outside of the usual course of professional practice. 21 CFR 1306.04(a). R.J.H. The Allegations The Show Cause Order alleged that from March 10, 2011 through November 30, 2011, Respondent repeatedly prescribed controlled substances to R.J.H. after he knew that R.J.H. was engaged in the abuse and/or diversion of controlled substances. Id. at 5. Specifically, the Government alleged that Respondent prescribed controlled substances to R.J.H., notwithstanding numerous red flags of diversion and/or abuse, including: [[Page 8234]] R.J.H. repeatedly sought early refills; R.J.H. repeatedly reported lost or stolen prescriptions; another patient reported that R.J.H. was selling his prescription of methadone and taking his girlfriend's prescription as his own; and R.J.H. was requesting controlled substances by name. Id. at 5. The Government also alleged that R.J.H.'s patient file and the prescriptions issued to him show that Respondent: Prescribed controlled substances to R.J.H. on his initial visit without taking actions typical of medical professionals such as conducting and documenting a complete medical history and physical examination, requiring that R.J.H. (a self-identified addict) sign a pain management contract or submit to a drug test, running a MAPS search on R.J.H., and creating a written treatment plan, which was periodically re-evaluated; never subjected R.J.H. to drug tests; never ran a MAPS report on R.J.H.; never required R.J.H. to sign a pain management agreement; and repeatedly prescribed methadone to R.J.H. to be taken ``PRN.'' Id. at 5. The Evidence The Government's presentation with respect to R.J.H. focused primarily on the manner in which Respondent escalated the amount of methadone he prescribed and ignored various red flags. R.J.H. first saw Respondent on March 10, 2011, at which time Respondent documented that R.J.H. had a history of narcotic abuse. GX 11, at 3, 57; see also Tr. 341. At the visit, Respondent issued to R.J.H. a prescription for 30 tablets of methadone 5 to be taken twice a day, providing a 15-day supply. GX 18, at 1-2; ALJ Ex. 50, at 4. Thereafter, on a March 24, 2011, Respondent issued to R.J.H. a prescription for 90 tablets of methadone TID, providing a 30-day supply, and on April 5, 2011, he issued to R.J.H. a prescription for 40 tablets of methadone 10 (QID and PRN). GX 18, at 5-6, 9-10; ALJ Ex. 50, at 4. Moreover, on April 19, 2011, Respondent issued to R.J.H. a prescription for 120 tablets of Methadone 10 (QID and PRN). GX 18, at 11-12; ALJ Ex. 50, at 4. Thus, between the March 10 and April 19 prescriptions, Respondent had quadrupled R.J.H.'s daily methadone dose from 10 to 40 milligrams. Dr. Mitchell testified that this was ``a significant escalation in'' the total ``24 hour dose'' of R.J.H.'s methadone regimen. Tr. 338. Dr. Mitchell further explained there was ``no'' justification for Respondent's having quadrupled R.J.H.'s daily dose. Id. Progress notes in R.J.H.'s file show that R.J.H. had appointments with Respondent on both May 18 and May 26, 2011. GX 11, at 52-53. Moreover, on May 17, 2011, Respondent wrote R.J.H. a new prescription for 120 tablets of methadone 10 QID and PRN), and on May 26, 2011, he wrote R.J.H. another prescription for 120 tablets of methadone 10 (QID and PRN). GX 18, at 15-16, 19-20. Attempting to interpret Respondent's handwriting on the May 26 progress note, Dr. Mitchell thought that R.J.H had reported ``that the prescription was stolen,'' Tr. 339, and according to a notation on the May 26 prescription, R.J.H. told the pharmacist that ``he was beat[en] up and his meds were stolen.'' GX 18, at 20. A further notation on the prescription states: ``Early refill Ok'd by Dr. Ataya Police Report on file. Per Christina @Dr. Ataya's.'' Id. Dr. Mitchell testified that when a patient claims that his medication has been stolen, ``there needs to be some action on the patient['s]'' part. Tr. 339. According Dr. Mitchell, ``part of the opioid contract [is] that if medications are stolen, you have to make a police report.'' Id. There is, however, no police report in R.J.H.'s file. See generally GX 11. Nor is there an opioid contract. See also generally id.; Tr. 341. On June 8, R.J.H. again saw Respondent. GX 11, at 51. A nurse's note on the progress note states: ``meds (stolen).'' Id. Dr. Mitchell testified that the appropriate response to this information would be to discharge the patient. Tr. 340-41. Dr. Mitchell subsequently explained that the point at which Respondent should have discharged R.J.H. was ``after the second report of medications being stolen'' without verification ``of that event happening.'' Id. at 342. Dr. Mitchell further noted that while Respondent documented that R.J.H. ``has a history of narcotic abuse,'' there is no evidence that Respondent required him to sign a pain management contract. Id. at 341. Dr. Mitchell also found no evidence that Respondent conducted any drug tests on R.J.H. and there were no MAPS reports in R.J.H.'s file. Id. at 341-42. The evidence also shows that on June 7, 2011, an employee of Respondent documented that he/she ``was told by another patient that [R.J.H.] was selling his prescription of methadone, and taking his girlfriend[']s prescription as his own.'' GX 11, at 9. While Respondent did not prescribe methadone to R.J.H. at the June 8 visit,\29\ on June 15, 2011, he issued R.J.H. another prescription for 60 tablets of methadone 5 to be taken twice a day or PRN. GX 18, at 21-24. --------------------------------------------------------------------------- \29\ Rather, he prescribed 30 tablets of Tylenol with Codeine No. 3 (``Tylenol 3''). --------------------------------------------------------------------------- While this prescription should have lasted R.J.H. for 30 days, only six days later on June 21, 2011, Respondent issued to R.J.H. a prescription for 60 tablets of methadone 10, thereby doubling the daily dose. Id. at 25-26. Thus, this refill was early by 24 days. Moreover, Respondent continued to provide R.J.H. with additional early refills. Specifically, only 15 days later on July 6, Respondent issued to R.J.H. a prescription for 60 methadone 10 (BID/PRN). Id. at 27-28. Even ignoring the June 15 prescription, this refill was early by 15 days. Only 13 days later on July 19, 2011, Respondent issued to R.J.H. a prescription for 120 of methadone 10 (QID, or four times a day), thereby doubling the daily dose and quantity. Id. at 29-30. And on August 11, 2011, he issued to R.J.H. another prescription for 120 tablets of methadone 10 to be taken four times a day or PRN. Id. at 31- 32. Even ignoring the prescriptions prior to July 19, this prescription was still one week early.\30\ --------------------------------------------------------------------------- \30\ Thereafter, Respondent issued additional methadone prescriptions to R.J.H. on an approximately monthly basis up until January 3, 2012, the same day he overdosed on heroin and was hospitalized. GX 23, at 6-8. As found above, R.J.H. died of an overdose on or about January 5, 2012. GX 5, at 1. --------------------------------------------------------------------------- As Dr. Mitchell testified, there was no justification for Respondent's rapid escalation of R.J.H.'s daily dose. Also, Respondent ignored red flags such as R.J.H.'s claim on two occasions that his prescription had been stolen, the report that he was selling his methadone and using his girlfriend's, and R.J.H.'s repeated seeking of early refills, some of which were weeks early. Moreover, while Respondent knew that R.J.H. had a history of narcotic abuse he did not require him to sign a pain contract, never conducted a drug test on him, and never obtained a MAPS report. Based on the above, I find that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice when prescribed methadone to R.J.H. 21 CFR 1306.04(a). J.H. The Allegations The Show Cause Order alleged that from June 10, 2010 through August 12, 2012, Respondent repeatedly prescribed controlled substances to J.H. even after he knew that she was engaged in the [[Page 8235]] abuse and/or diversion of controlled substances. ALJ Ex. 1, at 5. Specifically, the Government alleged that Respondent repeatedly prescribed controlled substances to her notwithstanding numerous red flags of diversion and/or abuse, including that: J.H. repeatedly sought early refills; J.H. requested controlled medications by name; J.H. was in frequent contact with Respondent's office regarding her pain medications; J.H. tested negative for controlled substances that Respondent had prescribed to her; Respondent diagnosed J.H. as narcotic dependent; hospital records in Respondent's file show that J.H. tested positive for illegal drugs; and J.H. exhibited symptoms of withdrawal. Id. at 5-6. The Show Cause Order also alleged that J.H.'s patient files and the prescriptions Respondent issued to her show that he: Issued controlled substance prescriptions to J.H. on her initial visit without taking actions typical of medical professionals such as conducting and documenting a complete medical history and physical examination, and creating a written treatment plan; diagnosed J.H. as being narcotic dependent but took no actions such as referring her to rehabilitation or a specialist, or even minimal precautionary steps such as requiring her to sign a pain management contract, subjecting her to comprehensive drug tests, or even running MAPS reports on her, and that MAPS reports would have shown that she was engaged in doctor and pharmacy shopping; prescribed two different benzodiazepines--Klonopin and Xanax--to J.H. even after she reported that she would not be using Xanax but using Klonopin instead; repeatedly prescribed methadone to J.H. to be taken ``PRN''; and prescribed Adderall to J.H. without any basis for doing so, continued to prescribe Adderall after drug tests showed that she was not taking the drug, stopped conducting drug tests to determine if J.H. was taking the Adderall he prescribed, and only stopped prescribing the drug when the Michigan Medicaid program asked him to substantiate his prescriptions. Id. at 6. The Evidence The progress note for J.H.'s November 10, 2010 visit shows that on that date, Respondent diagnosed J.H. as ``narcotic dependent.'' GX 12, at 125; Tr. 343. While Dr. Mitchell stated that he did not know if Respondent was ``trying to indicate a history of abuse by that statement or he wasn't familiar with the definitions of addiction versus dependence,'' he explained that the decision to start a patient on methadone ``depends on the history you gleaned from the patient and what the old medical records showed,'' because ``you're essentially becoming their addictionologist and beginning treatment for them.'' Id. at 346. However, according to Dr. Mitchell, when a physician determines that a patient is narcotic dependent, it is not appropriate to prescribe methadone without requiring the patient to sign an opioid agreement, conduct drug tests, and obtain a prescription monitoring program report. Id. at 346-47. There is, however, no evidence that Respondent required J.H. to enter an opioid agreement. Tr. 347; see also GX 12 (J.H.'s patient file). Moreover, while Respondent did eventually obtain a MAPS report, he did not do so until November 30, 2012, more than two years after he diagnosed her as narcotic dependent.\31\ See GX 12, at 8-13. --------------------------------------------------------------------------- \31\ The report shows prescriptions beginning only on August 31, 2011. GX 12, at 8-13. The report shows several instances in which J.H. obtained small amounts of hydrocodone and acetaminophen with codeine from a dentist in the May 2012 time period, and a further prescription for a small amount of hydrocodone from another dentist on September 14, 2011. GX 12, at 8, 13. However, every other prescription listed in this report was issued by Respondent. Of note, the Government also submitted a MAPS report it obtained showing J.H.'s prescriptions from January 8, 2010 through February 2013. However, the questioning regarding the MAPS reports was interrupted by telephonic interference seven times and is not clear what the precise questions were and which of the MAPS reports the Government was referring to in its questions. Tr. 348-49. --------------------------------------------------------------------------- The evidence shows that on November 26, 2010, Respondent issued to J.H. a prescription for 90 methadone 5 (TID), a 30-day supply. GX 19, at 21-22. Yet, according to J.H.'s file, on December 1, 2010, she was suffering from narcotic withdrawal. Tr. 349. Dr. Mitchell testified that when confronted with this situation, the appropriate response of a physician acting within the bounds of professional practice is to send the patient ``to the hospital.'' Id. When then asked if it was an appropriate response to continue to issue controlled substance medication to the patient, Dr. Mitchell testified ``absolutely not.'' \32\ Id. at 349-50. At this point, the ALJ declared the line of questioning ``redundant'' and no further clarification was obtained as to whether Dr. Mitchell was referring to prescribing or administering. Yet the evidence shows that Respondent continued to prescribe methadone and other controlled substances to her. GX 24. --------------------------------------------------------------------------- \32\ A DEA regulation, however, expressly authorizes a physician to administer (but not prescribe) a ``narcotic drug[ ] to a person for the purpose of relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment.'' 21 CFR 1306.07(b). This is so even when the physician ``is not specifically registered to conduct a narcotic treatment program.'' Id. However, the physician may not administer ``more than one day's medication'' at a time and may not do this for ``more than three days.'' Id. --------------------------------------------------------------------------- The evidence further shows that on September 8, 2010, J.H. called Respondent's office ``and stated that she stopped Xanax \33\ and went back to Klonopin b/c she didn't like the way it made her feel.'' GX 12, at 7. Respondent provided J.H. with prescriptions for 60 clonazepam on September 15, October 13, November 10, and a prescription for 30 tablets on November 30, 2010. GX 24, at 5-8. --------------------------------------------------------------------------- \33\ Respondent had prescribed 30 alprazolam .25 mg to J.H. on August 31, 2010. GX 24, at 4. --------------------------------------------------------------------------- However, on December 1, 2010, he issued J.H. a prescription for 60 alprazolam 1.\34\ Id. at 8. Moreover, only one week later on December 8, Respondent issued J.H. a prescription for 90 clonazepam. Id. While on January 4, 2011, Respondent issued her another prescription for 90 clonazepam, on January 13, he issued her a prescription for 30 alprazolam 1. Id. In the ensuing months, Respondent continued to provide J.H. with both clonazepam and alprazolam prescriptions, even though both drugs are benzodiazepines.\35\ According to Dr. Mitchell, there was ``[n]o'' medical reason for Respondent to prescribe both drugs after J.H. stated that she did not like how the alprazolam made her feel. Tr. 351. --------------------------------------------------------------------------- \34\ J.H. filled the Nov. 30 clonazepam prescription and the December 1 alprazolam prescription on the days they were they were issued. \35\ The evidence shows that during 2011, Respondent issued J.H. prescriptions for 90 clonazepam on Feb. 2, Mar. 1, April 5, May 3, June 1, June 28, July 26, August 25 (with three refills which were filled on Sept. 21, Oct. 15, and Nov. 10), and Dec. 13. GX 24, at 9- 12. During 2011, he also issued J.H. prescriptions for 90 alprazolam 1 on Mar. 15, for 30 alprazolam .5 on April 20, and for 30 alprazolam .25 on June 21. Id. at 9-11. During 2012, Respondent issued J.H. a prescription for 90 clonazepam on Jan. 5, with three refills that were filled on Feb. 1, Feb. 19, and Mar. 10; a prescription for 90 clonazepam on Mar. 28; a prescription for 120 clonazepam on April 25, with three refills, two of which were filled on May 15 and June 6; a second prescription for 120 clonazepam on April 25, which was filled on July 4; and two prescriptions for 90 clonazepam on August 14, one of which was filled the same date, the other being filled on December 8. Id. at 14-17. Respondent also issued her a prescription for 15 alprazolam .5 on May 22, 2012. Id. at 15-16. --------------------------------------------------------------------------- The evidence also shows that on August 3, 2011, Respondent issued J.H. [[Page 8236]] a prescription for 30 Adderall 10, with a dosing instruction to take one tablet daily. GX 19, at 71-72. However, at J.H.'s August 31, 2011 appointment, J.H. tested negative for the drug; a note on the drug screening results sheet states: ``last Adderall 2 days ago.'' GX 12, at 61. Respondent, however, issued her a new prescription for 30 Adderall 10 at the visit. GX 19, at 77-78. Dr. Mitchell testified that J.H.'s clean urine tests raised the same concerns (i.e., that the patient was either abusing or diverting the drug to others) as he testified to when asked about the significance of a negative test for methadone. Tr. 352. He also testified that Respondent's issuance of a new Adderall prescription after the negative test result raised the same concern that the prescription was ``outside the typical practice of medicine.'' Id. Finally, the Government questioned Dr. Mitchell as to whether there was a point at which Respondent should have stopped prescribing controlled substances to J.H. Id. at 355. According to Dr. Mitchell, ``in the face of [J.H.'s] history of drug abuse . . . [a]fter the second negative urine that would be a [sic] unavoidable, irrevocable sign to discharge her from the practice.'' Id. However, while the Patient Drug Screening Results form states that J.H. was negative for amphetamine on October 11, 2011 and includes the notation ``Ran out 8 days ago,'' GX 12, at 61; on the date of this test, Respondent had last issued her an Adderall prescription on August 31, 2011, and that prescription provided her with a 30-day supply.\36\ As there is no evidence as to how long amphetamines would still be present in a patient's urine after the last use, no weight can be given to this testimony. What is notable, however, is that over the entire course of Respondent's prescribing to J.H., which lasted from June 10, 2010 through August 12, 2012, Respondent conducted only three urine tests, with the last one being done on November 15, 2011. GX 12, at 61. --------------------------------------------------------------------------- \36\ According to the ALJ, the parties stipulated that Respondent issued a prescription for 60 Adderall 10 on October 1, 2011. ALJ Ex. 50, at 5. However, the patient file does not contain a prescription for this date (as opposed to October 11, 2011) and the MAPS report which the Government obtained does not list any Adderall/amphetamine prescription as having been issued between August 31 and October 11, 2011. GX 24, at 12-13. --------------------------------------------------------------------------- Notwithstanding that no weight can be given to Dr. Mitchell's testimony regarding the October 11, 2011 drug tests, I find that the evidence otherwise supports a finding that Respondent provided J.H. with controlled substance prescriptions which lacked a legitimate medical purpose and were issued outside of the usual course of professional practice. 21 CFR 1306.04(a). As the evidence shows, while Respondent knew that J.H. was dependent on narcotics, he: (1) Did not require her to sign an opioid agreement; (2) did not obtain a MAPS report on her until two years after he determined that she was dependent; (3) conducted only three drug tests over the course of the 26 months that he prescribed to her; (4), did not refer her to treatment when she was suffering from withdrawal even though he had given her a 30-day methadone prescription only five days earlier and continued to prescribe methadone to her; and (5) repeatedly prescribed both alprazolam and clonazepam to her, even after she had told him that she did not like the way the Xanax (alprazolam) made her feel. Concluding its direct examination, the Government asked Dr. Mitchell: ``Of the prescriptions that we have discussed today, are there any that you've found to be legitimate, issued for [a] legitimate purpose or within the usual practice of medicine?'' Tr. 356. Dr. Mitchell answered: ``Not for the controlled substances.''Id. Respondent's Testimony Respondent testified on his own behalf. According to Respondent, he graduated from medical school in Damascus, Syria in 1993, and after moving to the United States, he did an internal medicine residency which he completed in 2002. Tr. 469. Thereafter, Respondent started practicing at nursing homes and assisted living facilities and also worked as an urgent care and ER physician. Id.; see also RX J. Respondent did this until 2009 when he purchased a ``very small practice'' of 120 patients in Davidson, Michigan from a retired physician. Tr. 470. Respondent testified that in the meantime he studied hospice and palliative medicine and became board certified in 2012. Id. at 469. On some date which Respondent did not specify, Respondent also began working at a medical practice in Lapeer, Michigan, which had 150 patients. Id. at 471. According to Respondent, when he started his internal medicine practice, he ``did not expect this influx of chronic pain patient[s], and . . . was not planning to have a clinic for chronic pain patients.'' Id. at 482. While addressing the DI's testimony regarding the statements he made in the 2013 interview, Respondent offered various statements regarding the ``general'' ``way'' in which he practices medicine. Id. at 484. Specifically, he testified that in 2011 and 2012, ``we start to do it [i.e., obtain MAPS reports] more often, but definitely not in every visit.'' Id. at 482. He further asserted that ``we do referral [of] patients for diagnostic, for another specialty, depends on their need.'' Id. He also asserted that he attempts to control his patients' symptoms, while ``try[ing] to taper them off the medication, if possible, while they are getting another treatment like the physical therapy or going to the pain management, some going to counseling.'' Id. at 484. As found above, Respondent acknowledged that he had ``listened to all of'' Dr. Mitchell's testimony. Id. Respondent then testified that Dr. Mitchell was ``right'' about his having ignored the red flags that the five patients were diverting or abusing drugs. Id. Respondent further testified that he had reviewed multiple online Continuing Medical Education courses,\37\ and that the week before the hearing, he attended a three-day ``course about prescribing medication and dealing with the addicted patients.'' Id. at 486, 495. He also stated that he was referring his patients who have chronic pain to ``pain management.'' Id. at 496. However, he then testified that it takes six to twelve weeks for a patient to obtain an appointment with pain management in the Lapeer, Michigan area and that in the meantime, he has ``to continue the patient's treatment.'' \38\ Id. --------------------------------------------------------------------------- \37\ However, it is unclear the extent to which these courses actually addressed the prescribing of controlled substances and the monitoring of patients for abuse and diversion. While Respondent also testified that he has subscribed to Audio Digest, a CME program which provides lessons on a CD with a questionnaire, he then acknowledged that this program ``[h]as nothing to do with'' his prescribing practices and involves ``medical education in general internal medicine.'' Tr. 504-05. \38\ Following his testimony regarding his referring his chronic pain patients to pain management, Respondent's counsel asked him if he had also employed ``some outside help to do criminal background checks of [his] existing patients, look at your current policies and procedures as they relate to pharmaceuticals that,'' at which point the transmission cut out. Tr. 497-98. When, however, the transmission was re-established, Respondent's counsel asked only: ``Did you make any efforts to hire outside consultants to come and make some recommendations regarding your office?'' Id. at 498. --------------------------------------------------------------------------- Respondent further asserted that ``[s]ince the interview on the show cause, it came to [his] attention some wrong way in doing and dealing with patients'' and he ``went back and review[ed] what he's been doing and inquire[d].'' Id. at 495. He also testified that he had invested in electronic medical records because with three offices, it was a ``major problem . . . following the patients.'' Id. He also [[Page 8237]] hired a consultancy to review his practice's policies and procedures which met with his employees and discussed issues such as ``communicat[ing] with the patients, keeping their records, follow[ing] their records, referring the patients, and talking to the families and patients.'' \39\ Id. at 499. Finally, Respondent bought a safe. Id. --------------------------------------------------------------------------- \39\ This, however, did not occur until mid-September 2014. Tr. 509. --------------------------------------------------------------------------- On cross-examination, Respondent further asserted that after being served with the Show Cause Order, he started doing more frequent drug screening ``to identify any problematic patients.'' Id. at 512. However, he also explained that ``before we tried to do drug screening but it was very expensive for the patient because [it was] not covered'' by a local insurance plan. Id. Moreover, he offered no further detail as to how frequent the screenings were. Asked whether, in the period 2010-2012, he believed that doctors should not prescribe controlled substances to patients who are abusing or diverting them, Respondent testified: ``If it is a proof they are abusing or diverting, yes.'' Id. at 520. Asked to explain what he meant by proof of abuse and diversion, Respondent answered: Well, counseling the patient in the room and talking to them about their pain and their using their pain medication and the way, and what is their answer, for me I will take whatever the patient tell me. If they said no, they are not abusing the medication, they are not diverting the medication, and I am entitled to treat their symptoms and make sure they are not going in withdrawal and take care of the patient. Id. at 521. Asked whether he believed this today as much as he did in the 2010-2012 period, Respondent answered: ``[y]es.'' Id. The Government then asked Respondent whether he ``believe[s] that doctors should detect when patients are abusing or diverting controlled substances?'' Id. Respondent's counsel objected, on the ground that it was outside the scope of his direct examination and the ALJ sustained the objection.\40\ Id. at 522. So too, when the Government asked Respondent if ``[d]octors should respond to red flags of abuse and diversion of controlled substances,'' Tr. 526, Respondent objected, and the ALJ sustained the objection. Id. --------------------------------------------------------------------------- \40\ When the Government attempted to re-ask the question, Respondent's counsel again objected on the ground that because Respondent has testified that Dr. Mitchell was correct in his criticism of his practice, ``how much stronger can we say that we adopt Dr. Mitchell's testimony as to us ignoring those red flags and prescribing in the face of those.'' Tr. 524. The ALJ against sustained the objection. --------------------------------------------------------------------------- Next, the Government asked Respondent: ``[w]hat are the signs for abuse and diversion of controlled substances?'' Id. Respondent's counsel objected. After the ALJ overruled the objection, Respondent testified: ``[w]hat do you mean diversion exactly?'' Id. This prompted the ALJ to instruct Respondent that ``if you don't know how to answer the question, just tell me that you don't know.'' Id. Respondent answered: ``I do not.'' Id. The Government then asked Respondent what signs he looks for to see if a patient is abusing medication. Id. at 527-28. Respondent answered: Well, if they're using, now a patient if he is taking the pain medication and they have extra pain and taking medication, extra pill or extra two, this is a view that what you intend that it is abusing, well, it's still a pain medication they are using to control their symptoms. I don't understand what exactly what answer you want for that. I'm telling you exactly what I think. If the patient using the pain medication instructed to control their pain medication, now if they come earlier to take medication that's if they have a chronic problem and they need it, somebody can call them abusing, some people calling them they are controlling their pain symptoms. Id. After again admitting that he ``did not pay attention too much to this [sic] signs with the red flags and things,'' id., Respondent asserted that in determining whether patients are abusing controlled substances, ``[w]e do the drug screen'' and ``[w]e run a MAP with the electronic medical records if they are taking the medication the right way and taking the other alternative medications.'' Id. at 529. Asked by the ALJ how he is now treating pain management patients, Respondent explained that if patients ``ask for more medication or [to] change to a specific medication and . . . looking in the drugs screen, if they are utilizing the medication.'' Id. After apparently more telephonic interference, Respondent added that when patients ask for an early refill or a different medication or to increase their pain medication, ``to confirm we'll do the drug screen and we'll run the MAP.'' Id. at 531.\41\ --------------------------------------------------------------------------- \41\ The Government then asked Respondent what steps ``a doctor should and could take in response to any signs that a patient is abusing their controlled substance medications?'' Id. at 531-32. The ALJ sustained Respondent's objection stating that he had ``a record of that.'' Id. at 532. --------------------------------------------------------------------------- After confirming that Respondent was adhering to his earlier testimony that Dr. Mitchell was correct that he had ignored red flags of abuse and diversion, the Government asked Respondent whether he also agreed with Dr. Mitchell's testimony that he had ``issued prescriptions outside of the usual course of practice or for nonlegitimate medical purposes?'' Id. at 534. Respondent's counsel objected, asserting that ``[w]e've said everything Dr. Mitchell has said about prescribing in the face of red flags is correct.'' Id. at 535. The ALJ did not, however, rule on the objection. See id. Instead, the ALJ asked Respondent if he had read the Show Cause Order, and after Respondent acknowledged that he had, the ALJ asked if he ``agree[d] that the facts that they allege there are all true?'' Id. Respondent answered ``[y]es.'' Id.\42\ --------------------------------------------------------------------------- \42\ Subsequently, during a colloquy with the ALJ as to whether it could cross-examine Respondent regarding the specific prescriptions discussed by Dr. Mitchell and whether he agreed with Dr. Mitchell's testimony that the prescriptions ``were issued illegitimately and outside of the usual course,'' the Government observed that Respondent was shaking his head; the Government thus argued ``that there is some ambiguity as to whether or not he's really admitting that he has actually issued those unlawfully.'' Tr. 538-39. The ALJ explained: ``[n]ot according to my record'' and that he had seen ``the shaking of the head.'' Id. at 539. The record does not, however, reflect the manner in which Respondent shook his head, and notwithstanding the tenor of the Government's statement, I am not free to speculate as to whether Respondent was disputing or acknowledging that he acted unlawfully. Notably, in his Post-Hearing Brief, Respondent states that Dr. Mitchell's testimony establishes that he ``wrote a substantial number of prescriptions . . . without a legitimate medical purpose and/or in the usual course of a practitioner's professional practice and/or in the face of paradigmatic `red flags' of diversion or abuse such as repeated requests for early refills, facially-evident documentation of doctor shopping, and testing results inconsistent with use of the prescribed controlled substances.'' Resp. Post-Hrng Br. at 12. --------------------------------------------------------------------------- Discussion As noted above, both parties filed exceptions to the ALJ's Recommended Decision. Having reviewed their briefs, I conclude that some of their exceptions are best addressed prior to discussing whether the Government is entitled to prevail under the public interest standard. These include Respondent's contention that the ALJ committed prejudicial error when he barred him from cross-examining the Diversion Investigator regarding the use of confidential informants. See Resp. Exceptions, at 9-12. As for the Government, it argues that the ALJ erred when he allowed Respondent to present his case by VTC. Gov. Exceptions, at 3-9. Respondent's Exception to the ALJ's Ruling Limiting Cross-Examination As found above, at the hearing, a DEA Diversion Investigator testified regarding the investigation she [[Page 8238]] conducted of Respondent's prescribing practices. On cross-examination, Respondent's counsel attempted to question the DI about two undercover agents who, according to the proffer, went to Respondent, and while posing as patients, attempted to entice him to prescribe controlled substances in exchange for cash. Tr. 222. The Government objected to this line of questioning, arguing that the evidence ``was not offered as part of the basis for the order to show cause.'' Id. In response to the objection, Respondent argued that the Agency ``is required to consider not just the evidence that [the Government] brought in on the direct, but evidence that we can bring out on cross examination.'' Id. Respondent then proffered that Respondent told the undercover agents that ``he would not'' prescribe to them. Id. Respondent argues that this ``is exculpatory'' because Respondent ``had no idea who he was talking to'' and this evidence ``would be very relevant to [assessing] his state of mind.'' Id. at 222-23. The ALJ sustained the objection, on the ground that Respondent had failed to disclose in advance of the hearing that he ``wanted to cover this subject.'' Id. at 223. Continuing, the ALJ explained that ``[i]f you knew about these things, and you wanted me to consider them, then you had a duty and the opportunity to come forward and tell me. And I saw nothing like that in your pre-hearing statements, or that of prior counsel.'' Id. at 223-24. Respondent then argued that his counsel had not had ``the time that the Government had to prepare'' for the hearing and that there was no prejudice to the Government, because ``these are their witnesses.'' Id. at 224-25. The ALJ rejected the contention, explaining that ``you had knowledge of this undercover operation. If you wanted to bring it to my attention, you clearly had it for a while.'' Id. at 226.\43\ --------------------------------------------------------------------------- \43\ The record shows that Respondent became aware that two undercover officers had visited Respondent from the return of the state search warrant which listed the two officers' files as being among the items seized. Resp. Ex. A, at 7. However, the return was executed on March 27, 2013, id. at 6; which was well in advance of the hearing. --------------------------------------------------------------------------- Even assuming that the Government's direct examination of the DI as to what steps she took in investigating Respondent opened the door to this line of inquiry, the ALJ did not abuse his discretion in sustaining the Government's objection. See Gunderson v. Department of Labor, 601 F.3d 1013, 1021 (10th Cir. 2010) (applying abuse of discretion standard in reviewing ALJ's exclusion of evidence); Walter A. Yoder & Sons, Inc. v. NLRB, 754 F.2d 531, 534 (4th Cir. 1985) (applying abuse of discretion standard in reviewing ALJ's decision to limit cross-examination). Moreover, the warrant return listed the actual names (as well as the undercover names) of both undercover officers. Thus, Respondent had ample opportunity to present this evidence either through calling the undercover officers to testify or by introducing any documentation he placed in their respective patient files regarding the incidents. See Randall L. Wolff, 77 FR 5106, 5120 n.23 (2012). To be sure, DEA has recognized that in some instances, evidence of ``prior good acts'' can refute evidence that a registrant knowingly or intentionally diverted controlled substances. See Jayam Krishna-Iyer, 74 FR 459, 462 n.6 (2009). Here, however, the Government put forward extensive evidence to show that Respondent acted with the requisite knowledge to support the conclusion that he lacked a legitimate medical purpose and acted outside of the usual course of professional practice and thereby violated the CSA on some 100 occasions when he prescribed to the five patients. See 21 CFR 1306.04(a); see also 21 U.S.C. 841(a)(1). Moreover, even if Respondent's testimony regarding Dr. Mitchell's criticism of his prescribing practices was ambiguous as to whether he was also admitting that he violated 21 CFR 1306.04(a), his post-hearing brief has resolved the issue. Accordingly, even if I had found that the ALJ abused his discretion in not permitting Respondent to cross-examine the DI about the two undercover visits, I would still conclude that this does not rise to the level of prejudicial error. See Gunderson, 601 F.3d at 1021(``An error is prejudicial only `if it can be reasonably concluded that with . . . such evidence, there would have been a contrary result.' '') (quoting Sanjuan v. IBP, Inc., 160 F.3d 1291, 1296 (10th Cir. 1998)); see also Air Canada v. Department of Trans., 148 F.3d 1142, 1156 (D.C. Cir. 1998) (``As incorporated into the APA, the harmless error rule requires the party asserting error to demonstrate prejudice from the error.'') (citing 5 U.S.C. 706). In his Exceptions, Respondent further notes that the ALJ ``frames this issue as one `regarding arguably exculpatory evidence that has been withheld by the Government.' '' Exceptions, at 9 (citing R.D. at 60-62). He then states that he adopts and incorporates by reference the ALJ's view, and requests that I consider it as a separate argument. Therein, the ALJ noted that the Agency has not adopted ``[t]he rule from Brady v. Maryland,'' 373 U.S. 83, 87 (1963), which requires the prosecution in a criminal case to disclose material exculpatory evidence to the defendant. R.D. at 61. Citing MacKay v. DEA, 664 F.3d 808, 819 (10th Cir. 2011), the ALJ correctly noted that ``even if Brady did apply in this case, the excluded evidence would have no outcome [sic] on my final recommendation.'' R.D. at 62. The ALJ nonetheless proceeded to discuss several cases in which other ALJs had either: (1) Ordered the Government to review its files for exculpatory evidence, or (2) suggested that DEA should provide for disclosure of exculpatory evidence because three other federal agencies provide for such disclosure. Id. The ALJ noted that the Agency has held that there is ```an ongoing duty to ensure that material evidence and argument made to a fact-finder is not knowingly contradicted by other material evidence in the Government's possession, but not otherwise disclosed.'' Id. (quoting Randall L. Wolff, 77 FR 5106, 5124 (2012)). However, based on an earlier case in which the Agency held that an ALJ did not have authority to require the Government to ``disclose any exculpatory information in its possession when such information is timely requested by a respondent,'' see Nicholas A. Sychak, 65 FR 75959, 75960-61 (2000), the ALJ opined ``that the DEA's view of releasing exculpatory evidence is `just trust me.' '' R.D. at 62. Unacknowledged by the ALJ is that several federal appeals courts have held that Brady does not apply to administrative proceedings. See Mister Discount Stockbrokers, Inc. v. SEC, 768 F.2d 875, 878 (7th Cir. 1985); NLRB v. Nueva Eng. Inc., 761 F.2d 961, 969 (4th Cir. 1985). Cf. Echostar Comm. Corp. v. FCC, 292 F.3d 749, 755-56 (D.C. Cir. 2002) (rejecting litigant's claim that ``the Agency's decision to deny it discovery . . . denied it due process''); Silverman v. CFTC, 549 F.2d 28, 33 (7th Cir. 1977) (``There is no basic constitutional right to pretrial discovery in administrative proceedings.'') (citations omitted). Instead, this Agency follows the holding of McClelland v. Andrus, 606 F.2d 1278 (D.C. Cir. 1979). Therein, the D.C. Circuit held that ``discovery must be granted [in an administrative proceeding] if in the particular situation a refusal to do so would so prejudice a party as to deny him due process.'' Id. at 1285-86; see also Margy Temponeras, 77 FR 45675, 45676 n.4 (2012); Beau Boshers, 76 FR 19401, 19403-04 (2011). However, ``the party seeking discovery must rely on more than speculation and must show that the evidence is relevant, material, and that the denial of access to the [evidence] is prejudicial.'' Boshers, [[Page 8239]] 76 FR at 19403 (citing Echostar, 292 F. 3d at 756; Silverman v. CFTC, 549 F.2d 28, 34 (7th Cir. 1977)). As explained previously, while evidence that Respondent refused to prescribe controlled substances to the undercover officers is relevant and material in assessing his experience as a dispenser of controlled substances, in light of his concession that he knowingly diverted controlled substances some 100 times to the five patients, he cannot show prejudice.\44\ I thus reject the exception.\45\ --------------------------------------------------------------------------- \44\ It is noted that Respondent requested that the ALJ provide him with a copy of the Agency's investigative files on him; the ALJ correctly held that he had no power to compel the Agency to provide Respondent with its investigative files. ALJ Ex. 3, at 5. \45\ I have considered the Government's Exception regarding the ALJ's decision to allow Respondent to present his case by Video Teleconferencing technology. While I acknowledge that technical difficulties caused a number of interruptions during the hearing in this matter, the record nonetheless contains overwhelming evidence supporting my Decision and Order. --------------------------------------------------------------------------- Discussion Section 304(a) of the Controlled Substances Act (CSA) provides that a registration to ``dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined under such section.'' 21 U.S.C. 824(a)(4) (emphasis added). With respect to a practitioner, the Act requires the consideration of the following factors in making the public interest determination: (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. 823(f).\46\ \46\ Section 304(a) also provides that a registration to ``dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has had his State license or registration suspended, revoked, or denied by competent state authority and is no longer authorized by State law to engage in the manufacturing, distribution, or dispensing of controlled substances.'' 21 U.S.C. 824(a)(3). Likewise, the CSA defines ``[t]he term `practitioner' [to] mean[ ] a physician . . . licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices . . . to distribute, dispense, [or] administer . . . a controlled substance in the course of professional practice.'' 21 U.S.C. 802(21). See also id. Sec. 823(f) (``The Attorney General shall register practitioners . . . to dispense . . . controlled substances in schedule II, III, IV, or V . . . if the applicant is authorized to dispense controlled substances under the laws of the State in which he practices.''). --------------------------------------------------------------------------- ``[T]hese factors are . . . considered in the disjunctive.'' Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I ``may rely on any one or a combination of factors, and may give each factor the weight [I] deem[ ] appropriate in determining whether a registration should be revoked.'' Id.; see also MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while I am required to consider each of the factors, I ``need not make explicit findings as to each one.'' MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482)).\47\ --------------------------------------------------------------------------- \47\ In short, this is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest; what matters is the seriousness of the registrant's misconduct. Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has recognized, findings under a single factor can support the revocation of a registration. MacKay, 664 F.3d at 821. --------------------------------------------------------------------------- The Government has the burden of proving, by a preponderance of the evidence, that the requirements for revocation or suspension pursuant to 21 U.S.C. 824(a) are met. 21 CFR 1301.44(e). However, ``once the [G]overnment establishes a prima facie case showing a practitioner has committed acts which render his registration inconsistent with the public interest, the burden shifts to the practitioner to show why his continued registration would be consistent with the public interest.'' MacKay, 664 F.3d at 817 (citing Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008) (citing cases)). In this matter, the Government's evidence focused on factors two, four, and five. Having reviewed the record in its entirety and having considered all of the factors, I find that the Government's evidence with respect to factors two and four satisfies its prima facie burden of showing that Respondent has committed acts ``which render his registration . . . inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). Factors Two and Four--Respondent's Experience in Dispensing Controlled Substances and Compliance With Applicable Laws Related to Controlled Substances Under a longstanding DEA 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). Continuing, the regulation 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)). Both this Agency and the federal courts have held that establishing a violation of the prescription requirement ``requires proof that the practitioner's conduct went `beyond the bounds of any legitimate medical practice, including that which would constitute civil negligence.' '' Laurence T. McKinney, 73 FR 43260, 43266 (2008) (quoting United States v. McIver, 470 F.3d 550, 559 (4th Cir. 2006)). See also United States v. Feingold, 454 F.3d 1001, 1010 (9th Cir. 2006) (``[T]he Moore Court based its decision not merely on the fact that the doctor had committed malpractice, or even intentional malpractice, but rather on the fact that his actions completely betrayed any semblance of legitimate medical treatment.''). Thus, in Moore, the Supreme Court reinstated the conviction of a physician under 21 U.S.C. 841(a)(1) and what is now 21 CFR 1306.04(a) for prescribing controlled substances outside of the usual course of professional practice. 423 U.S. at 139-43. The Court explained: The evidence presented at trial was sufficient for the jury to find that respondent's conduct exceeded the bounds of ``professional practice.'' As detailed above, he gave inadequate physical examinations or none at all. He ignored the results of the tests [[Page 8240]] he did make. He did not give methadone at the clinic and took no precautions against its misuse and diversion. He did not regulate the dosage at all, prescribing as much and as frequently as the patients demanded. . . . In practical effect, he acted as a large scale ``pusher''--not as a physician. Id. at 142-43. Under the CSA, it is fundamental that a practitioner must establish a bona fide doctor-patient relationship in order to act ``in the usual course of . . . professional practice'' and to issue a prescription for a ``legitimate medical purpose.'' See, e.g., Moore, 423 U.S. at 142-43; United States v. Lovern, 590 F.3d 1095, 1100-01 (10th Cir. 2009); United States v. Smith, 573 F.3d 639, 657 (8th Cir. 2009); Jack A. Danton, 76 FR 60900, 60904 (2011) (finding violations of 21 CFR 1306.04(a) ``where a physician has utterly failed to comply with multiple requirements of state law for evaluating her patients and determining whether controlled substances are medically indicated and thus has ` ``completely betrayed any semblance of legitimate medical treatment'' ' '') (quoting McKinney, 73 FR at 43266 (quoting Feingold, 454 F.3d at 1010)). However, while the Government frequently relies on a physician's failure to establish a bona-fide doctor-patient relationship to prove a violation of 21 CFR 1306.04(a), no ``specific set of facts ha[s] to be present in order to find that a physician stepped outside of his role and issued prescriptions without a legitimate medical purpose.'' United States v. McKay, 715 F.3d 807, 823 (10th Cir. 2013). Thus, as the Tenth Circuit explained, the question is whether sufficient evidence ``exist[s] for a fact finder to affirmatively determine that the physician issued the drugs for an improper purpose.'' Id. As found above, Dr. Mitchell offered extensive and uncontested testimony that included identifying specific acts and omissions by Respondent, which support the conclusion that Respondent acted outside of the usual course of professional practice and without a legitimate medical purpose when he prescribed controlled substances to each of the five patients. He also opined that none of the prescriptions he discussed complied with 21 CFR 1306.04(a). Tr. 356. In his post-hearing brief, Respondent states that Dr. Mitchell's testimony establishes that he ``wrote a substantial number of prescriptions . . . without a legitimate medical purpose and/or in the usual course of a practitioner's professional practice and/or in the face of paradigmatic `red flags' of diversion or abuse such as repeated requests for early refills, facially-evident documentation of doctor shopping, and testing results inconsistent with use of the prescribed controlled substances.'' Resp. Proposed Recommended Rulings, Findings of Fact and Conclusions of Law, at 12. Respondent, however, also attempts to portray himself as a soft touch, suggesting that it is ``culturally ingrained'' that he could ``not say no'' to patients, and that he prescribed ``with some naivety and perhaps even full-blown gullibility,'' which was ``laid bare when the size of his practice grew exponentially faster than he and his staff'' were capable of managing. Respondent's Post-Hrng. Submission, at 1-2. See also id. (``These proceedings have also opened [his] eyes to the fact that his knowledge and experience as a medical practitioner contained gaps that proved easy to exploit.''). The ALJ embraced this argument. See R.D. at 43 (quoting Resp. Post- Hrng. Submission, at 2) (Respondent's ``lack of knowledge, experience, and familiarity with accepted protocols for prescribing controlled substances, combined with some naivety and perhaps full-blown gullibility, where laid bare when the size of his practice great exponentially faster. . . .''); see also id. at 43-44 (``Here, it appeared [Respondent] became a very popular weak link used by those seeking to circumvent [controlled substance prescribing] protocols.''). The ALJ also stated his agreement ``with the proposition appearing in [his] post-hearing brief that `his practice did not consist of a ``pill mill''' and that however misguided, he was nevertheless treating his patients, not merely processing their prescriptions in furtherance of a larger criminal enterprise.'' R.D. 47 (quoting Resp. Prop. Recommended Rulings, etc., at 12) (first emphasis added; second emphasis in original). See also id. at 44 (``I found no evidence to suggest the failures in his practice were the results of avarice or greed . . . .''). Contrary to the ALJ's understanding, the Government was not required to prove that Respondent was motivated by avarice or greed to establish a violation of 21 CFR 1306.04(a) and 21 U.S.C. 841(a)(1). Nor did the ALJ reconcile the inconsistency between his findings that that Respondent violated 21 CFR 1306.04(a) with respect to each of the patients--findings which establish that he knowingly diverted drugs-- with his embrace of Respondent's claim that he was merely na[iuml]ve and gullible. Indeed, Respondent offered no testimony to support the claims made in his brief that he prescribed out of naivety or gullibility, or that his inability to say no was ``culturally ingrained.'' As for the ALJ's embrace of Respondent's claim that he was not running a pill mill and was treating his patients, to be sure, there is some evidence that Respondent referred patients for MRIs, a sleep study, and alternative treatments such a chiropractor and physical therapy. However, the overwhelming weight of the evidence shows that Respondent issued the prescriptions knowing that the patients were either abusing or diverting the drugs. With respect to R.E.H., Dr. Mitchell found Respondent's initial evaluation to be inadequate based on Respondent's failure to adequately develop his substance abuse history and how much methadone he was currently taking. He further found that Respondent did not perform an adequate physical examination. He therefore concluded that Respondent acted outside of the usual course of professional practice in issuing the initial methadone prescriptions. Based on this testimony, I find that Respondent did not establish a bona fide doctor-patient relationship and I further conclude that at no point in the course of his treatment of R.E.H. did Respondent do so. Dr. Mitchell further described a plethora of instances in which Respondent provided R.E.H. with early refills and failed to document that he had engaged R.E.H. as to why he needed the early refills. Dr. Mitchell pointed out that Respondent failed to enforce his medication contract which required R.E.H. to use his medicine only at the prescribed rate. He also pointed out that Respondent continued to prescribe without obtaining urine samples, and only rarely obtained a MAPS report. Moreover, even when he did obtain and review a MAPS report, the MAPS report showed that R.E.H. had filled the same prescriptions at different pharmacies, and yet Respondent failed to even address R.E.H.'s behavior and continued to prescribe methadone to him. So too, Respondent was notified on multiple occasions that R.E.H. was trying to fill multiple prescriptions and presenting forged prescriptions, and yet did nothing to address this obvious drug-seeking behavior and continued to prescribe to him. Finally, even after he received a report that R.E.H. had tested positive for cocaine and was diagnosed as polysubstance dependent, he continued to prescribe to R.E.H. In short, given the numerous times that R.E.H. sought early refills, coupled with the information Respondent obtained from MAPS reports, pharmacies and the hospital, Respondent cannot credibly [[Page 8241]] argue that he was merely gullible or na[iuml]ve. Rather, Respondent knowingly diverted controlled substances to R.E.H. The same holds true with respect to Respondent's prescribings to J.W. Here too, Dr. Mitchell testified that there was no clinical basis to diagnose J.W. with a condition that would support prescribing both Adderall and methadone. He also testified that it was inappropriate to prescribe methadone on a PRN basis. Moreover, Respondent ignored evidence that J.W. was obtaining Adderall from another physician, in violation of the medication contract, as well as that J.W. was obtaining Suboxone from the other physician. J.W. also sought early refills on multiple occasions, yet Respondent continued to prescribe to him. Also, the same day that Respondent was informed that J.W. was in the county jail, Respondent obtained a MAPS report which showed that J.W. had continued to obtain controlled substances for Suboxone and Adderall from another doctor at the same time he was obtaining prescriptions from Respondent. Moreover, Respondent was notified by J.W.'s niece that her uncle was selling his medications. Yet notwithstanding this information, after J.W. was released from jail, Respondent eventually resumed prescribing controlled substances to him. Here again, the evidence amply refutes the contention that Respondent was merely gullible or na[iuml]ve. With respect to R.K., the evidence showed that Respondent issued multiple prescriptions for Xanax, which frequently authorized multiple refills, resulting in R.K. obtaining, in a nine-month period, approximately 1,000 pills more than were necessary based on Respondent's dosing instructions. Given that R.K.'s chart contained copies of the prescriptions, Respondent cannot credibly argue that he was duped by R.K. into issuing the excessive prescriptions. Also, while Respondent prescribed methadone to R.K., on two occasions, R.K. tested negative for the drug, stating after the first test that he had run out a week earlier, and after the second, stating that he had run out several days earlier. Yet there was no documentation that R.K. had undergone withdrawal, this being a clear indication that R.K. was diverting the drug. Respondent continued to prescribe the drug to R.K. (going so far as to double the strength after the first negative test) and did not subject him to any more drug tests after the second test. The evidence thus shows that Respondent was willfully blind to what R.K. was doing with the drugs. Moreover, Dr. Mitchell testified that there was no medical evidence to support the methadone prescriptions. Here again, the evidence amply refutes the contention that Respondent issued the prescriptions because he was gullible or na[iuml]ve. Respondent knew that R.J.H. had a history of drug abuse. Yet over the course of just six weeks, Respondent quadrupled R.J.H.'s daily dosage of methadone with no medical justification. Moreover, within three months of R.J.H.'s seeing Respondent, R.J.H. had twice claimed that his prescriptions were stolen, and the day before the second such incident, Respondent's office had been told by another patient that R.J.H. was selling his prescription and using his girlfriend's medication. Yet Respondent issued him another prescription and continued to prescribe methadone to him, even though R.J.H. sought early refills. Here again, the evidence refutes Respondent's contention that he issued the prescriptions because he was gullible or na[iuml]ve. So too, the evidence with respect to J.H. refutes Respondent's claim that he was gullible or na[iuml]ve. Here the evidence shows that only five days after Respondent issued her a prescription for a 30-day supply of methadone, she was suffering from narcotic withdrawal. Yet, instead of sending her for treatment, Respondent continuing prescribing controlled substances to her. Moreover, over the course of his treatment of J.H., on multiple occasions, Respondent prescribed either alprazolam or clonazepam to her, both being benzodiazepines, even though he had recently prescribed the other drug to her. Also, even after J.H. reported that she did not like how alprazolam made her feel, he still issued her more prescriptions for the drug. So too, even after J.H. tested negative for Adderall, he issued her a new prescription for the drug. Finally, over the course of the 26 months Respondent treated her, he only drug tested her three times, with all three tests occurring in a three-month period. I thus conclude that Respondent knew or was willfully blind to the fact that J.H. was either abusing or diverting her drugs to others. In addition to his issuance of numerous unlawful prescriptions, Respondent also violated federal law by writing a methadone prescription for R.E.H. which he dated as having been issued on November 8, 2012, when he likely issued it on October 30, 2012. Notably, the evidence shows that on October 8, 2012, Respondent issued R.E.H. a methadone prescription, which R.E.H. filled the same day. GX 15, at 135-36. The evidence also shows that on October 30, R.E.H. was seeking more methadone and his medical record states that it was not time yet and includes a copy of a prescription bearing an issue date of November 8, 2012. GX 8, at 15; id. at 31. The evidence further shows that a second prescription with an issue date of October 8, 2012 (which appears to have been altered) was filled on October 30, 2012. GX 15, at 137-38; GX 20, at 14. Moreover, there are no notes corresponding to a visit by R.E.H. on November 8, 2012, and the MAPS data contains no entry for a methadone prescription with an issue date of November 8, 2012. See GX 8, at 15; id. at 99-100; see also GX 20. Under a DEA regulation, ``[a]ll prescriptions for controlled substances shall be dated as of, and signed on, the day when issued.'' 21 CFR 1306.05(a). Based on Respondent's failure to address the DI's testimony regarding this prescription and there being no evidence that R.E.H. saw Respondent on November 8, 2012, I find that Respondent violated this regulation when he post-dated the prescription.\48\ --------------------------------------------------------------------------- \48\ Even if it was R.E.H. who altered the date to ``10/08/12,'' if Respondent's intent was to provide R.E.H. with a prescription that he could not fill until November 8, than he should have written on the prescription ``the earliest date on which a pharmacy'' could fill it. 21 CFR 1306.12(b)(ii). In any event, Respondent was still required to date the prescription as of the date he issued it. --------------------------------------------------------------------------- The evidence also shows that Respondent repeatedly failed to include the patients' addresses on their prescriptions. See, e.g., GX 8, at 21, 23, 27-38, 40-42, 52, 54-57, 64, 233, 240, 248-49, 253-54 (Pt. R.E.H.); see also GX 9, at 5-6, 45, 54, 57-59, 61-63, 68 (Pt. J.W.). This too is a violation of 21 CFR 1306.05(a). Finally, the evidence shows that on several occasions, Respondent issued prescriptions that authorized six refills. GX 8, at 23 (Xanax Rx issued to R.E.H.); GX 17, at 49 (Xanax Rx issued to R.K.); GX 19, at 117 (Klonopin Rx issued to J.H.). Respondent violated DEA regulations when he issued the prescriptions because, with respect to schedule III and IV controlled substances, a prescription may not ``refilled more than five times.'' 21 CFR 1306.22(a). Accordingly, I find that the Government's evidence with respect to Factors Two and Four conclusively establishes that Respondent has committed such acts as to render his registrations ``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4); see also id. Sec. 823(f). I further conclude that his misconduct is especially egregious and supports the revocation of his [[Page 8242]] existing registrations and the denial of his pending applications. Moreover, while the Government put on no evidence as to Factor One--the recommendation of the state licensing board--in response to my November 10, 2015 order, the Parties have acknowledged that on October 30, 2015, the Michigan Board of Medicine revoked Respondent's medical license and that he is longer legally authorized to dispense controlled substances in the State in which he is registered and seeks additional registrations.\49\ --------------------------------------------------------------------------- \49\ No evidence was presented regarding Factor Three-- Respondent's conviction record for offenses related to the manufacture, distribution or dispensing of controlled substances. However, the Agency has held that the absence of a conviction is not dispositive of the public interest inquiry. Dewey C. MacKay, 75 FR 49956, 49973 (2010), pet. for rev. denied, MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011). As for Factor Five, as explained above, the Government did not take exception to the ALJ's findings regarding the allegation that Respondent made various false statements in the interview. --------------------------------------------------------------------------- Sanction Under Agency precedent, where, as here, ``the Government has proved that a registrant has committed acts inconsistent with the public interest, a registrant must `` `present sufficient mitigating evidence to assure the Administrator that [he] can be entrusted with the responsibility carried by such a registration.'' ' '' Medicine Shoppe- Jonesborough, 73 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); 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).\50\ --------------------------------------------------------------------------- \50\ However, while a registrant must accept responsibility and demonstrate that he will not engage in future misconduct in order to establish that his/her continued registration is consistent with the public interest, DEA has repeatedly held these are not the only factors that are relevant in determining the appropriate sanction. See, e.g., Joseph Gaudio, 74 FR 10083, 10094 (2009); Southwood Pharmaceuticals, Inc., 72 FR 36487, 36504 (2007). Obviously, the egregiousness and extent of a registrant's misconduct are significant factors in determining the appropriate sanction. See Jacobo Dreszer, 76 FR 19386, 19387-88 (2011) (explaining that a respondent can ``argue that even though the Government has made out a prima facie case, his conduct was not so egregious as to warrant revocation''); Paul H. Volkman, 73 FR 30630, 30644 (2008); see also Paul Weir Battershell, 76 FR 44359, 44369 (2011) (imposing six-month suspension, noting that the evidence was not limited to security and recordkeeping violations found at first inspection and ``manifested a disturbing pattern of indifference on the part of [r]espondent to his obligations as a registrant''); Gregory D. Owens, 74 FR 36751, 36757 n.22 (2009). The Agency has also held that `` `[n]either Jackson, nor any other agency decision, holds . . . that the Agency cannot consider the deterrent value of a sanction in deciding whether a registration should be [suspended or] revoked.' '' Gaudio, 74 FR at 10094 (quoting Southwood, 72 FR at 36504); see also Robert Raymond Reppy, 76 FR 61154, 61158 (2011); Michael S. Moore, 76 FR 45867, 45868 (2011). This is so, both with respect to the respondent in a particular case and the community of registrants. See Gaudio, 74 FR at 10095 (quoting Southwood, 71 FR at 36503). Cf. McCarthy v. SEC, 406 F.3d 179, 188-89 (2d Cir. 2005) (upholding SEC's express adoptions of ``deterrence, both specific and general, as a component in analyzing the remedial efficacy of sanctions''). --------------------------------------------------------------------------- The ALJ found that Respondent ``failed to take the full and unconditional acceptance of responsibility required by'' the Agency's case law. R.D. at 55. As support for this conclusion, the ALJ noted that during his cross-examination of Dr. Mitchell, Respondent ``challenged multiple aspects of the Government's evidence regarding [his] treatment of the patients that were fundamental to the Government's case against him.'' Id. The ALJ also found that ``Respondent's repeated and persistent pre-hearing assertions that his prescription practice was within the usual course of medical practice stand as compelling evidence that [he] had not accepted responsibility for his actions under the high standard established by the'' Agency. Id. Thus, the ALJ declined to credit Respondent's testimony that he did not dispute Dr. Mitchell's criticism of his prescribing practices with respect to the five patients, notwithstanding that he characterized Respondent's testimony as ``unequivocally stat[ing]'' as much. Id. The ALJ did not, however, reconcile his finding with his statement during the hearing that ``right now I have fairly compelling evidence that [Respondent] has accepted responsibility, even though he didn't tell me he did so or he was going to do so in his prehearing statement.'' Tr. 491. Moreover, as discussed previously, because Respondent did not provide notice in his pre-hearing statements that he intended to admit to the truth of the Government's allegations, the ALJ granted the Government's motion to bar him from introducing evidence of his remedial measures.\51\ --------------------------------------------------------------------------- \51\ As found above, Respondent did offer extensive testimony of his remedial measures. However, Respondent was barred from introducing testimony by a third party on the issue. --------------------------------------------------------------------------- Respondent takes exception to the ALJ's finding that he did not accept responsibility for his misconduct. Resp. Exceptions, at 2-9. He argues that the ALJ misapplied Agency precedent, ``in effect penaliz[ing] him for his failure to immediately confess wrongdoing in response to naked allegations.'' Id. at 4-5 n.11. Alternatively, he argues that: [i]f the applicable precedent really provides that the gateway to presentation of mitigation evidence requires [him to] demonstrate penitence in the form of ``accepting responsibility for'' conduct in which he did not engage . . . and/or to admit to counterfactual matters, e.g., that some of the prescriptions at issue were written outside of a legitimate[] physician patient relationship, then that precedent is inconsistent with procedural due process. Id. at 4; see also id. at 5 n.11 (``to the extent that the Agency concludes the [ALJ's] application was proper, however, the precedent is inconsistent with procedural due process''). Respondent thus seeks ``a functional remand to allow the parties to fully develop [his] remediation evidence and to allow'' for the consideration of ``that evidence in assessing the appropriate sanction.'' Id. at 9. While I find some of Respondent's arguments well taken, I reject his exception. As for the ALJ's pre-hearing ruling barring Respondent from eliciting the testimony of Ms. Richards, (who would have testified regarding a risk assessment audit and the training she provided to Respondent's staff), in his Recommended Decision, the ALJ asserted that he would have allowed Ms. Richards to testify if Respondent had ``informed the Government in its prehearing statements that he acknowledged the noncompliance of his prescription practice.'' R.D. at 60. However, while not mentioned in the Recommended Decision, the ALJ granted the Government's motion based also on Respondent's failure to describe Ms. Richard's testimony ``with sufficient particularity.'' Tr. 39 (Nov. 3, 2014). This was an independent and adequate ground to bar her testimony, and yet, Respondent does not challenge the ALJ's ruling on this basis. Had the ALJ's ruling barring Ms. Richard's testimony been based solely on Respondent's failure to state in his pre-hearing statements that he was acknowledging his misconduct, I would agree with Respondent. Contrary to the ALJ's understanding, although the Agency has held that proof of remedial measures is rendered irrelevant where a respondent fails to accept responsibility [[Page 8243]] for his knowing or intentional misconduct, none of the cases cited by the Government or the ALJ have held that a respondent, as a condition of being able to offer evidence of his remedial measures, is required to admit to the allegations before he even has the opportunity to challenge the Government's evidence and the Agency has never held as much. Indeed, while the Agency frequently places dispositive weight on a respondent's failure to fully acknowledge his misconduct, in each of the cases cited by the ALJ, the Agency discussed the respondent's failure to acknowledge his/her/its misconduct only after discussing the evidence put forward by the Government and determining which allegations had been proved. See, e.g., Joe Morgan, 78 FR 61961, 61963 (2013) (``where the Government has proved that a respondent has knowingly or intentionally diverted controlled substances, a registrant's acceptance of responsibility is an essential showing for rebutting the Governments prima facie case)'' (emphasis added); Medicine Shoppe-Jonesborough, 73 FR at 387. Notwithstanding that the Government provided, in its prehearing statements, notice of the evidence it intended to rely on in supporting the allegations of the Show Cause Order, Respondent was entitled to challenge the reliability of that evidence at the hearing and to show that the allegations were untrue. However, I decline to decide the question of whether it was consistent with principles of due process to require Respondent, as a condition of being able to subsequently present evidence of his remedial measures, to admit to his misconduct before it had even been proven on the record.\52\ Notably, while Respondent suggests that if the ALJ's reading of the Agency's precedent was correct--as explained above, it was not--``the precedent is inconsistent with procedural due process,'' and the ALJ reasoned that Respondent's ``concern regarding due process is not wholly unfounded,'' R.D. at 56, neither Respondent nor the ALJ offered anything more than these conclusory assertions. Moreover, as explained previously, the ALJ's original ruling barring Respondent from putting on Ms. Richard's testimony was also supported by the independent basis that Respondent failed to adequately disclose the nature of her proposed testimony with sufficient particularity.\53\ --------------------------------------------------------------------------- \52\ The constitutional question presented by this scenario can be avoided by waiting until the hearing itself and moving to bar or strike the testimony and evidence of remedial measures when the Respondent fails to acknowledge the misconduct proven by the Government. However, where, as here, a respondent fails to provide an adequate disclosure of its proposed evidence of its remedial measures, the Government can still move to bar the admission of the evidence prior to the hearing. \53\ In his Exceptions, Respondent ``incorporates as if fully set out herein the [ALJ's] additional observations as to recent Agency precedent's misapplication of Hoxie v. DEA, 419 F.3d 477 (6th Cir. 2005).'' Resp. Exceptions, at 4 n.11 (citing R.D. at 58). According to the ALJ, the Agency has been misreading the Sixth Circuit's Hoxie decision because ``while admitting fault is an important factor, it is not the sole factor.'' R.D. 58. The ALJ criticized the Agency's decisions in two cases, which he viewed as being ``representative of the coercive pressure to either fully accept responsibility or contest all possible allegations.'' R.D. 56 (discussing Jeri Hassman, M.D., 75 FR 8194 (2010), and George Mathew, M.D., 75 FR 66138 (2010)). According to the ALJ, his discussion was ``intended to present the argument that the DEA is holding registrants to an unfair standard. Although accepting responsibility for one's actions is an important factor to consider once the Government proves its prima facie case, there is much more to determining what constitutes the public interest than this one criterion.'' R.D. at 58. However, the ALJ then noted that in Respondent's case, ``the outcome would arguably not be different if [he] had been allowed to present additional rehabilitation witnesses. His admitted misconduct while treating patients and his lackluster efforts of rehabilitation require that result.'' R.D. 58- 59. I respectfully disagree with the ALJ's assertion that the Agency ``is holding registrants to an unfair standard.'' On the contrary, given the harm to public safety caused by the diversion of controlled substances, the Agency's policy of requiring those respondents, who have been shown to have engaged in knowing or intentional misconduct to acknowledge their misconduct, is fully within the Agency's discretion. Hoxie is not to the contrary. As the Tenth Circuit explained in MacKay, a case which received barely a mention by the ALJ: When faced with evidence that a doctor has a history of distributing controlled substances unlawfully, it is reasonable for the . . . Administrator to consider whether that doctor will change his or her behavior in the future. And that consideration is vital to whether [his] continued registration is in the public interest. Without Dr. MacKay's testimony, the . . . Administrator had no evidence that Dr. MacKay recognized the extent of his misconduct and was prepared to remedy his prescribing practices. 664 F.3d at 820. Absent evidence that a registrant acknowledges his misconduct in intentionally or knowingly diverting controlled substances, there is no basis to conclude that the registrant is prepared to remedy his prescribing practices and allowing the registrant to maintain his registration ``is inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). As for the ALJ's further contention that there is ``more to determining what constitute the public interest than this one criterion,'' R.D. 58, the Agency considers other factors including the egregiousness of the proven misconduct. Thus, in cases of less egregious misconduct, the Agency has frequently imposed sanctions less than a denial or revocation notwithstanding that a respondent failed to fully acknowledge his misconduct. However, the intentional or knowing diversion of controlled substances strikes at the CSA's core purpose of preventing drug abuse and diversion. As for the ALJ's reliance on Hassman and Mathew, neither of these cases supports his assertion that the Agency is imposing an unfair standard on registrants. As for Hassman, the ALJ's characterization of the Agency's decision as having ``found that the respondent had issued several prescriptions not for a legitimate medical purpose for several of her patients,'' R.D. at 56, is a gross understatement of the Agency's findings in the case, which established that the respondent had issued hundreds of unlawful prescriptions to some 15 patients, and continued to deny material facts even when there was conclusive proof to the contrary. See, e.g., 75 FR at 8200-237. And his reliance on Mathew is especially remarkable given that Dr. Mathew was implicated in prescribing controlled substances for two separate internet prescribing rings and did not testify in the proceeding. Of further note, while both physicians sought judicial review of the respective agency decision, in each case, the Court of Appeals denied their petitions in an unpublished decision. See Hassman v. DEA, 515 Fed. App'x. 667 (9th Cir. 2013) (Holding that ``[n]one of her proffered statements amount to an admission of wrongdoing; they are nothing more than further denials and claims that she was the unwitting victim of cunning patients. While Hassman offered some evidence of corrective measures, the DEA was entitled to give greater weight to the evidence indicating that Hassman has not learned from or improved upon her past misconduct.''); Mathew v. DEA, 472 Fed Appx. 453 (9th Cir. 2012). --------------------------------------------------------------------------- Nor was Respondent the only party displeased with the ALJ's ruling on the issue of the adequacy of his acceptance of responsibility. Indeed, the Government argues that the ALJ obstructed its cross- examination of Respondent on this very issue. Gov. Exceptions, at 9-18. The Government sets forth various instances in which the ALJ precluded it from conducting a meaningful inquiry into the sincerity of Respondent's acceptance of responsibility and the scope of his present understanding of lawfully appropriate prescribing practices. See id. at 10-11; 17-18. The Government further points to various incongruities in the ALJ's decision, including his conclusion that Respondent `` `failed to take the full and unconditional acceptance of responsibility,' '' while later in the same paragraph, finding that Respondent `` `unequivocally stated that he did not dispute the evidence brought against him.' '' Gov. Exceptions, at 12 (quoting R.D. 55). To similar effect, the Government argues that notwithstanding the various instances in which the ALJ cut off its cross-examination of Respondent, the ALJ later explained that he could not evaluate Respondent's contention that he should be able to continue to prescribe controlled substances subject to various restrictions, `` `without first providing the Government a full and fair opportunity to first thoroughly test the depth of [Respondent's] acknowledgment of noncompliance.' '' Gov. Exceptions, at 12 (quoting R.D. 63). The Government also argues that ``[t]he ALJ's decisions make it difficult for the Administrator to know if Respondent would have `acknowledg[ed] that his conduct violated the law' at hearing.'' Gov. [[Page 8244]] Exceptions, at 13 (citing Morgan, 78 FR 61961, 61980 (2013)). I agree, and while Respondent bore the burden of production on the issue, given the ALJ's on-the-record statement that ``right now I have fairly compelling evidence that [Respondent] has accepted responsibility, even though he didn't tell me he did so or he was going to do so in his prehearing statement,'' Tr. 491, it was not unreasonable for Respondent's counsel to conclude that it was not necessary to further develop the record on this issue.\54\ --------------------------------------------------------------------------- \54\ While Respondent's counsel raised numerous objections to the Government's attempts to cross-examine him as to the sincerity of his acceptance of responsibility, Respondent's counsel was obliged to zealously defend his client. Thus, the state of the record is primarily attributable to the ALJ's undue limitation of the Government's cross-examination. --------------------------------------------------------------------------- I conclude, however, that a remand is unwarranted for multiple reasons. As explained above, see supra n.53, while a registrant must accept responsibility and demonstrate that he will not engage in future misconduct in order to establish that his/her continued registration is consistent with the public interest, the Agency has repeatedly held that it is entitled to consider the egregiousness and extent of a registrant's misconduct in determining the appropriate sanction. See Dreszer, 76 FR at 19387-88; Volkman, 73 FR at 30644. Indeed, while proceedings under 21 U.S.C. 823 and 824 are remedial in nature, there are cases in which, notwithstanding a finding that a registrant has credibly accepted responsibility, the misconduct is so egregious and extensive that the protection of the public interest nonetheless warrants the revocation of a registration or the denial of an application. See Fred Samimi, 79 FR 18698, 18714 (2014) (denying recommendation to grant restricted registration, explaining that ``even assuming . . . that Respondent has credibly accepted responsibility for his misconduct, this is a case where actions speak louder than words''). Here, the evidence shows that Respondent is an egregious violator of the CSA in that he ignored countless red flags presented by the patients that they were either abusing or diverting (or both) the controlled substances he prescribed for them. And with respect to Patients J.H. and R.E.H., the evidence shows that this went on for several years. Given the egregiousness of his misconduct, the Agency's interest in protecting the public by both preventing him from being able to dispense controlled substances as well as by deterring misconduct by others is substantial. I thus conclude that continuing Respondent's existing registrations and granting his applications for the additional registrations would be ``inconsistent with the public interest.'' 21 U.S.C. 823(f), 824(a)(4). There is further reason to conclude that a remand is unwarranted. As found above, the State of Michigan has now revoked Respondent's medical license, thus rendering him without authority to dispense controlled substances in the State in which he holds his registrations and seeks the additional registrations. Thus, Respondent no longer meets the CSA's prerequisite for obtaining and maintaining a registration. See 21 U.S.C. 802(21) (defining ``the term `practitioner' [to] mean[ ] a . . . physician . . . or other person licensed, registered or otherwise permitted, by . . . the jurisdiction in which he practices . . . to distribute, dispense, [or] administer . . . a controlled substance in the course of professional practice''); see also id. Sec. 823(f) (``The Attorney General shall register practitioners . . . to dispense . . . controlled substances . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.''). Thus, pursuant to 21 U.S.C. 824(a)(3), the Attorney General is also authorized to suspend or revoke a registration issued under section 823, ``upon a finding that the registrant . . . has had his State license or registration suspended [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.'' Because Congress has clearly mandated that a practitioner possess state authority in order to be deemed a practitioner under the Act, DEA has long held that the revocation of a practitioner's registration is the appropriate sanction whenever he is no longer authorized to dispense controlled substances under the laws of the State in which he practices medicine. See James L. Hooper, 76 FR 71371 (2011), pet. for rev. denied, 481 Fed. Appx . 826 (4th Cir. 2012); see also Maynard v. DEA, 117 Fed. Appx. 941, 945 (5th Cir. 2004); Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920 (1988). The Government nonetheless argues that because this issue was ``never raised in the Order to Show Cause,'' a decision on this ground ``could arguably upend basic protections afforded to DEA registrants and would surely diminish the perceived fairness of the . . . administrative process.'' Govt's Resp. to Admin. Order, at 11. The Government acknowledges that it ``is certainly empowered to issue an Order to Show Cause (or an Amended Order to Show Cause) alleging this factual basis and legal ground for revocation or denial'' and to submit evidence. Id. However, it then contends that to impose a sanction ``based on events that occurred outside of the administrative litigation process . . . runs up against `one of the fundamental tenets of Due Process,' '' this being that the `` `Agency must provide a Respondent with notice of those acts which the Agency intends to rely on in seeking . . . revocation . . . so as to provide a full and fair opportunity to challenge the factual and legal basis for the Agency's action.' '' Id. at 11-12. (quoting Farmacia Yani, 80 FR 29053, 29059 (2015)). For his part, Respondent does not dispute that the Michigan Board has revoked his medical license and that he ``no longer has any legal authority to dispense controlled substances.'' Respondent's Resp. to Admin. Order, at 1. However, he then states that as a procedural matter, he agrees with the Government that ``simply skipping ahead to a 21 U.S.C. 824(a)(3) revocation that the parties never litigated would likely be inconsistent with due process.'' Id. at 4. Respondent acknowledges that ``it might well be within the Administrator's purview . . . to invite the Government to issue an Amended Order to Show Cause seeking revocation [under section] 824(a)(3) grounds because of [his] loss of his license.'' Id. at 4-5. I reject both parties' contention that I cannot rely on Respondent's loss of his state authority absent the Government's submission of an amended show cause order. Because the possession of state authority is a prerequisite for obtaining a registration and for maintaining a registration, the issue can be raised sua sponte even at this stage of the proceeding.\55\ Indeed, under the Government's position, had I rejected the Government's case, I would be required to grant Respondent's applications even though he does not meet a statutory requirement for obtaining a registration. --------------------------------------------------------------------------- \55\ Under the Administrative Procedure Act (APA), an agency ``may take official notice of facts at any stage in a proceeding-- even in the final decision.'' U.S. Dept. of Justice, Attorney General's Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). --------------------------------------------------------------------------- Notably, the Government's position is fundamentally inconsistent with the position it has taken in numerous cases where it has issued an Order to Show Cause based on public interest grounds only to subsequently move for summary disposition upon learning that the [[Page 8245]] applicable state board had taken action which rendered the practitioner without state authority. See, e.g., Morgan, 78 FR at 61973-74 (upholding ALJ's granting of government motion for summary disposition based on physician's loss of state authority which occurred post- hearing and holding that due process did not require amending the show cause order; motion for summary disposition provided adequate notice); Roy E. Berkowitz, 74 FR 36758, 36759-60 (2009) (rejecting argument that revocation based on loss of state authority was improper based on board action not alleged in the Show Cause Order; ``The rules governing DEA hearings do not require the formality of amending a show cause order to comply with the evidence. The Government's failure to file an amended Show Cause Order alleging that Respondent's state CDS license had expired does not render the proceeding fundamentally unfair.''). See also Kamal Tiwari, et al., 76 FR 71604 (2011); Silviu Ziscovici, 76 FR 71370 (2011); Deanwood Pharmacy, 68 FR 41662 (2003); Michael D. Jackson, 68 FR 24760; Robert P. Doughton, 65 FR 30614 (2000); Michael G. Dolin, 65 FR 5661 (2000). Here, by virtue of my order directing the parties to address the issues of: (1) Whether Respondent currently possesses authority to dispense controlled substances, and (2) if Respondent does not possess such authority, what consequence attaches for this proceeding, Respondent was provided with a meaningful opportunity to show that he retains his state authority. Of consequence, Respondent does not dispute that he no longer holds authority to dispense controlled substances under Michigan law, this being the only material fact that must be adjudicated in determining whether Respondent's registrations can be revoked and his applications denied under 21 U.S.C. 823(f) and 824(a)(3) as well as the Agency's precedent. That there are no dispositive legal arguments to preclude my reliance on this basis as an additional ground to revoke Respondent's registrations and to deny his applications is not the result of constitutionally inadequate notice. Rather, it is the result of the statute itself, which makes the possession of state authority mandatory for obtaining and maintaining a registration and renders irrelevant the issues of acceptance of responsibility and the adequacy of remedial measures. Accordingly, I will order that Respondent's registrations be revoked and that his pending applications be denied. Order Pursuant to the authority vested in me by 21 U.S.C. 824(a) and 28 CFR 0.100(b), I order that DEA Certificates of Registration BA7776353 and FA2278201 issued to Hatem M. Ataya, M.D., be, and they hereby are, revoked. Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 CFR 0.100(b), I order that all pending applications submitted by Hatem M. Ataya, M.D. be, and they hereby are, denied. This Order is effective immediately.\56\ --------------------------------------------------------------------------- \56\ Based on the extensive findings of egregious misconduct by Respondent, I conclude that the public interest necessitates that this Order be effective immediately. Dated: February 10, 2016. Chuck Rosenberg, Acting Administrator. [FR Doc. 2016-03359 Filed 2-17-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices 8221
Hearing-impaired persons are advised (v) explain how the requested DEPARTMENT OF JUSTICE
that information on this matter can be remedial orders would impact United
obtained by contacting the States consumers. Drug Enforcement Administration
Commission’s TDD terminal on (202) Written submissions must be filed no [Docket No. 14–20]
205–1810. later than by close of business, eight
SUPPLEMENTARY INFORMATION: The calendar days after the date of Hatem M. Ataya, M.D.; Decision and
Commission has received a complaint publication of this notice in the Federal Order; Introduction and Procedural
and a submission pursuant to section History
Register. There will be further
210.8(b) of the Commission’s Rules of opportunities for comment on the
Practice and Procedure filed on behalf On July 23, 2014, the Deputy
public interest after the issuance of any Assistant Administrator, Office of
of Immersion Corporation on February
final initial determination in this Diversion Control, issued an Order to
11, 2016. The complaint alleges
investigation. Show Cause to Hatem M. Ataya
violations of section 337 of the Tariff
Act of 1930 (19 U.S.C. 1337) in the Persons filing written submissions (Respondent), of Lapeer, Michigan. ALJ
importation into the United States, the must file the original document Ex. 1, at 1. The Show Cause Order
electronically on or before the deadlines proposed the revocation of
sale for importation, and the sale within
stated above and submit 8 true paper Respondent’s DEA Certificates of
the United States after importation of
Registration, pursuant to which he is
certain mobile electronic devices copies to the Office of the Secretary by
authorized to dispense controlled
incorporating haptics (including noon the next day pursuant to section
substances in schedules II through V, as
smartphones and smartwatches) and 210.4(f) of the Commission’s Rules of a practitioner, at the registered address
components thereof. The complaint Practice and Procedure (19 CFR of 971 Baldwin Road, Lapeer, Michigan
names as respondents Apple Inc. of 210.4(f)). Submissions should refer to (FA2278201), and at the registered
Cupertino, CA; AT&T Inc. of Dallas, TX; the docket number (‘‘Docket No. 3120’’) address of 3217 W. M–55 Suite B, West
and AT&T Mobility LLC of Atlanta, GA. in a prominent place on the cover page Branch, Michigan (BA7776353), on the
The complainant requests that the and/or the first page. (See Handbook for ground that he has committed acts
Commission issue a limited exclusion Electronic Filing Procedures, Electronic which render his registration
order and cease and desist orders. Filing Procedures).4 Persons with inconsistent with the public
Proposed respondents, other questions regarding filing should interest.1 Id. (citing 21 U.S.C. 824(a)(4)).
interested parties, and members of the contact the Secretary (202–205–2000). The Order also proposed the denial of
public are invited to file comments, not Respondent’s applications for two
to exceed five (5) pages in length, Any person desiring to submit a
document to the Commission in additional registrations,2 on the ground
inclusive of attachments, on any public that ‘‘it is not consistent with the public
interest issues raised by the complaint confidence must request confidential
interest . . . for [him] to be registered
or section 210.8(b) filing. Comments treatment. All such requests should be
with the [Agency] to handle controlled
should address whether issuance of the directed to the Secretary to the substances.’’ Id. (citing 21 U.S.C. 823(f)).
relief specifically requested by the Commission and must include a full The Show Cause Order alleged that
complainant in this investigation would statement of the reasons why the from 2010 through 2013, Respondent
affect the public health and welfare in Commission should grant such ‘‘repeatedly violated [his] obligation
the United States, competitive treatment. See 19 CFR 201.6. Documents under federal law by prescribing
conditions in the United States for which confidential treatment by the controlled substances to [his] patients
economy, the production of like or Commission is properly sought will be outside of the normal course of
directly competitive articles in the treated accordingly. All nonconfidential professional medical practice.’’ Id. at 2
United States, or United States written submissions will be available for (citing 21 CFR 1306.04(a)). Continuing,
consumers. public inspection at the Office of the the Order specifically alleged that
In particular, the Commission is Secretary and on EDIS.5 Respondent’s ‘‘practice of regularly
interested in comments that: prescribing controlled substances to five
(i) Explain how the articles This action is taken under the
patients [who were identified by the
potentially subject to the requested authority of section 337 of the Tariff Act
initials R.E.H., J.W., R.K., R.J.H., and
remedial orders are used in the United of 1930, as amended (19 U.S.C. 1337), J.H.] despite numerous and repeated red
States; and of sections 201.10 and 210.8(c) of flags of drug abuse and diversion, [his]
(ii) identify any public health, safety, the Commission’s Rules of Practice and repeated failures to take appropriate
or welfare concerns in the United States Procedure (19 CFR 201.10, 210.8(c)). steps to monitor [his] patients’ use of
relating to the requested remedial By order of the Commission. controlled substances, and numerous
orders; Issued: February 12, 2016. other actions [he] took in the course of
(iii) identify like or directly treating these patients all indicate that
Lisa R. Barton,
competitive articles that complainant, [he] violated [his] obligations under
its licensees, or third parties make in the Secretary to the Commission. federal law by ‘prescribing [controlled
United States which could replace the [FR Doc. 2016–03344 Filed 2–17–16; 8:45 am] substances] as much and as frequently
subject articles if they were to be BILLING CODE 7020–02–P as the patient demanded’ so that ‘[in]
excluded; practical effect, [he] acted as a large-
mstockstill on DSK4VPTVN1PROD with NOTICES
(iv) indicate whether complainant, scale ‘‘pusher’’ not as a physician.’ ’’ Id.
complainant’s licensees, and/or third
party suppliers have the capacity to 1 The Order alleged that Respondent’s registration
replace the volume of articles 4 Handbook for Electronic Filing Procedures:
number FA2278201 expires on June 30, 2016, and
potentially subject to the requested that his registration number BA7776353 expires on
http://www.usitc.gov/secretary/fed_reg_notices/ June 30, 2017. ALJ Ex. 1, at 1.
exclusion order and/or a cease and rules/handbook_on_electronic_filing.pdf. 2 The applications are for proposed registered
desist order within a commercially 5 Electronic Document Information System
locations in Davidson and Flint, Michigan. ALJ Ex.
reasonable time; and (EDIS): http://edis.usitc.gov. 1, at 1.
VerDate Sep<11>2014 19:03 Feb 17, 2016 Jkt 238001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\18FEN1.SGM 18FEN1](https://thefederalregister.org/doc/81_FR_8253/page/1.svg)
![8222 Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices
(quoting U.S. v. Moore, 423 U.S. 122, make available its DEA District or Field reasoned that under agency precedent,
143 (1975)). The Show Cause Order then Office for this purpose.’’ Id. at 19–20. ‘‘ ‘mitigation’ evidence is not admissible
set forth detailed allegations regarding On November 3, 2014, the ALJ unless and until the registrant fully and
Respondent’s prescribing to each of conducted a further on-the-record unequivocally accepts responsibility for
these patients.3 See id. at 2–6. conference during which he reviewed the wrongful or unlawful conduct on
In addition, the Show Cause Order the parties’ proposed stipulations and which registration consequences are
alleged that on March 26, 2013, ruled on the Government’s Motion to sought.’’ Id. at 5.
Respondent was interviewed by a DEA Exclude Respondent’s Witnesses. See The ALJ granted the Government’s
Diversion Investigator and a local generally Tr. (Nov. 3, 2014). The ALJ motion, agreeing with both of the
Detective. Id. at 6. The Show Cause granted the Government’s motion with Government’s arguments. Specifically,
Order further alleged that during the respect to twelve of Respondent’s the ALJ agreed that Respondent had
interview, Respondent made multiple proposed fact witnesses on the ground failed to describe Ms. Richards’
false statements regarding his controlled that Respondent had not identified with testimony ‘‘with sufficient particularity’’
substance prescribing practices.4 Id. at sufficient particularity their proposed and thus had not complied with his
6–7. testimony because his pre-hearing prehearing order. Tr. 39 (Nov. 3, 2014).
Following service of the Show Cause statements did ‘‘not clearly indicate Also, the ALJ explained that because
Order, Respondent timely requested a each and every matter Respondent Respondent intended to testify that in
hearing on the allegations. ALJ Ex. 2. intend[ed] to introduce in opposition to prescribing to the five patients he had
The matter was placed on the docket of the allegations.’’ Id. at 35–36; see also ‘‘at all times comported with reasonable
the Office of Administrative Law Judges id. at 37–38. The ALJ also granted the and minimally accepted standards’’ and
and assigned to Administrative Law Government’s motion to exclude the that all of the prescriptions were issued
Judge (ALJ) Christopher B. McNeil, who testimony of Respondent’s six witnesses within the usual course of professional
commenced to conduct pre-hearing who were to ‘‘either testify or provide practice and for a legitimate medical
procedures and ordered the parties to testimonials . . . as to [his] character, purpose, this ‘‘compels the conclusion
submit their respective pre-hearing reputation, and qualifications as a that Respondent does not accept
statements. GX 3. Thereafter, the parties physician,’’ ALJ Ex. 39, at 3; stating his responsibility for any failure to conform
submitted their pre-hearing and agreement with the Government’s to the requirements of the’’ CSA. Id. at
supplemental pre-hearing statements. contention that their testimony was 40–41. The ALJ thus concluded that
The parties also filed various motions, irrelevant and that Respondent did not there was ‘‘no need to address whether
the most significant of these being proffer that ‘‘any of these witnesses plan the remedial measures that
(given the issues raised by the Parties in to testify about his treatment of’’ the five [Respondent] claims to have instituted
their Exceptions), the Government’s patients. Id.; see also Tr. 38 (Nov. 3, are adequate to protect the public
Motion to Exclude Respondent’s 2014). interest.’’ Id. at 41.
Witnesses (ALJ Ex. 41). The Government also sought to Notably, during the conference, the
Also, on September 29, 2014, the ALJ exclude the testimony of Ms. Michelle ALJ did not address Respondent’s
conducted an on-the-record conference Ann Richards, who, according to contention that the ALJ had
with the Parties at which he set the Respondent, would ‘‘testify that she is misinterpreted the Agency’s precedents,
initial date for the evidentiary phase of certified in healthcare compliance and that if the case law actually
the proceeding. Tr. 1, 16–17 (Sept. 29, consulting, coding, and office required him to admit to misconduct
2014). During the conference, the ALJ management,’’ and ‘‘that she was which he did not engage in, ‘‘then that
authorized the taking of testimony at retained by Respondent to do risk precedent is inconsistent with
either the Agency’s Arlington, Virginia assessment audit and risk mitigation for procedural due process.’’ ALJ Ex. 45, at
hearing facility or ‘‘by video- his practice.’’ ALJ Ex. 39, at 3. 1 (Resp.’s Response in Opposition to
teleconferencing in the Detroit DEA Respondent also stated that Ms. Govt’s Mot. to Exclude Resp.’s
Office.’’ Id. at 19. The ALJ also Richards would testify that she had Witnesses). Nor did the ALJ address
authorized Respondent and his counsel ‘‘provided compliance training to Respondent’s suggestion that he ‘‘defer’’
to appear at either the Arlington hearing Respondent’s staff [and] that she is his ruling ‘‘until the hearing itself,’’ at
facility or the ‘‘video-teleconferencing continuing to monitor and implement which time the ALJ and the parties
site’’ and ‘‘direct[ed] the Government to changes to ensure [his] medical practice would be in ‘‘a better position to
with all State and Federal laws.’’ Tr. 39. determine whether’’ he ‘‘ha[d]
3 The patient-specific allegations will be set forth In addition to the ground that sufficiently titrated his contrition to
in discussing the evidence pertinent to each patient. Respondent had not adequately permit the introduction of such
4 The Show Cause Order specifically alleged that
summarized Ms. Richards’ testimony, testimony.’’ Id.
Respondent attempted to mislead investigators in the Government also argued that the Finally, the Government moved to
an interview on March 26, 2013, when he told a
DEA Diversion Investigator and a Lapeer City testimony should be barred because exclude the testimony of two physicians
Detective that he was not aware of any prescription Respondent had represented that he who Respondent proposed would testify
pads being stolen, that patient R.E.H.’s fraudulent ‘‘intend[ed] to testify that he has never on his behalf as experts. While
practices were in the past and he was no longer a been out of compliance with such Respondent identified some eight areas
patient, that no controlled substance prescriptions
are phoned in, that he attempted to taper patients laws,’’ and that his ‘‘ ‘care and treatment on which he ‘‘anticipated’’ that the
off of methadone over time, that chronic pain [of the five patients] at all times experts would testify, ALJ Ex. 39, at 3–
patients must have some diagnostic finding to comported with reasonable and 5; the Government argued that the
support their pain and are required to see a specific
mstockstill on DSK4VPTVN1PROD with NOTICES
minimally accepted standards and that disclosure was inadequate because
psychiatrist and attend physical therapy, that each
chronic pain patient must sign and annually renew
all prescriptions were issued for a ‘‘Respondent has not disclosed any
a pain management contract, that MAPS searches legitimate medical purpose by a conclusions that the witnesses have
are usually run for chronic pain patients on every registered physician within the course actually reached regarding the
visit, and that he was unaware of any of his patients of professional practice.’ ’’ ALJ Ex. 42, at prescribing conduct at issue.’’ ALJ Ex.
dying. Id. at 6–7. The Government alleged that
Respondent’s patient files and its investigation
4–5 (Gov. Mot.) (quoting Resp. Pre- 42, at 6. The Government further argued
indicated that these statements and others were Hearing Statement, at 3–4 (Sept. 15, that ‘‘[i]t remains a mystery if these
false. Id. at 7. 2014)). Continuing, the Government doctors have actually reached any
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opinions, to which they will subscribe Respondent testified on his own The ALJ thus concluded that ‘‘the
under oath, to support Respondent’s behalf. He also submitted several Government has established its prima
view that his prescribing was entirely exhibits for the record. After the facie case by at least a preponderance of
legitimate.’’ Id. hearing, both parties submitted briefs the evidence.’’ Id. at 69. The ALJ
The ALJ granted the Government’s containing their proposed findings of explained that ‘‘[w]hen responding to
motion, reasoning that he could not fact and conclusions of law.5 the Government’s prima facie case . . .
‘‘tell from the supplemental prehearing Thereafter, the ALJ issued his Respondent has the opportunity to
statement which witness will espouse Recommended Decision (hereinafter demonstrate that he recognizes any
each of the opinions presented in the cited as R.D.). Therein, the ALJ found noncompliance with controlled
supplemental prehearing statement’’ that the Government’s evidence with substance laws and has taken steps to
and ‘‘whether either of the witnesses respect to Factors Two (Respondent’s ensure against future noncompliance.’’
has a sufficient foundation, obtained experience in dispensing controlled Id. at 68–69. The ALJ then reasoned that
through the review of patient records, or substances) and Four (compliance with under the Agency’s case law, ‘‘in the
otherwise, to express the opinions applicable laws related to controlled absence of evidence of ‘sincere[ ]
presented in the supplemental substances) supported the conclusion remorse[ ],’ a ‘generalized acceptance of
prehearing statement.’’ Tr. 42. The ALJ that ‘‘Respondent’s continued responsibility to the allegations’ is not
also explained that he could not tell registration would be inconsistent with enough to open the hearing so as to
which professional standards the the public interest.’’ R.D. 66–68. permit evidence of remediation.’’ Id.
witnesses were relying on to reach their More specifically, with respect to (citing Govt’s Post-Hrng. Br. 48).
opinions. Id. at 42–43. Finally, while Factor Two, the ALJ found that Finding that ‘‘Respondent has not
the ALJ noted that Respondent proposed ‘‘Respondent demonstrated a material provided substantial evidence meeting
that one of the doctors (who was also lack of . . . experience regarding a this standard,’’ the ALJ concluded that
from Flint, Michigan) would testify that prescribing source’s responsibilities to he ‘‘failed to establish a basis that would
this area ‘‘is infested with drug-seeking resolve red flags when prescribing permit him to rebut the Government’s
addicts, who employ sophisticated controlled substances for persons prima facie case.’’ Id. The ALJ thus
presenting with symptoms of chronic recommended that I revoke Respondent
tricks to deceive and frustrate the most
pain and terminate from his practice registrations and deny his pending
vigilant anti-diversion efforts of
patients whose drug-seeking behavior applications. Id.
healthcare providers,’’ the ALJ reasoned
indicates the potential for abuse or Both parties filed Exceptions to the
that this evidence was irrelevant
diversion (or both) of controlled ALJ’s Recommended Decision.
because Respondent ‘‘intends to
substances.’’ Id. at 67. And with respect Thereafter, the record was forwarded to
establish that his prescription practice
to Factor Four, the ALJ found that ‘‘[a] my Office for Final Agency Action.
complied fully with the requirements of
preponderance of the evidence On review of the record, I noted that
the’’ CSA. Id. at 43. Subsequently, the
establishes that Respondent issued it contained no evidence as to whether
ALJ issued a Journal Entry and Order
controlled substance prescriptions for Respondent is currently authorized
memorializing his various rulings as under Michigan law to dispense
the five patients identified [in the Show
well as the various stipulations agreed controlled substances. Order at 1 (Nov.
Cause Order], in a manner that was not
to by the parties. 10, 2015). Accordingly, I directed the
in the ordinary course of professional
On November 17–18, 2015, the ALJ parties to address whether Respondent
medical practice and was not based
presided over the evidentiary phase of currently possesses authority under
upon legitimate medical justification.’’
the proceeding, conducting a video- Michigan law to dispense controlled
Id. (citing 21 CFR 1306.04(a)). The ALJ
teleconference with he and the reporter substances and if Respondent does not
also found that Respondent violated
being present in Arlington, Virginia, and possess such authority, to address what
Michigan law by post-dating controlled
the witnesses (including Respondent) consequence attaches for this
substance prescriptions and failing to
and the parties’ counsels present at the proceeding. Id.
include ‘‘the patient’s full name and
DEA Detroit, Michigan Field Division On November 17, 2015, the
address’’ on the prescription. Id. at 67–
Office. Id. at 73–74; id. at 423. Notably, Government submitted its Response.
68 (citing Mich. Comp. Laws
from the outset, the proceeding was Therein, the Government noted that on
§§ 333.7333(7), 338.3161(1)(a)); see also
marked by telephonic interference and July 6, 2015, the Michigan Department
id. at 64 (Finding of Fact (FoF) # 3).
interruptions of the transmission, with of Licensing and Regulatory Affairs had
Finally, the ALJ found that Respondent
interruptions occurring nearly 60 times filed an Administrative Complaint with
violated state and federal law by issuing
over the course of a day and half of the Board of Medicine Disciplinary
prescriptions for schedule IV controlled
testimony. See id. at 72 et seq. Subcommittee. Govt’s. Resp., at 7–8;
substances which authorized more than
At the hearing, the Government called five refills. Id. at 68 (citing 21 U.S.C. Govt’s Resp. Ex. 3, at 8–14
four witnesses to testify, including Dr. 829(b); Mich. Comp. Laws
Eugene O. Mitchell, who was accepted § 333.7333(4)); see also id. at 64–65 not support the revocation of his registrations and
as an expert in pain medicine. The (FoF#s 3, 5).6
denial of his pending applications. Id. at 67.
Government also submitted for the As for Factor Five—such other conduct which
may threaten public health or safety—the ALJ found
record an extensive amount of 5 These briefs will be referred to as Post-hearing
that the Government had not proved the allegation
documentary evidence including, inter Briefs. that Respondent made various false statements to
alia, the medical records of the five 6 Noting that ‘‘the record is silent with respect to the Diversion Investigator and Detective. Id. at 68.
the recommendation of the . . . state licensing The ALJ based his conclusion on the fact that ‘‘the
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patients identified in the Show Cause
board,’’ the ALJ found that this factor ‘‘neither written record of that interview was not present’’
Order, copies of various prescriptions supports nor contradicts a finding that and ‘‘the questions presented and answers given
issued to the patients, and copies of Respondent’s continued . . . registration is were not sufficiently established in the record so as
reports obtained from the Michigan inconsistent with the public interest.’’ R.D. 66. The to permit a determination of Respondent’s candor
Automated Prescription System (MAPS) ALJ also found that the Government had neither during [the] interview.’’ Id. Because the
alleged nor provided evidence that Respondent was Government did not take exception to the ALJ’s
showing the controlled substance convicted of a federal or state offense related to the findings on the issue of Respondent’s candor during
prescriptions obtained and filled by manufacture, distribution, or dispensing of the interview, I deem it unnecessary to make any
each of the five patients. controlled substances, and thus, Factor Three does findings related to the allegation.
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(Administrative Complaint, In re Ataya, before the Government was even location of 971 Baldwin Road, Lapeer,
No. 43–15–137995 (Mich. Bd. of Med. required to put on its evidence. Contrary Michigan and does not expire until June
July 6, 2015)). When Respondent failed to the ALJ’s understanding, while a 30, 2016. GX 3, at 1. Respondent has
to respond to the allegations of the respondent’s failure to acknowledge his also applied for two additional
complaint, the allegations were deemed misconduct renders evidence of his registrations: One at the address of 3390
admitted, and on October 30, 2015, the remedial measures irrelevant, the N. State Road, Davison, Michigan; the
Board revoked his medical license. Gov. Agency has never held that a other at the address of 3400
Resp. Ex. 3, at 2–3, 5. In his Response respondent must admit to his Fleckenstein, Flint, Michigan.
to my Order, Respondent states that he misconduct prior to even being able to
does not dispute that the Board has The Investigation of Respondent
test the Government’s evidence at the
revoked his medical license and that he hearing. Respondent first came to the attention
‘‘no longer has any legal authority to I reject, however, Respondent’s of law enforcement on January 5, 2012,
dispense controlled substances, which, contention that a remand is warranted when a Detective with the City of
as a practical matter, he could not for multiple reasons. First, as explained Lapeer Police Department responded to
accomplish from the jail cell he has above, I agree with the ALJ’s conclusion the death of R.J.H., one of the patients
occupied for the past several months that Respondent did not adequately identified in the Show Cause Order. Tr.
anyway.’’ Respondent’s Resp., at 1. disclose the scope of the proposed 90; ALJ Ex. 1, at 1–2. According to the
Having considered the record in its testimony on the adequacy of his Detective, he knew R.J.H. from his
entirety, including the parties’ remedial measures. Second, even were I experience in law enforcement and
Exceptions, as well as the recent action to credit Respondent’s admissions at the knew him to be an abuser of both
taken by the Michigan Board of hearing and give weight to his testimony ‘‘prescription drugs [and] illegal drugs.’’
Medicine, I issue this Decision and regarding the remedial measures he has Tr. 93. The Detective testified that R.J.H.
Final Order. I agree with the ALJ that undertaken, I would nonetheless find bore no signs of external injuries and
the record supports findings that that his conduct was so egregious that there was no evidence that injuries had
Respondent ignored multiple red flags the protection of the public interest led to his death. Id. The police did,
of abuse and/or diversion with respect warrants the revocation of his however, find three empty prescription
to each of the five patients (FoF #2). I registrations and the denial of his vials, including a vial bearing a label for
also agree that the record supports the pending applications. Finally, because 120 methadone 10 7 and clonazepam
ALJ’s factual findings specific to of the recent action of the Michigan (Klonopin), as well as a syringe, on a
Respondent’s prescribing of controlled Board of Medicine, Respondent is nightstand in R.J.H.’s bedroom. Id. The
substances to each of the five patients precluded from being registered because Detective subsequently obtained a
(FOF#s 3, 4, 5, 6, and 7), as well as his he no longer holds authority under state report from the Michigan Automated
legal conclusions that Respondent acted law to dispense controlled substances, Prescription System (MAPS) and found
outside of the usual course of and thus evidence of his acceptance of that both the methadone and Klonopin
professional practice and lacked a responsibility and remedial measures is had been prescribed to R.J.H. by
legitimate medical purpose in irrelevant. See 21 U.S.C. 802(21), 823(f). Respondent on January 3, 2012. Id.
prescribing controlled substances to
Findings of Fact According to the detective, toxicology
each of the five patients in violation of
testing led to the conclusion that R.J.H.
21 CFR 1306.04(a). See R.D. at 66–67. I Respondent’s Licensure and had died of an overdose. Id. at 95. The
further agree with the ALJ that Registration Status Detective also learned that R.J.H. had
Respondent violated federal and state
Respondent was formerly licensed as overdosed on heroin two days before
law when he issued prescriptions
a physician by the Michigan Board of and was taken to the hospital. Id. at 107;
authorizing more than five refills of
Medicine. However, on July 6, 2015, the GX 5, at 1.
schedule IV controlled substances, as
well as when he post-dated a Bureau of Professional Licensing, acting On January 22, 2012, the Detective
prescription and failed to include the on behalf of the Michigan Department of responded to the death of J.W. Tr. 95.
patients’ names and addresses on Professional Licensing and Regulatory The authorities found two pill bottles in
numerous prescriptions. Finally, I agree Affairs, filed a complaint against J.W.’s coat, as well as marijuana. Id. at
with the ALJ’s conclusion that the Respondent. Administrative Complaint, 96, 108. One vial, which bore a label for
Government made out a prima facie In re Ataya, No. 43–15–137995 (Mich. 120 methadone, contained only nine
case that Respondent’s registration is Bd. of Med. July 6, 2015). The methadone pills; however, the vial also
inconsistent with the public interest. Department also ordered that included four Klonopin pills and two
With respect to Respondent’s rebuttal Respondent’s medical license be diazepam. Id. The second vial, which
case, for reasons explained below, I find summarily suspended. Order of bore a label for 120 Klonopin, contained
troubling the ALJ’s handling of the issue Summary Suspension, In re Ataya. only 91 pills. Id. According to the
of whether Respondent has adequately Thereafter, on October 30, 2015, the Detective, J.W.’s body bore possible
accepted responsibility for his Board of Medicine revoked needle marks. Id. at 112.
misconduct. And as for the ALJ’s ruling Respondent’s medical license. Final During his investigation, the Detective
barring Respondent from presenting Order, In re Ataya. determined that on January 19 (three
evidence of his remedial measures, I Respondent currently holds two DEA days earlier), J.W. had obtained
agree with the ALJ that Respondent did practitioner’s registrations, pursuant to prescriptions from Respondent for 120
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not sufficiently disclose the scope of the which he is authorized to dispense methadone 10 and 120 clonazepam 1.
proposed testimony. While this alone is controlled substances in schedules II Id. at 96. According to the Detective, the
sufficient reason to reject Respondent’s through V. GX 4, at 1–2. The first of investigation and toxicology test results
exception, the ALJ further reasoned that these (BA7776353) is for the registered led to the conclusion that J.W. had died
under the Agency’s precedent, location of 5097 Miller Road, Flint, of an overdose. Id. at 96–97.
Respondent is barred from introducing Michigan and does not expire until June
evidence of his remedial measures 30, 2017. Id. at 1. The second 7 All numbers which follow the name of a drug
absent his admission to the allegations (FA2278201) is for the registered refer to the dose per pill in milligrams.
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During the course of his investigation, shows that on July 17, Respondent [h]ydrocodone, and . . . [a]lprazolam’’
the Detective spoke with both J.W.’s issued to R.K. a prescription for 90 and that the patients were ‘‘getting them
mother and niece. The Detective tablets of methadone 10, which R.K. on a regular basis.’’ Id. at 146. The DI
testified that J.W.’s mother said that J.W. filled the next day. GX 22, at 16. The also testified that when alprazolam is
did not like methadone and usually sold cause of R.K.’s death was a drug taken with methadone or hydrocodone,
it to buy other drugs. Id. at 112. overdose. Id. at 101. According to a ‘‘it enhances the effect of the narcotic
According to the Detective, J.S. (J.W.’s police report, a person with Community causing somewhat of a heroin-type
niece) told him that J.W. had been Mental Health stated that R.K. was high.’’ Id. at 147. The DI further testified
released from jail only ‘‘a week or two known to abuse heroin, Tramadol, and that she participated in the execution of
prior to his death.’’ Id. at 98. J.S.’s niece other prescription medications. GX 5, at the search warrant and that she assisted
also told the Detective that she had 17. in the seizure of patient charts and
contacted Respondent’s office and told The Detective testified that because conducted employee interviews. Id. at
him that her uncle ‘‘had a problem’’ his agency did not have a lot of 149. According to the DI, she
with controlled substances ‘‘and asked experience in prescription drug determined what charts to seize by
him not to prescribe any controlled investigations, after R.K.’s death, he reviewing MAPS data and conducting
substances’’ to her uncle. Id. sought the assistance of DEA, and on ‘‘criminal history searches to determine
J.S. subsequently testified that her August 13, 2012, met with a DEA what patients were known to be drug
uncle’s drug problem ‘‘was obvious’’ Diversion Investigator (DI). Tr. 102. Two seekers or had a positive criminal
and that ‘‘[e]verybody knew.’’ Id. at 125. days after the meeting, the mother of history.’’ Id.
She testified that she spoke with another of Respondent’s patients (J.L.H.) The DI testified that ‘‘many of the
Respondent on the phone a couple of contacted the Lapeer Police and charts contained information that
weeks before her uncle was released and reported that she had taken her daughter [showed] that the patients were not
told Respondent that her uncle ‘‘was to see Respondent the day before and taking the controlled substances as they
sick and he didn’t need the medications that he had issued her prescriptions for had been prescribed, or that they had
because he wasn’t taking them’’ and methadone, tramadol and clonazepam. drug addiction issues, or they were
‘‘was selling them.’’ Id. at 128–29. Id. at 102–03. However, the day after narcotic dependent, or any of a number
According to J.S., Respondent initially J.L.H. saw Respondent, her mother of red flags that were indicated in the
‘‘blew [her] off.’’ Id. at 129. However, reported that she was unable to contact charts, and then we sent the patient
when J.S. told Respondent that the J.L.H. at her residence and could not get charts out for expert review.’’ Id. at 156–
police ‘‘wanted to know why [J.W.] had her to answer the door; she thus 57. The DI explained that there were
two prescriptions for Methadone’’ requested the assistance of the police. ‘‘instances where the patient was
which he had not filled, Respondent Id. at 103. The Detective testified that coming [back] before the 30-day[s] had
asked for J.W.’s name, address and date ‘‘[a] neighbor had climbed up on the expired, and were [sic] obtaining
of birth. Id. J.S. also told Respondent roof and looked through a second story additional prescriptions for the same
that J.W. had ‘‘nearly died from window and observed [J.L.H.] on the medication or,’’ the patients were
withdrawal’’ and asked Respondent not couch unresponsive.’’ Id. A police ‘‘obtaining refills of a prescription that
to ‘‘give him these strong medications.’’ officer entered J.L.H.’s home and found had refills written on [it] prior to the
Id. While Respondent said that ‘‘he her ‘‘blue in color and unresponsive.’’ time [that] they should have used [ ] the
wouldn’t do it anymore,’’ id. at 130, as Id. J.L.H. was taken to the hospital. Id. medication up if they were taking it as
found above, Respondent subsequently Several months later, the Detective
directed.’’ Id. at 157.
issued the methadone and clonazepam obtained a warrant to search
The DI testified that the patient
prescriptions to J.W.8 Id. at 96. Respondent’s Lapeer office for several
The Detective also testified regarding patient charts, and on March 26, 2013, records included evidence that
an investigation conducted by a the Lapeer Police Department, DEA, and pharmacies had called Respondent
subordinate into the death of R.K. on or members of the Thumb Narcotics Unit raising issues of whether the patients
about July 21, 2012. Id. at 98–100. (a local multijurisdictional task force) ‘‘were doctor shopping or obtaining
According to the Detective, there was no executed the warrant. Id. at 104. refills early.’’ Id. at 158. The DI also
evidence that R.K. had died of injuries However, the Detective and the DI testified that the files contained ‘‘reports
and upon arriving at the scene, the decided to interview Respondent, who from the State alerting [Respondent]
police found a prescription vial which, was at his Davidson office, prior to about medication issues that they
according to the label, had been issued searching his Lapeer office. Id. wanted him to be aware of’’ regarding
by Respondent four days earlier for 90 During the search of the Lapeer office, ‘‘his prescribing of certain drugs,’’ as
Xanax. Id. at 100. However, the vial was the Detective determined that several of well as ‘‘police reports’’ and ‘‘hospital
empty. Id. the patient files that were being sought reports on several patients indicating
The Detective also obtained a MAPS under the warrant were not at that that they had a history of drug abuse or
report for R.K. Id. The MAPS report office. Id. at 105. Accordingly, the they had been admitted for a drug-
Detective obtained an amended warrant, related issue.’’ Id. The DI testified that
8 Respondent testified that he does not recall the
which authorized searches of she provided Dr. Eugene Mitchell, Jr.,
phone conversation about which J.S. testified, Respondent’s Flint and Davidson with the files of the five patients at issue
explaining that he would not remember what in this proceeding and asked him to
patient the conversation involved because he has offices. Id. The records were
7,500 patients. Tr. 485. He also testified that if subsequently seized and provided to the review the files and identify examples
of Respondent’s issuance of controlled
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someone calls and wants to speak to him about a DI, who had them scanned. Id.
patient, his assistants ask the person ‘‘to come with The Government also called the DI substance prescriptions outside of ‘‘the
the patient and discuss the matter.’’ Id. The ALJ did usual course of medical practice’’ and
not make a finding as to whether J.S.’s testimony who worked with the Detective on the
was credible. R.D. at 9–10. I find her testimony investigation. The DI testified that she which lacked a legitimate medical
credible, noting that while it may be that obtained MAPS reports for Respondent purpose. Id. at 160. According to the DI,
Respondent would not recall the conversation given these specific charts were selected for
the large number of patients he treated, one would
and found that they showed that he
recall a conversation she had with a doctor about prescribed ‘‘a lot of combinations of review by Dr. Mitchell because ‘‘the
a family member. prescriptions for [m]ethadone, findings in these files . . . were
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egregious’’ and four of the five patients Dr. Mitchell holds a medical license Dr. Mitchell also testified that in
were deceased. Id. at 160–61.9 issued by the State of Michigan and is Michigan, a task force of physicians
The DI further testified that in board certified in both anesthesiology developed Guidelines for the
reviewing the patient files she found and pain medicine. Id. at 2. He is also ‘‘appropriate prescribing’’ of controlled
evidence of other violations of the a member of numerous professional substances for the treatment of pain. Id.
Controlled Substance Act and DEA societies including the American at 243; GX 26. These Guidelines have
regulations. Tr. 172–73. These included Academy of Pain Medicine and the been issued by both the Board of
instances in which Respondent American Society of Regional Medicine and the Board of Osteopathic
authorized more than five refills on a Anesthesia and Pain Medicine. Id. Medicine & Surgery. GX 26, at 1. The
prescription; instances in which he Since February 2001, Dr. Mitchell has Guidelines ‘‘recognize that controlled
issued early refills; instances in which held the position of Clinical Assistant substances, including opioid analgesics,
he failed to include a patient’s address, Professor in the Department of may be essential in the treatment of
which is required information on a Anesthesiology, Division of acute pain due to trauma or surgery and
prescription; and instances in which Interventional Pain Medicine, at the chronic pain, whether due to cancer or
Respondent post-dated prescriptions. Id. University of Michigan Medical Center. non-cancer origins.’’ Id. However, the
at 173–74. The DI then testified as to the Id. In this position, he lectures medical Guidelines caution ‘‘that inappropriate
following examples: (1) A Xanax students on pain medicine and trains prescribing of controlled substances,
prescription dated Feb. 9, 2013 issued to fellows in pain medicine as well as including opioid analgesics, may lead to
R.E.H. authorizing six refills (GX 8, at residents, interns, and nursing staff. Id. drug diversion and abuse by individuals
23); (2) a Klonopin prescription dated at 3, Tr. 234. He also is active in who seek them for other than legitimate
August 14, 2012 issued to J.H. practice. Id. Dr. Mitchell was qualified medical use’’ and that ‘‘[p]hysicians
authorizing six refills (GX 19, at 117); as an expert. Id. at 239. should be diligent in preventing the
and (3) a Xanax prescription dated April diversion of drugs for illegitimate
10, 2012 issued to R.K. authorizing six Dr. Mitchell testified ‘‘all controlled purposes.’’ Id. According to the
refills (GX 17, at 49). Tr. 184–86.10 The substances have the risk of significant Guidelines, they ‘‘are not intended to
DI also discussed two examples of morbidities including death from define complete or best practice, but
prescriptions which Respondent issued overdose,’’ ‘‘withdrawal from their use,’’ rather to communicate what the Board
to Patient R.E.H. without including his and ‘‘addiction.11 ’’ Id. He testified that considers to be within the boundaries of
address, and did so even after to reduce the risks associated with the professional practice.’’ Id. at 2.
Respondent had received information abuse and diversion of controlled Dr. Mitchell then testified regarding
that R.E.H., who shared the same first substances, a physician must ‘‘be the ‘‘typical steps taken by doctors in
name as his father, had attempted to fill familiar with the patient’s medical treating patients who suffer from
a methadone prescription using his history’’ and review the patient’s chronic pain.’’ Tr. 247. Dr. Mitchell
father’s name and date of birth. Tr. 182– records so that the physician has ‘‘a testified that when a new patient seeks
84; see also GX 8, at 42 (methadone and clear understanding’’ of the patient’s treatment, a physician ‘‘take[s] a
Xanax prescriptions dated April 19, diagnosis. Id. at 240. Also, the physician detailed history’’ and asks the patient
2012 with patient’s address left blank). must review the patient’s ‘‘history of ‘‘to bring [his/her] records’’ including
abuse’’ and ‘‘[a]ny issue of addictive imaging findings. Tr. 247; see also GX
The Government Expert’s Testimony illness,’’ whether it involves tobacco, 26, at 3–4. Dr. Mitchell explained that
The Government called Dr. Eugene O. alcohol, and both ‘‘licit’’ and ‘‘illicit’’ a physician ‘‘document[s] what [his/her]
Mitchell, Jr., who testified as an expert drugs. Id. chief complaint is’’ and why the patient
on pain management. Dr. Mitchell Dr. Mitchell further testified that there is seeking ‘‘to begin care.’’ Tr. 247.
received a Bachelor of Science in are various compliance tools that he Dr. Mitchell testified that the
Biochemistry in 1975 from the uses to determine whether patients are ‘‘standard medical doctoring for a new
University of Florida and a Bachelor of abusing or diverting controlled patient encounter’’ includes a ‘‘review
Science in Medicine in 1979 from the substances. The first of these is a of [the patient’s] systems’’ and ‘‘[a]n
University of Florida’s Physician’s ‘‘medication agreement’’ between the appropriately detailed physical
Assistant Program. GX 25, at 1. Dr. physician and the patient which sets examination.’’ Id. The physician then
Mitchell subsequently obtained a Doctor forth the ‘‘criteria that [the patient] will makes a diagnosis and creates a
of Medicine in 1985 from the Wayne adhere to’’ while ‘‘being prescribed treatment plan. Id. The physician also
State University School of Medicine. Id. controlled substances.’’ Id. Dr. Mitchell ‘‘modulates the treatment plan’’ in
His post-doctoral training includes an testified that an essential part of the accordance with the patient’s disease
internship in internal medicine and a agreement is ‘‘a clause that allows the process.12 Id. at 248.
residency in anesthesiology (both at the physician to ask the patient’’ to provide
12 With respect to the initial evaluation of the
University of Illinois), and a fellowship ‘‘a random body fluid sample,’’ whether
patient, the Michigan Guidelines state:
in pain medicine at the University of of blood or urine, ‘‘on demand to verify
A complete medical history and physical
Michigan. Id. what is or isn’t present in’’ the patient’s examination must be conducted and documented in
body. Id. at 241. Dr. Mitchell explained the medical record. The medical record should
9 In addition to obtaining each patient’s medical that a further compliance tool is to use document the nature and intensity of the pain,
file, the DI used the MAPS data to obtain copies of the MAPS, Michigan’s controlled current and past treatments for pain, underlying or
the original prescriptions from the various coexisting diseases or conditions, the effect of the
pharmacies.
substance prescription monitoring pain on physical and psychological function, and
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10 The DI also testified regarding two methadone program, which allows a physician to history of substance abuse. The medical record also
prescriptions Respondent issued to R.E.H. in obtain a list of the controlled substance should document the presence of one or more
October 2012, including one which was issued prescriptions filled by a patient in the recognized medical indications for the use of a
notwithstanding that R.E.H. was a week early, and controlled substance.
State. Id. GX 26, at 3. With respect to the creation of a
on which the date of the copy in R.E.H.’s file
appears to have been altered. Tr. 175–80. These treatment plan, the Guidelines state:
prescriptions are discussed more fully in the 11 He also testified that the use of controlled The written treatment plan should state
findings regarding Respondent’s prescribing to substances presents a risk of developing both renal objectives that will be used to determine treatment
R.E.H. and hepatic disease. Tr. 239. success, such as pain relief and improved physical
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Re-emphasizing his earlier testimony, The Patient Specific Evidence prescriptions using his father’s birthdate
Dr. Mitchell testified that as part of the to avoid being detected, Respondent did
R.E.H.
process of formulating a plan involving not take the minimal preventative step
the long term prescribing of controlled The Allegations of including R.E.H’s address on his
substances, the physician reviews the With respect to R.E.H., the methadone prescriptions as required by
medication agreement/opioid contract Government alleged that from August 5, state and federal law;
with the patient and explains that if the 2010 through at least March 13, 2013, • issued a prescription for Xanax to
patient violates the agreement, the Respondent repeatedly prescribed be refilled six times, in violation of state
controlled substances to the patient and federal law; and
patient will be discharged from the
• falsified records to post-date a
practice.13 Id. at 249. Dr. Mitchell further even after Respondent knew that R.E.H.
methadone prescription in order to
explained that the first time a patient ‘‘was engaged in the abuse and/or
provide R.E.H. with an early refill in
presents with a red flag, regardless of diversion of controlled substances, as
violation of state and federal law,
whether the patient has a history of well as prescription fraud.’’ ALJ Ex. 1,
circumventing the efforts by his staff
addiction, the red flag should be at 2. Specifically, the Government
noting that an early refill should not be
documented and the patient should be alleged that Respondent repeatedly
issued.
brought in and given the ‘‘opportunity prescribed methadone, a schedule II
narcotic controlled substance, and other Id. at 3.
to explain what’s going on.’’ Id. at 249–
controlled substances to R.E.H., The Evidence
50. Dr. Mitchell explained that there is
notwithstanding that he presented
a spectrum of red flags which runs from On August 5, 2010, R.E.H. made his
‘‘numerous red flags of diversion and/or
such incidents as a patient claiming to first visit to Respondent. Tr. 254; GX 8,
abuse.’’ Id. The allegations included
have lost a prescription but having ‘‘no at 143. According to his medical record,
that:
other infractions,’’ to a patient whose • R.E.H. repeatedly sought early R.E.H.’s chief complaint was back pain.
‘‘urine screens are inappropriate’’ or refills; Tr. 256; GX 8, at 143. R.E.H. also
whose MAPS report shows they are • R.E.H. repeatedly claimed that his reported a history of abusing heroin,
‘‘multi sourcing. ’’ Id. at 250. prescriptions were lost or stolen; which is a ‘‘significant addictive illness
• pharmacists repeatedly contacted history,’’ Tr. 257, as well as tobacco
Regarding the five patients identified abuse and that he was taking
Respondent’s office to report suspicious
in the Show Cause Order, Dr. Mitchell methadone; however, there is no
behavior by R.E.H.;
testified that he reviewed the patient • MAPS reports in R.E.H.’s file indication that Respondent determined
files including the visit notes, MAPS corroborated reports that R.E.H. and his how much methadone R.E.H. was
reports, and copies of the prescriptions wife were committing prescription taking, which according to Dr. Mitchell
which included the pharmacy labels. Id. fraud; was ‘‘a critical bit of information . . .
at 251. Dr. Mitchell testified that he had • R.E.H. had been recently released because methadone . . . is
identified specific prescriptions which from jail; and approximately five times as potent as
he believed were issued outside of the • hospital records in his file showed morphine.’’ Id. at 256. Dr. Mitchell also
usual course of professional medical that R.E.H. was using illegal drugs. explained that Respondent did not
practice. Id. at 252. Dr. Mitchell further Id. at 2. determine if R.E.H.’s heroin abuse,
explained that he has been ‘‘practicing The Show Cause Order also alleged which he characterized as a ‘‘significant
medicine for nearly 30 years,’’ and that that R.E.H.’s patient file and the addictive illness history’’ was
he is ‘‘familiar with what constitutes prescriptions issued to him show that ‘‘currently active’’ and whether he had
general[ly] appropriate behavior Respondent prescribed methadone on gone (or was going to rehabilitation) for
R.E.H.’s ‘‘first visit without undertaking it. Id. at 257.
regarding prescribing controlled Dr. Mitchell further found that
substances.’’ Id. other actions typical of medical
professionals[,] such as conducting and Respondent’s physical examination was
documenting a complete medical ‘‘very cursory for a new patient’’ as he
and psychosocial function, and should indicate if did not conduct neurological and spinal
any further diagnostic evaluations or other history and physical examination,
requiring that R.E.H. (a self-identified examinations. Id. at 256. He also did not
treatments are planned. After treatment begins, the
physician should adjust drug therapy to the addict) sign a pain management contract require that R.E.H. sign a medication
individual medical needs of each patient. Other or undergo a drug test, running a MAPS contract, id. at 257–58, even though he
treatment modalities or a rehabilitation program search on R.E.H., or creating a written prescribed 30 tablets of methadone 10,
may be necessary depending on the etiology of the
treatment plan.’’ Id. at 2–3. The Show with a dosing instruction of TID or one
pain and the extent to which the pain is associated tablet, to be taken three times per day.
with physical and psychosocial impairment.
Cause Order then alleged that
Respondent: Id. at 255. Dr. Mitchell opined that this
Id. prescription was not issued in the usual
13 Relevant to this testimony, the Guidelines state • Never subsequently required R.E.H.
to sign a pain management contract; course of medical practice. Id. I agree.
that:
• ‘‘repeatedly issued prescriptions to Even though the prescription should
[i]f the patient is determined to be at high risk
for medication abuse or have a history of substance [him] with instructions to take his have lasted for ten days, R.E.H. returned
abuse, the physician may employ the use of a methadone ‘PRN’—thus directing that to Respondent only six days later and
written agreement between physician and patient this self-identified addict should take obtained a new prescription, which was
outlining patient responsibilities, including . . . this powerful opioid analgesic (properly for 90 tablets of methadone, TID (three
mstockstill on DSK4VPTVN1PROD with NOTICES
urine/serum medication levels screening when used in scheduled dosages) on an ‘as times a day). Id. at 258–59. Dr. Mitchell
requested; . . . number and frequency of all testified that this was an early refill and
needed’ basis’’;
prescriptions, refills; and . . . reasons for which
drug therapy may be discontinued (i.e., violation of
• issued at least one prescription on thus required that Respondent ask
agreement). a date when R.E.H.’s patient file R.E.H. why he needed to refill his
GX 26, at 3. The Guidelines further advise indicates that he did not have an prescription four days early and
physicians to periodically ‘‘monitor patient appointment; document the reason he needed the
compliance in medication usage and related • notwithstanding that he knew that early refill. Tr. 259–60. Dr. Mitchell thus
treatment plans.’’ Id. at 4. R.E.H. was attempting to fill the found that the prescription was not
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issued in the usual course of medical contract until apparently December 23, usual course of professional practice to
practice. Id. at 259. He further explained 2010.15 Tr. 270–71; GX 8, at 242. issue a new prescription for a controlled
that R.E.H.’s seeking of the refill was a R.E.H. returned on January 4, 2011. substance in these circumstances. Id. at
matter of concern because of R.E.H.’s GX 8, at 136; GX 15, at 17. Even though 277.
history of drug abuse.14 Id. at 260. R.E.H. was 18 days early, and R.E.H.’s file includes a MAPS report
R.E.H.’s third visit occurred on notwithstanding that the pain contract which was obtained on the morning of
September 21, 2010. Tr. 262. The required him to use his ‘‘medicine at a February 17, 2011, two days after the
progress note documents, however, that rate no greater than the prescribed rate’’ Respondent’s office was notified that
R.E.H. was ‘‘just release [sic] from jail’’ and stated that if he used it at a greater R.E.H. had filled two prescriptions since
and that he had been in jail ‘‘15 days.’’ rate, he would be ‘‘without medication January 26 and had attempted to fill a
GX 8, at 141; Tr. 262. The note further for a period of time,’’ GX 8, at 242; third. GX 8, 236. The MAPS report
states that R.E.H.’s methadone dose was Respondent issued him another corroborated the pharmacy’s report and
increased to 10 mg five times a day for prescription for 90 tablets of methadone showed that R.E.H. had managed to fill
two weeks, suggesting that this had 10 with a dosing instruction of TID and Respondent’s January 26 prescription on
occurred when he was in jail. Id. The PRN (take as needed). GX 8, at 136; GX both that date and on February 1, 2011
note also states: ‘‘methadone x 6 months 15, at 17. Dr. Mitchell testified that this at two different pharmacies. Id. Of
Heroin addiction.’’ GX 8, at 141. prescription was not issued in the usual further note, various entries for these
course of professional practice and that two dispensings are circled, thus
Respondent issued R.E.H. a the usual course of professional practice indicating that someone reviewed them.
prescription for 90 pills of methadone would be to discharge a patient seeking Id. Dr. Mitchell testified that this raised
10, TID. Id. While this should have a prescription two weeks early. Tr. 269. ‘‘another obvious problem with
provided a 30-day supply and thus He also testified that it is not in the [R.E.H.’s] compliance,’’ and that given
lasted until October 21, R.E.H. returned usual course of medical practice to his ‘‘known history of heroin abuse . . .
to Respondent on October 13, eight days prescribe methadone with a dosing appropriate medical care would dictate
early, and obtained a new prescription instruction of PRN because the drug engaging the patient in this behavior,’’
for 90 tablets of methadone 10. Tr. 263– ‘‘has [a] very long half-life’’ and ‘‘takes followed by ‘‘discharging’’ him and
64. Dr. Mitchell testified that R.E.H. was a while . . . to enter the blood’’ stream, urging him ‘‘to go to rehabilitation.’’ Tr.
manifesting a pattern of seeking early and the reason the drug is used for pain 279.
refills and Respondent’s issuance of the is to provide ‘‘a stable blood level’’ of While R.E.H. saw Respondent on both
prescriptions was not within the usual medication. Id. at 274. February 17 and 22, 2011, there is no
course of medical practice because there Respondent did not, however, evidence that Respondent even
was ‘‘no documentation’’ that discharge R.E.H., who returned on addressed R.E.H.’s drug-seeking
Respondent engaged R.E.H. ‘‘as to why January 26, 2011. GX 8, at 135. behavior, let alone discharged him. Id.
this is going on.’’ Id. at 265. Moreover, Notwithstanding that R.E.H. was eight at 280–81; see GX 8, at 132–33. While
Respondent did not attempt to days early, Respondent issued him a Respondent did not prescribe
determine if R.E.H. was ‘‘even taking the new prescription and increased the methadone to R.E.H. at any of his three
medication’’ by demanding that he quantity to 120 pills and the dosing to visits in February 2011, Tr. 281, on
provide ‘‘a urine sample.’’ Id. He also four tablets per day. GX 15, at 19–20. Dr. March 2, he issued R.E.H. a new
did not obtain a MAPS report. Id. Mitchell testified that this prescription prescription for 120 methadone 10, a 30-
R.E.H. returned to Respondent on was also not issued within the usual day supply based on the dosing
November 1, 2010. GX 8, at 139. While course of medical practice. Tr. 270. instruction (QID and PRN). GX 8, at 131;
R.E.H. was 11 days early, Respondent An entry in R.E.H.’s medical record GX 15, at 25. Yet only 21 days later on
issued him another prescription for 90 documents that on February 15, 2011, a March 23, Respondent issued to R.E.H.
tablets of methadone 10 with the same pharmacy called and reported that another prescription for 120 methadone
dosing instruction. GX 8, at 139; Tr. 266. R.E.H. had tried to fill three 10 (also QID and PRN), and only six
While R.E.H. was not early at his next prescriptions for 120 tablets of days later on March 29, Respondent
visit (November 30), when he again methadone in less than one month. GX issued him a prescription for 90 more
obtained a prescription for 90 8, at 18. The note documented that on methadone 10 (TID). Tr. 282; GX 15, at
methadone 10 (one tablet TID, or three January 26, 2011, R.E.H. had filled one 27–30.
times per day), he returned to such prescription at a different Dr. Mitchell testified that there was
Respondent on December 23, and pharmacy using insurance, and that on no justification in R.E.H.’s chart for
obtained a new prescription, which he February 1, 2011, he had filled the Respondent’s issuance of prescriptions,
increased to 120 tablets (TID) even second prescription at a second which authorized the dispensing of a
though he was a week early. Tr. 266–67; pharmacy paying cash. Id. Moreover, on three-month supply of the drug. Tr. 283.
GX 8, at 137–38; GX 15, at 15–16. February 15, R.E.H. had attempted to fill He also testified that these prescriptions
According to Dr. Mitchell, none of the a third prescription at still another were not issued in the usual course of
prescriptions Respondent issued in pharmacy but was denied, after which professional practice. Id.
November-December 2010 were issued he took it to the pharmacy that called The evidence further shows that on
in the usual course of professional Respondent’s office. Id. June 2, 2011,16 Respondent issued to
practice. Tr. 268. However, Respondent Dr. Mitchell testified that ‘‘this is
16 While the Government did not ask Dr. Mitchell
did not require that R.E.H. sign a pain obviously very concerning behavior’’
about the methadone prescriptions issued in April
mstockstill on DSK4VPTVN1PROD with NOTICES
and that a doctor acting the usual course and May 2011, the pattern of early refills continued,
14 The transcript includes a question by of medical practice would summon the as on April 20, 2011, Respondent issued R.E.H. a
Government’s counsel which suggests that R.E.H.’s patient and ask for an explanation. Tr. new prescription for 90 methadone 10 TID, this
second visit occurred on October 11, 2010. See Tr. 276–77. He further testified that it being eight days early (ignoring that R.E.H. had also
260, at Ls 5–6. However, R.E.H.’s medical record obtained methadone on March 23). GX 15, at 31–
includes a progress note for August 11, 2010 and would ‘‘[a]bsolutely not’’ be within the 32. Thereafter, on May 10, 2011, Respondent issued
contains no note for an October 11, 2010 visit. See R.E.H. a prescription for 120 methadone QID, this
GX 8, at 140–42 (progress notes for visits of Aug. 15 The date does not, however, include the year. being 10 days early. Id. at 33–34. Thus, the June 2
11, Sept., 21, and Oct. 13, 2010). GX 8, at 242. prescription was one week early.
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R.E.H. a prescription for 100 tablets of prescriptions listed on the first page of call from a pharmacy, which reported
methadone 10 QID. GX 15, at 37–38. the report has check marks and that R.E.H. was using his father’s
This was followed by additional Respondent’s initial/signature 17 is on birthdate to fill the prescriptions. GX 8,
prescriptions for 120 tablets of the page, thus establishing that at 43. The pharmacy also reported that
methadone 10 QID on June 16, July 12, Respondent reviewed the document. Id. it had called R.E.H.’s father who stated
July 14, August 9, and August 23, 2011. at 185. that ‘‘he doesn’t receive [sic] this
Id. at 41–42, 45–46, 47–48, 51–52, 53– Dr. Mitchell testified that the report script.’’ Id. As Dr. Mitchell testified, this
54. The June 16 prescription was 11 would indicate ‘‘[g]reat concern for was evidence that R.E.H. was forging
days early, and while the July 12 what’s going on’’ to a doctor acting in prescriptions. Tr. 296; see also 21 U.S.C.
prescription was only four days early, as the usual course of medical practice as 843(a)(3) (rendering it unlawful to
Dr. Mitchell testified, the July 14 it showed that R.E.H. was ‘‘[o]btaining ‘‘knowingly or intentionally . . .
prescription was 28 days early. Tr. 284– hundreds of tablets of methadone.’’ Tr. acquire . . . a controlled substance by
85. Moreover, the August 9 prescription 291. The report also showed that R.E.H. misrepresentation, fraud, forgery,
was also early, and the August 23 had obtained other controlled deception, or subterfuge’’). Asked
prescription was 16 days early. Id. at substances (alprazolam and whether it was appropriate for
286. Yet there is no progress note for the hydrocodone) from two additional Respondent to continue to issue
August 23 prescription and no entry in pharmacies during these two months. controlled substance prescriptions to
the log used to document various GX 8, at 185–86. Thus, R.E.H. had used R.E.H., Dr. Mitchell answered:
activities. GX 8, at 15–20 (log entries); a total of six pharmacies. Id.; Tr. 291– ‘‘[a]bsolutely no.’’ Tr. 297. Yet, on
id. at 120–21 (progress notes for Aug. 9 92. March 6, 2012, Respondent issued
and Sept. 13, 2011, but not Aug. 23). Dr. The evidence also showed that another prescription to R.E.H. for 120
Mitchell testified that Respondent’s Respondent was prescribing methadone methadone 10.18 GX 15, at 107.
issuance of the early methadone refills and other controlled substances On July 12, 2012 (in the interim,
during the June through August period (alprazolam and hydrocodone) to Respondent had continued issuing
was not within the usual course of R.S.H., who was R.E.H.’s wife, and that prescriptions for 120 methadone 10 to
professional practice. Id. at 287. he obtained a MAPS report on her only R.E.H., several of which were early 19),
R.E.H.’s patient file also includes minutes after obtaining the MAPS report Respondent obtained another MAPS
copies of two prescriptions for 120 on R.E.H. GX 13, at 161–68. The MAPS report showing the controlled substance
Vicodin ES (QID), which were dated report showed that between October 11, prescriptions filled by R.E.H. GX 8, at
November 17 and 22, 2011. GX 8, at 2011 and November 28, 2011, R.S.H. 204–12. The report includes the
191–92. The document bearing the filled seven prescriptions for 120 handwritten notation of ‘‘was not seen
November 17 prescription includes the methadone 10, four prescriptions for 90 on this day’’ in 14 separate entries for
notation: ‘‘Please verify—just filled this alprazolam (in either .5 or 1 mg dose), methadone prescriptions which list
RX on 11/17 for 30 day supply—then and prescriptions for 90 and 120 Respondent as the authorizing
the follow[ing] RX was brought in 11/ hydrocodone 7.5. Id. at 161–63. Notably, practitioner.20 See id. at 204–09. The
23/11.’’ Id. at 192. The document further the MAPS reports listed the same report also bears Respondent’s signature
asked: ‘‘please call Walmart’’ and address for R.S.H. and R.E.H. Compare on the first page. Id. at 204. Dr. Mitchell
included the notation of ‘‘suspicious GX 13, at 161; with GX 8, at 185. explained that these entries ‘‘typically
RX.’’ Id. Regarding this information, Dr. mean[ ]’’ either that Respondent was
Dr. Mitchell testified that ‘‘as a stand- Mitchell testified that ‘‘the concerns issuing the prescriptions without seeing
alone incident it’s very concerning’’ speak[ ] for itself [sic]. There’s R.E.H. or that R.E.H. had stolen a
because ‘‘[i]t smacks of prescription something very troublesome and prescription pad. Tr. 299. Yet
forgery.’’ Tr. 288. However, in R.E.H.’s potentially life threatening going on Respondent issued R.E.H. still more
case, it was ‘‘just another incident . . . here with multitudes of refills, repeated prescriptions for 120 methadone 10 on
in his history that just masked a horrible incidents,’’ given ‘‘there’s some July 24, August 15, September 18, and
addictive illness, diversion or both.’’ Id. indication that they’re cohabiting October 8, 2012, as well as a
at 288–89. Dr. Mitchell then explained together and have the same last name.’’ prescription for 60 methadone 10 on
that a physician’s ‘‘primary concern’’ is Tr. 294–95. Dr. Mitchell then testified September 4; each of the last four
the welfare of his/her patients, and a that it was not within the usual course prescriptions was early. GX 15, at 125–
physician ‘‘need[s] to protect them from of professional practice to continue 36.
their addictive illness and document it writing methadone and other controlled The evidence further shows that even
and refer them to a’’ detoxification substance prescriptions given these when Respondent’s nurse noted in
facility and not just ‘‘feed’’ their circumstances. Id. at 295. However, R.E.H.’s file that R.E.H. was seeking an
addiction ‘‘by continuing to write Respondent did not stop issuing early refill, Respondent nonetheless
medications.’’ Id. at 289. methadone and other controlled issued a post-dated prescription to him.
R.E.H.’s patient file also includes a As found above, the evidence shows
substance prescriptions to R.E.H. after
MAPS report which Respondent that on October 8, 2012, Respondent
he learned of this. Id. at 295. Instead, on
obtained on December 9, 2011. GX 8, at
both December 21 and 22, 2011,
185–90. The report showed that during 18 There is, however, no progress note for this
Respondent issued R.E.H. two more
the months of October and November visit. See GX 8, at 113–14 (notes for visits of Mar.
prescriptions for 120 methadone 10, and 22 and Feb. 28, 2012 but not for Mar. 6).
2011, R.E.H. had filled six prescriptions
he continued issuing methadone 19 The prescriptions were issued on March 22,
mstockstill on DSK4VPTVN1PROD with NOTICES
for 120 methadone 10 (with four of the
prescriptions to R.E.H. for another 15 April 19, May 15, June 6, and June 26. GX 15, at
prescriptions having been filled 109–24. Each of the prescriptions was for a 30-day
months. GX 15, at 87–90, 155–56.
between Nov. 10 and 29) and that R.E.H. Moreover, on February 29, 2012, supply, and thus the March 22, June 6, and June
had used four different pharmacies. Id. Respondent’s office received a phone
26 prescriptions were early.
20 The ‘‘was not seen on this day’’ notations are
at 185–86. However, R.E.H.’s patient file
also written in entries for an alprazolam
includes progress notes only for visits 17 This initial/signature is the same as that used prescription (filled on 1/3/12) and for two
on October 10 and November 11. Id. at on the numerous prescriptions contained in the hydrocodone prescriptions (filled on 12/30/11 and
116–119. Notably, each of the record. 11/19/11). GX 8, at 207, 209.
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issued R.E.H. a prescription for 120 the practice. With the option to go to J.W. was engaged in the abuse and/or
methadone 10.21 GX 8, at 32. However, rehabilitation. diversion of controlled substances.’’ ALJ
a progress note for an October 29, 2012 You can’t just let him go off and not have Ex. 1, at 3. Specifically, the Show Cause
visit includes a nurse’s note stating: some kind of aftercare. I mean—he’s a very Order alleged that Respondent
sick individual . . . regarding his addictive
‘‘med refills—Ibuprophen—asked for illness.
repeatedly prescribed controlled
methadone, last refill 10/8/12.’’ Id. at Id. at 303–04. Yet even after the substances to J.W. notwithstanding
100. Also, a note in a log dated October December 12, 2012 hospitalization, numerous red flags of diversion and/or
30, 2012 states: ‘‘Pt requests a refill on Respondent continued to issue more abuse. Id. These included that:
methadone—and last refill was 10/8/ methadone prescriptions to R.E.H. See • J.W. repeatedly sought early refills;
12—not time yet.’’ Id. at 15. A MAPS GX 15, at 143 (Rx of 12/27/12); 145 (Rx • the Michigan Medicaid program
report obtained by the Government notified Respondent that J.W. was
of 1/22/13); 149 (Rx 2/19/13); 155 (Rx 3/
shows that R.E.H. filled two methadone doctor-shopping;
13/13). Moreover, on February 19, 2013,
prescriptions with an issue date of
Respondent issued R.E.H. a prescription • a pharmacy also notified
October 8, 2012—one on October 8th, Respondent that J.W. was doctor-
for 90 Xanax with six refills.22 GX 15,
the other on October 30th. GX 20, at 14; shopping;
at 151.
see also GX 15, at 135–36 (Rx filled on • J.W. was incarcerated;
Oct. 8); id. at 137–38 (Rx filled on Oct. Following Dr. Mitchell’s testimony, • J.W. exhibited withdrawal
30). Not only was the second Respondent testified on his own behalf. symptoms; and
prescription post-dated—a violation of After acknowledging that he had • a MAPS report obtained by
21 CFR 1306.05(a) which requires that listened to all of Dr. Mitchell’s Respondent in October of 2011 showed
‘‘[a]ll prescriptions for controlled testimony, Respondent was asked by his that J.W. was engaged in a persistent
substances shall be dated as of, and counsel if Dr. Mitchell is ‘‘right or pattern of doctor and pharmacy
signed on, the day when issued’’—it wrong about you ignoring the red flags shopping.
was also another early refill which about patients who are or could be
Id.
should not have been filled. Tr. 301 abusing or diverting drugs?’’ Tr. 484.
Respondent answered: ‘‘He’s right.’’ Id. The Show Cause Order also alleged
(testimony of Dr. Mitchell).
On December 12, 2012, R.E.H. was Subsequently, the ALJ asked that J.W.’s patient file and the
admitted to a hospital after he Respondent if he (the ALJ) was ‘‘correct prescriptions issued to him show that
overdosed on Seroquel. GX 8, at 158. in understanding that you’ve read the Respondent:
While in the hospital, R.E.H. provided order to show cause?’’ Id. 535. • Prescribed Adderall, a schedule II
a urine drug test which was positive for Respondent answered: ‘‘I did.’’ Id. The stimulant, to J.W. on his first visit
cocaine. Id. He also was diagnosed as ALJ then asked Respondent: ‘‘Do you without diagnosing him with Attention
‘‘polysubstance dependen[t].’’ Id. at 159. agree that the facts that they allege there Deficit Disorder (ADD), and that he
A copy of the hospital report was are all true?’’ Respondent answered: ‘‘I prescribed other controlled substances
provided to Respondent and bears his did.’’ Id. The ALJ followed up by asking: without taking actions typical of
signature. Id. at 158. ‘‘Your answer was yes you do?’’ Id. medical professionals such as
Dr. Mitchell testified that upon Respondent answered: ‘‘Yes.’’ Id. conducting and documenting a
learning that R.E.H. was using cocaine, I find (as did the ALJ) that Dr. complete medical history and physical
the appropriate response was to refer Mitchell provided credible testimony examination, or creating a written
him to inpatient drug rehabilitation as that Respondent ignored multiple red treatment plan;
R.E.H. ‘‘obviously’’ had ‘‘a life flags that R.E.H. was abusing and • prescribed numerous controlled
threatening illness manifested by his diverting controlled substances and that substances to J.W. without conducting a
addicting behavior’’ as well as to cease Respondent lacked a legitimate medical MAPS search ‘‘that a typical Michigan
prescribing controlled substances to purpose and acted outside of the usual doctor would have conducted,’’ and that
him. Tr. 303. Asked by the Government course of professional practice when he such a search would have shown that
whether there ever was a point at which continued to prescribe methadone and J.W. was engaged in ‘‘a dangerous
Respondent should have stopped other drugs in the face of the red flags. pattern of doctor and pharmacy
writing controlled substance While this alone constitutes substantial shopping (through which J.W. obtained
prescriptions to R.E.H., Dr. Mitchell evidence to support a finding that 11 monthly prescriptions for Adderall
testified: Respondent violated 21 CFR 1306.04(a) within the first six months of 2011)’’;
and 21 U.S.C. 841(a)(1) in prescribing to • prescribed methadone to J.W. with
The short answer is yes. But the whole
format of the care is so appalling that he J.E.H., this conclusion is buttressed by a PRN (take as needed) dosing
never had a drug contract in the beginning Respondent’s testimony that Dr. instruction ‘‘within a week of meeting
and it’s just one infraction after another. Mitchell was ‘‘right’’ when he testified him and repeatedly thereafter’’;
So if you had started from the very that Respondent ignored multiple red • ‘‘never subjected J.W. to any drug
beginning, the patient already told you that tests’’; and
flags.
he has a history of heroin abuse. So if you • ‘‘took no action to enforce the pain
were to make the decision to treat his . . . J.W. management contract that J.W. signed
back pain . . . there has to be
documentation. The Allegations on his first visit, in which [J.W.]
Discussing with the patient about concerns committed (among other things) to
The Show Cause Order alleged that obtain controlled medications from only
regarding his illness, contract agreed upon
from December 23, 2010 through one provider (Respondent), fill them at
mstockstill on DSK4VPTVN1PROD with NOTICES
and . . . random urine samples as well as
MAPS surveys being pulled. January 4, 2012, Respondent one pharmacy, and take them at the
In my opinion, in this case, after the ‘‘repeatedly prescribed controlled prescribed dosages.’’
second early refill, he’d be discharged from substances after [he] came to know that
Id. at 3–4.
21 Here again, there is no progress note for this 22 However, the pharmacy apparently caught the The Evidence
visit. See GX 8, at 100–101 (progress noted for visits fact that Respondent had provided too many refills,
on Oct. 3 and 29, 2012). However, a copy of the and noted that only five refills were authorized. GX J.W. first saw Respondent on
prescription is in R.E.H.’s patient file. 15, at 152. December 23, 2010. GX 9, at 42.
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According to a nurse’s notation on the J.W.’s file includes a fax of a ‘‘Notice Compare GX 9, at 4; with id. at 69. Thus,
progress note, J.W. was seeking of Prior Authorization Determination,’’ J.W. was simultaneously obtaining
treatment for pain. Id. Respondent which Respondent received from the prescriptions for both methadone and
prescribed to J.W. 60 tablets of Adderall Michigan Medicaid program on or about Suboxone, which according to Dr.
20, with a dosing instruction of BID or January 21, 2011. GX 9, at 69. The form Mitchell ‘‘is not done.’’ Tr. 316.
one tablet to be taken twice a day. GX noted that a prior authorization request Dr. Mitchell testified that in response
16, at 1. One week later, J.W. returned had been received and provided the to this information, the appropriate
to Respondent, who wrote him a name of another physician (Dr. M.) who course would be to discharge the patient
prescription for 90 tablets of methadone had prescribed Adderall to J.W.; it also and recommend that he go to inpatient
5, with a dosing of TID and PRN. Id. listed a pharmacy other than the one drug rehabilitation. Id. at 316. Dr.
at 3. which J.W. had listed on the Pain Mitchell testified that he would ‘‘have
Dr. Mitchell testified that neither Management Agreement he entered into called the other physician’’ to tell him/
prescription was issued in the usual at his first visit with Respondent. her that J.W. was engaged in
course of professional practice. Tr. 308. Compare GX 9, at 69; with id. at 70. As ‘‘potentially . . . life threatening’’
As for the Adderall prescription, Dr. Dr. Mitchell explained, this is ‘‘evidence behavior. Id. Yet there is no evidence in
Mitchell explained that the drug is that . . . J.W. [wa]s multi-sourcing for J.W.’s file that Respondent did this. Id.
‘‘typically’’ prescribed to treat ADD amphetamine from another physician.’’ On both March 16 and April 6, 2011,
(Attention Deficit Disorder) or ADHD Tr. 311. However, in the Pain Respondent wrote J.W. additional
(Attention Deficit Hyperactivity Management Agreement, J.W. had prescriptions for 60 Adderall. GX 16, at
Disorder). Id. Dr. Mitchell explained agreed that he would ‘‘not attempt to 21–22; id.at 25–26. According to Dr.
that neither J.W.’s chief complaint nor obtain controlled medicine, including Mitchell, J.W. was a week early when he
history ‘‘would indicate an appropriate . . . stimulants . . . from any other received the April 6 prescription.23 Tr.
diagnosis for the prescribing of doctor, provider or facility.’’ GX 9, at 70; 317. Dr. Mitchell explained that J.W.’s
Adderall.’’ Id. Dr. Mitchell also see also Tr. 312. While the Pain early refills and doctor shopping was ‘‘a
observed that Respondent’s assessment Management Agreement also stated that continued obvious flag to the physician
and plan also contained ‘‘no indication if J.W. broke the agreement, Respondent that there’s something going on here
of any appropriate diagnosis for’’ would stop prescribing controlled that can potentially put the patient’s life
Adderall. Id. Reviewing the notes for the substances and discharge him, at risk.’’ Id.
first visit, Dr. Mitchell also questioned Respondent did not do so. See GX 9, at The evidence also shows that in the
whether Respondent had performed a 70. first six months of 2011, Respondent
physical exam, as in the space on the Dr. Mitchell further explained that wrote J.W. six prescriptions for 60
progress note for listing the exam upon learning that J.W. was obtaining Adderall.24 GX 21, at 19–25. Dr.
findings, Respondent had scribbled ‘‘an Adderall from another doctor, Mitchell testified that these
S.’’ GX 9, at 42. Regarding the notation, Respondent should have engaged J.W. prescriptions were not issued in the
Dr. Mitchell testified that ‘‘I don’t know and obtained an explanation for why he usual course of professional practice. Tr.
what that signifies.’’ Id. at 309. While was obtaining prescriptions from two 317–18.
Dr. Mitchell also noted that the margin different doctors and documented the The evidence further shows that
of the progress note included a listing of encounter. Tr. 313. Respondent, Respondent issued to J.W. prescriptions
various areas with boxes in which however, did not do this. Id. at 314 (GX
for 60 Adderall 30 (BID) and 120
9, at 39). Instead, he issued J.W. another
Respondent wrote either plus or minus Klonopin (QID) on both July 6 and 26.
prescription for 60 Adderall. Tr. 314;
signs, he further testified that he was GX 16, at 41–52. According to Dr.
ALJ Ex. 50, at 2; GX 16, at 7–8. Asked
‘‘not sure what they’re trying to Mitchell, both of the July 26
whether Respondent’s issuance of the
communicate.’’ Id. prescriptions were ‘‘approximately a
prescription was within the usual
Dr. Mitchell testified that it was week early’’ (actually, they were 10 days
course of professional practice, Dr.
inappropriate for Respondent to issue early), and there was no justification in
Mitchell answered ‘‘no’’ and added that
the methadone prescription at J.W.’s the patient file for issuing the
‘‘[t]he whole beginning for the
second visit. Id. Asked to explain why, prescription when Respondent did. Tr.
prescriptions of Adderall were not
Dr. Mitchell testified that: 318.
issued in the course of legitimate
There’s no documentation that the patient methods of practice.’’ Tr. 314–15. On October 25, 2011, Respondent
is having any findings based on physical On February 16, 2011 (22 days later), received a fax from the Medical
examination that would serve as a foundation J.W. again saw Respondent. GX 9, at 38. Department of the Lapeer County Jail.
for prescribing [me]thadone. Even though the Respondent wrote J.W. a new The fax stated that J.W. was an inmate
records are reviewed, I don’t see any and requested information as to his
prescription for 60 Adderall even
documentation where it states the patient prescriptions and diagnosis. GX 9, at 47.
had previously taken [m]ethadone or was on though he was eight days early. Tr. 315.
Respondent also wrote J.W. a Respondent reported that J.W. was on
any analgesics whatsoever. methadone for chronic pain and
And then there’s some notation that’s very prescription for 120 methadone 10. GX
hard to make out, it says something Vicodin. 16, at 11. Adderall for EDS and ADD. Id. at 47.
I can’t really read it, but it’s in the middle However, only two days later (Feb. The same day, Respondent obtained a
of the HPI box. 18), Respondent’s office received a MAPS report on J.W. GX 9, at 48–51;
I’m not really sure what it’s trying to phone call from a pharmacy reporting 79–83. The report showed that J.W. was
communicate. Whether it’s regarding prior still obtaining controlled substance
mstockstill on DSK4VPTVN1PROD with NOTICES
that insurance would not cover J.W.’s
Vicodin prescription or what. So it’s really methadone prescriptions and that he prescriptions for Suboxone and
not legible. was seeing Dr. M. who was prescribing Adderall from Dr. M., while also
Id. at 309–10. As he testified regarding Suboxone to him—Dr. M. being the
23 Actually, he was nine days early.
Respondent’s prescribing to R.E.H., Dr. same doctor listed as the medical 24 While Dr. Mitchell testified that 10
Mitchell re-iterated that it was not provider on the prior authorization prescriptions were issued to J.W. in this period,
appropriate to prescribe methadone for request form Respondent had received three of them were issued by Dr. M., the other by
pain on a PRN basis. Id. from the Michigan Medicaid program. a Dr. R. GX 21, at 19–25.
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obtaining prescriptions for methadone, then asked by his counsel if Dr. Mitchell allowed R.K. to obtain up to 2,250
hydrocodone and Adderall from is ‘‘right or wrong about you ignoring tablets of Xanax;
Respondent. See id. As found above, the red flags about patients who are or • issued a prescription for Xanax to
while J.W. was incarcerated, his niece could be abusing or diverting drugs?’’ be refilled six times, in violation of state
contacted Respondent and told him that Tr. 484. Respondent answered: ‘‘He’s and federal law; and
J.W. had ‘‘nearly died from withdrawal’’ right.’’ Id. • stopped testing R.K. to determine if
and that he was selling his medications; Based on Dr. Mitchell’s credible he was taking the methadone
she also asked him to stop prescribing testimony, I find that the controlled Respondent prescribed after R.K. tested
controlled substances to J.W. Tr. 128– substance prescriptions Respondent negative on two consecutive monthly
29. Dr. Mitchell explained that under provided to J.W. lacked a legitimate drug tests.
these circumstances, he would confront medical purpose and were issued Id. at 4–5.
the patient regarding whatever the outside of the usual course of The Evidence
family reported and ‘‘let the patient professional practice and violated the
react and respond.’’ Tr. 323. CSA. 21 CFR 1306.04(a); 21 U.S.C. At the beginning of the Government’s
J.W. did not see Respondent again 841(a)(1). This finding is buttressed by examination of Dr. Mitchell about
until December 21, 2011. GX 9, at 25. Respondent’s admission that Dr. Respondent’s prescribing to R.K., the
Regarding the progress note for the visit, Mitchell was correct in his criticism that ALJ raised his ‘‘concern about evidence
Dr. Mitchell testified that ‘‘the physical he ignored red flags. that becomes cumulative at some point
exam is really nothing, it says awake in a preceding [sic].’’ 26 Tr. 326. The
and stable.’’ Tr. 324. As for J.W.’s chief R.K. Government thus did not ask Dr.
complaint, Dr. Mitchell testified that The Allegations Mitchell about the prescriptions
Respondent’s writing was illegible. Id.; Respondent issued to R.K. from his first
see also GX 9, at 25. Respondent did not The Show Cause Order alleged that visit (January 27, 2011), through and
issue any prescriptions to J.W. on this from January 27, 2011 through July 17,
day.25 ALJ Ex 50, at 3. 2012, Respondent repeatedly prescribed 26 According to the ALJ, ‘‘[t]hat can happen in
J.W. returned on January 4, 2012. On controlled substances to R.K. after two ways in this particular preceding [sic]. And one
the progress note, Respondent lined Respondent knew that R.K. was engaged way is that you [the Government] present evidence
in the abuse and/or diversion of of many patients and the other way is to present
through a box next to the words stating evidence of many forms of failure to treat in a
‘‘substance abuse +, reviewed w/ controlled substances. ALJ Ex. 1, at 4. manner that’s required in the ordinary course of
patie[nt].’’ GX 9, at 24. However, the The Show Cause Order specifically medical practice.’’ Tr. 326–27. Continuing, the ALJ
progress note is otherwise illegible. See alleged that Respondent repeatedly explained that:
prescribed to R.K. controlled substances So far I’ve heard more than one instance. In fact,
id. Also, Respondent resumed multiple instances of prescribing [m]ethadone on a
prescribing controlled substances to despite the numerous red flags of PRN basis, which the witness has told me is
J.W., issuing him prescriptions for 30 diversion and/or abuse R.K. presented. inconsistent with medical practice.
tablets of Valium 10 mg and 120 tablets Id. These included that: Not having a complete medical history, not
of Tylenol with Codeine No. 4. ALJ Ex • R.K. repeatedly sought early refills; having a physical examination noted in the file, not
50, at 3. • Respondent was notified by the writing a treatment plan, diagnosing controlled
substances without sufficient support in the
On January 19, 2012, J.W. made his Michigan Department of Community medical record through objected[sic] testing,
final visit to Respondent and obtained a Health Drug Utilization Review that imagining [sic] or other data, prescribing controlled
prescription for 120 tablets of R.K. was doctor shopping; substances prematurely before the expiration of the
methadone 10 with a dosing instruction • a pharmacist contacted [his] office prior prescription, concurrent prescriptions from
more than one prescribing source, filling those
of QID and PRN. Tr. 325; GX 16, at 59– reporting suspicious conduct by R.K.; prescriptions in more than one pharmacy, failure to
60. Asked whether the prescription was and properly utilize the MAPS data in the record,
issued in the usual course of • two consecutive drug tests on April failure to discharge and failure to enforce the pain
10, 2012 and May 8, 2012 showed that medication treatment plan and contract.
professional practice, Dr. Mitchell Id. The ALJ then announced that ‘‘[t]o the extent
answered ‘‘no.’’ Tr. 325. Asked ‘‘why R.K. was not taking the methadone that
that proposed testimony is redundant in these
not,’’ Dr. Mitchell explained: ‘‘[w]ell Respondent had prescribed to him. fields, I will be sensitive to an objection that the
again, the same basis. Where is the Id. evidence does not have an informative role and
The Show Cause Order also alleged becomes less useful to me as it is cumulative at that
justification, based on the patient[’s] point.’’ Id. The ALJ thus directed the Government
clinical complaints, a detailed that R.K.’s patient file and the to ‘‘tailor your questions appropriately’’ and
examination, a clear diagnosis that prescriptions issued to him show that advised Respondent’s counsel that ‘‘I will be
[m]ethadone was justified.’’ Id. As for at Respondent: listening to you for your concern as well.’’ Id. at
what point during his treatment of J.W. • Prescribed controlled substances to 328.
R.K. on his first visit without taking Contrary to the ALJ’s understanding, the
Respondent should have refused to Government was entitled to put on evidence
prescribe controlled substance and actions typical of medical professionals, regarding each and every allegation it had raised in
discharged him, Dr. Mitchell answered: such as conducting and documenting a the Order to Show Cause and its pre-hearing
complete medical history and physical statements. That the Government had previously
Again, it would be early on with the early shown that Respondent failed to obtain a complete
refills. The behavior that is an obvious flag examination, or creating a written
history and conduct an adequate physical exam, or
by the patient for addiction illness. Which he treatment plan; that he failed to address red flags such as repeated
has a history of. History of drug abuse is • never required R.K. to sign a pain early refill requests or ignored evidence of doctor
documented in the chart. management contract or ran a MAPS shopping and the use of multiple pharmacies, etc.,
with respect to patients R.E.H. and J.W., does not
mstockstill on DSK4VPTVN1PROD with NOTICES
Id. at 326. report on him;
render evidence as to whether he acted in the same
• engaged in a pattern of issuing
As found above, Respondent testified manner with respect to the other three patients
Xanax prescriptions to R.K. on a near redundant. Furthermore, notwithstanding that
that he had listened to all of Dr.
monthly basis that authorized multiple evidence of a single act of diversion can, in
Mitchell’s testimony. Respondent was appropriate circumstances, support an order of
refills, and that while the dosing
revocation, it is for the Government to decide, in
25 However, on October 18, 2011, J.W. had filled instructions directed R.K. to take 690 the exercise of its prosecutorial discretion, on the
an Adderall prescription which Respondent had tablets in the 10-month period number of patients (and prescriptions) that are
written for him on the same day. GX 16, at 57–58. preceding his death, the prescriptions necessary to prove its case.
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including R.K.’s visit of October 4, 2011. (by more than 1,000 pills) of what was new prescription for 90 methadone 10.
See id. at 330–36; GX 10, at 52–65. necessary based on Respondent’s dosing GX 10, at 6, 43; GX 17, at 55–56.
On October 20, 2011, Respondent instructions.27 Tr. 331. Dr. Mitchell Notwithstanding that R.K. had provided
issued R.K. a prescription for 60 tablets further testified that Respondent pattern negative urine samples on his two
of Xanax .5 mg, with a dosing of issuing multi-month prescriptions on previous visits, there is no evidence that
instruction of BID or PRN. ALJ Ex. 50, top of one another is ‘‘not a customary, Respondent required R.K. to provide a
at 3; Tr. 330. The prescription legitimate medical practice behavior.’’ new urine sample. Tr. 335. And while
authorized three refills, ALJ Ex. 50, at 3; Id. at 332. Respondent put a slash mark through
and based on the dosing instruction, the The Government also questioned Dr. the box next to the entry ‘‘Substance
prescription provided R.K. with a four- Mitchell about Respondent’s prescribing Abuse +, reviewed w/patient,’’ GX 10, at
month supply of the drug. However, Dr. of methadone to R.K. On March 13, 43; as Dr. Mitchell explained: ‘‘There’s
Mitchell testified that there was nothing 2012, Respondent first prescribed 90 no detail, it’s just merely a swipe of the
in the progress note for this visit which methadone 5 mg (TID + PRN), a 30-day pen.’’ Tr. 336. Continuing, Dr. Mitchell
justified providing R.K. with a four- supply, to R.K. GX 17, at 45–46. noted that there is ‘‘[n]o documentation
month supply of the drug. Tr. 330. However, on April 10, 2012, R.K. tested of, I discussed with the patient two
Yet, not even six weeks later on negative for methadone. GX 10, at 31. A negative urines samples, so forth and so
November 29, 2011, Respondent issued note in the entry states: ‘‘ran out week . . . my plan was so forth and so on.’’
R.K. an additional prescription for 60 ago.’’ Id. Id.
Xanax .5 mg (BID or PRN), with three Regarding this incident, Dr. Mitchell
Asked by the Government whether
refills. ALJ Ex. 50, at 3; Tr. 330. Here testified that ‘‘[i]f a patient was truly
there was ever a point when Respondent
again, Dr. Mitchell testified that there taking [m]ethadone . . . and they
should have discharged R.K., Dr.
was no medical justification in the abruptly ran out, they would go through
visit’s progress note for providing R.K. significant medical withdrawal.’’ Tr. Mitchell answered ‘‘[y]es.’’ Id. While Dr.
with another four-month supply of 333. Dr. Mitchell further explained that Mitchell explained that he would give
Xanax. Tr. 330–31. a physician ‘‘would engage the patient, the patient the benefit of the doubt, after
On January 17, 2012, Respondent are you taking, what’s the problem here? the second negative urine test, ‘‘he
provided R.K. with another prescription Find out why the chaotic pattern in would definitely be discharged.’’ Id. Dr.
for 60 Xanax (BID and PRN), with three your lab results, when you are Mitchell further agreed that every
refills. ALJ Ex. 50, at 3. Moreover, prescribing the medication for them and controlled substance prescription
Respondent increased the strength of give them a chance to respond.’’ Id. Dr. Respondent issued to R.K.’s after the
the drug to 1 mg. Id. While this Mitchell also stated that even if he second negative urine test was issued
prescription alone again provided R.K. believed in giving the benefit of the outside of the usual course of
with a four-month supply, on February doubt to the patient he would still ask professional practice. Id. at 336–37.
15, 2012, Respondent provided R.K. the patient why the patient ‘‘never During cross examination, Dr.
with another prescription for 60 Xanax bothered to contact’’ him and would Mitchell agreed that by referring R.K. to
1(BID and PRN) with three refills. Id. also express his ‘‘concern[ ] about a physical therapist to treat the patient’s
On April 10, 2012, Respondent what’s going on with [the patient’s] back pain, Respondent was employing a
provided R.K. with another prescription behavior.’’ Id. at 334. multifaceted treatment plan. Id. at 446.
for Xanax 1, increasing the quantity to At the April 10 visit, Respondent However, Dr. Mitchell found that there
90 tablets and the dosing to TID (and issued R.K. a new prescription for 90 was no medical evidence to support
PRN). Id. Moreover, Respondent methadone 10 mg (TID), which was Respondent’s prescribing of methadone,
authorized six refills, this being a double the strength of what he had and there was no evidence that
separate violation of the Controlled previously prescribed. GX 17, at 47–48. Respondent ever tested R.K. to
Substances Act, which, with respect to Moreover, while Respondent subjected determine if he was using the
a schedule IV drug, prohibits refilling a R.K. to another drug test during his next medication as prescribed. Id. at 335.
prescription ‘‘more than five times’’ visit (May 8, 2012), R.K. again tested Based on the above, I find that all of
unless the practitioner renews the negative for methadone claiming that he the controlled substance prescriptions
prescription. See 21 U.S.C. 829(b). had run out several days earlier.28 GX issued by Respondent to R.K. on and
Notwithstanding the numerous refills 10, at 31. Yet here again, Respondent after October 20, 2011 lacked a
R.K. had remaining on both the issued R.K. a new prescription for 90 legitimate medical purpose and were
February 15 and April 10 prescriptions methadone 10 TID. GX 17, at 51–52. issued outside of the usual course of
(not to mention the supply R.K. had Dr. Mitchell testified that ‘‘[t]here is professional practice. 21 CFR
likely obtained from the earlier no legitimate foundation for’’ the 1306.04(a).
prescriptions), Respondent provided prescription. Tr. 335. And when asked
him with new prescriptions for 90 what the appropriate response was to R.J.H.
Xanax 1 (TID or PRN) on May 8 and R.K.’s having provided a second The Allegations
May 30, 2012. ALJ Ex. 50, at 4. While negative urine test for methadone, Dr.
these two prescriptions did not Mitchell answered: ‘‘[d]ischarge.’’ Id. The Show Cause Order alleged that
authorize any refills, on June 21, 2012, On May 30, 2012, R.K. again saw from March 10, 2011 through November
Respondent provided R.K. with another Respondent, who provided him with a 30, 2011, Respondent repeatedly
prescription for 90 Xanax 1(TID or prescribed controlled substances to
mstockstill on DSK4VPTVN1PROD with NOTICES
27 A review of the MAPS data suggests that the
PRN), which authorized three refills. Id. R.J.H. after he knew that R.J.H. was
actual figure was 1890 tablets, as one dispensing
Finally, at R.K.’s last visit, Respondent which occurred on January 15, 2012 is listed twice.
engaged in the abuse and/or diversion of
provided him with another prescription GX 22, at 11. Either way, the amount of alprazolam controlled substances. Id. at 5.
for 90 Xanax 1 (TID or PRN). Id. R.K. was able to obtain based on Respondent’s Specifically, the Government alleged
According to Dr. Mitchell, from prescriptions far exceeded what was necessary that Respondent prescribed controlled
based on the dosing instructions.
October 20, 2011 through July 17, 2012, 28 The actual notation in R.K. drug screening
substances to R.J.H., notwithstanding
R.K. ‘‘obtained 1950 tablets of record states: ‘‘last pill Saturday.’’ GX 10, at 31. In numerous red flags of diversion and/or
alprazolam,’’ an amount far in excess May 2012, May 8 was a Tuesday. abuse, including:
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• R.J.H. repeatedly sought early regimen. Tr. 338. Dr. Mitchell further methadone to R.J.H. at the June 8 visit,29
refills; explained there was ‘‘no’’ justification on June 15, 2011, he issued R.J.H.
• R.J.H. repeatedly reported lost or for Respondent’s having quadrupled another prescription for 60 tablets of
stolen prescriptions; R.J.H.’s daily dose. Id. methadone 5 to be taken twice a day or
• another patient reported that R.J.H. Progress notes in R.J.H.’s file show PRN. GX 18, at 21–24.
was selling his prescription of that R.J.H. had appointments with While this prescription should have
methadone and taking his girlfriend’s Respondent on both May 18 and May lasted R.J.H. for 30 days, only six days
prescription as his own; and 26, 2011. GX 11, at 52–53. Moreover, on later on June 21, 2011, Respondent
• R.J.H. was requesting controlled May 17, 2011, Respondent wrote R.J.H. issued to R.J.H. a prescription for 60
substances by name. a new prescription for 120 tablets of tablets of methadone 10, thereby
Id. at 5. methadone 10 QID and PRN), and on doubling the daily dose. Id. at 25–26.
The Government also alleged that May 26, 2011, he wrote R.J.H. another Thus, this refill was early by 24 days.
R.J.H.’s patient file and the prescriptions prescription for 120 tablets of Moreover, Respondent continued to
issued to him show that Respondent: methadone 10 (QID and PRN). GX 18, at provide R.J.H. with additional early
• Prescribed controlled substances to 15–16, 19–20. Attempting to interpret refills. Specifically, only 15 days later
R.J.H. on his initial visit without taking Respondent’s handwriting on the May on July 6, Respondent issued to R.J.H.
actions typical of medical professionals 26 progress note, Dr. Mitchell thought a prescription for 60 methadone 10
such as conducting and documenting a that R.J.H had reported ‘‘that the (BID/PRN). Id. at 27–28. Even ignoring
prescription was stolen,’’ Tr. 339, and the June 15 prescription, this refill was
complete medical history and physical
according to a notation on the May 26 early by 15 days.
examination, requiring that R.J.H. (a
prescription, R.J.H. told the pharmacist Only 13 days later on July 19, 2011,
self-identified addict) sign a pain Respondent issued to R.J.H. a
management contract or submit to a that ‘‘he was beat[en] up and his meds
were stolen.’’ GX 18, at 20. A further prescription for 120 of methadone 10
drug test, running a MAPS search on (QID, or four times a day), thereby
R.J.H., and creating a written treatment notation on the prescription states:
‘‘Early refill Ok’d by Dr. Ataya Police doubling the daily dose and quantity.
plan, which was periodically re- Id. at 29–30. And on August 11, 2011,
evaluated; Report on file. Per Christina @Dr.
he issued to R.J.H. another prescription
• never subjected R.J.H. to drug tests; Ataya’s.’’ Id.
for 120 tablets of methadone 10 to be
• never ran a MAPS report on R.J.H.; Dr. Mitchell testified that when a
taken four times a day or PRN. Id. at 31–
• never required R.J.H. to sign a pain patient claims that his medication has
32. Even ignoring the prescriptions prior
management agreement; and been stolen, ‘‘there needs to be some
to July 19, this prescription was still one
• repeatedly prescribed methadone to action on the patient[’s]’’ part. Tr. 339.
According Dr. Mitchell, ‘‘part of the week early.30
R.J.H. to be taken ‘‘PRN.’’ As Dr. Mitchell testified, there was no
Id. at 5. opioid contract [is] that if medications
justification for Respondent’s rapid
are stolen, you have to make a police
The Evidence escalation of R.J.H.’s daily dose. Also,
report.’’ Id. There is, however, no police
Respondent ignored red flags such as
The Government’s presentation with report in R.J.H.’s file. See generally GX
R.J.H.’s claim on two occasions that his
respect to R.J.H. focused primarily on 11. Nor is there an opioid contract. See
prescription had been stolen, the report
the manner in which Respondent also generally id.; Tr. 341.
that he was selling his methadone and
escalated the amount of methadone he On June 8, R.J.H. again saw
using his girlfriend’s, and R.J.H.’s
prescribed and ignored various red Respondent. GX 11, at 51. A nurse’s
repeated seeking of early refills, some of
flags. R.J.H. first saw Respondent on note on the progress note states: ‘‘meds
which were weeks early. Moreover,
March 10, 2011, at which time (stolen).’’ Id. Dr. Mitchell testified that
while Respondent knew that R.J.H. had
Respondent documented that R.J.H. had the appropriate response to this
a history of narcotic abuse he did not
a history of narcotic abuse. GX 11, at 3, information would be to discharge the
require him to sign a pain contract,
57; see also Tr. 341. At the visit, patient. Tr. 340–41. Dr. Mitchell
never conducted a drug test on him, and
Respondent issued to R.J.H. a subsequently explained that the point at
never obtained a MAPS report. Based on
prescription for 30 tablets of methadone which Respondent should have
the above, I find that Respondent lacked
5 to be taken twice a day, providing a discharged R.J.H. was ‘‘after the second
a legitimate medical purpose and acted
15-day supply. GX 18, at 1–2; ALJ Ex. report of medications being stolen’’
outside of the usual course of
50, at 4. Thereafter, on a March 24, without verification ‘‘of that event
professional practice when prescribed
2011, Respondent issued to R.J.H. a happening.’’ Id. at 342. Dr. Mitchell
methadone to R.J.H. 21 CFR 1306.04(a).
prescription for 90 tablets of methadone further noted that while Respondent
TID, providing a 30-day supply, and on documented that R.J.H. ‘‘has a history of J.H.
April 5, 2011, he issued to R.J.H. a narcotic abuse,’’ there is no evidence The Allegations
prescription for 40 tablets of methadone that Respondent required him to sign a
10 (QID and PRN). GX 18, at 5–6, 9–10; pain management contract. Id. at 341. The Show Cause Order alleged that
ALJ Ex. 50, at 4. Moreover, on April 19, Dr. Mitchell also found no evidence that from June 10, 2010 through August 12,
2011, Respondent issued to R.J.H. a Respondent conducted any drug tests on 2012, Respondent repeatedly prescribed
prescription for 120 tablets of R.J.H. and there were no MAPS reports controlled substances to J.H. even after
Methadone 10 (QID and PRN). GX 18, at in R.J.H.’s file. Id. at 341–42. he knew that she was engaged in the
The evidence also shows that on June
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11–12; ALJ Ex. 50, at 4. Thus, between 29 Rather, he prescribed 30 tablets of Tylenol with
the March 10 and April 19 7, 2011, an employee of Respondent
Codeine No. 3 (‘‘Tylenol 3’’).
prescriptions, Respondent had documented that he/she ‘‘was told by 30 Thereafter, Respondent issued additional
quadrupled R.J.H.’s daily methadone another patient that [R.J.H.] was selling methadone prescriptions to R.J.H. on an
dose from 10 to 40 milligrams. his prescription of methadone, and approximately monthly basis up until January 3,
taking his girlfriend[’]s prescription as 2012, the same day he overdosed on heroin and was
Dr. Mitchell testified that this was ‘‘a hospitalized. GX 23, at 6–8. As found above, R.J.H.
significant escalation in’’ the total ‘‘24 his own.’’ GX 11, at 9. While died of an overdose on or about January 5, 2012.
hour dose’’ of R.J.H.’s methadone Respondent did not prescribe GX 5, at 1.
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abuse and/or diversion of controlled Respondent diagnosed J.H. as ‘‘narcotic point, the ALJ declared the line of
substances. ALJ Ex. 1, at 5. Specifically, dependent.’’ GX 12, at 125; Tr. 343. questioning ‘‘redundant’’ and no further
the Government alleged that While Dr. Mitchell stated that he did not clarification was obtained as to whether
Respondent repeatedly prescribed know if Respondent was ‘‘trying to Dr. Mitchell was referring to prescribing
controlled substances to her indicate a history of abuse by that or administering. Yet the evidence
notwithstanding numerous red flags of statement or he wasn’t familiar with the shows that Respondent continued to
diversion and/or abuse, including that: definitions of addiction versus prescribe methadone and other
• J.H. repeatedly sought early refills; dependence,’’ he explained that the controlled substances to her. GX 24.
• J.H. requested controlled decision to start a patient on methadone The evidence further shows that on
medications by name; ‘‘depends on the history you gleaned September 8, 2010, J.H. called
• J.H. was in frequent contact with from the patient and what the old Respondent’s office ‘‘and stated that she
Respondent’s office regarding her pain medical records showed,’’ because stopped Xanax 33 and went back to
medications; ‘‘you’re essentially becoming their Klonopin b/c she didn’t like the way it
• J.H. tested negative for controlled addictionologist and beginning made her feel.’’ GX 12, at 7. Respondent
substances that Respondent had treatment for them.’’ Id. at 346. provided J.H. with prescriptions for 60
prescribed to her; However, according to Dr. Mitchell, clonazepam on September 15, October
• Respondent diagnosed J.H. as when a physician determines that a 13, November 10, and a prescription for
narcotic dependent; patient is narcotic dependent, it is not 30 tablets on November 30, 2010. GX 24,
• hospital records in Respondent’s appropriate to prescribe methadone at 5–8.
file show that J.H. tested positive for without requiring the patient to sign an However, on December 1, 2010, he
illegal drugs; and opioid agreement, conduct drug tests, issued J.H. a prescription for 60
• J.H. exhibited symptoms of and obtain a prescription monitoring alprazolam 1.34 Id. at 8. Moreover, only
withdrawal. program report. Id. at 346–47. one week later on December 8,
Id. at 5–6. There is, however, no evidence that Respondent issued J.H. a prescription
The Show Cause Order also alleged Respondent required J.H. to enter an for 90 clonazepam. Id. While on January
that J.H.’s patient files and the opioid agreement. Tr. 347; see also GX 4, 2011, Respondent issued her another
prescriptions Respondent issued to her 12 (J.H.’s patient file). Moreover, while prescription for 90 clonazepam, on
show that he: Respondent did eventually obtain a January 13, he issued her a prescription
• Issued controlled substance MAPS report, he did not do so until for 30 alprazolam 1. Id. In the ensuing
prescriptions to J.H. on her initial visit November 30, 2012, more than two months, Respondent continued to
without taking actions typical of years after he diagnosed her as narcotic provide J.H. with both clonazepam and
medical professionals such as dependent.31 See GX 12, at 8–13. alprazolam prescriptions, even though
conducting and documenting a The evidence shows that on both drugs are benzodiazepines.35
complete medical history and physical November 26, 2010, Respondent issued According to Dr. Mitchell, there was
examination, and creating a written to J.H. a prescription for 90 methadone ‘‘[n]o’’ medical reason for Respondent to
treatment plan; 5 (TID), a 30-day supply. GX 19, at 21– prescribe both drugs after J.H. stated
• diagnosed J.H. as being narcotic 22. Yet, according to J.H.’s file, on that she did not like how the alprazolam
dependent but took no actions such as December 1, 2010, she was suffering made her feel. Tr. 351.
referring her to rehabilitation or a from narcotic withdrawal. Tr. 349. Dr. The evidence also shows that on
specialist, or even minimal Mitchell testified that when confronted August 3, 2011, Respondent issued J.H.
precautionary steps such as requiring with this situation, the appropriate
her to sign a pain management contract, response of a physician acting within for referral for treatment.’’ 21 CFR 1306.07(b). This
subjecting her to comprehensive drug the bounds of professional practice is to is so even when the physician ‘‘is not specifically
registered to conduct a narcotic treatment
tests, or even running MAPS reports on send the patient ‘‘to the hospital.’’ Id. program.’’ Id. However, the physician may not
her, and that MAPS reports would have When then asked if it was an administer ‘‘more than one day’s medication’’ at a
shown that she was engaged in doctor appropriate response to continue to time and may not do this for ‘‘more than three
and pharmacy shopping; issue controlled substance medication days.’’ Id.
• prescribed two different
33 Respondent had prescribed 30 alprazolam .25
to the patient, Dr. Mitchell testified mg to J.H. on August 31, 2010. GX 24, at 4.
benzodiazepines—Klonopin and ‘‘absolutely not.’’ 32 Id. at 349–50. At this 34 J.H. filled the Nov. 30 clonazepam prescription
Xanax—to J.H. even after she reported and the December 1 alprazolam prescription on the
that she would not be using Xanax but 31 The report shows prescriptions beginning only days they were they were issued.
using Klonopin instead; on August 31, 2011. GX 12, at 8–13. The report 35 The evidence shows that during 2011,
• repeatedly prescribed methadone to shows several instances in which J.H. obtained
small amounts of hydrocodone and acetaminophen
Respondent issued J.H. prescriptions for 90
clonazepam on Feb. 2, Mar. 1, April 5, May 3, June
J.H. to be taken ‘‘PRN’’; and with codeine from a dentist in the May 2012 time 1, June 28, July 26, August 25 (with three refills
• prescribed Adderall to J.H. without period, and a further prescription for a small which were filled on Sept. 21, Oct. 15, and Nov.
any basis for doing so, continued to amount of hydrocodone from another dentist on 10), and Dec. 13. GX 24, at 9–12. During 2011, he
prescribe Adderall after drug tests September 14, 2011. GX 12, at 8, 13. However, also issued J.H. prescriptions for 90 alprazolam 1
every other prescription listed in this report was on Mar. 15, for 30 alprazolam .5 on April 20, and
showed that she was not taking the issued by Respondent. for 30 alprazolam .25 on June 21. Id. at 9–11.
drug, stopped conducting drug tests to Of note, the Government also submitted a MAPS During 2012, Respondent issued J.H. a
determine if J.H. was taking the report it obtained showing J.H.’s prescriptions from prescription for 90 clonazepam on Jan. 5, with three
Adderall he prescribed, and only January 8, 2010 through February 2013. However, refills that were filled on Feb. 1, Feb. 19, and Mar.
the questioning regarding the MAPS reports was 10; a prescription for 90 clonazepam on Mar. 28;
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stopped prescribing the drug when the interrupted by telephonic interference seven times a prescription for 120 clonazepam on April 25, with
Michigan Medicaid program asked him and is not clear what the precise questions were and three refills, two of which were filled on May 15
to substantiate his prescriptions. which of the MAPS reports the Government was and June 6; a second prescription for 120
Id. at 6. referring to in its questions. Tr. 348–49. clonazepam on April 25, which was filled on July
32 A DEA regulation, however, expressly 4; and two prescriptions for 90 clonazepam on
The Evidence authorizes a physician to administer (but not August 14, one of which was filled the same date,
prescribe) a ‘‘narcotic drug[ ] to a person for the the other being filled on December 8. Id. at 14–17.
The progress note for J.H.’s November purpose of relieving acute withdrawal symptoms Respondent also issued her a prescription for 15
10, 2010 visit shows that on that date, when necessary while arrangements are being made alprazolam .5 on May 22, 2012. Id. at 15–16.
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a prescription for 30 Adderall 10, with medical purpose and were issued obtain MAPS reports] more often, but
a dosing instruction to take one tablet outside of the usual course of definitely not in every visit.’’ Id. at 482.
daily. GX 19, at 71–72. However, at professional practice. 21 CFR He further asserted that ‘‘we do referral
J.H.’s August 31, 2011 appointment, J.H. 1306.04(a). As the evidence shows, [of] patients for diagnostic, for another
tested negative for the drug; a note on while Respondent knew that J.H. was specialty, depends on their need.’’ Id.
the drug screening results sheet states: dependent on narcotics, he: (1) Did not He also asserted that he attempts to
‘‘last Adderall 2 days ago.’’ GX 12, at 61. require her to sign an opioid agreement; control his patients’ symptoms, while
Respondent, however, issued her a new (2) did not obtain a MAPS report on her ‘‘try[ing] to taper them off the
prescription for 30 Adderall 10 at the until two years after he determined that medication, if possible, while they are
visit. GX 19, at 77–78. she was dependent; (3) conducted only getting another treatment like the
Dr. Mitchell testified that J.H.’s clean three drug tests over the course of the physical therapy or going to the pain
urine tests raised the same concerns 26 months that he prescribed to her; (4), management, some going to
(i.e., that the patient was either abusing did not refer her to treatment when she counseling.’’ Id. at 484.
or diverting the drug to others) as he was suffering from withdrawal even As found above, Respondent
testified to when asked about the though he had given her a 30-day acknowledged that he had ‘‘listened to
significance of a negative test for methadone prescription only five days all of’’ Dr. Mitchell’s testimony. Id.
methadone. Tr. 352. He also testified earlier and continued to prescribe Respondent then testified that Dr.
that Respondent’s issuance of a new methadone to her; and (5) repeatedly Mitchell was ‘‘right’’ about his having
Adderall prescription after the negative prescribed both alprazolam and ignored the red flags that the five
test result raised the same concern that clonazepam to her, even after she had patients were diverting or abusing
the prescription was ‘‘outside the told him that she did not like the way drugs. Id.
typical practice of medicine.’’ Id. the Xanax (alprazolam) made her feel. Respondent further testified that he
Finally, the Government questioned Concluding its direct examination, the had reviewed multiple online
Dr. Mitchell as to whether there was a Government asked Dr. Mitchell: ‘‘Of the Continuing Medical Education
point at which Respondent should have prescriptions that we have discussed courses,37 and that the week before the
stopped prescribing controlled today, are there any that you’ve found hearing, he attended a three-day ‘‘course
substances to J.H. Id. at 355. According to be legitimate, issued for [a] legitimate about prescribing medication and
to Dr. Mitchell, ‘‘in the face of [J.H.’s] purpose or within the usual practice of dealing with the addicted patients.’’ Id.
history of drug abuse . . . [a]fter the medicine?’’ Tr. 356. Dr. Mitchell at 486, 495. He also stated that he was
second negative urine that would be a answered: ‘‘Not for the controlled referring his patients who have chronic
[sic] unavoidable, irrevocable sign to substances.’’Id. pain to ‘‘pain management.’’ Id. at 496.
discharge her from the practice.’’ Id. However, he then testified that it takes
Respondent’s Testimony
However, while the Patient Drug six to twelve weeks for a patient to
Respondent testified on his own obtain an appointment with pain
Screening Results form states that J.H.
behalf. According to Respondent, he management in the Lapeer, Michigan
was negative for amphetamine on
graduated from medical school in area and that in the meantime, he has
October 11, 2011 and includes the
Damascus, Syria in 1993, and after ‘‘to continue the patient’s
notation ‘‘Ran out 8 days ago,’’ GX 12,
moving to the United States, he did an treatment.’’ 38 Id.
at 61; on the date of this test,
internal medicine residency which he Respondent further asserted that
Respondent had last issued her an
completed in 2002. Tr. 469. Thereafter, ‘‘[s]ince the interview on the show
Adderall prescription on August 31,
Respondent started practicing at nursing cause, it came to [his] attention some
2011, and that prescription provided her
homes and assisted living facilities and wrong way in doing and dealing with
with a 30-day supply.36 As there is no also worked as an urgent care and ER
evidence as to how long amphetamines patients’’ and he ‘‘went back and
physician. Id.; see also RX J. Respondent review[ed] what he’s been doing and
would still be present in a patient’s did this until 2009 when he purchased
urine after the last use, no weight can inquire[d].’’ Id. at 495. He also testified
a ‘‘very small practice’’ of 120 patients that he had invested in electronic
be given to this testimony. What is in Davidson, Michigan from a retired
notable, however, is that over the entire medical records because with three
physician. Tr. 470. Respondent testified offices, it was a ‘‘major problem . . .
course of Respondent’s prescribing to that in the meantime he studied hospice following the patients.’’ Id. He also
J.H., which lasted from June 10, 2010 and palliative medicine and became
through August 12, 2012, Respondent board certified in 2012. Id. at 469. On 37 However, it is unclear the extent to which these
conducted only three urine tests, with some date which Respondent did not courses actually addressed the prescribing of
the last one being done on November specify, Respondent also began working controlled substances and the monitoring of
15, 2011. GX 12, at 61. at a medical practice in Lapeer, patients for abuse and diversion. While Respondent
Notwithstanding that no weight can also testified that he has subscribed to Audio
Michigan, which had 150 patients. Id. at Digest, a CME program which provides lessons on
be given to Dr. Mitchell’s testimony 471. a CD with a questionnaire, he then acknowledged
regarding the October 11, 2011 drug According to Respondent, when he that this program ‘‘[h]as nothing to do with’’ his
tests, I find that the evidence otherwise started his internal medicine practice, prescribing practices and involves ‘‘medical
supports a finding that Respondent education in general internal medicine.’’ Tr. 504–
he ‘‘did not expect this influx of chronic 05.
provided J.H. with controlled substance pain patient[s], and . . . was not 38 Following his testimony regarding his referring
prescriptions which lacked a legitimate planning to have a clinic for chronic his chronic pain patients to pain management,
Respondent’s counsel asked him if he had also
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36 According to the ALJ, the parties stipulated that
pain patients.’’ Id. at 482. While
employed ‘‘some outside help to do criminal
Respondent issued a prescription for 60 Adderall 10
addressing the DI’s testimony regarding background checks of [his] existing patients, look at
on October 1, 2011. ALJ Ex. 50, at 5. However, the the statements he made in the 2013 your current policies and procedures as they relate
patient file does not contain a prescription for this interview, Respondent offered various to pharmaceuticals that,’’ at which point the
date (as opposed to October 11, 2011) and the statements regarding the ‘‘general’’ transmission cut out. Tr. 497–98. When, however,
MAPS report which the Government obtained does the transmission was re-established, Respondent’s
not list any Adderall/amphetamine prescription as
‘‘way’’ in which he practices medicine. counsel asked only: ‘‘Did you make any efforts to
having been issued between August 31 and October Id. at 484. Specifically, he testified that hire outside consultants to come and make some
11, 2011. GX 24, at 12–13. in 2011 and 2012, ‘‘we start to do it [i.e., recommendations regarding your office?’’ Id. at 498.
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hired a consultancy to review his objected, and the ALJ sustained the Government asked Respondent whether
practice’s policies and procedures objection. Id. he also agreed with Dr. Mitchell’s
which met with his employees and Next, the Government asked testimony that he had ‘‘issued
discussed issues such as Respondent: ‘‘[w]hat are the signs for prescriptions outside of the usual course
‘‘communicat[ing] with the patients, abuse and diversion of controlled of practice or for nonlegitimate medical
keeping their records, follow[ing] their substances?’’ Id. Respondent’s counsel purposes?’’ Id. at 534. Respondent’s
records, referring the patients, and objected. After the ALJ overruled the counsel objected, asserting that ‘‘[w]e’ve
talking to the families and objection, Respondent testified: ‘‘[w]hat said everything Dr. Mitchell has said
patients.’’ 39 Id. at 499. Finally, do you mean diversion exactly?’’ Id. about prescribing in the face of red flags
Respondent bought a safe. Id. This prompted the ALJ to instruct is correct.’’ Id. at 535. The ALJ did not,
On cross-examination, Respondent Respondent that ‘‘if you don’t know however, rule on the objection. See id.
further asserted that after being served how to answer the question, just tell me Instead, the ALJ asked Respondent if he
with the Show Cause Order, he started that you don’t know.’’ Id. Respondent had read the Show Cause Order, and
doing more frequent drug screening ‘‘to answered: ‘‘I do not.’’ Id. after Respondent acknowledged that he
identify any problematic patients.’’ Id. The Government then asked had, the ALJ asked if he ‘‘agree[d] that
at 512. However, he also explained that Respondent what signs he looks for to the facts that they allege there are all
‘‘before we tried to do drug screening see if a patient is abusing medication. true?’’ Id. Respondent answered ‘‘[y]es.’’
but it was very expensive for the patient Id. at 527–28. Respondent answered: Id.42
because [it was] not covered’’ by a local Well, if they’re using, now a patient if he Discussion
insurance plan. Id. Moreover, he offered is taking the pain medication and they have
As noted above, both parties filed
no further detail as to how frequent the extra pain and taking medication, extra pill
or extra two, this is a view that what you exceptions to the ALJ’s Recommended
screenings were. Decision. Having reviewed their briefs,
intend that it is abusing, well, it’s still a pain
Asked whether, in the period 2010– medication they are using to control their I conclude that some of their exceptions
2012, he believed that doctors should symptoms. I don’t understand what exactly are best addressed prior to discussing
not prescribe controlled substances to what answer you want for that. whether the Government is entitled to
patients who are abusing or diverting I’m telling you exactly what I think. If the prevail under the public interest
them, Respondent testified: ‘‘If it is a patient using the pain medication instructed standard. These include Respondent’s
proof they are abusing or diverting, to control their pain medication, now if they contention that the ALJ committed
yes.’’ Id. at 520. Asked to explain what come earlier to take medication that’s if they prejudicial error when he barred him
he meant by proof of abuse and have a chronic problem and they need it,
from cross-examining the Diversion
diversion, Respondent answered: somebody can call them abusing, some
people calling them they are controlling their Investigator regarding the use of
Well, counseling the patient in the room pain symptoms. confidential informants. See Resp.
and talking to them about their pain and their Id.
Exceptions, at 9–12. As for the
using their pain medication and the way, and Government, it argues that the ALJ erred
what is their answer, for me I will take After again admitting that he ‘‘did not when he allowed Respondent to present
whatever the patient tell me. pay attention too much to this [sic] signs his case by VTC. Gov. Exceptions, at
If they said no, they are not abusing the with the red flags and things,’’ id., 3–9.
medication, they are not diverting the Respondent asserted that in determining
medication, and I am entitled to treat their whether patients are abusing controlled Respondent’s Exception to the ALJ’s
symptoms and make sure they are not going substances, ‘‘[w]e do the drug screen’’ Ruling Limiting Cross-Examination
in withdrawal and take care of the patient.
and ‘‘[w]e run a MAP with the As found above, at the hearing, a DEA
Id. at 521. Asked whether he believed electronic medical records if they are Diversion Investigator testified
this today as much as he did in the taking the medication the right way and regarding the investigation she
2010–2012 period, Respondent taking the other alternative
answered: ‘‘[y]es.’’ Id. medications.’’ Id. at 529. Asked by the 42 Subsequently, during a colloquy with the ALJ
ALJ how he is now treating pain as to whether it could cross-examine Respondent
The Government then asked regarding the specific prescriptions discussed by
management patients, Respondent Dr. Mitchell and whether he agreed with Dr.
Respondent whether he ‘‘believe[s] that
explained that if patients ‘‘ask for more Mitchell’s testimony that the prescriptions ‘‘were
doctors should detect when patients are issued illegitimately and outside of the usual
medication or [to] change to a specific
abusing or diverting controlled course,’’ the Government observed that Respondent
medication and . . . looking in the
substances?’’ Id. Respondent’s counsel was shaking his head; the Government thus argued
drugs screen, if they are utilizing the ‘‘that there is some ambiguity as to whether or not
objected, on the ground that it was
medication.’’ Id. After apparently more he’s really admitting that he has actually issued
outside the scope of his direct those unlawfully.’’ Tr. 538–39. The ALJ explained:
telephonic interference, Respondent
examination and the ALJ sustained the ‘‘[n]ot according to my record’’ and that he had seen
added that when patients ask for an
objection.40 Id. at 522. So too, when the ‘‘the shaking of the head.’’ Id. at 539. The record
early refill or a different medication or does not, however, reflect the manner in which
Government asked Respondent if
to increase their pain medication, ‘‘to Respondent shook his head, and notwithstanding
‘‘[d]octors should respond to red flags of the tenor of the Government’s statement, I am not
confirm we’ll do the drug screen and
abuse and diversion of controlled free to speculate as to whether Respondent was
we’ll run the MAP.’’ Id. at 531.41 disputing or acknowledging that he acted
substances,’’ Tr. 526, Respondent
After confirming that Respondent was unlawfully.
39 This, however, did not occur until mid-
adhering to his earlier testimony that Dr. Notably, in his Post-Hearing Brief, Respondent
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Mitchell was correct that he had ignored states that Dr. Mitchell’s testimony establishes that
September 2014. Tr. 509. he ‘‘wrote a substantial number of prescriptions
40 When the Government attempted to re-ask the red flags of abuse and diversion, the . . . without a legitimate medical purpose and/or
question, Respondent’s counsel again objected on in the usual course of a practitioner’s professional
the ground that because Respondent has testified 41 The Government then asked Respondent what
practice and/or in the face of paradigmatic ‘red
that Dr. Mitchell was correct in his criticism of his steps ‘‘a doctor should and could take in response flags’ of diversion or abuse such as repeated
practice, ‘‘how much stronger can we say that we to any signs that a patient is abusing their requests for early refills, facially-evident
adopt Dr. Mitchell’s testimony as to us ignoring controlled substance medications?’’ Id. at 531–32. documentation of doctor shopping, and testing
those red flags and prescribing in the face of those.’’ The ALJ sustained Respondent’s objection stating results inconsistent with use of the prescribed
Tr. 524. The ALJ against sustained the objection. that he had ‘‘a record of that.’’ Id. at 532. controlled substances.’’ Resp. Post-Hrng Br. at 12.
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conducted of Respondent’s prescribing & Sons, Inc. v. NLRB, 754 F.2d 531, 534 (1963), which requires the prosecution
practices. On cross-examination, (4th Cir. 1985) (applying abuse of in a criminal case to disclose material
Respondent’s counsel attempted to discretion standard in reviewing ALJ’s exculpatory evidence to the defendant.
question the DI about two undercover decision to limit cross-examination). R.D. at 61. Citing MacKay v. DEA, 664
agents who, according to the proffer, Moreover, the warrant return listed the F.3d 808, 819 (10th Cir. 2011), the ALJ
went to Respondent, and while posing actual names (as well as the undercover correctly noted that ‘‘even if Brady did
as patients, attempted to entice him to names) of both undercover officers. apply in this case, the excluded
prescribe controlled substances in Thus, Respondent had ample evidence would have no outcome [sic]
exchange for cash. Tr. 222. The opportunity to present this evidence on my final recommendation.’’ R.D. at
Government objected to this line of either through calling the undercover 62. The ALJ nonetheless proceeded to
questioning, arguing that the evidence officers to testify or by introducing any discuss several cases in which other
‘‘was not offered as part of the basis for documentation he placed in their ALJs had either: (1) Ordered the
the order to show cause.’’ Id. respective patient files regarding the Government to review its files for
In response to the objection, incidents. See Randall L. Wolff, 77 FR exculpatory evidence, or (2) suggested
Respondent argued that the Agency ‘‘is 5106, 5120 n.23 (2012). that DEA should provide for disclosure
required to consider not just the To be sure, DEA has recognized that of exculpatory evidence because three
evidence that [the Government] brought in some instances, evidence of ‘‘prior other federal agencies provide for such
in on the direct, but evidence that we good acts’’ can refute evidence that a disclosure. Id. The ALJ noted that the
can bring out on cross examination.’’ Id. registrant knowingly or intentionally Agency has held that there is ‘‘‘an
Respondent then proffered that diverted controlled substances. See ongoing duty to ensure that material
Respondent told the undercover agents Jayam Krishna-Iyer, 74 FR 459, 462 n.6 evidence and argument made to a fact-
that ‘‘he would not’’ prescribe to them. (2009). Here, however, the Government finder is not knowingly contradicted by
Id. Respondent argues that this ‘‘is put forward extensive evidence to show other material evidence in the
exculpatory’’ because Respondent ‘‘had that Respondent acted with the requisite Government’s possession, but not
no idea who he was talking to’’ and this knowledge to support the conclusion otherwise disclosed.’’ Id. (quoting
evidence ‘‘would be very relevant to that he lacked a legitimate medical Randall L. Wolff, 77 FR 5106, 5124
[assessing] his state of mind.’’ Id. at purpose and acted outside of the usual (2012)). However, based on an earlier
222–23. course of professional practice and case in which the Agency held that an
The ALJ sustained the objection, on thereby violated the CSA on some 100 ALJ did not have authority to require
the ground that Respondent had failed occasions when he prescribed to the five the Government to ‘‘disclose any
to disclose in advance of the hearing patients. See 21 CFR 1306.04(a); see also exculpatory information in its
that he ‘‘wanted to cover this subject.’’ 21 U.S.C. 841(a)(1). Moreover, even if possession when such information is
Id. at 223. Continuing, the ALJ Respondent’s testimony regarding Dr. timely requested by a respondent,’’ see
explained that ‘‘[i]f you knew about Mitchell’s criticism of his prescribing Nicholas A. Sychak, 65 FR 75959,
these things, and you wanted me to practices was ambiguous as to whether 75960–61 (2000), the ALJ opined ‘‘that
consider them, then you had a duty and he was also admitting that he violated the DEA’s view of releasing exculpatory
the opportunity to come forward and 21 CFR 1306.04(a), his post-hearing evidence is ‘just trust me.’ ’’ R.D. at 62.
tell me. And I saw nothing like that in brief has resolved the issue. Unacknowledged by the ALJ is that
your pre-hearing statements, or that of Accordingly, even if I had found that several federal appeals courts have held
prior counsel.’’ Id. at 223–24. the ALJ abused his discretion in not that Brady does not apply to
Respondent then argued that his permitting Respondent to cross-examine administrative proceedings. See Mister
counsel had not had ‘‘the time that the the DI about the two undercover visits, Discount Stockbrokers, Inc. v. SEC, 768
Government had to prepare’’ for the I would still conclude that this does not F.2d 875, 878 (7th Cir. 1985); NLRB v.
hearing and that there was no prejudice rise to the level of prejudicial error. See Nueva Eng. Inc., 761 F.2d 961, 969 (4th
to the Government, because ‘‘these are Gunderson, 601 F.3d at 1021(‘‘An error Cir. 1985). Cf. Echostar Comm. Corp. v.
their witnesses.’’ Id. at 224–25. The ALJ is prejudicial only ‘if it can be FCC, 292 F.3d 749, 755–56 (D.C. Cir.
rejected the contention, explaining that reasonably concluded that with . . . 2002) (rejecting litigant’s claim that ‘‘the
‘‘you had knowledge of this undercover such evidence, there would have been a Agency’s decision to deny it discovery
operation. If you wanted to bring it to contrary result.’ ’’) (quoting Sanjuan v. . . . denied it due process’’); Silverman
my attention, you clearly had it for a IBP, Inc., 160 F.3d 1291, 1296 (10th Cir. v. CFTC, 549 F.2d 28, 33 (7th Cir. 1977)
while.’’ Id. at 226.43 1998)); see also Air Canada v. (‘‘There is no basic constitutional right
Even assuming that the Government’s Department of Trans., 148 F.3d 1142, to pretrial discovery in administrative
direct examination of the DI as to what 1156 (D.C. Cir. 1998) (‘‘As incorporated proceedings.’’) (citations omitted).
steps she took in investigating into the APA, the harmless error rule Instead, this Agency follows the
Respondent opened the door to this line requires the party asserting error to holding of McClelland v. Andrus, 606
of inquiry, the ALJ did not abuse his demonstrate prejudice from the error.’’) F.2d 1278 (D.C. Cir. 1979). Therein, the
discretion in sustaining the (citing 5 U.S.C. 706). D.C. Circuit held that ‘‘discovery must
Government’s objection. See Gunderson In his Exceptions, Respondent further be granted [in an administrative
v. Department of Labor, 601 F.3d 1013, notes that the ALJ ‘‘frames this issue as proceeding] if in the particular situation
1021 (10th Cir. 2010) (applying abuse of one ‘regarding arguably exculpatory a refusal to do so would so prejudice a
discretion standard in reviewing ALJ’s evidence that has been withheld by the party as to deny him due process.’’ Id.
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exclusion of evidence); Walter A. Yoder Government.’ ’’ Exceptions, at 9 (citing at 1285–86; see also Margy Temponeras,
R.D. at 60–62). He then states that he 77 FR 45675, 45676 n.4 (2012); Beau
43 The record shows that Respondent became adopts and incorporates by reference the Boshers, 76 FR 19401, 19403–04 (2011).
aware that two undercover officers had visited ALJ’s view, and requests that I consider However, ‘‘the party seeking discovery
Respondent from the return of the state search it as a separate argument. must rely on more than speculation and
warrant which listed the two officers’ files as being
among the items seized. Resp. Ex. A, at 7. However,
Therein, the ALJ noted that the must show that the evidence is relevant,
the return was executed on March 27, 2013, id. at Agency has not adopted ‘‘[t]he rule from material, and that the denial of access to
6; which was well in advance of the hearing. Brady v. Maryland,’’ 373 U.S. 83, 87 the [evidence] is prejudicial.’’ Boshers,
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76 FR at 19403 (citing Echostar, 292 F. ‘‘[T]hese factors are . . . considered Factors Two and Four—Respondent’s
3d at 756; Silverman v. CFTC, 549 F.2d in the disjunctive.’’ Robert A. Leslie, Experience in Dispensing Controlled
28, 34 (7th Cir. 1977)). As explained M.D., 68 FR 15227, 15230 (2003). It is Substances and Compliance With
previously, while evidence that well settled that I ‘‘may rely on any one Applicable Laws Related to Controlled
Respondent refused to prescribe or a combination of factors, and may Substances
controlled substances to the undercover give each factor the weight [I] deem[ ] Under a longstanding DEA regulation,
officers is relevant and material in appropriate in determining whether a a prescription for a controlled substance
assessing his experience as a dispenser registration should be revoked.’’ Id.; see is not ‘‘effective’’ unless it is ‘‘issued for
of controlled substances, in light of his also MacKay v. DEA, 664 F.3d 808, 816 a legitimate medical purpose by an
concession that he knowingly diverted (10th Cir. 2011); Volkman v. DEA, 567 individual practitioner acting in the
controlled substances some 100 times to F.3d 215, 222 (6th Cir. 2009); Hoxie v. usual course of his professional
the five patients, he cannot show DEA, 419 F.3d 477, 482 (6th Cir. 2005). practice.’’ 21 CFR 1306.04(a).
prejudice.44 I thus reject the Continuing, the regulation provides that
Moreover, while I am required to
exception.45 ‘‘an order purporting to be a
consider each of the factors, I ‘‘need not
Discussion make explicit findings as to each one.’’ prescription issued not in the usual
Section 304(a) of the Controlled MacKay, 664 F.3d at 816 (quoting course of professional treatment . . . is
Substances Act (CSA) provides that a Volkman, 567 F.3d at 222 (quoting not a prescription within the meaning
registration to ‘‘dispense a controlled Hoxie, 419 F.3d at 482)).47 and intent of [21 U.S.C. 829] and . . .
substance . . . may be suspended or the person issuing it, shall be subject to
The Government has the burden of the penalties provided for violations of
revoked by the Attorney General upon proving, by a preponderance of the
a finding that the registrant . . . has the provisions of law relating to
evidence, that the requirements for controlled substances.’’ Id.
committed such acts as would render revocation or suspension pursuant to 21
his registration under section 823 of this As the Supreme Court has explained,
U.S.C. 824(a) are met. 21 CFR ‘‘the prescription requirement . . .
title inconsistent with the public 1301.44(e). However, ‘‘once the
interest as determined under such ensures patients use controlled
[G]overnment establishes a prima facie substances under the supervision of a
section.’’ 21 U.S.C. 824(a)(4) (emphasis
case showing a practitioner has doctor so as to prevent addiction and
added). With respect to a practitioner,
committed acts which render his recreational abuse. As a corollary, [it]
the Act requires the consideration of the
following factors in making the public registration inconsistent with the public also bars doctors from peddling to
interest determination: interest, the burden shifts to the patients who crave the drugs for those
practitioner to show why his continued prohibited uses.’’ Gonzales v. Oregon,
(1) The recommendation of the appropriate registration would be consistent with 546 U.S. 243, 274 (2006) (citing United
State licensing board or professional
the public interest.’’ MacKay, 664 F.3d States v. Moore, 423 U.S. 122, 135, 143
disciplinary authority.
(2) The applicant’s experience in at 817 (citing Medicine Shoppe- (1975)).
dispensing . . . controlled substances. Jonesborough, 73 FR 364, 387 (2008) Both this Agency and the federal
(3) The applicant’s conviction record under (citing cases)). courts have held that establishing a
Federal or State laws relating to the violation of the prescription
manufacture, distribution, or dispensing of
In this matter, the Government’s requirement ‘‘requires proof that the
controlled substances. evidence focused on factors two, four, practitioner’s conduct went ‘beyond the
(4) Compliance with applicable State, and five. Having reviewed the record in bounds of any legitimate medical
Federal, or local laws relating to controlled its entirety and having considered all of practice, including that which would
substances. the factors, I find that the Government’s constitute civil negligence.’ ’’ Laurence
(5) Such other conduct which may threaten evidence with respect to factors two and
the public health and safety. T. McKinney, 73 FR 43260, 43266 (2008)
four satisfies its prima facie burden of (quoting United States v. McIver, 470
Id. 823(f).46 showing that Respondent has F.3d 550, 559 (4th Cir. 2006)). See also
44 It is noted that Respondent requested that the
committed acts ‘‘which render his United States v. Feingold, 454 F.3d
ALJ provide him with a copy of the Agency’s registration . . . inconsistent with the 1001, 1010 (9th Cir. 2006) (‘‘[T]he Moore
investigative files on him; the ALJ correctly held public interest.’’ 21 U.S.C. 824(a)(4). Court based its decision not merely on
that he had no power to compel the Agency to the fact that the doctor had committed
provide Respondent with its investigative files. ALJ
Ex. 3, at 5.
malpractice, or even intentional
45 I have considered the Government’s Exception malpractice, but rather on the fact that
regarding the ALJ’s decision to allow Respondent to dispense, [or] administer . . . a controlled his actions completely betrayed any
present his case by Video Teleconferencing substance in the course of professional practice.’’ 21 semblance of legitimate medical
technology. While I acknowledge that technical U.S.C. 802(21). See also id. § 823(f) (‘‘The Attorney
treatment.’’).
difficulties caused a number of interruptions during General shall register practitioners . . . to dispense
the hearing in this matter, the record nonetheless . . . controlled substances in schedule II, III, IV, or
Thus, in Moore, the Supreme Court
contains overwhelming evidence supporting my V . . . if the applicant is authorized to dispense reinstated the conviction of a physician
Decision and Order. controlled substances under the laws of the State under 21 U.S.C. 841(a)(1) and what is
46 Section 304(a) also provides that a registration in which he practices.’’). now 21 CFR 1306.04(a) for prescribing
to ‘‘dispense a controlled substance . . . may be 47 In short, this is not a contest in which score controlled substances outside of the
suspended or revoked by the Attorney General is kept; the Agency is not required to mechanically usual course of professional practice.
upon a finding that the registrant . . . has had his
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count up the factors and determine how many favor 423 U.S. at 139–43. The Court
State license or registration suspended, revoked, or the Government and how many favor the registrant.
denied by competent state authority and is no explained:
Rather, it is an inquiry which focuses on protecting
longer authorized by State law to engage in the The evidence presented at trial was
the public interest; what matters is the seriousness
manufacturing, distribution, or dispensing of
controlled substances.’’ 21 U.S.C. 824(a)(3). of the registrant’s misconduct. Jayam Krishna-Iyer, sufficient for the jury to find that
Likewise, the CSA defines ‘‘[t]he term ‘practitioner’ 74 FR 459, 462 (2009). Accordingly, as the Tenth respondent’s conduct exceeded the bounds of
[to] mean[ ] a physician . . . licensed, registered, Circuit has recognized, findings under a single ‘‘professional practice.’’ As detailed above,
or otherwise permitted, by the United States or the factor can support the revocation of a registration. he gave inadequate physical examinations or
jurisdiction in which he practices . . . to distribute, MacKay, 664 F.3d at 821. none at all. He ignored the results of the tests
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he did make. He did not give methadone at early refills, facially-evident or that his inability to say no was
the clinic and took no precautions against its documentation of doctor shopping, and ‘‘culturally ingrained.’’
misuse and diversion. He did not regulate the testing results inconsistent with use of As for the ALJ’s embrace of
dosage at all, prescribing as much and as Respondent’s claim that he was not
frequently as the patients demanded. . . . In
the prescribed controlled substances.’’
practical effect, he acted as a large scale Resp. Proposed Recommended Rulings, running a pill mill and was treating his
‘‘pusher’’—not as a physician. Findings of Fact and Conclusions of patients, to be sure, there is some
Id. at 142–43. Law, at 12. Respondent, however, also evidence that Respondent referred
attempts to portray himself as a soft patients for MRIs, a sleep study, and
Under the CSA, it is fundamental that touch, suggesting that it is ‘‘culturally alternative treatments such a
a practitioner must establish a bona fide ingrained’’ that he could ‘‘not say no’’ chiropractor and physical therapy.
doctor-patient relationship in order to to patients, and that he prescribed ‘‘with However, the overwhelming weight of
act ‘‘in the usual course of . . . some naivety and perhaps even full- the evidence shows that Respondent
professional practice’’ and to issue a issued the prescriptions knowing that
blown gullibility,’’ which was ‘‘laid bare
prescription for a ‘‘legitimate medical the patients were either abusing or
when the size of his practice grew
purpose.’’ See, e.g., Moore, 423 U.S. at diverting the drugs.
exponentially faster than he and his
142–43; United States v. Lovern, 590 With respect to R.E.H., Dr. Mitchell
staff’’ were capable of managing.
F.3d 1095, 1100–01 (10th Cir. 2009); found Respondent’s initial evaluation to
Respondent’s Post-Hrng. Submission, at
United States v. Smith, 573 F.3d 639, be inadequate based on Respondent’s
1–2. See also id. (‘‘These proceedings
657 (8th Cir. 2009); Jack A. Danton, 76 failure to adequately develop his
have also opened [his] eyes to the fact
FR 60900, 60904 (2011) (finding substance abuse history and how much
that his knowledge and experience as a
violations of 21 CFR 1306.04(a) ‘‘where methadone he was currently taking. He
medical practitioner contained gaps that
a physician has utterly failed to comply further found that Respondent did not
with multiple requirements of state law proved easy to exploit.’’).
perform an adequate physical
for evaluating her patients and The ALJ embraced this argument. See
examination. He therefore concluded
determining whether controlled R.D. at 43 (quoting Resp. Post-Hrng.
that Respondent acted outside of the
substances are medically indicated and Submission, at 2) (Respondent’s ‘‘lack of
usual course of professional practice in
thus has ‘ ‘‘completely betrayed any knowledge, experience, and familiarity
issuing the initial methadone
semblance of legitimate medical with accepted protocols for prescribing
prescriptions. Based on this testimony,
treatment’’ ’ ’’) (quoting McKinney, 73 FR controlled substances, combined with
I find that Respondent did not establish
at 43266 (quoting Feingold, 454 F.3d at some naivety and perhaps full-blown
a bona fide doctor-patient relationship
1010)). gullibility, where laid bare when the
and I further conclude that at no point
However, while the Government size of his practice great exponentially in the course of his treatment of R.E.H.
frequently relies on a physician’s failure faster. . . .’’); see also id. at 43–44 did Respondent do so.
to establish a bona-fide doctor-patient (‘‘Here, it appeared [Respondent] Dr. Mitchell further described a
relationship to prove a violation of 21 became a very popular weak link used plethora of instances in which
CFR 1306.04(a), no ‘‘specific set of facts by those seeking to circumvent Respondent provided R.E.H. with early
ha[s] to be present in order to find that [controlled substance prescribing] refills and failed to document that he
a physician stepped outside of his role protocols.’’). The ALJ also stated his had engaged R.E.H. as to why he needed
and issued prescriptions without a agreement ‘‘with the proposition the early refills. Dr. Mitchell pointed out
legitimate medical purpose.’’ United appearing in [his] post-hearing brief that that Respondent failed to enforce his
States v. McKay, 715 F.3d 807, 823 (10th ‘his practice did not consist of a ‘‘pill medication contract which required
Cir. 2013). Thus, as the Tenth Circuit mill’’’ and that however misguided, he R.E.H. to use his medicine only at the
explained, the question is whether was nevertheless treating his patients, prescribed rate. He also pointed out that
sufficient evidence ‘‘exist[s] for a fact not merely processing their Respondent continued to prescribe
finder to affirmatively determine that prescriptions in furtherance of a larger without obtaining urine samples, and
the physician issued the drugs for an criminal enterprise.’’ R.D. 47 (quoting only rarely obtained a MAPS report.
improper purpose.’’ Id. Resp. Prop. Recommended Rulings, etc., Moreover, even when he did obtain and
As found above, Dr. Mitchell offered at 12) (first emphasis added; second review a MAPS report, the MAPS report
extensive and uncontested testimony emphasis in original). See also id. at 44 showed that R.E.H. had filled the same
that included identifying specific acts (‘‘I found no evidence to suggest the prescriptions at different pharmacies,
and omissions by Respondent, which failures in his practice were the results and yet Respondent failed to even
support the conclusion that Respondent of avarice or greed . . . .’’). address R.E.H.’s behavior and continued
acted outside of the usual course of Contrary to the ALJ’s understanding, to prescribe methadone to him. So too,
professional practice and without a the Government was not required to Respondent was notified on multiple
legitimate medical purpose when he prove that Respondent was motivated occasions that R.E.H. was trying to fill
prescribed controlled substances to each by avarice or greed to establish a multiple prescriptions and presenting
of the five patients. He also opined that violation of 21 CFR 1306.04(a) and 21 forged prescriptions, and yet did
none of the prescriptions he discussed U.S.C. 841(a)(1). Nor did the ALJ nothing to address this obvious drug-
complied with 21 CFR 1306.04(a). Tr. reconcile the inconsistency between his seeking behavior and continued to
356. findings that that Respondent violated prescribe to him. Finally, even after he
In his post-hearing brief, Respondent 21 CFR 1306.04(a) with respect to each received a report that R.E.H. had tested
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states that Dr. Mitchell’s testimony of the patients—findings which positive for cocaine and was diagnosed
establishes that he ‘‘wrote a substantial establish that he knowingly diverted as polysubstance dependent, he
number of prescriptions . . . without a drugs—with his embrace of continued to prescribe to R.E.H. In
legitimate medical purpose and/or in Respondent’s claim that he was merely short, given the numerous times that
the usual course of a practitioner’s naı̈ve and gullible. Indeed, Respondent R.E.H. sought early refills, coupled with
professional practice and/or in the face offered no testimony to support the the information Respondent obtained
of paradigmatic ‘red flags’ of diversion claims made in his brief that he from MAPS reports, pharmacies and the
or abuse such as repeated requests for prescribed out of naivety or gullibility, hospital, Respondent cannot credibly
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argue that he was merely gullible or medical evidence to support the on October 30, R.E.H. was seeking more
naı̈ve. Rather, Respondent knowingly methadone prescriptions. Here again, methadone and his medical record
diverted controlled substances to R.E.H. the evidence amply refutes the states that it was not time yet and
The same holds true with respect to contention that Respondent issued the includes a copy of a prescription
Respondent’s prescribings to J.W. Here prescriptions because he was gullible or bearing an issue date of November 8,
too, Dr. Mitchell testified that there was naı̈ve. 2012. GX 8, at 15; id. at 31. The
no clinical basis to diagnose J.W. with Respondent knew that R.J.H. had a evidence further shows that a second
a condition that would support history of drug abuse. Yet over the prescription with an issue date of
prescribing both Adderall and course of just six weeks, Respondent October 8, 2012 (which appears to have
methadone. He also testified that it was quadrupled R.J.H.’s daily dosage of been altered) was filled on October 30,
inappropriate to prescribe methadone methadone with no medical 2012. GX 15, at 137–38; GX 20, at 14.
on a PRN basis. Moreover, Respondent justification. Moreover, within three Moreover, there are no notes
ignored evidence that J.W. was months of R.J.H.’s seeing Respondent, corresponding to a visit by R.E.H. on
obtaining Adderall from another R.J.H. had twice claimed that his November 8, 2012, and the MAPS data
physician, in violation of the prescriptions were stolen, and the day contains no entry for a methadone
medication contract, as well as that J.W. before the second such incident, prescription with an issue date of
was obtaining Suboxone from the other Respondent’s office had been told by November 8, 2012. See GX 8, at 15; id.
physician. J.W. also sought early refills another patient that R.J.H. was selling at 99–100; see also GX 20.
on multiple occasions, yet Respondent his prescription and using his Under a DEA regulation, ‘‘[a]ll
continued to prescribe to him. girlfriend’s medication. Yet Respondent prescriptions for controlled substances
Also, the same day that Respondent issued him another prescription and shall be dated as of, and signed on, the
was informed that J.W. was in the continued to prescribe methadone to day when issued.’’ 21 CFR 1306.05(a).
county jail, Respondent obtained a him, even though R.J.H. sought early Based on Respondent’s failure to
MAPS report which showed that J.W. refills. Here again, the evidence refutes address the DI’s testimony regarding
had continued to obtain controlled Respondent’s contention that he issued this prescription and there being no
substances for Suboxone and Adderall the prescriptions because he was evidence that R.E.H. saw Respondent on
from another doctor at the same time he gullible or naı̈ve. November 8, 2012, I find that
was obtaining prescriptions from So too, the evidence with respect to Respondent violated this regulation
Respondent. Moreover, Respondent was J.H. refutes Respondent’s claim that he when he post-dated the prescription.48
notified by J.W.’s niece that her uncle was gullible or naı̈ve. Here the evidence The evidence also shows that
was selling his medications. Yet shows that only five days after Respondent repeatedly failed to include
notwithstanding this information, after Respondent issued her a prescription for the patients’ addresses on their
J.W. was released from jail, Respondent a 30-day supply of methadone, she was prescriptions. See, e.g., GX 8, at 21, 23,
eventually resumed prescribing suffering from narcotic withdrawal. Yet, 27–38, 40–42, 52, 54–57, 64, 233, 240,
controlled substances to him. Here instead of sending her for treatment, 248–49, 253–54 (Pt. R.E.H.); see also GX
again, the evidence amply refutes the Respondent continuing prescribing 9, at 5–6, 45, 54, 57–59, 61–63, 68 (Pt.
contention that Respondent was merely controlled substances to her. Moreover, J.W.). This too is a violation of 21 CFR
gullible or naı̈ve. over the course of his treatment of J.H., 1306.05(a).
With respect to R.K., the evidence on multiple occasions, Respondent Finally, the evidence shows that on
showed that Respondent issued prescribed either alprazolam or several occasions, Respondent issued
multiple prescriptions for Xanax, which clonazepam to her, both being prescriptions that authorized six refills.
frequently authorized multiple refills, benzodiazepines, even though he had GX 8, at 23 (Xanax Rx issued to R.E.H.);
resulting in R.K. obtaining, in a nine- recently prescribed the other drug to GX 17, at 49 (Xanax Rx issued to R.K.);
month period, approximately 1,000 pills her. Also, even after J.H. reported that GX 19, at 117 (Klonopin Rx issued to
more than were necessary based on she did not like how alprazolam made J.H.). Respondent violated DEA
Respondent’s dosing instructions. Given her feel, he still issued her more regulations when he issued the
that R.K.’s chart contained copies of the prescriptions for the drug. So too, even prescriptions because, with respect to
prescriptions, Respondent cannot after J.H. tested negative for Adderall, he schedule III and IV controlled
credibly argue that he was duped by issued her a new prescription for the substances, a prescription may not
R.K. into issuing the excessive drug. Finally, over the course of the 26 ‘‘refilled more than five times.’’ 21 CFR
prescriptions. Also, while Respondent months Respondent treated her, he only 1306.22(a).
prescribed methadone to R.K., on two drug tested her three times, with all Accordingly, I find that the
occasions, R.K. tested negative for the three tests occurring in a three-month Government’s evidence with respect to
drug, stating after the first test that he period. I thus conclude that Respondent Factors Two and Four conclusively
had run out a week earlier, and after the knew or was willfully blind to the fact establishes that Respondent has
second, stating that he had run out that J.H. was either abusing or diverting committed such acts as to render his
several days earlier. Yet there was no her drugs to others. registrations ‘‘inconsistent with the
documentation that R.K. had undergone In addition to his issuance of public interest.’’ 21 U.S.C. 824(a)(4); see
withdrawal, this being a clear indication numerous unlawful prescriptions, also id. § 823(f). I further conclude that
that R.K. was diverting the drug. Respondent also violated federal law by his misconduct is especially egregious
Respondent continued to prescribe the writing a methadone prescription for and supports the revocation of his
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drug to R.K. (going so far as to double R.E.H. which he dated as having been
the strength after the first negative test) issued on November 8, 2012, when he 48 Even if it was R.E.H. who altered the date to
and did not subject him to any more likely issued it on October 30, 2012. ‘‘10/08/12,’’ if Respondent’s intent was to provide
drug tests after the second test. The Notably, the evidence shows that on R.E.H. with a prescription that he could not fill
evidence thus shows that Respondent October 8, 2012, Respondent issued until November 8, than he should have written on
the prescription ‘‘the earliest date on which a
was willfully blind to what R.K. was R.E.H. a methadone prescription, which pharmacy’’ could fill it. 21 CFR 1306.12(b)(ii). In
doing with the drugs. Moreover, Dr. R.E.H. filled the same day. GX 15, at any event, Respondent was still required to date the
Mitchell testified that there was no 135–36. The evidence also shows that prescription as of the date he issued it.
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existing registrations and the denial of The ALJ found that Respondent Respondent takes exception to the
his pending applications. ‘‘failed to take the full and ALJ’s finding that he did not accept
Moreover, while the Government put unconditional acceptance of responsibility for his misconduct. Resp.
on no evidence as to Factor One—the responsibility required by’’ the Agency’s Exceptions, at 2–9. He argues that the
recommendation of the state licensing case law. R.D. at 55. As support for this ALJ misapplied Agency precedent, ‘‘in
board—in response to my November 10, conclusion, the ALJ noted that during effect penaliz[ing] him for his failure to
2015 order, the Parties have his cross-examination of Dr. Mitchell, immediately confess wrongdoing in
acknowledged that on October 30, 2015, Respondent ‘‘challenged multiple response to naked allegations.’’ Id. at
the Michigan Board of Medicine aspects of the Government’s evidence 4–5 n.11. Alternatively, he argues that:
revoked Respondent’s medical license regarding [his] treatment of the patients [i]f the applicable precedent really provides
and that he is longer legally authorized that were fundamental to the that the gateway to presentation of mitigation
to dispense controlled substances in the Government’s case against him.’’ Id. The evidence requires [him to] demonstrate
State in which he is registered and seeks ALJ also found that ‘‘Respondent’s penitence in the form of ‘‘accepting
additional registrations.49 repeated and persistent pre-hearing responsibility for’’ conduct in which he did
assertions that his prescription practice not engage . . . and/or to admit to
Sanction was within the usual course of medical counterfactual matters, e.g., that some of the
Under Agency precedent, where, as prescriptions at issue were written outside of
practice stand as compelling evidence
a legitimate[] physician patient relationship,
here, ‘‘the Government has proved that that [he] had not accepted responsibility then that precedent is inconsistent with
a registrant has committed acts for his actions under the high standard procedural due process.
inconsistent with the public interest, a established by the’’ Agency. Id. Thus,
registrant must ‘‘ ‘present sufficient the ALJ declined to credit Respondent’s Id. at 4; see also id. at 5 n.11 (‘‘to the
mitigating evidence to assure the testimony that he did not dispute Dr. extent that the Agency concludes the
Administrator that [he] can be entrusted Mitchell’s criticism of his prescribing [ALJ’s] application was proper,
with the responsibility carried by such practices with respect to the five however, the precedent is inconsistent
a registration.’’ ’ ’’ Medicine Shoppe- patients, notwithstanding that he with procedural due process’’).
Jonesborough, 73 FR 364, 387 (2008) characterized Respondent’s testimony as Respondent thus seeks ‘‘a functional
(quoting Samuel S. Jackson, 72 FR ‘‘unequivocally stat[ing]’’ as much. Id. remand to allow the parties to fully
23848, 23853 (2007) (quoting Leo R. The ALJ did not, however, reconcile his develop [his] remediation evidence and
Miller, 53 FR 21931, 21932 (1988))). finding with his statement during the to allow’’ for the consideration of ‘‘that
‘‘Moreover, because ‘past performance is hearing that ‘‘right now I have fairly evidence in assessing the appropriate
the best predictor of future compelling evidence that [Respondent] sanction.’’ Id. at 9.
performance,’ ALRA Labs, Inc. v. DEA, has accepted responsibility, even While I find some of Respondent’s
54 F.3d 450, 452 (7th Cir.1995), [DEA] though he didn’t tell me he did so or he arguments well taken, I reject his
has repeatedly held that where a was going to do so in his prehearing exception. As for the ALJ’s pre-hearing
registrant has committed acts statement.’’ Tr. 491. Moreover, as ruling barring Respondent from eliciting
inconsistent with the public interest, the discussed previously, because the testimony of Ms. Richards, (who
registrant must accept responsibility for Respondent did not provide notice in would have testified regarding a risk
[his] actions and demonstrate that [he] his pre-hearing statements that he assessment audit and the training she
will not engage in future misconduct.’’ intended to admit to the truth of the provided to Respondent’s staff), in his
Medicine Shoppe, 73 FR at 387; see also Government’s allegations, the ALJ Recommended Decision, the ALJ
Jackson, 72 FR at 23853; John H. granted the Government’s motion to bar asserted that he would have allowed
Kennedy, 71 FR 35705, 35709 (2006); him from introducing evidence of his Ms. Richards to testify if Respondent
Prince George Daniels, 60 FR 62884, remedial measures.51 had ‘‘informed the Government in its
62887 (1995). See also Hoxie v. DEA, prehearing statements that he
419 F.3d at 483 (‘‘admitting fault’’ is Jacobo Dreszer, 76 FR 19386, 19387–88 (2011) acknowledged the noncompliance of his
(explaining that a respondent can ‘‘argue that even prescription practice.’’ R.D. at 60.
‘‘properly consider[ed] ’’ by DEA to be though the Government has made out a prima facie
an ‘‘important factor[ ]’’ in the public case, his conduct was not so egregious as to warrant However, while not mentioned in the
interest determination).50 revocation’’); Paul H. Volkman, 73 FR 30630, 30644 Recommended Decision, the ALJ
(2008); see also Paul Weir Battershell, 76 FR 44359, granted the Government’s motion based
49 No evidence was presented regarding Factor
44369 (2011) (imposing six-month suspension, also on Respondent’s failure to describe
noting that the evidence was not limited to security
Three—Respondent’s conviction record for offenses and recordkeeping violations found at first Ms. Richard’s testimony ‘‘with sufficient
related to the manufacture, distribution or inspection and ‘‘manifested a disturbing pattern of particularity.’’ Tr. 39 (Nov. 3, 2014).
dispensing of controlled substances. However, the indifference on the part of [r]espondent to his
Agency has held that the absence of a conviction
This was an independent and adequate
obligations as a registrant’’); Gregory D. Owens, 74
is not dispositive of the public interest inquiry. FR 36751, 36757 n.22 (2009).
ground to bar her testimony, and yet,
Dewey C. MacKay, 75 FR 49956, 49973 (2010), pet. The Agency has also held that ‘‘ ‘[n]either Respondent does not challenge the
for rev. denied, MacKay v. DEA, 664 F.3d 808 (10th Jackson, nor any other agency decision, holds . . . ALJ’s ruling on this basis.
Cir. 2011). As for Factor Five, as explained above,
the Government did not take exception to the ALJ’s
that the Agency cannot consider the deterrent value Had the ALJ’s ruling barring Ms.
of a sanction in deciding whether a registration Richard’s testimony been based solely
findings regarding the allegation that Respondent should be [suspended or] revoked.’ ’’ Gaudio, 74 FR
made various false statements in the interview. at 10094 (quoting Southwood, 72 FR at 36504); see on Respondent’s failure to state in his
50 However, while a registrant must accept
also Robert Raymond Reppy, 76 FR 61154, 61158 pre-hearing statements that he was
responsibility and demonstrate that he will not (2011); Michael S. Moore, 76 FR 45867, 45868 acknowledging his misconduct, I would
engage in future misconduct in order to establish (2011). This is so, both with respect to the
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that his/her continued registration is consistent respondent in a particular case and the community agree with Respondent. Contrary to the
with the public interest, DEA has repeatedly held of registrants. See Gaudio, 74 FR at 10095 (quoting ALJ’s understanding, although the
these are not the only factors that are relevant in Southwood, 71 FR at 36503). Cf. McCarthy v. SEC, Agency has held that proof of remedial
determining the appropriate sanction. See, e.g., 406 F.3d 179, 188–89 (2d Cir. 2005) (upholding measures is rendered irrelevant where a
Joseph Gaudio, 74 FR 10083, 10094 (2009); SEC’s express adoptions of ‘‘deterrence, both
Southwood Pharmaceuticals, Inc., 72 FR 36487, specific and general, as a component in analyzing respondent fails to accept responsibility
36504 (2007). Obviously, the egregiousness and the remedial efficacy of sanctions’’).
extent of a registrant’s misconduct are significant 51 As found above, Respondent did offer extensive Respondent was barred from introducing testimony
factors in determining the appropriate sanction. See testimony of his remedial measures. However, by a third party on the issue.
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for his knowing or intentional by the independent basis that Nor was Respondent the only party
misconduct, none of the cases cited by Respondent failed to adequately displeased with the ALJ’s ruling on the
the Government or the ALJ have held disclose the nature of her proposed issue of the adequacy of his acceptance
that a respondent, as a condition of testimony with sufficient of responsibility. Indeed, the
being able to offer evidence of his particularity.53 Government argues that the ALJ
remedial measures, is required to admit obstructed its cross-examination of
to the allegations before he even has the 53 In his Exceptions, Respondent ‘‘incorporates as
Respondent on this very issue. Gov.
opportunity to challenge the if fully set out herein the [ALJ’s] additional Exceptions, at 9–18. The Government
observations as to recent Agency precedent’s
Government’s evidence and the Agency misapplication of Hoxie v. DEA, 419 F.3d 477 (6th sets forth various instances in which the
has never held as much. Indeed, while Cir. 2005).’’ Resp. Exceptions, at 4 n.11 (citing R.D. ALJ precluded it from conducting a
the Agency frequently places dispositive at 58). According to the ALJ, the Agency has been meaningful inquiry into the sincerity of
weight on a respondent’s failure to fully misreading the Sixth Circuit’s Hoxie decision
because ‘‘while admitting fault is an important
Respondent’s acceptance of
acknowledge his misconduct, in each of factor, it is not the sole factor.’’ R.D. 58. The ALJ responsibility and the scope of his
the cases cited by the ALJ, the Agency criticized the Agency’s decisions in two cases, present understanding of lawfully
discussed the respondent’s failure to which he viewed as being ‘‘representative of the appropriate prescribing practices. See
acknowledge his/her/its misconduct coercive pressure to either fully accept
responsibility or contest all possible allegations.’’
id. at 10–11; 17–18.
only after discussing the evidence put R.D. 56 (discussing Jeri Hassman, M.D., 75 FR 8194 The Government further points to
forward by the Government and (2010), and George Mathew, M.D., 75 FR 66138 various incongruities in the ALJ’s
determining which allegations had been (2010)). According to the ALJ, his discussion was decision, including his conclusion that
proved. See, e.g., Joe Morgan, 78 FR ‘‘intended to present the argument that the DEA is
holding registrants to an unfair standard. Although Respondent ‘‘ ‘failed to take the full and
61961, 61963 (2013) (‘‘where the accepting responsibility for one’s actions is an unconditional acceptance of
Government has proved that a important factor to consider once the Government responsibility,’ ’’ while later in the same
respondent has knowingly or proves its prima facie case, there is much more to paragraph, finding that Respondent
intentionally diverted controlled determining what constitutes the public interest
than this one criterion.’’ R.D. at 58. However, the ‘‘ ‘unequivocally stated that he did not
substances, a registrant’s acceptance of ALJ then noted that in Respondent’s case, ‘‘the dispute the evidence brought against
responsibility is an essential showing outcome would arguably not be different if [he] had him.’ ’’ Gov. Exceptions, at 12 (quoting
for rebutting the Governments prima been allowed to present additional rehabilitation R.D. 55). To similar effect, the
facie case)’’ (emphasis added); Medicine witnesses. His admitted misconduct while treating
patients and his lackluster efforts of rehabilitation Government argues that
Shoppe-Jonesborough, 73 FR at 387. require that result.’’ R.D. 58–59. notwithstanding the various instances
Notwithstanding that the Government I respectfully disagree with the ALJ’s assertion in which the ALJ cut off its cross-
provided, in its prehearing statements, that the Agency ‘‘is holding registrants to an unfair examination of Respondent, the ALJ
notice of the evidence it intended to rely standard.’’ On the contrary, given the harm to
later explained that he could not
on in supporting the allegations of the public safety caused by the diversion of controlled
substances, the Agency’s policy of requiring those evaluate Respondent’s contention that
Show Cause Order, Respondent was respondents, who have been shown to have engaged he should be able to continue to
entitled to challenge the reliability of in knowing or intentional misconduct to prescribe controlled substances subject
that evidence at the hearing and to show acknowledge their misconduct, is fully within the
to various restrictions, ‘‘ ‘without first
that the allegations were untrue. Agency’s discretion. Hoxie is not to the contrary. As
the Tenth Circuit explained in MacKay, a case providing the Government a full and fair
However, I decline to decide the which received barely a mention by the ALJ: opportunity to first thoroughly test the
question of whether it was consistent When faced with evidence that a doctor has a depth of [Respondent’s]
with principles of due process to require history of distributing controlled substances
unlawfully, it is reasonable for the . . . acknowledgment of noncompliance.’ ’’
Respondent, as a condition of being able
Administrator to consider whether that doctor will Gov. Exceptions, at 12 (quoting R.D. 63).
to subsequently present evidence of his change his or her behavior in the future. And that The Government also argues that
remedial measures, to admit to his consideration is vital to whether [his] continued ‘‘[t]he ALJ’s decisions make it difficult
misconduct before it had even been registration is in the public interest. Without Dr.
MacKay’s testimony, the . . . Administrator had no for the Administrator to know if
proven on the record.52 Notably, while
evidence that Dr. MacKay recognized the extent of Respondent would have
Respondent suggests that if the ALJ’s his misconduct and was prepared to remedy his ‘acknowledg[ed] that his conduct
reading of the Agency’s precedent was prescribing practices.
violated the law’ at hearing.’’ Gov.
correct—as explained above, it was 664 F.3d at 820. Absent evidence that a registrant
not—‘‘the precedent is inconsistent with acknowledges his misconduct in intentionally or
knowingly diverting controlled substances, there is understatement of the Agency’s findings in the case,
procedural due process,’’ and the ALJ no basis to conclude that the registrant is prepared which established that the respondent had issued
reasoned that Respondent’s ‘‘concern to remedy his prescribing practices and allowing hundreds of unlawful prescriptions to some 15
regarding due process is not wholly the registrant to maintain his registration ‘‘is patients, and continued to deny material facts even
unfounded,’’ R.D. at 56, neither inconsistent with the public interest.’’ 21 U.S.C. when there was conclusive proof to the contrary.
824(a)(4). As for the ALJ’s further contention that See, e.g., 75 FR at 8200–237. And his reliance on
Respondent nor the ALJ offered there is ‘‘more to determining what constitute the Mathew is especially remarkable given that Dr.
anything more than these conclusory public interest than this one criterion,’’ R.D. 58, the Mathew was implicated in prescribing controlled
assertions. Moreover, as explained Agency considers other factors including the substances for two separate internet prescribing
previously, the ALJ’s original ruling egregiousness of the proven misconduct. Thus, in rings and did not testify in the proceeding.
cases of less egregious misconduct, the Agency has Of further note, while both physicians sought
barring Respondent from putting on Ms. frequently imposed sanctions less than a denial or judicial review of the respective agency decision, in
Richard’s testimony was also supported revocation notwithstanding that a respondent failed each case, the Court of Appeals denied their
to fully acknowledge his misconduct. However, the petitions in an unpublished decision. See Hassman
52 The constitutional question presented by this intentional or knowing diversion of controlled v. DEA, 515 Fed. App’x. 667 (9th Cir. 2013)
substances strikes at the CSA’s core purpose of (Holding that ‘‘[n]one of her proffered statements
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scenario can be avoided by waiting until the
hearing itself and moving to bar or strike the preventing drug abuse and diversion. amount to an admission of wrongdoing; they are
testimony and evidence of remedial measures when As for the ALJ’s reliance on Hassman and nothing more than further denials and claims that
the Respondent fails to acknowledge the Mathew, neither of these cases supports his she was the unwitting victim of cunning patients.
misconduct proven by the Government. However, assertion that the Agency is imposing an unfair While Hassman offered some evidence of corrective
where, as here, a respondent fails to provide an standard on registrants. As for Hassman, the ALJ’s measures, the DEA was entitled to give greater
adequate disclosure of its proposed evidence of its characterization of the Agency’s decision as having weight to the evidence indicating that Hassman has
remedial measures, the Government can still move ‘‘found that the respondent had issued several not learned from or improved upon her past
to bar the admission of the evidence prior to the prescriptions not for a legitimate medical purpose misconduct.’’); Mathew v. DEA, 472 Fed Appx. 453
hearing. for several of her patients,’’ R.D. at 56, is a gross (9th Cir. 2012).
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Exceptions, at 13 (citing Morgan, 78 FR continuing Respondent’s existing acknowledges that it ‘‘is certainly
61961, 61980 (2013)). I agree, and while registrations and granting his empowered to issue an Order to Show
Respondent bore the burden of applications for the additional Cause (or an Amended Order to Show
production on the issue, given the ALJ’s registrations would be ‘‘inconsistent Cause) alleging this factual basis and
on-the-record statement that ‘‘right now with the public interest.’’ 21 U.S.C. legal ground for revocation or denial’’
I have fairly compelling evidence that 823(f), 824(a)(4). and to submit evidence. Id. However, it
[Respondent] has accepted There is further reason to conclude then contends that to impose a sanction
responsibility, even though he didn’t that a remand is unwarranted. As found ‘‘based on events that occurred outside
tell me he did so or he was going to do above, the State of Michigan has now of the administrative litigation process
so in his prehearing statement,’’ Tr. 491, revoked Respondent’s medical license, . . . runs up against ‘one of the
it was not unreasonable for thus rendering him without authority to fundamental tenets of Due Process,’ ’’
Respondent’s counsel to conclude that it dispense controlled substances in the this being that the ‘‘ ‘Agency must
was not necessary to further develop the State in which he holds his registrations provide a Respondent with notice of
record on this issue.54 and seeks the additional registrations. those acts which the Agency intends to
I conclude, however, that a remand is Thus, Respondent no longer meets the rely on in seeking . . . revocation . . .
unwarranted for multiple reasons. As CSA’s prerequisite for obtaining and so as to provide a full and fair
explained above, see supra n.53, while maintaining a registration. See 21 U.S.C. opportunity to challenge the factual and
a registrant must accept responsibility 802(21) (defining ‘‘the term legal basis for the Agency’s action.’ ’’ Id.
and demonstrate that he will not engage ‘practitioner’ [to] mean[ ] a . . . at 11–12. (quoting Farmacia Yani, 80 FR
in future misconduct in order to physician . . . or other person licensed, 29053, 29059 (2015)).
establish that his/her continued registered or otherwise permitted, by For his part, Respondent does not
registration is consistent with the public . . . the jurisdiction in which he dispute that the Michigan Board has
interest, the Agency has repeatedly held practices . . . to distribute, dispense, revoked his medical license and that he
that it is entitled to consider the [or] administer . . . a controlled ‘‘no longer has any legal authority to
egregiousness and extent of a substance in the course of professional dispense controlled substances.’’
registrant’s misconduct in determining practice’’); see also id. § 823(f) (‘‘The Respondent’s Resp. to Admin. Order, at
the appropriate sanction. See Dreszer, Attorney General shall register 1. However, he then states that as a
76 FR at 19387–88; Volkman, 73 FR at practitioners . . . to dispense . . . procedural matter, he agrees with the
30644. Indeed, while proceedings under controlled substances . . . if the Government that ‘‘simply skipping
21 U.S.C. 823 and 824 are remedial in applicant is authorized to dispense . . . ahead to a 21 U.S.C. 824(a)(3) revocation
nature, there are cases in which, controlled substances under the laws of that the parties never litigated would
notwithstanding a finding that a the State in which he practices.’’). likely be inconsistent with due
registrant has credibly accepted Thus, pursuant to 21 U.S.C. 824(a)(3), process.’’ Id. at 4. Respondent
responsibility, the misconduct is so the Attorney General is also authorized acknowledges that ‘‘it might well be
egregious and extensive that the to suspend or revoke a registration within the Administrator’s purview . . .
protection of the public interest issued under section 823, ‘‘upon a to invite the Government to issue an
nonetheless warrants the revocation of a finding that the registrant . . . has had Amended Order to Show Cause seeking
registration or the denial of an his State license or registration revocation [under section] 824(a)(3)
application. See Fred Samimi, 79 FR suspended [or] revoked . . . by grounds because of [his] loss of his
18698, 18714 (2014) (denying competent State authority and is no license.’’ Id. at 4–5.
recommendation to grant restricted longer authorized by State law to engage I reject both parties’ contention that I
registration, explaining that ‘‘even in the . . . dispensing of controlled cannot rely on Respondent’s loss of his
assuming . . . that Respondent has substances.’’ Because Congress has state authority absent the Government’s
credibly accepted responsibility for his clearly mandated that a practitioner submission of an amended show cause
misconduct, this is a case where actions possess state authority in order to be order. Because the possession of state
speak louder than words’’). deemed a practitioner under the Act, authority is a prerequisite for obtaining
Here, the evidence shows that DEA has long held that the revocation a registration and for maintaining a
Respondent is an egregious violator of of a practitioner’s registration is the registration, the issue can be raised sua
the CSA in that he ignored countless red appropriate sanction whenever he is no sponte even at this stage of the
flags presented by the patients that they longer authorized to dispense controlled proceeding.55 Indeed, under the
were either abusing or diverting (or substances under the laws of the State Government’s position, had I rejected
both) the controlled substances he in which he practices medicine. See the Government’s case, I would be
prescribed for them. And with respect to James L. Hooper, 76 FR 71371 (2011), required to grant Respondent’s
Patients J.H. and R.E.H., the evidence pet. for rev. denied, 481 Fed. Appx . 826 applications even though he does not
shows that this went on for several (4th Cir. 2012); see also Maynard v. meet a statutory requirement for
years. Given the egregiousness of his DEA, 117 Fed. Appx. 941, 945 (5th Cir. obtaining a registration.
misconduct, the Agency’s interest in 2004); Sheran Arden Yeates, M.D., 71 Notably, the Government’s position is
protecting the public by both preventing FR 39130, 39131 (2006); Dominick A. fundamentally inconsistent with the
him from being able to dispense Ricci, 58 FR 51104, 51105 (1993); Bobby position it has taken in numerous cases
controlled substances as well as by Watts, 53 FR 11919, 11920 (1988). where it has issued an Order to Show
deterring misconduct by others is The Government nonetheless argues Cause based on public interest grounds
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substantial. I thus conclude that that because this issue was ‘‘never only to subsequently move for summary
raised in the Order to Show Cause,’’ a disposition upon learning that the
54 While Respondent’s counsel raised numerous decision on this ground ‘‘could arguably
objections to the Government’s attempts to cross- upend basic protections afforded to DEA 55 Under the Administrative Procedure Act
examine him as to the sincerity of his acceptance registrants and would surely diminish (APA), an agency ‘‘may take official notice of facts
of responsibility, Respondent’s counsel was obliged at any stage in a proceeding—even in the final
to zealously defend his client. Thus, the state of the
the perceived fairness of the . . . decision.’’ U.S. Dept. of Justice, Attorney General’s
record is primarily attributable to the ALJ’s undue administrative process.’’ Govt’s Resp. to Manual on the Administrative Procedure Act 80
limitation of the Government’s cross-examination. Admin. Order, at 11. The Government (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979).
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applicable state board had taken action Order company’s compliance with state and
which rendered the practitioner without Pursuant to the authority vested in me local laws, and reviewing the company’s
state authority. See, e.g., Morgan, 78 FR by 21 U.S.C. 824(a) and 28 CFR 0.100(b), background and history.
at 61973–74 (upholding ALJ’s granting I order that DEA Certificates of Therefore, pursuant to 21 U.S.C.
of government motion for summary Registration BA7776353 and FA2278201 823(a), and in accordance with 21 CFR
disposition based on physician’s loss of issued to Hatem M. Ataya, M.D., be, and 1301.33, the above-named company is
state authority which occurred post- they hereby are, revoked. Pursuant to granted registration as a bulk
hearing and holding that due process the authority vested in me by 21 U.S.C.
did not require amending the show manufacturer of the following basic
823(f) and 28 CFR 0.100(b), I order that classes of controlled substances:
cause order; motion for summary all pending applications submitted by
disposition provided adequate notice); Hatem M. Ataya, M.D. be, and they
Roy E. Berkowitz, 74 FR 36758, 36759– hereby are, denied. This Order is
60 (2009) (rejecting argument that effective immediately.56
revocation based on loss of state Controlled substance Schedule
authority was improper based on board Dated: February 10, 2016.
Chuck Rosenberg, Gamma Hydroxybutyric Acid I
action not alleged in the Show Cause (2010).
Order; ‘‘The rules governing DEA Acting Administrator.
Tetrahydrocannabinols (7370) ..... I
hearings do not require the formality of [FR Doc. 2016–03359 Filed 2–17–16; 8:45 am] Codeine-N-oxide (9053) ............... I
amending a show cause order to comply BILLING CODE 4410–09–P Dihydromorphine (9145) ............... I
with the evidence. The Government’s Difenoxin (9168) ........................... I
failure to file an amended Show Cause Morphine-N-oxide (9307) ............. I
Order alleging that Respondent’s state DEPARTMENT OF JUSTICE Normorphine (9313) ..................... I
CDS license had expired does not Norlevorphanol (9634) .................. I
render the proceeding fundamentally Drug Enforcement Administration
Acetyl Fentanyl (N-(1- I
unfair.’’). See also Kamal Tiwari, et al., [Docket No. DEA–392] phenethylpiperidin-4-yl)-N-
76 FR 71604 (2011); Silviu Ziscovici, 76 phenylacetamide) (9821).
FR 71370 (2011); Deanwood Pharmacy, Manufacturer of Controlled Amphetamine (1100) .................... II
68 FR 41662 (2003); Michael D. Jackson, Substances Registration: Mallinckrodt, Methamphetamine (1105) ............ II
68 FR 24760; Robert P. Doughton, 65 FR LLC Lisdexamfetamine (1205) ............. II
30614 (2000); Michael G. Dolin, 65 FR Methylphenidate (1724) ................ II
5661 (2000). ACTION: Notice of registration. Nabilone (7379) ............................ II
Here, by virtue of my order directing 4-Anilino-N-phenethyl-4-piperidine II
SUMMARY: Mallinckrodt, LLC applied to (ANPP) (8333).
the parties to address the issues of: (1) be registered as a manufacturer of Codeine (9050) ............................. II
Whether Respondent currently certain basic classes of controlled Dihydrocodeine (9120) ................. II
possesses authority to dispense substances. The Drug Enforcement Oxycodone (9143) ........................ II
controlled substances, and (2) if Administration (DEA) grants Hydromorphone (9150) ................ II
Respondent does not possess such Mallinckrodt, LLC registration as a Diphenoxylate (9170) ................... II
authority, what consequence attaches manufacturer of those controlled Ecgonine (9180) ........................... II
for this proceeding, Respondent was substances. Hydrocodone (9193) ..................... II
provided with a meaningful opportunity Levorphanol (9220) ...................... II
to show that he retains his state SUPPLEMENTARY INFORMATION: By notice
dated September 16, 2015, and Meperidine (9230) ........................ II
authority. Of consequence, Respondent Methadone (9250) ........................ II
does not dispute that he no longer holds published in the Federal Register on
September 23, 2015, 80 FR 57388, Methadone intermediate (9254) ... II
authority to dispense controlled Dextropropoxyphene, bulk (non- II
substances under Michigan law, this Mallinckrodt, LLC, 3600 North Second
dosage forms) (9273).
being the only material fact that must be Street, Saint Louis, Missouri 63147
Morphine (9300) ........................... II
adjudicated in determining whether applied to be registered as a
Oripavine (9330) ........................... II
Respondent’s registrations can be manufacturer of certain basic classes of
Thebaine (9333) ........................... II
revoked and his applications denied controlled substances. No comments or
Opium tincture (9630) .................. II
under 21 U.S.C. 823(f) and 824(a)(3) as objections were submitted for this
Opium, powdered (9639) ............. II
well as the Agency’s precedent. That notice.
Oxymorphone (9652) ................... II
there are no dispositive legal arguments The DEA has considered the factors in
Noroxymorphone (9668) .............. II
to preclude my reliance on this basis as 21 U.S.C. 823(a) and determined that Alfentanil (9737) ........................... II
an additional ground to revoke the registration of Mallinckrodt, LLC to Remifentanil (9739) ...................... II
Respondent’s registrations and to deny manufacture the basic classes of Sufentanil (9740) .......................... II
his applications is not the result of controlled substances is consistent with Tapentadol (9780) ........................ II
constitutionally inadequate notice. the public interest and with United Fentanyl (9801) ............................ II
Rather, it is the result of the statute States obligations under international
itself, which makes the possession of treaties, conventions, or protocols in
effect on May 1, 1971. The DEA The company plans to manufacturer
state authority mandatory for obtaining bulk active pharmaceutical ingredients
investigated the company’s maintenance
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and maintaining a registration and (API) for distribution to its customers.
renders irrelevant the issues of of effective controls against diversion by
acceptance of responsibility and the inspecting and testing the company’s Dated: February 10, 2016.
adequacy of remedial measures. physical security systems, verifying the Louis J. Milione,
Accordingly, I will order that 56 Based on the extensive findings of egregious
Deputy Assistant Administrator.
Respondent’s registrations be revoked misconduct by Respondent, I conclude that the [FR Doc. 2016–03357 Filed 2–17–16; 8:45 am]
and that his pending applications be public interest necessitates that this Order be BILLING CODE 4410–09–P
denied. effective immediately.
VerDate Sep<11>2014 19:03 Feb 17, 2016 Jkt 238001 PO 00000 Frm 00073 Fmt 4703 Sfmt 9990 E:\FR\FM\18FEN1.SGM 18FEN1](https://thefederalregister.org/doc/81_FR_8253/page/25.svg)
Document Created: 2016-02-18 07:46:39
Document Modified: 2016-02-18 07:46:39
| 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 | |
| FR Citation | 81 FR 8221 |
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