83 FR 14028 - Bernard Wilberforce Shelton, M.D.; Decision and Order
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 63 (April 2, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 63 (April 2, 2018)
| Page Range | 14028-14043 | |
| FR Document | 2018-06617 |
[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)] [Notices] [Pages 14028-14043] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06617] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration Bernard Wilberforce Shelton, M.D.; Decision and Order On February 16, 2017, the Assistant Administrator, Diversion Control Division, Drug Enforcement Administration, issued an Order to Show Cause to Bernard Wilberforce Shelton, M.D. (hereinafter, Registrant), which proposed the revocation of his DEA Certificates of Registration Nos. BS9770961 and FS6457407, as well as the denial of any pending application to renew these registrations or for any other registration. GX 2, at 1. As grounds for the proposed actions, the Government alleged that Registrant's continued registration is ``inconsistent with the public interest'' and that he is without state authority to handle controlled substances in the State of Michigan, the State in which he holds his registrations. Id. at 1-2 (citing 21 U.S.C. 824(a)(3) and (4), 823(f)). With respect to the Agency's jurisdiction, the Show Cause Order alleged that Registrant holds two [[Page 14029]] registrations, pursuant to which he is authorized to dispense controlled substances in schedules II-V as a practitioner in the State of Michigan: No. BS9770961, at the registered address of 30140 Harper Avenue, Suite #300, Saint Clair Shores, which was due to expire on February 28, 2018, and No. FS6457407, at the registered address of 21700 Greenfield Road, Suite 130, Oak Park, which expires on February 29, 2020. Id. at 1. As to the substantive grounds for the proceeding, the Show Cause Order alleged that the Michigan Department of Licensing and Regulatory Affairs (hereinafter, DLRA) summarily suspended Registrant's Michigan Medical License on January 12, 2017, and that pursuant to Mich. Comp. Laws Sec. 333.7311(6), ``a controlled substance license is automatically void if a licensee's license to practice is suspended or revoked under Article 15 of the Code.'' Id. at 2. The Order alleged that as a result of the DLRA's action, Registrant ``is without authority to handle controlled substances in the State of Michigan,'' and ``[c]onsequently, DEA must revoke [his] DEA registration.'' Id. (citing 21 U.S.C. 824(a)(3)). Next, the Show Cause Order alleged that Registrant violated Federal law on numerous occasions when he issued controlled substance prescriptions to four patients outside the usual course of professional practice and for other than a legitimate medical purpose, and that these ``multiple instances of unlawful prescribing in violation of federal law weigh[] in favor of the revocation of [his registration].'' Id. at 2 (citing 21 U.S.C. 841(a)(1), 823(f)(2) and 823(f)(4) and 21 CFR 1306.04). The Order also alleged that Registrant's prescribing to the four patients violated Michigan law, id. (citing Mich. Comp. Laws Sec. Sec. 333.7401(1), 333.7333, 333.7405(1)(a)), and the Michigan Guidelines for the Use of Controlled Substances for the Treatment of Pain (hereinafter, Michigan Guidelines). Id. at 2-3. The Show Cause Order then alleged that between October 2013 and February 2016, Registrant failed to comply with Federal and State law and the Michigan minimal standards when he issued controlled substance prescriptions to an undercover investigator (hereinafter, UC) and three other patients, D.S., A.L. and R.H. Id. at 3-10. Specifically, the Show Cause Order alleged that on April 1, May 1 and June 15, 2015, Registrant issued prescriptions to the UC for hydrocodone-acetaminophen, a schedule II controlled substance, and alprazolam, a schedule IV controlled substance, which were not for a legitimate medical purpose and outside the scope of professional practice. Id. at 3-6 (citing 21 CFR 1306.04(a) and Mich. Comp. Laws Sec. Sec. 333.7311(1)(e), 333.733, 333.7401(1) and 333.7405(1)(a)). The Order alleged that Registrant issued the controlled substance prescriptions to the UC ``without undertaking actions typical of medical professionals or in accordance with the Michigan Guidelines, such as conducting and documenting a complete medical history, conducting a physical examination, or properly assessing the needs of [the UC] for controlled substances.'' Id. at 3. The Order further alleged that Registrant did not make any attempt to address or resolve numerous ``red flags that [the UC] was abusing and/or diverting controlled substances'' before issuing the controlled substance prescriptions to him. Id. at 3-6. Further, it alleged that Registrant's medical records for the three visits ``contain multiple false or misleading statements which [are] inconsistent with the Michigan Guidelines standard that medical records are to be ``accurate and complete'''' and gave numerous specific examples. Id. at 4-6. Next, the Show Cause Order alleged that Registrant issued a total of 73 prescriptions to patients D.S., A.L., and R.H., ``despite failing in most instances to conduct an appropriate medical examination and meeting the minimal medical standards required under Michigan law in prescribing controlled substances (or documenting such in the patient's file),'' in violation of Federal and Michigan law. Id. at 6-9 (citing 21 CFR 1306.04(a) and Mich. Comp. Laws Sec. Sec. 333.7311(1)(e), 333.733, 333.7401(1) and 333.7405(1)(a)). Specifically, the Show Cause Order alleged that ``[f]rom on or about January 12, 2015, through on or about February 29, 2016,'' Registrant issued to D.S. 14 prescriptions for oxycodone 30 mg, a schedule II controlled substance; two prescriptions for phendimetrazine tartrate 105 mg, a schedule III controlled substance; four prescriptions for phentermine 37.5 mg and five prescriptions for Ultram (tramadol) 50 mg, both schedule IV controlled substances. Id. at 7. The Order also alleged that Registrant ``issued these orders despite the presence of . . . red flags that D.S. was abusing and/or diverting controlled substances, '' including a Michigan Automated Prescriptions Report (MAPS) which showed ``that D.S. had been prescribed combinations of opioids, benzoids and stimulants'' between February and June 2011, by up to three different medical providers; that his ``medical records indicate that D.S. was likely suffering from drug dependence''; and that ``D.S.'s urine drug tests showed signs of dangerous drug use or dependency,'' including positive results for methadone, cocaine and amphetamines when none of these drugs had been prescribed in the previous month. Id. at 7. The Order further alleged ``there is no documentation in D.S.'s medical records demonstrating that [Registrant] conducted any appropriate medical examination or review to address or resolve these indicators of possible abuse and/or diversion.'' Id. at 8. With respect to A.L., the Show Cause Order alleged that between October 17, 2013 and May 6, 2014, Registrant issued to her three prescriptions for Norco (hydrocodone/acetaminophen), then a schedule III controlled substance; three prescriptions for Adipex (phentermine) 37.5 mg, two prescriptions for Xanax (alprazolam) 2 mg, and three prescriptions for Soma (carisoprodol) 350 mg, and authorized two refills for each prescription. Id. at 8. The Order alleged that the combination of hydrocodone, alprazolam and carisoprodol is a drug ``cocktail'' known as the ``Holy Trinity'' and ``is widely known to be abused and/or diverted.'' Id. The Order also alleged that on three occasions in 2011, Registrant prescribed to A.L. ``another variation of the Holy Trinity cocktail,'' substituting Roxicodone (oxycodone) for hydrocodone and that ``[t]here is no documentation in A.L's medical records demonstrating any legitimate medical need for prescribing her that cocktail.'' Id. The Show Cause Order further alleged A.L.'s medical records show that she presented various red flags and that ``there is no documentation in [her] medical records demonstrating that [Registrant] conducted any appropriate medical examination or review to address or resolve these indicators of possible abuse and/or diversion.'' Id. at 8-9. The Order alleged that these included a MAPS report dated January 24, 2011 showing that A.L. ``had been prescribed combinations of opioids, benzoids, and stimulants by up to eight different medical providers'' between January 2010 and January 2011, and that this combination of stimulants with opioids or benzoids or both is known to drug users as ``speed-balling.'' Id. at 8-9. The Order also alleged that on a ``Health History Questionnaire'' which A.L. completed when she first became Registrant's patient, she listed the drugs she was currently taking as including Roxicodone, Xanax and Soma, and that [[Page 14030]] this combination ``also constitutes the `Holy Trinity' drug cocktail.'' Id. at 9. The Order further alleged that a Feb. 25, 2013 chart entry showed that A.L. was possibly engaged in diversion as it states: ``She says she cannot get her pain medications and has to be buying it off the streets to satisfy her pain. The last time she was given pain medication from this office was in September of last year.'' Id. With respect to patient R.H., the Show Cause Order alleged that from June 2015 through February 24, 2016, Registrant issued to him 10 prescriptions for Norco (hydrocodone-acetaminophen \1\) 10/325 mg, 10 prescriptions for morphine sulfate 30 mg tablets, and 10 prescriptions for morphine sulfate 100 mg tablets, each of these being a schedule II controlled substance; five prescriptions for alprazolam 1 mg; and two prescriptions for Soma (carisoprodol) 350 mg tablets. Id. The Order again alleged that ``there [was] no documentation in R.H.'s medical records demonstrating any legitimate medical need for prescribing him the [combination of Hydrocodone, Alprazolam and Carisoprodol drugs known as the] Holy Trinity cocktail,'' ``which is widely known to be abused and/or diverted.'' Id. --------------------------------------------------------------------------- \1\ Effective October 6, 2014, combination hydrocodone drugs were moved from schedule III to schedule II. See DEA, Schedules of Controlled Substances: Rescheduling of Hydrocodone Combinations Products from Schedule III to Schedule II, 79 FR 49661 (2014). --------------------------------------------------------------------------- The Show Cause Order also alleged that on six other occasions in 2011, Registrant prescribed other variations of this cocktail to R.H. despite the presence of red flags in his medical records. Id. at 10. Specifically, the Order alleged that Registrant's ``medical records indicated that R.H. was possibly suffering from drug dependency'' because the ``medical chart dated December 21, 2011 states `he [sic] is taking the valium three times ad [sic] although he is given it twice daily so he runs out early [sic].''' Id. The Show Cause Order further alleged that R.H.'s urine drug test results showed signs of dangerous drug use or drug dependency. The Order alleged that on seven occasions during 2015 through 2016, R.H. tested positive for amphetamines and that on three occasions during 2015, he tested positive for benzodiazepines and that Registrant ``had not prescribed'' either class of drugs to him in the months preceding the positive results. Id. Finally, the Order alleged that ``[t]here is no documentation in R.H.'s medical records demonstrating that [Registrant] conducted any appropriate medical examination or review to address or resolve these indicators of possible abuse and/or diversion.'' Id. The Show Cause Order then asserted that Registrant ``fail[ed] in most instances to conduct an appropriate medical examination'' and failed to meet ``the minimal medical standards required under Michigan law in prescribing controlled substances (or documenting such in the patient's file).'' Id. at 9 (citing 21 CFR 1306.04(a) and Mich. Comp. Laws Sec. Sec. 333.7311(1)(e), 333.733, 333.7401(1) and 333.7405(1)(a)). The Order further asserted that Registrant's conduct ``completely betrayed any semblance of legitimate medical treatment'' in that he ``failed to take reasonable steps, like conduct medical examinations, to guard against diversion of controlled substances.'' Id. at 10 (citing Jack A. Danton 76 FR 60,900 (2011); Hatem M. Ataya 81 FR 8221 (2016) (other citations omitted)). The Show Cause Order notified Registrant of his right to request a hearing on the allegations or to submit a written statement in lieu of a hearing, the procedure for electing either option, and the consequence for failing to elect either option. Id. at 11 (citing 21 CFR 1301.43). The Show Cause Order also notified Registrant of his opportunity to submit a Corrective Action Plan in accordance with 21 U.S.C. 824(c)(2)(C). Id. at 11-12. On February 23, 2017, a DEA Special Agent and a Diversion Investigator (DI) personally served Registrant with the Order to Show Cause at his office located at 30140 Harper Avenue, Suite #300, Saint Clair Shores, Michigan. GX 31 (Declaration of Special Agent), at 4. According to the Agent, Registrant signed a DEA Receipt for the Show Cause Order. Id., see also GX 29. On May 8, 2017, the Government filed its Request for Final Agency Action (RFAA) with my Office and forwarded the evidentiary record, stating that more than 30 days have passed since Registrant was personally served, and DEA has not received a request for a hearing or any other reply from Registrant. RFAA, at 1. Based on the Government's representations that more than 30 days have now passed since the date of service of the Show Cause Order and that Registrant has not submitted a request for a hearing or any other reply including a Corrective Action Plan, I find that Registrant has waived his right to a hearing or to submit a written statement in lieu of a hearing. 21 CFR 1301.43(d). I therefore issue this Decision and Final Order based on relevant evidence contained in the record submitted by the Government. 21 CFR 1301.43(d) & (e). I make the following findings of fact. Findings of Fact Registrant is the holder of DEA Certificate of Registration No. FS6457407, pursuant to which he is authorized to dispense controlled substances in schedules II--V, at the registered location of 21700 Greenfield Road, Oak Park, Michigan. GX 1 (Copy of Registrations). This registration does not expire until February 29, 2020. Id. Registrant also held DEA Certification of Registration No. BS9770961, pursuant to which he was authorized to dispensed controlled substances at the registered location of 30140 Harper Avenue, Suite #300, in Saint Clair Shores. Id. He was also authorized, under DATA-Waiver Identification Number XO9770961, to dispense Suboxone and Subutex to up to 100 opiate- addicted patients pursuant to the Drug Addiction Treatment Act of 2000 (DATA). Id.; see 21 U.S.C. 823(g)(2). However, Registration No. BS9770961 and DATA-Waiver Identification No. XO9770961 expired on February 28, 2018, when Registrant failed to renew this registration. Registrant holds a license to practice medicine in the State of Michigan, as well as several controlled substance and drug control licenses issued by the Michigan Board of Pharmacy. GX 30, at 1-2. However, on January 12, 2017, the Director of the Bureau of Professional Licensing, Michigan Department of Licensing and Regulatory Affairs (DLRA), ordered the summary suspension of Registrant's medical license based on the Department's ``find[ing] that the public health, safety, and welfare requires emergency action.'' See GX 30, at 1. The Order also stated that ``[Public Health] Code Sec. 7311(6) provides that a controlled substance license is automatically void if a licensee's license to practice is suspended or revoked.''\2\ --------------------------------------------------------------------------- \2\ According to the website of the Michigan Department of Licensing and Regulatory Affairs, Registrant held: a Pharmacy CS-3 license 5315079480, which was issued on November 23, 2016 but is currently in a ``lapsed'' status; a Pharmacy Drug Treatment Program Prescriber license 5304001334, which was issued November 3, 2016 but is currently in ``lapsed'' status; and a Pharmacy Drug Control Location license 5315079209, which was issued November 14, 2016 but is also currently in ``lapsed'' status. See https://w2.lara.state.mi.us. --------------------------------------------------------------------------- According to the online records of the DLRA, of which I take official notice, see 5 U.S.C. 556(e),\3\ on July 12, 2017, [[Page 14031]] Registrant entered into a consent order with the Board of Medicine pursuant to which the summary suspension was dissolved but his medical license was suspended for 15 months to include the period ``during which the order of summary suspension was in effect.'' See In re Bernard Wilberforce Shelton, M.D., No. 43-16-140510, Consent Order at 2 (Mich. Bd. of Med., July 12, 2017). The Consent Order further ordered that ``[r]einstatement of [Registrant's] license shall not be automatic'' and he must petition for reinstatement. Id. Under the consent order, to obtain reinstatement, ``Respondent must demonstrate . . . by clear and convincing evidence: (1) Good moral character; (2) the ability to practice the profession with reasonable skill and safety; (3) satisfaction of the guidelines on reinstatement adopted by the Department; and (4) that it is in the public interest for the license to be reinstated.'' Consent Order, at 2. --------------------------------------------------------------------------- \3\ In the RFAA, the Government noted that it had been notified by the DLRA that a settlement had been reached with Registrant subject to Board approval; however, the Consent Order had not been issued at the time the RFAA was submitted to my office. RFAA, at 2 n.1. 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). While under DEA's regulations, ``any party, on timely request, shall be afforded [an] opportunity to controvert such fact,'' 21 CFR 1316.59(e), Registrant waived his right to a hearing or to submit a written statement and is therefore not entitled to refute my findings with respect to the Consent Order. --------------------------------------------------------------------------- The DLRA also required that Registrant pay a $10,000 fine. Id. I also take official notice that Respondent's medical license remains suspended as of the date of this Decision and Order. See also https://w2.state.mi.us. The Investigation In January 2015, DEA began its investigation of Registrant after receiving information from the St. Clair Shores Police Department and Michigan Blue Cross/Blue Shield (MBCBS) about the investigation they were conducting of Registrant. GX 31, at 1 (Declaration of Special Agent). DEA then initiated this investigation, which included supervising three undercover visits by an MBC/BS investigator (hereinafter, also referred to as UC) to Registrant at his office in St. Clair Shores. Id. at 1-2; see also GX 8. As part of the investigation, on September 29, 2015, a Special Agent (SA) and a Diversion Investigator (DI) interviewed Registrant. GX 31, at 2-3. During the interview, Registrant informed the SA and DI about ``his [patient] protocols . . . including how his office conducts drug screens and his new patient procedures, how he conducts physical exams on his patients, and how he determines what controlled substances to prescribe over time.'' Id. at 2. According to the SA, in the interview he ``also discussed with [Registrant] his patient `James Howard' (the MBC/BS investigator), specifically discuss[ing] the three visits and how Mr. Howard's diagnoses were determined, . . . reviewed the associated patient records, discussed his urine drug screen results and how those were evaluated, and . . . discussed the controlled substances [Registrant] had prescribed to'' the investigator. Id. The same day, the St. Clair Shores Police Department executed a state search warrant at Registrant's office and a second warrant at his residence. Id. at 2-3. During the execution of the warrant, the SA and another SA conducted a second interview with Registrant, who ``stated that he conducts physical exams on his patients and that he can do an exam by looking at the patient.'' Id. at 3. On approximately February 22, 2016, the SA subpoenaed various patient records, and Registrant provided copies of the electronic patient records that were requested. Id. The SA also subpoenaed Registrant's records for specific patients, including those of D.S., A.L., and R.H., from Network Technology Inc., d/b/a RXNT, a firm which develops and implements products related to electronic health records and electronic prescribing. Id. at 2-3. On June 22, 2016, after reviewing MAPS and RxNT's records to identify specific prescriptions, the SA also subpoenaed from various pharmacies copies of the prescriptions issued by Registrant to various patients, including D.S., A.L., and R.H. Id. Subsequently, the SA also subpoenaed and obtained from Registrant the patient records of the MBC/BS Investigator. Id. The Undercover Visits On April 1, 2015, the MBC/BS Investigator (UC) conducted the first of three undercover visits to Registrant at his St. Claire Shores Medical office. GX 12, at 5. During each visit, he posed as patient D.H., whose occupation was driving. Id. The investigative record includes video recordings of each of his visits, transcripts of the recorded visits, his medical file, and photographs of the vials containing the filled controlled substance prescriptions issued by Registrant. GXs 3-12. At the visit, the UC filled out new patient paperwork which included a registration form, a health history questionnaire, a pain questionnaire, and signed a narcotics contract. GX 12, at 5, 6-9, 11- 12, 13-14. On the Health History Questionnaire, the UC wrote the name of a referring doctor and stated that his last exam had been in the ``summer 2014,'' and that ``Nerves'' and ``Back'' were ``medical problems that other doctors have diagnosed.'' Id. at 6. Under ``prescribed drugs,'' he wrote ``Zanax [sic] Strength 1 Frequency Taken 2.'' Id. at 7. He left the ``Health Habits and Personal Safety'' section mostly blank, including questions about his alcohol intake and recreational or street drug use. Id. at 7-8. In the Mental Health section, he circled ``no'' as his answer to the questions: ``Is stress a major problem for you?''; ``Do you feel depressed?''; ``Do you feel panic when stressed?''; and ``Have you ever been to a counselor?'' Id. at 9. He circled ``yes'' to the question ``Do you have trouble sleeping?'' Id. The UC also filled out a Pain Questionnaire. Id. at 11. This consisted of a body diagram where he circled the lower back portion, and a section where he was to circle words describing his pain, such as ``Aching, Stabbing, Gnawing, Sharp, Burning, Exhausting, Tiring, Nagging, Numb, Miserable or Unbearable.'' UC did not, however, circle any of these descriptors, and instead, wrote ``Stiff.'' Id. He indicated that his pain was ``worst'' in the morning, but left blank four questions which asked him to rate his pain level at its worst, least, average for the month, as well as ``right now,'' on a scale of one to ten. Id. He wrote that ``Meds'' made his pain better, and left blank what made it worse. Id. at 12. He circled ``None'' in answer to ``what treatment or medication are you receiving for your pain?'' Id. He also left blank a series of questions asking him to rate the level of interference of pain on his general activity, mood, normal work, sleep, enjoyment of life, ability to concentrate, and relationships with other people. Id. He signed and dated this form ``7-9-70.'' Id. A section at the bottom of the form for Notes, Action Plan details and the Clinician's Signature are blank. Id. UC also signed a narcotic contract, stating that he would use a Walgreens pharmacy. Id. at 13-14. The video recording and transcript of the visit show that after he filled out the paperwork, he saw a nurse in an exam room, who asked a series of questions from a form while taking notes, including: ``Have anxiety? I noticed that you take uh . . . .'' GX 4, at 3. UC stated ``I don't know what you call it. . . uh . . . you know my nerves get jacked up and what not. I don't know what you call it.'' Id. UC added that he took Xanax and Norco, and that he had previously seen a physician in Flint, but it was ``too far and I travel a lot.'' Id.; GX 3, Video Recording (VR) 2, at 15:45:20-15:46:41. [[Page 14032]] The nurse asked: ``As far as your medical history goes you want me just . . . to put anxiety down?'' GX4, at 3. UC stated: ``Whatever you call that, I don't know what the word,'' which prompted the nurse to ask: ``What brings you here?'' Id. UC answered: ``Just to get Xanax refills.'' Id. The nurse then asked UC if he ``had pain anywhere?'' and UC answered: ``Ah . . . like my back is stiff. But I don't know . . . Pretty much a stiff back. I drive a lot and what not, know what I'm saying.'' Id. at 3-4; GX 3, VR 2, at 15:46:41-15:47:11. Following a discussion of Registrant's background, the Nurse then told UC that Registrant ``drug test[s] everybody.'' GX 4, at 4. As the Nurse proceeded with obtaining his weight, UC said that he was ``cool,'' that he did not ``want to cause any problems for anybody'' including Registrant, and that he was ``[m]ore or less healthy. You know what I'm saying?'' Id. at 4-5; GX 3, VR 2, at 15:47:11-15:48:48. After determining UC's marital status, the nurse said: ``So, basically, you don't even--you don't have any problems besides the little bit of anxiety and your back gets stiff because of driving.'' GX 4, at 5. UC replied: ``Yeah, yeah. You got it.'' Id.; see also GX 3, VR 2, at 15:48:48-15:49:22. The nurse continued to take UC's vitals as the two discussed his work as a driver, after which UC mentioned a patient in the lobby who, in UC's words, was ``yip-yapping and jaw-jacking.'' GX 4, at 6-7. The nurse denied that patients could easily get their prescriptions and stated that patients were tested and ``if they have other stuff in their system they cannot get their script . . . because they could drop dead if they mix.'' Id. at 7-8. Continuing, the nurse stated that Registrant is ``really strict about that'' and UC said: ``The worst thing I do is drink moonshine here and there. Little liquor on the weekends you know. But when I take that Xanax, I'm pretty chilled, so I don't really need to drink too much. You know it keeps me from getting stupid.'' Id. at 8; GX 3, VR 2, at 15:49:22-15:53:59. As the nurse continued to review UC's medical history and discussed various subjects with him, UC noted that a sign on the wall ``says our office is no longer writing prescriptions for . . . ah . . . oxycodone or [R]oxicodone. Is that what that says?'' GX 4, at 11. The nurse replied: ``I don't think it says that. He writes that.'' Id. UC pointed out where he read the statement, and the nurse replied that ``it's for people that come in here just one time . . . [T]hey can't come in here (unintelligible).\4\ Id. at 11-12; see also GX 3, VR 2 at 15:53:59- 16:01:44. --------------------------------------------------------------------------- \4\ The sign is not, however, visible on the video. GX 3, VR 2, at 16:00:52-16:01:44. --------------------------------------------------------------------------- Registrant eventually entered the exam room, greeted UC while donning a headphone set connected to the computer, resolved an issue with another patient, and appeared to dictate and record into the computer while he spoke to UC. GX 4, at 14. The nurse informed Registrant that UC was a new patient, and Registrant read aloud UC's height, weight, age and occupation from the computer screen. Id. at 16; see also GX3, VR3, at 16:16:23-16:19:39. Registrant confirmed with UC that he drove for a living, and asked: ``And you have pain or what?'' ``What is your problem mostly?'' GX 4, at 17. UC stated: ``My back gets stiff because I drive a lot so sitting down too much. My back, you know, so it's stiff pretty much.'' Id. Registrant determined that UC did not have a CDL (commercial driver's license) and asked, ``You don't use methadone?'' UC responded: ``Absolutely not. I use moonshine. You know what that is?'' Id. Registrant asked: ``Too much?'' UC answered: ``No'' and ``You know if I take that Xanax it keeps me from drinking too much so it works out good.'' Id. at 17-18; GX 3, VR 3, at 16:19:40-16:21:22. Registrant then asked: ``So what can I give you today to help you out?'' Id. UC answered: ``Usually Xanax helps me out. And Norco helps my back. That's all I really need. I don't have any--I'm pretty healthy.'' GX 4, at 18; GX 3, VR 3, 16:21:27-16:21:41. Thereafter, Registrant resolved a problem with accessing the dictation software on his computer and began dictating into it, stating that UC ``is here for his first visit. . . . He is suffering also from anxiety and back spasms due to his long sitting. He currently does not have a CDL.'' GX 4, at 18. After UC told Registrant that he drove eight to 12 hours a day, Registrant stated: ``He denies drinking or using any stimulants such as methadone.'' Id. Registrant then asked whether UC was diabetic, and after UC said that he was not, Registrant dictated: ``He only uses Xanax occasionally for his anxiety. . . . Today, he is complaining mostly of some level of anxiety.'' Id. Registrant then asked UC if had ever seen a psychiatrist and UC answered: ``No, if I did, it was a long, long time ago.'' Id.; GX 3, VR 3, at 16:21:41- 16:24:16. Registrant then asked UC if he ``suffered from any childhood mental disorder'' such as ``attention deficit'' disorder. GX 4, at 18. UC said: ``Well . . . yeah. I don't know what they called it, but I didn't do very good in school.'' Id. Registrant asked: ``But not diagnosed? Not medicated?'' Id. UC replied: ``I use to take ADD--Ritalin.'' Id. Registrant asked: ``Ritalin as a child?'' Id. at 19. UC replied: ``Yeah. You know sometimes I do lose focus so I mean it might help me focus.'' Id. Registrant then resumed dictating and stated: ``After questioning the patient, admits to having had some childhood diagnosis of attention deficit disorder and was on Ritalin occasionally as a child. Sometime he complains of losing some focus but other than that he is doing well.'' Id. After dictating several additional comments, Registrant told UC to ``[l]ook at me'' and said ``ok.'' Id.; GX 3, VR 3, at 16:24:16-16:25:18. UC told Registrant that he was ``[p]retty much a healthy guy'' and ``I try to take care of myself.'' GX 4, at 19. Continuing, UC said: ``Drink a little too much on the weekends sometimes, but you know.'' Id.; GX 3, VR 3, at 16:25:18-16:25:29. Registrant then told UC: ``You know in this business of what I do, I don't know who is who. I have to be very careful when patients come in here.'' GX 4, at 19. UC replied: ``Oh you don't want trouble makers coming in here'' and Registrant said: Not the trouble makers. You know people come in here in all different shapes and forms. Sometimes they are investigators. Sometimes they are undercover cops. Sometimes they're anything and when I miss something it's just the right time for them to jump on me for something. So don't be worried that I'm paying attention to almost everything, you know. Did they give you a urine screen and test? Id. UC said ``[n]o.'' Id. Registrant again asked UC if he gave a urine; UC again said ``no.'' Id.; GX 3, VR 3, at 16:25:30-16:26:20. Again looking at his computer screen, Registrant stated: ``Your last physician recorded here was Dr. Vora Kandarp. He gave you Norco. He also gave you Xanax 0.5mg. He also gave you Naproxen. You saw a Dr. Miky in September.'' GX 4, at 19. UC said, ``I did,'' after which Registrant named three other doctors who he believed UC had seen in July and May of the previous year, noted that one of doctors had prescribed Adderall, and named the drug store which had filled this prescription. Id. Registrant then asked UC if he had high blood pressure because ``somebody gave you blood pressure medication.'' Id. UC denied having high blood pressure, stating that it was ``low actually'' and ``I never took that.'' Id. at 19-20; GX 3, VR 3, at 16:26:20-16:27:15. UC then asked Registrant: ``How do you see that on there? You guys on the [[Page 14033]] same computer system?'' GX 4, at 20. Registrant replied: ``Everything. Everything shows up.'' UC then noted that the nurse had said that Registrant had ``a lot of problems with idiots coming in here trying to get drugs'' but ``that's not me.'' Id. Registrant discussed with UC his use of amphetamines, with UC noting that he ``didn't take it all the time'' and it ``[t]ook [him] a while to use it.'' Id. Registrant stated that he ``shouldn't take it all the time'' and did not prescribe the drug. Id.; GX 3, VR 3, at 16:27:15-16:27:46; see also GXs 5 & 12. Registrant then moved on to UC's use of Xanax, noting that ``it seems like you started with .25 Xanax. You're up to .5 now, double it, to 60, that's in December. Is that sufficient for you?'' GX 4, at 20. UC said ``Yeah . . . Probably,'' and Registrant said: ``Okay. I will do that for you, sir.'' Id.; GX 3, VR 3, at 16:27:45-16:28:11. Registrant further noted, ``And . . . you did get a few pain medication'' and asked: ``You want that too?'' GX 4, at 20. UC said ``[y]es'' and Registrant said ``[a]lright.'' Id.; GX 3, VR 3, at 16:28:11-16:28:18. Registrant then stated: ``It's just the good thing is nothing is hidden anymore, you know. You can't come and hide anything.'' GX 4, at 20. Continuing, Registrant said: ``And these medications are good medications.'' Registrant then discussed the dosing of two non- controlled medications he was prescribing (Baclofen and Naproxen). Id. at 20-22; GX 3, VR 3, at 16:28:18-16:28:48. Registrant proceeded to dictate dosing instructions for the prescriptions and asked UC which pharmacy he used. GX 4, at 22. UC asked if there was ``a good pharmacy around here'' or if he could ``take them on paper and go wherever I want?'' Id. Registrant suggested a pharmacy that was ``right up the street.'' Id. UC asked: ``They won't give me a hard time?'' and Registrant said ``no.'' Id. at 23. Registrant then wrote electronic prescriptions which he sent to the pharmacy that he and UC had agreed upon. Id.; GX 3, VR 3, at 16:28:48- 16:31:56. As the visit was about to end, Registrant noted that ``we need to get a urine from him'' and added: ``All the new patients--did they draw blood from you? You'll give a urine on the way out.'' GX 4, at 23. UC said he wasn't ``too good with needles'' and avoided the blood test but provided a urine sample. Id. at 26. See also GX 3, VR 3, at 16:31:56- 16:44:32. In the subjective section of the visit note, Registrant documented UC's chief complaint as: ``I drive for a living my back gets very stiff anxiety as well.'' GX 12, at 16. Under ``History of Present Illness,'' Registrant wrote that UC: is here for his first visit . . . he is suffering also from anxiety and back spasms due to his long sitting . . . he denies drinking or using any stimulants such as methadone or is a diabetic nor . . . on insulin. On the only use is Xanax occasionally for his anxiety. Today he is complaining mostly of [] some level of anxiety. . . . [P]atient admits to having had . . . a diagnosis of attention deficit disorder. . . . Sometimes he complains of losing some focus but other than that he's doing well. Id. The visit note's Review of Systems section contained fourteen different areas. Id. at 16-17. With the exception of ``BJE/ Muscoskeltal,'' next to which Registrant noted ``Back Pain'' but ``Negative for Arhitis [sic], Joint Pain, Joint Swelling, Muscle Cramps, Muscle Weakness, Stiffness and Leg Cramps,'' all the areas contained negative findings, including the entry for Psychiatric, next to which Registrant documented: ``Negative for Anxiety, Depression, Hallucinations, Memory Loss, Mental Disturbance, Paranoia, Suicidal Ideation, Panic Attacks.'' Id. In the ``Physical Examination'' section, Registrant noted UC's ``General Appearance'' as: ``Patient appears to be appropriate for age dressed appropriate for work responded to questions and no acute distress at this time.'' Id. at 17. Registrant noted that there were ``[n]o abnormal findings'' with respect to the ``exam'' of UC's ``[m]uscoskeletal'' and ``[n]eurologic'' systems. Id. at 18. Yet Registrant then noted diagnoses of ``Spasm of Muscle,'' ``Anxiety State not Otherwise Specified,'' as well as ``Attention or Concentration Deficit.'' \5\ Id. For each diagnosis, he documented that ``7/22/2015,'' a date more than three months into the future, was both the date of onset and the date of diagnosis; he also noted that each diagnosis was active. Id. at 18. --------------------------------------------------------------------------- \5\ He also documented a diagnosis of ``Body Mass Index Between 29.0-29.9 Adult.'' GX 12, at 18. --------------------------------------------------------------------------- As for Registrant's treatment plan, he listed only medications, which included ``naproxen 500 mg,'' ``hydrocodone 7.5 mg-acetaminophen 325 mg,'' \6\ and ``alprazolam 0.5 mg,'' and a follow-up visit ``after [one] month.'' Id. at 19. Consistent with other evidence, the record includes two photographs of a pharmacy bottle with the label for 90 tablets of hydrocodone APAP'' 7.5/325 mg prescribed to D.H. (UC's alias) by Registrant, to be taken three times daily as needed for back pain and stiffness, which was filled by a pharmacy in Mt. Clemens, Michigan on April 1, 2015. GX 5, at 1-2. Two other photos show the label attached to a vial which indicates that it was a prescription for 60 Alprazolam 0.5 mg, to be taken twice daily for anxiety, which was also prescribed by Registrant to UC and was filled at the same pharmacy. Id. at 5-6. --------------------------------------------------------------------------- \6\ Hereinafter, referred to as hydrocodone/apap. --------------------------------------------------------------------------- UC's medical file includes the report of the urine drug screen obtained at his April 1 visit, as well as a report run on the same date from the Michigan Automated Prescription System (MAPS). GX 12, at 20 (UDS report); id. at 3 (MAPS report). As for the drug screen results, which were reported back to Registrant on April 9, 2015, the results were negative for all controlled substances listed, including alprazolam, hydrocodone, and hydromorphone, the latter being a metabolite of hydrocodone. Id. at 20. As found above, UC had represented to Registrant (and his nurse) that he took both hydrocodone and Xanax, and the visit note listed hydrocodone as a current medication. GX 4, at 18 (transcript of visit); GX 12, at 7 (questionnaire), 17 (visit note), and 20 (UDS report noting UC was prescribed hydrocodone and Xanax). As for the MAPS report, it showed that on December 15, 2014, UC had last filled prescriptions which were issued by Dr. Vora of Gladwin, Michigan for 90 tablets of hydrocodone/apap 7.5/325 mg and 60 tablets of alprazolam .5 mg. Id. at 3. The report also showed that the UC had obtained four prescriptions for various quantities and dosages of alprazolam from four different providers, two of whom were located in Flint, the others in Marquette and Detroit. Id. The Government also submitted a declaration by the UC. GX 32. With respect to the April 1 visit, UC stated that Registrant reviewed his alias's purported medical history and saw that he had seen at least three other doctors in the months prior to his first visit, but did not conduct any further inquiry or follow up with him on that issue. Id. at 2. UC also stated that during the April 1 visit, Registrant conducted virtually no physical examination, and that the portion of his visit with Registrant lasted only a few minutes and consisted mainly of answering questions. Id. He also stated that during the visit, Registrant was repeatedly distracted by issues he was having with the dictation software for his electronic patient records. Id. My review of the video evidence corroborates each of these statements. GX 3, VR 3, 16:15:22-16:33:22. UC further stated that he reviewed Registrant's patient records for him and determined that portions of it either [[Page 14034]] misstate his statements during the visit or falsely indicate the extent to which he received or did not receive a medical examination. GX 32, at 2. UC explained: For instance, the patient record lists ``spasm of muscle'' as one diagnosis, even though I did not complain of spasms during the visit. And the record states that I ``den[ied] drinking'' even though I indicated that I do drink. The record also documents findings from a physical exam in categories such as ``Eyes,'' ``ENT,'' ``Cardiovascular,'' ``Muscoskeletal'' and ``Neurologic'' even though other than the taking of my vitals no physical exam was performed during the visit. Id. Second Undercover Visit On May 1, 2015, UC again saw Registrant at the St. Claire Shores clinic. GX 12, at 22; GX 6 (video recording of visit). After UC provided a urine sample, a medical assistant (MA) took his vitals and UC asked if he could get paper prescriptions. GX 7, at 12 (transcript of recording). The MA asked what medications he was taking, UC said ``Norco and Xanax'' and that he had gotten them last month. Id. As the MA continued to take his vitals, she asked UC if he had a ``pharmacy problem'' and UC said: ``They take forever.'' Id.; GX 6, VR 5, at 11:19:58-11:22:31. The MA then asked: ``[W]hat's bothering you actually?'' GX 7, at 12. UC replied: ``Just refills. I'm just here for refills. I'm just here for my back pills and my nerves.'' Id. The MA asked, ``Your lower back?'' and UC replied ``Yeah.'' Id.; GX 6, VR 5, at 11:22:31-11:23:03. After she confirmed that ``just your back is [the] problem,'' the MA asked UC if he ``had a back injury before?'' GX 7, at 13. UC said that he didn't know and didn't ``know what it was.'' Id. The MA went through a list of symptoms including headaches and anxiety and asked if he had none of them; UC answered: ``I get headaches when I drink too much liquor'' and ``I do it big sometimes.'' Id. After a discussion of her shoes, MA asked UC: ``just back right?'' Id. UC said ``Uh-Huh,'' after which MA asked if he ``sometimes'' took medicine for headaches; UC answered: ``No, I just take the Xanax and Norco.'' Id.; see also GX 6, VR5, at 11:23:03-11:24:23. The MA then asked if he had an ``anxiety problem?'' GX 7, at 13. Id. UC replied: ``Yeah. No--I don't know what you call it. But my nerves,'' prompting the MA to interject ``Anxiety'' and UC said ``I call it nerves.'' Id. The MA then asked UC if he took Xanax, and after UC confirmed this and that he took the one milligram dosage form, UC added: ``7.5 Norcos. That's all I need. I'm easy. What do you need?'' after which the MA asked UC to fill out a questionnaire. Id.; GX 6, VR 5, at 11:24:20-11:25:44. UC filled out the questionnaire, and after the MA asked him if he had undergone various tests and had his blood drawn, UC was escorted to Registrant's office where the visit took place. Notably, the video shows that Registrant sat behind his desk for the duration of the visit, which lasted approximately three and a half minutes. See GX 6, VR 5, at 11:46:33-11:49:46; VR 6, at 11:49:47-11:50:01. Registrant greeted the UC, confirmed his name, checked his computer screen, and discussed his lunch order with an unidentified employee, after which he asked UC about his insurance, and finally inquired if ``the medication [he] had last time went well?'' GX 7, at 16-17; UC replied ``Yep.'' After commenting about UC's blood pressure and height, Registrant asked: ``So you're okay with what we have?'' Id. at 18. UC said ``Yes'' and asked: ``Can I get it on paper this time?'' Id. Registrant asked ``why'' and if he went to a particular pharmacy, to which UC replied that ``it took forever,'' that he ``waited in line behind eight people,'' and he was ``going the other way this time too . . . to Detroit.'' Id. Registrant then agreed to give UC a paper prescription. Id.; GX 6, VR 5, at 11:46:3-11:48:05. Registrant and UC proceeded to discuss the latter's job as a driver for a car transporter and cars in general, and were interrupted by the MA. GX 7, at 18-20. While Registrant discussed another patient with the MA, she handed several paper prescriptions to Registrant. Registrant signed the prescriptions and handed them to UC, saying, ``Here, sir'' and ``Alright, Take care.'' Id. at 19-20. UC thanked Registrant and said he would see Registrant ``in a month,'' and the visit ended. Id. 20; GX 6, VR 5, at 11:49:23-11:49:46; VR 6, at 11:49:50-11:50:01. The evidence includes a visit note dated May 1, 2015, which lists UC's Chief Complaint as: ``I am having lower back pain with anxiety problem[.]'' GX 12, at 22. In the note's Review of Systems section, Registrant documented: ``BJE/Musculoskeletal: ``Back Pain:--.Negative for Arhitis [sic], Joint Pain, Joint Swelling, Muscle Cramps, Muscle Weakness, Stiffness, Leg Cramps.'' Id. Registrant noted UC's psychiatric condition as ``Anxiety:--.Negative for, Depression, Hallucinations, Memory Loss, Mental Disturbance, Paranoia, Suicidal ideation, Panic Attacks.'' Id. With respect to all other systems, including ``neurological,'' Registrant noted: ``No symptoms at this time.'' Id. In the Physical Examination section, Registrant noted under ``General Appearance,'' that ``patient doesn't seems [sic] to be in any distress, appropriate to respond to questions alert,'' and under ``Muscoskeletal,'' he noted ``Limited Motion:--Arthritis.'' Id. at 23. Registrant again listed his diagnoses as ``Attention or Concentration Deficit,'' ``Spasm of Muscle,'' and ``Anxiety State Not Otherwise Specified.'' Id. at 23-24. For each diagnosis, he again listed ``7/22/ 2015'' as both the date of diagnosis and the date of onset and noted that the diagnosis was ``[a]ctive.'' Id. In the Plan section of the note, Registrant did not list any prescriptions. See id. The evidence, however, includes copies of the prescriptions he issued at this visit; these include a prescription for 90 hydrocodone/apap 7.5/325 mg, 60 alprazolam 0.5 mg, as well as naproxen and baclofen. GX 8, at 1-4. As part of his plan Registrant ordered a ``urine drug screen'' and noted a follow-up visit ``after one month.'' GX 12, at 24. A result sheet for the urine drug screen which was done on this date and apparently tested by Registrant's clinic \7\ states that UC's test results were ``normal'' for amphetamines, benzodiazepines, opiates and oxycodone, as well as other controlled substances. Id. at 25. A second report shows the results of a test which was done by a lab (which were reported on May 6, 2015). Id. at 26. Notably, the lab reported ``Not Detected'' for both alprazolam and hydrocodone as well as each drug's metabolites \8\ even though Registrant had prescribed the drugs at UC's previous visit. Id. --------------------------------------------------------------------------- \7\ The result sheet indicates that these results were obtained within 20 minutes of the time of the test. \8\ These include hydroxyalprazolam, a metabolite of alprazolam, and norhydrocodone and hydromorphone, which are metabolites of hydrocodone. GX 12, at 26. --------------------------------------------------------------------------- In his declaration, UC stated that Registrant ``did not conduct any physical examination'' and ``sat behind his [office] desk the entire time we talked'' which ``lasted only a few minutes.'' GX 32, at 3. He also stated that he had reviewed Registrant's patient records for the May 1, 2015 visit and determined that ``portions of them either misstate my statements during the visit or falsely indicate the extent to which I received (or did not receive) a medical examination.'' Id. These included the diagnosis of ``spasm of muscle'' even though ``I did not complain of and was not found to have muscle spasms during the visit,'' as well as that the medical ``record quotes me as saying `I am having lower back pain' [[Page 14035]] even though I made no such statement.'' Id. Third Undercover Visit On June 15, 2015, UC again saw Registrant. GX 9 (Video Record), GX 10 (transcript), GX 32 (UC's Declaration); see also GX 12, at 28 (Pt. file). According to the visit transcript, UC paid a co-pay and provided a urine sample. GX 10, at 1-3. Next, UC met with a nurse, who took his blood pressure and heart rate and asked him his weight and height. Id. at 4; GX 9, VR 3, at 13:32:58-13:35:43. After UC noted that the last visit had taken place in Registrant's office and that he had ``sat across from the doctor who wrote me up,'' the nurse asked: ``you just needed your refills?'' GX 10, at 5. UC said: ``Yeah. That's all I need. I'm easy. Easy for sure.'' Id.; GX 9, VR 3, at 13:35:43-13:36:08. The nurse accessed UC's electronic medical record and asked: ``So you're here for meds?'' Id. at 6. UC said: ``That's it. I'm pretty healthy.'' Id. The nurse then asked: ``Any new pain or anything? Pain is about the same?''; UC said: ``It's the same. Everything is the same.'' Id. The nurse replied: ``Unfortunately we still have to do all this charting, you know . . . [f]or DEA . . . It's just really crazy . . . those controlled things are really . . . it's like impossible to find meds . . . . It's being purposely done. People don't realize that, but DEA is behind it . . . .'' Id. UC remarked ``[c]lamping down?'' to which she replied ``Yep.'' Id.; GX 9, VR 3, at 13:36:08-13:37:59. The nurse had UC fill out some paperwork, after which she proceeded to question UC as to whether he had experienced various symptoms including appetite problems, chills, fatigue, fevers, night sweats, weight gain or loss, ringing ears (which prompted UC to say that ``[m]y ears only ring after I drink a jug of moonshine''), blurry or double vision, coughing, difficulty breathing, wheezing, snoring, chest pain, or heart skippings; UC answered ``no'' to each of these. GX 10, at 9- 10; GX 9, VR 3, at 13:39:26-13:43:52. Continuing, the nurse asked UC if he had ``[a]ny muscular skeletal problems? Pain? Back pain, joint pain, and arthritis? No? No back pain?'' GX 10, at 10. UC stated: ``I got like, you know, the normal,'' to which the nurse said, ``No, I don't'' and asked again: ``You got back pain?'' Id. UC responded ``I got stiffness.'' Tr. at 10. UC then denied having joint pain. Id.; GX 9, VR 3, at 13:43:52-13:44:54. The nurse then asked: ``Any anxiety, depression?'' GX 10, at 10. UC replied: ``No. Just my nerves get jacked up a little bit, but,'' prompting the nurse to ask: ``Panic attacks?'' Id. UC replied: ``I don't know what you would call it. Like I drink a couple cocktails on the weekend and I'm cool or that Xanax pretty much chills me down, so . . . Basically I take that Xanax, I don't need to drink too much. Everything is smooth. Makes sense?'' Id.; GX 9, VR 3, at 13:44:54- 13:45:16. The nurse stated: ``Makes perfect sense'' and asked if UC had ``[a]ny memory loss?'' Id. UC denied memory loss. GX 10, at 10. The nurse asked UC ``[w]hen was the last time'' he had visited; UC stated ``a month and a half ago'' and added that the ``last time they just let me go in his office.'' Id. at 11; GX 9, VR 3, at 13:45:15-13:46:16. The nurse then asked what medications UC was taking; he answered ``Norco, Xanax, Baclofen'' and ``sometimes'' Naproxen. GX 10, at 11. The Nurse asked UC about his daily dosing for each drug, before asking if he had ``been out of some of these meds?'' Id. at 12. UC admitted that he had been out, and after the Nurse noted that his visit had been on May 1, asked: ``So what have you been doing?'' Id. UC replied: ``I have to get them from my neighbor. Well, I tried to get in here. They cancelled my appointment. The doctor was sick one day.'' Id.; GX 9, VR 3, at 13:46:40-13:48:48. The nurse and UC discussed what pharmacy he used, stating that Registrant wanted to have one in case UC needed to have something called in, and that it was easier for e-scripting. GX 10, at 12. The nurse then encountered some difficulty with the electronic records and stated she was ``just putting no symptoms, because I'm not going through all that again. We already went through it.'' Id. at 14; GX 9, VR 3, at 13:48:50-13:52:00. After a discussion of the use of suboxone, the nurse asked: ``Did you say you have joint pain, back pain?'' GX 10, at 15. UC replied: ``My back's stiff, but when I take that Norco, I'm cool'' and asked if ``[t]that make[s] sense?'' Id. The nurse replied: ``that's a reason to have it . . . for insurance purposes. You know what I mean?'' and UC said: ``As long as I take that, I'm smooth.'' Id.; GX 9, VR 3, at 13:54:36-13:54:47. UC and the nurse then went to Registrant's office, where the latter was seated behind his desk and an MA was seated facing him. During this period, the nurse and MA remained in the office, and Registrant asked UC if he was a new patient. GX 9, at 16. After UC said ``No,'' Registrant asked: ``You a regular? How many times?'' Id. UC said: ``It's the third time I've been here . . . you cancelled me last time.'' Id.; GX 9, VR 3, at 13:55:02-13:55:40. After several minutes of discussing whether Registrant remembered UC, the nurse told Registrant, ``he just needs these four,'' and that ``he needs them printed.'' GX 10, at 17. Apparently referring to the pharmacy UC wanted to use, Registrant asked UC if he didn't know which pharmacy he normally went to and whether he went ``to different people?'' Id. UC said he ``was going to Walgreens,'' but ``last time they didn't have some of my stuff. I had to come back two days later. So I'll just take them on paper if I can.'' Id. Registrant said ``ok.'' Id.; GX 9, VR 3, at 13:55:40-13:57:37. Registrant and UC then discussed where the latter worked as well as Registrant's car and its gas mileage, after which Registrant demonstrated the versatility of a Bluetooth speaker system in his office, followed by the MA, Registrant and UC discussing their musical tastes and sharing stories about Registrant's daughter. GX 10, at 17- 20. As the video shows, during the course of this conversation, Registrant checked his computer screen, signed the prescriptions which he handed to the nurse, who in turn handed them to the UC saying ``[y]ou're all set,'' UC asked ``Am I good, ok?'' and Nurse said ``yep.'' Id. at 22. Registrant told the UC to ``take care''; UC thanked Registrant and left his office. Id.; GX 9, VR 3, at 13:57:37-14:03:06. The visit note lists UC's chief complaint as ``I am having lower back pains and anxiety.'' GX 12, at 28. In the Review of Systems section, Registrant again noted ``Stiffness'' under BJE/Muscoskeletal; however, he also noted ``negative'' for each of the symptoms that were listed including ``back pain'' and ``muscle cramps.'' Id. Under Psychiatric, he noted ``Anxiety'' and ``Panic Attacks.'' Id. In the Physical Exam section, Registrant noted under ``General Appearance'' that ``patient states hes [sic] very anxious appears to be in mild pain alert to question and appropriate with his response.'' Id. at 29. As for his purported ``Muscoskeletal'' findings, Registrant noted: ``Limited Motion:--Muscle Spasm:--Tenderness:--Arthritis.'' And as for his purported ``Neurologic'' findings, Registrant noted: ``Abnormal reflexes:--Abnormal Gait:--Weakness Atrophy.'' Id. As for his diagnoses, Registrant again listed ``Attention or Concentration Deficit,'' ``Spasm of Muscle'' and ``Anxiety State Not Otherwise Specified,'' and noted ``7/22/2015'' as the date of both diagnosis and onset for [[Page 14036]] each diagnosis. He further noted that each diagnosis was ``Active.'' Id. As for his plan, Registrant listed hydrocodone/apap 7.5/325 mg, Xanax 0.5 mg, as well as Baclofen 10 mg and Naproxen 500 mg. Id. at 30. He also noted a follow-up in one month. Id. The Government's evidence includes copies of the prescriptions issued by Registrant to UC at this visit; the prescriptions include 60 tablets of alprazolam .5 mg and 90 tablets hydrocodone 7.5/325 mg, as well as baclofen and naproxen. GX 11. UC's patient file includes a report for a urine drug sample collected from him at the June 15, 2015 visit which was tested at Registrant's clinic the same day. The report noted that neither benzodiazepines or opiates were detected and listed the results as ``normal.'' Id. at 31. While these results were available the same day, UC's visit occurred approximately two weeks after the medication from his previous visit would have run out.\9\ --------------------------------------------------------------------------- \9\ UC file's also includes the results of the UDS which was tested by an outside laboratory on June 18, 2015. GX 12, at 32. The report noted that the results were inconsistent with the drugs prescribed in that neither alprazolam nor hydrocodone were detected. Id. --------------------------------------------------------------------------- In his declaration, UC stated that he told Registrant's staff that when he ran out of medication, he obtained controlled substances from a neighbor to fill the gap between visits and that neither Registrant nor his staff conducted any further inquiry on this issue. GX 32, at 3. UC also stated that Registrant did not conduct any physical examination and that the portion of his visit with Registrant occurred in Registrant's office, where Registrant ``sat behind his desk the entire time.'' Id. UC further stated that his patient record quotes him ``as saying `I am having lower back pains' even though I explicitly stated that I had `stiffness.' '' Id. at 4 (Compare GX 12, at 28 with GX 10, at 10 (Nurse asks ``You got back pain?'' and UC responds: ``I got stiffness.''). Finally, UC stated that the visit note lists the results of a muscoskeletal exam, but other than the taking of his vital signs, no physical exam was performed during this visit and none of the conditions listed were discussed or found. GX 32, at 4. The Government's Expert The Government retained Dr. R. Andrew Chambers, M.D., to review the videos, transcripts and prescriptions related to the undercover visits made by the UC investigator, as well as the medical files for three patients, D.S., A.L. and R.H., which were obtained during the investigation. Dr. Chambers is an addiction psychiatrist in Indiana. GX 33 (Expert's Declaration). He is also an Associate Professor of Psychiatry at the Indiana University (IU) School of Medicine in the IU Neuroscience Center where he trains psychiatrists and physicians on the diagnosis and treatment of mental illness and drug addiction. Id. at 1. He also runs a university-affiliated mental health center and addiction treatment clinic where he treats patients. Id. He has been board certified in addiction medicine since 2008 and addiction psychiatry since 2012, and has published over 40 peer-reviewed journal articles and approximately nine textbook sections. Id. In addition, Dr. Chambers has provided expert testimony which was found credible in a previous DEA proceeding. See Lon F. Alexander, 82 FR 49704, 49714, 49725-26 (2017). Dr. Chambers stated that he reviewed various materials to familiarize himself with the standard of care for the prescribing of controlled substances in Michigan, including the Michigan Board of Medicine's Guidelines for the Use of Controlled Substances for the Treatment of Pain, (hereinafter, ``Michigan Guidelines''), as well as various state laws, a document of the Michigan Board of Pharmacy entitled ``Pharmacy--Controlled Substances,'' and information posted by the Michigan Advisory Committee on Pain and Symptom Management. Id. at 2. Dr. Chambers stated that ``as a professor and practicing psychiatrist, I have an understanding of how to prescribe controlled substances and the risks associated with doing so. I am also familiar with how doctors and practitioners should conduct themselves when prescribing controlled substances for a legitimate medical purpose in the usual c[o]urse of their profession.'' Id. Based on his ``professional experience and review'' of the Michigan Guidelines and state law, he opined that ``the standard of care for prescribing controlled substances in Michigan is similar to and consistent with that in Indiana . . . and that the standards in Michigan are similar to and consistent with the national norms in the medical profession for prescribing controlled substances.'' Id. He then discussed the standards for prescribing controlled substances in Michigan: First, in accordance with Michigan state law, any controlled substance must be prescribed for a legitimate or professionally recognized therapeutic purpose. To determine that, the practitioner must take a complete medical history of the patient and conduct an adequate physical examination to determine if there is a legitimate medical basis for so prescribing. Second, as explained in the Michigan Guidelines, ``when evaluating the use of controlled substances for pain control, . . . [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 guidelines also instruct on providing a written treatment plan, obtaining informed consent and agreement for treatment, conducting a periodic review at ``reasonable intervals based on the individual circumstances of the pain,'' and ``referring the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives.'' Third, practitioners must keep accurate and complete records of the forgoing and other aspects of medical care. Although that requirement is explicitly stated in the Michigan Guidelines, I can also [] attest based on my knowledge and experience that keeping accurate and complete patient records is required to meet the standard of care for the prescribing of any controlled substance, not just that which relate to pain control. Id. at 3. Dr. Chambers also stated that he was ``aware of red flags, or possible indicators of potential abuse, addiction or diversion, and the need for red flags to be addressed and resolved by a practitioner.'' Id. According to Dr. Chambers, these include ``patients seeking to have medications refilled early, patients asking for specific medications, and indications that the patient is addicted to or is diverting medications.'' Id. He further stated that ``under the standard of care, practitioners' records should identify any potential red flags and steps taken to resolve them.'' Id. I find that Dr. Chambers is qualified to provide an expert opinion on the standards of professional practice for prescribing controlled substances under the Michigan Board's Guidelines and Michigan law, as well as the standard of care generally with respect to the treatment of both pain and anxiety. I also find that Dr. Chambers is qualified to provide expert testimony as to the risks associated with prescribing controlled substances. Dr. Chambers provided a written report regarding Registrant's prescribing of controlled substances to UC and three other patients (D.S., R.H., and A.L.). With respect to UC, Dr. Chambers stated that he ``reviewed the undercover videos, transcripts, and prescriptions,'' as well as the medical records related to each of the three visits. Dr. Chambers opined that Registrant prescribed both hydrocodone, an opioid, and alprazolam, a [[Page 14037]] benzodiazepine, and that this combination of drugs raises a serious overdose risk. Id. He further opined that ``[t]here are three clinical contexts in which the risks associated with opioid and benzodiazepine combination therapies are considered acceptable, these being for hospice care, for ``critical-care or closely monitored inpatient settings,'' and ``for short-term, closely monitored detoxification protocols for patients with addictions,'' none of which are relevant in assessing Registrant's prescribing to UC. Id. at 3-4. Dr. Chambers opined that at UC's first visit, Registrant failed to do a ``proper evaluation of current substance use symptoms or substance disorder history.'' GX 33, Attachment B, at 19. As Dr. Chambers explained, UC had admitted to significant alcohol use at this visit yet Registrant did not further question UC about his alcohol use. Id. While UC had represented that he was taking Xanax and Registrant reviewed his MAPS report which showed that he had obtained the drug from multiple providers, some of whom were hundreds of miles apart, Registrant did not do a ``proper evaluation of current psychiatric symptoms or psychiatric history of present illness.'' Id. Dr. Chambers also noted that while a nurse obtained UC's vital signs and weight, ``a physical exam was never performed'' and yet the medical records include ``normal physical examination findings.'' Id. at 20. Moreover, the patient record ``falsely states that the patient denies drinking.'' Id. With respect to Registrant's diagnoses, Dr. Chambers opined that none of them was properly supported. As for the diagnosis of muscle spasm, Dr. Chambers noted that ``there was no physical exam . . . to confirm muscle spasm or any other somatic source of pain or muscular- skeletal disorder.'' Id. at 21. He further observed that Registrant prescribed opioids but there was no diagnosis of pain and ``opioids are not indicated for muscle spasm.'' Id. As for the diagnosis of anxiety, Dr. Chamber reiterated that Registrant did not perform an ``adequate psychiatric evaluation.'' Id. Dr. Chambers also observed that the diagnosis of an attention or concentration deficit ``was not evaluated[,] or measured in any current way.'' Id at 20. Dr. Chambers observed that while Registrant went over the dosing instructions, he did not caution UC about the risks of combining opioids and benzodiazepines, which ``may produce serious hazards for driving''' even though UC said he was professional driver. Id. at 19. Addressing UC's second visit, Dr. Chambers noted that ``there [was] no physical examination.'' Id. at 19. Dr. Chambers further observed that ``[t]he actual clinical encounter and evaluation with [Registrant] last[ed] three minutes'' and that ``[t]he most substantial evaluative questions'' which Registrant asked the UC were: ``Doing OK?'' and ``Med went well?'' Id. With respect to UC's third visit, Dr. Chambers noted that UC had ``again ma[de] comments that he engage[d] in significant drinking.'' Id. Dr. Chambers then observed that ``[t]his information was ignored and/or falsified in the Medical Record by'' Registrant. Id. at 22. Dr. Chambers also noted that UC stated that because his third appointment was two weeks late, he had run out of medications and had obtained controlled substances from his neighbor. Id. at 20. Dr. Chambers observed that ``this activity was never addressed by'' Registrant. Id. As for UC's interaction with Registrant, Dr. Chambers noted that this occurred in Registrant's office, that the entire encounter lasted eight minutes, during which ``there [was] essentially no clinical evaluation of the patient to assess symptoms, illness course or treatment response,'' and ``the only questions'' asked by Registrant were ``where the patient work[ed] and what pharmacy he use[d].'' Id. Dr. Chambers also observed that most of the encounter was spent discussing matters that had nothing to do with the UC's medical condition and a physical exam was not performed. Id. In addition, Dr. Chambers noted that Registrant falsified the visit note in various respects. These include: (1) The statement that UC ``appears to be in mild pain,'' which Dr. Chambers opined was inconsistent with the UC's ``voice, affect and thought content,'' notwithstanding that the video does not show how UC appeared; (2) the statement that ``patient states he is very anxious,'' which UC ``never stated''; and (3) the exam findings of ``limited motion, spasm, tenderness,'' as well as ``abnormal reflexes'' and ``weakness/ atrophy,'' as Registrant ``never performed a physical exam or touched the patient.'' Id. at 21. Dr. Chambers thus concluded that ``the controlled substances prescriptions that [Registrant] issued to the investigator during the undercover visits were not issued for any legitimate medical basis and were issued outside of the standard of care in . . . Michigan.'' GX 33, at 4. The Expert's Chart Review of Registrant's Patients D.S., A.L. and R.H.D.S. Dr. Chambers reviewed the patient file for D.S., whose ``typical chief complaints were back and neck pain, and sometimes knee pain'' during the five years she was treated by Registrant. GX 33, at 4. According to the patient file, D.S.'s initial appointment with Registrant was on August 31, 2011. GX 14, at 5. Dr. Chambers found that documented prescription records from Registrant's electronic patient file showed a prescribing pattern which rapidly escalated from D.S.'s initial visit. GX 33, Attachment B, at 7. Dr. Chambers specifically expert found that on August 31, 2011, Registrant prescribed 90 mg/day morphine, yet only two weeks later (September 14, 2011), Registrant doubled the dosage to 180 mg/day. Id. Only one month later (October 14, 2011), Registrant increased D.S.'s dosing to 320 mg/day morphine and added 700 mg/day carisoprodol. Id. at 8. Dr. Chambers also found that in two years of appointments between January 2014 and February 2016, Registrant's records show diagnoses of pain and depression. Id. The Expert found, however, that over this period, D.S.'s patient file contained no evidence that Registrant did physical exams other than to take vital signs; he also found that Registrant's treatment plans were essentially non-existent. Id. Yet during this period, Registrant prescribed to D.S. such narcotics as hydrocodone 10/325 mg. and oxycodone 30 mg. which included repeated prescriptions for 120 dosage units of the latter drug; he also repeatedly prescribed carisoprodol, a schedule IV muscle relaxant during this period. GX 13, at 1-48. Dr. Chambers noted, however, that the D.S.'s ``records do not typically document evidence of improvement in pain symptoms.'' GX 33, at 6. Registrant also repeatedly prescribed other controlled substances including stimulants such as Adipex-P (phentermine) and Bontril (phendimetrazine), which are schedule III and IV controlled substances. GX 13, at 6. Dr. Chambers further found that Registrant's introduction of these stimulants into D.S.'s medication regimen was ``not accompanied by a diagnosis or clinical indication in the charting.'' GX 33, Attachment B, at 8.\10\ --------------------------------------------------------------------------- \10\ He also found that Registrant made a diagnosis of depression on January 15, 2014, but there was no attempt to treat it. Id., see also GX 15, at 1-3. In fact, the record shows that under Review of Systems, Registrant noted ``no [psychiatric] symptoms at this time: Negative for anxiety, depression . . . mental disturbance . . . panic attacks.'' Id. at 1. There were also ``no [psychiatric] symptoms at this time'' noted at D.S.'s following visit. Id. at 4. --------------------------------------------------------------------------- [[Page 14038]] Dr. Chambers identified multiple instances in which D.S.'s medical records indicated that she was suffering from addiction. These include notes on April 11 and May 9, 2012 documenting ``dependence,'' a note on June 8, 2012 that ``she constantly needs more [pain medications],'' a note on September 28, 2012 of ``medication dependence,'' a note on October 26, 2012 of ``[m]edication dependence illness,'' and a note on November 20, 2012 of ``patient continues to display dependence.'' GX 33, at 6. Dr. Chambers also identified multiple instances in which D.S. provided aberrant urine drug screens. These included tests which showed the presence of methadone on February 14, 2014 and buprenorphine on November 10, 2014, neither of which were prescribed to D.S.; the presence of cocaine on March 14, 2014; the presence of psychostimulants (amphetamines) on March 14, April 14, and May 12, 2014 which were not prescribed by Registrant; instances in which the tests were negative for drugs prescribed by Registrant (Nov. 10, 2014 negative test for oxycodone and morphine and June 22, 2015 negative test for oxycodone); and four tests which found levels of oxycodone which were above the recommended therapeutic range of those drugs.\11\ GX 33, Attachment B, at 8-9. --------------------------------------------------------------------------- \11\ Two tests also found amphetamines at levels above the recommended therapeutic range. GX 33, Attachment B, at 9. --------------------------------------------------------------------------- Dr. Chambers explained that the drug test results show ``a number of different problems that represent serious warning signs of dangerous drug use and or addiction.'' Id. at 8. He further observed that Registrant's records contain no acknowledgment of D.S.'s aberrational drug tests results and reflect that he did not change the treatment plan or any clinical actions to address the results. Id. at 9. Dr. Chambers concluded that ``D.S. was very likely suffering from drug addiction that was not adequately diagnosed or treated, and [Registrant] failed to act on an overall lack of treatment response to the controlled substance combinations he was prescribing.'' GX 33, at 6. He further opined that Registrant ``was prescribing dangerous combinations of controlled substances without documenting a medical need for so doing, and he failed to adequately document ongoing examinations and treatment planning . . . and/or he failed to perform these professional functions altogether.'' Id. Dr. Chambers thus concluded that Registrant issued numerous prescriptions without ``any legitimate medical basis'' and acted ``outside of the standard of care in the state of Michigan.'' Id. A.L. Registrant treated patient A.L. from January 17, 2011 through April 30, 2014. Id. at 14-16. See also GX 18 (patient medical file), GX 19 and 20 (electronic patient files). Regarding Registrant's patient records for A.L., Dr. Chambers reported that they contain notes for various medical issues including anxiety, depression, and pain, the latter including knee, lower back, ankle and neck pain. GX 33, at 6-7. Dr. Chambers reviewed 11 controlled substance prescriptions Registrant issued to A.L. between October 17, 2013 and May 6, 2014. Id. at 7. The prescriptions included three prescriptions for 120 du of hydrocodone/apap 10/325 mg with two refills, three prescriptions for 30 du of phentermine 37.5 mg with two refills, three prescriptions for 150 du of carisoprodol 350 mg with two refills, and three prescriptions for 120 du of alprazolam 2 mg. GX 17, at 2-23 (copies of prescriptions obtained from filling pharmacy, and pharmacy patient profile report). Dr. Chambers observed that ``[f]or the most part there are no physical examinations documented in the medical records.'' GX 33, at 7. Dr. Chambers also noted that ``the combination of Hydrocodone, Alprazolam and Carisoprodol drugs . . . is a prescription `cocktail' known among users and law enforcement as the `Trinity,''' and that it ``is widely known to be used non-therapeutically as part of a substance disorder and/or diverted.'' Id. He further noted that on four occasions in 2011, Registrant had also prescribed another variation of this cocktail, which substituted Roxicodone (oxycodone) for hydrocodone. Id. He then opined that ``there is no documentation in A.L.'s medical records demonstrating a legitimate medical justification or clinical context for prescribing this dangerous combination of controlled substances.'' Id. Dr. Chambers also found that ``[t]here are numerous signs of addiction'' in A.L.'s patient file, beginning with her initial visit with Registrant on January 17, 2011. Id. Dr. Chambers noted that the MAPS report showed that A.L. ``had seen up to eight prior prescribers over the prior year for various controlled substances, including combinations of opioids, benzodiazepines, and stimulants,'' resulting in 50 dispensings of drugs which included hydrocodone, oxymorphone, oxycodone, morphine, diazepam, alprazolam and amphetamine. GX, 33 at 7- 8; see also GX 18, at 32-40. He also observed that on her ``Health History Questionnaire,'' which was completed in January 2011, she reported taking Roxicodone, Xanax, and Soma, which as Dr. Chambers previously explained, comprises the highly abused ```Trinity' drug cocktail.'' Id. at 8; see also GX 18, at 14.\12\ --------------------------------------------------------------------------- \12\ The same Health History Questionnaire also lists Opana, Vickodin [sic], and MS Contin as ``prescribed drugs.'' GX 18, at 14. --------------------------------------------------------------------------- Dr. Chambers further noted that A.L.'s medical records documented that she ``was possibly engag[ed] in diversion.'' Id. at 8. As support for this observation, Dr. Chambers pointed to a chart entry of February 25, 2013 which states: ``She says she cannot get her pain medications and has to be buying it off the streets to satisfy her pain. The last time she was given pain medication from this office was in September of last year.'' Id. at 8; see also GX 19, at 8. Dr. Chambers found that there was no evidence in the patient record that Registrant ``addressed or resolved these red flags.'' GX 33, at 8. Moreover, Dr. Chambers found that Registrant's ``charting is devoid of UDS data collection or tracking.'' GX 33, Attachment B, at 18. Based on his review of A.L.'s record and the prescriptions, Dr. Chambers concluded that that she ``was suffering from a drug addiction that was not adequately diagnosed or treated; [that Registrant] was prescribing extremely dangerous combinations of controlled substances without documenting an appropriate medical context or justification for so doing, and [that he] failed to adequately document ongoing examinations and treatment planning . . . and/or he failed to perform these professional functions altogether.'' GX 33, at 8. Dr. Chambers thus opined that ``the prescriptions [Registrant] issued to A.L. were not issued for any legitimate medical basis and were issued outside of the standard of care in the state of Michigan.'' Id. R.H. Dr. Chambers also reviewed the controlled substances Registrant issued to R.H. from June 2, 2015 through February 24, 2016. According to Dr. Chambers, during this time period, R.H. presented a variety of chief complaints which ``included complaints of lower back and hand joint pain, anxiety, [[Page 14039]] numbness, a rash on face/head, fractured left toes, sciatica, and arms and shoulder pain.'' Id. During this period, Registrant issued to R.H. 10 prescriptions for 90 du of hydrocodone/apap 10/325 mg; 10 prescriptions for 60 du of morphine sulfate 100 mg; 10 prescriptions for 120 du of morphine sulfate 30 mg; five prescriptions for 60 du of alprazolam 1 mg, including one which provided for two refills; and two prescriptions for 60 du of carisoprodol 350 mg, each of which provided for two refills. Id. at 8-10. Dr. Chambers again noted that the combination of hydrocodone, alprazolam, and carisoprodol comprise the Trinity cocktail. Id. at 10. He also found that on six occasions between March 11, 2011 and September 26, 2011, Registrant prescribed hydrocodone, carisoprodol and Valium (diazepam), another version of the Trinity cocktail. Id. Dr. Chambers found that ``[f]or the most part there are no physical exams documented in the medical records.'' Id. He also found that ``[t]here is no documentation in R.H.'s medical records demonstrating a legitimate medical justification or clinical context for prescribing this dangerous combination of controlled substances.'' Id. Dr. Chambers noted that R.H.'s records contain ``numerous signs of possible addiction or abuse.'' Id. at 11. These include a note (Dec. 21, 2011) in which Registrant documented that ``R.H. is taking the valium three times a [day] although he is given it twice daily so he runs out eary'' [sic]. Id. Dr. Chambers also found that ``R.H.'s urine drug screens also show[] a number of different problems that represent serious warnings signs of dangerous drug use and or addiction, including the presence of amphetamines and benzodiazepine[s] that [were] not prescribed by'' Registrant. Id. Dr. Chambers further found that ``[t]here are no indications in the patient records that [Registrant] addressed or resolved these red flags.'' Id. Based upon his review of R.H.'s patient file and prescriptions, Dr. Chambers concluded that he ``was suffering from drug addiction that was not adequately diagnosed or treated.'' Id. Dr. Chambers further concluded that Registrant ``was prescribing extremely dangerous combinations of controlled substances without documenting a medical need for so doing, and [that Registrant] failed to adequately document ongoing examinations and treatment planning . . . and/or he failed to perform these professional functions altogether.'' Id. Dr. Chambers thus opined that the prescriptions Registrant issued to R.H. ``were not issued for any legitimate medical basis and were issued outside of the standard of care in . . . Michigan.'' Id. Summary of the Expert's Findings With respect to the UC and the three other patients, Dr. Chambers opined that: The evidence reveals that [Registrant] has been engaged in prescribing dangerous levels and combinations of opioid and benzoid drugs to multiple patients in chronic patterns that have no legitimate medical purpose, and are not supported by the evidence base. Moreover, it is precisely these types of controlled substance patterns that are shown by a wealth of biomedical, clinical and epidemiological evidence to produce diversion and to contribute to addiction, worsening mental illness, and premature death. The case evidence suggests to various degrees that all of these outcomes have happened as a result of [Registrant's] prescribing and clinical practices. This prescribing was also occurring in the absence of minimally adequate practice standards of care by [Registrant], including failures to appropriately evaluate, diagnose and monitor disease processes, and treatment outcomes or treatment side effects. All 4 cases presented strong evidence that patients were suffering with mental illness and addiction of some kind when initially presenting for treatment. In 3 cases, these conditions did not change and/or worsened over time even as they were not appropriately treated, or referred elsewhere for treatment, and even as these conditions were adversely contributed to by the benzoid-opioid combination of drugs [Registrant] was prescribing. Id. at Attachment B, at 5. Dr. Chambers further opined that Registrant was not practicing in ``good faith'' as defined by Michigan Code Sec. 333.7333(1). Id. This provision defines ``good faith'' as: The prescribing or dispensing of a controlled substance by a practitioner licensed under section 7303 in the regular course of professional treatment to or for an individual who is under treatment by the practitioner for a pathology or condition other than that individual's physical or psychological dependence upon or addiction to a controlled substance, except as provided in this article. Mich. Code Sec. 333.7333(1). Dr. Chambers thus concluded that ``rather than providing legitimate medical care, [Registrant] was actually using the guise of medical practice . . . to deal addictive drugs to patients with untreated addictions and mental illness.'' GX 33, Attachment B, at 5. Dr. Chambers also evaluated the evidence in light of the Michigan Guidelines for the Use of Controlled Substances for the Treatment of Pain. Dr. Chambers explained that the Guidelines ``set forth six key components of legitimate medical practice that should be observed in the use of controlled substance for the treatment of pain,'' to ``include appropriate: (1) Evaluation (history taking and physical examination, psychiatric screening); (2) Treatment Planning; (3) Informed consent (discussion of risks and benefits of medications . . .); (4) Periodic Review (evaluate and monitoring of treatment progress); (5) Consultation; and (6) Medical record keeping.'' Id. at 5-6. Dr. Chambers opined that ``there are 2 other key aspects of the evidence that highlight the particularly malignant nature of [Registrant's] practices and prescribing pattern.'' Id. at 6. First, Dr. Chambers concluded that the ``evidence suggest[s] that Registrant deliberately acted to obscure, in the medical record, the dangerousness of his practice, to cover-up the degree to which it was a drug dealing operation, instead of a legitimate medical practice.'' Id. As he further explained, the evidence ``show[s] that [Registrant] is padding the medical record with initial PDMP evaluations and UDS testing that he never acts on regardless of what these data show, as if the point is to create the appearances of maintaining standards and adequate monitoring in the medical record without actually doing so.'' Id. Second, Dr. Chambers explained that the evidence shows that ``[h]e not only engages in little history taking and no physical examination of the patient, but he falsely documents examination findings that do not exist, in an examination that was never performed, in order to justify the continuing prescription of controlled drugs.'' Id. Dr. Chambers thus concluded that ``this evidence shows that [Registrant] is performing well below the standard of care, and is a danger to []his patients and the public at large with respect to his prescribing of controlled substances. The evidence is highly suggestive that he is providing prescriptions for addictive substances, not in `good faith' consistent with medical norms, but as a distribution business, i.e. as a drug dealing operation under the guise of legitimate health care.'' Id. I agree. Discussion In its Request for Final Agency Action, the Government seeks revocation on two independent grounds. First, it argues that revocation is warranted because Registrant lacks authority under state law to dispense controlled substances. RFAA, at 6 (citing 21 U.S.C. 824(a)(3)). Second, it [[Page 14040]] argues that Registrant has committed acts which render his registration inconsistent with the public interest because he unlawfully distributed controlled substances in violation of 21 U.S.C. 841(a)(1) and 21 CFR 1306.04(a). Id. at 9. I agree that the Government is entitled to an order of revocation on both grounds. Lack of State Authority Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823, ``upon a finding that the registrant . . . has had his State license . . . suspended [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.'' Moreover, DEA has held repeatedly that the possession of authority to dispense controlled substances under the laws of the State in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner's registration. See, e.g., James L. Hooper, 76 FR 71371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); Frederick Marsh Blanton, 43 FR 27616 (1978). This rule derives from the text of two provisions of the CSA. First, Congress defined ``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.'' 21 U.S.C. 802(21). Second, in setting the requirements for obtaining a practitioner's registration, Congress directed that ``[t]he Attorney General shall register practitioners . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.'' 21 U.S.C. 823(f). Because Congress has clearly mandated that a practitioner possess state authority in order to be deemed a practitioner under the Act, DEA has held repeatedly that 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, e.g., Calvin Ramsey, 76 FR 20034, 20036 (2011); 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). See also Frederick Marsh Blanton, 43 FR 27616 (1978). Here, while the Michigan Board's Consent Order suspended Registrant's medical license for 15 months, the Board's Order further provides that ``reinstatement shall not be automatic,'' and that Registrant must petition for reinstatement by demonstrating, ``by clear and convincing evidence,'' that he: (1) Is of ``good moral character''; (2) has ``the ability to practice the profession with reasonable skill and safety''; (3) has satisfied ``the guidelines on reinstatement adopted by the Department''; and (4) ``that it is in the public interest for the license to be reinstated.'' Consent Order, at 2. Thus, it is far from certain that Registrant will be able to satisfy these conditions and be reinstated to the practice of medicine. More importantly, this Agency has held that even where a State has imposed a suspension of finite duration of a practitioner's medical license, revocation is nonetheless warranted because the controlling question is not whether a practitioner's license to practice medicine in the State is suspended or revoked; rather, it is whether the Registrant is currently authorized to handle controlled substances in the State. Hooper, 76 FR at 71371 (citing Anne Lazar Thorn, 62 FR 12847, 12848 (1997)). Because one cannot obtain a practitioner's registration unless one holds authority under state law to dispense controlled substances, and because where a registered practitioner's state authority has been revoked or suspended, the practitioner no longer meets the statutory definition of a practitioner, DEA has held repeatedly that the possession of authority to dispense controlled substances under the laws of the State in which a practitioner engages in professional practice is a fundamental condition for both obtaining and maintaining a practitioner's registration. See Blanton, 43 FR 27616 (1978) (revoking registration based on one-year suspension of medical license); Hooper, 76 FR at 71371 (same). Thus, because Registrant is no longer currently authorized to dispense controlled substances in Michigan, the State in which he is registered with the Agency, I find that he is not entitled to maintain a DEA registration in the State. Accordingly, I will order the revocation of his existing registration on this ground. See 21 U.S.C. 824(a)(3) . The Public Interest Analysis 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). 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. Sec. 823(f) ``These factors are * * * considered in the disjunctive.'' Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or a combination of factors, and may give each factor the weight [I] deem[ ] appropriate in determining whether a registration should be revoked.'' Id.; see also Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009). While I must consider each factor, I am ``not required to make findings as to all of the factors.'' Volkman, 567 F.3d at 222; see also Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005). 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, M.D., 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 v. DEA, 664 F.3d. 808, 821 (10th Cir. 2011). Even in a non-contested proceeding, the Government has the burden of producing substantial evidence to support the allegations and its proposed sanction. See Gabriel Sanchez, 78 FR 59060, 59063 (2013); 21 CFR 1301.44(e). In this case, I find that the Government's evidence with respect to Factors Two and Four \13\ establishes that Registrant [[Page 14041]] ``has committed such acts as would render his registration . . . inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). --------------------------------------------------------------------------- \13\ In its Request for Final Agency Action, the Government states that Factors I, III and V do not weigh in favor of or against revoking Registrant's registration. RFAA at 8, fn. 4 (citing 21 U.S.C Sec. Sec. 823(f)(1), (3) and (5)). As explained above, with respect to Factor One--the Recommendation of the State Board--the Board made no recommendation to the Agency in this matter. More importantly, as discussed above, the Board has suspended his medical license thus rendering him ineligible to maintain his registration. With respect to Factor Three, I acknowledge that there is no evidence that Respondent has been convicted of an offense under either Federal or Michigan law ``relating to the manufacture, distribution or dispensing of controlled substances.'' 21 U.S.C. 823(f)(3). However, there are a number of reasons why even a person who has engaged in criminal misconduct may never have been convicted of an offense under this factor, let alone prosecuted for one. Dewey C. MacKay, 75 FR 49956, 49973 (2010), pet. for rev. denied, MacKay v. DEA, 664 F.3d at 822. The Agency has therefore held that ``the absence of such a conviction is of considerably less consequence in the public interest inquiry'' and is therefore not dispositive. Id. The Government makes no argument that Factor Five is implicated in this matter. --------------------------------------------------------------------------- Factors Two and Four--Registrant'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). See also Mich. Comp. Laws Sec. 333.7333(1) (``As used in this section, `good faith' means the prescribing of a controlled substance by a practitioner licensed under section 7303 in the regular course of professional treatment to or for an individual who is under treatment by the practitioner for a pathology or condition other than that individual's physical or psychological dependence upon or addiction to a controlled substance, except as provided in this article.''); id. Sec. 333.7401 (``A practitioner licensed by the administrator under this article shall not dispense, prescribe, or administer a controlled substance for other than a legitimate and professionally recognized therapeutic or scientific purposes or outside the scope of practice of the practitioner . . . .''). Under the CSA, it is fundamental that a practitioner must establish a bonafide 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 United States v. Moore, 423 U.S. 122, 142-43 (1975); 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); see also 21 CFR 1306.04(a) (``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.''). 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 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)). However, as the Sixth Circuit (and other federal circuits have noted), `` `[t]here are no specific guidelines concerning what is required to support a conclusion that an accused acted outside the usual course of professional practice. Rather, the courts must engage in a case-by-case analysis of the evidence to determine whether a reasonable inference of guilt may be drawn from specific facts.' '' United States v. August, 984 F.2d 705, 713 (6th Cir. 1992) (citations omitted) (quoted in United States v. Singh, 54 F.3d 1182, 1187 (4th Cir. 1995)). Thus, in Moore, the Supreme Court held the evidence in a criminal trial was sufficient to find that a physician's ``conduct exceeded the bounds of `professional practice,' '' where the physician ``gave inadequate physical examinations or none at all,'' ``ignored the results of the tests he did make,'' ``took no precautions against . . . misuse and diversion,'' ``did not regulate the dosage at all'' and ``graduated his fee according to the number of tablets desired.'' 423 U.S. at 142-43. However, as the Sixth Circuit has explained, ``[o]ne or more of the foregoing factors, or a combination of them, but usually not all of them, may be found in reported decisions of prosecutions of physicians for issuing prescriptions for controlled substances exceeding the usual course of professional practice.'' United States v. Kirk, 584 F.2d 773, 785 (6th Cir. 1978). See also United States v. Hooker, 541 F.2d 300, 305 (1st Cir. 1976) (affirming conviction under section 841 where physician ``carried out little more than cursory physical examinations, if any, frequently neglected to inquire as to past medical history and made little to no exploration of the type of problem a patient allegedly'' had, and that ``[i]n light of the conversations with the agents, the jury could reasonably infer that the minimal `professional' procedures followed were designed only to give an appearance of propriety to [the] unlawful distributions''); United States v. Tran Trong Cuong, 18 F.3d 1132, 1139 (4th Cir. 1994) (holding evidence sufficient to find physician prescribed outside of professional practice, in that ``in most cases the patients complained of such nebulous things as headaches, neckaches, backaches and nervousness, conditions that normally do not require . . . controlled substances,'' physician was ``aware that some of the[] patients were obtaining the same drugs from other doctors,'' ``[m]ost of the patients were given very superficial physical examinations,'' and patients were not ``referred to specialists''); United States v. Bek, 493 F.3d 790, 799 (7th Cir. 2007) (upholding convictions; noting that the evidence included ``uniform, superficial, and careless examinations,'' ``exceedingly poor record-keeping,'' ``a disregard of blatant signs of drug abuse,'' ``prescrib[ing] multiple medications having the same effects . . . and drugs that are dangerous when taken in combination''); 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.''); United States v. Joseph, 709 F.3d 1082, 1104 (11th Cir. 2013) (upholding conviction of physician where ``record establishe[d] that [physician] prescribed an inordinate amount of certain controlled substances, that he did so after conducting no physical examinations or only a cursory physical examination, that [physician] knew or should have known that his patients were misusing their prescriptions, and that many of the combinations of prescriptions drugs were not medically necessary'').\14\ --------------------------------------------------------------------------- \14\ However, as the Agency has held in multiple cases, ``the Agency's authority to deny an application [and] to revoke an existing registration . . . is not limited to those instances in which a practitioner intentionally diverts a controlled substance.'' Bienvenido Tan, 76 FR 17673, 17689 (2011) (citing Paul J. Caragine, Jr., 63 FR 51592, 51601 (1998)); see also Dewey C. MacKay, 75 FR at 49974. As Caragine explained: ``[j]ust because misconduct is unintentional, innocent, or devoid of improper motive, [it] does not preclude revocation or denial. Careless or negligent handling of controlled substances creates the opportunity for diversion and [can] justify'' the revocation of an existing registration or the denial of an application for a registration. 63 FR at 51601. ``Accordingly, under the public interest standard, DEA has authority to consider those prescribing practices of a physician, which, while not rising to the level of intentional or knowing misconduct, nonetheless create a substantial risk of diversion.'' MacKay, 75 FR at 49974; see also Patrick K. Chau, 77 FR 36003, 36007 (2012). --------------------------------------------------------------------------- [[Page 14042]] The evidence shows that Registrant unlawfully distributed controlled substances by issuing prescriptions to the UC on multiple occasions outside the usual course of professional practice and for other than a legitimate medical purpose, in violation of 21 U.S.C. 841(a)(1) and 21 CFR 1306.04(a). See also Mich. Comp. Laws Sec. 333.7401(1) (``A practitioner . . . shall not . . . prescribe . . . a controlled substance for other than legitimate and professionally recognized therapeutic or scientific purposes or outside the scope of practice of the practitioner.''); id. Sec. 333.7405(1)(a) (a licensed practitioner shall not ``distribute, prescribe, or dispense a controlled substance in violation of section 7333''). The Michigan Guidelines set forth the applicable standards of professional practice for the prescribing of controlled substances in the State. GX 28. The Guidelines provide that: when evaluating the use of controlled substances for pain control . . . [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. GX 28. The Guidelines also state that the physician is to keep ``accurate and complete records'' of the forgoing and other aspects of medical care. Id. The Government's evidence shows that Registrant dispensed controlled substances to the UC on multiple occasions, notwithstanding his failure to conduct an adequate evaluation, including any physical examination to support a finding that the prescribing of both hydrocodone and the Xanax was medical necessary to treat the UC. GX 3- 4, 6-7, 9-10. Dr. Chambers explained that Registrant failed to do a proper evaluation of the UC's substance use even though he admitted to significant alcohol use, did not properly evaluate his psychiatric symptoms even though he said he was using Xanax and the PMP report showed that he had obtained this drug from multiple providers, failed to perform a physical examination of the [UC] at any point, and failed to perform adequate treatment planning. Dr. Chambers further explained that Registrant falsified the medical record by fraudulently documenting in it that the UC denied drinking, as well as by making physical exam findings such as ``[l]imited motion, spasm, tenderness, weakness, atrophy, abnormal reflexes,'' when he did not perform the tests necessary to make these findings. GX 33, Attachment B, at 22. Moreover, on the pain questionnaire, the UC did not circle any of the descriptors, did not rate his pain, nor indicate whether his pain interfered with various life activities listed on the form. Yet Registrant made no inquiry as to why the UC left most of the form blank. Most significantly, during his visit with Registrant, the UC never complained of anything more than back stiffness, made no complaint that he suffered from anxiety and stated that he took Xanax because it kept him from drinking too much on the weekends. Here again, Registrant falsified the medical record by documenting: ``Today [the UC] is complaining mostly of [ ] some level of anxiety.'' Dr. Chambers further concluded that there was no basis for the various diagnoses which Registrant documented in the UC's record, including anxiety and muscle spasms; he also noted that Registrant made no diagnosis of pain and that opioids are not indicated for muscle spasms. The UC's second visit with Registrant lasted all of three and a half minutes. As Dr. Chambers explained, the most substantial questions Registrant asked the UC for evaluating his need for the (hydrocodone and alprazolam, were: ``Doing OK?'' and ``Med went well?'' Moreover, Registrant did not perform a physical exam during the visit and yet, he again falsified the medical record by noting various exam findings. As for the third visit, Dr. Chambers noted that Registrant did not address the UC's statements regarding his drinking and statements that he had run out of medication and obtained controlled substances from his neighbor. Dr. Chambers further opined that there was essentially no clinical evaluation of the UC's symptoms, illness course or treatment response. Registrant again falsified the visit note by indicating that the UC ``appears to be in mild pain'' and ``states he is very anxious,'' as well as by making physical exam findings of ``limited motion, spasm, tenderness,'' ``abnormal reflexes'' and ``weakness/ atrophy,'' when he did not perform the tests necessary to make these findings. I thus conclude that Registrant acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he issued the prescriptions for hydrocodone and alprazolam at each of the UC's visits. 21 CFR 1306.04(a); 21 U.S.C. 841(a)(1); see also Mich. Comp. Laws Sec. 333.7401(1). With respect to the UC, I conclude, based on Dr. Chambers' testimony, that Registrant failed to comply with the Michigan Guidelines in that he failed to take a complete medical history, conduct a physical examination, and document in the medical record ``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.'' Michigan Guidelines, Section II.1. Based on Dr. Chambers' testimony, I also conclude that Registrant ``essentially'' failed to comply with each of the standards of the Michigan Guidelines, including developing a treatment plan which sets forth objectives for determining treatment success and considering other treatment modalities, obtaining informed consent, conducting periodic reviews, and maintaining accurate and complete records. GX 33, Attachment B, at 5-6. (Expert Declaration), at 6. I further conclude that Registrant violated Michigan Law and the CSA in that he acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed controlled substances to the UC. 21 CFR 1306.04(a); see also Mich. Comp. Laws Sec. Sec. 333.7401(1). I also find that Registrant failed to comply with the Michigan Guidelines, and violated both Michigan Law and the CSA in that he acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed controlled substances to patients D.S., A.L. and R.H. 21 CFR 1306.04(a); see also Mich. Comp. Laws Sec. 333.7401(1). As discussed above, Dr. Chambers found that there was evidence that all three patients were suffering from drug addiction which Registrant did not adequately diagnose or treat, and that Registrant's prescribing practices contributed to their addiction. With respect to each of the chart review patients, Dr. Chambers also found that Registrant ``was prescribing extremely dangerous combinations of controlled substances without documenting an appropriate medical context or justification for so [[Page 14043]] doing, and [that he] failed to adequately document ongoing examinations and treatment planning . . . and/or he failed to perform these professional functions altogether.'' GX 33, at 6 (D.S.), 8 (A.L.), 11 (R.H.). With respect to D.S., Dr. Chambers found that over the two-year period between January 2014 and February 2016, there was no evidence in the patient file that Registrant performed physical exams other than to take vital signs and that his treatment plan was essentially non- existent. He also found that D.S.'s chart contained multiples notations that she was suffering from addiction but no evidence that Registrant addressed this with her. Most significantly, as Dr. Chambers observed, D.S. provided multiple aberrational drug tests which included: (1) The presence of controlled substances which he did not prescribe on six occasions, including methadone, buprenorphine, cocaine, and amphetamines; (2) the non-presence of controlled substances (oxycodone and morphine) which he had prescribed on two occasions; and (3) the presence of oxycodone above the recommended therapeutic range on four occasions. Yet there is no evidence that Registrant addressed any of these aberrational test results with D.S. As for A.L., Dr. Chambers found that ``for the most part,'' Registrant did not document the performance of a physical exam and there is no documentation in the patient file to support Registrant's prescribing of the combinations of narcotics, benzodiazepines, and carisoprodol that he did. GX 33, at 7. Moreover, A.L.'s MAPS report showed that she had seen eight other providers in the year prior to her first visit with Registrant and that she had obtained controlled substances on 50 occasions \15\ which included hydrocodone, oxymorphone, oxycodone, morphine, diazepam, alprazolam and amphetamine based on prescriptions issued by these providers. Moreover, at her first visit with Registrant, A.L. reported that she was taking the Trinity of oxycodone, Xanax, and Soma, and while at one point, Registrant even documented that A.L. stated that she was buying drugs off the street, Registrant did not address this aberrant behavior. Moreover, as Dr. Chambers observed, her chart is devoid of evidence that she was monitored through the use of urine drug screens. See GXs 18-20. --------------------------------------------------------------------------- \15\ In some instances, she obtained the controlled substances through a refill of a previously issued prescription. See, e.g., GX 18, at 32 (alprazolam refill); id. at 33-34 (refills of hydrocodone). --------------------------------------------------------------------------- With respect to R.H., Dr. Chambers found that ``[f]or the most part there are no physical exams documented in the medical records'' and ``[t]here is no documentation in R.H.'s medical records demonstrating a legitimate medical justification . . . for [Registrant's] prescribing'' the ``dangerous combination[s]'' of narcotics, benzodiazepines, and carisoprodol to R.H. GX 33, at 10. Dr. Chambers also found that R.H.'s urine drug screens showed the presence of controlled substances including amphetamines and benzodiazepines that Registrant did not prescribe to him and that Registrant had also documented that R.H. was overmedicating with respect to Valium. However, R.H.'s medical record contains no indication that Registrant resolved these red flags. Accordingly, I agree with Dr. Chambers that Registrant lacked a legitimate medical purpose and acted outside of the usual course of professional practice when he issued the various controlled substance prescriptions identified above to D.S., A.L., and R.H. 21 CFR 1306.04(a); 21 U.S.C. 841(a)(1). I also agree with Dr. Chambers that Registrant's prescribing to D.S., A.L. and R.H. violated Mich. Comp. Laws Sec. 333.7401(1) and did not comply with the Michigan Guidelines. I thus conclude that Registrant's multiple violations of 21 CFR 1306.04 (a), 21 U.S.C. 841(a)(1), and Mich. Comp. Laws Sec. 333.7401(1) are egregious and support the conclusion that he ``has committed such acts as would render his registration . . . inconsistent with the public interest.'' 21 U.S.C. 824(a)(4).\16\ I therefore conclude that the Government's evidence with respect to Factors Two and Four makes out a prima facie case for revoking his existing registration and denying any applications for a new registration. As Registrant has waived his right to a hearing or to submit a written statement of position, there is no evidence to refute the conclusion that his registration is inconsistent with the public interest. I will therefore order that Registrant's remaining registration be revoked and that any pending application be denied. --------------------------------------------------------------------------- \16\ This provides a separate and independent ground from the finding that he does not currently possess state authority for revoking his registration and denying his application. --------------------------------------------------------------------------- Order Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration No. FS6457407 issued to Bernard Wilberforce Shelton, M.D., be, and it hereby is, revoked. I further order that any pending application of Bernard Wilberforce Shelton to renew or modify the above registration, as well as any other pending application for registration be, and it hereby is, denied. This Order is effective immediately.\17\ --------------------------------------------------------------------------- \17\ Based on the egregious nature of Respondent's prescribing violations, I conclude that the public interest necessitates that this Order be effective immediately. 21 CFR 1316.67. Dated: March 24, 2018. Robert W. Patterson, Acting Administrator. [FR Doc. 2018-06617 Filed 3-30-18; 8:45 am] BILLING CODE 4410-09-P
![14028 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
pursuant to section 201.12 of the collection instrument with instructions, Bureau, that the list of imported items
Commission’s rules, shall not be or desire any additional information, were received. The records are
accepted unless good cause is shown for please contact Desiree Dickinson either maintained at the registrant’s business
accepting such submissions, or unless by mail at Firearms and Explosives premises where they are available for
the submission is pursuant to a specific Imports Branch, 244 Needy Road inspection by ATF officers during
request by a Commissioner or Martinsburg, WV 25405, by email at compliance inspections or criminal
Commission staff. desiree.dickinson@atf.gov, or by investigations.
In accordance with sections 201.16(c) telephone at (304) 616–4584. 5. An estimate of the total number of
and 207.3 of the Commission’s rules, SUPPLEMENTARY INFORMATION: Written respondents and the amount of time
each document filed by a party to the comments and suggestions from the estimated for an average respondent to
investigations must be served on all public and affected agencies concerning respond: An estimated 50 respondents
other parties to the investigations (as the proposed collection of information will utilize this information collection,
identified by either the public or BPI are encouraged. Your comments should and it will take each respondent
service list), and a certificate of service address one or more of the following approximately 5 hours to provide a
must be timely filed. The Secretary will four points: response.
not accept a document for filing without —Evaluate whether the proposed 6. An estimate of the total public
a certificate of service. collection of information is necessary burden (in hours) associated with the
Authority: These investigations are being for the proper performance of the collection: The estimated annual public
conducted under authority of title VII of the functions of the agency, including burden associated with this collection is
Tariff Act of 1930; this notice is published whether the information will have 250 hours, which is equal to 50 (total #
pursuant to section 207.21 of the practical utility; of responses) *5 (# of hours to provide
Commission’s rules. —Evaluate the accuracy of the each response).
By order of the Commission. agency’s estimate of the burden of the If additional information is required
Issued: March 27, 2018. proposed collection of information, contact: Melody Braswell, Department
including the validity of the Clearance Officer, United States
Lisa Barton,
methodology and assumptions used; Department of Justice, Justice
Secretary to the Commission.
—Evaluate whether and if so how the Management Division, Policy and
[FR Doc. 2018–06565 Filed 3–30–18; 8:45 am] Planning Staff, Two Constitution
quality, utility, and clarity of the
BILLING CODE 7020–02–P
information to be collected can be Square, 145 N Street NE, 3E.405A,
enhanced; and Washington, DC 20530.
—Minimize the burden of the Dated: March 28, 2018.
DEPARTMENT OF JUSTICE collection of information on those who Melody Braswell,
are to respond, including through the Department Clearance Officer for PRA, U.S.
Bureau of Alcohol, Tobacco, Firearms use of appropriate automated,
and Explosives Department of Justice.
electronic, mechanical, or other [FR Doc. 2018–06593 Filed 3–30–18; 8:45 am]
[OMB Number 1140–0031] technological collection techniques or
BILLING CODE 4410–FY–P
other forms of information technology,
Agency Information Collection e.g., permitting electronic submission of
Activities; Proposed eCollection responses. DEPARTMENT OF JUSTICE
eComments Requested; Extension
without Change of a Currently Overview of This Information
Collection Drug Enforcement Administration
Approved Collection; Records of
Acquisition and Disposition, 1. Type of Information Collection Bernard Wilberforce Shelton, M.D.;
Registered Importers of Arms, (check justification or form 83): Decision and Order
Ammunition & Implements of War on Extension, without change, of a
the U.S. Munitions Import List currently approved collection. On February 16, 2017, the Assistant
2. The Title of the Form/Collection: Administrator, Diversion Control
AGENCY: Bureau of Alcohol, Tobacco, Records of Acquisition and Disposition, Division, Drug Enforcement
Firearms and Explosives, Department of Registered Importers of Arms, Administration, issued an Order to
Justice. Ammunition & Implements of War on Show Cause to Bernard Wilberforce
ACTION: 60-Day notice. the U.S. Munitions Import List. Shelton, M.D. (hereinafter, Registrant),
3. The agency form number, if any, which proposed the revocation of his
SUMMARY: The Department of Justice DEA Certificates of Registration Nos.
(DOJ), Bureau of Alcohol, Tobacco, and the applicable component of the
Department sponsoring the collection: BS9770961 and FS6457407, as well as
Firearms and Explosives (ATF), will the denial of any pending application to
Form number (if applicable): None.
submit the following information renew these registrations or for any
Component: Bureau of Alcohol,
collection request to the Office of other registration. GX 2, at 1. As
Tobacco, Firearms and Explosives, U.S.
Management and Budget (OMB) for grounds for the proposed actions, the
Department of Justice.
review and approval in accordance with 4. Affected public who will be asked Government alleged that Registrant’s
the Paperwork Reduction Act of 1995. or required to respond, as well as a brief continued registration is ‘‘inconsistent
DATES: Comments are encouraged and abstract: with the public interest’’ and that he is
will be accepted for 60 days until June Primary: Business or other for profit. without state authority to handle
daltland on DSKBBV9HB2PROD with NOTICES
1, 2018. Other (if applicable): None. controlled substances in the State of
FOR FURTHER INFORMATION CONTACT: If Abstract: This information collection Michigan, the State in which he holds
you have additional comments, involves records of imported items that his registrations. Id. at 1–2 (citing 21
particularly with respect to the are on the United States Munitions U.S.C. 824(a)(3) and (4), 823(f)).
estimated public burden or associated Import List. The importers must register With respect to the Agency’s
response time, have suggestions, need a with ATF, file an intent to import jurisdiction, the Show Cause Order
copy of the proposed information specific items, as well as certify to the alleged that Registrant holds two
VerDate Sep<11>2014 19:06 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1](https://thefederalregister.org/doc/83_FR_14091/page/1.svg)
![Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices 14029
registrations, pursuant to which he is IV controlled substance, which were not providers; that his ‘‘medical records
authorized to dispense controlled for a legitimate medical purpose and indicate that D.S. was likely suffering
substances in schedules II–V as a outside the scope of professional from drug dependence’’; and that
practitioner in the State of Michigan: practice. Id. at 3–6 (citing 21 CFR ‘‘D.S.’s urine drug tests showed signs of
No. BS9770961, at the registered 1306.04(a) and Mich. Comp. Laws dangerous drug use or dependency,’’
address of 30140 Harper Avenue, Suite §§ 333.7311(1)(e), 333.733, 333.7401(1) including positive results for
#300, Saint Clair Shores, which was due and 333.7405(1)(a)). The Order alleged methadone, cocaine and amphetamines
to expire on February 28, 2018, and No. that Registrant issued the controlled when none of these drugs had been
FS6457407, at the registered address of substance prescriptions to the UC prescribed in the previous month. Id. at
21700 Greenfield Road, Suite 130, Oak ‘‘without undertaking actions typical of 7. The Order further alleged ‘‘there is no
Park, which expires on February 29, medical professionals or in accordance documentation in D.S.’s medical records
2020. Id. at 1. with the Michigan Guidelines, such as demonstrating that [Registrant]
As to the substantive grounds for the conducting and documenting a conducted any appropriate medical
proceeding, the Show Cause Order complete medical history, conducting a examination or review to address or
alleged that the Michigan Department of physical examination, or properly resolve these indicators of possible
Licensing and Regulatory Affairs assessing the needs of [the UC] for abuse and/or diversion.’’ Id. at 8.
(hereinafter, DLRA) summarily controlled substances.’’ Id. at 3. The With respect to A.L., the Show Cause
suspended Registrant’s Michigan Order further alleged that Registrant did Order alleged that between October 17,
Medical License on January 12, 2017, not make any attempt to address or 2013 and May 6, 2014, Registrant issued
and that pursuant to Mich. Comp. Laws resolve numerous ‘‘red flags that [the to her three prescriptions for Norco
§ 333.7311(6), ‘‘a controlled substance UC] was abusing and/or diverting (hydrocodone/acetaminophen), then a
license is automatically void if a controlled substances’’ before issuing schedule III controlled substance; three
licensee’s license to practice is the controlled substance prescriptions prescriptions for Adipex (phentermine)
suspended or revoked under Article 15 to him. Id. at 3–6. Further, it alleged that 37.5 mg, two prescriptions for Xanax
of the Code.’’ Id. at 2. The Order alleged Registrant’s medical records for the (alprazolam) 2 mg, and three
that as a result of the DLRA’s action, three visits ‘‘contain multiple false or prescriptions for Soma (carisoprodol)
Registrant ‘‘is without authority to misleading statements which [are] 350 mg, and authorized two refills for
handle controlled substances in the inconsistent with the Michigan each prescription. Id. at 8. The Order
State of Michigan,’’ and Guidelines standard that medical alleged that the combination of
‘‘[c]onsequently, DEA must revoke [his] records are to be ‘‘accurate and hydrocodone, alprazolam and
DEA registration.’’ Id. (citing 21 U.S.C. complete’’’’ and gave numerous specific carisoprodol is a drug ‘‘cocktail’’ known
824(a)(3)). examples. Id. at 4–6. as the ‘‘Holy Trinity’’ and ‘‘is widely
Next, the Show Cause Order alleged Next, the Show Cause Order alleged known to be abused and/or diverted.’’
that Registrant violated Federal law on that Registrant issued a total of 73 Id. The Order also alleged that on three
numerous occasions when he issued prescriptions to patients D.S., A.L., and occasions in 2011, Registrant prescribed
controlled substance prescriptions to R.H., ‘‘despite failing in most instances to A.L. ‘‘another variation of the Holy
four patients outside the usual course of to conduct an appropriate medical Trinity cocktail,’’ substituting
professional practice and for other than examination and meeting the minimal Roxicodone (oxycodone) for
a legitimate medical purpose, and that medical standards required under hydrocodone and that ‘‘[t]here is no
these ‘‘multiple instances of unlawful Michigan law in prescribing controlled documentation in A.L’s medical records
prescribing in violation of federal law substances (or documenting such in the demonstrating any legitimate medical
weigh[] in favor of the revocation of [his patient’s file),’’ in violation of Federal need for prescribing her that cocktail.’’
registration].’’ Id. at 2 (citing 21 U.S.C. and Michigan law. Id. at 6–9 (citing 21 Id.
841(a)(1), 823(f)(2) and 823(f)(4) and 21 CFR 1306.04(a) and Mich. Comp. Laws The Show Cause Order further alleged
CFR 1306.04). The Order also alleged §§ 333.7311(1)(e), 333.733, 333.7401(1) A.L.’s medical records show that she
that Registrant’s prescribing to the four and 333.7405(1)(a)). presented various red flags and that
patients violated Michigan law, id. Specifically, the Show Cause Order ‘‘there is no documentation in [her]
(citing Mich. Comp. Laws alleged that ‘‘[f]rom on or about January medical records demonstrating that
§§ 333.7401(1), 333.7333, 12, 2015, through on or about February [Registrant] conducted any appropriate
333.7405(1)(a)), and the Michigan 29, 2016,’’ Registrant issued to D.S. 14 medical examination or review to
Guidelines for the Use of Controlled prescriptions for oxycodone 30 mg, a address or resolve these indicators of
Substances for the Treatment of Pain schedule II controlled substance; two possible abuse and/or diversion.’’ Id. at
(hereinafter, Michigan Guidelines). Id. prescriptions for phendimetrazine 8–9. The Order alleged that these
at 2–3. tartrate 105 mg, a schedule III controlled included a MAPS report dated January
The Show Cause Order then alleged substance; four prescriptions for 24, 2011 showing that A.L. ‘‘had been
that between October 2013 and February phentermine 37.5 mg and five prescribed combinations of opioids,
2016, Registrant failed to comply with prescriptions for Ultram (tramadol) 50 benzoids, and stimulants by up to eight
Federal and State law and the Michigan mg, both schedule IV controlled different medical providers’’ between
minimal standards when he issued substances. Id. at 7. The Order also January 2010 and January 2011, and that
controlled substance prescriptions to an alleged that Registrant ‘‘issued these this combination of stimulants with
undercover investigator (hereinafter, orders despite the presence of . . . red opioids or benzoids or both is known to
UC) and three other patients, D.S., A.L. flags that D.S. was abusing and/or drug users as ‘‘speed-balling.’’ Id. at 8–
daltland on DSKBBV9HB2PROD with NOTICES
and R.H. Id. at 3–10. diverting controlled substances, ’’ 9.
Specifically, the Show Cause Order including a Michigan Automated The Order also alleged that on a
alleged that on April 1, May 1 and June Prescriptions Report (MAPS) which ‘‘Health History Questionnaire’’ which
15, 2015, Registrant issued prescriptions showed ‘‘that D.S. had been prescribed A.L. completed when she first became
to the UC for hydrocodone- combinations of opioids, benzoids and Registrant’s patient, she listed the drugs
acetaminophen, a schedule II controlled stimulants’’ between February and June she was currently taking as including
substance, and alprazolam, a schedule 2011, by up to three different medical Roxicodone, Xanax and Soma, and that
VerDate Sep<11>2014 19:06 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1](https://thefederalregister.org/doc/83_FR_14091/page/2.svg)
![14030 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
this combination ‘‘also constitutes the examination or review to address or record submitted by the Government. 21
‘Holy Trinity’ drug cocktail.’’ Id. at 9. resolve these indicators of possible CFR 1301.43(d) & (e). I make the
The Order further alleged that a Feb. 25, abuse and/or diversion.’’ Id. following findings of fact.
2013 chart entry showed that A.L. was The Show Cause Order then asserted
that Registrant ‘‘fail[ed] in most Findings of Fact
possibly engaged in diversion as it
states: ‘‘She says she cannot get her pain instances to conduct an appropriate Registrant is the holder of DEA
medications and has to be buying it off medical examination’’ and failed to Certificate of Registration No.
the streets to satisfy her pain. The last meet ‘‘the minimal medical standards FS6457407, pursuant to which he is
time she was given pain medication required under Michigan law in authorized to dispense controlled
from this office was in September of last prescribing controlled substances (or substances in schedules II—V, at the
year.’’ Id. documenting such in the patient’s file).’’ registered location of 21700 Greenfield
With respect to patient R.H., the Show Id. at 9 (citing 21 CFR 1306.04(a) and Road, Oak Park, Michigan. GX 1 (Copy
Cause Order alleged that from June 2015 Mich. Comp. Laws §§ 333.7311(1)(e), of Registrations). This registration does
through February 24, 2016, Registrant 333.733, 333.7401(1) and not expire until February 29, 2020. Id.
issued to him 10 prescriptions for Norco 333.7405(1)(a)). The Order further Registrant also held DEA Certification of
(hydrocodone-acetaminophen 1) 10/325 asserted that Registrant’s conduct Registration No. BS9770961, pursuant to
mg, 10 prescriptions for morphine ‘‘completely betrayed any semblance of which he was authorized to dispensed
sulfate 30 mg tablets, and 10 legitimate medical treatment’’ in that he controlled substances at the registered
prescriptions for morphine sulfate 100 ‘‘failed to take reasonable steps, like location of 30140 Harper Avenue, Suite
mg tablets, each of these being a conduct medical examinations, to guard #300, in Saint Clair Shores. Id. He was
schedule II controlled substance; five against diversion of controlled also authorized, under DATA-Waiver
prescriptions for alprazolam 1 mg; and substances.’’ Id. at 10 (citing Jack A. Identification Number XO9770961, to
two prescriptions for Soma Danton 76 FR 60,900 (2011); Hatem M. dispense Suboxone and Subutex to up
(carisoprodol) 350 mg tablets. Id. The Ataya 81 FR 8221 (2016) (other citations to 100 opiate-addicted patients pursuant
Order again alleged that ‘‘there [was] no omitted)). to the Drug Addiction Treatment Act of
documentation in R.H.’s medical The Show Cause Order notified 2000 (DATA). Id.; see 21 U.S.C.
records demonstrating any legitimate Registrant of his right to request a 823(g)(2). However, Registration No.
medical need for prescribing him the hearing on the allegations or to submit BS9770961 and DATA-Waiver
[combination of Hydrocodone, a written statement in lieu of a hearing, Identification No. XO9770961 expired
Alprazolam and Carisoprodol drugs the procedure for electing either option, on February 28, 2018, when Registrant
known as the] Holy Trinity cocktail,’’ and the consequence for failing to elect failed to renew this registration.
‘‘which is widely known to be abused either option. Id. at 11 (citing 21 CFR Registrant holds a license to practice
and/or diverted.’’ Id. 1301.43). The Show Cause Order also medicine in the State of Michigan, as
The Show Cause Order also alleged notified Registrant of his opportunity to well as several controlled substance and
that on six other occasions in 2011, submit a Corrective Action Plan in drug control licenses issued by the
Registrant prescribed other variations of accordance with 21 U.S.C. 824(c)(2)(C). Michigan Board of Pharmacy. GX 30, at
this cocktail to R.H. despite the Id. at 11–12. 1–2. However, on January 12, 2017, the
presence of red flags in his medical On February 23, 2017, a DEA Special Director of the Bureau of Professional
records. Id. at 10. Specifically, the Order Agent and a Diversion Investigator (DI) Licensing, Michigan Department of
alleged that Registrant’s ‘‘medical personally served Registrant with the Licensing and Regulatory Affairs
records indicated that R.H. was possibly Order to Show Cause at his office (DLRA), ordered the summary
suffering from drug dependency’’ located at 30140 Harper Avenue, Suite suspension of Registrant’s medical
because the ‘‘medical chart dated #300, Saint Clair Shores, Michigan. GX license based on the Department’s
December 21, 2011 states ‘he [sic] is 31 (Declaration of Special Agent), at 4. ‘‘find[ing] that the public health, safety,
taking the valium three times ad [sic] According to the Agent, Registrant and welfare requires emergency action.’’
although he is given it twice daily so he signed a DEA Receipt for the Show See GX 30, at 1. The Order also stated
runs out early [sic].’’’ Id. Cause Order. Id., see also GX 29. that ‘‘[Public Health] Code § 7311(6)
The Show Cause Order further alleged On May 8, 2017, the Government filed provides that a controlled substance
that R.H.’s urine drug test results its Request for Final Agency Action license is automatically void if a
showed signs of dangerous drug use or (RFAA) with my Office and forwarded licensee’s license to practice is
drug dependency. The Order alleged the evidentiary record, stating that more suspended or revoked.’’2
that on seven occasions during 2015 than 30 days have passed since According to the online records of the
through 2016, R.H. tested positive for Registrant was personally served, and DLRA, of which I take official notice,
amphetamines and that on three DEA has not received a request for a see 5 U.S.C. 556(e),3 on July 12, 2017,
occasions during 2015, he tested hearing or any other reply from
positive for benzodiazepines and that Registrant. RFAA, at 1. 2 According to the website of the Michigan
Registrant ‘‘had not prescribed’’ either Based on the Government’s Department of Licensing and Regulatory Affairs,
representations that more than 30 days Registrant held: a Pharmacy CS–3 license
class of drugs to him in the months 5315079480, which was issued on November 23,
preceding the positive results. Id. have now passed since the date of 2016 but is currently in a ‘‘lapsed’’ status; a
Finally, the Order alleged that ‘‘[t]here service of the Show Cause Order and Pharmacy Drug Treatment Program Prescriber
is no documentation in R.H.’s medical that Registrant has not submitted a license 5304001334, which was issued November 3,
request for a hearing or any other reply 2016 but is currently in ‘‘lapsed’’ status; and a
records demonstrating that [Registrant]
daltland on DSKBBV9HB2PROD with NOTICES
Pharmacy Drug Control Location license
conducted any appropriate medical including a Corrective Action Plan, I 5315079209, which was issued November 14, 2016
find that Registrant has waived his right but is also currently in ‘‘lapsed’’ status. See https://
1 Effective October 6, 2014, combination to a hearing or to submit a written w2.lara.state.mi.us.
hydrocodone drugs were moved from schedule III statement in lieu of a hearing. 21 CFR 3 In the RFAA, the Government noted that it had
to schedule II. See DEA, Schedules of Controlled been notified by the DLRA that a settlement had
Substances: Rescheduling of Hydrocodone
1301.43(d). I therefore issue this been reached with Registrant subject to Board
Combinations Products from Schedule III to Decision and Final Order based on approval; however, the Consent Order had not been
Schedule II, 79 FR 49661 (2014). relevant evidence contained in the issued at the time the RFAA was submitted to my
VerDate Sep<11>2014 19:06 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1](https://thefederalregister.org/doc/83_FR_14091/page/3.svg)
![Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices 14031
Registrant entered into a consent order controlled substances to prescribe over that his last exam had been in the
with the Board of Medicine pursuant to time.’’ Id. at 2. According to the SA, in ‘‘summer 2014,’’ and that ‘‘Nerves’’ and
which the summary suspension was the interview he ‘‘also discussed with ‘‘Back’’ were ‘‘medical problems that
dissolved but his medical license was [Registrant] his patient ‘James Howard’ other doctors have diagnosed.’’ Id. at 6.
suspended for 15 months to include the (the MBC/BS investigator), specifically Under ‘‘prescribed drugs,’’ he wrote
period ‘‘during which the order of discuss[ing] the three visits and how ‘‘Zanax [sic] Strength 1 Frequency
summary suspension was in effect.’’ See Mr. Howard’s diagnoses were Taken 2.’’ Id. at 7. He left the ‘‘Health
In re Bernard Wilberforce Shelton, M.D., determined, . . . reviewed the Habits and Personal Safety’’ section
No. 43–16–140510, Consent Order at 2 associated patient records, discussed his mostly blank, including questions about
(Mich. Bd. of Med., July 12, 2017). The urine drug screen results and how those his alcohol intake and recreational or
Consent Order further ordered that were evaluated, and . . . discussed the street drug use. Id. at 7–8. In the Mental
‘‘[r]einstatement of [Registrant’s] license controlled substances [Registrant] had Health section, he circled ‘‘no’’ as his
shall not be automatic’’ and he must prescribed to’’ the investigator. Id. answer to the questions: ‘‘Is stress a
petition for reinstatement. Id. Under the The same day, the St. Clair Shores major problem for you?’’; ‘‘Do you feel
consent order, to obtain reinstatement, Police Department executed a state depressed?’’; ‘‘Do you feel panic when
‘‘Respondent must demonstrate . . . by search warrant at Registrant’s office and stressed?’’; and ‘‘Have you ever been to
clear and convincing evidence: (1) Good a second warrant at his residence. Id. at a counselor?’’ Id. at 9. He circled ‘‘yes’’
moral character; (2) the ability to 2–3. During the execution of the to the question ‘‘Do you have trouble
practice the profession with reasonable warrant, the SA and another SA sleeping?’’ Id.
skill and safety; (3) satisfaction of the conducted a second interview with The UC also filled out a Pain
guidelines on reinstatement adopted by Registrant, who ‘‘stated that he conducts Questionnaire. Id. at 11. This consisted
the Department; and (4) that it is in the physical exams on his patients and that of a body diagram where he circled the
public interest for the license to be he can do an exam by looking at the lower back portion, and a section where
reinstated.’’ Consent Order, at 2. patient.’’ Id. at 3. he was to circle words describing his
The DLRA also required that On approximately February 22, 2016, pain, such as ‘‘Aching, Stabbing,
Registrant pay a $10,000 fine. Id. I also the SA subpoenaed various patient
Gnawing, Sharp, Burning, Exhausting,
take official notice that Respondent’s records, and Registrant provided copies
Tiring, Nagging, Numb, Miserable or
medical license remains suspended as of the electronic patient records that
Unbearable.’’ UC did not, however,
of the date of this Decision and Order. were requested. Id. The SA also
circle any of these descriptors, and
See also https://w2.state.mi.us. subpoenaed Registrant’s records for
instead, wrote ‘‘Stiff.’’ Id. He indicated
specific patients, including those of
The Investigation that his pain was ‘‘worst’’ in the
D.S., A.L., and R.H., from Network
morning, but left blank four questions
In January 2015, DEA began its Technology Inc., d/b/a RXNT, a firm
which asked him to rate his pain level
investigation of Registrant after which develops and implements
at its worst, least, average for the month,
receiving information from the St. Clair products related to electronic health
records and electronic prescribing. Id. at as well as ‘‘right now,’’ on a scale of one
Shores Police Department and Michigan to ten. Id. He wrote that ‘‘Meds’’ made
Blue Cross/Blue Shield (MBCBS) about 2–3. On June 22, 2016, after reviewing
MAPS and RxNT’s records to identify his pain better, and left blank what
the investigation they were conducting made it worse. Id. at 12. He circled
of Registrant. GX 31, at 1 (Declaration of specific prescriptions, the SA also
subpoenaed from various pharmacies ‘‘None’’ in answer to ‘‘what treatment or
Special Agent). DEA then initiated this medication are you receiving for your
investigation, which included copies of the prescriptions issued by
Registrant to various patients, including pain?’’ Id. He also left blank a series of
supervising three undercover visits by questions asking him to rate the level of
an MBC/BS investigator (hereinafter, D.S., A.L., and R.H. Id. Subsequently,
the SA also subpoenaed and obtained interference of pain on his general
also referred to as UC) to Registrant at activity, mood, normal work, sleep,
his office in St. Clair Shores. Id. at 1– from Registrant the patient records of
the MBC/BS Investigator. Id. enjoyment of life, ability to concentrate,
2; see also GX 8. As part of the and relationships with other people. Id.
investigation, on September 29, 2015, a The Undercover Visits He signed and dated this form ‘‘7–9–
Special Agent (SA) and a Diversion 70.’’ Id. A section at the bottom of the
On April 1, 2015, the MBC/BS
Investigator (DI) interviewed Registrant. form for Notes, Action Plan details and
Investigator (UC) conducted the first of
GX 31, at 2–3. the Clinician’s Signature are blank. Id.
During the interview, Registrant three undercover visits to Registrant at
his St. Claire Shores Medical office. GX UC also signed a narcotic contract,
informed the SA and DI about ‘‘his
12, at 5. During each visit, he posed as stating that he would use a Walgreens
[patient] protocols . . . including how
patient D.H., whose occupation was pharmacy. Id. at 13–14.
his office conducts drug screens and his
driving. Id. The investigative record The video recording and transcript of
new patient procedures, how he
includes video recordings of each of his the visit show that after he filled out the
conducts physical exams on his
visits, transcripts of the recorded visits, paperwork, he saw a nurse in an exam
patients, and how he determines what
his medical file, and photographs of the room, who asked a series of questions
office. RFAA, at 2 n.1. Under the Administrative vials containing the filled controlled from a form while taking notes,
Procedure Act (APA), an agency ‘‘may take official substance prescriptions issued by including: ‘‘Have anxiety? I noticed that
notice of facts at any stage in a proceeding—even Registrant. GXs 3–12. you take uh . . . .’’ GX 4, at 3. UC stated
in the final decision.’’ U.S. Dept. of Justice, At the visit, the UC filled out new ‘‘I don’t know what you call it. . . uh
daltland on DSKBBV9HB2PROD with NOTICES
Attorney General’s Manual on the Administrative
Procedure Act 80 (1947) (Wm. W. Gaunt & Sons,
patient paperwork which included a . . . you know my nerves get jacked up
Inc., Reprint 1979). While under DEA’s regulations, registration form, a health history and what not. I don’t know what you
‘‘any party, on timely request, shall be afforded [an] questionnaire, a pain questionnaire, and call it.’’ Id. UC added that he took Xanax
opportunity to controvert such fact,’’ 21 CFR signed a narcotics contract. GX 12, at 5, and Norco, and that he had previously
1316.59(e), Registrant waived his right to a hearing
or to submit a written statement and is therefore not
6–9, 11–12, 13–14. On the Health seen a physician in Flint, but it was ‘‘too
entitled to refute my findings with respect to the History Questionnaire, the UC wrote the far and I travel a lot.’’ Id.; GX 3, Video
Consent Order. name of a referring doctor and stated Recording (VR) 2, at 15:45:20–15:46:41.
VerDate Sep<11>2014 19:06 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1](https://thefederalregister.org/doc/83_FR_14091/page/4.svg)
![14032 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
The nurse asked: ‘‘As far as your (unintelligible).4 Id. at 11–12; see also it, but I didn’t do very good in school.’’
medical history goes you want me just GX 3, VR 2 at 15:53:59–16:01:44. Id. Registrant asked: ‘‘But not
. . . to put anxiety down?’’ GX4, at 3. Registrant eventually entered the diagnosed? Not medicated?’’ Id. UC
UC stated: ‘‘Whatever you call that, I exam room, greeted UC while donning replied: ‘‘I use to take ADD—Ritalin.’’
don’t know what the word,’’ which a headphone set connected to the Id. Registrant asked: ‘‘Ritalin as a
prompted the nurse to ask: ‘‘What brings computer, resolved an issue with child?’’ Id. at 19. UC replied: ‘‘Yeah.
you here?’’ Id. UC answered: ‘‘Just to get another patient, and appeared to dictate You know sometimes I do lose focus so
Xanax refills.’’ Id. The nurse then asked and record into the computer while he I mean it might help me focus.’’ Id.
UC if he ‘‘had pain anywhere?’’ and UC spoke to UC. GX 4, at 14. The nurse Registrant then resumed dictating and
answered: ‘‘Ah . . . like my back is stiff. informed Registrant that UC was a new stated: ‘‘After questioning the patient,
But I don’t know . . . Pretty much a stiff patient, and Registrant read aloud UC’s admits to having had some childhood
back. I drive a lot and what not, know height, weight, age and occupation from diagnosis of attention deficit disorder
what I’m saying.’’ Id. at 3–4; GX 3, VR the computer screen. Id. at 16; see also and was on Ritalin occasionally as a
2, at 15:46:41–15:47:11. GX3, VR3, at 16:16:23–16:19:39. child. Sometime he complains of losing
Registrant confirmed with UC that he some focus but other than that he is
Following a discussion of Registrant’s
drove for a living, and asked: ‘‘And you doing well.’’ Id. After dictating several
background, the Nurse then told UC that
have pain or what?’’ ‘‘What is your additional comments, Registrant told
Registrant ‘‘drug test[s] everybody.’’ GX problem mostly?’’ GX 4, at 17. UC
4, at 4. As the Nurse proceeded with UC to ‘‘[l]ook at me’’ and said ‘‘ok.’’ Id.;
stated: ‘‘My back gets stiff because I GX 3, VR 3, at 16:24:16–16:25:18.
obtaining his weight, UC said that he drive a lot so sitting down too much. My
was ‘‘cool,’’ that he did not ‘‘want to UC told Registrant that he was
back, you know, so it’s stiff pretty ‘‘[p]retty much a healthy guy’’ and ‘‘I try
cause any problems for anybody’’ much.’’ Id. Registrant determined that
including Registrant, and that he was to take care of myself.’’ GX 4, at 19.
UC did not have a CDL (commercial Continuing, UC said: ‘‘Drink a little too
‘‘[m]ore or less healthy. You know what driver’s license) and asked, ‘‘You don’t
I’m saying?’’ Id. at 4–5; GX 3, VR 2, at much on the weekends sometimes, but
use methadone?’’ UC responded: you know.’’ Id.; GX 3, VR 3, at 16:25:18–
15:47:11–15:48:48. ‘‘Absolutely not. I use moonshine. You 16:25:29.
After determining UC’s marital status, know what that is?’’ Id. Registrant Registrant then told UC: ‘‘You know
the nurse said: ‘‘So, basically, you don’t asked: ‘‘Too much?’’ UC answered: in this business of what I do, I don’t
even—you don’t have any problems ‘‘No’’ and ‘‘You know if I take that know who is who. I have to be very
besides the little bit of anxiety and your Xanax it keeps me from drinking too careful when patients come in here.’’
back gets stiff because of driving.’’ GX much so it works out good.’’ Id. at 17– GX 4, at 19. UC replied: ‘‘Oh you don’t
4, at 5. UC replied: ‘‘Yeah, yeah. You got 18; GX 3, VR 3, at 16:19:40–16:21:22. want trouble makers coming in here’’
it.’’ Id.; see also GX 3, VR 2, at 15:48:48– Registrant then asked: ‘‘So what can I and Registrant said:
15:49:22. give you today to help you out?’’ Id. UC Not the trouble makers. You know people
The nurse continued to take UC’s answered: ‘‘Usually Xanax helps me come in here in all different shapes and
vitals as the two discussed his work as out. And Norco helps my back. That’s forms. Sometimes they are investigators.
a driver, after which UC mentioned a all I really need. I don’t have any—I’m Sometimes they are undercover cops.
patient in the lobby who, in UC’s words, pretty healthy.’’ GX 4, at 18; GX 3, VR Sometimes they’re anything and when I
was ‘‘yip-yapping and jaw-jacking.’’ GX 3, 16:21:27–16:21:41. miss something it’s just the right time for
4, at 6–7. The nurse denied that patients Thereafter, Registrant resolved a them to jump on me for something. So don’t
problem with accessing the dictation be worried that I’m paying attention to
could easily get their prescriptions and
software on his computer and began almost everything, you know. Did they give
stated that patients were tested and ‘‘if you a urine screen and test?
they have other stuff in their system dictating into it, stating that UC ‘‘is here
for his first visit. . . . He is suffering also Id. UC said ‘‘[n]o.’’ Id. Registrant
they cannot get their script . . . because
from anxiety and back spasms due to his again asked UC if he gave a urine; UC
they could drop dead if they mix.’’ Id.
long sitting. He currently does not have again said ‘‘no.’’ Id.; GX 3, VR 3, at
at 7–8. Continuing, the nurse stated that
a CDL.’’ GX 4, at 18. After UC told 16:25:30–16:26:20.
Registrant is ‘‘really strict about that’’
Registrant that he drove eight to 12 Again looking at his computer screen,
and UC said: ‘‘The worst thing I do is
hours a day, Registrant stated: ‘‘He Registrant stated: ‘‘Your last physician
drink moonshine here and there. Little
denies drinking or using any stimulants recorded here was Dr. Vora Kandarp. He
liquor on the weekends you know. But
such as methadone.’’ Id. Registrant then gave you Norco. He also gave you Xanax
when I take that Xanax, I’m pretty
asked whether UC was diabetic, and 0.5mg. He also gave you Naproxen. You
chilled, so I don’t really need to drink
after UC said that he was not, Registrant saw a Dr. Miky in September.’’ GX 4, at
too much. You know it keeps me from
dictated: ‘‘He only uses Xanax 19. UC said, ‘‘I did,’’ after which
getting stupid.’’ Id. at 8; GX 3, VR 2, at
occasionally for his anxiety. . . . Today, Registrant named three other doctors
15:49:22–15:53:59.
he is complaining mostly of some level who he believed UC had seen in July
As the nurse continued to review and May of the previous year, noted that
of anxiety.’’ Id. Registrant then asked
UC’s medical history and discussed one of doctors had prescribed Adderall,
UC if had ever seen a psychiatrist and
various subjects with him, UC noted and named the drug store which had
UC answered: ‘‘No, if I did, it was a
that a sign on the wall ‘‘says our office filled this prescription. Id. Registrant
long, long time ago.’’ Id.; GX 3, VR 3, at
is no longer writing prescriptions for then asked UC if he had high blood
16:21:41–16:24:16.
. . . ah . . . oxycodone or pressure because ‘‘somebody gave you
Registrant then asked UC if he
daltland on DSKBBV9HB2PROD with NOTICES
[R]oxicodone. Is that what that says?’’ blood pressure medication.’’ Id. UC
‘‘suffered from any childhood mental
GX 4, at 11. The nurse replied: ‘‘I don’t denied having high blood pressure,
disorder’’ such as ‘‘attention deficit’’
think it says that. He writes that.’’ Id. stating that it was ‘‘low actually’’ and ‘‘I
disorder. GX 4, at 18. UC said: ‘‘Well
UC pointed out where he read the never took that.’’ Id. at 19–20; GX 3, VR
. . . yeah. I don’t know what they called
statement, and the nurse replied that 3, at 16:26:20–16:27:15.
‘‘it’s for people that come in here just 4 The sign is not, however, visible on the video. UC then asked Registrant: ‘‘How do
one time . . . [T]hey can’t come in here GX 3, VR 2, at 16:00:52–16:01:44. you see that on there? You guys on the
VerDate Sep<11>2014 19:06 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1](https://thefederalregister.org/doc/83_FR_14091/page/5.svg)
![Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices 14033
same computer system?’’ GX 4, at 20. back gets very stiff anxiety as well.’’ GX 5, at 1–2. Two other photos show the
Registrant replied: ‘‘Everything. 12, at 16. Under ‘‘History of Present label attached to a vial which indicates
Everything shows up.’’ UC then noted Illness,’’ Registrant wrote that UC: that it was a prescription for 60
that the nurse had said that Registrant is here for his first visit . . . he is suffering Alprazolam 0.5 mg, to be taken twice
had ‘‘a lot of problems with idiots also from anxiety and back spasms due to his daily for anxiety, which was also
coming in here trying to get drugs’’ but long sitting . . . he denies drinking or using prescribed by Registrant to UC and was
‘‘that’s not me.’’ Id. Registrant discussed any stimulants such as methadone or is a filled at the same pharmacy. Id. at 5–6.
with UC his use of amphetamines, with diabetic nor . . . on insulin. On the only use UC’s medical file includes the report
UC noting that he ‘‘didn’t take it all the is Xanax occasionally for his anxiety. Today of the urine drug screen obtained at his
time’’ and it ‘‘[t]ook [him] a while to use he is complaining mostly of [] some level of April 1 visit, as well as a report run on
it.’’ Id. Registrant stated that he anxiety. . . . [P]atient admits to having had the same date from the Michigan
‘‘shouldn’t take it all the time’’ and did . . . a diagnosis of attention deficit disorder. Automated Prescription System
. . . Sometimes he complains of losing some
not prescribe the drug. Id.; GX 3, VR 3, (MAPS). GX 12, at 20 (UDS report); id.
focus but other than that he’s doing well.
at 16:27:15–16:27:46; see also GXs 5 & at 3 (MAPS report). As for the drug
12. Id. screen results, which were reported
Registrant then moved on to UC’s use The visit note’s Review of Systems back to Registrant on April 9, 2015, the
of Xanax, noting that ‘‘it seems like you section contained fourteen different results were negative for all controlled
started with .25 Xanax. You’re up to .5 areas. Id. at 16–17. With the exception substances listed, including alprazolam,
now, double it, to 60, that’s in of ‘‘BJE/Muscoskeltal,’’ next to which hydrocodone, and hydromorphone, the
December. Is that sufficient for you?’’ Registrant noted ‘‘Back Pain’’ but latter being a metabolite of
GX 4, at 20. UC said ‘‘Yeah . . . ‘‘Negative for Arhitis [sic], Joint Pain, hydrocodone. Id. at 20. As found above,
Probably,’’ and Registrant said: ‘‘Okay. I Joint Swelling, Muscle Cramps, Muscle UC had represented to Registrant (and
will do that for you, sir.’’ Id.; GX 3, VR Weakness, Stiffness and Leg Cramps,’’ his nurse) that he took both
3, at 16:27:45–16:28:11. all the areas contained negative hydrocodone and Xanax, and the visit
Registrant further noted, ‘‘And . . . findings, including the entry for note listed hydrocodone as a current
you did get a few pain medication’’ and Psychiatric, next to which Registrant medication. GX 4, at 18 (transcript of
asked: ‘‘You want that too?’’ GX 4, at 20. documented: ‘‘Negative for Anxiety, visit); GX 12, at 7 (questionnaire), 17
UC said ‘‘[y]es’’ and Registrant said Depression, Hallucinations, Memory (visit note), and 20 (UDS report noting
‘‘[a]lright.’’ Id.; GX 3, VR 3, at 16:28:11– Loss, Mental Disturbance, Paranoia, UC was prescribed hydrocodone and
16:28:18. Suicidal Ideation, Panic Attacks.’’ Id. Xanax).
Registrant then stated: ‘‘It’s just the In the ‘‘Physical Examination’’ As for the MAPS report, it showed
good thing is nothing is hidden section, Registrant noted UC’s ‘‘General that on December 15, 2014, UC had last
anymore, you know. You can’t come Appearance’’ as: ‘‘Patient appears to be filled prescriptions which were issued
and hide anything.’’ GX 4, at 20. appropriate for age dressed appropriate by Dr. Vora of Gladwin, Michigan for 90
Continuing, Registrant said: ‘‘And these for work responded to questions and no tablets of hydrocodone/apap 7.5/325 mg
medications are good medications.’’ acute distress at this time.’’ Id. at 17. and 60 tablets of alprazolam .5 mg. Id.
Registrant then discussed the dosing of Registrant noted that there were ‘‘[n]o at 3. The report also showed that the UC
two non-controlled medications he was abnormal findings’’ with respect to the had obtained four prescriptions for
prescribing (Baclofen and Naproxen). Id. ‘‘exam’’ of UC’s ‘‘[m]uscoskeletal’’ and various quantities and dosages of
at 20–22; GX 3, VR 3, at 16:28:18– ‘‘[n]eurologic’’ systems. Id. at 18. alprazolam from four different
16:28:48. Yet Registrant then noted diagnoses of providers, two of whom were located in
Registrant proceeded to dictate dosing ‘‘Spasm of Muscle,’’ ‘‘Anxiety State not Flint, the others in Marquette and
instructions for the prescriptions and Otherwise Specified,’’ as well as Detroit. Id.
asked UC which pharmacy he used. GX ‘‘Attention or Concentration The Government also submitted a
4, at 22. UC asked if there was ‘‘a good Deficit.’’ 5 Id. For each diagnosis, he declaration by the UC. GX 32. With
pharmacy around here’’ or if he could documented that ‘‘7/22/2015,’’ a date respect to the April 1 visit, UC stated
‘‘take them on paper and go wherever I more than three months into the future, that Registrant reviewed his alias’s
want?’’ Id. Registrant suggested a was both the date of onset and the date purported medical history and saw that
pharmacy that was ‘‘right up the street.’’ of diagnosis; he also noted that each he had seen at least three other doctors
Id. UC asked: ‘‘They won’t give me a diagnosis was active. Id. at 18. in the months prior to his first visit, but
hard time?’’ and Registrant said ‘‘no.’’ As for Registrant’s treatment plan, he did not conduct any further inquiry or
Id. at 23. Registrant then wrote listed only medications, which included follow up with him on that issue. Id. at
electronic prescriptions which he sent ‘‘naproxen 500 mg,’’ ‘‘hydrocodone 7.5 2. UC also stated that during the April
to the pharmacy that he and UC had mg-acetaminophen 325 mg,’’ 6 and 1 visit, Registrant conducted virtually
agreed upon. Id.; GX 3, VR 3, at ‘‘alprazolam 0.5 mg,’’ and a follow-up no physical examination, and that the
16:28:48–16:31:56. visit ‘‘after [one] month.’’ Id. at 19. portion of his visit with Registrant
As the visit was about to end, Consistent with other evidence, the lasted only a few minutes and consisted
Registrant noted that ‘‘we need to get a record includes two photographs of a mainly of answering questions. Id. He
urine from him’’ and added: ‘‘All the pharmacy bottle with the label for 90 also stated that during the visit,
new patients—did they draw blood from tablets of hydrocodone APAP’’ 7.5/325 Registrant was repeatedly distracted by
you? You’ll give a urine on the way mg prescribed to D.H. (UC’s alias) by issues he was having with the dictation
out.’’ GX 4, at 23. UC said he wasn’t Registrant, to be taken three times daily software for his electronic patient
daltland on DSKBBV9HB2PROD with NOTICES
‘‘too good with needles’’ and avoided as needed for back pain and stiffness, records. Id. My review of the video
the blood test but provided a urine which was filled by a pharmacy in Mt. evidence corroborates each of these
sample. Id. at 26. See also GX 3, VR 3, Clemens, Michigan on April 1, 2015. GX statements. GX 3, VR 3, 16:15:22–
at 16:31:56–16:44:32. 16:33:22.
In the subjective section of the visit 5 He also documented a diagnosis of ‘‘Body Mass UC further stated that he reviewed
note, Registrant documented UC’s chief Index Between 29.0–29.9 Adult.’’ GX 12, at 18. Registrant’s patient records for him and
complaint as: ‘‘I drive for a living my 6 Hereinafter, referred to as hydrocodone/apap. determined that portions of it either
VerDate Sep<11>2014 19:06 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1](https://thefederalregister.org/doc/83_FR_14091/page/6.svg)
![14034 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
misstate his statements during the visit do you need?’’ after which the MA In the Physical Examination section,
or falsely indicate the extent to which asked UC to fill out a questionnaire. Id.; Registrant noted under ‘‘General
he received or did not receive a medical GX 6, VR 5, at 11:24:20–11:25:44. Appearance,’’ that ‘‘patient doesn’t
examination. GX 32, at 2. UC explained: UC filled out the questionnaire, and seems [sic] to be in any distress,
For instance, the patient record lists after the MA asked him if he had appropriate to respond to questions
‘‘spasm of muscle’’ as one diagnosis, even undergone various tests and had his alert,’’ and under ‘‘Muscoskeletal,’’ he
though I did not complain of spasms during blood drawn, UC was escorted to noted ‘‘Limited Motion:—Arthritis.’’ Id.
the visit. And the record states that I Registrant’s office where the visit took at 23. Registrant again listed his
‘‘den[ied] drinking’’ even though I indicated place. Notably, the video shows that diagnoses as ‘‘Attention or
that I do drink. The record also documents Registrant sat behind his desk for the
findings from a physical exam in categories Concentration Deficit,’’ ‘‘Spasm of
such as ‘‘Eyes,’’ ‘‘ENT,’’ ‘‘Cardiovascular,’’ duration of the visit, which lasted Muscle,’’ and ‘‘Anxiety State Not
‘‘Muscoskeletal’’ and ‘‘Neurologic’’ even approximately three and a half minutes. Otherwise Specified.’’ Id. at 23–24. For
though other than the taking of my vitals no See GX 6, VR 5, at 11:46:33–11:49:46; each diagnosis, he again listed ‘‘7/22/
physical exam was performed during the VR 6, at 11:49:47–11:50:01. 2015’’ as both the date of diagnosis and
visit. Registrant greeted the UC, confirmed the date of onset and noted that the
Id. his name, checked his computer screen, diagnosis was ‘‘[a]ctive.’’ Id.
and discussed his lunch order with an In the Plan section of the note,
Second Undercover Visit unidentified employee, after which he Registrant did not list any prescriptions.
On May 1, 2015, UC again saw asked UC about his insurance, and See id. The evidence, however, includes
Registrant at the St. Claire Shores clinic. finally inquired if ‘‘the medication [he] copies of the prescriptions he issued at
GX 12, at 22; GX 6 (video recording of had last time went well?’’ GX 7, at 16– this visit; these include a prescription
visit). After UC provided a urine 17; UC replied ‘‘Yep.’’ After for 90 hydrocodone/apap 7.5/325 mg, 60
sample, a medical assistant (MA) took commenting about UC’s blood pressure alprazolam 0.5 mg, as well as naproxen
his vitals and UC asked if he could get and height, Registrant asked: ‘‘So you’re and baclofen. GX 8, at 1–4. As part of
paper prescriptions. GX 7, at 12 okay with what we have?’’ Id. at 18. UC his plan Registrant ordered a ‘‘urine
(transcript of recording). The MA asked said ‘‘Yes’’ and asked: ‘‘Can I get it on drug screen’’ and noted a follow-up visit
what medications he was taking, UC paper this time?’’ Id. Registrant asked ‘‘after one month.’’ GX 12, at 24.
said ‘‘Norco and Xanax’’ and that he had ‘‘why’’ and if he went to a particular A result sheet for the urine drug
gotten them last month. Id. As the MA pharmacy, to which UC replied that ‘‘it screen which was done on this date and
continued to take his vitals, she asked took forever,’’ that he ‘‘waited in line apparently tested by Registrant’s clinic 7
UC if he had a ‘‘pharmacy problem’’ and behind eight people,’’ and he was states that UC’s test results were
UC said: ‘‘They take forever.’’ Id.; GX 6, ‘‘going the other way this time too . . .
‘‘normal’’ for amphetamines,
VR 5, at 11:19:58–11:22:31. to Detroit.’’ Id. Registrant then agreed to
The MA then asked: ‘‘[W]hat’s benzodiazepines, opiates and
give UC a paper prescription. Id.; GX 6,
bothering you actually?’’ GX 7, at 12. UC oxycodone, as well as other controlled
VR 5, at 11:46:3–11:48:05.
replied: ‘‘Just refills. I’m just here for Registrant and UC proceeded to substances. Id. at 25. A second report
refills. I’m just here for my back pills discuss the latter’s job as a driver for a shows the results of a test which was
and my nerves.’’ Id. The MA asked, car transporter and cars in general, and done by a lab (which were reported on
‘‘Your lower back?’’ and UC replied were interrupted by the MA. GX 7, at May 6, 2015). Id. at 26. Notably, the lab
‘‘Yeah.’’ Id.; GX 6, VR 5, at 11:22:31– 18–20. While Registrant discussed reported ‘‘Not Detected’’ for both
11:23:03. another patient with the MA, she alprazolam and hydrocodone as well as
After she confirmed that ‘‘just your handed several paper prescriptions to each drug’s metabolites 8 even though
back is [the] problem,’’ the MA asked Registrant. Registrant signed the Registrant had prescribed the drugs at
UC if he ‘‘had a back injury before?’’ GX prescriptions and handed them to UC, UC’s previous visit. Id.
7, at 13. UC said that he didn’t know saying, ‘‘Here, sir’’ and ‘‘Alright, Take In his declaration, UC stated that
and didn’t ‘‘know what it was.’’ Id. The care.’’ Id. at 19–20. UC thanked Registrant ‘‘did not conduct any
MA went through a list of symptoms Registrant and said he would see physical examination’’ and ‘‘sat behind
including headaches and anxiety and Registrant ‘‘in a month,’’ and the visit his [office] desk the entire time we
asked if he had none of them; UC ended. Id. 20; GX 6, VR 5, at 11:49:23– talked’’ which ‘‘lasted only a few
answered: ‘‘I get headaches when I 11:49:46; VR 6, at 11:49:50–11:50:01. minutes.’’ GX 32, at 3. He also stated
drink too much liquor’’ and ‘‘I do it big The evidence includes a visit note that he had reviewed Registrant’s
sometimes.’’ Id. After a discussion of dated May 1, 2015, which lists UC’s patient records for the May 1, 2015 visit
her shoes, MA asked UC: ‘‘just back Chief Complaint as: ‘‘I am having lower and determined that ‘‘portions of them
right?’’ Id. UC said ‘‘Uh-Huh,’’ after back pain with anxiety problem[.]’’ GX either misstate my statements during the
which MA asked if he ‘‘sometimes’’ took 12, at 22. In the note’s Review of visit or falsely indicate the extent to
medicine for headaches; UC answered: Systems section, Registrant which I received (or did not receive) a
‘‘No, I just take the Xanax and Norco.’’ documented: ‘‘BJE/Musculoskeletal: medical examination.’’ Id. These
Id.; see also GX 6, VR5, at 11:23:03– ‘‘Back Pain:—.Negative for Arhitis [sic], included the diagnosis of ‘‘spasm of
11:24:23. Joint Pain, Joint Swelling, Muscle muscle’’ even though ‘‘I did not
The MA then asked if he had an Cramps, Muscle Weakness, Stiffness, complain of and was not found to have
‘‘anxiety problem?’’ GX 7, at 13. Id. UC Leg Cramps.’’ Id. Registrant noted UC’s muscle spasms during the visit,’’ as well
replied: ‘‘Yeah. No—I don’t know what psychiatric condition as ‘‘Anxiety:— as that the medical ‘‘record quotes me
daltland on DSKBBV9HB2PROD with NOTICES
you call it. But my nerves,’’ prompting .Negative for, Depression, as saying ‘I am having lower back pain’
the MA to interject ‘‘Anxiety’’ and UC Hallucinations, Memory Loss, Mental
said ‘‘I call it nerves.’’ Id. The MA then Disturbance, Paranoia, Suicidal 7 The result sheet indicates that these results were
asked UC if he took Xanax, and after UC ideation, Panic Attacks.’’ Id. With obtained within 20 minutes of the time of the test.
8 These include hydroxyalprazolam, a metabolite
confirmed this and that he took the one respect to all other systems, including of alprazolam, and norhydrocodone and
milligram dosage form, UC added: ‘‘7.5 ‘‘neurological,’’ Registrant noted: ‘‘No hydromorphone, which are metabolites of
Norcos. That’s all I need. I’m easy. What symptoms at this time.’’ Id. hydrocodone. GX 12, at 26.
VerDate Sep<11>2014 19:06 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1](https://thefederalregister.org/doc/83_FR_14091/page/7.svg)
![Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices 14035
even though I made no such statement.’’ little bit, but,’’ prompting the nurse to you cancelled me last time.’’ Id.; GX 9,
Id. ask: ‘‘Panic attacks?’’ Id. UC replied: ‘‘I VR 3, at 13:55:02–13:55:40.
don’t know what you would call it. Like After several minutes of discussing
Third Undercover Visit
I drink a couple cocktails on the whether Registrant remembered UC, the
On June 15, 2015, UC again saw weekend and I’m cool or that Xanax nurse told Registrant, ‘‘he just needs
Registrant. GX 9 (Video Record), GX 10 pretty much chills me down, so . . . these four,’’ and that ‘‘he needs them
(transcript), GX 32 (UC’s Declaration); Basically I take that Xanax, I don’t need printed.’’ GX 10, at 17. Apparently
see also GX 12, at 28 (Pt. file). to drink too much. Everything is referring to the pharmacy UC wanted to
According to the visit transcript, UC smooth. Makes sense?’’ Id.; GX 9, VR 3, use, Registrant asked UC if he didn’t
paid a co-pay and provided a urine at 13:44:54–13:45:16. know which pharmacy he normally
sample. GX 10, at 1–3. Next, UC met The nurse stated: ‘‘Makes perfect went to and whether he went ‘‘to
with a nurse, who took his blood sense’’ and asked if UC had ‘‘[a]ny different people?’’ Id. UC said he ‘‘was
pressure and heart rate and asked him memory loss?’’ Id. UC denied memory going to Walgreens,’’ but ‘‘last time they
his weight and height. Id. at 4; GX 9, VR loss. GX 10, at 10. The nurse asked UC didn’t have some of my stuff. I had to
3, at 13:32:58–13:35:43. ‘‘[w]hen was the last time’’ he had come back two days later. So I’ll just
After UC noted that the last visit had visited; UC stated ‘‘a month and a half take them on paper if I can.’’ Id.
taken place in Registrant’s office and ago’’ and added that the ‘‘last time they Registrant said ‘‘ok.’’ Id.; GX 9, VR 3, at
that he had ‘‘sat across from the doctor just let me go in his office.’’ Id. at 11; 13:55:40–13:57:37.
who wrote me up,’’ the nurse asked:
GX 9, VR 3, at 13:45:15–13:46:16. Registrant and UC then discussed
‘‘you just needed your refills?’’ GX 10,
The nurse then asked what where the latter worked as well as
at 5. UC said: ‘‘Yeah. That’s all I need.
medications UC was taking; he Registrant’s car and its gas mileage, after
I’m easy. Easy for sure.’’ Id.; GX 9, VR
answered ‘‘Norco, Xanax, Baclofen’’ and which Registrant demonstrated the
3, at 13:35:43–13:36:08.
The nurse accessed UC’s electronic ‘‘sometimes’’ Naproxen. GX 10, at 11. versatility of a Bluetooth speaker system
medical record and asked: ‘‘So you’re The Nurse asked UC about his daily in his office, followed by the MA,
here for meds?’’ Id. at 6. UC said: dosing for each drug, before asking if he Registrant and UC discussing their
‘‘That’s it. I’m pretty healthy.’’ Id. The had ‘‘been out of some of these meds?’’ musical tastes and sharing stories about
nurse then asked: ‘‘Any new pain or Id. at 12. UC admitted that he had been Registrant’s daughter. GX 10, at 17–20.
anything? Pain is about the same?’’; UC out, and after the Nurse noted that his As the video shows, during the course
said: ‘‘It’s the same. Everything is the visit had been on May 1, asked: ‘‘So of this conversation, Registrant checked
same.’’ Id. The nurse replied: what have you been doing?’’ Id. UC his computer screen, signed the
‘‘Unfortunately we still have to do all replied: ‘‘I have to get them from my prescriptions which he handed to the
this charting, you know . . . [f]or DEA neighbor. Well, I tried to get in here. nurse, who in turn handed them to the
. . . It’s just really crazy . . . those They cancelled my appointment. The UC saying ‘‘[y]ou’re all set,’’ UC asked
controlled things are really . . . it’s like doctor was sick one day.’’ Id.; GX 9, VR ‘‘Am I good, ok?’’ and Nurse said ‘‘yep.’’
impossible to find meds . . . . It’s being 3, at 13:46:40–13:48:48. Id. at 22. Registrant told the UC to ‘‘take
purposely done. People don’t realize The nurse and UC discussed what care’’; UC thanked Registrant and left
that, but DEA is behind it . . . .’’ Id. UC pharmacy he used, stating that his office. Id.; GX 9, VR 3, at 13:57:37–
remarked ‘‘[c]lamping down?’’ to which Registrant wanted to have one in case 14:03:06.
she replied ‘‘Yep.’’ Id.; GX 9, VR 3, at UC needed to have something called in, The visit note lists UC’s chief
13:36:08–13:37:59. and that it was easier for e-scripting. GX complaint as ‘‘I am having lower back
The nurse had UC fill out some 10, at 12. The nurse then encountered pains and anxiety.’’ GX 12, at 28. In the
paperwork, after which she proceeded some difficulty with the electronic Review of Systems section, Registrant
to question UC as to whether he had records and stated she was ‘‘just putting again noted ‘‘Stiffness’’ under BJE/
experienced various symptoms no symptoms, because I’m not going Muscoskeletal; however, he also noted
including appetite problems, chills, through all that again. We already went ‘‘negative’’ for each of the symptoms
fatigue, fevers, night sweats, weight gain through it.’’ Id. at 14; GX 9, VR 3, at that were listed including ‘‘back pain’’
or loss, ringing ears (which prompted 13:48:50–13:52:00. and ‘‘muscle cramps.’’ Id. Under
UC to say that ‘‘[m]y ears only ring after After a discussion of the use of Psychiatric, he noted ‘‘Anxiety’’ and
I drink a jug of moonshine’’), blurry or suboxone, the nurse asked: ‘‘Did you say ‘‘Panic Attacks.’’ Id.
double vision, coughing, difficulty you have joint pain, back pain?’’ GX 10, In the Physical Exam section,
breathing, wheezing, snoring, chest at 15. UC replied: ‘‘My back’s stiff, but Registrant noted under ‘‘General
pain, or heart skippings; UC answered when I take that Norco, I’m cool’’ and Appearance’’ that ‘‘patient states hes
‘‘no’’ to each of these. GX 10, at 9–10; asked if ‘‘[t]that make[s] sense?’’ Id. The [sic] very anxious appears to be in mild
GX 9, VR 3, at 13:39:26–13:43:52. nurse replied: ‘‘that’s a reason to have pain alert to question and appropriate
Continuing, the nurse asked UC if he it . . . for insurance purposes. You with his response.’’ Id. at 29. As for his
had ‘‘[a]ny muscular skeletal problems? know what I mean?’’ and UC said: ‘‘As purported ‘‘Muscoskeletal’’ findings,
Pain? Back pain, joint pain, and long as I take that, I’m smooth.’’ Id.; GX Registrant noted: ‘‘Limited Motion:—
arthritis? No? No back pain?’’ GX 10, at 9, VR 3, at 13:54:36–13:54:47. Muscle Spasm:—Tenderness:—
10. UC stated: ‘‘I got like, you know, the UC and the nurse then went to Arthritis.’’ And as for his purported
normal,’’ to which the nurse said, ‘‘No, Registrant’s office, where the latter was ‘‘Neurologic’’ findings, Registrant noted:
I don’t’’ and asked again: ‘‘You got back seated behind his desk and an MA was ‘‘Abnormal reflexes:—Abnormal Gait:—
daltland on DSKBBV9HB2PROD with NOTICES
pain?’’ Id. UC responded ‘‘I got seated facing him. During this period, Weakness Atrophy.’’ Id.
stiffness.’’ Tr. at 10. UC then denied the nurse and MA remained in the As for his diagnoses, Registrant again
having joint pain. Id.; GX 9, VR 3, at office, and Registrant asked UC if he listed ‘‘Attention or Concentration
13:43:52–13:44:54. was a new patient. GX 9, at 16. After UC Deficit,’’ ‘‘Spasm of Muscle’’ and
The nurse then asked: ‘‘Any anxiety, said ‘‘No,’’ Registrant asked: ‘‘You a ‘‘Anxiety State Not Otherwise
depression?’’ GX 10, at 10. UC replied: regular? How many times?’’ Id. UC said: Specified,’’ and noted ‘‘7/22/2015’’ as
‘‘No. Just my nerves get jacked up a ‘‘It’s the third time I’ve been here . . . the date of both diagnosis and onset for
VerDate Sep<11>2014 19:06 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1](https://thefederalregister.org/doc/83_FR_14091/page/8.svg)
![14036 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
each diagnosis. He further noted that is an addiction psychiatrist in Indiana. in the Michigan Guidelines, ‘‘when
each diagnosis was ‘‘Active.’’ Id. GX 33 (Expert’s Declaration). He is also evaluating the use of controlled substances
As for his plan, Registrant listed an Associate Professor of Psychiatry at for pain control, . . . [a] complete medical
hydrocodone/apap 7.5/325 mg, Xanax the Indiana University (IU) School of history and physical examination must be
0.5 mg, as well as Baclofen 10 mg and conducted and documented in the medical
Medicine in the IU Neuroscience Center record. The medical record should document
Naproxen 500 mg. Id. at 30. He also where he trains psychiatrists and the nature and intensity of the pain, current
noted a follow-up in one month. Id. The physicians on the diagnosis and and past treatments for pain, underlying or
Government’s evidence includes copies treatment of mental illness and drug coexisting diseases or conditions, the effect
of the prescriptions issued by Registrant addiction. Id. at 1. He also runs a of the pain on physical and psychological
to UC at this visit; the prescriptions university-affiliated mental health function, and history of substance abuse.’’
include 60 tablets of alprazolam .5 mg center and addiction treatment clinic The guidelines also instruct on providing a
and 90 tablets hydrocodone 7.5/325 mg, where he treats patients. Id. He has been written treatment plan, obtaining informed
as well as baclofen and naproxen. GX board certified in addiction medicine consent and agreement for treatment,
11. conducting a periodic review at ‘‘reasonable
since 2008 and addiction psychiatry intervals based on the individual
UC’s patient file includes a report for since 2012, and has published over 40 circumstances of the pain,’’ and ‘‘referring
a urine drug sample collected from him peer-reviewed journal articles and the patient as necessary for additional
at the June 15, 2015 visit which was approximately nine textbook sections. evaluation and treatment in order to achieve
tested at Registrant’s clinic the same Id. In addition, Dr. Chambers has treatment objectives.’’ Third, practitioners
day. The report noted that neither provided expert testimony which was must keep accurate and complete records of
benzodiazepines or opiates were found credible in a previous DEA the forgoing and other aspects of medical
detected and listed the results as proceeding. See Lon F. Alexander, 82 care. Although that requirement is explicitly
‘‘normal.’’ Id. at 31. While these results FR 49704, 49714, 49725–26 (2017). stated in the Michigan Guidelines, I can also
were available the same day, UC’s visit [] attest based on my knowledge and
Dr. Chambers stated that he reviewed
occurred approximately two weeks after experience that keeping accurate and
various materials to familiarize himself complete patient records is required to meet
the medication from his previous visit with the standard of care for the the standard of care for the prescribing of any
would have run out.9 prescribing of controlled substances in controlled substance, not just that which
In his declaration, UC stated that he Michigan, including the Michigan Board relate to pain control.
told Registrant’s staff that when he ran of Medicine’s Guidelines for the Use of
out of medication, he obtained Id. at 3.
Controlled Substances for the Treatment Dr. Chambers also stated that he was
controlled substances from a neighbor to of Pain, (hereinafter, ‘‘Michigan
fill the gap between visits and that ‘‘aware of red flags, or possible
Guidelines’’), as well as various state indicators of potential abuse, addiction
neither Registrant nor his staff
laws, a document of the Michigan Board or diversion, and the need for red flags
conducted any further inquiry on this
of Pharmacy entitled ‘‘Pharmacy— to be addressed and resolved by a
issue. GX 32, at 3. UC also stated that
Controlled Substances,’’ and practitioner.’’ Id. According to Dr.
Registrant did not conduct any physical
information posted by the Michigan Chambers, these include ‘‘patients
examination and that the portion of his
Advisory Committee on Pain and seeking to have medications refilled
visit with Registrant occurred in
Symptom Management. Id. at 2. early, patients asking for specific
Registrant’s office, where Registrant ‘‘sat Dr. Chambers stated that ‘‘as a
behind his desk the entire time.’’ Id. UC medications, and indications that the
professor and practicing psychiatrist, I patient is addicted to or is diverting
further stated that his patient record have an understanding of how to
quotes him ‘‘as saying ‘I am having medications.’’ Id. He further stated that
prescribe controlled substances and the ‘‘under the standard of care,
lower back pains’ even though I risks associated with doing so. I am also
explicitly stated that I had ‘stiffness.’ ’’ practitioners’ records should identify
familiar with how doctors and any potential red flags and steps taken
Id. at 4 (Compare GX 12, at 28 with GX practitioners should conduct themselves
10, at 10 (Nurse asks ‘‘You got back to resolve them.’’ Id.
when prescribing controlled substances I find that Dr. Chambers is qualified
pain?’’ and UC responds: ‘‘I got for a legitimate medical purpose in the
stiffness.’’). Finally, UC stated that the to provide an expert opinion on the
usual c[o]urse of their profession.’’ Id. standards of professional practice for
visit note lists the results of a Based on his ‘‘professional experience
muscoskeletal exam, but other than the prescribing controlled substances under
and review’’ of the Michigan Guidelines the Michigan Board’s Guidelines and
taking of his vital signs, no physical and state law, he opined that ‘‘the
exam was performed during this visit Michigan law, as well as the standard of
standard of care for prescribing care generally with respect to the
and none of the conditions listed were controlled substances in Michigan is
discussed or found. GX 32, at 4. treatment of both pain and anxiety. I
similar to and consistent with that in also find that Dr. Chambers is qualified
The Government’s Expert Indiana . . . and that the standards in to provide expert testimony as to the
The Government retained Dr. R. Michigan are similar to and consistent risks associated with prescribing
Andrew Chambers, M.D., to review the with the national norms in the medical controlled substances.
videos, transcripts and prescriptions profession for prescribing controlled Dr. Chambers provided a written
related to the undercover visits made by substances.’’ Id. He then discussed the report regarding Registrant’s prescribing
the UC investigator, as well as the standards for prescribing controlled of controlled substances to UC and three
medical files for three patients, D.S., substances in Michigan: other patients (D.S., R.H., and A.L.).
A.L. and R.H., which were obtained First, in accordance with Michigan state With respect to UC, Dr. Chambers stated
daltland on DSKBBV9HB2PROD with NOTICES
during the investigation. Dr. Chambers law, any controlled substance must be that he ‘‘reviewed the undercover
prescribed for a legitimate or professionally videos, transcripts, and prescriptions,’’
recognized therapeutic purpose. To
9 UC file’s also includes the results of the UDS
determine that, the practitioner must take a
as well as the medical records related to
which was tested by an outside laboratory on June each of the three visits.
18, 2015. GX 12, at 32. The report noted that the complete medical history of the patient and
results were inconsistent with the drugs prescribed conduct an adequate physical examination to Dr. Chambers opined that Registrant
in that neither alprazolam nor hydrocodone were determine if there is a legitimate medical prescribed both hydrocodone, an
detected. Id. basis for so prescribing. Second, as explained opioid, and alprazolam, a
VerDate Sep<11>2014 19:06 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1](https://thefederalregister.org/doc/83_FR_14091/page/9.svg)
![Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices 14037
benzodiazepine, and that this Addressing UC’s second visit, Dr. The Expert’s Chart Review of
combination of drugs raises a serious Chambers noted that ‘‘there [was] no Registrant’s Patients D.S., A.L. and
overdose risk. Id. He further opined that physical examination.’’ Id. at 19. Dr. R.H.D.S.
‘‘[t]here are three clinical contexts in Chambers further observed that ‘‘[t]he Dr. Chambers reviewed the patient
which the risks associated with opioid actual clinical encounter and evaluation file for D.S., whose ‘‘typical chief
and benzodiazepine combination with [Registrant] last[ed] three minutes’’ complaints were back and neck pain,
therapies are considered acceptable, and that ‘‘[t]he most substantial and sometimes knee pain’’ during the
these being for hospice care, for evaluative questions’’ which Registrant five years she was treated by Registrant.
‘‘critical-care or closely monitored asked the UC were: ‘‘Doing OK?’’ and GX 33, at 4. According to the patient
inpatient settings,’’ and ‘‘for short-term, ‘‘Med went well?’’ Id. file, D.S.’s initial appointment with
closely monitored detoxification
With respect to UC’s third visit, Dr. Registrant was on August 31, 2011. GX
protocols for patients with addictions,’’
Chambers noted that UC had ‘‘again 14, at 5.
none of which are relevant in assessing Dr. Chambers found that documented
Registrant’s prescribing to UC. Id. at 3– ma[de] comments that he engage[d] in
significant drinking.’’ Id. Dr. Chambers prescription records from Registrant’s
4.
then observed that ‘‘[t]his information electronic patient file showed a
Dr. Chambers opined that at UC’s first
visit, Registrant failed to do a ‘‘proper was ignored and/or falsified in the prescribing pattern which rapidly
evaluation of current substance use Medical Record by’’ Registrant. Id. at 22. escalated from D.S.’s initial visit. GX 33,
symptoms or substance disorder Attachment B, at 7. Dr. Chambers
Dr. Chambers also noted that UC
history.’’ GX 33, Attachment B, at 19. As specifically expert found that on August
stated that because his third
Dr. Chambers explained, UC had 31, 2011, Registrant prescribed 90 mg/
appointment was two weeks late, he had
admitted to significant alcohol use at day morphine, yet only two weeks later
run out of medications and had
this visit yet Registrant did not further (September 14, 2011), Registrant
obtained controlled substances from his
question UC about his alcohol use. Id. doubled the dosage to 180 mg/day. Id.
neighbor. Id. at 20. Dr. Chambers
While UC had represented that he was Only one month later (October 14,
observed that ‘‘this activity was never
taking Xanax and Registrant reviewed 2011), Registrant increased D.S.’s dosing
addressed by’’ Registrant. Id.
his MAPS report which showed that he to 320 mg/day morphine and added 700
As for UC’s interaction with mg/day carisoprodol. Id. at 8.
had obtained the drug from multiple
Registrant, Dr. Chambers noted that this Dr. Chambers also found that in two
providers, some of whom were
hundreds of miles apart, Registrant did occurred in Registrant’s office, that the years of appointments between January
not do a ‘‘proper evaluation of current entire encounter lasted eight minutes, 2014 and February 2016, Registrant’s
psychiatric symptoms or psychiatric during which ‘‘there [was] essentially records show diagnoses of pain and
history of present illness.’’ Id. Dr. no clinical evaluation of the patient to depression. Id. The Expert found,
Chambers also noted that while a nurse assess symptoms, illness course or however, that over this period, D.S.’s
obtained UC’s vital signs and weight, ‘‘a treatment response,’’ and ‘‘the only patient file contained no evidence that
physical exam was never performed’’ questions’’ asked by Registrant were Registrant did physical exams other
and yet the medical records include ‘‘where the patient work[ed] and what than to take vital signs; he also found
‘‘normal physical examination pharmacy he use[d].’’ Id. Dr. Chambers that Registrant’s treatment plans were
findings.’’ Id. at 20. Moreover, the also observed that most of the encounter essentially non-existent. Id. Yet during
patient record ‘‘falsely states that the was spent discussing matters that had this period, Registrant prescribed to D.S.
patient denies drinking.’’ Id. nothing to do with the UC’s medical such narcotics as hydrocodone 10/325
With respect to Registrant’s diagnoses, condition and a physical exam was not mg. and oxycodone 30 mg. which
Dr. Chambers opined that none of them performed. Id. included repeated prescriptions for 120
was properly supported. As for the In addition, Dr. Chambers noted that dosage units of the latter drug; he also
diagnosis of muscle spasm, Dr. Registrant falsified the visit note in repeatedly prescribed carisoprodol, a
Chambers noted that ‘‘there was no various respects. These include: (1) The schedule IV muscle relaxant during this
physical exam . . . to confirm muscle statement that UC ‘‘appears to be in period. GX 13, at 1–48. Dr. Chambers
spasm or any other somatic source of mild pain,’’ which Dr. Chambers opined noted, however, that the D.S.’s ‘‘records
pain or muscular-skeletal disorder.’’ Id. was inconsistent with the UC’s ‘‘voice, do not typically document evidence of
at 21. He further observed that affect and thought content,’’ improvement in pain symptoms.’’ GX
Registrant prescribed opioids but there notwithstanding that the video does not 33, at 6.
was no diagnosis of pain and ‘‘opioids show how UC appeared; (2) the Registrant also repeatedly prescribed
are not indicated for muscle spasm.’’ Id. statement that ‘‘patient states he is very other controlled substances including
As for the diagnosis of anxiety, Dr. stimulants such as Adipex-P
anxious,’’ which UC ‘‘never stated’’; and
Chamber reiterated that Registrant did (phentermine) and Bontril
(3) the exam findings of ‘‘limited
not perform an ‘‘adequate psychiatric (phendimetrazine), which are schedule
motion, spasm, tenderness,’’ as well as
evaluation.’’ Id. Dr. Chambers also III and IV controlled substances. GX 13,
‘‘abnormal reflexes’’ and ‘‘weakness/
observed that the diagnosis of an at 6. Dr. Chambers further found that
atrophy,’’ as Registrant ‘‘never
attention or concentration deficit ‘‘was Registrant’s introduction of these
performed a physical exam or touched
not evaluated[,] or measured in any stimulants into D.S.’s medication
the patient.’’ Id. at 21.
current way.’’ Id at 20. regimen was ‘‘not accompanied by a
Dr. Chambers observed that while Dr. Chambers thus concluded that diagnosis or clinical indication in the
daltland on DSKBBV9HB2PROD with NOTICES
Registrant went over the dosing ‘‘the controlled substances prescriptions charting.’’ GX 33, Attachment B, at 8.10
instructions, he did not caution UC that [Registrant] issued to the
about the risks of combining opioids investigator during the undercover visits 10 He also found that Registrant made a diagnosis
and benzodiazepines, which ‘‘may were not issued for any legitimate of depression on January 15, 2014, but there was
no attempt to treat it. Id., see also GX 15, at 1–3.
produce serious hazards for driving’’’ medical basis and were issued outside In fact, the record shows that under Review of
even though UC said he was of the standard of care in . . . Systems, Registrant noted ‘‘no [psychiatric]
professional driver. Id. at 19. Michigan.’’ GX 33, at 4. Continued
VerDate Sep<11>2014 19:06 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1](https://thefederalregister.org/doc/83_FR_14091/page/10.svg)
![14038 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
Dr. Chambers identified multiple . . . and/or he failed to perform these substances, including combinations of
instances in which D.S.’s medical professional functions altogether.’’ Id. opioids, benzodiazepines, and
records indicated that she was suffering Dr. Chambers thus concluded that stimulants,’’ resulting in 50 dispensings
from addiction. These include notes on Registrant issued numerous of drugs which included hydrocodone,
April 11 and May 9, 2012 documenting prescriptions without ‘‘any legitimate oxymorphone, oxycodone, morphine,
‘‘dependence,’’ a note on June 8, 2012 medical basis’’ and acted ‘‘outside of the diazepam, alprazolam and
that ‘‘she constantly needs more [pain standard of care in the state of amphetamine. GX, 33 at 7–8; see also
medications],’’ a note on September 28, Michigan.’’ Id. GX 18, at 32–40. He also observed that
2012 of ‘‘medication dependence,’’ a on her ‘‘Health History Questionnaire,’’
A.L.
note on October 26, 2012 of which was completed in January 2011,
‘‘[m]edication dependence illness,’’ and Registrant treated patient A.L. from she reported taking Roxicodone, Xanax,
a note on November 20, 2012 of ‘‘patient January 17, 2011 through April 30, and Soma, which as Dr. Chambers
continues to display dependence.’’ GX 2014. Id. at 14–16. See also GX 18 previously explained, comprises the
33, at 6. (patient medical file), GX 19 and 20 highly abused ‘‘‘Trinity’ drug cocktail.’’
Dr. Chambers also identified multiple (electronic patient files). Regarding Id. at 8; see also GX 18, at 14.12
instances in which D.S. provided Registrant’s patient records for A.L., Dr. Dr. Chambers further noted that A.L.’s
aberrant urine drug screens. These Chambers reported that they contain medical records documented that she
included tests which showed the notes for various medical issues ‘‘was possibly engag[ed] in diversion.’’
presence of methadone on February 14, including anxiety, depression, and pain, Id. at 8. As support for this observation,
2014 and buprenorphine on November the latter including knee, lower back, Dr. Chambers pointed to a chart entry of
10, 2014, neither of which were ankle and neck pain. GX 33, at 6–7. February 25, 2013 which states: ‘‘She
prescribed to D.S.; the presence of Dr. Chambers reviewed 11 controlled says she cannot get her pain
cocaine on March 14, 2014; the presence substance prescriptions Registrant medications and has to be buying it off
of psychostimulants (amphetamines) on issued to A.L. between October 17, 2013 the streets to satisfy her pain. The last
March 14, April 14, and May 12, 2014 and May 6, 2014. Id. at 7. The time she was given pain medication
which were not prescribed by prescriptions included three from this office was in September of last
Registrant; instances in which the tests prescriptions for 120 du of year.’’ Id. at 8; see also GX 19, at 8. Dr.
were negative for drugs prescribed by hydrocodone/apap 10/325 mg with two Chambers found that there was no
Registrant (Nov. 10, 2014 negative test refills, three prescriptions for 30 du of evidence in the patient record that
for oxycodone and morphine and June phentermine 37.5 mg with two refills,
Registrant ‘‘addressed or resolved these
22, 2015 negative test for oxycodone); three prescriptions for 150 du of
red flags.’’ GX 33, at 8. Moreover, Dr.
and four tests which found levels of carisoprodol 350 mg with two refills,
Chambers found that Registrant’s
oxycodone which were above the and three prescriptions for 120 du of
‘‘charting is devoid of UDS data
recommended therapeutic range of alprazolam 2 mg. GX 17, at 2–23 (copies
collection or tracking.’’ GX 33,
those drugs.11 GX 33, Attachment B, at of prescriptions obtained from filling
Attachment B, at 18.
8–9. pharmacy, and pharmacy patient profile Based on his review of A.L.’s record
Dr. Chambers explained that the drug report). and the prescriptions, Dr. Chambers
test results show ‘‘a number of different Dr. Chambers observed that ‘‘[f]or the
concluded that that she ‘‘was suffering
problems that represent serious warning most part there are no physical
from a drug addiction that was not
signs of dangerous drug use and or examinations documented in the
medical records.’’ GX 33, at 7. Dr. adequately diagnosed or treated; [that
addiction.’’ Id. at 8. He further observed Registrant] was prescribing extremely
that Registrant’s records contain no Chambers also noted that ‘‘the
combination of Hydrocodone, dangerous combinations of controlled
acknowledgment of D.S.’s aberrational substances without documenting an
drug tests results and reflect that he did Alprazolam and Carisoprodol drugs . . .
is a prescription ‘cocktail’ known among appropriate medical context or
not change the treatment plan or any justification for so doing, and [that he]
clinical actions to address the results. users and law enforcement as the
‘Trinity,’’’ and that it ‘‘is widely known failed to adequately document ongoing
Id. at 9. examinations and treatment planning
Dr. Chambers concluded that ‘‘D.S. to be used non-therapeutically as part of
a substance disorder and/or diverted.’’ . . . and/or he failed to perform these
was very likely suffering from drug professional functions altogether.’’ GX
addiction that was not adequately Id. He further noted that on four
occasions in 2011, Registrant had also 33, at 8. Dr. Chambers thus opined that
diagnosed or treated, and [Registrant] ‘‘the prescriptions [Registrant] issued to
failed to act on an overall lack of prescribed another variation of this
cocktail, which substituted Roxicodone A.L. were not issued for any legitimate
treatment response to the controlled medical basis and were issued outside
substance combinations he was (oxycodone) for hydrocodone. Id. He
then opined that ‘‘there is no of the standard of care in the state of
prescribing.’’ GX 33, at 6. He further Michigan.’’ Id.
opined that Registrant ‘‘was prescribing documentation in A.L.’s medical
dangerous combinations of controlled records demonstrating a legitimate R.H.
substances without documenting a medical justification or clinical context Dr. Chambers also reviewed the
medical need for so doing, and he failed for prescribing this dangerous controlled substances Registrant issued
to adequately document ongoing combination of controlled substances.’’ to R.H. from June 2, 2015 through
examinations and treatment planning Id. February 24, 2016. According to Dr.
Dr. Chambers also found that ‘‘[t]here
Chambers, during this time period, R.H.
daltland on DSKBBV9HB2PROD with NOTICES
symptoms at this time: Negative for anxiety, are numerous signs of addiction’’ in
presented a variety of chief complaints
depression . . . mental disturbance . . . panic A.L.’s patient file, beginning with her
which ‘‘included complaints of lower
attacks.’’ Id. at 1. There were also ‘‘no [psychiatric] initial visit with Registrant on January
symptoms at this time’’ noted at D.S.’s following back and hand joint pain, anxiety,
17, 2011. Id. Dr. Chambers noted that
visit. Id. at 4.
11 Two tests also found amphetamines at levels the MAPS report showed that A.L. ‘‘had 12 The same Health History Questionnaire also
above the recommended therapeutic range. GX 33, seen up to eight prior prescribers over lists Opana, Vickodin [sic], and MS Contin as
Attachment B, at 9. the prior year for various controlled ‘‘prescribed drugs.’’ GX 18, at 14.
VerDate Sep<11>2014 19:06 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1](https://thefederalregister.org/doc/83_FR_14091/page/11.svg)
![Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices 14039
numbness, a rash on face/head, opined that the prescriptions Registrant Guidelines ‘‘set forth six key
fractured left toes, sciatica, and arms issued to R.H. ‘‘were not issued for any components of legitimate medical
and shoulder pain.’’ Id. legitimate medical basis and were practice that should be observed in the
During this period, Registrant issued issued outside of the standard of care in use of controlled substance for the
to R.H. 10 prescriptions for 90 du of . . . Michigan.’’ Id. treatment of pain,’’ to ‘‘include
hydrocodone/apap 10/325 mg; 10 appropriate:
prescriptions for 60 du of morphine Summary of the Expert’s Findings
(1) Evaluation (history taking and physical
sulfate 100 mg; 10 prescriptions for 120 With respect to the UC and the three examination, psychiatric screening);
du of morphine sulfate 30 mg; five other patients, Dr. Chambers opined (2) Treatment Planning;
prescriptions for 60 du of alprazolam 1 that: (3) Informed consent (discussion of risks
mg, including one which provided for The evidence reveals that [Registrant] has and benefits of medications . . .);
two refills; and two prescriptions for 60 been engaged in prescribing dangerous levels (4) Periodic Review (evaluate and
and combinations of opioid and benzoid monitoring of treatment progress);
du of carisoprodol 350 mg, each of (5) Consultation; and
which provided for two refills. Id. at 8– drugs to multiple patients in chronic patterns
that have no legitimate medical purpose, and (6) Medical record keeping.’’
10. Dr. Chambers again noted that the
are not supported by the evidence base. Id. at 5–6.
combination of hydrocodone, Moreover, it is precisely these types of
alprazolam, and carisoprodol comprise controlled substance patterns that are shown Dr. Chambers opined that ‘‘there are
the Trinity cocktail. Id. at 10. He also by a wealth of biomedical, clinical and 2 other key aspects of the evidence that
found that on six occasions between epidemiological evidence to produce highlight the particularly malignant
March 11, 2011 and September 26, diversion and to contribute to addiction, nature of [Registrant’s] practices and
2011, Registrant prescribed worsening mental illness, and premature prescribing pattern.’’ Id. at 6. First, Dr.
hydrocodone, carisoprodol and Valium death. The case evidence suggests to various Chambers concluded that the ‘‘evidence
(diazepam), another version of the degrees that all of these outcomes have
happened as a result of [Registrant’s]
suggest[s] that Registrant deliberately
Trinity cocktail. Id. prescribing and clinical practices. acted to obscure, in the medical record,
Dr. Chambers found that ‘‘[f]or the This prescribing was also occurring in the the dangerousness of his practice, to
most part there are no physical exams absence of minimally adequate practice cover-up the degree to which it was a
documented in the medical records.’’ Id. standards of care by [Registrant], including drug dealing operation, instead of a
He also found that ‘‘[t]here is no failures to appropriately evaluate, diagnose legitimate medical practice.’’ Id. As he
documentation in R.H.’s medical and monitor disease processes, and treatment further explained, the evidence
records demonstrating a legitimate outcomes or treatment side effects. All 4 ‘‘show[s] that [Registrant] is padding the
medical justification or clinical context cases presented strong evidence that patients medical record with initial PDMP
for prescribing this dangerous were suffering with mental illness and
addiction of some kind when initially
evaluations and UDS testing that he
combination of controlled substances.’’ never acts on regardless of what these
presenting for treatment. In 3 cases, these
Id. conditions did not change and/or worsened data show, as if the point is to create the
Dr. Chambers noted that R.H.’s over time even as they were not appearances of maintaining standards
records contain ‘‘numerous signs of appropriately treated, or referred elsewhere and adequate monitoring in the medical
possible addiction or abuse.’’ Id. at 11. for treatment, and even as these conditions record without actually doing so.’’ Id.
These include a note (Dec. 21, 2011) in were adversely contributed to by the Second, Dr. Chambers explained that
which Registrant documented that ‘‘R.H. benzoid-opioid combination of drugs the evidence shows that ‘‘[h]e not only
is taking the valium three times a [day] [Registrant] was prescribing. engages in little history taking and no
although he is given it twice daily so he Id. at Attachment B, at 5. physical examination of the patient, but
runs out eary’’ [sic]. Id. Dr. Chambers he falsely documents examination
also found that ‘‘R.H.’s urine drug Dr. Chambers further opined that
Registrant was not practicing in ‘‘good findings that do not exist, in an
screens also show[] a number of examination that was never performed,
different problems that represent serious faith’’ as defined by Michigan Code
in order to justify the continuing
warnings signs of dangerous drug use § 333.7333(1). Id. This provision defines
prescription of controlled drugs.’’ Id.
and or addiction, including the presence ‘‘good faith’’ as: Dr. Chambers thus concluded that
of amphetamines and benzodiazepine[s] The prescribing or dispensing of a ‘‘this evidence shows that [Registrant] is
that [were] not prescribed by’’ controlled substance by a practitioner
licensed under section 7303 in the regular
performing well below the standard of
Registrant. Id. Dr. Chambers further care, and is a danger to []his patients
course of professional treatment to or for an
found that ‘‘[t]here are no indications in individual who is under treatment by the and the public at large with respect to
the patient records that [Registrant] practitioner for a pathology or condition his prescribing of controlled substances.
addressed or resolved these red flags.’’ other than that individual’s physical or The evidence is highly suggestive that
Id. psychological dependence upon or addiction he is providing prescriptions for
Based upon his review of R.H.’s to a controlled substance, except as provided addictive substances, not in ‘good faith’
patient file and prescriptions, Dr. in this article. consistent with medical norms, but as a
Chambers concluded that he ‘‘was Mich. Code § 333.7333(1). Dr. distribution business, i.e. as a drug
suffering from drug addiction that was Chambers thus concluded that ‘‘rather dealing operation under the guise of
not adequately diagnosed or treated.’’ than providing legitimate medical care, legitimate health care.’’ Id. I agree.
Id. Dr. Chambers further concluded that [Registrant] was actually using the guise
Registrant ‘‘was prescribing extremely of medical practice . . . to deal Discussion
dangerous combinations of controlled addictive drugs to patients with In its Request for Final Agency
daltland on DSKBBV9HB2PROD with NOTICES
substances without documenting a untreated addictions and mental Action, the Government seeks
medical need for so doing, and [that illness.’’ GX 33, Attachment B, at 5. revocation on two independent grounds.
Registrant] failed to adequately Dr. Chambers also evaluated the First, it argues that revocation is
document ongoing examinations and evidence in light of the Michigan warranted because Registrant lacks
treatment planning . . . and/or he failed Guidelines for the Use of Controlled authority under state law to dispense
to perform these professional functions Substances for the Treatment of Pain. controlled substances. RFAA, at 6
altogether.’’ Id. Dr. Chambers thus Dr. Chambers explained that the (citing 21 U.S.C. 824(a)(3)). Second, it
VerDate Sep<11>2014 19:06 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1](https://thefederalregister.org/doc/83_FR_14091/page/12.svg)
![14040 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
argues that Registrant has committed medical license for 15 months, the committed such acts as would render
acts which render his registration Board’s Order further provides that his registration under section 823 of this
inconsistent with the public interest ‘‘reinstatement shall not be automatic,’’ title inconsistent with the public
because he unlawfully distributed and that Registrant must petition for interest as determined under such
controlled substances in violation of 21 reinstatement by demonstrating, ‘‘by section.’’ 21 U.S.C. 824(a)(4). With
U.S.C. 841(a)(1) and 21 CFR 1306.04(a). clear and convincing evidence,’’ that he: respect to a practitioner, the Act
Id. at 9. I agree that the Government is (1) Is of ‘‘good moral character’’; (2) has requires the consideration of the
entitled to an order of revocation on ‘‘the ability to practice the profession following factors in making the public
both grounds. with reasonable skill and safety’’; (3) has interest determination:
satisfied ‘‘the guidelines on (1) The recommendation of the appropriate
Lack of State Authority
reinstatement adopted by the State licensing board or professional
Pursuant to 21 U.S.C. 824(a)(3), the Department’’; and (4) ‘‘that it is in the disciplinary authority.
Attorney General is authorized to public interest for the license to be (2) The applicant’s experience in
suspend or revoke a registration issued reinstated.’’ Consent Order, at 2. Thus, dispensing * * * controlled substances.
under section 823, ‘‘upon a finding that (3) The applicant’s conviction record under
it is far from certain that Registrant will Federal or State laws relating to the
the registrant . . . has had his State be able to satisfy these conditions and manufacture, distribution, or dispensing of
license . . . suspended [or] revoked be reinstated to the practice of controlled substances.
. . . by competent State authority and is medicine. (4) Compliance with applicable State,
no longer authorized by State law to More importantly, this Agency has Federal, or local laws relating to controlled
engage in the . . . dispensing of held that even where a State has substances.
controlled substances.’’ Moreover, DEA imposed a suspension of finite duration (5) Such other conduct which may threaten
has held repeatedly that the possession of a practitioner’s medical license, the public health and safety.
of authority to dispense controlled revocation is nonetheless warranted Id. § 823(f)
substances under the laws of the State because the controlling question is not
in which a practitioner engages in whether a practitioner’s license to ‘‘These factors are * * * considered
professional practice is a fundamental practice medicine in the State is in the disjunctive.’’ Robert A. Leslie,
condition for obtaining and maintaining suspended or revoked; rather, it is M.D., 68 FR 15227, 15230 (2003). I ‘‘may
a practitioner’s registration. See, e.g., whether the Registrant is currently rely on any one or a combination of
James L. Hooper, 76 FR 71371 (2011), authorized to handle controlled factors, and may give each factor the
pet. for rev. denied, 481 Fed. Appx. 826 substances in the State. Hooper, 76 FR weight [I] deem[ ] appropriate in
(4th Cir. 2012); Frederick Marsh at 71371 (citing Anne Lazar Thorn, 62 determining whether a registration
Blanton, 43 FR 27616 (1978). FR 12847, 12848 (1997)). Because one should be revoked.’’ Id.; see also
This rule derives from the text of two cannot obtain a practitioner’s Volkman v. DEA, 567 F.3d 215, 222 (6th
provisions of the CSA. First, Congress registration unless one holds authority Cir. 2009). While I must consider each
defined ‘‘the term ‘practitioner’ [to] under state law to dispense controlled factor, I am ‘‘not required to make
mean[] a . . . physician . . . or other substances, and because where a findings as to all of the factors.’’
person licensed, registered or otherwise registered practitioner’s state authority Volkman, 567 F.3d at 222; see also
permitted, by . . . the jurisdiction in has been revoked or suspended, the Hoxie v. DEA, 419 F.3d 477, 482 (6th
which he practices . . . to distribute, practitioner no longer meets the Cir. 2005); see also Morall v. DEA, 412
dispense, [or] administer . . . a statutory definition of a practitioner, F.3d 165, 173–74 (D.C. Cir. 2005).
controlled substance in the course of DEA has held repeatedly that the In short, this is not a contest in which
professional practice.’’ 21 U.S.C. possession of authority to dispense score is kept; the Agency is not required
802(21). Second, in setting the controlled substances under the laws of to mechanically count up the factors
requirements for obtaining a the State in which a practitioner engages and determine how many favor the
practitioner’s registration, Congress in professional practice is a Government and how many favor the
directed that ‘‘[t]he Attorney General fundamental condition for both registrant. Rather, it is an inquiry which
shall register practitioners . . . if the obtaining and maintaining a focuses on protecting the public
applicant is authorized to dispense . . . practitioner’s registration. See Blanton, interest; what matters is the seriousness
controlled substances under the laws of 43 FR 27616 (1978) (revoking of the registrant’s misconduct. Jayam
the State in which he practices.’’ 21 registration based on one-year Krishna—Iyer, M.D., 74 FR 459, 462
U.S.C. 823(f). Because Congress has suspension of medical license); Hooper, (2009). Accordingly, as the Tenth
clearly mandated that a practitioner 76 FR at 71371 (same). Circuit has recognized, findings under a
possess state authority in order to be Thus, because Registrant is no longer single factor can support the revocation
deemed a practitioner under the Act, currently authorized to dispense of a registration. MacKay v. DEA, 664
DEA has held repeatedly that revocation controlled substances in Michigan, the F.3d. 808, 821 (10th Cir. 2011).
of a practitioner’s registration is the State in which he is registered with the Even in a non-contested proceeding,
appropriate sanction whenever he is no Agency, I find that he is not entitled to the Government has the burden of
longer authorized to dispense controlled maintain a DEA registration in the State. producing substantial evidence to
substances under the laws of the State Accordingly, I will order the revocation support the allegations and its proposed
in which he practices medicine. See, of his existing registration on this sanction. See Gabriel Sanchez, 78 FR
e.g., Calvin Ramsey, 76 FR 20034, 20036 ground. See 21 U.S.C. 824(a)(3) . 59060, 59063 (2013); 21 CFR 1301.44(e).
(2011); Sheran Arden Yeates, M.D., 71 In this case, I find that the Government’s
daltland on DSKBBV9HB2PROD with NOTICES
FR 39130, 39131 (2006); Dominick A. The Public Interest Analysis evidence with respect to Factors Two
Ricci, 58 FR 51104, 51105 (1993); Bobby Section 304(a) of the Controlled and Four 13 establishes that Registrant
Watts, 53 FR 11919, 11920 (1988). See Substances Act (CSA) provides that a
13 In its Request for Final Agency Action, the
also Frederick Marsh Blanton, 43 FR registration to ‘‘dispense a controlled
Government states that Factors I, III and V do not
27616 (1978). substance * * * may be suspended or weigh in favor of or against revoking Registrant’s
Here, while the Michigan Board’s revoked by the Attorney General upon registration. RFAA at 8, fn. 4 (citing 21 U.S.C
Consent Order suspended Registrant’s a finding that the registrant * * * has §§ 823(f)(1), (3) and (5)). As explained above, with
VerDate Sep<11>2014 19:06 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1](https://thefederalregister.org/doc/83_FR_14091/page/13.svg)
![Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices 14041
‘‘has committed such acts as would purporting to be a prescription issued See also United States v. Hooker, 541
render his registration . . . inconsistent not in the usual course of professional F.2d 300, 305 (1st Cir. 1976) (affirming
with the public interest.’’ 21 U.S.C. treatment . . . is not a prescription conviction under section 841 where
824(a)(4). within the meaning and intent of [21 physician ‘‘carried out little more than
U.S.C. 829] and . . . the person issuing cursory physical examinations, if any,
Factors Two and Four—Registrant’s
it, shall be subject to the penalties frequently neglected to inquire as to
Experience in Dispensing Controlled
provided for violations of the provisions past medical history and made little to
Substances and Compliance With
of law relating to controlled no exploration of the type of problem a
Applicable Laws Related to Controlled
substances.’’). patient allegedly’’ had, and that ‘‘[i]n
Substances As the Supreme Court has explained, light of the conversations with the
Under a longstanding DEA regulation, ‘‘the prescription requirement . . . agents, the jury could reasonably infer
a prescription for a controlled substance ensures patients use controlled that the minimal ‘professional’
is not ‘‘effective’’ unless it is ‘‘issued for substances under the supervision of a procedures followed were designed only
a legitimate medical purpose by an doctor so as to prevent addiction and to give an appearance of propriety to
individual practitioner acting in the recreational abuse. As a corollary, [it] [the] unlawful distributions’’); United
usual course of his professional also bars doctors from peddling to States v. Tran Trong Cuong, 18 F.3d
practice.’’ 21 CFR 1306.04(a). See also patients who crave the drugs for those 1132, 1139 (4th Cir. 1994) (holding
Mich. Comp. Laws § 333.7333(1) (‘‘As prohibited uses.’’ Gonzales v. Oregon, evidence sufficient to find physician
used in this section, ‘good faith’ means 546 U.S. 243, 274 (2006) (citing Moore, prescribed outside of professional
the prescribing of a controlled substance 423 U.S. 122, 135, 143 (1975)). practice, in that ‘‘in most cases the
by a practitioner licensed under section Both this Agency and the federal patients complained of such nebulous
7303 in the regular course of courts have held that establishing a things as headaches, neckaches,
professional treatment to or for an violation of the prescription backaches and nervousness, conditions
individual who is under treatment by requirement ‘‘requires proof that the that normally do not require . . .
the practitioner for a pathology or practitioner’s conduct went ‘beyond the controlled substances,’’ physician was
condition other than that individual’s bounds of any legitimate medical ‘‘aware that some of the[] patients were
physical or psychological dependence practice, including that which would obtaining the same drugs from other
upon or addiction to a controlled constitute civil negligence.’ ’’ Laurence doctors,’’ ‘‘[m]ost of the patients were
substance, except as provided in this T. McKinney, 73 FR 43260, 43266 (2008) given very superficial physical
article.’’); id. § 333.7401 (‘‘A practitioner (quoting United States v. McIver, 470 examinations,’’ and patients were not
licensed by the administrator under this F.3d 550, 559 (4th Cir. 2006)). However, ‘‘referred to specialists’’); United States
article shall not dispense, prescribe, or as the Sixth Circuit (and other federal v. Bek, 493 F.3d 790, 799 (7th Cir. 2007)
administer a controlled substance for circuits have noted), ‘‘ ‘[t]here are no (upholding convictions; noting that the
other than a legitimate and specific guidelines concerning what is evidence included ‘‘uniform,
professionally recognized therapeutic or required to support a conclusion that an superficial, and careless examinations,’’
scientific purposes or outside the scope accused acted outside the usual course ‘‘exceedingly poor record-keeping,’’ ‘‘a
of practice of the practitioner . . . .’’). of professional practice. Rather, the disregard of blatant signs of drug
Under the CSA, it is fundamental that courts must engage in a case-by-case abuse,’’ ‘‘prescrib[ing] multiple
a practitioner must establish a bonafide analysis of the evidence to determine medications having the same effects
doctor-patient relationship in order to whether a reasonable inference of guilt . . . and drugs that are dangerous when
act ‘‘in the usual course of . . . may be drawn from specific facts.’ ’’ taken in combination’’); United States v.
professional practice’’ and to issue a United States v. August, 984 F.2d 705, Feingold, 454 F.3d 1001, 1010 (9th Cir.
prescription for a ‘‘legitimate medical 713 (6th Cir. 1992) (citations omitted) 2006) (‘‘[T]he Moore Court based its
purpose.’’ See United States v. Moore, (quoted in United States v. Singh, 54 decision not merely on the fact that the
423 U.S. 122, 142–43 (1975); United F.3d 1182, 1187 (4th Cir. 1995)). doctor had committed malpractice, or
States v. Lovern, 590 F.3d 1095, 1100– Thus, in Moore, the Supreme Court even intentional malpractice, but rather
01 (10th Cir. 2009); United States v. held the evidence in a criminal trial was on the fact that his actions completely
Smith, 573 F.3d 639, 657 (8th Cir. 2009); sufficient to find that a physician’s betrayed any semblance of legitimate
see also 21 CFR 1306.04(a) (‘‘An order ‘‘conduct exceeded the bounds of medical treatment.’’); United States v.
‘professional practice,’ ’’ where the Joseph, 709 F.3d 1082, 1104 (11th Cir.
respect to Factor One—the Recommendation of the physician ‘‘gave inadequate physical 2013) (upholding conviction of
State Board—the Board made no recommendation examinations or none at all,’’ ‘‘ignored physician where ‘‘record establishe[d]
to the Agency in this matter. More importantly, as the results of the tests he did make,’’
discussed above, the Board has suspended his that [physician] prescribed an
medical license thus rendering him ineligible to ‘‘took no precautions against . . . inordinate amount of certain controlled
maintain his registration. misuse and diversion,’’ ‘‘did not substances, that he did so after
With respect to Factor Three, I acknowledge that regulate the dosage at all’’ and conducting no physical examinations or
there is no evidence that Respondent has been ‘‘graduated his fee according to the
convicted of an offense under either Federal or
only a cursory physical examination,
Michigan law ‘‘relating to the manufacture,
number of tablets desired.’’ 423 U.S. at that [physician] knew or should have
distribution or dispensing of controlled 142–43. known that his patients were misusing
substances.’’ 21 U.S.C. 823(f)(3). However, there are However, as the Sixth Circuit has their prescriptions, and that many of the
a number of reasons why even a person who has explained, ‘‘[o]ne or more of the combinations of prescriptions drugs
engaged in criminal misconduct may never have foregoing factors, or a combination of were not medically necessary’’).14
daltland on DSKBBV9HB2PROD with NOTICES
been convicted of an offense under this factor, let
alone prosecuted for one. Dewey C. MacKay, 75 FR them, but usually not all of them, may
49956, 49973 (2010), pet. for rev. denied, MacKay be found in reported decisions of 14 However, as the Agency has held in multiple
v. DEA, 664 F.3d at 822. The Agency has therefore prosecutions of physicians for issuing cases, ‘‘the Agency’s authority to deny an
held that ‘‘the absence of such a conviction is of prescriptions for controlled substances application [and] to revoke an existing registration
considerably less consequence in the public interest . . . is not limited to those instances in which a
inquiry’’ and is therefore not dispositive. Id. exceeding the usual course of practitioner intentionally diverts a controlled
The Government makes no argument that Factor professional practice.’’ United States v. substance.’’ Bienvenido Tan, 76 FR 17673, 17689
Five is implicated in this matter. Kirk, 584 F.2d 773, 785 (6th Cir. 1978). Continued
VerDate Sep<11>2014 19:06 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00099 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1](https://thefederalregister.org/doc/83_FR_14091/page/14.svg)
![14042 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
The evidence shows that Registrant PMP report showed that he had ‘‘abnormal reflexes’’ and ‘‘weakness/
unlawfully distributed controlled obtained this drug from multiple atrophy,’’ when he did not perform the
substances by issuing prescriptions to providers, failed to perform a physical tests necessary to make these findings.
the UC on multiple occasions outside examination of the [UC] at any point, I thus conclude that Registrant acted
the usual course of professional practice and failed to perform adequate outside of the usual course of
and for other than a legitimate medical treatment planning. Dr. Chambers professional practice and lacked a
purpose, in violation of 21 U.S.C. further explained that Registrant legitimate medical purpose when he
841(a)(1) and 21 CFR 1306.04(a). See falsified the medical record by issued the prescriptions for
also Mich. Comp. Laws § 333.7401(1) fraudulently documenting in it that the hydrocodone and alprazolam at each of
(‘‘A practitioner . . . shall not . . . UC denied drinking, as well as by the UC’s visits. 21 CFR 1306.04(a); 21
prescribe . . . a controlled substance for making physical exam findings such as U.S.C. 841(a)(1); see also Mich. Comp.
other than legitimate and professionally ‘‘[l]imited motion, spasm, tenderness, Laws § 333.7401(1). With respect to the
recognized therapeutic or scientific weakness, atrophy, abnormal reflexes,’’ UC, I conclude, based on Dr. Chambers’
purposes or outside the scope of when he did not perform the tests testimony, that Registrant failed to
practice of the practitioner.’’); id. necessary to make these findings. GX comply with the Michigan Guidelines in
§ 333.7405(1)(a) (a licensed practitioner 33, Attachment B, at 22. that he failed to take a complete medical
shall not ‘‘distribute, prescribe, or Moreover, on the pain questionnaire, history, conduct a physical
dispense a controlled substance in the UC did not circle any of the examination, and document in the
violation of section 7333’’). descriptors, did not rate his pain, nor medical record ‘‘the nature and
The Michigan Guidelines set forth the indicate whether his pain interfered intensity of the pain, current and past
applicable standards of professional with various life activities listed on the treatments for pain, underlying or
practice for the prescribing of controlled form. Yet Registrant made no inquiry as coexisting diseases or conditions, the
substances in the State. GX 28. The to why the UC left most of the form effect of the pain on physical and
Guidelines provide that: blank. psychological function, and history of
when evaluating the use of controlled Most significantly, during his visit substance abuse.’’ Michigan Guidelines,
substances for pain control . . . [a] complete with Registrant, the UC never Section II.1. Based on Dr. Chambers’
medical history and physical examination complained of anything more than back testimony, I also conclude that
must be conducted and documented in the stiffness, made no complaint that he Registrant ‘‘essentially’’ failed to comply
medical record. The medical record should suffered from anxiety and stated that he with each of the standards of the
document the nature and intensity of the took Xanax because it kept him from
pain, current and past treatments for pain,
Michigan Guidelines, including
underlying or coexisting diseases or drinking too much on the weekends. developing a treatment plan which sets
conditions, the effect of the pain on physical Here again, Registrant falsified the forth objectives for determining
and psychological function, and history of medical record by documenting: ‘‘Today treatment success and considering other
substance abuse. [the UC] is complaining mostly of [ ] treatment modalities, obtaining
GX 28. The Guidelines also state that some level of anxiety.’’ Dr. Chambers informed consent, conducting periodic
the physician is to keep ‘‘accurate and further concluded that there was no reviews, and maintaining accurate and
complete records’’ of the forgoing and basis for the various diagnoses which complete records. GX 33, Attachment B,
other aspects of medical care. Id. Registrant documented in the UC’s at 5–6. (Expert Declaration), at 6. I
The Government’s evidence shows record, including anxiety and muscle further conclude that Registrant violated
that Registrant dispensed controlled spasms; he also noted that Registrant Michigan Law and the CSA in that he
substances to the UC on multiple made no diagnosis of pain and that acted outside of the usual course of
occasions, notwithstanding his failure to opioids are not indicated for muscle professional practice and lacked a
conduct an adequate evaluation, spasms. legitimate medical purpose when he
including any physical examination to The UC’s second visit with Registrant prescribed controlled substances to the
support a finding that the prescribing of lasted all of three and a half minutes. As UC. 21 CFR 1306.04(a); see also Mich.
both hydrocodone and the Xanax was Dr. Chambers explained, the most Comp. Laws §§ 333.7401(1).
medical necessary to treat the UC. GX substantial questions Registrant asked I also find that Registrant failed to
3–4, 6–7, 9–10. Dr. Chambers explained the UC for evaluating his need for the comply with the Michigan Guidelines,
that Registrant failed to do a proper (hydrocodone and alprazolam, were: and violated both Michigan Law and the
evaluation of the UC’s substance use ‘‘Doing OK?’’ and ‘‘Med went well?’’ CSA in that he acted outside of the
even though he admitted to significant Moreover, Registrant did not perform a usual course of professional practice
alcohol use, did not properly evaluate physical exam during the visit and yet, and lacked a legitimate medical purpose
his psychiatric symptoms even though he again falsified the medical record by when he prescribed controlled
he said he was using Xanax and the noting various exam findings. substances to patients D.S., A.L. and
As for the third visit, Dr. Chambers R.H. 21 CFR 1306.04(a); see also Mich.
(2011) (citing Paul J. Caragine, Jr., 63 FR 51592, noted that Registrant did not address the Comp. Laws § 333.7401(1). As discussed
51601 (1998)); see also Dewey C. MacKay, 75 FR at UC’s statements regarding his drinking above, Dr. Chambers found that there
49974. As Caragine explained: ‘‘[j]ust because and statements that he had run out of was evidence that all three patients
misconduct is unintentional, innocent, or devoid of
improper motive, [it] does not preclude revocation medication and obtained controlled were suffering from drug addiction
or denial. Careless or negligent handling of substances from his neighbor. Dr. which Registrant did not adequately
controlled substances creates the opportunity for Chambers further opined that there was diagnose or treat, and that Registrant’s
diversion and [can] justify’’ the revocation of an essentially no clinical evaluation of the prescribing practices contributed to
daltland on DSKBBV9HB2PROD with NOTICES
existing registration or the denial of an application
for a registration. 63 FR at 51601. UC’s symptoms, illness course or their addiction. With respect to each of
‘‘Accordingly, under the public interest standard, treatment response. Registrant again the chart review patients, Dr. Chambers
DEA has authority to consider those prescribing falsified the visit note by indicating that also found that Registrant ‘‘was
practices of a physician, which, while not rising to the UC ‘‘appears to be in mild pain’’ and prescribing extremely dangerous
the level of intentional or knowing misconduct,
nonetheless create a substantial risk of diversion.’’
‘‘states he is very anxious,’’ as well as combinations of controlled substances
MacKay, 75 FR at 49974; see also Patrick K. Chau, by making physical exam findings of without documenting an appropriate
77 FR 36003, 36007 (2012). ‘‘limited motion, spasm, tenderness,’’ medical context or justification for so
VerDate Sep<11>2014 19:06 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00100 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1](https://thefederalregister.org/doc/83_FR_14091/page/15.svg)
![Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices 14043
doing, and [that he] failed to adequately no physical exams documented in the hereby is, revoked. I further order that
document ongoing examinations and medical records’’ and ‘‘[t]here is no any pending application of Bernard
treatment planning . . . and/or he failed documentation in R.H.’s medical Wilberforce Shelton to renew or modify
to perform these professional functions records demonstrating a legitimate the above registration, as well as any
altogether.’’ GX 33, at 6 (D.S.), 8 (A.L.), medical justification . . . for other pending application for
11 (R.H.). [Registrant’s] prescribing’’ the registration be, and it hereby is, denied.
With respect to D.S., Dr. Chambers ‘‘dangerous combination[s]’’ of This Order is effective immediately.17
found that over the two-year period narcotics, benzodiazepines, and Dated: March 24, 2018.
between January 2014 and February carisoprodol to R.H. GX 33, at 10. Dr. Robert W. Patterson,
2016, there was no evidence in the Chambers also found that R.H.’s urine
Acting Administrator.
patient file that Registrant performed drug screens showed the presence of
physical exams other than to take vital [FR Doc. 2018–06617 Filed 3–30–18; 8:45 am]
controlled substances including
signs and that his treatment plan was amphetamines and benzodiazepines BILLING CODE 4410–09–P
essentially non-existent. He also found that Registrant did not prescribe to him
that D.S.’s chart contained multiples and that Registrant had also
notations that she was suffering from DEPARTMENT OF JUSTICE
documented that R.H. was
addiction but no evidence that overmedicating with respect to Valium. Drug Enforcement Administration
Registrant addressed this with her. Most However, R.H.’s medical record
significantly, as Dr. Chambers observed, contains no indication that Registrant Angela L. Lorenzo, P.A.: Decision and
D.S. provided multiple aberrational resolved these red flags. Order
drug tests which included: (1) The Accordingly, I agree with Dr.
presence of controlled substances which Chambers that Registrant lacked a On December 18, 2017, the Acting
he did not prescribe on six occasions, legitimate medical purpose and acted Assistant Administrator, Diversion
including methadone, buprenorphine, outside of the usual course of Control Division, Drug Enforcement
cocaine, and amphetamines; (2) the non- professional practice when he issued Administration (DEA), issued an Order
presence of controlled substances the various controlled substance to Show Cause to Angela L. Lorenzo,
(oxycodone and morphine) which he prescriptions identified above to D.S., P.A. (Registrant), of Las Vegas, Nevada.
had prescribed on two occasions; and A.L., and R.H. 21 CFR 1306.04(a); 21 The Show Cause Order proposed the
(3) the presence of oxycodone above the U.S.C. 841(a)(1). I also agree with Dr. revocation of Registrant’s Certificate of
recommended therapeutic range on four Chambers that Registrant’s prescribing Registration No. ML0901985 on the
occasions. Yet there is no evidence that to D.S., A.L. and R.H. violated Mich. ground that she lacks ‘‘authority to
Registrant addressed any of these Comp. Laws § 333.7401(1) and did not handle controlled substances in the
aberrational test results with D.S. comply with the Michigan Guidelines. State of Nevada, the State in which [she
As for A.L., Dr. Chambers found that I thus conclude that Registrant’s is] registered with the DEA.’’ Order to
‘‘for the most part,’’ Registrant did not multiple violations of 21 CFR 1306.04 Show Cause, Government Exhibit (GX)
document the performance of a physical (a), 21 U.S.C. 841(a)(1), and Mich. A–3, at 1 (citing 21 U.S.C. 824(a)(3)).1
exam and there is no documentation in Comp. Laws § 333.7401(1) are egregious For the same reason, the Order also
the patient file to support Registrant’s and support the conclusion that he ‘‘has proposed the denial of any of
prescribing of the combinations of committed such acts as would render Registrant’s ‘‘pending applications for a
narcotics, benzodiazepines, and his registration . . . inconsistent with new registration or for renewal.’’ Id.
carisoprodol that he did. GX 33, at 7. the public interest.’’ 21 U.S.C. With respect to the Agency’s
Moreover, A.L.’s MAPS report showed 824(a)(4).16 I therefore conclude that the jurisdiction, the Show Cause Order
that she had seen eight other providers Government’s evidence with respect to alleged that Registrant is registered as a
in the year prior to her first visit with Factors Two and Four makes out a practitioner in schedules II through V,
Registrant and that she had obtained prima facie case for revoking his pursuant to DEA Certificate of
controlled substances on 50 occasions 15 existing registration and denying any Registration No. ML0901985, at the
which included hydrocodone, applications for a new registration. As address of 811 N Buffalo Road, Suite
oxymorphone, oxycodone, morphine, Registrant has waived his right to a 113, Las Vegas, Nevada. Id. at 1–2. The
diazepam, alprazolam and amphetamine hearing or to submit a written statement Order also alleged that this registration
based on prescriptions issued by these of position, there is no evidence to
providers. Moreover, at her first visit refute the conclusion that his 17 Based on the egregious nature of Respondent’s
with Registrant, A.L. reported that she registration is inconsistent with the prescribing violations, I conclude that the public
was taking the Trinity of oxycodone, public interest. I will therefore order interest necessitates that this Order be effective
Xanax, and Soma, and while at one that Registrant’s remaining registration immediately. 21 CFR 1316.67.
1 The Show Cause Order also proposed that
point, Registrant even documented that be revoked and that any pending Registrant’s DEA registration should be revoked
A.L. stated that she was buying drugs off application be denied. because she ‘‘committed acts which render [her]
the street, Registrant did not address registration inconsistent with the public interest.’’
this aberrant behavior. Moreover, as Dr. Order GX 3, at 1 (citing 21 U.S.C. 823(f), 824(a)(4)).
Chambers observed, her chart is devoid Pursuant to the authority vested in me However, the Government did not include evidence
to support this allegation with its Request for Final
of evidence that she was monitored by 21 U.S.C. 823(f) and 824(a), as well Agency Action (RFFA). Instead, the Government
through the use of urine drug screens. as 28 CFR 0.100(b), I order that DEA requested ‘‘leave to supplement its [R]equest to
daltland on DSKBBV9HB2PROD with NOTICES
See GXs 18–20. Certificate of Registration No. include the grounds for revocation under 21 U.S.C.
With respect to R.H., Dr. Chambers FS6457407 issued to Bernard 823(f), 824(a)(4)’’ should Registrant ‘‘regain her
Nevada state license during the pendency of this
found that ‘‘[f]or the most part there are Wilberforce Shelton, M.D., be, and it Request for Final Agency Action.’’ RFFA at 1 n.1.
The Government has not filed a request to
15 In some instances, she obtained the controlled 16 This provides a separate and independent supplement its RFFA, apparently because
substances through a refill of a previously issued ground from the finding that he does not currently Registrant has not regained her Nevada state
prescription. See, e.g., GX 18, at 32 (alprazolam possess state authority for revoking his registration medical license. Accordingly, I do not consider the
refill); id. at 33–34 (refills of hydrocodone). and denying his application. Government’s public interest allegation.
VerDate Sep<11>2014 19:06 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00101 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1](https://thefederalregister.org/doc/83_FR_14091/page/16.svg)
Document Created: 2018-11-01 09:09:04
Document Modified: 2018-11-01 09:09:04
| 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 | 83 FR 14028 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR