Garrett Howard Smith, M.D.; Decision and Order, 18882-18911 [2018-09020]

Download as PDF 18882 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 16–25] sradovich on DSK3GMQ082PROD with NOTICES2 Garrett Howard Smith, M.D.; Decision and Order On June 13, 2016, the Deputy Assistant Administrator, of the then Office of Diversion Control, issued an Order to Show Cause to Garrett Howard Smith, M.D. (hereinafter, Respondent), of Southfield, Michigan. ALJ Ex. 1, at 1. The Show Cause Order proposed the revocation of Respondent’s Certificate of Registration, the denial of any pending applications to renew or modify his registration, and the denial of any applications for any other registration, on the ground that his ‘‘registration is inconsistent with the public interest.’’ Id. (citing 21 U.S.C. 824(a)(4) & 823(f)). With respect to the Agency’s jurisdiction, the Show Cause Order alleged that Respondent is registered as a practitioner in schedules II through V, pursuant to Certificate of Registration No. FS2592005, at the registered address of 29193 Northwestern Highway, Suite 571, Southfield, Michigan. Id. The Order also alleged that Respondent’s ‘‘registration expires by its terms on February 28, 2017.’’ Id. As to the substantive grounds for the proceeding, the Show Cause Order alleged that Respondent ‘‘failed to comply with Federal and state laws relating to the prescribing of controlled substances by issuing purported ‘prescriptions’ outside the usual course of professional practice or for other than a legitimate medical purpose.’’ Id. at 2 (citing 21 U.S.C. 841(a), 21 CFR 1306.04, Mich. Comp. Laws §§ 333.7333(1), (3), & (4), 333.7405(1)(a)). The Show Cause Order then alleged that in three instances, Respondent unlawfully prescribed controlled substances to two undercover investigators (hereinafter, BCI 1 and BCI 2) for Blue Cross/Blue Shield of Michigan. Id. at 2–3. As to the first such instance, the Show Cause Order alleged that on February 19, 2015, Respondent prescribed to BCI 1, 65 dosage units of Norco 7.5/325 mg (hydrocodone), a schedule II controlled substance, as well as 60 Xanax .5 mg (alprazolam) and 30 Soma 350 mg (carisoprodol), the latter two drugs being schedule IV controlled substances. Id. at 2. The Show Cause Order also alleged that each of the prescriptions did not include information required under 21 CFR 1306.05(a) and (f), as they did not contain the patient’s address. Id. As to the second instance, the Show Cause Order alleged that on March 19, VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 2015, BCI 1 returned to Respondent’s office ‘‘for a follow-up visit’’ and that Respondent again provided him with prescriptions for 65 dosage units of Norco 7.5/325 mg, 60 Xanax .5 mg, and 30 Soma 350 mg. Id. at 2–3. The Order again alleged that each of the prescriptions did not include information required under 21 CFR 1306.05(a) and (f), as they did not contain the patient’s address. Id. at 3. As to the third instance, the Show Cause Order alleged that on March 19, 2015, BCI 2 ‘‘presented for an office visit at’’ Respondent’s office and ‘‘asked for refills of . . . prescriptions for Norco and Soma previously issued by another physician at the clinic . . . on February 20, 2015.’’ Id. at 3. The Order alleged that Respondent issued BCI 2 prescriptions for 60 Norco 5/325 mg and 60 Soma 350 mg. Id. The Order again alleged that each prescription did not include information required under 21 CFR 1306.05(a) and (f), as they did not contain the patient’s address.1 Id. The Show Cause Order notified Respondent of his right to request a hearing on the allegations or to submit a written statement of position while waiving his right to a hearing, the procedure for electing either option, and the consequence of failing to elect either option. Id. at 3–4. The Show Cause Order also notified Respondent of his right to submit a corrective action plan pursuant to 21 U.S.C. 824(c)(2)(C). Id. at 1, 4. On July 13, 2016, Respondent, through his counsel, requested a hearing on the allegations. ALJ Ex. 2. The matter was placed on the docket of the Office of Administrative Law Judges and assigned to Chief Administrative Law Judge John J. Mulrooney, II (hereinafter, CALJ), who conducted pre-hearing procedures. ALJ Ex. 3. Following prehearing procedures, the CALJ conducted an evidentiary hearing on November 29–30, 2016 in Detroit, Michigan, after which both parties submitted briefs containing their proposed findings of fact and conclusions of law. Recommended Decision, at 2. Moreover, while the matter was pending the issuance of the Recommended Decision, the Government notified the CALJ that, on December 16, 2016, the Director of the Michigan Department of Licensing and Regulatory Affairs Bureau of Professional Licensing temporarily suspended his medical license thus rendering him without authority to 1 The Show Cause Order also made detailed factual allegations as to various acts performed by Respondent and the office staff as well as the statements made by Respondent and the Investigators at each of the visits. ALJ Ex. 1, at 2–3. PO 00000 Frm 00002 Fmt 4701 Sfmt 4703 handle controlled substances in the State of Michigan. Id. at 86. On February 8, 2017, the CALJ issued his Recommended Decision. Therein, the CALJ found proved the allegations that all of the prescriptions issued to both undercover investigators ‘‘were issued outside of the usual course of professional practice, for no legitimate medical purpose, and outside the professional standards of a Michigan controlled substance prescriber.’’ Id. at 80 (Feb. 19, 2015 prescriptions issued to BCI 1); see also id. at 82 (Mar. 19, 2015 prescriptions issued to BCI 1); id. at 84 (Mar. 19, 2015 prescriptions issued to BCI 2). The CALJ further noted that ‘‘the record evidence of the three undercover visits under Factors 2 and 4 militates powerfully in favor of the revocation sanction sought by the Government.’’ Id. at 85. The CALJ also found proved the allegations that Respondent failed to include the patient’s addresses on each of the eight prescriptions he issued to the two undercover investigators. Id. The CALJ further found that Respondent’s failure to include the addresses violated 21 CFR 1306.05(a) and (f) and that these violations ‘‘weigh in some support of a sanction under Public Interest Factor 4.’’ Id. at 85–86. Finally, the CALJ found that ‘‘the parties have stipulated that the Respondent’s Michigan medical license is currently suspended.’’ Id. at 90. The CALJ rejected Respondent’s claim that his lack of state authority could not be ‘‘properly considered against him in this matter because the allegation was not included in the’’ Show Cause Order. Id. at 86. The CALJ explained that notwithstanding the lack of notice in the Show Cause Order or the pleadings, ‘‘the Respondent here was put on notice of this essentially legal issue, and has had an opportunity to respond to the allegation that he lacks state authority.’’ Id. at 88. The CALJ also rejected Respondent’s contention that the Director of the Department of Licensing and Regulatory Affairs ‘‘is not ‘a competent state authority’ ’’ within the meaning of 21 U.S.C. 824(a)(3) because he ‘‘ ‘does not have the ability to suspend, revoke, or otherwise discipline a license without a full vote of the Disciplinary Subcommittee,’ ’’ noting that Respondent ‘‘concede[d] that the Director does have authority to summarily suspend’’ and that, under agency precedent, the issue is whether he is currently authorized under state law to dispense controlled substances. Id. at 89. The CALJ thus found that because ‘‘Respondent does not presently possess the requisite authority to maintain his DEA registration, Agency E:\FR\FM\30APN2.SGM 30APN2 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices precedent ‘‘compels the revocation of ’’ his registration. Id. at 90. The CALJ also addressed whether Respondent’s prescribing of controlled substances supported a sanction. Noting that ‘‘the Government has met its prima facie burden of proving that the requirements for revocation or suspension . . . are satisfied,’’ the CALJ found that Respondent did not ‘‘offer[ ] an unequivocal acceptance of responsibility,’’ that he ‘‘offered excuses for his conduct that smacked more of contrivance than contrition, and lacked any present indication of remedial steps beyond not desiring to practice pain medicine in the future.’’ Id. at 91. While noting that ‘‘the actual tally of transgressions on the present record is by no means overwhelming,’’ and that ‘‘had this record presented a registrant who signaled at least some indication that he had committed serious errors in judgment, a persuasive argument could be made for a sanction short of revocation,’’ the CALJ explained that this ‘‘was not the case here.’’ Id. at 92. The CALJ then concluded that ‘‘the issue of [specific] deterrence favors revocation of the Respondent’s [registration] because he still remains committed to the concept that he acted within the bounds of his responsibilities as a registrant.’’ Id. The CALJ subsequently observed that: sradovich on DSK3GMQ082PROD with NOTICES2 [i]t was clear in the undercover recordings that this Respondent was not engaging in a thorough physical examination or asking probing, sincere questions regarding symptoms present in the two undercover investigators that would warrant pain medicine; he was merely exchanging a few pleasantries and going through some meaningless motions prior to doling out the medications that he knew he was giving-and the patients knew they were getting-from the moment they walked into the office. Specific deterrence is best served by revocation here. Id. at 92–93. With respect to the Agency’s interest in general deterrence, the CALJ concluded that ‘‘[t]o impose a sanction short of revocation on these facts would send a message to the regulated community that the plausible deniability that comes from walking into a practice as a locum tenens with no preparation can act as a shield to insulate a practitioner from consequences for failing to execute the responsibilities of a DEA registration in deterring diversion. . . . [A] sanction that falls short of revocation here . . . would communicate to the regulated community that there is no meaningful consequence to handing out powerful medications based on little more than small talk.’’ Id. at 93. VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 The CALJ also concluded that Respondent’s misconduct ‘‘does not present a picture of a lack of due care borne of a harried physician keeping up with the demands of practice, or an isolated blunder that has its genesis in lack of training; but rather, . . . measured, calculated decisions to issue powerful controlled substances backed up by little more than incomplete charts, vague answers, and casual banter and made in the face of talk of trading drugs and the street value of the medications.’’ Id. Continuing, the CALJ explained that ‘‘[f]or a DEA registrant, the answer to a deficit of records and questionable patient responses cannot be to prescribe anyway and sort matters out at some future date.’’ Id. at 93–94. The CALJ thus concluded that Respondent’s misconduct ‘‘was sufficiently egregious to merit the sanction of revocation.’’ Id. The CALJ recommended that Respondent’s registration be revoked and that any pending application for renewal be denied. Id. Neither party filed exceptions to the CALJ’s Recommended Decision. Thereafter, the CALJ forwarded the record to my Office for Final Agency Action. Having considered the record in its entirety, I adopt the CALJ’s factual findings including his credibility determinations, his conclusions of law, and his recommendation that I revoke Respondent’s registration and deny any pending application to renew his registration. I make the following factual findings. Findings of Fact Respondent is a medical doctor licensed by the Michigan Board of Medicine. While on December 13, 2016, the Board summarily suspended Respondent’s medical license, on February 16, 2017 (eight days after the CALJ issued his Recommended Decision and well before the record was forward to my Office), the Board’s Disciplinary Subcommittee and the Board entered into a Consent Order and Stipulation with Respondent.2 Under the Consent 2 I take official notice of the Consent Order and Stipulation entered by Respondent with the Board on February 16, 2017. See 5 U.S.C. 556(e). The parties are entitled to refute the findings based on the Consent Order and Stipulation by filing a properly supported motion for reconsideration within 10 business days of the issuance of this decision. It is further noted that while the CALJ’s order directing the parties to ‘‘provide timely updates to this tribunal regarding any developments’’ pertaining to the status of Respondent’s state license lapsed upon issuance of the Recommended Decision, ALJ Ex. 29, it is perplexing that neither party notified this Office that the summary suspension had been dissolved on February 16, 2017. PO 00000 Frm 00003 Fmt 4701 Sfmt 4703 18883 Order, the Board found ‘‘that the allegations of fact contained in the complaint are true and that Respondent has violated section 16221(a) of the Public Health code.’’ Id. at 2. As a consequence, the Board placed Respondent on probation for a period of two years from the effective date of the Order. Id. As one of the terms of the Consent Order, Respondent agreed that he ‘‘shall not obtain, possess, prescribe, dispense or administer any drug designated as a controlled substance under the Public Health Code or its counterpart in federal law except in a hospital or other institutional setting.’’ Id. In addition to imposing a variety of additional probationary terms, the Board fined Respondent $7,500. Id. at 5. The parties, however, also agreed to the dissolution of the summary suspension. Id. at 1. Respondent also previously held DEA Certificate of Registration No. FS2592005, pursuant to which he was authorized to dispense controlled substances in schedules II through V, at the registered address of 29193 Northwestern Hwy., Suite 571, Southfield, Michigan. R.D. 3 (Stipulation of Fact No. 1). The expiration date of this registration was February 28, 2017. Id. According to the registration records of this Agency, of which I also take official notice, Respondent did not submit a renewal application until March 16, 2017, after the expiration date of his registration. I therefore find that Respondent’s renewal application was untimely and that his registration expired on February 28, 2017. See 21 CFR 1301.36(i). I further find, however, that Respondent’s March 16, 2017 application remains pending before the Agency.3 See Paul Volkman, 73 FR 30641, 30644 (2008), pet. for rev. denied, Volkman v. DEA, 567 F.3d 215, 225 (6th Cir. 2009). The Investigation of Respondent This investigation arose out of the investigation of another physician (Dr. Vora), who, the Chief of Police of Gladwin, Michigan suspected was issuing prescriptions that lacked a legitimate medical purpose. Tr. 37. Because the physicians in the town knew local police officers 4 and the officers could not ‘‘do any undercover work,’’ an officer with the Gladwin Police Department contacted James 3 The parties are also entitled to refute the findings with respect to Respondent’s registration status and application by filing a properly supported motion for reconsideration within 10 business days of the issuance of this decision. 4 According to the Chief of the Gladwin Police Department, the Department has four full-time officers and six part-time officers. Tr. 21. E:\FR\FM\30APN2.SGM 30APN2 18884 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices Howell, an investigator for Michigan Blue Cross/Blue Shield (hereinafter, BC) who the Chief had met at a state drug diversion conference, as they had ‘‘the tools to do’’ undercover work. Id. at 21. Mr. Howell (hereinafter, BCI 1 5) agreed to assist the Gladwin Police by performing undercover visits to Dr. V’s clinic; Jill Kraczon, a second BC Investigator (hereinafter, BCI 2 6) also made several visits to the clinic. sradovich on DSK3GMQ082PROD with NOTICES2 BCI 1’s Visits Using the name of James Howard, on November 10, 2014, BCI 1 made his first visit to the clinic. There, he completed an authorization for the release of his records from one Dr. Lindsay, a ‘‘Controlled Substances Management Agreement,’’ a Medical History Form (on which he did not check any of the symptoms but did list Xanax as a medication he was currently taking), as well as other forms including one on which he noted that the reason for his visit was ‘‘refills.’’ GX 10, at 14, 16–17, 19–20. At this visit, BCI I saw Dr. Vora. GX 10, at 5–6. Dr. Vora created a visit note which documented BCI 1’s chief complaints as including anxiety, back pain, and back stiffness; the note also listed vital signs, a history, a review of systems and various physical examination findings. Id. at 5. However, the physical exam section contained no findings as to the Investigator’s back. Id. Nor were there any findings as to the Investigator’s psychiatric condition. As the treatment plan, Dr. Vora simply noted ‘‘Follow Up’’ and ‘‘After 1 month(s).’’ Id. at 5–6. Although the progress note for this visit does not list any prescriptions, the patient file includes copies of prescriptions issued by Dr. Vora to BCI 1for 60 Norco 7.5 mg and 60 Xanax 0.5 mg which are dated ‘‘11–10–14.’’ Id. at 21. BCI 1’s patient file also includes a copy of a report from 5 Mr. Howell (BCI 1) had previously been employed by the Lincoln Park, Michigan Police Department for twenty-three years, where he did ‘‘all type[s] of police work including uniform patrol, detective work, undercover work, [and] violent crime investigations,’’ retiring with the rank of lieutenant. Tr. 58. He testified that he had ‘‘attended a basic drug diversion school’’ which ‘‘was put on by the National Association of Drug Diversion Investigators,’’ as well as ‘‘over 40 hours of training in other drug diversion seminars.’’ Id. at 58–59. 6 Ms. Kraczon (BCI 2) testified that prior to working for BC she had been a police officer with the Lansing Police Department for 16 years and that she had done undercover work for the last three years of her employment with the Department which included ‘‘over prescribing doctor cases.’’ Tr. 190. She also testified that she had professional training with the National Association of Drug Diversion Investigators, as well as in-house training with Blue Cross, and had ‘‘done over 100 undercovers at Blue Cross.’’ Id. VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 the Michigan Automated Prescription System dated ‘‘10/20/2014.’’ Id. at 23. It shows that James Howard had obtained alprazolam from four different providers, including one in Marquette, one in Detroit, and two with different addresses in Flint; the report also shows that one of the providers from Flint had also prescribed amphetamines to Howard. Id. On December 15, 2014, BCI 1 again saw Dr. Vora, who noted that the former’s ‘‘[p]roblem [l]ist’’ included both back pain and anxiety (both with an onset date of ‘‘12/15/2014’’), as well as generalized anxiety disorder and lumbar paraspinal muscle spasm. Id. at 3. In the Review of Systems section of the visit note, Dr. Vora made negative findings 7 except for with respect to ‘‘lower back pain’’ and ‘‘endocrinology anxiety.’’ Id. In the physical examination section, Dr. Vora documented findings of ‘‘lumbar spine point tenderness,’’ ‘‘TTP L/S spine, pain with flexion/extension[,] Negative SLR [straight leg raise], No weakness with Toe/Heel walk b/l).’’ Id. at 4. Dr. Vora listed diagnoses of generalized anxiety disorder and lumbar paraspinal muscle spasm. Id. His treatment plan included an X-Ray of the Investigator’s lumbar spine, a recommendation to BCI 1 to ice his back for 20 minutes two to three times per day, and four prescriptions, including for 60 Norco 7.5/325 mg, 60 Xanax .5 mg, and two non-controlled drugs. Id. On January 12, 2015, BCI 1 again saw Dr. Vora. Id. at 1. In the Review of Systems section of the visit note, Dr. Vora indicated the existence of musculoskeletal joint pain, muscle pain, lower back pain, back pain, and endocrinology anxiety. Id. However, in contrast to the previous visit note, there are no physical exam findings related to the Investigator’s back pain. Id. at 1–2. Nor are there any findings related to BCI 1’s anxiety. Id. Although the Treatment Plan section of the visit lists Zithromax Z-Pak as having been prescribed at this visit, it does not list any controlled substances as having been prescribed on this date. Id. at 2. Nonetheless, both Norco and Xanax are listed in the visit note under the ‘‘Reconciled Medications’’ and the patient file includes two prescriptions that were copied onto the same page: One for 66 Xanax (pill strength unclear) and one for 66 Norco 7.5/325 mg.8 Id. at 10. 7 These negative findings included ‘‘Psychiatry depression.’’ GX 10, at 3. 8 While only the full date of the Norco prescription is clear, the year of the Xanax prescription is listed as ‘‘15,’’ and both prescriptions were written on Dr. Vora’s prescription forms. GX 10, at 10. Respondent was PO 00000 Frm 00004 Fmt 4701 Sfmt 4703 On February 19, 2015, BCI 1 returned to the clinic where he finally saw Respondent. After checking in and waiting for two hours, BCI 1 was required to provide a urine sample for drug testing after which he was taken to an exam room where a medical assistant took his blood pressure and told him to wait for Respondent. Tr. 66, 69. Respondent entered the exam room and after he and BCI 1 exchanged pleasantries, Respondent asked: ‘‘what brings you here? What hurts you?’’ to which BCI 1 replied that he had come back for refills’’ and had ‘‘been seeing Dr. Vora here.’’ GX 3, at 5. Respondent then asked BCI 1 what he was ‘‘getting the medication for?’’ Id. BCI 1 stated: ‘‘I take Norco for my back and I take Xanax on the weekends,’’ prompting Respondent to ask: ‘‘Okay so you have back pain and some anxiety?’’ Id. BCI 1 replied, ‘‘I guess.’’ Id. Respondent asked BCI 1 when his other doctor was ‘‘going to be here,’’ to which the latter stated that he didn’t know. Id. at 5–6. Respondent then asked BCI 1 why he needed a Z-Pak (Zithromax) and if he had had an infection?; BCI 1 answered that he ‘‘didn’t get one,’’ prompting Respondent to ask: ‘‘You didn’t take it-any? Because it says.’’ Id. at 6. BCI 1 answered that while he ‘‘saw some paperwork for that,’’ he ‘‘didn’t get it,’’ stated that he was ‘‘cool,’’ and denied that he was sick. Id. BCI 1 then asked Respondent if he was taking over for Dr. Vora. Id. Respondent replied that he did not know, that it was his ‘‘first time’’ at the clinic and ‘‘in this area ever,’’ that he was from East Lansing,’’ and that the Gladwin area was very rural and a lot different. Id. at 6–7. After determining the Investigator’s age (44), Respondent asked BCI 1 how long he had had back pain; the latter answered: ‘‘probably ten years. Mostly just stiff.’’ Id. at 7. Respondent then asked BCI 1 if he got ‘‘any muscle spasms with the pain?’’ Id. BCI 1 replied: ‘‘I don’t know. It[ ] gets like tight . . . so I don’t know. I don’t know—I don’t know what the word is for that. Stiff.’’ Id. After a discussion about Respondent’s being left-handed, Respondent asked the Investigator: ‘‘[d]o you ever have to walk with a limp because your pain gets so bad?’’ Id. at 8. BCI 1 replied that ‘‘I strut a little bit. Does that count?’’ and added that ‘‘I got a little flavor to my stroll.’’ Id. Respondent then asked BCI 1 if he had ever fallen, BCI 1 answered in the affirmative, whether he ‘‘had any loss of the only other physician seen by the Investigator at this clinic in 2015. E:\FR\FM\30APN2.SGM 30APN2 sradovich on DSK3GMQ082PROD with NOTICES2 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices muscle strength?’’ to which BCI 1 stated that he was ‘‘just getting older’’ and was not ‘‘a young buck,’’ followed by his asking Respondent ‘‘are you a back doctor?’’ Id. Respondent answered that he ‘‘actually [does] procedures’’ and ‘‘reads MRI’’ and ‘‘CT scans.’’ Id. at 8–9. Respondent then asked BCI 1 to stand up, turn around, and ‘‘point to one spot in your back that hurts the most?’’ Id. BCI 1 pointed to the small of his lower back, about two inches above his tail bone, Tr. 164–65, and stated: ‘‘[m]ostly just stiff. Right there.’’ GX 3, at 9. Id. BCI 1 testified that when this occurred he was wearing outdoor winter clothing which he did not take off.9 Tr. 73. BCI 1 also testified that Respondent did not palpate the area of his back that he pointed to, and that neither he nor Respondent lifted up the clothing that he was wearing. Id. at 175. Respondent asked if the pain ‘‘shot anywhere’’ or ‘‘is it just localized?’’ GX 3, at 9. BCI 1 stated that ‘‘[i]t’s localized.’’ Id. Respondent then had BCI 1 hold out his arms, and as Respondent held the top of BCI 1’s arms, Tr. 166– 67, he had BCI 1 push up and then push down. GX 3, at 9. Notably, as he performed these tests, Respondent did not ask BCI 1 if either one caused pain and BCI 1 did not complain that either test caused pain. Id.; see also GX 3, Video 5, at 14:48:06–12. Thereafter, Respondent told BCI 1 to have a seat and asked if he smoked or used marijuana; BCI 1 answered ‘‘[n]ope’’ to both questions. GX 3, at 9. Next, Respondent asked BCI 1 if he was a social drinker. Id. BCI 1 answered in the affirmative and added: ‘‘That’s why I take the Xanax. Because when I do that it keeps me from drinking too much moonshine on the weekends.’’ Id. BCI 1 then asked Respondent if he ‘‘like[d] moonshine’’; Respondent answered in the negative and added that he ‘‘heard its very strong.’’ Id. BCI 1 agreed and said: ‘‘But, y[ou] know, if I take those Xanax[,] I’m cool with it.’’ Id. Respondent asked BCI 1 what he did on the weekends ‘‘[a]round here?’’ BCI 1 replied: ‘‘Yeah. I go—I leave. I go to East Lansing with you and kick it at the club. Nah. There’s not a lot going on. I like outdoors stuff myself.’’ Id. at 9–10. Respondent and BCI 1 then discussed a variety of topics including hunting, whether Respondent would be coming to the clinic on a ‘‘steady’’ basis, where 9 While the video reflects the presence of an item of clothing which BCI 1 brought with him and which he was not wearing during his visit with Respondent, BCI 1 testified that ‘‘normally,’’ he wears multiple layers and that ‘‘[d]uring the exam, I had a hooded sweatshirt and some type of coat [or vest] over it.’’ Tr. 174. VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 else Respondent worked, where BCI 1 had lived, and the traffic in the Washington, DC area, where Respondent had done his residency. Id. at 10–12. Respondent told BCI 1 that he was going to prescribe an ‘‘additional medication for [his] muscle spasm[,] Soma,’’ prompting the latter to say ‘‘[p]erfect.’’ Id. at 12. Respondent then asked BCI 1 if he had high blood pressure or diabetes; the latter answered ‘‘No’’ to both questions. Id. After a lengthy discussion of the recent Super Bowl, the conversation turned to whether Respondent had any other offices and worked for himself. Id. at 12–14. Respondent answered that he worked in East Lansing and that he was ‘‘on a contract’’ and ‘‘share[d] in the profits,’’ after which he turned to discussing the hassle of getting insurance companies to pay for medication. Id. at 14. While BCI 1 said that he had not ‘‘had that problem’’ but had ‘‘heard about it,’’ Respondent replied that ‘‘[i]ts crazy’’ and ‘‘[t]hose guys are making bank.’’ Id. Continuing, Respondent added that ‘‘I’d imagine these scripts right here that you are going to get would be like 6 or 7 hundred dollars. You know the pharmaceutical company are [sic] making bank.’’ Id. BCI 1 commented: ‘‘Big cheese involved in that, ain[’]t there?’’ Id. Respondent answered: ‘‘Right,’’ prompting BCI 1 to state: ‘‘Wonder why that is. They’re worth a lot of money on the street.’’ Id. Respondent then explained: ‘‘That’s the whole point. They’re pure. You know there is nothing cut down about them. So when you’re selling them—its like you know—the person buying—legit.’’ Id. BCI 1 replied ‘‘Right[,] Yeah,’’ and Respondent added: ‘‘Its not cut or anything like that. That’s one reason.’’ Id. at 15. BCI 1 then noted: ‘‘Well, it’s a little safer to do it that way. You know what I mean,’’ prompting Respondent to say ‘‘Right.’’ Id. BCI 1 then told Respondent that ‘‘[a] couple of time I ran out of pills’’ and had to ‘‘trade with my neighbor.’’ Id. Respondent remarked: ‘‘You did? Was it an equal trade?’’ to which BCI 1 answered: ‘‘Yeah. It was—like I just asked Dr. Vora for a couple extra. . . . And then I just gave them back to old boy.’’ Id. Respondent stated ‘‘okay,’’ and BCI 1 stated: ‘‘So we’re cool. He wrote it for 66. I said I don’t think they will fill that[.] [H]e said oh yeah they’ll fill it for me. They did. Do they fill odd numbers like that? They did for me.’’ Id. Respondent replied: ‘‘Yeah. I mean they can fill it. He probably should have maybe said 65,’’ prompting BCI 1 to say PO 00000 Frm 00005 Fmt 4701 Sfmt 4703 18885 ‘‘Oh.’’ Id. Laughing, Respondent stated: ‘‘66 you know, 65, 70, you know, something like that. But 66 what’s that about?’’ Id. BCI 1 then stated: ‘‘Yeah. Because I can’t be paying—buying them on the street. You know what I mean?’’ Id. Respondent stated ‘‘Right’’ and BCI 1 stated: ‘‘that’s why I got good—this insurance I got is the whip. . . . I got Blue Cross. I figure I’d use it.’’ Id. Respondent replied: ‘‘Right. They’ll pay for it,’’ and BCI 1 stated that he would use the insurance ‘‘while I can.’’ Id. Respondent stated ‘‘okay’’ and added: ‘‘So what I did is I re-wrote your Xanax, your Norco and your—and Soma.’’ Id. BCI 1 replied: ‘‘Sweet. Thanks doctor,’’ after which Respondent and BCI 1 discussed the timing of his next appointment (‘‘in a month’’) and the visit ended. Id. at 15–16. In the progress note for this visit, Respondent wrote in the ‘‘subjective’’ section that BCI 1 had ‘‘DDD [degenerative disc disease] for approximately 10 years. Pt does have associated muscle spasm.’’ GX 10, at 31. Respondent also noted physical exam findings which included: ‘‘Slight limp that favors RLE [Right Lower Extremity],’’ ‘‘Moderate point tenderness to low back that is localized,’’ ‘‘Good muscle tone, ‘‘5/5 Muscle Strength,’’ ‘‘CN IV—XII intact,’’ and ‘‘Oriented x 3.’’ Id. Respondent noted diagnoses of ‘‘DDD,’’ ‘‘Etoh’’ or Ethyl Alcohol,’’ and ‘‘Anxiety.’’ Id. The visit note lists three prescriptions: (1) 65 dosage units of Norco (hydrocodone and acetaminophen) 7.5/325 mg; (2) 60 dosage units of Xanax 0.5 mg; and (3) 30 dosage units of Soma (carisoprodol) 350 mg. Id. The Investigator’s patient file contains copies of each of these prescriptions. Id. at 29–30. Respondent did not include BCI 1’s address on the prescriptions. See id; see also GX 4, at 1–3. The patient file also includes the lab report for the urine sample provided by BCI 1 at this visit. Id. at 24–25. While the urine sample was not received by the lab until February 23, 2015 and the test results were not certified until the next day, BCI 1 was negative for every drug listed on the result form, including alprazolam and hydrocodone, which had been prescribed to him by Dr. Vora at the previous visit. Id. at 24–25; 10. On March 19, 2015, BCI 1 returned to the clinic and again saw Respondent. Tr. 81. After completing various forms and providing another urine sample, BCI 1 was taken to an exam room. Id. at 84. Upon Respondent’s entering the room, he and BCI 1 greeted each other, engaged in a short discussion of the E:\FR\FM\30APN2.SGM 30APN2 sradovich on DSK3GMQ082PROD with NOTICES2 18886 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices NCAA basketball tournament, after which, Respondent asked: ‘‘So how has everything been going with your pain?’’ GX 5, at 3–4. BCI 1 replied: ‘‘Great. Yup everything is cool.’’ Id. at 4. Respondent said ‘‘Ok[,] alright,’’ and BCI 1 stated: ‘‘I just pretty much need refills. I am easy. You got a special on old people today it looks like. Problem is I am one of them.’’ Id. Respondent directed BCI 1 to ‘‘just walk back and forth for me’’ and told him to ‘‘just point to where it hurts in your back.’’ Id. BCI 1 stated that ‘‘I just got stiffness pretty much like right down there,’’ and pointed to a spot about two inches above his tailbone in the middle of his back. Tr. 181. Respondent then asked: ‘‘Does it go to your leg or anything?’’ and BCI 1 replied: ‘‘No just like . . . you know.’’ GX 5, at 4. Respondent had BCI 1 hold out his arms and had BCI 1 push up and down. Id. Here again, Respondent did not ask BCI 1 if either test caused pain and BCI 1 did not complain that either test caused pain. Id. Instead, upon completion of this test, Respondent asked: ‘‘so how would you rate your pain on a scale of 1–10 today?’’ Id. BCI 1 replied: ‘‘I am good today. I am good today.’’ Id. Respondent then told BCI 1 that he was ‘‘going to just refill [his] prescriptions’’ to which BCI 1 replied: ‘‘Ok that is perfect. Straight. I am good then.’’ Id. Respondent stated: ‘‘Yeah you are good.’’ Id. BCI 1 thanked Respondent and said he would see him in a month, and after Respondent determined that BCI 1 had provided a urine sample, the visit ended. Id. Respondent wrote in the subjective section of the visit note that BCI 1 had ‘‘DDD For approximately 10 yrs’’ and that ‘‘Pt has associated muscle spasm [with] lbp’’ or lower back pain. Id. at 32. In the note’s physical exam section, Respondent documented findings which included ‘‘[w]alks [with] a slight limp that Favors RLE,’’ ‘‘Moderate point tenderness to low back that is localized,’’ ‘‘CN [illegible]—XII intact,’’ ‘‘5/5 Muscle Strength,’’ ‘‘good muscle tone,’’ ‘‘2+ pulses throughout,’’ ‘‘2/2 reflexes Full ROM.’’ Id. As for his diagnoses, Respondent noted: ‘‘DDD—Lumbar,’’ ‘‘Etoh,’’ ‘‘Anxiety,’’ and ‘‘Muscle Spasm.’’ Id. Respondent also documented the issuance of prescriptions for 65 dosage units of Norco 7.5/325 mg, 60 Xanax 0.5 mg, and 30 Soma 350 mg. Id. While the patient file includes copies of only the Xanax and Soma prescriptions, see generally GX 10, the Government submitted a separate exhibit which contains a copy of all three prescriptions issued by Respondent at VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 this visit including the Norco prescription. See GX 6, at 1–3. Respondent also failed to include BCI 1’s address on these prescriptions. See id. BCI 2’s Visit to the Clinic Using the name Noelle Garcia, the second BC Investigator also made several visits to Dr. Vora’s clinic. At her first visit (January 21, 2015), BCI 2 completed various forms including a medical history form on which she did not check any symptoms or conditions but listed Norco, Ambien and Xanax as medications she was currently taking. GX 11, at 10. Her file also includes a Michigan Automated Prescription System report (dated ‘‘1/12/2015’’), which shows that Noelle Garcia, whose residence was reported as being in Grand Rapids, had last obtained controlled substance prescriptions eight months earlier on May 13, 2014 from a Nurse Practitioner in Flint. Id. at 15. The report also showed that the prescriptions were for 60 hydrocodone/ apap 5/325 mg, 60 alprazolam .25 mg, and 30 zolpidem 5 mg. Id. At the visit, BCI 2 saw Dr. Vora, who documented in the visit note that she: [p]resents with complaints of chronic back pain, anxiety and inability to sleep through a night. States has been taking Norco, Ambien and Xanax for years. States that her back pain fluctuates and today rates pain 0/ 10. States has tried physical therapy and states it helped temporarily and would like referral to physical therapy again, has not seen PT in over three years. Denies seeking therapy for anxiety but would like referral to physical therapy again, has not seen PT in over three years. Denies seeking therapy for anxiety but would like referral to speak so something, stating that anxiety stems from ‘‘struggling for change.’’ GX 11, at 1. The visit note further lists BCI 2’s problems as ‘‘anxiety,’’ ‘‘Chronic lumbar pain,’’ ‘‘Sleep-wake disorder,’’ ‘‘GAD (generalized anxiety disorder),’’ ‘‘Chronic pain,’’ and ‘‘Sleep disorder,’’ and states that BCI 2 ‘‘needs refills on Norco[,] Ambien and Xanax.’’ Id. In the visit note, Dr. Vora documented negative findings for every item, including lower back pain. Id. Dr. Vora also documented a variety of physical exam findings and made diagnoses of generalized anxiety disorder, chronic pain and sleep disorder. While Dr. Vora prescribed only a seven-day supply of Motrin 800 mg (a non-controlled substance), he made the following additional notes in the ‘‘Treatment Plan’’ section of the visit note. First, with respect to BCI 2’s ‘‘[h]istory of chronic lumbar pain,’’ he documented: States in the past was prescribed Norco for pain by a provider in Flint. Has not been prescribed PO 00000 Frm 00006 Fmt 4701 Sfmt 4703 medication in over four months and has been ‘‘borrowing from a friend.’’ Referral to Pain Clinic for treatment of chronic pain. Referral to physical therapy. 7 days of 800 mg Motrin prescribed. Id. at 2. Second, with respect to BCI 2’s anxiety, Dr. Vora documented: ‘‘States that in the past was prescribed Xanax by a provider in Flint MI[.] Has not had filled prescription in over four months. States has been borrowing from a friend. Referral to MidMichigan Mental Health for evaluation and recommendation of treatment.’’ Id. Two days later, BCI 2 was seen by the Pain Clinic (which shared the building or adjoined Dr. Vora’s clinic) and completed additional forms including a Pain Clinic History Questionnaire and a Narcotic Agreement. Id. at 23–24 (Pain Hx form); id. at 26 (Narcotic Agreement). On this form, BCI 2 indicated that her ‘‘pain problem’’ was an old injury and that on a ‘‘0 to 10 pain scale,’’ her pain was presently a ‘‘0’’ but was ‘‘[u]sually a ‘‘4’’ and ranged from ‘‘0–4.’’ Id. She noted that her pain was decreased by medication and that her current medications, which she listed as Norco 5/325 mg, Ambien 5 mg and Xanax .25 mg were ‘‘very good.’’ Id. at 23. She also circled numerous medications that she had tried, indicated that she had previously had physical therapy, and that she had not seen ‘‘any neurologist, neurosurgeon, orthopedic surgeons or any other pain physicians.’’ Id. While she admitted to using alcohol, she denied marijuana use. Id. at 24. Notably, BCI 2 did not indicate on the form the location of her pain, how long she had suffered it, nor any activity which increased it. See id. at 23. According to the visit note, BCI 2 was seen by Dr. R., who documented that she complained of ‘‘[p]ain in the lumbar spine.’’ Id. at 16. Dr. R. noted that BCI 2 ‘‘fell off a horse 10 years ago and since then has had pain in her right lumbar area’’; she also noted that ‘‘PT didn’t help’’ and that ‘‘she has not been considered for spinal interventions or seen by a surgeon.’’ Id. Dr. R. conducted a review of various symptoms, documenting under ‘‘[m]usculoskeletal’’ that BCI 2 had ‘‘[n]o joint pain, redness or swelling’’ but had ‘‘[l]umbar back pain.’’ Id. Dr. R. also documented that she performed a physical exam. In her findings as to the ‘‘musculoskeletal’’ portion, Dr. R. noted ‘‘tenderness in lumbar spine, no pain on ROM [range of motion] of lumbar spine, pinprick intact b/l lower extremities, 4/5 strength b/l lower extremities, [D]TR 2+ lower extremities.’’ Id. Dr. R. made a diagnosis of ‘‘[l]umbar facet pain.’’ Id. As for her E:\FR\FM\30APN2.SGM 30APN2 sradovich on DSK3GMQ082PROD with NOTICES2 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices plan, Dr. R. listed ‘‘[o]btain updated MRI of lumbar spine,’’ ‘‘consider LMBB,’’ and issued prescriptions for 60 Norco 5/325 mg, 30 Ambien 5 mg with four refills, and 60 Xanax 0.25 mg, also with four refills. Id. See also id. at 28 (copies of each prescription). On February 20, 2015, BCI 2 returned to the Pain Clinic and again saw Dr. R. In the visit note, Dr. R. documented that ‘‘[p]atient is having good pain control on Norco. Did not get MRI.’’ Id. at 18; see also id. at 29. Under review of systems, Dr. R. documented that ‘‘[a]ll 14 systems within normal limits.’’ Id. at 18. Dr. R.’s physical exam findings included ‘‘tenderness in lumbar spine, pinprick intact, some pain on ROM of spine[,] 5/5 strength in upper and lower extremities.’’ Id. Dr. R noted the same diagnosis as before of lumbar facet pain. Id. Her plan included having BCI 2 get an MRI of her lumbar spine, ‘‘try[ing] [S]oma this month instead of Norco,’’ and ‘‘consider spinal interventions.’’ Id. BCI 2’s patient file contains copies of two prescriptions issued this date: one for 120 du of Soma 350 mg, the other for five du of Norco 5/325. Id. at 30. The file also includes a signed order by Dr. R. for an MRI of BCI 2’s lumbar spine; the form lists the date and time of the appointment as ‘‘3/5’’ at ‘‘10:30 a.m.’’ Id. at 31. BCI 2’s patient file also includes a lab report which shows that BCI 2 provided a urine sample at her February 20, 2015 visit. Id. at 32. According to the report, the specimen was received by the lab on February 26, 2015 and the results, which were negative for all drugs including those prescribed to her at the previous visit (Norco (hydrocodone) and Xanax (alprazolam)). Id. The report further indicates that BCI 2’s sample failed validity tests and lists a urine creatinine level (27 mg/dl) below the reference range (37–300 mg/dl). Id. at 32–33. On March 19, 2015, BCI 2 returned to the clinic and saw Respondent. Tr. 191– 92. After providing a urine sample, BCI 2 was taken to an exam room, and after a short wait, Respondent entered the room. Id. at 194. Respondent and BCI 2 exchanged pleasantries, after which Respondent asked: ‘‘so tell me what’s going on?’’ GX 7, at 2. BCI 2 stated that she was ‘‘just here for refills,’’ prompting Respondent to state: ‘‘Ok. Alright and how are you feeling?’’ Id. BCI 2 replied: ‘‘I feel great today. It’s awesome outside.’’ Id. Respondent noted that he had ‘‘[g]one outside pretty early this morning’’ and that ‘‘it was like barely light out,’’ prompting BCI 2 to state that ‘‘[t]hat’s too early to start work.’’ Id. VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 Respondent then asked BCI 2: ‘‘[t]ell me how you, you been doing?’’ Id. BCI 2 answered: ‘‘actually I have been doing really good I have no complaints.’’ Id. Respondent replied: ‘‘Ok well that’s what I like to hear. You know, you know that’s a good thing.’’ Id. BCI 2 then noted that there were ‘‘a lot of chairs in this room’’ and this ‘‘makes it look like an intervention,’’ prompting Respondent to comment: ‘‘Right, Right. One of those, you know surprise interventions. Families about to show up.’’ Id. In response, BCI 2 stated that she ‘‘was about to see, like a camera man and relatives. Why are you here for pain pills?’’ Id. at 3. Respondent then asked: ‘‘what’s going on. Now where is it hurting you the most?’’ Id. BCI 2 replied: ‘‘Right, lower right but umm. No we are good[.] I don’t want to bug you. Right, lower right.’’ Id. Next, Respondent asked BCI 2 to ‘‘stand up for’’ him and ‘‘[p]oint to right where it is real quick.’’ Id. BCI 2 stood up, pointed to her right lower hip area about three inches from her spine, Tr. 285,10 and said ‘‘[u]mm right here.’’ GX 7, at 3. Respondent acknowledged the location to which BCI 2 had pointed and asked ‘‘does it shoot to like your hip or like your leg?’’ Id. BCI 2 responded: ‘‘Ummm. No it just stays there. But umm like right now I have like nothing. I feel good. I have good days and bad.’’ Id. Respondent then had BCI 2 hold out her arms, placed his hands on her arms, Tr. 213, and directed her to press up and press down, id., after which he asked: ‘‘[d]oes it ever cause you to limp?’’ GX 7, at 3; see also Tr. 213. BCI 2 answered ‘‘[n]o.’’ GX 7, at 3. Respondent had BCI 2 ‘‘[w]alk towards the wall and back,’’ after which he asked if she was ‘‘a smoker.’’ Id. BCI 2 said ‘‘no’’ and asked if she ‘‘look[ed] like one,’’ prompting Respondent to say: ‘‘No, you look . . . That’s one of those medical questions. Just in case.’’ Id. BCI 2 then asked if she ‘‘ha[d] more refills than I am supposed too?’’ Id. Respondent answered: ‘‘No. . . . [N]ot at all’’ and asked ‘‘And how long have you had the pain? And how old are you now?’’ Id. After BCI 2 said she was ‘‘41,’’ Respondent told her she could ‘‘sit down’’ and asked: ‘‘How long have you had the lower back pain.’’ Id. BCI 2 replied: ‘‘Uh god for over 10 years,’’ and Respondent asked: ‘‘how did it start?’’ and ‘‘[w]as it [an] injury?’’ Id. BCI 2 answered that she ‘‘fell off of a horse,’’ and Respondent said ‘‘ok.’’ Id. BCI 2 then said: ‘‘And umm. Actually everything was fine though and I wasn’t 10 BCI 2 also described this area as her ‘‘lower right back.’’ Tr. 213. PO 00000 Frm 00007 Fmt 4701 Sfmt 4703 18887 sure but I had the MRI but there was . . . there is nothing wrong, nothing broken, X-rays and all that stuff.’’ Id. at 4. Respondent asked her when she had last had an MRI, and BCI 2 answered that she was ‘‘actually going today at 2 p.m.’’ Id. Respondent then asked: ‘‘MRI of what? Your spine?’’ and BCI 2 replied: ‘‘Yep yep, cause doctor [R.] wanted me to get one and umm. So it’s actually today at 2.’’ Id. Respondent asked BCI 2 ‘‘do you get ‘muscle spasms?’’; BCI 2 said ‘‘nope.’’ Id. Respondent then asked: ‘‘And when does it hurt the most?’’ Id. BCI 2 answered: ‘‘Sometimes on occasion like when my alarm clock goes off in the morning and I am totally dead asleep and I’ll twist to shut off my alarm . . . That’s when it kind of screws it up.’’ Id. Respondent said ‘‘ok,’’ and BCI 2 added: ‘‘But I haven’t had that happen in a very long time like literally I have been really doing well.’’ Id. Respondent asked if she had ‘‘lost any flexibility or anything like that?’’ Id. BCI 2 answered that she did not ‘‘think so.’’ Id. Respondent then asked BCI 2 if she had any allergies. Id. BCI 2 answered: ‘‘Nope. She [Dr. R.] put me on Soma,’’ prompting Respondent to comment that he saw that and Dr. R. ‘‘put you on quite a bit.’’ Id. Respondent then told BCI 2 that ‘‘I will give you some Norco and I’ll give you some Soma but I will only give you Soma for like twice a day.’’ Id. BCI 2 said ‘‘ok,’’ and Respondent repeated ‘‘[t]wice a day but I will give you some Norcos,’’ and asked BCI 2 if she ‘‘ha[d] any questions.’’ Id. After Respondent confirmed that BCI 2 had given a urine sample the visit ended. Id. at 4–5. Consistent with Respondent’s statement, the evidence shows that Respondent issued to BCI 2 prescriptions for 60 Norco (hydrocodone/apap) 5/325 mg. and 60 Soma (carisoprodol) 350 mg. GX 8, at 1–2. Respondent did not include BCI 2’s address on either prescription. See id. In the subjective section of the visit note, Respondent wrote; ‘‘LBP x 10 yrs [secondary] to falling off a horse.’’ GX 11, at 35. As for his physical exam findings, he documented: ‘‘[p]oint tenderness to [right] lower back, shoots to left hip,’’ ‘‘Full ROM,’’ ‘‘slight limp,’’ ‘‘5/5 Muscle strength,’’ ‘‘Good Muscle tone,’’ ‘‘CN II–XII intact,’’ ‘‘2+ pulses throughout,’’ ‘‘oriented x 3,’’ and ‘‘2/2 reflexes.’’ Id. As for his diagnoses, he listed ‘‘LBP x 10 yrs,’’ ‘‘spasm,’’ ‘‘; Smoking,’’ and ‘‘Abnormal Gait periodically.’’ Id. The Government’s Expert’s Testimony The Government called Carl W. Christensen, M.D. and Ph.D., as an E:\FR\FM\30APN2.SGM 30APN2 sradovich on DSK3GMQ082PROD with NOTICES2 18888 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices Expert witness in pain management and the standard of care applicable in Michigan to general practitioners treating patients who complain of pain. Tr. 350–51. Following voir dire, the CALJ accepted Dr. Christensen as an expert in these areas and the CALJ ultimately found his testimony generally credible. R.D. at 40–41. Dr. Christensen holds a Bachelor of Arts in Biology from Wayne State University (W.S.U.), which he obtained in 1977, as well as both a Doctor of Medicine and Doctor of Biochemistry from the W.S.U. School of Medicine, which he obtained in 1979 and 1985, respectively. GX 12, at 1–2. While much of his initial professional experience was in the specialty of obstetrics and gynecology, in 2002, Dr. Christensen began working with another physician who specialized in treating pregnant heroin addicts and became Board Certified in Addiction Medicine; he also testified that he has been practicing chronic pain medicine ‘‘since.’’ Tr. 350; see also GX 12, at 9. His professional experience includes serving as Director of Addiction Medicine Services, Detroit Medical Center, and as Medical Director of both the Dawn Farm Treatment Center in Ypsilanti, Michigan, and Spera Detox Center in Ann Arbor, Michigan. GX 12, at 5. He is a member and Distinguished Fellow of the American Society of Addiction Medicine, a member and former President of the Michigan Society of Addiction Medicine, and a member of the American Academy of Pain Management. Id. at 7. Dr. Christensen holds a current Michigan Medical License and Michigan Controlled Substance License, as well as a current DEA registration and DATA-Waiver Identification Number for treating patient with buprenorphine. Id. at 8. Dr. Christensen is also ‘‘one of two speakers employed by the Michigan State Medical Society to teach safe opioid practices . . . to local medical societies.’’ Tr. 354; see also id. at 361– 62 (discussing Risk Evaluation Mitigation Strategy lectures, in which he discusses the ‘‘safe prescribing of all opioids, including the new CDC . . . FDA guidelines’’). Dr. Christensen testified that his practice primarily involves treating patients who are already taking controlled substances and who have been referred to him because the medication is no longer effective, the patient’s physician suspects the patient is misusing or abusing the medication, or the patient needs to be prepared for surgery. Id. at 353. He also testified that he ‘‘do[es] pain medication management’’ and that he ‘‘manage[s] VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 pain medications and associated medications, such as sedatives, muscle relaxers, and any medication that may interfere with pain management.’’ Id. at 355. On voir dire, Dr. Christensen acknowledged that he is not board certified in pain management because he does not do interventional pain management and that he does not believe he is eligible to sit for that board’s examination. Id. at 357–58. However, he testified that he does take patients without referrals who are addicted to pain medication, and that ‘‘probably over half’’ of his patients are patients who are being treated solely for pain. Id. at 360–61. Also, on cross-examination, Dr. Christensen acknowledged that he had previously testified in court in two painrelated cases for the government. Id. at 484–85. He testified that since 2012, he has reviewed ‘‘between 10 and 20’’ cases total for the government, and that in approximately two-thirds of these matters, he rendered an opinion that supported the government allegations.11 Id. at 485–86. He also testified that he has reviewed one case on behalf of a physician accused of improper prescribing and rendered an opinion that ‘‘was positive for the physician’’ and that case ‘‘was dismissed.’’ Id. at 486. Dr. Christensen’s Testimony on the Standard of Care Dr. Christensen testified that as a general matter, the standard of care requires that a patient present a complaint, after which ‘‘the first thing [a] physician should do is take a history,’’ id. at 489, which is ‘‘relevant to [the] complaint.’’ Id. at 365. The physician should then do ‘‘a physical examination that deals with that complaint.’’ Id.; see also id. at 489. After the exam, the physician may need to do lab work and diagnostic tests ‘‘depending upon . . . the specific complaint . . . . [a]nd then make a diagnosis and offer a plan of treatment.’’ Id. at 365; see also id. at 489–90. Dr. Christensen acknowledged, however, that a physician may not be able to do diagnostic and lab tests at the initial visit but that these tests can be ordered. Id. at 367–68. He also testified that while a treatment plan should be offered, the plan may need to wait until the diagnosis is confirmed through testing. Id. at 490. 11 Dr. Christensen also testified as to his hourly rate for both reviewing cases and testifying in court, as well as various functions he performs for Blue Cross/Blue Shield which include serving on the Medicare Drug Utilization Review Committee. Tr. 487–88. PO 00000 Frm 00008 Fmt 4701 Sfmt 4703 In taking the history of a pain patient, Dr. Christensen testified that he uses and teaches medical students to use a mnemonic called ‘‘OLD CARTS.’’ Id. at 373–74. He further testified that the steps set forth by this mnemonic constitute the standard of care in Michigan. Id. at 374. Dr. Christensen explained the questions pertinent to each letter as follows: O, the onset of the pain (when it began); L, the location of the pain; D, the duration of the pain; C, the character of pain (i.e., whether it is dull, squeezing, burning, or shooting); A, factors that aggravate the pain; R, factors that relieve the pain; T, timing or what brings the pain on; S, the severity of the pain. Id. at 373–74. He further explained that as part of this process, the standard of care requires the assessment of the patient’s functional or activity level with the pain. Id. at 374. With respect to a chronic pain patient, who would be a patient ‘‘who has had pain for more than four to six months,’’ Dr. Christensen would be concerned about the patient’s psychiatric history as anxiety or depression ‘‘can dramatically affect [a patient’s] pain level.’’ Id. at 368. Dr. Christensen would also want to know if a patient has a substance abuse problem and ‘‘do an addiction evaluation to find out if there was also a co-occurring or a primary substance abuse problem.’’ Id. Dr. Christensen further explained that he ‘‘would want to know what surgeries [the patient] had in the past and what procedures had been done.’’ Id. Dr. Christensen explained that once a physician makes a diagnosis of chronic pain and determines the patient’s underlying condition, a treatment plan is offered to the patient. Id. at 369. He testified that on a return visit, the physician would focus on the patient’s chief complaint, a review of systems, and the history of the patient’s present illness, the latter involving asking the patient ‘‘how the pain’s affecting you?’’ ‘‘how strong the pain is?’’ ‘‘does it radiate?’’ and ‘‘what makes it worse and what make it better?’’ Id. at 370. Dr. Christensen testified that the physician ‘‘would then be involved primarily in medical decision-making, which means . . . look[ing] at the level of risk that the patient has,’’ and that ‘‘in chronic pain management[,] . . . using a controlled substance [is] consider[ed] to be moderate risk.’’ Id. The physician would also ‘‘look at the amount of information that [the physician] need[s] or the information that [the physician] ha[s]’’ and ‘‘the number of problems that the E:\FR\FM\30APN2.SGM 30APN2 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices sradovich on DSK3GMQ082PROD with NOTICES2 patient has’’ and formulate a treatment plan.12 Id. Asked on cross-examination whether his OLD CARTS + ‘‘sets the minimum standard of care,’’ Dr. Christensen testified that ‘‘[t]his applies to [the] history of present illness, which depending upon the level of the visit requires a certain number of elements depending on the visit.’’ Id. at 506. He further agreed that OLD CARTS ‘‘is a helpful mnemonic’’ that helps a physician ‘‘remember the types of things to ask that meet that standard.’’ Id. The Government also asked Dr. Christensen whether the standard of care is different when ‘‘a physician is acting as a locum tenens physician or is in a group practice?’’ Id. at 375. Dr. Christensen testified that ‘‘the standard of care is the same whether somebody is in a solo practice, a group practice, a hospital practice, or locum tenens. You’re held to the same standards of care in the practice of medicine, and the underlying ethical principles are still the same.’’ Id. Turning to BCI I’s first visit with Respondent (February 19, 2015), Dr. Christensen testified that the former’s statement that ‘‘I just came back for refills’’ raised a red flag that he was just seeking medication ‘‘and has no other complaint.’’ Id. at 376. As for BCI I’s statement that ‘‘I take Norco for my back, and I take Xanax on the weekends,’’ Dr. Christensen testified that this raised a red flag that the patient was either misusing or diverting controlled substances. Id. at 377. Dr. Christensen also noted that the statement ‘‘I take Xanax on the weekends . . . does not appear to be someone who’s complaining about an anxiety diagnosis who’s being prescribed Xanax for a documented anxiety disorder.’’ Id. at 379. Dr. Christensen further found concerning the statement ‘‘I take Norco for my 12 With respect to how a physician should evaluate whether to continue prescribing controlled substances after a patient’s initial visit, Dr. Christensen testified as to the use of what he called ‘‘the five As’’ to assess the patient. Id. at 370. Dr. Christensen explained that these involve: (1) Assessing the level of ‘‘analgesia’’ or pain level; (2) asking the patient about his/her activity or ‘‘functional level’’; (3) asking ‘‘about adverse effects, which for opioids typically consist of . . . constipation, sweating, [and] swelling’’; (4) looking for aberrant behavior such as use of illicit drugs or the failure to use prescribed drugs by conducting drug screens and obtaining MAPS reports to look for doctor shopping; and (5) looking at how the drugs ‘‘affect’’ the patient and how the patient appears and behaves during the visit. Id. at 370–72. Dr. Christensen testified that findings as to the five As should be documented every time. Id. at 373. Yet on cross-examination, Dr. Christensen answered ‘‘no’’ when asked: ‘‘[t]here’s no absolute standard of care requirement to go through these five As, right?’’ Tr. 506. VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 back,’’ because while ‘‘back pain is one possible explanation,’’ BCI 1 did not specifically complain of back pain, and while BCI 1 may have meant that, it may also ‘‘be a sign of somebody who is selfmedicating.’’ Id. at 379–80. With respect to BCI 1’s seeking Xanax, Dr. Christensen testified that ‘‘a reasonable practitioner . . . would want to know’’ if there had been a diagnosis of anxiety disorder, who ‘‘made the diagnosis,’’ and what treatments had been tried. Id. at 381. With respect to BCI 1’s seeking Norco, Dr. Christensen explained that he would ‘‘want to know the same thing,’’ including what the diagnosis was, what medications had been tried, ‘‘and who made the diagnosis.’’ Id. Dr. Christensen also testified that the combination of drugs that BCI 1 claimed to be taking, i.e., Norco and Xanax, was also a concern because ‘‘[t]hey are both controlled substances’’ and are ‘‘synergistic,’’ in that ‘‘[t]hey are much more euphoric when taken together.’’ Id. Dr. Christensen explained that this combination of controlled substances would cause concern as to the ‘‘underlying diagnosis’’ in that the ‘‘primary diagnosis is chemical dependence rather than a combination of moderate to severe back pain and a documented anxiety disorder.’’ Id. at 382; see also id. at 406 (testimony of Dr. Christensen: ‘‘[F]rom this visit, it would appear that the diagnosis of back pain and anxiety is in doubt. There’s a strong possibility of another diagnosis, which would be chemical dependency, and that would mean that you would not be prescribing these medications. And, again, I would recommend referral to a substance abuse specialist.’’). Next, Dr. Christensen testified that BCI I’s statement that his back was ‘‘[m]ostly just stiff’’ is ‘‘not an indication for prescribing Norco’’ (hydrocodone). Id. at 383. As for the physical exam Respondent performed, Dr. Christensen testified that BCI 1 stated that his pain did not shoot anywhere and was localized, which means it ‘‘is more likely to be joint or musculoskeletal pain.’’ Id. at 386. Dr. Christensen then explained that the tests Respondent performed in which he held BCI 1’s arms and had him push up and push down ‘‘is a test for the cervical and upper thoracic nerves essentially in the neck.’’ Id. Dr. Christensen noted, however, that BCI 1 complained of lower back pain and that this test was not appropriate for evaluating lower back pain. Id.; see also id. at 390. Asked what the standard of care required of Respondent after he had BCI 1 point to where his pain was, Dr Christensen acknowledged that this was PO 00000 Frm 00009 Fmt 4701 Sfmt 4703 18889 ‘‘a return visit for this patient.’’ Id. at 386. Dr. Christensen explained, however, that ‘‘if a physical examination were to be done as part of the . . . visit, then you would want to check for tenderness and spasm in that area,’’ and that this would be done either by ‘‘push[ing] on the patient’s back or hav[ing] the patient push on their [sic] back and tell you if it hurts.’’ Id. at 386–87. Dr. Christensen subsequently testified that a reasonable practitioner would put his hands on the patient’s back and feel for tenderness and for a muscle spasm. Id. at 387. As for whether a physician could properly check for tenderness or spasm if the patient is wearing clothing, Dr. Christensen testified that ‘‘[i]t would be difficult’’ but ‘‘you could check for tenderness if you pushed hard enough.’’ Id. Dr. Christensen testified, however, that he did not ‘‘believe that you could test for spasm’’ if the patient was wearing clothing. Id.; see also id. at 389. As for the scope of an appropriate physical exam for evaluating lower back pain, Dr. Christensen testified that ‘‘at a minimum’’ a reasonable practitioner ‘‘would check for flexion and extension,’’ id. at 391, which involves seeing ‘‘[h]ow far [a patient] can bend over before [he/she] has[s] moderate to severe pain’’ and ‘‘how far can they lean back.’’ Id. at 390.13 Dr. Christensen again testified that on a return visit, a physical exam is not required and the physician can rely on the history and the medical decisionmaking. Id. at 391. Asked by the CALJ if he would have expected to see ‘‘these tests . . . documented in the initial exam’’ or would have ‘‘just looked for the diagnosis,’’ Dr. Christensen answered that ‘‘if this was a return visit for the patient and I was seeing the patient for the first time, I would hopefully find these things in the initial examination and the reasons for the diagnosis in the initial examination.’’ Id. at 392. On further questioning as to whether, under such circumstances, he would be looking in the chart for documentation of various tests to support a diagnosis before he prescribed controlled substances, Dr. Christensen answered: ‘‘If the diagnosis is in question, if the initial evaluation did not document this, I would want to confirm 13 Dr. Christensen identified other tests including ‘‘checking for side to side motion,’’ doing a straight leg raise test if the patient complains of radiation, checking muscle strength in the lower extremities by having the patient push in and push out, checking the lower extremities for edema, checking the reflexes in the lower extremities, and if there is a neurological complaint of numbness or pain, ‘‘check[ing] for touch and sensation and pain in the bottom or the top . . . of the feet.’’ Tr. 390. E:\FR\FM\30APN2.SGM 30APN2 sradovich on DSK3GMQ082PROD with NOTICES2 18890 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices the diagnosis before I prescribed controlled substances.’’ Id. at 393. As for BCI 1’s statement that his back was ‘‘mostly just stiff,’’ Dr. Christensen acknowledged that there could be ‘‘multiple reasons for it’’ such as ‘‘joint disease,’’ ‘‘deconditioning,’’ ‘‘central pain syndrome,’’ or an ‘‘underlying medical condition.’’ Id. at 389. Dr. Christensen nonetheless testified that he would ‘‘[n]ot automatically’’ equate stiffness with a complaint of pain and that to connect the two, the patient would also have to complain of pain. Id. at 389–90. Addressing BCI 1’s statement that he took Xanax ‘‘[b]ecause when I do that it keeps me from drinking too much moonshine on the weekends,’’ Dr. Christensen noted that drinking and taking Xanax is ‘‘a potentially lethal combination. And if you add [h]ydrocodone, it’s even more dangerous.’’ Id. at 394. He explained that ‘‘[t]he combination of alcohol and benzodiazepines, [such as] Xanax, increases [the] chance of respiratory depression,’’ and that when you ‘‘throw in an opiate . . . like [h]ydrocodone,’’ the combination is ‘‘even more dangerous.’’ Id. Continuing, Dr. Christensen testified that ‘‘[i]f somebody told me they were drinking on the weekends and there was a prescription for Xanax, [he] would be very concerned.’’ Id. He added that drinking is ‘‘a contraindication to’’ Xanax, and because ‘‘the ethical principle here is do no harm[,] [he] would not prescribe . . . Xanax.’’ Id. at 395. Asked by the CALJ if this was his personal standard or the standard of care in Michigan, Dr. Christensen explained that because the FDA warning label strongly recommends against the use of alcohol when taking this medication, if the physician believes the patient is ‘‘going to continue drinking,’’ ‘‘the standard of care is not to prescribe the medication.’’ Id. at 396. Dr. Christensen then testified that ‘‘with that statement’’ (presumably BCI 1’s statement), a reasonable general practitioner would refer the patient to an addiction specialist or counselor and not prescribe the medication. Id. at 396– 397. Dr. Christensen also found concerning Respondent’s prescribing of Soma (carisoprodol) to BCI 1. Id. at 397. Dr. Christensen explained that carisoprodol ‘‘is now a controlled substance based on its abuse potential’’ and that with respect to BCI 1, ‘‘you’ve got somebody who admits to alcohol use, who is prescribed Xanax, and now you’re adding a third sedation which also increased the risk of accidents and overdose and death.’’ Id. at 397–98. Dr. VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 Christensen then testified that the combination of hydrocodone, Xanax, and Soma ‘‘is commonly known as the holy trinity,’’ which is ‘‘a very euphoric combination, and [is] dangerous because you’re mixing two sedatives together’’ as well as hydrocodone, which creates ‘‘the additive effect on respiratory depression.’’ Id. at 398–99. With respect to Respondent‘s statement that he was prescribing carisoprodol for BCI I’s muscle spasms, GX 3, at 12, Dr. Christensen testified that he ‘‘didn’t see any diagnosis of muscle spasms’’ and that a physician would diagnose a patient as suffering from spasms by palpating the patient’s back. Tr. 399. According to Dr. Christensen, Respondent did not do this. Id. Turning to the colloquy between Respondent and BCI 1 regarding the value of the drugs on the street, see GX 3, at 14–15, Dr. Christensen opined that this raised a concern because BCI 1 ‘‘did not initially raise it but was engaging in a discussion of diversion’’ and yet Respondent was ‘‘prescribing him controlled substances.’’ Id. at 400–01. Dr. Christensen further testified that in response to this conversation, a physician acting in accordance with the Michigan standard of care would need to ‘‘make sure that there was an opioid agreement’’ with the patient and ‘‘to reinforce the opioid agreement and to monitor’’ the patient ‘‘or correct use’’ by doing urine drug screening. Id. at 402. Next, the Government asked Dr. Christensen whether concerns were raised by the colloquy during which BCI 1 stated that ‘‘a couple of times’’ he had ‘‘r[un] out of pills’’ and had to ‘‘trade’’ with his neighbor, Respondent asked if it was ‘‘an equal trade,’’ and BCI I added that he had asked Dr. Vora ‘‘for a couple [of] extra’’ pills’’ and that Dr. Vora had given him a couple of extra pills which he had given back to his neighbor. Tr. 402–03; GX 3, at 15. Dr. Christensen testified that the patient ‘‘is admitting to diversion’’ and that a physician must explain to the patient that this is illegal and that the patient ‘‘ha[d] signed an opioid agreement’’ and that ‘‘according to the . . . agreement . . . if this occurs [the patient] will not be able to receive controlled substances.’’ Id. at 403. Dr. Christensen further testified that, ‘‘at a minimum,’’ a reasonable practitioner would explain that the opioid agreement prohibits trading and selling pills, ‘‘and that if it were to happen, [the physician] would not be able to prescribe him medications anymore.’’ Id. at 405. He also testified that based on the transcript, the standard of care would require referral to an addiction specialist. Id. at 406. PO 00000 Frm 00010 Fmt 4701 Sfmt 4703 Turning to BCI 1’s patient file, Dr. Christensen testified that the November 10, 2014 medical history form was largely ‘‘blank, including [the section pertinent to] muscle, joint and bone.’’ Id. at 410. Dr. Christensen testified that ‘‘[i]f you are getting a history and this isn’t complete, you have to verify it independently’’ and that a physician ‘‘would be responsible for confirming the portion of the history and exam that dealt with your treatment plan, especially if it included controlled medications.’’ Id. at 410–11. Dr. Christensen then testified that he ‘‘would look at the remainder of the file, which would be Dr. [Vora’s] initial electronic medical record.’’ Id. Dr. Christensen noted, however, that this record was also missing information, and that a reasonable practitioner would have to ‘‘[o]btain the information’’ and the missing history ‘‘if you are going to prescribe controlled substances.’’ Id. at 411–12. With respect to the form which asked various questions about BCI 1’s family history and which were not answered, GX 10, at 19, Dr. Christensen testified that the standard of care required obtaining this information because ‘‘[i]f you are treating the patient for back pain and . . . ruling out substances abuse’’ by the patient, ‘‘a family history of psychiatric or substance use disorders is important.’’ Tr. 413; see also id. at 551 (testimony of Dr. Christensen agreeing that a physician ‘‘would want to look through the . . . medical record to see if . . . a proper history [was] conducted and . . . fill in the gaps from what the patient failed to report on [his] questionnaire’’).14 As found above, BCI 1’s file also contained a MAPS report. GX 10, at 23. Dr. Christensen found it notable that the report showed that BCI 1 had gotten four different prescriptions for Xanax and one prescription for amphetamines and that some of the providers, those whose offices were in Detroit and Marquette, were ‘‘400 miles apart.’’ Id. 14 As for the history listed by Dr. Vora at the December 15, 2014 visit, which included both a social history and diet history, Dr. Christensen testified that there was ‘‘no mention . . . of [the] presence or absence . . . of drug or alcohol use.’’ Tr. 552. While Dr. Christensen acknowledged that BCI 1’s self-report of alcohol use and Respondent’s questioning BCI 1 as to whether he used marijuana rendered the history complete, Dr. Christensen expressed skepticism as to whether either Dr. Vora at the December 15, 2015 visit or Ms. S.A. (the person listed on the EMR as having reviewed BCI 1’s Social History and Consumption/Diet) at the January 12, 2015 visit had actually done so. Id. at 553. When asked if ‘‘it would be fair to assume that there were two separate people who looked at the patient’s history,’’ he replied: ‘‘I believe it indicated that two different log-ons checked off that box’’ and ‘‘I don’t know that it indicates they ever reviewed the history with the patient.’’ Id. E:\FR\FM\30APN2.SGM 30APN2 sradovich on DSK3GMQ082PROD with NOTICES2 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices at 413–14. Dr. Christensen testified that the ‘‘high geographic distance between providers’’ and the ‘‘multiple providers’’ are ‘‘signs of doctor shopping’’ and ‘‘diversion or misuse.’’ Id. at 414. Turning to Respondent’s progress note for the visit, Dr. Christensen noted that while it documented a complaint of ‘‘associated muscle spasm,’’ BCI 1 had ‘‘complained of stiffness,’’ which ‘‘is a symptom.’’ Id. at 415. Dr. Christensen testified that ‘‘spasm is a physical finding’’ which ‘‘would need to be corroborated later on in the examination’’ by ‘‘palpation,’’ but according to the testimony of BCI 1, Respondent never touched him and thus could not possibly have diagnosed BCI 1 as having a muscle spasm. Id. at 415–16. As for the other exam findings in this visit note, Dr. Christensen testified that he ‘‘didn’t see documentation of [a] complaint of point tenderness.’’ Id. at 417. Dr. Christensen acknowledged that he had no ‘‘way of knowing whether [BCI 1] had a limp that you couldn’t see on the video’’ and that ‘‘[h]is muscle tone in the upper extremities may have been excellent.’’ Id. As for the notation that ‘‘CN IV–XII intact,’’ Dr. Christensen testified that video did not show that Respondent did the various cranial nerve tests as documented in the note. Id. at 417–19. After noting Respondent’s diagnoses of degenerative disc disease, positive ETOH, and anxiety, and the three prescriptions (Norco 7.5/325, SOMA 350, and Xanax .5), Dr. Christensen then opined that based on his review of the video, the transcript and the medical file, Respondent’s prescription for Norco was inappropriate as ‘‘[t]here was no documentation of moderate to moderately severe pain.’’ Id. at 419–20. There was also the ‘‘concern[ ] about another underlying diagnosis,’’ i.e., substance abuse, ‘‘that would have mandated either a referral or not writing the prescription.’’ Id. at 420. Dr. Christensen opined that the Xanax prescription was ‘‘not appropriate’’ because the drug is ‘‘contraindicated in somebody who is actively drinking.’’ Id. Dr. Christensen also noted that he ‘‘did not see any documentation of an anxiety diagnosis.’’ Id. Dr. Christensen also opined that the Soma prescription was ‘‘not appropriate.’’ Id. He explained that this drug is ‘‘indicated for short-term treatment of muscle spasms,’’ but that ‘‘there is no documentation of this’’ condition. Id. Dr. Christensen further explained that Soma was ‘‘contraindicated with this patient’s history.’’ Id. He then opined that each of the three prescriptions Respondent VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 issued at BCI 1’s first visit was not issued for a legitimate medical purpose and in the usual course of professional practice. Id. at 425–26. Turning to BCI 1’s second visit (Mar. 19, 2015), Dr. Christensen noted that when Respondent asked BCI 1 about his pain, the latter responded that ‘‘everything is cool,’’ and that ‘‘there’s no pain level.’’ Id. at 428. He also noted that BCI 1 complained only of stiffness, that BCI 1denied having pain that radiated down his leg, and that when Respondent asked BCI 1 to rate his pain level on a 1–10 scale, BCI 1 replied that he was ‘‘good today.’’ Id. at 428–29. Dr. Christensen opined that BCI 1’s response when asked to rate his pain on the numeric scale was ‘‘a nonresponsive . . . and . . . an evasive answer, which can be signs of drugseeking behavior.’’ Id. at 431. Dr. Christensen opined that this ‘‘was a negative evaluation for moderate to moderately severe pain.’’ Id. at 429. Dr. Christensen also testified that a reasonable practitioner ‘‘would have asked [BCI 1] about [his] functional level. . . . He would have asked about side effects. . . . And he would have . . . inquired about any aberrant behaviors.’’ Id. He further testified that whether BCI 1’s second visit was evaluated either on the basis of ‘‘face-toface time,’’ which was under two minutes, or ‘‘by complexity,’’ this was not an adequate evaluation. Id. at 431. While Dr. Christensen noted that at a return visit, only two of the three components of a history, physical, and medical decisionmaking must be performed, he opined that if the adequacy of the evaluations was based on its ‘‘complexity,’’ there was not ‘‘enough of an examination . . . to allow the medical decision-making.’’ Id. As noted above, the subjective section of the visit note repeats nearly verbatim the subjective notes written in the February 19 visit note in that it states: ‘‘44 y/o WM c DDD For approximately 10 yrs. Pt has associate muscle spasm c LBP.’’ GX 10, at 32; see also Tr. 432. Dr. Christensen testified that the subjective section of the visit note ‘‘appears to be a repeat of the history from the previous examination.’’ Tr. 432. Dr. Christensen noted, however, that while it is allowable to repeat the history from a previous examination, ‘‘there’s no additional information from the visit that occurred’’ and nothing occurred at this visit to substantiate what was written in the subjective section of the note. Id. at 432–33. Dr. Christensen further testified that neither the video nor the transcript provide evidence that Respondent performed the tests necessary to make PO 00000 Frm 00011 Fmt 4701 Sfmt 4703 18891 several of the findings he documented in the note’s physical exam section. Dr. Christensen specifically identified the findings of ‘‘moderate point tenderness to low back,’’ ‘‘cranial nerves 2 through 12 intact,’’ ‘‘2+ pulses throughout,’’ 15 and ‘‘2/2 reflexes’’ as not supported by tests. Id at 433–35. Dr. Christensen also testified that with the exception of the diagnosis of Etoh, which was based on BCI 1’s admission that he used alcohol, there was no documentation of findings to support the diagnoses of degenerative disc disease in the lumbar area, anxiety, and muscle spasm. Id. at 447; see also GX 10, at 32. Noting the prescriptions for Norco and Xanax that were issued by Dr. Vora at BCI 1’s January 12, 2015 visit, the Government asked Dr. Christensen whether the results of the urine drug screen administered on February 19, 2015, which were negative for these drugs, were aberrational. Tr. 439–441. Dr. Christensen noted, however, that the prescriptions were for a one-month supply and the drug screen was administered five weeks after the prescriptions were issued. Dr. Christensen testified that while it is possible the drugs should still show up in the urine screen even if BCI 1 has stopped taking the drugs one week earlier, ‘‘[t]here’s no definite answer that I can give’’ because these results may have been caused by ‘‘run[ning] out of medications, which is legitimate.’’ Id. at 440–41. Dr. Christensen testified that the standard of care required repeating the drug screen and doing so ‘‘at a time when the patient is taking the medications to see what happens’’ as well to consult with the patient. Id. at 441–42. Although Respondent repeated the drug screen at the second visit, he did not address the results with BCI 1. See GX 10, at 34. While Dr. Christensen further testified that the standard of care required that Respondent document how he addressed the test result, there is no such documentation in the March 19 visit note. Tr. 443–444; see also GX 10, at 32. With respect to each of the three prescriptions (65 Norco 7.5/325 mg, 60 Xanax 0.5 mg, and 30 Soma 350 mg) issued by Respondent to BCI 1 at this visit, Dr. Christensen opined that the prescriptions lacked a legitimate medical purpose. Tr. 448. 15 With respect to this notation, Dr. Christensen testified that the notation ‘‘that the pulses are normal throughout . . . implies the upper and lower extremities.’’ Tr. 434. He then explained that to make this finding, ‘‘[y]ou check typically for the radial pulse in both wrists and either the posterior tibia, which is behind your ankle, or the dorsalis pedis pulse, which is in the front of, the top of your foot.’’ Id. at 435. E:\FR\FM\30APN2.SGM 30APN2 sradovich on DSK3GMQ082PROD with NOTICES2 18892 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices Dr. Christensen also testified about BCI 2’s March 19, 2015 visit with Respondent. As found above, after an exchange of pleasantries, BCI 2 stated that she was ‘‘[j]ust here for refills’’ and answered his question ‘‘how are you feeling,’’ stating: ‘‘I feel great today.’’ Tr. 449. When further asked by Respondent to ‘‘tell me how you have been doing,’’ BCI 2 replied: ‘‘actually, I’ve been doing really good. I have no complaints.’’ Id. With respect to this exchange, Dr. Christensen testified that BCI 2’s statement that she had ‘‘no complaints . . . by itself does not mean anything.’’ Id. at 450. Continuing, Dr. Christensen explained that ‘‘there’s no identification yet if she’s been taking the medication and if the medication is the reason . . . for how she feels. And, again, [BCI 2] states, ‘I’m just here for refills.’ ’’ Id. Dr. Christensen testified that a practitioner acting under the standard of care would follow up this exchange by ‘‘ask[ing] if [the patient has] been taking the medications, . . . then ask[ing] about pain level, activity level, side effects, and mak[ing] inquiries about are they [sic] having any problem with aberrant behavior, are they [sic] running out early.’’ Id. Dr. Christensen then testified that none of this was done. Id. Addressing the portion of the colloquy in which Respondent asked BCI 2 ‘‘where is it hurting the most’’ and BCI 2 replied ‘‘[r]ight, lower right but . . . no, we are good,’’ Dr. Christensen testified that while BCI 2 ‘‘identifie[d] a location . . . again, there’s no direct answer.’’ Id. at 450–51. As for the physical exam Respondent performed (after BCI 2 pointed to her lower back near her right hip) which involved having BCI 2 hold out her arms and press up and down as he held them, Dr. Christensen again testified that this ‘‘tests for upper extremity strength and integrity of the nerves in the neck and upper thoracic areas, which is the upper back’’ and would have no value in evaluating a rear right hip issue. Id. As found above, after BCI 2 denied that she got muscle spasms, Respondent asked ‘‘when does it hurt most,’’ and BCI 2 replied that ‘‘sometimes,’’ when she was asleep, she would ‘‘twist to shut [her] alarm off’’ and ‘‘screw[ ] it up,’’ but this had not ‘‘happen[ed] in a very long time’’ and she had ‘‘been really doing well.’’ GX 7, at 4. Regarding this exchange, Dr. Christensen testified that ‘‘[t]here’s no documentation of a moderate or higher pain level other than being stiff in the morning when you wake up. There’s no discussion of whether or not this is due to her pain medications.’’ Tr. 454. Dr. Christensen then opined that a reasonable practitioner would ask a patient who VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 said she was not having any pain if she was taking her pain medications and then evaluate based on the answer. Id. at 455. Dr. Christensen noted that there was no indication in the transcript that Respondent asked this question. Id. Dr. Christensen further noted that nothing was checked on the medical history form filled in by BCI 2 with respect to any symptoms of muscle, joint or bone pain even though she presented with ‘‘potential complaints of back pain’’ and that this should have prompted a discussion between Respondent and her. Id. at 456. Dr. Christensen further testified that a reasonable ‘‘practitioner is responsible for obtaining the history, so . . . he or she would need to ask the patients the questions directly’’ and fill in the blanks. Id. at 457. As for the drugs (Norco, Ambien, and Xanax) which BCI 2 listed on the medical history form as her current medications, see GX 11, at 10, Dr. Christensen again observed ‘‘that Norco and Xanax is a potentially dangerous combination and a patient who is prescribed these or taking these, I’m concerned about another underlying diagnosis,’’ that being dependence. Tr. 457–58. Dr. Christensen further explained that while Ambien ‘‘is not technically a benzodiazepine . . . it is very similar and its side effects’’ and risks are similar to those of benzodiazepines. Id. at 457. Dr. Christensen testified that this drug combination raises concern as to why it ‘‘is being prescribed or taken’’ and a practitioner would ‘‘need to confirm that there was a legitimate medical diagnosis for it and not another underlying diagnosis, such as dependence.’’ Id. at 458. Turning to the family history form (GX 11, at 12) on which BCI 2 noted that the reason for her visit was ‘‘Refills— Norco, Ambien[,] Xanax,’’ Dr. Christensen testified that this explanation is not one that he would typically expect a patient to provide at a first visit, id. at 462–63, and that ‘‘[a] practitioner would need to be concerned that someone was drug seeking’’ and visiting the doctor ‘‘simply to get the medications,’’ especially given the combination of drugs. Id. at 458. Moreover, even after the CALJ questioned whether the concern would exist if it was not the patient’s first visit to the practice, but was the first visit with the doctor, Dr. Christensen explained that ‘‘[i]f you are going to prescribe a controlled substance, the practitioner needs to confirm the diagnosis.’’ Id. at 460. As for the Pain Clinic History Questionnaire completed by BCI 2, Dr. PO 00000 Frm 00012 Fmt 4701 Sfmt 4703 Christensen noted that there was no ‘‘description circled for the pain,’’ and nothing was ‘‘circled for what’’ increased the pain’’ and for how the pain made her feel. Id. at 461; see also GX 11, at 23. He observed that while her ‘‘pain level is listed as 0 to 4,’’ there was no notation as to whether this was with medication or without medication. Id. at 461. He also noted that the location of the pain was not circled. Id. Dr. Christensen further observed that various sections of the form, including BCI 2’s work history, domestic situation, and family history were left blank. Id. at 462. Turning to the next page of the form, Dr. Christensen noted that while BCI 2 had indicated that she used alcohol, there was no discussion as to ‘‘how much [she was] drinking,’’ because depending upon ‘‘the amount and the frequency, it will put [the patient] at risk of increased side effects and risks from the combination of medications they’re currently taking.’’ Id. Dr. Christensen further noted that the standard of care requires a physician to obtain this information. Id. at 462. Addressing the note Respondent wrote for this visit, Dr. Christensen took issue with the adequacy of the subjective section, observing that it contained no notations about BCI 2’s ‘‘pain level, [her] medications, any side effects, [and] any problems with medications.’’ Id. at 464; see also GX 11, at 35. As for the physical exam findings documented by Respondent, Dr. Christensen identified multiple findings which the video and transcript show did not occur. Tr. 464–65. With respect to his finding of point tenderness to BCI 2’s right lower back, Dr. Christensen noted that ‘‘the investigator said she was good and she was great and there was no problem.’’ Id. at 464. He also reiterated his earlier testimony that point tenderness would be evaluated by palpating the patient and asking if it hurt or not; Dr. Christensen testified that he did not see that this occurred at this visit. Id. at 464–65. As for Respondent finding that BCI 2’s pain ‘‘shoots to left hip,’’ consistent with the evidence, Dr. Christensen testified that he did not ‘‘believe that she complained about any radiation to the hip.’’ Id. at 465; see also GX 7, at 1–5. With respect to Respondent’s finding of ‘‘Full RoM,’’ Dr. Christensen testified that while ‘‘she did abduct and adduct her upper extremities . . . [t]here was no other testing of range of motion that I saw either in the upper or lower extremities.’’ Id. Finally, while Respondent also made findings of ‘‘CN II–XII intact,’’ ‘‘2+ pulses throughout,’’ E:\FR\FM\30APN2.SGM 30APN2 sradovich on DSK3GMQ082PROD with NOTICES2 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices and ‘‘2/2 reflexes,’’ he did not see evidence that Respondent performed the tests used to make these findings. Id. at 465–66; see also GX 11, at 35. Dr. Christensen reiterated his earlier testimony that on a repeat visit, the standard of care does not require a physical examination. Tr. 366. However, he further testified that a physical exam for a complaint of back pain would involve ‘‘check[ing] for spasm in the lower back by palpation,’’ checking both flexion and extension of the lower back, ‘‘check[ing] the gait,’’ and ‘‘check[ing] the strength and reflexes in the lower extremities.’’ Id. As for the items listed as Respondent’s impression, Dr. Christensen acknowledged that while there was documentation of lower back pain based on BCI 2’s statement that she fell off a horse 10 years ago as well as that she was a non-smoker, there was no documentation to support the diagnosis of spasm or an abnormal gait periodically. Id. at 467. Dr. Christensen further observed that BCI 2’s March 19, 2015 drug test produced several aberrational results. These included that she tested positive for THC and tested negative for Ambien and Xanax which had been prescribed with four refills at BCI 2’s January 23, 2015 visit. Id. at 471; see also GX 11, at 37–38. He also testified that BCI 2 should have tested positive for Soma as this was prescribed to her at the February 20, 2015 visit. Id. at 471–72. Dr. Christensen acknowledged, however, that the March 19, 2015 test results were not available to Respondent on that date. Id. at 472. Dr. Christensen then opined that the Norco and Soma prescriptions issued to BCI 2 on March 19, 2015 were not issued for a legitimate medical purpose. Id. at 473. Dr. Christensen further noted that because BCI 2’s Xanax prescription had four refills, with Respondent’s prescribing to her, she had current prescriptions for Norco, Xanax, Soma and Ambien, and that this ‘‘combination of sedatives’’ increases the patient’s risk level and is ‘‘a highly addictive . . . and . . . dangerous combination.’’ Id. at 474. On cross-examination, Dr. Christensen admitted that on the morning of his testimony, he had prescribed methadone to one of his pain management patients electronically and without either speaking with or seeing the patient. Tr. 475–76, 478. Dr. Christensen testified, however, that this patient has severe lumbar stenosis, that he has been on the same drug for eight years, that he sees the patient every 60 days, and that in between visits, the patient provides a urine drug screen two weeks before his prescription is reissued and a MAPS report is run on the day his VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 prescription is due for renewal. Id. at 479. Dr. Christensen then explained that it is okay to simply issue a ‘‘refill’’ 16 if a ‘‘patient is stable,’’ the drug screens and MAPS reports are confirmatory, there is no evidence of aberrant behavior, and the patient is ‘‘not experiencing undue adverse side effects.’’ Id. Dr. Christensen subsequently acknowledged that performing two of the three items (of history, physical examination, and medical decisionmaking) is not strictly required to prescribe controlled substances each month under the standard of care and that determining the past diagnosis and whether ‘‘the patient is well managed on the medication . . . are two of the requirements’’ of the standard of care. Id. at 481. He also acknowledged that Respondent’s encounters with both undercovers were follow-up visits and that Respondent was not obligated to do all three things that are done at an initial visit but that he needed to verify that another physician had done these things. Id. at 490–91. Dr. Christensen explained, however, that whether it is okay to trust another physician’s diagnosis ‘‘would depend on what the record[s] showed’’ and that he ‘‘would want to see evidence of a pertinent examination’’ by the other physician if he was to ‘‘prescrib[e] a controlled substance for a history of back pain.’’ Id. at 492; see also id. at 529–30. After Dr. Christensen reiterated that a physician ‘‘need[s] to make sure that it [the prescription] is for a legitimate medical purpose,’’ Respondent’s counsel asked him ‘‘[w]here is that standard that you’ve said is the standard of care enumerated?’’ Id. at 493. Dr. Christensen then asked to ‘‘see the MCL,’’ apparently referring to the Michigan Compiled Laws setting forth the ‘‘good faith’’ standard for prescribing controlled substances and testified: So it says that the prescribing is done . . . in the regular course of professional treatment by an individual who is under treatment by the practitioner for a condition other than the individual’s physical or psychological dependence upon an addiction to a controlled substance. So I need to confirm, I believe the standard of care is you need to confirm that this is not an addictive disorder when you are seeing this combination of controlled substances being prescribed. Id. at 493–94. Then asked ‘‘where it is enumerated that the standard requires you to not trust the diagnosis of an initial 16 While called a refill, this was actually a new prescription. PO 00000 Frm 00013 Fmt 4701 Sfmt 4703 18893 physician when you’re conducting a follow-up visit,’’ Dr. Christensen answered that the Michigan pain guidelines ‘‘state that an examination shall be performed’’ and that when he ‘‘reviewed Dr. Vora’s records, I did not see any musculoskeletal examination except for noting edema.’’ Id. at 494. Dr. Christensen acknowledged that there was a plus mark next to both lower back pain and endocrinology anxiety in the review of systems section of the note created by Dr. Vora for BCI 1’s December 15, 2014 visit. Id. at 495 (discussing GX 10, at 3–4). He acknowledged that Dr. Vora’s note contained various physical exam findings pertinent to BCI’s 1 back, including that he had ‘‘lumbar spine point tenderness’’ and another notation indicated ‘‘tenderness to palpation,’’ thus indicating that Dr. Vora had palpated the spine and found it tender. Id. at 497, 530–31. Dr. Christensen also acknowledged that Dr. Vora’s note documented ‘‘Pain with Flexion/ Extension,’’ thus indicating that BCI 1 ‘‘was asked to flex and extend [his] back’’; he also testified that other notations indicated that Dr. Vora did other tests including a straight leg raise test, a toe heel walk, and that he palpated and did range of motion testing on various parts of BCI 1’s spine. Id. at 497–500, 530. Dr. Christensen then conceded that if all of these tests were done, this would be an appropriate physical examination of a patient complaining of lower back pain on a ‘‘follow-up visit.’’ 17 Id. at 500, 530–31. While Dr. Christensen testified that a finding of lumbar spine tenderness would ‘‘assist with a determination of back pain,’’ he added that back pain is a symptom even though it has its own billing code and that it is not a real diagnosis which would involve determining the cause of the pain. Id. at 500–01. He acknowledged that in some cases back pain could be caused by neuropathy and that there may be no physical manifestation of an injury such as on radiology exams (MRI or X-rays) or other physical findings. Id. at 501. Dr. Christensen also acknowledged that a patient’s complaint of pain is an important indicator of whether he/she has pain and that this ‘‘should be taken as part of the history.’’ Id. at 502. However, asked hypothetically whether a physician should believe a patient when a patient complains of high level 17 Notably, Dr. Vora’s note for BCI 1’s November visit contains no physical examination findings pertinent to BCI 1’s back. See GX 10, at 5–6. However, Dr. Christensen was not asked whether these findings reflect the performance of an appropriate physical examination for an initial visit. E:\FR\FM\30APN2.SGM 30APN2 sradovich on DSK3GMQ082PROD with NOTICES2 18894 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices of pain (nine out of 10) which cannot be verified by imaging or a physical exam, he answered that this ‘‘depends on the rest of the history and examination.’’ Id. Dr. Christensen then agreed that the existence or non-existence of aberrant behavior would be a factor in whether a physician should believe such a patient. Id. at 503. Turning to the undercover visits, Respondent’s counsel questioned Dr. Christensen regarding Respondent’s engaging in the various steps set forth by the OLD CARTS mnemonic. Dr. Christensen acknowledged that Respondent asked both BCIs to identify the location of their pain (the L in OLDCARTS) at their initial visits with him. Id. at 506–07. As for the onset of the pain, Dr. Christensen disagreed with the suggestion of Respondent’s counsel that Respondent’s question (‘‘So how long have you had low back pain?’’) and BCI 1’s answer (‘‘Probably 10 years. Mostly just stiff.’’), was an indication of the onset of BCI’s pain, explaining that this exchange simply addressed the pain’s duration; however, Dr. Christensen acknowledged that onset and duration are only different if the pain had gone away and returned. Id. at 508–09, 511. Asked if BCI 1’s statement about back stiffness ‘‘could also mean there is some pain,’’ Dr. Christensen replied: ‘‘it could mean there is almost anything associated with it.’’ Id. at 510. Turning to the character of the pain (the C in OLD CARTS), while Dr. Christensen acknowledged that Respondent’s question (‘‘Is the pain shooting or localized’’) was designed to question whether one type of pain existed, he did ‘‘not necessarily’’ agree that Respondent satisfied this element, explaining that if BCI 1 had ‘‘complained of only shooting pain, then it would.’’ Id. at 511–12. However, Dr. Christensen acknowledged that BCI 1 had stated that the pain was localized. Id. As for the aggravating or associated factors (the A in OLD CARTS), Respondent’s counsel asked Dr. Christensen if he saw ‘‘an indication in this visit that the patient made a statement about what makes [his] pain worse?’’ Id. Dr. Christensen testified that he would need ‘‘to go back over the,’’ at which point, Respondent’s counsel interrupted and stated: ‘‘No need to go back over it.’’ Id. Then asked if the questions embodied in the OLD CARTS mnemonic are ‘‘enumerated in the Michigan guidelines . . . for the use of controlled substance for the treatment of pain,’’ Dr. Christensen initially testified to his belief that ‘‘if you go through the entire document,’’ those questions ‘‘are in VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 there.’’ Id. at 513. However, asked if he believed ‘‘all of the [OLD CARTS] elements are met in the Michigan guidelines,’’ Dr. Christensen answered: ‘‘No, I believe they refer to the four As actually.’’ Id. Dr. Christensen then disagreed with Respondent’s counsel that ‘‘OLD CARTS isn’t in the Michigan standard,’’ explaining that he ‘‘believe[s] [that the] history of present illness is, which is what we’re referring to’’ and that some of the elements are in the standard. Id. Turning to BCI 1’s statement at his first visit with Respondent (‘‘I take Norco for my back and Xanax on the weekends’’), Dr. Christensen adhered to his earlier testimony that the combination of Norco and Xanax was concerning, as was his statement that he took Xanax on the weekends. Id. at 513–14. While Dr. Christensen acknowledged that the statement ‘‘can be interpreted that Norco is for back pain,’’ he noted that BCI 1’s statement ‘‘doesn’t specify that’’ and that additional questions to ‘‘confirm that’’ were necessary. Id. at 514. While Dr. Christensen acknowledged that Respondent did engage in further questioning when he asked BCI 1 ‘‘so you have back pain and some anxiety,’’ he disagreed with the suggestion of Respondent’s counsel that BCI 1’s answer of ‘‘I guess’’ was confirmation that the latter had pain, characterizing the answer as ‘‘evasive’’ and subject to ‘‘many’’ possible interpretations. Id. at 515. As for BCI 1’s statement that he took Xanax because it kept him ‘‘from drinking too much moonshine on the weekends,’’ GX 3, at 9, Dr. Christensen acknowledged that Dr. Vora’s January 12, 2015 visit note (GX 10, at 2) lists anxiety as a diagnosis. Tr. 516. Dr. Christensen also acknowledged that it is ‘‘okay to trust medical documentation of a physician if . . . the elements of a diagnosis are met.’’ Id. Dr. Christensen disagreed with the suggestion that BCI 1’s earlier statement that ‘‘I take Xanax on the weekends’’ could ‘‘refer to the patient having increased periods of anxiety because of whatever he does on the weekend,’’ explaining that he did not know and would need to do ‘‘appropriate questioning’’ to reach this conclusion. Id. at 517. Dr. Christensen also testified that while the medical record lists a diagnosis of anxiety, he was ‘‘not agreeing with any diagnosis of anxiety.’’ Id. Asked whether it is ‘‘ever appropriate to simply cut . . . off’’ a person who has been ‘‘on Xanax for a long period of time,’’ Dr. Christensen testified that it does not depend on the time the patient has been on the drug, but rather, ‘‘[i]t PO 00000 Frm 00014 Fmt 4701 Sfmt 4703 depends on the situation.’’ Id. at 518. Continuing, Dr. Christensen testified that ‘‘[i]f somebody is mixing Xanax with another medication that is lethal, the patient should be referred immediately, but the medication, the prescription should not be continued.’’ Id. Then asked if a physician ‘‘might want to consider cutting that patient off’’ where ‘‘the harm of taking . . . Xanax and the other substance is greater than the potential harm for withdrawal from Xanax,’’ Dr. Christensen answered ‘‘[y]es’’ and added that ‘‘if somebody’s taking Xanax on the weekend, there is no physical dependence to Xanax.’’ Id. Referring to BCI 1’s statement that a couple of times he had run out of pills and traded with his neighbor, Dr. Christensen did not agree that this statement ‘‘indicate[d] that the patient was consistently using the Xanax in a manner that he actually ran out of his pills prior to the end of the prescription,’’ noting that BCI 1 did not ‘‘specify which medication he’s talking about.’’ Id. at 520. While Dr. Christensen acknowledged that a patient going through alcohol withdrawal could suffer delirium tremens and be treated with benzodiazepines such as Xanax, he disagreed that BCI 1’s statement that ‘‘I take Xanax because it keeps me from drinking too much moonshine’’ was a reference to his using Xanax to address ‘‘withdrawal from alcoholism [sic].’’ Id. at 521–22. Still later on cross-examination, Dr. Christensen testified with respect to BCI 1’s acknowledgment of having traded pills, that a patient’s admission of diversion is ‘‘not an automatic reason to discharge’’ the patient and that ‘‘you have to review the opioid agreement, let [the patient] know that this will not be tolerated, and monitor [the patient] more closely.’’ Id. at 547. Dr. Christensen acknowledged that conducting urine drugs screens would be one of the things to do to monitor the patient more closely but that various guidelines including the Michigan guidelines do not require monthly drug screens. Id. at 547–48. On further questioning as to the significance of BCI 1’s statement about running out and trading pills, Respondent’s counsel asked Dr. Christensen if this conduct could be explained by pseudo-addiction, which Respondent’s counsel explained involved a patient engaging in aberrant behaviors because of under-treatment of this condition and not necessarily because of abuse or addiction. Id. at 549. While Dr. Christensen testified that pseudo-addiction occurs ‘‘[i]n very rare cases’’ and ‘‘[p]rimarily in cancer patients,’’ and that ‘‘[i]t’s possible’’ this E:\FR\FM\30APN2.SGM 30APN2 sradovich on DSK3GMQ082PROD with NOTICES2 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices could happen ‘‘[i]f a patient had uncontrolled pain,’’ when asked whether this could explain BCI 1’s statement about trading narcotics with a neighbor, he answered: ‘‘None of which I have seen.’’ Id. at 549–51. Turning to the physical exam Respondent performed on BCI 1, Dr. Christensen testified that the arm adduction and abduction tests do ‘‘not determine pain’’ but ‘‘determine normal function’’ in the upper spine and neck areas. Id. at 524. While Dr. Christensen acknowledged that a patient ‘‘may have more difficulty exerting resistance if they have increased pain,’’ he further explained that ‘‘[t]he primary reason for doing that is to assess for damage, whether there’s stenosis there.’’ Id. at 524–25. He testified that this test is not used to determine ‘‘a lack of function due to pain,’’ explaining that ‘‘[y]ou can have somebody who has give-away pain who can’t tolerate the test at all. But when you perform what [Respondent] did, you’re primarily assessing whether . . . there’s [an] injury to the spinal nerves and spinal cord at that area.’’ Id. at 525. After recounting Dr. Christensen’s testimony that the straight leg raise test is used to diagnose pain in the lower back, Respondent’s counsel asked him if he was ‘‘saying that you can’t use a test like that to determine back pain in the upper extremities.’’ Id. After clarifying that Respondent’s counsel was referring to the straight leg test, Dr. Christensen explained that ‘‘the straight leg test pulls on the sciatic nerve, which comes out of the bottom of the spinal cord.’’ Id. Respondent’s counsel then asked: ‘‘Isn’t it possible that pushing down on the arms could be a test for referred pain from the lower back to the upper spine?’’ Id. at 525–26. Dr. Christensen answered that there is a test (the Waddell Test) which involves ‘‘push[ing] on various parts of the body, and if the patient complains of pain all over . . . it’s felt to be psychosomatic pain.’’ Id. Dr. Christensen also rejected the suggestion of Respondent’s counsel that the abduction test on BCI 1’s arms would have shown an inconsistency with his complaint of only lower back pain if BCI 1 had given up resisting and complained of pain. Id. at 526–27. As he explained, Respondent did not ask BCI 1 if the test ‘‘was painful.’’ Id. at 527. Nor did BCI 1 complain that the test was painful. GX 3, at 9. Dr. Christensen further rejected the suggestion of Respondent’s counsel that that this test could be a sign of malingering by BCI 1. Tr. 527. Respondent’s counsel asked Dr. Christensen what the standard of care VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 requires for a physical exam of a patient who complains of localized lower back pain. Id. at 528. Dr. Christensen testified that he ‘‘would check for tenderness,’’ ‘‘for spasm actually next to the spine,’’ and ‘‘test for range of motion.’’ Id. When Respondent’s counsel asked if a physical exam is needed on a follow-up visit if the first exam was sufficient, Dr. Christensen testified that ‘‘[i]f you are doing a physical exam as part of your office visit, then that [sic] would be the elements that I would do for low back pain.’’ Id. at 529. Respondent’s counsel then revisited his earlier questioning regarding the physical examination documented by Dr. Vora in his December 15, 2014 visit note, with Dr. Christensen again acknowledging that the note documented that the various elements of an appropriate physical exam had been performed. Id. at 530–31. Dr. Christensen acknowledged that a second physician can reasonably rely on a medical record created by another physician who did a full and complete physical exam, provided that ‘‘a diagnosis is confirmed’’ and there is no indication that the first physician has not ‘‘been truthful in his medical documentation.’’ Id. at 531–32. While Dr. Christensen testified that when he ‘‘see[s] a[n] electronic medical record like this that shows a complete visit, I’m always suspicious,’’ he added that ‘‘that’s not a standard of care issue.’’ Id. at 533. Subsequently, he agreed that ‘‘if a physical exam was noted in the record, you wouldn’t need to reconfirm the diagnosis.’’ Id. at 534. Dr. Christensen acknowledged that based on his review of the case, he did not know whether Respondent actually saw the urinalysis results. Id. However, he acknowledged that Respondent could not have seen BCI 2’s March 19 test results and that her previous test result (Feb. 19, 2015) was below the level of detection. Id. at 534–36. Dr. Christensen also acknowledged that the documentation by Dr. R. of her January 23, 2015 examination of BCI 2 reflected an ‘‘appropriate’’ musculoskeletal examination in that it involved identifying if there were spasms, checking for tenderness, and testing the range of motion of the lumbar spine. Id. at 537–38. Dr. Christensen agreed that Dr. R.’s decision to order an MRI was a reasonable step to confirm her diagnosis of lower back pain and that patients ‘‘occasionally’’ do not get their MRI done before their next visit. Id. at 539– 40. Dr. Christensen then acknowledged that it was reasonable for Respondent ‘‘to trust’’ the medical records created by Dr. R. for BCI 2’s January 23 and PO 00000 Frm 00015 Fmt 4701 Sfmt 4703 18895 February 20 visits. Id. at 540. He agreed that Dr. R. had issued to BCI 2 prescriptions for Norco, carisoprodol, and Xanax at these visits. Id. at 540–41. He acknowledged that there is no specific standard as to how often a physician should run a MAPS report and that this ‘‘depends on the patient.’’ Id. at 541–42. Dr. Christensen also testified that the MAPS report in BCI 2’s file, which showed that she had last obtained Xanax from a Nurse Practitioner eight months earlier, was actually obtained prior to Dr. R.’s issuance of the prescriptions on January 23, 2015. Id. at 544. While Respondent’s counsel then suggested that based on the MAPS report and Dr. R.’s February 20 note, Respondent ‘‘would have no indication that [BCI 2] had an outstanding prescription for Xanax at [the] time’’ of her March 19 visit with him, Dr. Christensen testified that Respondent would know without running another MAPS report if ‘‘the prescriptions were in the chart’’ or if ‘‘he asked the patient.’’ Id. at 545. Dr. Christensen added that he ‘‘saw no indication that [Respondent] asked her what medications she was taking.’’ Id. at 545. And on questioning by the CALJ, Dr. Christensen testified that Dr. R.’s January 23, 2015 visit note (GX 11, at 16) documented that the Xanax prescription she wrote that date provided four refills and that Respondent ‘‘would know that [BCI 2] was also taking Xanax.’’ Id. at 546. Asked by Respondent’s counsel whether, based on ‘‘a review of her history and her MAPS report,’’ BCI 2 ‘‘appeared to be a doctor shopper,’’ Dr. Christensen testified: ‘‘she [did] not appear to have legitimate pain complaints and [was] seeking Norco and Xanax and Ambien.’’ Id. at 555. Respondent’s counsel then asked whether ‘‘it was reasonable for [Respondent] to prescribe [to her] based on her MAPS report and her prior history?’’ Id. While Dr. Christensen acknowledged that the MAPS report did not show that BCI 2 was engaged in doctor shopping and that this was not a red flag, he then explained: ‘‘[e]xcept that she presented requesting refills and there was no sign that she was getting medication.’’ Id. at 556. Observing that in the note for BCI 2’s January 21, 2015 visit, Dr. Vora had written that his treatment plan included a referral for a mental health evaluation (GX11, at 14), Respondent’s counsel asked Dr. Christensen if ‘‘a referral like that would be for the purpose of treating potential addiction?’’ Id. at 558. Dr. Christensen testified ‘‘[n]ot necessarily, no,’’ and after reading the contents of E:\FR\FM\30APN2.SGM 30APN2 sradovich on DSK3GMQ082PROD with NOTICES2 18896 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices the note, added: ‘‘It doesn’t say whether it’s for addiction or anxiety.’’ Id. at 558– 59. While Dr. Christensen acknowledged that ‘‘[i]t’s possible’’ that the referral was made because BCI 2 was engaged in ‘‘drug-seeking behavior,’’ this was ‘‘[n]ot necessarily’’ the case. Id. Dr. Christensen agreed that both Norco 5 mg and 7.5 mg are indicated for moderate to severe pain, and that on a pain scale, moderate pain is pain above 4. Id. at 559–60. Asked if the pain level which BCI 2 noted on her pain history questionnaire as the usual level of her pain (‘‘4’’ on a 0 to 10 scale) should not be considered as ‘‘moderate pain,’’ Dr. Christensen initially said ‘‘yes’’ but agreed that there is no universal agreement as to that standard. Id. at 561. He then acknowledged that it would be okay to prescribe Norco to someone complaining of pain at a level of 4, but that would be the minimum level for prescribing the drug. Id. Noting that BCI 2’s pain history questionnaire indicated that her present pain was at the ‘‘0’’ level and that her pain was decreased by ‘‘medication,’’ Dr. Christensen disagreed that it would ‘‘be fair to assume’’ that Norco was the reason for her experiencing ‘‘0 pain.’’ Id. at 562. He testified that this was ‘‘not necessarily’’ the case, noting that ‘‘when she said everything is great, we don’t know that that’s because of her pain medication.’’ 18 Id. Dr. Christensen acknowledged that ‘‘[i]t’s possible’’ that BCI 2’s statement to Respondent that ‘‘I’m good today’’ was ‘‘an indication that she’s being well managed on her pain . . . with medication.’’ Id. at 563– 64. Dr. Christensen disagreed, however, with the suggestion of Respondent’s counsel that it was ‘‘not unreasonable for [Respondent] to conclude that that statement means my current regime is appropriate.’’ Id. at 564. As he further testified: ‘‘For a physician not to bother asking someone how much medication they’re taking? Reasonable? . . . I’m sorry, sir, but I don’t think it’s reasonable for an interviewer to completely ignore asking, are you taking your medication? How much medication are you taking? It’s missing.’’ Id. As for BCI 2’s response (‘‘Uh, just here for refills’’) to Respondent’s question (‘‘so tell me what’s going on?’’), GX 7, at 2, Dr. Christensen acknowledged that BCI 2’s answer could potentially be ‘‘an indication that she is taking her 18 Dr. Christensen correctly observed that BCI 2’s pain history questionnaire was not dated. Tr. 563. While Dr. Christensen testified that the document was used by Dr. R., he did not know if it was completed before BCI 2’s first or second visit with Dr. R. Id. VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 medication and needs refills.’’ 19 Tr. 566. Apparently interpreting the question as asking whether BCI 2 was taking the medications as prescribed, Dr. Christensen disagreed that this was a reasonable conclusion. Id. at 566–67. As he explained: ‘‘How much? . . . I will stand by my statement [that] it’s inappropriate for a physician to ignore asking whether or not someone’s taking their medication as prescribed, especially if there’s been a change in the pain level.’’ Id. at 567. In response to a similar question by Respondent’s counsel, Dr. Christensen testified that ‘‘I believe that’s insufficient information to assume they’re [sic] taking the medication according to the prescribed schedule.’’ Id. Asked how often a physical exam is required of a patient the same age as BCI 2 (41) who complains of back pain and was receiving Norco and ‘‘the more dangerous things have been ruled out,’’ Dr. Christensen testified that DEA regulations require a visit ‘‘every 90 days for a schedule II medication’’ such as Norco.20 Id. at 568. Dr. Christensen then testified that under DEA regulations, Respondent was not even required to conduct a visit with BCI 2 if she had previously received a prescription for Norco. Id. However, when then asked whether requiring the visit was ‘‘[o]ver and above what [he] believe[s] is required [by] the standard of care in Michigan,’’ Dr. Christensen testified that ‘‘my interpretation of this patient is apparently different than [Respondent’s], so I can’t confirm your question.’’ Id. at 569. Asked by the CALJ if there is ‘‘a different standard that prevails in Michigan than the one that’s in the DEA regulations in regards to the requirement of a visit,’’ Dr. Christensen testified that he believed ‘‘the DEA 19 Respondent’s counsel’s question simply asked: ‘‘Is that to you an indication that she is taking her medication and needs refills of those medications?’’ Tr. 566. He did not ask if BCI 2’s statement was an indication that she was taking her medication as prescribed. Id. 20 DEA’s regulation does not, however, specify how often a patient who is being prescribed schedule II controlled substances must return for an office visit. See 21 CFR 1306.12. Rather, the regulation allows an individual practitioner to ‘‘issue multiple prescriptions authorizing the patient to receive up to a 90-day supply of a Schedule II’’ drug provided various conditions are met. Id. § 1306.12(b)(1). Indeed, the regulation states that ‘‘[n]othing in [it] shall be construed as mandating or encouraging individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days when prescribing Schedule II controlled substances. Rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so.’’ Id. § 1306.12(b)(2). PO 00000 Frm 00016 Fmt 4701 Sfmt 4703 prescriber manual . . . does give the 90day interval as a requirement but also recommends that the visit be more frequent.’’ Id. Then asked by the CALJ if Michigan’s standard requires more frequent visits than every 90 days, Dr. Christensen testified: ‘‘I don’t believe we have a standard.’’ Id. Respondent’s counsel then asked if it would have been ‘‘okay for [Respondent] to prescribe controlled substances for a patient such as [BCI 2], assuming all the information you know about her, and not see her for 90 days?’’ Id. at 569–70. After clarifying that Respondent’s counsel was referring to the information available at BCI 2’s visit with Respondent, Dr. Christensen testified: ‘‘at that time, if you schedule a 90-day return visit and her urine drug screen came up negative for prescribed medications, you would need—I believe it would be appropriate to intervene.’’ Id. at 570. Dr. Christensen testified that this would involve having her come back ‘‘about a week later’’ and doing a pill count. Id. Dr. Christensen then agreed that Respondent did not have the results of the March 19 drug test available to him 21 ‘‘[a]t the time of the visit.’’ Id. On cross-examination, Respondent’s counsel also questioned Dr. Christensen regarding his direct testimony questioning Respondent’s notation in the visit note that ‘‘[p]ain shoots to left hip.’’ Id. at 571 (GX 11, at 35). As Dr. Christensen testified, the Investigator testified that when asked by Respondent ‘‘to point to where it is real quick,’’ (GX 7, at 3), she pointed to her lower right hip area and not her left hip. Tr. 285; see also id. at 572. Respondent’s counsel then asked: ‘‘this statement here, shoots to left hip, if somebody’s complaining of back pain, but when they’re asked where it hurts and it manifests itself on the hip side, would that appear to you that the pain is shooting from one area to another area?’’ Id. at 572. Dr. Christensen testified: ‘‘If they complained of pain in both areas.’’ Id. Then asked if ‘‘that would be consistent with shooting pain,’’ Dr. Christensen testified: ‘‘If they said it was shooting. You could have pain in two separate locations. The shooting pain typically refers to nerve irritation or injury.’’ Id. However, as found above, BCI 2 did not complain of shooting pain but said ‘‘it just stays there.’’ GX 7, at 3. 21 However, the results of the February 20 drug test, which was negative for all drugs including those that had previously been prescribed to her, would have been available on the date of BCI 2’s visit, although Respondent claimed that he still did not have access to the results. E:\FR\FM\30APN2.SGM 30APN2 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices sradovich on DSK3GMQ082PROD with NOTICES2 On re-direct, Dr. Christensen testified that Respondent’s prescribing of 60 Norco and 60 Soma to BCI 2 was a departure from Dr. R.’s treatment plan which she instituted at the February visit, and that while there was some discussion as to why Respondent reduced the Soma prescription, there was ‘‘no discussion’’ as to why he increased the Norco prescription. Id. at 576. Dr. Christensen explained that the standard of care in Michigan includes ‘‘the principle of informed consent’’ and that this ‘‘require[s] [that] if you’re making a major change in a controlled substance, . . . to discuss it, [and] why you’re recommending it.’’ Id. at 577. Dr. Christensen testified that he found no evidence in the video that there was any discussion as to why Respondent increased the Norco. Id. He also testified that it appeared that Respondent was ‘‘ignoring the planned taper by Dr. [R.]’’ and that Respondent was trading an ‘‘increase’’ in the Norco prescription for a ‘‘decrease’’ in the Soma. Id. While on re-cross, Dr. Christensen agreed that Respondent’s decreasing of the Soma prescription was reasonable and this drug has an analgesic effect ‘‘in short-term treatment,’’ he testified that increasing BCI 2’s Norco prescription ‘‘to maintain the analgesic effect’’ was not ‘‘a rational therapeutic choice.’’ Id. at 580. Then asked if he would rather have BCI 2 ‘‘on Norco only and not Soma or Soma only and not Norco,’’ Dr. Christensen answered ‘‘[n]either.’’ Id. at 580–81. Respondent’s Case Respondent testified on his own behalf and called two other witnesses. The first of these was Dr. Carla Scott, a physician who is the medical director for the Wayne County Juvenile Detention Facility. Tr. 592. Dr. Scott, who did residencies in both internal medicine and pediatrics and is board certified in pediatrics, testified that her duties involve overseeing the facility’s Health Services Department, including its Mental Health Department, and that the facility has a psychiatrist, two psychologists, three social workers, and two contractor physicians. Id. at 593–94. Dr. Scott also testified that she had ‘‘worked as a professor for a year at Baylor.’’ Id. at 593. Dr. Scott testified that when she first moved back to Detroit she had worked at an outpatient public health clinic for ‘‘[a]bout nine or 10 months, ’’ id. at 595, but had left because she did not like the way the clinic practiced medicine, as ‘‘[t]hey really expected physicians to just pass out drugs’’ as ‘‘they got paid per capita’’ and ‘‘the more patients you saw, the faster you saw them, the more VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 money the clinic made.’’ Id. at 596. She explained that ‘‘they felt like I spent too much time with the patients’’ and because the clinic ‘‘push[ed] the doctors to . . . just keep the patients coming in . . . we had a lot of patients there who were just drug-seeking.’’ Id. at 596–97. She testified that she was ‘‘threatened several times’’ and ‘‘had to have people removed from the clinic because’’ she was not ‘‘going to write the scripts.’’ Id. at 597. Dr. Scott also testified that she ‘‘clearly . . . learned something’’ about identifying drug-seeking behavior, but acknowledged that ‘‘I can’t say that I was an expert.’’ Id. Dr. Scott testified that she went to medical school with Respondent and that they ‘‘were pretty good friends’’ until their residencies led them to go their ‘‘separate ways.’’ Id. at 598. Dr. Scott testified that she did not ‘‘hear from [Respondent] for like 25 years,’’ at which point Respondent called and asked her to supervise him pursuant to an order of the Michigan Medical Board.22 Id. As Dr. Scott did not have any available positions, Respondent worked at the detention center as a volunteer. Id. According to Dr. Scott, the letter she received from the Board after she agreed to supervise Respondent ‘‘was really vague’’ as to what this entailed, so Dr. Scott asked him where else he was working and asked to see some of his patient charts. Id. at 599. Respondent told Dr. Scott ‘‘that he had opened up his own private pain clinic,’’ which sent Dr. Scott’s ‘‘antennas up . . . because [she] ha[s] an issue about narcotics.’’ Id. Dr. Scott asked to see these files and also went over to see his pain clinic. Id. Dr. Scott testified that she reviewed Respondent’s charts and that after she fired one of the detention center’s physicians, she hired Respondent as a part-time contractor. Id. at 603. Dr. Scott testified that her supervision began around April 2014 and lasted for one year, after which she wrote a letter to the Board. Id. at 604– 05. She testified that she reviewed about 10 of his pain clinic charts, and that all of these charts were for patients who were receiving controlled substances. Id. at 605. While Dr. Scott also reviewed hundreds of charts maintained by 22 Respondent had been accepted for a fellowship at Johns Hopkins but was required to have a permanent license and list the license number on the application. Tr. 628. According to Respondent, he then had only a temporary educational license so he listed his roommate’s license number. Id. While Respondent did receive a permanent license, he was sanctioned for falsifying his application. Id. at 628–30; see also id. at 601–02. Respondent testified that he ‘‘made a severe error in judgment’’ and that he ‘‘was dishonest on [his] application to Johns Hopkins.’’ Id. at 628. PO 00000 Frm 00017 Fmt 4701 Sfmt 4703 18897 Respondent in the course of his employment at the detention center, she acknowledged that ‘‘not a lot of these’’ involve patients on controlled substances as ‘‘we give out little to no narcotics at the . . . detention facility.’’ Id. at 606. She subsequently testified that controlled substances for pain were ‘‘probably less than five percent,’’ and ‘‘might even be less than two percent’’ of the drugs that are prescribed at the detention facility. Id. at 607. While Dr. Scott testified that ‘‘we have a lot of kids on’’ controlled substances for psychiatric conditions, those prescriptions are ‘‘always done by the psychiatrist’’ unless the ‘‘psychiatrist is absent’’ and ‘‘they’re always reviewed.’’ Id. Dr. Scott testified that she ‘‘did not have any problems with the’’ the 10 charts she reviewed from Respondent’s private pain clinic. Id. at 610. She did, however, ‘‘talk to him about . . . making sure that he . . . sent people to physical therapy, and he already was.’’ Id. Dr. Scott also testified that Respondent showed her that ‘‘they had to bring in films’’ and ‘‘different things’’; Dr. Scott did not, however, clarify what these ‘‘different things’’ involved. Id. Asked what she was looking for in reviewing Respondent’s charts, Dr. Scott testified: . . . just that as a physician that someone gave him a good reason why they needed narcotics and that he had a plan in place on how to get them off narcotics, that there were . . . other modalities offered to people, that you talked to them about other things that they could do for pain control, that you made sure that, because . . . pain is nebulous. It’s very difficult. I mean, you can tell me you’re in pain, but . . . how do I know that you really are? So you, as a physician, you’re going to have to try to figure out how, you know, this person’s saying they’re in pain . . . so what are the best steps in terms of getting them out of pain . . . . and what kind, what other kinds of things can you do besides give them pills. And that’s what I wanted to see. Id. at 610–11. Dr. Scott also testified that she never had an issue with Respondent’s charting of his treatment of patients at the detention facility. Id. at 611. However, Dr. Scott offered no testimony to even establish that Respondent treated any of the detention facility’s patients with narcotics.23 Id. Next, Respondent called Ms. Tyanna Clemmons. Id. at 613. Ms. Clemmons 23 Dr. Scott also testified that Respondent had an ‘‘excellent’’ work ethic at the detention facility, that she ‘‘would like for him to continue to be an employee,’’ and that he is ‘‘providing a valuable service to the community.’’ Id. at 611–12. None of this testimony is relevant in the public interest determination. See Gregory Owens, 74 FR 36751, 36756–57 (2009). E:\FR\FM\30APN2.SGM 30APN2 sradovich on DSK3GMQ082PROD with NOTICES2 18898 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices testified that she is a Certified Nursing Assistant and that she worked as Respondent’s office manager at a clinic he owned in Flint, Michigan from March through July 2016. Id. at 616–17. Ms. Clemmons testified that her duties involved ‘‘scheduling patients, collecting documentation for patients,’’ and managing the patient files. Id. at 617–18. Asked what type of documentation she would see in the patient files, she testified that ‘‘all of our patients had to have imaging studies.’’ Id. at 618. She also testified that ‘‘[w]e had the patients sign their consent forms,’’ that she ‘‘would contact [the patient’s] previous doctor to receive their documentation,’’ and that Respondent ‘‘always reviewed’’ these records ‘‘to see . . . what was exactly going on with the patient.’’ Id. at 619. Ms. Clemmons testified that the patients would undergo monthly urinalysis testing, that Respondent reviewed each drug test result, and that there was one patient, who tested positive for cocaine and was discharged by Respondent. Id. at 619–20. Asked how she knew that Respondent reviewed the drug test results, Ms. Clemmons testified: ‘‘Because I specifically gave them to [Respondent]. He would have them inside of his file . . . [and] he always reviewed his files before his examination.’’ Id. at 620. Ms. Clemmons testified that Respondent would see ‘‘about 10’’ patients a day and that he would spend ‘‘[r]oughly about 30 minutes’’ with the patients, although the amount of time per visit varied and was ‘‘[s]ometimes maybe 15 minutes, sometime maybe 45 minutes.’’ Id. at 621. She also testified that a MAPS report would be obtained for every visit by a patient and that ‘‘every time’’ the report indicated that a patient was engaged in doctor shopping, the patient would be discharged. Id. at 622–23. Finally, she testified that patients were given referrals for ‘‘outpatient therapy, chiropractors and . . . home care services.’’ Id. Finally, Respondent testified on his own behalf. Id. at 624–700. Respondent testified that he received his undergraduate degree from the University of Michigan and his medical degree from Wayne State University. Id. at 624. Following medical school, Respondent did both an internship and a residency in radiology at Howard University Hospital. Id. at 625. He also did a fellowship in interventional radiology at the Detroit Medical Center and in neuroradiology at the University of Arizona. Id. Respondent testified that his neuroradiology fellowship involved interpreting MRIs of the brain, face, neck and spine and that he was ‘‘taught VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 to evaluate pain pumps, kyphoplasty, vertebroplasty, nerve blocks, facet blocks, blood patches, [and] SI joint injections.’’ Id. at 625. As for his fellowship in interventional radiology, Respondent testified that ‘‘you get taught in pain management as far as facet blocks, epidural injections, nerve blocks, [and] pain pump evaluations.’’ Id. at 627. He also testified that while he is board eligible, he is not board certified. Id. Subsequently, Respondent testified that prescribing narcotics was ‘‘[p]art of the training in each of [his] fellowships . . . because that’s pain management.’’ Id. at 647. Respondent also testified that he has had significant training in pain management. Id. at 648. He further testified that he has ‘‘a few months’’ of experience doing office-based pain management. Id. at 652. Respondent testified that notwithstanding the earlier sanctions that were imposed on his medical licenses, all of his licenses are now ‘‘free and clear’’ with ‘‘no restrictions.’’ Id. at 631. Describing his work at the juvenile detention facility, Respondent testified that it involved doing physicals and minor procedures and ‘‘not that much’’ prescribing of narcotics. Id. Continuing, Respondent offered vague testimony that ‘‘the anti-psychotics, stuff like that, I would say it’s 10 to 20 percent because . . . the psychiatrists might not be there.’’ Id. Respondent did not, however, identify what specific ‘‘antipsychotics’’ he prescribed, and thus, there is no evidence as to whether this prescribing involved any drugs that are controlled substances. Moving on to the allegations of the Show Cause Order, Respondent testified that in January 2015, he started doing locum tenens work for a company called Michigan Healthcare. Id. at 633. Respondent did one or two shifts at Michigan Healthcare before taking on locum tenens work at Dr. Vora’s office.24 Id. at 634. Respondent testified that he understood his work at Dr. Vora’s office would involve ‘‘just see[ing] patients and that I’d be doing procedures since I have been fellowship trained.’’ Id. at 635. He testified that he was not informed that he would specifically be seeing pain management patients. Id. Rather, he explained: ‘‘The setup that it was supposed to be was that I’d go to Dr. Vora, Dr. Vora would set up [the] patient, and then I would see patients, because it was done through, at least the patient list was done through Dr. Vora’s 24 Respondent testified that he became aware of the position at Dr. Vora’s office through Michigan Healthcare. Tr. 635. PO 00000 Frm 00018 Fmt 4701 Sfmt 4703 officer manager and the office manager at Michigan Healthcare.’’ Id. Respondent testified that he worked ‘‘two or three’’ days total at Dr. Vora’s practice. Id. Respondent testified that his first day at Dr. Vora’s practice was February 19, 2015, the day he saw BCI 1. Id. at 636. Respondent testified that ‘‘[p]rior to showing up’’ on that morning, he had no communication with either Dr. Vora or his staff other than a conversation he had ‘‘on the way to Gladwin’’ (the location of the office), when ‘‘all [he] was told was that he was going to have some patients and . . . see patients.’’ Id. at 636–37. He testified that he had ‘‘zero’’ opportunity to review the patient charts prior to arriving at the office and did not know how many patients he would see until he arrived and was provided with ‘‘a patient list’’ of 25 patients by the office manager. Id. at 637–38. Respondent denied that he had access to the urine drug screen, stating that he did not ‘‘have access through the EMR’’ (the electronic medical records), because ‘‘something was going on with [the office’s] computer system.’’ Id. at 638–39. Respondent testified: ‘‘What Dr. Vora, his staff would do would give me these printouts of the charts and I would, you know, request.’’ Continuing, Respondent testified: ‘‘I had at the very least to have the MAPS, but I said I also need the urinalysis in order to see what’s going on with the patients and to . . . have what I would think is a complete access to the medical records.’’ 25 Id. Respondent further testified that he did not know if anyone could access the urine drug screen reports.26 Id. at 639. Asked whether he had ‘‘any discussions with Dr. Vora prior to walking in for [his] first patient,’’ Respondent initially testified: ‘‘[z]ero . . . [o]ther than that he introduced 25 Respondent also maintained that after his first day, he told the staff that he ‘‘wanted to have access to the urinalysis’’ and ‘‘access to the[ ] full . . . EMR.’’ Tr. 687. He also wanted ‘‘advance knowledge of which patients [he] would be seeing’’ and ‘‘to have the MAPS there prior to . . . coming to the office.’’ Id. Respondent testified that when he showed up on March 19, 2015, his instructions ‘‘were not’’ followed. Id. However, later during cross-examination, Respondent testified that ‘‘for every patient I got [a] MAPS’’ and ‘‘[b]efore I saw any patient I was able to get the MAPS’’ without specifying that he got MAPS reports only on March 19, 2015. Id. at 692. While on cross-examination, Respondent reiterated that the UDSs were missing when asked what else was missing ‘‘apart from the urinalysis records,’’ ‘‘I didn’t think anything was missing off of the top of my head . . . .’’ Id. at 693. 26 Respondent also testified that he was told that he would have access to the urine drug screens ‘‘either later on that day or even the next visit.’’ Tr. 639. E:\FR\FM\30APN2.SGM 30APN2 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices himself to me.’’ Id. However, when then asked by his counsel if Dr. Vora said ‘‘anything about his prior treatment of the patients or a care plan,’’ Respondent testified: Oh, yeah. He said that all the patients that I was receiving he had seen, he had established a patient management plan, and that he would, because they were his patients, that he would prefer that if there was [sic] any drastic changes that I’d discuss them with him. Id. As for why he did not refuse to see the patients until he could see their urine drug screen results, Respondent explained: Well, initially, number one, they’re established patients. Number two is that it’s not necessarily a requirement to have urine drug screens every time you see the patient. Therefore . . . you can have . . . you have judgment. It’s up to me to decide whether okay, I’ll see this patient, or it is definitely a . . . requirement for me to have the urine screens. Id. at 640. As for how he knew that the patients were established patients, Respondent testified that the office manager gave him ‘‘printouts of the patient’s prior history . . . what he had decided to treat.’’ Id. Respondent testified that he took ‘‘into account the patients’ medical records and prior history.’’ Id. Asked what he was looking at based on the videos which show him flipping through pages during BCI 1’s visits and looking at a tablet during BCI 2’s visit, Respondent testified that: sradovich on DSK3GMQ082PROD with NOTICES2 [t]he second time I came, and I think that’s with [BCI 2], it was all mixed up. It was that I got part of the medical records [that] were given to me through the printout that [the] office manager gave me, and then . . . I had limited access via . . . my computer, but because it was not the computer established with [the] EMR, I can [sic] only get access to certain areas of the patients’ medical records. Id. at 641. Respondent then testified that ‘‘the paper was the prior medical history as far as that goes’’ for BCI 1 and the tablet had ‘‘some additional information on him.’’ Id. Addressing BCI 1’s first visit, Respondent testified that he ‘‘definitely’’ recalled the visit and that ‘‘[i]t was very memorable’’ as ‘‘the language that he was using was inappropriate. . . . I don’t think that anybody talks to their physician, yeah, brother, yeah, you know, in a hot month he’s going to be back. I think that no one talks like that, number one.’’ Id. at 642. Respondent then explained that this language elicited this reaction because Gladwin, Michigan ‘‘is like Leesburg[,] [Virginia] 40 or 50 years ago. So, when VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 I go to Gladwin, it’s like I am a sore thumb standing out.’’ Id. at 642–43. Asked by the CALJ what he meant by that, Respondent testified: ‘‘I mean there are no African-American people there, period.’’ Id. at 643. Then asked by his counsel if he was ‘‘suggesting that [he was] treated differently because of [his] race by’’ BCI 1, Respondent answered: ‘‘There’s no other way I could say it because I can’t see him saying those things if I were not African-American.’’ Id. Asked by his counsel what he was ‘‘feeling about some of the statements he made and whether . . . he was cooperating as a patient with’’ him, Respondent testified that the ‘‘main thing’’ was ‘‘to try to connect [with the patient] on a human level.’’ Id. Continuing, Respondent explained that ‘‘you want to talk to the patient, you want to let them know that you’re a regular person, you’re there to take care of them, you’re there to help them out. You’re no different than they are. So you want to initially just establish a rapport with the patient.’’ Id. at 643–44. Respondent further explained that: [i]f they [sic] feel comfortable with you, then they [sic] can feel comfortable accepting what you advise them to do, your orders, whatever it may be. But if they [sic] feel that you are coming from a condescending type of attitude and you’re there to bigfoot them, them . . . they [sic] might not be as receptive to following your plan. Id. at 644. Addressing some of the dialogue at BCI 1’s first visit with him, Respondent was asked to explain ‘‘[w]hat [was] going through [his] mind when’’ BCI 1 said that ‘‘I take Norco for my back and I take Xanax on the weekends.’’ Id. Respondent testified: Multiple things. You know, I’m thinking that he was taking the Norco for his back pain. The Xanax is, which was for anxiety which was previously diagnosed from Dr. Vora’s records, and that’s my impression of that. I would think, . . . anybody would—I don’t think it’s unreasonable to say that when he says I’m taking Norco for my back that it’s for back pain. I don’t think that’s unreasonable. Id. at 644–45. As for his subsequent question to BCI 1 (‘‘Okay, so you have back pain, some anxiety?’’), Respondent explained that, in his mind, he viewed BCI 1’s answer of ‘‘I guess,’’ ‘‘as an affirmative answer’’ to his question, and that BCI 1was confirming the diagnoses of back pain and anxiety which were documented in the patient record. Id. at 645. Respondent also testified that prior to asking these questions, he had looked through the medical record and noticed both diagnoses, id. at 645, and that he PO 00000 Frm 00019 Fmt 4701 Sfmt 4703 18899 believed the diagnoses were substantiated as he had no other reason to believe that the medical records were not legitimate as far as that goes.’’ Id. at 645–46. On questioning by the CALJ, Respondent testified that he knew ‘‘[z]ero’’ about Dr. Vora before going to the clinic and ‘‘[t]hat’s the way locums works.’’ Id. at 646. The CALJ then asked Respondent if it was clear to him ‘‘after [he] started seeing patients that [he was] doing pain management?’’ Id. at 646–47. Respondent answered: At that time, I went specifically to Dr. Vora and I said this is not really what I had signed up for, was just to see pain patients. You know, however, as a matter of professional courtesy, I said okay, you know, I’ll do this, but this is not what I signed up for. I want to do something else. This is not for me per se. Id. at 647. Suggesting that Respondent ‘‘almost want[ed] to have it both ways’’ in that ‘‘[o]n the one hand,’’ he was claiming that he ‘‘didn’t understand anything about this and . . . didn’t know what to look for and . . . didn’t have . . . access to the records[,] [b]ut on the other hand . . . talked about [his] extensive training . . . in the science of pain management,’’ the CALJ asked ‘‘which one is it?’’ Id. at 649. Respondent answered: ‘‘when you say access, that is like EMR . . . Electronic Medical Record. That is something that you have to have a password for. So I am reliant upon somebody else to provide those for me as far as that goes. And as far as my fellowship training, pain is just part of that. It’s not the only thing about interventional radiology or neuroradiology.’’ Id. at 649–50. After Respondent acknowledged that as an interventional radiologist he would not perform a procedure (such as an epidural) in a complex case without the necessary tools, the CALJ again asked Respondent to explain why, given his training on prescribing opioids, he was willing to prescribe pain medication without ‘‘more access’’ to the medical records. Id. at 650–51. Respondent answered: . . . This is the way it works. With pain management, first, you have to go conservative . . . . You can go three months and you can see a patient and not perform a procedure. So that’s not unreasonable. It’s not unreasonable for a physician to see a patient for three months, and then after that three months, if they’re just getting medication, you have to ask them if they want or if they are amenable to a procedure. So it’s not like you—because that’s not the way medicine works. You first start out conservatively. Then after you start out conservatively, if the pain is not being controlled, it’s over three to four months, E:\FR\FM\30APN2.SGM 30APN2 18900 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices then you offer them a procedure. If they are not amenable to the procedure, you are supposed to discharge or refer them to another physician or not see them. It’s their choice really. Id. at 651–52. Returning to the dialog of BCI 1’s first visit, Respondent testified that when he asked how long BCI 1 had his lower back pain and BCI 1 said ‘‘Uh, probably 10 years,’’ he believed that BCI 1 ‘‘has chronic back pain, degenerative disc disease,’’ that this is ‘‘the most common low back pain diagnosis,’’ and that he took BCI 1’s statement ‘‘as an affirmative.’’ Id. at 653. Then asked what BCI 1’s statement ‘‘[m]ostly just stiff’’ meant to him, Respondent answered: sradovich on DSK3GMQ082PROD with NOTICES2 The thing when you’re evaluating a patient, and again, this patient, he’s stating that he’s having difficulty reading. You do not want patients coming in using medical terminology. You want them to describe it. If they start using medical terminology during the office visit, you can get suspicious that they’re either Googling it or they’re trying to, you know, skew their answers to make it seem like they have these certain illnesses. Id. at 653–54. Respondent added that ‘‘mostly just stiff . . . means back pain’’ to him. Id. at 654. As for his questioning BCI 1 as to whether he had ‘‘any muscle spasms with the pain’’ and BCI 1’s response to the effect that ‘‘[i]t gets tight . . . so I don’t know . . . I don’t know what the word is for that. Stiff,’’ Respondent testified that ‘‘[t]o me, when you say tight . . . that it would be indicative of muscle spasm.’’ Id. Respondent further explained that ‘‘[t]here’s various ways that people describe . . . low back pain and that’s one of them, in addition to muscle spasm.’’ Id. at 654–55. Respondent also asserted that BCI 1’s failure to deny muscles spasms also played into his belief that he had muscle spasms. Id. at 655. As for his asking BCI 1 if he ‘‘ever ha[s] to walk with a limp because [his] pain gets so bad,’’ Respondent explained that ‘‘you want to know the degree of pain, if it’s causing him a lifestyle type of change. You’re trying to measure how severe the pain is.’’ Id. As for BCI 1’s answer (‘‘No, I strut a little bit. Does that count?’’), Respondent answered that he considered ‘‘the language that he’s using . . . strut. I would consider that a limp . . . at the very least abnormality of his gait.’’ Id. As for why someone would answer his question this way, Respondent testified: ‘‘[a]gain, I’m trying to get to know the patient. You know, for him, with him. I just took it as that he did walk with . . . he had abnormality of his gait.’’ Id. at 655–56. VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 Addressing his asking BCI 1 if he had ever fallen and BCI 1’s response (‘‘I’m a grown-ass man. Yeah, I’ve fallen.’’), Respondent testified that ‘‘it’s very difficult to determine what he’s trying to say. However, when someone says that they have fallen, to me, that means muscle weakness.’’ Id. Respondent then recited BCI 1’s answer to his question as to whether the latter had lost muscle strength (‘‘I mean, just getting older, what not. I don’t know how you, you know.’’), and Respondent’s counsel asked if he felt ‘‘like the patient in this case was being evasive or answering your questions in a straight-up manner?’’ Id. at 656. Respondent answered: ‘‘[t]here are multiple things that are going through my mind. Number one, I think he’s trying to overcompensate. He’s using a lot of slang. . . .’’ Id. Asked by the CALJ what he meant by his use of the term ‘‘overcompensate,’’ Respondent testified: ‘‘Like I don’t think that he’s used to seeing somebody like myself . . . evaluate him.’’ Id. at 657. Then asked by the CALJ what he meant by ‘‘somebody like yourself,’’ Respondent answered: ‘‘An AfricanAmerican. I don’t think that he’s . . . I just can’t see a person who comes to a doctor’s office using the language that he does.’’ Id. at 657. Respondent then testified that he had issues with his race while at the Gladwin office as ‘‘[t]here were times that some of the patients did not want me to touch them. So, you know, there’s nothing I can do about that as far as that goes, so it can be, you know.’’ Id. Continuing, Respondent testified that ‘‘[t]he only reason why I could deduce is that . . . I’m AfricanAmerican.’’ Id. Respondent then testified that patients had not only said that they did not want him to touch him but also that they ‘‘don’t like black people.’’ Id. Asked when he encountered these persons, Respondent testified that ‘‘it happened twice. It happened right before [BCI 2], and then it happened . . . two or three patients prior to seeing [BCI 1] . . . [t]he second time.’’ Id. at 658. Respondent did not, however, assert that either BCI 1 or BCI 2 acted in this fashion. While Respondent further testified that this had an effect on how he interacted with patients, he then explained that this led him to ‘‘want to . . . instill trust in the patients that I know what I’m doing and that I’m there to help them.’’ Id. As for the portion of BCI 1’s first visit when Respondent asked the former to stand up and point to the part of his back that hurts the most, Respondent asserted that ‘‘he had his coat on his arm’’ and that he did not ‘‘believe’’ that PO 00000 Frm 00020 Fmt 4701 Sfmt 4703 BCI 1’s testimony that he was wearing a coat during the physical exam ‘‘to be credible.’’ Id. at 658–59. Respondent also maintained that BCI 1 ‘‘had some type of a thick shirt on’’ and ‘‘when I asked him to turn around, I lifted up his shirt and then I pressed on his back.’’ Id. at 659. Respondent then reiterated that he ‘‘personally press[ed] on [BCI 1’s] back’’ and testified that when he did so, he ‘‘was feeling tightness, feeling . . . whether he was going to elicit some pain. That’s it. Muscle tone, spasm.’’ Id. As found above, as BCI 1 pointed to his back, he stated ‘‘[m]ostly just stiff.’’ GX 3, at 9. Respondent testified that he took this statement ‘‘as pain.’’ Tr. 659. Respondent then explained that he asked BCI 1 if his pain shot anywhere or was localized because he ‘‘wanted to see if [BCI 1] had any nerve symptoms’’ which would indicate ‘‘[t]hat he ha[d] radiculopathy’’ or ‘‘degenerative disc disease.’’ Id. at 660. As also found above, BCI 1 said that his pain was localized. GX 3, at 9. Respondent testified that this statement ‘‘could mean a lot of things,’’ including ‘‘that he had a herniated disc,’’ that ‘‘it could be a degenerative disc, or it could be a narrowing of his neuroforamina.’’ Tr. 660. Respondent then testified that ‘‘[y]ou can feel a herniated disc’’ but not degenerative disc disease with your finger. Id. at 660–61. Respondent further testified that BCI 1’s ‘‘prior medical records’’ showed that he had been referred to radiology. Id. at 660–61. However, while the ‘‘Orders’’ section of Dr. Vora’s progress note for BCI 1’s December 15, 2014 visit contain the notations ‘‘Radiology’’ and ‘‘lumbar spine,’’ GX 10, at 3, there is no radiology report in BCI 1’s patient file.27 See generally GX 10. As for the abduction/adduction test he performed, Respondent explained that his purpose was to determine muscle strength and referred pain, which he explained that ‘‘many times, if you lift up your arms, you also have to contract your low back, and sometimes that can lead to referred pain.’’ Id. at 661–62. However, as the video shows, when Respondent performed this test on BCI 1, he did not ask if it caused pain and BCI 1 made no comment to the effect that it caused him pain.28 See GX 3, at 9; see also GX 3, Video 5, at 14:48:06–12. 27 Respondent also testified that ‘‘you can’’ see degenerative disc disease on an X-ray. Tr. 661. Respondent did not, however, testify that he reviewed either an X-ray or radiology report at either of BCI 1’s visits. 28 Likewise, when Respondent performed this test at BCI 1’s second visit, he did not ask BCI 1 if it caused pain and BCI 1 did not complain that it caused pain. GX 5, at 4. E:\FR\FM\30APN2.SGM 30APN2 sradovich on DSK3GMQ082PROD with NOTICES2 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices Respondent testified that he asked Respondent if he smoked because ‘‘many times cigarette smokers . . . can have a problem with healing’’ and ‘‘if you’re planning on doing a procedure, you want them to cease smoking.’’ Id. at 662. As for why he asked BCI 1 if he used marijuana, Respondent explained that if BCI 1 had acknowledged marijuana use, you would want to know if he was certified by a physician and had been prescribed medical marijuana as well as to ‘‘get a general history of his use of narcotics and drugs.’’ Id. at 662– 63. Next, Respondent explained that he asked BCI 1 about his drinking because BCI 1 said ‘‘he’s on Xanax and he does it on the weekends, and he relates it to his drinking.’’ Id. at 663. Respondent then explained that ‘‘Dr. Vora had established a pain management plan for him,’’ and ‘‘reading through the notes . . . it [the reason for Xanax] could have been twofold, that he was worried about his anxiety, which was documented that he had anxiety, or he could have worried about whether he was going to go into DTs if he stopped drinking.’’ Id. Respondent testified that he agreed with Dr. Christensen’s statement that it is sometime appropriate to prescribe benzodiazepines to prevent delirium tremens. Id. at 663–64. Respondent also testified that, in his mind, BCI 1’s statement that he took Xanax to keep him from drinking too much on the weekends meant that BCI 1 ‘‘is not educated on . . . his medical condition,’’ that ‘‘[h]e doesn’t really know what’s going on,’’ and that ‘‘Dr. Vora has not told him exactly that he’s on his Xanax for not only his anxiety but also for the potential of going into DTs.’’ Id. at 664. Respondent added: ‘‘And that’s how I viewed reading the medical record.’’ Id. However, on cross-examination, Respondent testified that he did not create a plan to address BCI 1’s drinking, because ‘‘in [his] opinion, the plan was already enacted by Dr. Vora’’ and that plan ‘‘was giving the Xanax for both the possibility of DTs and the anxiety that that was documented in [the] prior notes.’’ Id. at 690. Respondent denied that he left the issue ‘‘unaddressed,’’ explaining that his ‘‘impression . . . was that if he felt that he was going into withdrawals [sic] he would take the Xanax.’’ Id. at 691–92. Respondent admitted, however, that he never asked Dr. Vora if this was his plan. Id. at 692. As for why he prescribed carisoprodol to BCI 1, Respondent testified that ‘‘in his prior medical records, he was getting Baclofen . . . a muscle relaxant. That’s the reason why I had given him the VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 Soma.’’ Id. Respondent then acknowledged that while Baclofen treats muscle spasms, it is not a controlled substance. Id. at 665. Next, Respondent offered his explanation regarding BCI 1’s statement that ‘‘[t]hey’re worth a lot of money on the street’’ and his response of ‘‘[t]hat’s the whole point. They’re pure. You know there is nothing cut down about them. So when you’re selling them—its like you know—the person buying— legit.’’ Id. at 665–666 (citing GX3, at 14). Asked what his reason was for engaging in this conversation, Respondent maintained: ‘‘Well, it’s just like educating him, you know, what is going on, why people are seeking this drug. It’s not like I’m trying to tell him to go out and sell his drugs.’’ Id. at 666. Then asked whether BCI I ‘‘ever admit[ted] to [him] at any point during the interaction that he was diverting his controlled substances,’’ Respondent answered: ‘‘No. Let’s see.’’ Id. As for what action Respondent felt was necessary after BCI 1’s subsequent admission that he had traded drugs with his neighbor, Respondent testified that ‘‘number one, you want to treat them, you want to give them a chance to be able to rectify their behavior as far as that goes. And if he continued with that, I would have just discharged him.’’ Id. As for how he would have determined if BCI I had continued this behavior, Respondent answered: ‘‘Number one, I would have, you know, inquired about that. And I would have seen, you know, as far as the MAPS, whatever he’s taking in the MAPS.’’ Id. at 667. The CALJ then asked Respondent why he discussed the street value of the drugs that he was prescribing to BCI 1. Id. Initially, Respondent testified that ‘‘it was an inappropriate conversation’’ but that he ‘‘was really trying to be accepted, trying to relate to the patient. It was a mistake.’’ Id. Pressed on the issue, Respondent testified: ‘‘Again, it’s like, I mean, I can honestly just say that I just wanted for him to feel comfortable for me. It was wrong. I admit that. It was something that I should not have said.’’ Id. Asked by the CALJ whether he ‘‘wanted to be [BCI 1’s] friend,’’ Respondent answered ‘‘[y]es’’ and added that he ‘‘wanted’’ BCI 1 to ‘‘trust’’ and ‘‘like’’ him and ‘‘to be able to say that this guy cares about me, he wants to help me.’’ Id. at 668. Then asked by the CALJ ‘‘if you wanted him to be your friend, why would you tell him that he could sell his drugs on the street for a lot of money,’’ Respondent answered: ‘‘I wasn’t telling him to sell the drugs.’’ Id. The CALJ then said: ‘‘You just told him what the value was,’’ prompting PO 00000 Frm 00021 Fmt 4701 Sfmt 4703 18901 Respondent’s counsel to object that the question was argumentative in that it’s ‘‘premise . . . assumed that he was educating him on how to sell drugs on the street.’’ Id. at 669. While the CALJ overruled the objection, he did not pursue this line of questioning. Id. Respondent subsequently testified that he, and not BCI 1, had engaged in the conversation about the street value of the drugs. Id. at 670. However, he then revised his testimony to state: ‘‘The thing I was trying to convey when I look at my statement is that I mention the pharmaceutical companies. And . . . I’d say most physicians feel that the pharmaceutical companies are . . . getting rich off the patients like himself. And that’s why I said that.’’ Id. at 670– 71. Respondent then maintained that when he stated that ‘‘these scripts . . . that you are going to get would be like 6 or 7 hundred dollars. You know the pharmaceutical company are making bank,’’ he was referring to the pharmaceutical value and not the street value. Id. Addressing the note he prepared for BCI 1’s first visit, Respondent testified that he wrote that Respondent had degenerative disc disease for approximately ten years because BCI 1 ‘‘had it [low back pain] for 10 years’’ and ‘‘[i]t would be consistent with degenerative disc disease of his low back.’’ Id. at 671. As for why he noted that BCI 1 had associated muscle spasm, Respondent explained that BCI 1 ‘‘was getting Baclofen. So the mere fact that he’s getting Baclofen from his prior medical records, I would say that the Baclofen which is for muscle spasm.’’ Id. at 672. Respondent also maintained that ‘‘[t]he physical exam that Dr. Vora gave and . . . my examination’’ were other reasons why he thought BCI 1 could have been getting Baclofen. Id. As for the notation that BCI 1 walked with a ‘‘slight limp,’’ Respondent testified that ‘‘to me, it looked like he walked with a limp.’’ Id. As for why he noted ‘‘moderate point tenderness,’’ Respondent maintained that ‘‘when I palpated or pushed on his lower back, I thought that he had moderate point tenderness that was localized.’’ Id. Respondent also maintained that he read Dr. Vora’s medical records for BCI I and ‘‘agreed with his management and I was just going to continue that until I got to know the patient better.’’ Id. at 673. After stating his diagnoses and noting that BCI 1 ‘‘was previously diagnosed with’’ anxiety, Respondent explained that he continued the Norco and Xanax prescriptions ‘‘[f]or the reasons that I previously mentioned’’ and that BCI 1 E:\FR\FM\30APN2.SGM 30APN2 18902 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices sradovich on DSK3GMQ082PROD with NOTICES2 ‘‘had documented anxiety and I was worried about him going into DTs.’’ Id. Turning to BCI 1’s second visit, as found above, after exchanging pleasantries, Respondent asked: ‘‘So how is everything been going with your pain?’’ and BCI 1 replied: ‘‘[g]reat, yup, everything is cool?’’ GX 5, at 4; Tr. 674. Respondent testified that, in his mind, BCI 1’s answer meant ‘‘that the regimen or the plan of his management is working. You want the patient to not have any back pain, or you don’t want them to, or the pain to be more tolerable.’’ Tr. 674. Respondent also testified that he asked BCI 1 to walk back and forth to see if he had a limp and that he ‘‘noticed a limp.’’ Id. As for why Respondent had BCI 1 point to where it hurt in his back, Respondent testified that he did this ‘‘[j]ust to gauge . . . the level of his back pain and to see if he had any muscle tightness, the tone, to see if it shot anywhere, if he had any progression of his disease.’’ Id. Respondent maintained that at this point, he palpated BCI 1’s back, and when asked if he did it through BCI 1’s clothing, Respondent testified that ‘‘[w]hat I would do is I’d lift the back of his shirt up and then I’d push on his back.’’ Id. at 675. As for BCI 1’s statement that ‘‘I got stiffness pretty much like right down there,’’ GX 5, at 4, Respondent explained that he interpreted this as ‘‘he has back pain. I’m specifically asking him about back pain. I’m, you know, asking him about that and, to me, when he responds, to me, that means that he has low back pain.’’ Tr. 675. As for why he performed the arm adduction and abduction tests, Respondent again testified that he did these tests ‘‘to see if he had referred pain, to check out his upper body musculature, and to see if he had good muscle tone. Id. As found above, Respondent then asked BCI 1 to ‘‘rate [his] pain on a scale of one to ten today’’; BCI 1 responded: ‘‘I am good today. I am good today.’’ GX 5, at 4. Asked why he still prescribed medications to BCI 1 ‘‘even though he’s just failed to give you a pain score,’’ Respondent explained: Well, number one, pain waxes and wanes. So he has had this chronic pain for 10 years. This might be just a time that when he comes into the office he might have just taken his medication, that he’s okay. Usually . . . if the patient takes the medication prior to coming to the office . . . he won’t have as much pain. Tr. 676. Next, Respondent testified that on March 19, 2015, he still ‘‘did not’’ have access to the urine drugs screens because ‘‘[t]hey still were saying that there was a computer issue.’’ Id. VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 Respondent maintained that he complained about his lack of access to the urine drug screens and ‘‘said that I needed to have these and that . . . that’s part of the treatment for the patient.’’ Id. at 676–77. As for why he just did not refuse to see patients that day, Respondent explained that ‘‘it’s not a requirement necessarily to have the urinalysis, but . . . for him, but the key to me about that is to make sure that I eventually do get it.’’ Id. at 677. Respondent, however, testified that he never saw a urinalysis test result for BCI I. Id. at 678. Noting Dr. Christensen’s testimony that BCI 1’s second visit with Respondent ‘‘was only about two minutes,’’ Respondent’s counsel asked him why it was ‘‘so brief.’’ Id. at 677. Respondent testified that he ‘‘had a[n] incident with a patient prior to [BCI 1], and . . . I’m a human being . . . as far as that goes,’’ and that the incident involved ‘‘a patient that did not want me to examine her’’ because of his race. Id. Asked why this would affect his treatment of BCI 1, Respondent answered: ‘‘Well, I mean, again, it’s hard to describe when somebody doesn’t think of you as an equal, and that affects you.’’ Id. Respondent then asserted that ‘‘[j]ust in general from just the language that [BCI 1] used during the examination,’’ he did not feel like BCI 1 was treating him ‘‘as an equal.’’ Id. at 678. Addressing Dr. Christensen’s testimony that he did not see evidence that Respondent did a cranial nerves examination yet documented having done so in the March 19 visit note, Respondent’s counsel asked: ‘‘[w]hy put down in the record that his CN were intact . . . ?’’ Id. Respondent answered: Okay. First of all, you can indirectly evaluate the cranial nerves. Like the facial nerve, if he has a facial palsy . . . one his cheeks is [sic] droopy, or his eyelid is not, it’s like droopy also, that is indication of an abnormality of one of the cranial nerves. If he . . . has speech patterns similar to somebody who is deaf, that would be indicative of a cranial nerve issue. So that’s why. That’s it. So you don’t necessarily have to, in order to say that the cranial nerves are intact, to directly palpate. Id. at 679. As found above, Respondent also documented in the March 19 visit note ‘‘2+ pulses throughout’’ and Dr. Christensen testified that neither the video nor the transcript show that Respondent took BCI 1’s pulses. GX 10, at 32; Tr. 433–35. Asked why he made the notation, Respondent testified: ‘‘On the radial pulse is the pulses in the wrist. Now, when I have the patient lift up their arms, I’m at the same time PO 00000 Frm 00022 Fmt 4701 Sfmt 4703 pinching their wrist and I’m feeling their pulse.’’ Tr. 678–79. As for BCI 2, Respondent testified that he reviewed her medical file including the records created by both Dr. Vora and Dr. R. prior to treating her and that he had no reason to not believe the statements in her medical record. Id. at 680. He further testified that he ‘‘reviewed [Dr. R.’s] physical and . . . what she gave the patient’’ and the pain clinic history questionnaire. Id. at 681. As found above, after exchanging pleasantries, Respondent asked BCI 2 ‘‘to tell [him] what’s going on’’ and she replied: ‘‘just here for refills.’’ Id. Asked what BCI 2’s response indicated to him, Respondent testified: ‘‘I mean, it’s subjective as far as that goes, it’s depending on, you know, I perceive it as that she came in to get her examination and that she was coming in there to have her pain evaluated.’’ Id. at 681–82. Respondent also testified that BCI 2’s statement that ‘‘I feel great today’’ meant to him ‘‘that she’s saying to me that the management that she’s getting is working.’’ Id. Respondent then testified that he believed that he knew BCI 2’s pain score from her previous visit with Dr. R. and that based on the Pain Clinic History Questionnaire, he believed her pain was ‘‘at least a 4,’’ which was the rating BCI 2 listed on the form as her usual pain level. Id. at 683; see also GX 11, at 23. As for his decision to increase the Norco and decrease the Soma from the quantities prescribed by Dr. R., Respondent testified that ‘‘she was getting 120 of the Soma,’’ and in his opinion, that was ‘‘too high.’’ Id. at 683. Respondent further testified that ‘‘Soma can be an anti-anxiety medication’’ and ‘‘can cause you to become drowsy,’’ and that, in his understanding, ‘‘the most that you can prescribe within a 30-day period is 90’’ and ‘‘she’s overmedicated.’’ Id. Respondent further maintained that he ‘‘looked at the MAPS and the MAPS said that she had gotten Xanax the prior month. And that, since I was seeing her, I was not going to write the prescription for Xanax.’’ Id. at 683– 84. Respondent added that he ‘‘didn’t notice a refill’’ in the MAPS report and that he ‘‘didn’t realize you could get refills.’’ Id. at 684. Respondent’s counsel then pointed out that ‘‘the MAPS report doesn’t show the prescription by Dr. [R.] for Xanax’’ and asked if he ‘‘look[ed] at another MAPS report somewhere?’’ Id. Respondent testified: ‘‘No, I thought that that was the whole point. I wasn’t going to, no matter what, I wasn’t going to prescribe her Xanax.’’ Id. As for why he increased BCI 2’s Norco, Respondent testified: ‘‘that the E:\FR\FM\30APN2.SGM 30APN2 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices reason why she’s on such a high dose of Soma is that she’s trying to control the pain through the Soma, and I just thought that, in my judgment, that was too much to be giving her at that time.’’ Id. Respondent then testified that he thought BCI 2’s Soma prescription was dangerous, ‘‘so [he] decreased it to 60 and . . . increased the Norco to 60, which she prior had been getting from Dr [R].’’ Id. at 685. Respondent also maintained that he was aware that Dr. R. had previously reduced BCI 2’s Norco prescription to 5 dosage units. Id. Respondent was then asked by his counsel why he increased the Norco prescription ‘‘if [he] saw that the other doctor had prescribed less?’’ Id. Respondent answered: sradovich on DSK3GMQ082PROD with NOTICES2 Well, the point being was that generally you want to, if you’re going to wean a patient off of a medication, again, it’s unique to each patient, but you can wean like 10 percent a week, 10 percent a month, but you have to gauge, or the patient has to be monitored. . . . And with that, I wanted to make sure that her pain was under control. Id. Respondent further testified that after his first day in Dr. Vora’s office, he tried to contact a psychiatrist because ‘‘many of these patients needed to be followed for the Xanax, for the anti-anxiety diagnosis.’’ Id. at 685–86. Respondent testified that there was ‘‘no one’’ in the phonebook for Gladwin and while he ‘‘Google[d] psychiatrists in’’ other cities, ‘‘[t]here’s this big procedure when you’re trying to get a patient to see a psychiatrist’’ which involves ‘‘arrang[ing] an appointment with the psychologist’’ who evaluates whether the patient needs to see a psychiatrist. Id. at 686. Respondent testified that he made these phone calls because he ‘‘wasn’t going to continue to see the patients that were on Xanax’’ and ‘‘did not want to keep prescribing Xanax.’’ Id. Respondent also testified that because his instructions regarding obtaining access to the EMR and the urine drug screen results were not followed, he ‘‘told them that I cannot do this anymore.’’ Id. at 687. Asked if he ‘‘recognize[d] . . . that there were some deficiencies in how [he] treated the patients at Dr. Vora’s office,’’ Respondent answered ‘‘yes.’’ Id. at 688. As for what he could ‘‘do better,’’ Respondent said ‘‘cut down the number of patients,’’ ‘‘make sure’’ he had ‘‘full access to all the records,’’ ‘‘make sure that everything was set up for, you know, I needed to offer them you know, procedures,’’ and to ‘‘let the patients know that there was going to be an African-American there and that if they didn’t want to come, that’s their choice.’’ Id. at 688–89. Respondent also VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 testified that he is no longer working as a locum tenens because he has not found a ‘‘satisfactory’’ job. Id. at 689. He then explained that ‘‘I want to do radiology’’ and ‘‘I do not really want to do pain management. . . . But right now the only thing that’s open is pain management.’’ Id. Asked if it is his ‘‘desire to ever engage in office-based pain management treatment again,’’ Respondent answered: ‘‘That’s not my goal at all.’’ Id. On cross-examination, the Government asked Respondent why he ‘‘still prescribed a 30-day supply of controlled substances’’ rather than ‘‘a lesser day . . . supply’’ at each of the three undercover visits ‘‘given [his] uncomfortableness with not having [the] urinalysis results.’’ Id. at 693. Respondent answered: ‘‘[f]irst of all, you can never just have the patient go cold turkey for any type of narcotic.’’ Id. Government counsel reminded Respondent that he ‘‘didn’t say cold turkey’’ and he had ‘‘said a lesser number.’’ Id. Respondent answered: So what would they, if I’m not going to be there or they’re not going to be seen for a month, what would they do—from my standpoint, this is rhetorical, is that if you do give a lesser amount . . . they run out. Then they’re going to self-medicate if they run out and they don’t have access. And then if the patient runs out, they go into withdrawals, they might be driving, then they might cross the median, they could kill somebody. So that’s my concern of like saying okay, I’m going to just give you 10.’’ Id. at 693–94. When the Government suggested that Respondent could have ‘‘had the patient return or . . . could have phoned in the additional pills later,’’ Respondent testified that ‘‘[y]ou can’t phone in Norco’’ and that ‘‘he’d go in[to] withdrawal from the Norco.’’ Id. at 694. Respondent then testified that he ‘‘would have to weigh the costs and the benefits’’ and that if ‘‘a patient has been on it for an extended period of time and then you decide to just stop them, . . . they’re going to have withdrawals.’’ Id. After the Government asked if ‘‘it would be too inconvenient for them to return,’’ Respondent answered: ‘‘It’s like this is— you guys know where you’re at. It’s Gladwin as far as that goes.’’ Id. at 694– 95. Then asked how hard it would be ‘‘to get back to the doctor’s office’’ if ‘‘only 3,000 people’’ live in Gladwin, Respondent answered: ‘‘It only takes one accident. That’s it. I’m just saying for me, I just used my—I did not want patient to go into withdrawals. I didn’t feel comfortable not giving him medication.’’ Id. at 695. Addressing BCI 1’s February 19, 2015 prescriptions, the Government asked PO 00000 Frm 00023 Fmt 4701 Sfmt 4703 18903 Respondent whether he believed, at the time he issued each of the prescriptions, that the prescriptions were ‘‘for a legitimate medical purpose within the usual course of professional practice and the Michigan standard of practice?’’ Id. Respondent generally testified that he did believe the prescriptions were lawful, although he acknowledged that ‘‘[i]t was a mistake’’ to prescribe Soma to BCI 1. Id. at 696. Respondent then explained that by this, he meant that he ‘‘wasn’t as aware of the holy trinity’’; he further explained that with the patients that ‘‘I’d come in contact with, this holy trinity was not that . . . common for me . . . So I wasn’t that familiar with that. So, when I wrote these out, I wrote it out in good faith. I was not as knowledgeable as I should have been.’’ Id. at 696–97. While Respondent admitted that it was a mistake to prescribe Soma to BCI 1 because he was on a different noncontrolled muscle relaxant, he again testified that if ‘‘I had been more knowledgeable about the holy trinity, I would not have given him the Soma.’’ Id. at 697. Respondent nonetheless believed that prescription was issued for a legitimate medical purpose and in the usual course of professional practice ‘‘[b]ased on the medical records from Dr. Vora and his history he gave me.’’ Id. Respondent offered testimony to the same effect with respect to the three prescriptions he issued to BCI 1 at the March 19, 2015 visit, testifying that he believed that he wrote the prescriptions ‘‘in good faith’’ and ‘‘[b]ased on Dr. Vora’s history, what he told me.’’ Id. at 698–99. While Respondent again admitted that the Soma prescription was a mistake, he testified that he ‘‘wrote it under good faith,’’ that ‘‘I wasn’t trying to write something that was illegal,’’ and that ‘‘I wasn’t trying to have somebody get something that . . . they shouldn’t have gotten.’’ Id. at 699. Finally, Respondent testified that both the Norco and Soma prescriptions he issued to BCI 2 were for a legitimate medical purpose, and within both the usual course of professional practice and the Michigan Standard of Practice. Id. at 699–700. Discussion Section 303(f) of the Controlled Substances Act (CSA) provides that ‘‘[t]he Attorney General may deny an application for [a practitioner’s] registration . . . if the Attorney General determines that the issuance of such registration . . . would be inconsistent with the public interest.’’ 21 U.S.C. 823(f). With respect to a practitioner, the Act requires the consideration of the E:\FR\FM\30APN2.SGM 30APN2 18904 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices 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. sradovich on DSK3GMQ082PROD with NOTICES2 Id. ‘‘[T]hese factors are . . . considered in the disjunctive.’’ Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that ‘‘I may rely on any one or a combination of factors, and may give each factor the weight [I] deem [ ] appropriate in determining whether . . . an application for registration [should be] denied.’’ Paul H. Volkman, 73 FR 30630, 30641 (2008) (citing id.), pet. for rev. denied, Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009); see also MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while I am required to consider each of the factors, I ‘‘need not make explicit findings as to each one.’’ MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482)).29 The Government has the burden of proving, by a preponderance of the evidence, that the requirements for denial of an application pursuant to 21 U.S.C. 823(f) are met. 21 CFR 1301.44(d). However, once the Government has made a prima facie showing that issuing a new registration to the applicant would be inconsistent with the public interest, an applicant must then present sufficient mitigating evidence to show why he can be entrusted with a new registration. Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008) (citing cases), pet. for rev. denied, 300 Fed. Appx. 409 (6th. Cir. 2008); see also MacKay, 664 F.3d at 817. Having considered all of the factors, I find that the Government’s evidence with respect to Factors Two and Four 29 In short, this is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest; what matters is the seriousness of the registrant’s misconduct. Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has recognized, findings under a single factor can support the revocation of a registration or the denial of an application. MacKay, 664 F.3d at 821. VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 satisfies its prima facie burden of showing that granting Respondent’s application would be inconsistent with the public interest.30 I further find that 30 As to Factor One, while on December 13, 2016, the Michigan Board imposed a summary suspension of Respondent’s medical license, on February 16, 2017, the Board entered into a Consent Order and Stipulation which dissolved the summary suspension while limiting Respondent’s authority to ‘‘obtain, possess, prescribe, dispense or administer any . . . controlled substance . . . except in a hospital or other institutional setting.’’ However, while Respondent does possess limited state authority as required to be registered under 21 U.S.C. 823(f), the Board has not made a recommendation to the Agency in this matter. Moreover, as the Agency has long held, this partial restoration of Respondent’s state authority is not dispositive of the public interest inquiry. See Mortimer Levin, 57 FR 8680, 8681 (1992) (‘‘[T]he Controlled Substances Act requires that the Administrator . . . make an independent determination [from that made by state officials] as to whether the granting of controlled substance privileges would be in the public interest.’’). See also 21 U.S.C. 802(21) (defining ‘‘the term ‘practitioner’ [to] mean[ ] a . . . physician . . . or other person licensed, registered or otherwise permitted, by . . . the jurisdiction in which he practices . . . to distribute, dispense, [or] administer . . . a controlled substance in the course of professional practice’’). To be sure, the Agency’s case law contains some older decisions which can be read as giving more than nominal weight in the public interest determination to a State Board’s decision (not involving a recommendation to DEA) either restoring or maintaining a practitioner’s state authority to dispense controlled substances. See, e.g., Gregory D. Owens, 67 FR 50461, 50463 (2002) (expressing agreement with ALJ’s conclusion that the board’s placing dentist on probation instead of suspending or limiting his controlled substance authority ‘‘reflects favorably upon [his] retaining his . . . [r]egistration, and upon DEA’s granting of [his] pending renewal application’’); Vincent J. Scolaro, 67 FR 42060, 42065 (2002) (concurring with ALJ’s ‘‘conclusion that’’ state board’s reinstatement of medical license ‘‘with restrictions’’ established that ‘‘[b]oard implicitly agrees that the [r]espondent is ready to maintain a DEA registration upon the terms set forth in’’ its order). Of note, these cases cannot be squared with the Agency’s longstanding holding that ‘‘[t]he Controlled Substances Act requires that the Administrator . . . make an independent determination [from that made by state officials] as to whether the granting of controlled substance privileges would be in the public interest.’’ Levin, 57 FR at 8681. Indeed, neither of these cases even acknowledged the existence of Levin, let alone attempted to reconcile the weight it gave the state board’s action with Levin. While in other cases, the Agency has given some weight to a Board’s action in allowing a practitioner to retain his state authority even in the absence of an express recommendation, see Tyson Quy, 78 FR 47412, 47417 (2013), the Agency has repeatedly held that a practitioner’s retention of his/her state authority is not dispositive of the public interest inquiry. See, e.g., Paul Weir Battershell, 76 FR 44359, 44366 (2011) (citing Edmund Chein, 72 FR 6580, 6590 (2007), pet. for rev. denied, Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008)). As 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 PO 00000 Frm 00024 Fmt 4701 Sfmt 4703 Respondent has failed to produce sufficient evidence to rebut the Government’s prima facie case. Factors Two and Four—Respondent’s Experience in Dispensing Controlled Substances and Record of Compliance With Applicable Controlled Substance Laws 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 § 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. § 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 . . . .’’).31 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 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. As for Factor Five, the Government made no allegations that implicate Factor Five. Nor did it claim that Respondent’s false testimony on certain issues implicates Factor Five. 31 As the CALJ noted, the Government did not cite this provision in the Show Cause Order or in its post-hearing brief. R.D., at 73–74. I find, however, that this provision imposes the same standard as 21 CFR 1306.04(a). E:\FR\FM\30APN2.SGM 30APN2 sradovich on DSK3GMQ082PROD with NOTICES2 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices 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 VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 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’’).32 32 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. PO 00000 Frm 00025 Fmt 4701 Sfmt 4703 18905 The CALJ found that Respondent violated 21 CFR 1306.04(a) with respect to each of the prescriptions issued to both investigators. I agree. Even considering the evidence that Respondent practiced at the clinic on a locum tenens basis and that both investigators had previously been seen by other physicians at the clinic, who documented findings in the medical records that, in some respects, tended to support the diagnosis of conditions that may justify the prescribing of controlled substances, I nonetheless conclude that the weight of the evidence supports the conclusion that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice when he issued the prescriptions. 21 CFR 1306.04(a). BCI 1’s Prescriptions With respect to BCI 1’s first visit, the CALJ credited Dr. Christensen’s testimony that the combination of drugs that Respondent prescribed (Norco, Xanax and carisoprodol), otherwise known as the Holy Trinity, has both a very high abuse potential because of its ‘‘euphoric’’ effects and creates a high risk of ‘‘respiratory depression,’’ especially in a patient who admits to drinking alcohol. Tr. 397–98. The CALJ also credited Dr. Christensen’s testimony that, under the standard of care, the Investigator’s admission of alcohol use required Respondent to not prescribe the Xanax.33 Tr. 395–96. While Respondent agreed with Dr. Christensen’s testimony that prescribing Xanax is medically appropriate to prevent delirium tremens, a condition caused by withdrawal from alcohol, and testified that he was simply following Dr. Vora’s plan, which he believed involved prescribing Xanax to both treat the Investigator’s anxiety and to prevent DTs, Respondent admitted that he never asked Dr. Vora if he was prescribing Xanax for the latter purpose. Id. at 692. Moreover, even though Dr. Vora’s progress notes list a diagnosis of anxiety, and Dr. Christensen testified that a physician can trust the medical documentation of another physician if ‘‘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). 33 Dr. Christensen also testified that a physician in primary care should refer a patient who admits to alcohol use to an addiction specialist or counselor. Tr. 396. Dr. Christensen did not, however, testify as to whether the standard of care would require a pain management specialist to refer the patient, and, in any event, it is unclear whether Respondent should be treated as a primary care physician or as a pain management specialist. E:\FR\FM\30APN2.SGM 30APN2 sradovich on DSK3GMQ082PROD with NOTICES2 18906 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices ‘‘the elements of a diagnosis are met,’’ he did not agree ‘‘with any diagnosis of anxiety.’’ Id. at 516–17. Dr. Christensen also testified that BCI 1’s statement that he ‘‘take[s] Xanax on the weekends . . . does not appear to be [that of] someone who’s complaining about an anxiety diagnosis who’s being prescribed Xanax for a documented anxiety disorder.’’ Id. at 379. And Dr. Christensen testified that if there was a diagnosis of anxiety disorder, ‘‘a reasonable practitioner . . . would want to know’’ what treatments had been tried. Id. at 381. However, Respondent made no such inquiry. As for Respondent’s prescribing of carisoprodol at the first visit, a muscle relaxant which is also a schedule IV drug with sedative effects and Respondent’s statements that he was going to prescribe this drug for muscle spasms, Dr. Christensen testified that muscle spasms would be diagnosed by palpating the patient but that he did not see evidence that Respondent had done so. Tr. 399. By contrast, Respondent, in addition to asserting that he interpreted BCI 1’s statements that his back was stiff with the presence of muscle spasms, also testified that he lifted up BCI 1’s shirt and palpated his back at this visit. Id. at 659. However, BCI 1 testified that neither he nor Respondent lifted up the clothing that he was wearing and Respondent never palpated his back. Id. at 175. Yet Respondent documented in the visit note a physical exam finding of ‘‘[m]oderate point tenderness to low back.’’ GX 10, at 31. Moreover, Respondent, at another point in his testimony, explained that he prescribed carisoprodol because Dr. Vora had previously prescribed Baclofen, a noncontrolled muscle relaxant to BCI 1. Tr. 665. He also testified that the prescription was a ‘‘mistake.’’ Id. Dr. Christensen opined that the Soma prescription was ‘‘not appropriate.’’ Id. at 420. He explained that the drug is ‘‘indicated for short-term treatment of muscle spasms,’’ but that ‘‘there is no documentation of this’’ condition. Id. Dr. Christensen further explained that Soma was ‘‘contraindicated with this patient’s history.’’ Id. Notably, the CALJ found BCI 1’s testimony ‘‘fully credible’’ as to all issues. R.D. 14 By contrast, the CALJ found Respondent’s testimony on the issue of why he prescribed the carisoprodol, to be ‘‘not just a little confusing’’ and ‘‘not convincing.’’ Id. at 54. Based on the CALJ’s credibility findings, I find that Respondent’s testimony that he lifted up BCI’s clothing and palpated BCI 1’s back was false, that Respondent had no basis for documenting in the visit note a finding of moderate point tenderness, and that VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 Respondent falsified BCI 1’s medical record. Thus, notwithstanding that BCI 1’s records showed that Dr. Vora had diagnosed him with muscle spasms and the somewhat ambiguous statements made by BCI 1 as to his condition, I conclude that the weight of the evidence supports the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate purpose when he prescribed carisoprodol to BCI 1. 21 CFR 1306.04(a). While Dr. Christensen testified that a physical exam is not required at a follow-up visit and a subsequent physician can rely on a diagnosis of another physician if there is evidence that a pertinent examination had previously been performed, I reject Respondent’s defense that he reasonably relied on the examinations as documented by Dr. Vora and that while ‘‘we now know’’ that Dr. Vora’s records ‘‘were largely false, Respondent had no indication that this was the case.’’ See Resp.’s Post-Hrng. Br. 30. First, as found above, BCI 1 told Respondent that he had asked Dr. Vora for a couple of extra pills, and based on the statements Respondent made regarding the quantity of the prescriptions (66 pills for both Norco and Xanax) written by Vora, I find that Respondent clearly knew that Vora had given extra pills to BCI 1, thus calling into question the legitimacy of Vora’s prescribing as well as his recordkeeping. Moreover, Respondent falsified the visit note to indicate a finding of moderate point tenderness, and in this proceeding, he falsely testified that he lifted up BCI 1’s clothing and palpated his back. Unexplained by Respondent is why, if he reasonably relied on Vora’s records and had ‘‘no indication’’ that they ‘‘were largely false,’’ he proceeded to create his own set of false physical exam findings and gave false testimony at the hearing. Indeed, Respondent’s testimony and his falsification of BCI 1’s visit note support the conclusion that Respondent did not merely make a mistake when he prescribed carisoprodol but that he knowingly diverted controlled substances when he prescribed the drug (as well as alprazolam and Norco) to BCI 1. 21 CFR 1306.04(a). As for the Norco prescription, Dr. Christensen noted that on his initial intake form, BCI 1 had listed ‘‘refills’’ as his reason for visit and that on the medical history form, BCI 1 did not check off any symptom listed on the form, let alone those that are relevant in assessing lower back pain. Tr. 410; see also GX 10, at 17, 19. He further explained that the standard of care PO 00000 Frm 00026 Fmt 4701 Sfmt 4703 required that Respondent obtain a family history of psychiatric and substance abuse disorders to rule out substance abuse as the reason BCI 1 was seeking medication. Id. at 413. While Dr. Christensen acknowledged that BCI 1 had been seen by Dr. Vora, he testified that if the medical record is incomplete, a subsequent physician must obtain the missing history which is relevant to the patient’s complaint, especially if the treatment plan involves controlled substances. Id. at 411–12. See also id. at 489 (‘‘the first thing you should do is take a history’’ that is relevant to the complaint). Dr. Christensen also testified as to the various items, which under the standard of care in Michigan, should be addressed in taking a pain patient’s history, including addressing the onset of the pain, the duration of the pain, factors that aggravate or relieve the pain, what brings the pain on, the severity of the pain, and how the pain affects the patient’s function. Id. at 374. Notably, the visit notes created by Dr. Vora contained no discussion of these issues other than to note that the onset date of BCI 1’s back pain was 12/15/2014. See GX 10, at 1 (Jan. 12, 2015 note); id. at 3 (Dec. 15, 2014 note); see also id. at 5 (Nov. 10, 2014 note which lists back pain and back stiffness as patient’s complaint but no other information). Moreover, while Respondent proceeded to ask BCI 1 as to how long he had back pain, whether he got muscle spasms with the pain, whether he walked with a limp, whether he had any loss of muscle strength, and whether the pain shot anywhere or was just localized, even when BCI 1’s answers were ambiguous, Respondent accepted them with no further questioning. He did not ask questions that would clarify whether BCI 1’s purported pain was caused by an injury, question BCI 1 about any prior treatments he received, nor clarify what BCI 1 meant when he said he was mostly just stiff. And while Respondent asked BCI 1 if he smoked, used marijuana, and was a social drinker, even after BCI 1 replied that he took Xanax to keep from drinking too much on the weekends, Respondent asked no further questions to determine the extent of Respondent’s alcohol use. As for Respondent’s physical exam, it is acknowledged that Dr. Vora’s visit note for BCI 1’s December 15, 2014 visit documented the performance of a physical exam and that Dr. Christensen acknowledged that this would be an appropriate exam on a follow-up visit.34 34 As found above, Dr. Vora made no physical exam findings pertinent to BCI 1’s complaint of back pain at his first visit (Nov. 2014), and Dr. E:\FR\FM\30APN2.SGM 30APN2 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices sradovich on DSK3GMQ082PROD with NOTICES2 However, even assuming that the findings documented in the December 2014 visit note establish that Dr. Vora performed an appropriate physical exam, as well as acknowledging that a physical exam is not necessarily required at a follow-up visit and that a subsequent physician can rely on the medical record absent some indication that the record is not truthful, Respondent nonetheless documented various findings of a physical exam when the evidence shows he did not perform the tests necessary to make those findings. These include not only his finding of moderate point tenderness as well as his findings that BCI 1’s cranial nerves IV–XII were intact. Compare GX 10, at 31, with Tr. 416 (testimony of Dr. Christensen noting no evidence of palpation of BCI 1’s lower back) and id. at 417–19 (testimony of Dr. Christensen noting no evidence of testing of BCI 1’s cranial nerves). Moreover, even as to the tests Respondent did perform, Dr. Christensen’s testimony suggests that Respondent was just going through the motions, as the arm abduction/ adduction test he did do is not used to assess lower back pain but rather nerve issues in the thoracic and cervical spine. Id. at 386. Indeed, while Respondent asserted that his purpose in doing this test was to establish if BCI 1 had ‘‘referred pain,’’ id. at 661, he did not ask BCI 1 if it caused pain, and BCI 1 did not complain that it caused pain at either visit. GX 3, at 9; GX 5, at 4. Thus, Respondent did not simply rely on Dr. Vora’s physical exam findings but deemed it necessary to document his own false findings to support his decision to prescribe Norco to BCI 1. Respondent also gave false testimony when he asserted that he had actually palpated BCI 1. Moreover, the statements made at various points in his interaction with BCI 1 show that Respondent knew that BCI 1 was not a legitimate pain patient. These include: Christensen was not asked if the findings made by Dr. Vora in the December 2014 visit establish that an appropriate physical exam was performed as part of the initial evaluation of BCI 1’s complaint. For purposes of this discussion, I assume, without deciding, that the December 2014 physical exam findings establish that Dr. Vora performed an appropriate exam, whether the visit is viewed as an initial evaluation or a follow-up. I also assume, without deciding, that at the time he commenced his February 2015 locum tenens service at Dr. Vora’s clinic and prior to his interaction with BCI 1, Respondent did not have sufficient information to conclude that Dr. Vora was not engaging in the legitimate practice of medicine. See Tr. 532 (testimony of Dr. Christensen that it was reasonable to trust Dr. Vora’s documentation absent an indication that the records were not truthful). VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 BCI 1’s statement that he took Xanax because it kept him from drinking too much moonshine on the weekends; BCI 1’s statement that the drugs he was getting from Respondent were ‘‘worth a lot of money on the street’’ and Respondent’s explanation that this is because the drugs are ‘‘pure’’ and ‘‘there is nothing cut down about them. So when you’re selling them’’ followed by BCI 1’s statement that ‘‘it’s a little safer to do it that way’’ and Respondent’s acknowledgement that this was ‘‘right’’; 35 BCI 1’s statements that ‘‘a couple of times’’ he had ‘‘r[u]n out of pills’’ and had to ‘‘trade with [his] neighbor,’’ as well as his statement that he asked Dr. Vora ‘‘for a couple extra’’ pills which he gave back to his neighbor; 36 and after Respondent asked BCI 1 ‘‘but 66’’ [the quantity of Dr. Vora’s previous Norco prescription] what’s that about?’’; BCI 1’s statement that ‘‘I can’t be paying—buying them on the street.’’ As further evidence that Respondent knew that BCI 1 was likely engaged in either abuse or diversion of controlled substances, BCI 1’s MAPS report 37 showed that he had obtained alprazolam from four different prescribers, including prescribers whose offices were in Detroit and Marquette, 400 miles apart. GX 10, at 23. Notably, while Respondent testified that on his first day at the clinic, he did not have access to urine drug screen reports, he also testified that he would request and the staff ‘‘would give’’ him ‘‘printouts of the charts’’; he also testified that ‘‘I had at the very least to have the MAPS.’’ Tr. 638. At no point did Respondent deny that he had received BCI 1’s MAPS report at the time of the first visit, nor did he offer testimony that he did not review BCI 1’s MAPS report. As Dr. Christensen explained, the ‘‘high geographic distance between [the] providers’’ and the ‘‘multiple providers’’ listed on BCI 1’s MAPS report are ‘‘signs 35 As for his statement that the prescriptions he was giving BCI 1 ‘‘would be like 6 or 7 hundred dollars,’’ Respondent initially testified that ‘‘it was an inappropriate conversation’’ but that he was ‘‘trying to relate to the patient,’’ only for him to claim that he ‘‘wasn’t telling him to sell the drugs’’ and that he was trying to convey that it was ‘‘the pharmaceutical companies’’ that were ‘‘getting rich off the patients like himself.’’ However, even were I to credit Respondent’s latter explanation that he discussed the high prices of drugs as being caused by the drug companies making lots of money, his subsequent explanation to BCI 1 that the reason the drugs were worth a lot of money is because ‘‘[t]hey’re pure’’ and ‘‘there is nothing cut down about them,’’ leaves no doubt that Respondent understood that BCI 1 was not a legitimate patient. 36 Of further note, while BCI 1 entered into a Controlled Substances Management Agreement, which prohibited him from sharing, selling or trading his medication, and Dr. Christensen testified that ‘‘at a minimum,’’ a reasonable practitioner would tell the patient that this is illegal and that if this was to happen again, the physician ‘‘would not be able to prescribe’’ any more controlled substances. Tr. 403, 406. 37 The report was dated October 29, 2014. GX 10, at 23. PO 00000 Frm 00027 Fmt 4701 Sfmt 4703 18907 of doctor shopping’’ and ‘‘diversion or misuse.’’ Id. at 414. Dr. Christensen opined that based on his review of the video, the transcript, and BCI 1’s medical file, Respondent’s issuance of the Norco prescription was inappropriate because ‘‘[t]here was no documentation of moderate to moderately severe pain.’’ Id. at 419–20. Dr. Christensen also explained that the evidence created ‘‘concern about another underlying diagnosis,’’ i.e., substance abuse, ‘‘that would have mandated either a referral or not writing the [Norco] prescription.’’ Id. Dr. Christensen thus opined, and the CALJ agreed, that none of the three prescriptions Respondent wrote for BCI 1 on February 19, 2015 were issued for a legitimate medical purpose by a practitioner acting in the usual course of his professional practice. Tr. 425–26. I agree. As for BCI 1’s second visit, as Dr. Christensen noted, when Respondent asked about his pain level, the former replied that ‘‘everything is cool.’’ Tr. 428. Dr. Christensen also noted that when Respondent then asked BCI 1 to rate his pain on a 1–10 scale, BCI 1 simply replied: ‘‘I’m good today.’’ Id. Dr. Christensen testified that these were ‘‘non-responsive’’ and ‘‘evasive answer[s], which can be signs of drugseeking behavior.’’ Id. at 430–31.38 Dr. Christensen further explained that a reasonable practitioner would have asked BCI 1 about his function level, 38 I have considered Respondent’s testimony that he interpreted BCI 1’s answer to his question, ‘‘[s]o how is everything going with your pain’’ (‘‘great, yup, everything is cool’’), as meaning ‘‘that the regimen or the plan of his management was working.’’ Tr. 674. I have also considered Respondent’s testimony that he interpreted BCI 1’s answer—when asked to rate his pain on a scale of one to ten—of ‘‘I am good today,’’ as ‘‘pain waxes and wanes’’ and ‘‘[t]his might be just a time when he comes into the office [and] he might have just taken his medication.’’ Id. at 676. Even were I to consider this testimony without regard to the CALJ’s findings that Respondent’s testimony was generally not credible, which I decline to do, Respondent did not ask any further questions to probe why BCI 1 answered his questions as he did, nor ask BCI 1 when he last took his medication. Also, as Dr. Christensen testified, Respondent did not engage in anything close to a meaningful assessment of how the pain affected BCI 1’s level of function, whether there were side effects, or ask about aberrant behavior. I thus find Respondent’s testimony on these issues not credible. Respondent also explained that the reasons he made various comments to BCI 1 was because he felt the latter’s comments to him were racially motivated and created a situation where he had to work to gain BCI1’s trust. Tr. 658. He also testified that he encountered racial animus from several other patients. Id. The CALJ rejected Respondent’s contention, noting that ‘‘[t]here was no evidence of any tension in any of the three office visits in the video recordings or the transcripts’’ and that this does not excuse his violations of federal law. R.D. at 84–85. I agree. E:\FR\FM\30APN2.SGM 30APN2 sradovich on DSK3GMQ082PROD with NOTICES2 18908 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices side effects of the medication, and inquired about any aberrant behaviors. Id. at 429. Yet none of this was done. Moreover, the entire interaction between BCI 1 and Respondent lasted less than two minutes, and while a physical exam is not necessarily required on a follow-up visit, Respondent nonetheless performed an exam. Significantly, his examination was limited to having BCI 1 walk back and forth and performing the arm abduction/adduction test, which as previously explained, tests for nerve damage in the thoracic and cervical spine and not nerve damage in the lower back. As Dr. Christensen explained, the examination was not adequate to support medical decision making and that this ‘‘was a negative evaluation for moderate to moderately severe pain.’’ Id. at 431, 429. Also, as Dr. Christensen explained, Respondent again falsified the visit note by documenting physical exam findings when he did not perform the tests necessary to make those findings. Id. at 433–35. Dr. Christensen specifically identified the findings of ‘‘moderate point tenderness to low back,’’ ‘‘cranial nerves 2 through 12 intact,’’ ‘‘2+ pulses throughout,’’ and ‘‘2/2 reflexes’’ as not supported by tests, and he further explained that there were no findings to support the diagnoses of degenerative disc disease in the lumbar area, anxiety, and muscle spasm. Id. at 447. While Respondent testified that he palpated BCI 1’s back, here again, BCI 1 credibly testified that he did not do so. Moreover, as for Respondent’s testimony that ‘‘you can indirectly evaluate the cranial nerves’’ by looking for facial palsy and if ‘‘speech patterns [are] similar to somebody who is deaf,’’ id. at 678–79, Dr. Christensen testified that an examination of a patient’s cranial nerves is far more extensive than what Respondent claim is required. See id. at 417–19. As for Respondent’s claim that he assessed BCI 1’s radial pulse when he performed the arm abduction/ adduction test by pinching his wrist, Dr. Christensen testified that a finding of ‘‘2+ pulses throughout’’ also requires testing of the pulse in the lower extremities. Id. at 434–35. There is, however, no evidence that Respondent touched BCI 1’s lower extremities. While Respondent also documented findings of ‘‘2/2 reflexes’’ and ‘‘Full RoM,’’ Respondent offered no testimony as to how he accomplished the tests necessary to make these findings and the video provides no evidence that he did so. Thus, the evidence shows that Respondent again falsified BCI 1’s medical record when he documented findings that would support prescribing VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 Norco and carisoprodol. Moreover, there are no findings in the March 19 (or the February 19) visit note that support a diagnosis of anxiety and the prescribing of alprazolam. Accordingly, based on the medical record, the video and transcript of the visit, Dr. Christensen’s testimony, and the inferences to be drawn from Respondent’s false testimony, I conclude that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice when he issued each of the three March 19, 2015 prescriptions to BCI 1. 21 CFR 1306.04(a). BCI 2’s Prescriptions The CALJ also concluded that Respondent violated 21 CFR 1306.04(a) when he issued the Norco and Carisoprodol prescriptions to BCI 2. R.D. 84. I agree. As found above, in responding to Respondent’s instruction to tell him how she was doing and how she was feeling, BCI 2 stated that she was ‘‘[j]ust here for refills,’’ that she was ‘‘feel[ing] great today,’’ and ‘‘actually,’’ she had ‘‘been doing really good’’ and ‘‘ha[d] no complaints.’’ GX 7, at 2. Dr. Christensen testified that the statement that she had ‘‘no complaints’’ did ‘‘not mean anything’’ and that Respondent did not determine whether BCI 2 had ‘‘been taking the medication and if the medication is the reason . . . for how she feels.’’ Tr. 450. According to Dr. Christensen’s unrefuted testimony, under the standard of care, Respondent was required to follow-up this exchange by asking BCI 2 if she had ‘‘been taking the medications,’’ as well as by asking about her ‘‘pain level, activity level, side effects,’’ and inquire as to whether she was engaged in any aberrant behavior. Id. Dr. Christensen noted that BCI 2 denied that she had muscle spasms and when asked ‘‘when does it hurt the most,’’ her answer was that ‘‘sometimes’’ when she was asleep and her alarm went off, she would twist to turn off her alarm and screw her back up, but that this had not ‘‘happened in a very long time’’ and she had ‘‘been doing really well.’’ Tr. 454. Dr. Christensen testified that this discussion did not support a finding ‘‘of a moderate or higher pain level’’ and that a reasonable practitioner would ask a patient who said she was not having pain if she was taking her medication and evaluate based on her answer. Id. at 454–55. Dr. Christensen noted that while BCI 2’s records listed a complaint of lower back pain, she did not check any of the PO 00000 Frm 00028 Fmt 4701 Sfmt 4703 symptoms of muscle, joint or bone pain listed on the Medical History Form. Id. at 456; see also GX 11, at 10. He also observed that, on this form, she had listed Norco, Ambien, and Xanax as her current medications. He then explained that Norco and Xanax is a potentially dangerous combination and that Ambien causes side effects and creates risks similar to benzodiazepines, that this combination of drugs raises the concern as to why it ‘‘is being prescribed or taken,’’ and if ‘‘there was a legitimate diagnosis for’’ the prescriptions. Tr. 457–58. With respect to the pain clinic history questionnaire, Dr. Christensen noted that BCI 2 had listed her pain level as ranging from ‘‘0 to 4,’’ but did not circle such items as its location, what made her pain worse, how the pain made her feel, and whether pain levels she listed were with or without medication. Id. at 461–62; see GX 11, at 23. He further observed that while BCI 2 indicated on the form that she used alcohol, she did not provide any information as to the extent of her drinking. Id. at 462; GX 11, at 24. He then explained that, under the standard of care, Respondent was required to obtain this information because the amount of her drinking could increase the side effects and risks from the combination of drugs she was prescribed. Id. Notably, Respondent did not ask BCI 2 any question about her use of alcohol. Dr. Christensen further observed that Respondent documented various findings in the progress note even though the video evidence shows that he had no basis to do so. Specifically, Respondent made a finding of ‘‘point tenderness to right lower back,’’ notwithstanding that he never palpated BCI 2. Tr. 464–65; GX 11, at 35. Dr. Christensen further noted that BCI 2 ‘‘said she was good and she was great and there was no problem.’’ Tr. 464. As for Respondent’s finding that the pain ‘‘shoots to left hip,’’ Dr. Christensen testified that BCI 2 did not complain that her pain radiated or shot to her left hip, and, in fact, when BCI 2 was asked ‘‘to point to where it is,’’ she pointed to her right hip area. Id. at 465, 285, 572. Indeed, BCI 2 said that ‘‘it just stays there.’’ GX 7, at 3. As for Respondent’s finding of ‘‘Full Rom,’’ while Dr. Christensen acknowledged that he performed the abduction/ adduction test on BCI 2’s arms, he did not perform any other range of motion testing. Tr. 465. Dr. Christensen also noted that Respondent did not perform the tests necessary to make his findings of ‘‘CN II–XII intact,’’ ‘‘2+ pulses E:\FR\FM\30APN2.SGM 30APN2 sradovich on DSK3GMQ082PROD with NOTICES2 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices throughout,’’ 39 and ‘‘2/2 reflexes.’’ Id. at 465–66. He further observed that while Respondent diagnosed BCI 2 as having muscle spasms, he did not palpate her and she specifically denied having spasms; he also noted that there was no documentation for his diagnosis of ‘‘abnormal gait periodically,’’ and BCI 2 denied that the pain caused her to limp. Id. at 467; GX 7, at 3–4. As found above, on January 23, 2015, Dr. R. had issued BCI 2 prescriptions for 30-day quantities of both Xanax and Ambien, with each prescription providing for four refills. Thus, when Respondent prescribed Norco and carisoprodol to BCI 2, she had current prescriptions for four different controlled substances. As Dr. Christensen explained, this combination of sedatives is ‘‘a highly addictive and dangerous combination.’’ Tr. 474. Respondent justified his prescribing, maintaining that he reviewed the medical records created by Dr. Vora and Dr. R., including the latter’s ‘‘physical and . . . what she gave the patient.’’ Id. at 681. However, in the January 23, 2015 visit note, Dr. R. indicated that she was issuing both Ambien and Xanax prescriptions, each of which provided for four refills. Moreover, the prescriptions were in the file, each clearly indicated that four refills were authorized, and, in contrast to his testimony that the medical files did not contain the UDS results, Respondent made no claim that the prescriptions were not in the files. Moreover, while Dr. Christensen testified that that Dr. R.’s documentation of her January 23, 2015 examination reflected an appropriate examination based on BCI 2’s complaint of lower back pain (as documented on her chart), notably, at BCI 2’s Feb. 19 visit (which immediately preceded her visit with Respondent), Dr. R. had reduced the Norco prescription from 60 dosage units to five dosage units (a five-day supply), doing what Dr. Christensen explained was ‘‘a planned taper.’’ Tr. 577; see also GX 11, at 30. Yet Respondent increased BCI 2’s Norco prescription back up to 60 dosage units even though BCI 2 never once claimed that she was currently in pain and, indeed, made statements that she was ‘‘feel[ing] great,’’ that she had ‘‘been doing really good’’ and ‘‘ha[d] no complaints,’’ that ‘‘like right now I have like nothing. I feel good. I have good days and bad,’’ and even when she identified when it hurt her the most, she added: ‘‘But I haven’t had that happen 39 For the same reasons that I rejected Respondent’s testimony that he made this finding with respect to BCI 1 based on the arm abduction/ adduction tests he performed, I reject it with respect to BCI 2 as well. VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 in a very long time like literally I have been really doing well.’’ Although Dr. Christensen acknowledged that these statements could be an indication that BCI 2’s condition was well managed with her medication, he explained that it was not reasonable for Respondent to conclude that her medication regimen was appropriate given that Respondent did not ask her if she was taking her medication and how much medication she was taking. Tr. 563–64. Moreover, while Respondent testified that he had reviewed what Dr. R. had prescribed to BCI 2, he did not issue the same prescriptions but rather increased her Norco prescription back up to 60 dosage units. As Dr. Christensen explained, while there was some discussion between Respondent and BCI 2 as to why he had decreased the carisoprodol prescription, there was no discussion between the two as to why he increased the Norco prescription. Id. at 576. Notably, Dr. Christensen explained that the standard of care in Michigan includes ‘‘the principle of informed consent,’’ which requires a physician to explain why the physician is ‘‘making a major change’’ in a patient’s controlled medications and the risks involved. Id. at 577. He testified that while Respondent’s decision to decrease BCI 2’s carisoprodol prescription was reasonable, it was ‘‘not a rational therapeutic choice’’ to increase her Norco ‘‘to maintain the analgesic effect’’ of her carisoprodol. Id. at 580. Indeed, he testified that BCI 2 should have been on ‘‘neither’’ drug. Id. at 580–81. As for why he increased BCI 2’s Norco prescription, Respondent testified that he was aware that Dr. R. had previously reduced it to five dosage units, but that he ‘‘wanted to make sure her pain was under control.’’ Id. at 685. However, as found above, BCI 2 generally denied having pain and certainly denied having had recent pain. Moreover, Respondent did not ask her if she was even taking the medications that Dr. R. had prescribed, let alone assess how her pain affected her ability to function, whether she had side effects from the medications, and whether she was engaged in any aberrant behavior.40 40 As found above, Respondent claimed that he was denied access to the urine drug screens at both visits, and thus, this means of determining if the patients were engaged in aberrant behavior was unavailable. Asked why he nonetheless prescribed 30-day quantities of narcotics such as hydrocodone, Respondent testified that ‘‘you can never just have the patient go cold turkey for any type of narcotic’’ and ‘‘if the patient runs out, they [sic] go into withdrawals [sic].’’ Tr. 693–94. Yet BCI 2 had been already tapered off of Norco by Dr. R. PO 00000 Frm 00029 Fmt 4701 Sfmt 4703 18909 Dr. Christensen opined that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice in issuing the Norco and carisoprodol prescriptions to BCI 2. I agree. Based on Dr. Christensen’s testimony that Respondent’s evaluation was totally inadequate, his testimony that increasing the Norco prescription was not a rational therapeutic choice, that the combinations of drugs prescribed to BCI 2 was highly addictive and dangerous, and Respondent’s falsification of the visit note to reflect various findings to support the prescribing of controlled substances when he failed to perform the necessary tests and BCI 2 made no complaint of pain, I conclude that the record as a whole supports the conclusion that Respondent did not simply engage in malpractice, but knowingly issued the prescriptions in violation of 21 CFR 1306.04(a). Issuance of Prescriptions That Did Not Include the Patient’s Address In addition to the violations of the CSA’s prescription requirement, the record supports a finding that Respondent violated 21 CFR 1306.05(a) when he failed to include the patient’s address on each of the eight prescriptions at issue in this matter. Under this regulation, ‘‘[a]ll prescriptions for controlled substances . . . shall bear the full name and address of the patient.’’ Id. § 1306.05(a). This regulation further provides that ‘‘the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations.’’ Id. § 1306.05(f). As found above, Respondent failed to include the patient’s address on each of the eight prescriptions he issued to BCI 1 and BCI 2 and thus violated section 1306.05(a) as well. Summary of Factors Two and Four As for Respondent’s evidence of his experience as a dispenser of controlled substances, it includes the testimony of Dr. Scott that, pursuant to the order of the Michigan Board, she had supervised Respondent beginning around April 2014 for a period of one year, that she reviewed about 10 of his pain clinic patient charts, and that she ‘‘did not have any problems with’’ them. Tr. 605, 610. Dr. Scott’s testimony does not, however, refute the proof of the specific violations found above. Moreover, Dr. Scott’s testimony suggests that the prescribing violations which have been proven on the record of this case occurred during the period in which E:\FR\FM\30APN2.SGM 30APN2 18910 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices sradovich on DSK3GMQ082PROD with NOTICES2 Respondent was under a Board-imposed probation. As for Respondent’s prescribing at the detention facility, Dr. Scott offered no testimony that he has treated any of the facility’s patients with narcotics and Respondent himself acknowledged that ‘‘not that much’’ of his work at the facility involves prescribing narcotics. Although Respondent also maintained that a small portion of his work at the facility involves prescribing ‘‘anti-psychotics’’ when psychiatrists are not at the facility, he offered no evidence that any of this prescribing involves controlled substances. Finally, while Respondent also testified that prescribing narcotics was part of his training in his fellowships, the manner in which he prescribed to the investigators suggests that he did not learn very much about the proper prescribing of controlled substances.41 In any event, even assuming that Respondent has complied with federal law with respect to every other controlled substance prescription he has issued in the course of his professional career, Respondent’s experience evidence does not refute my findings that he lacked a legitimate medical purpose and acted outside of the usual course of professional practice in issuing each of the eight different prescriptions and that he knowingly diverted controlled substances. See 21 CFR 1306.04(a). I therefore conclude that the evidence with respect to Factors Two and Four establishes that Respondent ‘‘has committed such acts as would render his registration . . . inconsistent with the public interest.’’ 21 U.S.C. 824(a)(4). Sanction Where, as here, the Government has established grounds to revoke a registration or deny an application, a respondent must then ‘‘present[ ] sufficient mitigating evidence’’ to show why he can be entrusted with a new registration. Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988)). ‘‘ ‘Moreover, because ‘‘past performance is the best predictor of future performance,’’ ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), [DEA] has repeatedly held that where [an applicant] has committed acts inconsistent with the public interest, the [applicant] must accept responsibility for [his] actions and demonstrate that [he] will not engage in future 41 As for the testimony of Ms. Clemmons, she worked for Respondent for a brief period of time, and she offered only generalized testimony about procedures at his clinic which does not address the specific violations alleged in this matter. VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 misconduct.’ ’’ Jayam Krishna-Iyer, 74 FR 459, 463 (2009) (quoting Medicine Shoppe, 73 FR 364, 387 (2008)); see also Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006); Cuong Tron Tran, 63 FR 64280, 64283 (1998); Prince George Daniels, 60 FR 62884, 62887 (1995). An applicant’s acceptance of responsibility must be unequivocal. See Lon F. Alexander, 82 FR 49704, 49728 (2017) (collecting cases). Also, an applicant’s candor during both an investigation and the hearing itself is an important factor to be considered in determining both whether he has accepted responsibility as well as the appropriate sanction. Michael S. Moore, 76 FR 45867, 45868 (2011); Robert F. Hunt, D.O., 75 FR 49995, 50004 (2010); see also Jeri Hassman, 75 FR 8194, 8236 (2010) (quoting Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005) (‘‘Candor during DEA investigations, regardless of the severity of the violations alleged, is considered by the DEA to be an important factor when assessing whether a physician’s registration is consistent with the public interest[.]’’)), pet. for rev. denied, 515 Fed. Appx. 667 (9th Cir. 2013). While a registrant must accept responsibility for his misconduct and demonstrate that he will not engage in future misconduct in order to establish that his registration would be consistent with the public interest, DEA has repeatedly held that these are not the only factors that are relevant in determining the appropriate disposition of the matter. See, e.g., Joseph Gaudio, 74 FR 10083, 10094 (2009); Southwood Pharmaceuticals, Inc., 72 FR 36487, 36504 (2007). Obviously, the egregiousness and extent of an applicant’s misconduct are significant factors in determining the appropriate sanction. See Jacobo Dreszer, 76 FR 19386, 19387–88 (2011) (explaining that a respondent can ‘‘argue that even though the Government has made out a prima facie case, his conduct was not so egregious as to warrant revocation’’); Paul H. Volkman, 73 FR 30630, 30644 (2008); see also Paul Weir Battershell, 76 FR 44359, 44369 (2011) (imposing six-month suspension, noting that the evidence was not limited to security and recordkeeping violations found at first inspection and ‘‘manifested a disturbing pattern of indifference on the part of [r]espondent to his obligations as a registrant’’); Gregory D. Owens, 74 FR 36751, 36757 n.22 (2009). So too, the Agency can consider the need to deter similar acts, both with respect to the respondent in a particular case and the community of registrants. See Gaudio, 74 FR at 10095 (quoting PO 00000 Frm 00030 Fmt 4701 Sfmt 4703 Southwood, 71 FR at 36503). Cf. McCarthy v. SEC, 406 F.3d 179, 188–89 (2d Cir. 2005) (upholding SEC’s express adoption of ‘‘deterrence, both specific and general, as a component in analyzing the remedial efficacy of sanctions’’). The CALJ found that Respondent has refused to accept responsibility for his misconduct. R.D. at 91. As the CALJ explained, ‘‘[f]ar from offering an unequivocal acceptance of responsibility . . . Respondent offered excuses for his conduct that smacked more of contrivance than contrition.’’ Id. Indeed, Respondent specifically denied that he violated 21 CFR 1306.04(a) with respect to any of the prescriptions. I therefore agree with the CALJ that Respondent has failed to accept responsibility for his misconduct. Given the egregious nature of his misconduct, which involves the knowing diversion of controlled substances, Respondent’s failure to acknowledge his misconduct provides reason alone to conclude that he has not rebutted the Government’s prima facie case.42 Indeed, this Agency has explained that because the knowing diversion of controlled substances strikes at the core of the CSA’s purpose, the Agency will not grant an application (or continue a registration) where the evidence shows that a practitioner has engaged in even a single act of the knowing diversion of a controlled substance and the practitioner refuses to acknowledge his/her misconduct. See Samuel Mintlow, 80 FR 3630, 3653 (2015) (citing Dewey C. MacKay, 75 FR 49956, 49977 (2010) (citing KrishnaIyer, 74 FR 459, 463 (2009) and Alan H. Olefsky, 57 FR 928, 928–29 (1992))). Moreover, while the Agency’s interest in specific deterrence is not triggered (because I deny his application), the Agency’s interest in deterring other practitioners who contemplate diverting controlled substances is manifest. I therefore conclude that granting Respondent’s application for a registration ‘‘would be inconsistent with the public interest.’’ 21 U.S.C. 823(f). Accordingly, I will order that his pending application be denied. Order Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 CFR 0.100(b), 42 Even had Respondent accepted responsibility, his evidence which is arguably relevant on the issue of remediation is not adequate to assure me that he can be entrusted with a registration. As found above, his evidence simply amounts to his promise to do better in the future and his non-binding desire that ‘‘I do not really want to do pain management . . . But right now the only thing that’s open is pain management.’’ Tr. 688–89. Thus, his promise is no more than a ‘‘goal.’’ Id. at 689. E:\FR\FM\30APN2.SGM 30APN2 Federal Register / Vol. 83, No. 83 / Monday, April 30, 2018 / Notices I order that the application of Garrett Howard Smith, M.D., for a DEA Certificate of Registration as a practitioner, be, and it hereby is, denied. This Order is effective immediately. 18911 Dated: April 17, 2018. Robert W. Patterson, Acting Administrator. [FR Doc. 2018–09020 Filed 4–27–18; 8:45 am] sradovich on DSK3GMQ082PROD with NOTICES2 BILLING CODE 4410–09–P VerDate Sep<11>2014 16:35 Apr 27, 2018 Jkt 244001 PO 00000 Frm 00031 Fmt 4701 Sfmt 9990 E:\FR\FM\30APN2.SGM 30APN2

Agencies

[Federal Register Volume 83, Number 83 (Monday, April 30, 2018)]
[Notices]
[Pages 18882-18911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09020]



[[Page 18881]]

Vol. 83

Monday,

No. 83

April 30, 2018

Part II





Department of Justice





-----------------------------------------------------------------------





Drug Enforcement Administration





-----------------------------------------------------------------------





Garrett Howard Smith, M.D.; Decision and Order; Notice

Federal Register / Vol. 83 , No. 83 / Monday, April 30, 2018 / 
Notices

[[Page 18882]]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 16-25]


Garrett Howard Smith, M.D.; Decision and Order

    On June 13, 2016, the Deputy Assistant Administrator, of the then 
Office of Diversion Control, issued an Order to Show Cause to Garrett 
Howard Smith, M.D. (hereinafter, Respondent), of Southfield, Michigan. 
ALJ Ex. 1, at 1. The Show Cause Order proposed the revocation of 
Respondent's Certificate of Registration, the denial of any pending 
applications to renew or modify his registration, and the denial of any 
applications for any other registration, on the ground that his 
``registration is inconsistent with the public interest.'' Id. (citing 
21 U.S.C. 824(a)(4) & 823(f)).
    With respect to the Agency's jurisdiction, the Show Cause Order 
alleged that Respondent is registered as a practitioner in schedules II 
through V, pursuant to Certificate of Registration No. FS2592005, at 
the registered address of 29193 Northwestern Highway, Suite 571, 
Southfield, Michigan. Id. The Order also alleged that Respondent's 
``registration expires by its terms on February 28, 2017.'' Id.
    As to the substantive grounds for the proceeding, the Show Cause 
Order alleged that Respondent ``failed to comply with Federal and state 
laws relating to the prescribing of controlled substances by issuing 
purported `prescriptions' outside the usual course of professional 
practice or for other than a legitimate medical purpose.'' Id. at 2 
(citing 21 U.S.C. 841(a), 21 CFR 1306.04, Mich. Comp. Laws Sec. Sec.  
333.7333(1), (3), & (4), 333.7405(1)(a)). The Show Cause Order then 
alleged that in three instances, Respondent unlawfully prescribed 
controlled substances to two undercover investigators (hereinafter, BCI 
1 and BCI 2) for Blue Cross/Blue Shield of Michigan. Id. at 2-3.
    As to the first such instance, the Show Cause Order alleged that on 
February 19, 2015, Respondent prescribed to BCI 1, 65 dosage units of 
Norco 7.5/325 mg (hydrocodone), a schedule II controlled substance, as 
well as 60 Xanax .5 mg (alprazolam) and 30 Soma 350 mg (carisoprodol), 
the latter two drugs being schedule IV controlled substances. Id. at 2. 
The Show Cause Order also alleged that each of the prescriptions did 
not include information required under 21 CFR 1306.05(a) and (f), as 
they did not contain the patient's address. Id.
    As to the second instance, the Show Cause Order alleged that on 
March 19, 2015, BCI 1 returned to Respondent's office ``for a follow-up 
visit'' and that Respondent again provided him with prescriptions for 
65 dosage units of Norco 7.5/325 mg, 60 Xanax .5 mg, and 30 Soma 350 
mg. Id. at 2-3. The Order again alleged that each of the prescriptions 
did not include information required under 21 CFR 1306.05(a) and (f), 
as they did not contain the patient's address. Id. at 3.
    As to the third instance, the Show Cause Order alleged that on 
March 19, 2015, BCI 2 ``presented for an office visit at'' Respondent's 
office and ``asked for refills of . . . prescriptions for Norco and 
Soma previously issued by another physician at the clinic . . . on 
February 20, 2015.'' Id. at 3. The Order alleged that Respondent issued 
BCI 2 prescriptions for 60 Norco 5/325 mg and 60 Soma 350 mg. Id. The 
Order again alleged that each prescription did not include information 
required under 21 CFR 1306.05(a) and (f), as they did not contain the 
patient's address.\1\ Id.
---------------------------------------------------------------------------

    \1\ The Show Cause Order also made detailed factual allegations 
as to various acts performed by Respondent and the office staff as 
well as the statements made by Respondent and the Investigators at 
each of the visits. ALJ Ex. 1, at 2-3.
---------------------------------------------------------------------------

    The Show Cause Order notified Respondent of his right to request a 
hearing on the allegations or to submit a written statement of position 
while waiving his right to a hearing, the procedure for electing either 
option, and the consequence of failing to elect either option. Id. at 
3-4. The Show Cause Order also notified Respondent of his right to 
submit a corrective action plan pursuant to 21 U.S.C. 824(c)(2)(C). Id. 
at 1, 4.
    On July 13, 2016, Respondent, through his counsel, requested a 
hearing on the allegations. ALJ Ex. 2. The matter was placed on the 
docket of the Office of Administrative Law Judges and assigned to Chief 
Administrative Law Judge John J. Mulrooney, II (hereinafter, CALJ), who 
conducted pre-hearing procedures. ALJ Ex. 3. Following pre-hearing 
procedures, the CALJ conducted an evidentiary hearing on November 29-
30, 2016 in Detroit, Michigan, after which both parties submitted 
briefs containing their proposed findings of fact and conclusions of 
law. Recommended Decision, at 2. Moreover, while the matter was pending 
the issuance of the Recommended Decision, the Government notified the 
CALJ that, on December 16, 2016, the Director of the Michigan 
Department of Licensing and Regulatory Affairs Bureau of Professional 
Licensing temporarily suspended his medical license thus rendering him 
without authority to handle controlled substances in the State of 
Michigan. Id. at 86.
    On February 8, 2017, the CALJ issued his Recommended Decision. 
Therein, the CALJ found proved the allegations that all of the 
prescriptions issued to both undercover investigators ``were issued 
outside of the usual course of professional practice, for no legitimate 
medical purpose, and outside the professional standards of a Michigan 
controlled substance prescriber.'' Id. at 80 (Feb. 19, 2015 
prescriptions issued to BCI 1); see also id. at 82 (Mar. 19, 2015 
prescriptions issued to BCI 1); id. at 84 (Mar. 19, 2015 prescriptions 
issued to BCI 2). The CALJ further noted that ``the record evidence of 
the three undercover visits under Factors 2 and 4 militates powerfully 
in favor of the revocation sanction sought by the Government.'' Id. at 
85.
    The CALJ also found proved the allegations that Respondent failed 
to include the patient's addresses on each of the eight prescriptions 
he issued to the two undercover investigators. Id. The CALJ further 
found that Respondent's failure to include the addresses violated 21 
CFR 1306.05(a) and (f) and that these violations ``weigh in some 
support of a sanction under Public Interest Factor 4.'' Id. at 85-86.
    Finally, the CALJ found that ``the parties have stipulated that the 
Respondent's Michigan medical license is currently suspended.'' Id. at 
90. The CALJ rejected Respondent's claim that his lack of state 
authority could not be ``properly considered against him in this matter 
because the allegation was not included in the'' Show Cause Order. Id. 
at 86. The CALJ explained that notwithstanding the lack of notice in 
the Show Cause Order or the pleadings, ``the Respondent here was put on 
notice of this essentially legal issue, and has had an opportunity to 
respond to the allegation that he lacks state authority.'' Id. at 88. 
The CALJ also rejected Respondent's contention that the Director of the 
Department of Licensing and Regulatory Affairs ``is not `a competent 
state authority' '' within the meaning of 21 U.S.C. 824(a)(3) because 
he `` `does not have the ability to suspend, revoke, or otherwise 
discipline a license without a full vote of the Disciplinary 
Subcommittee,' '' noting that Respondent ``concede[d] that the Director 
does have authority to summarily suspend'' and that, under agency 
precedent, the issue is whether he is currently authorized under state 
law to dispense controlled substances. Id. at 89. The CALJ thus found 
that because ``Respondent does not presently possess the requisite 
authority to maintain his DEA registration, Agency

[[Page 18883]]

precedent ``compels the revocation of '' his registration. Id. at 90.
    The CALJ also addressed whether Respondent's prescribing of 
controlled substances supported a sanction. Noting that ``the 
Government has met its prima facie burden of proving that the 
requirements for revocation or suspension . . . are satisfied,'' the 
CALJ found that Respondent did not ``offer[ ] an unequivocal acceptance 
of responsibility,'' that he ``offered excuses for his conduct that 
smacked more of contrivance than contrition, and lacked any present 
indication of remedial steps beyond not desiring to practice pain 
medicine in the future.'' Id. at 91. While noting that ``the actual 
tally of transgressions on the present record is by no means 
overwhelming,'' and that ``had this record presented a registrant who 
signaled at least some indication that he had committed serious errors 
in judgment, a persuasive argument could be made for a sanction short 
of revocation,'' the CALJ explained that this ``was not the case 
here.'' Id. at 92.
    The CALJ then concluded that ``the issue of [specific] deterrence 
favors revocation of the Respondent's [registration] because he still 
remains committed to the concept that he acted within the bounds of his 
responsibilities as a registrant.'' Id. The CALJ subsequently observed 
that:

[i]t was clear in the undercover recordings that this Respondent was 
not engaging in a thorough physical examination or asking probing, 
sincere questions regarding symptoms present in the two undercover 
investigators that would warrant pain medicine; he was merely 
exchanging a few pleasantries and going through some meaningless 
motions prior to doling out the medications that he knew he was 
giving-and the patients knew they were getting-from the moment they 
walked into the office. Specific deterrence is best served by 
revocation here.

Id. at 92-93.
    With respect to the Agency's interest in general deterrence, the 
CALJ concluded that ``[t]o impose a sanction short of revocation on 
these facts would send a message to the regulated community that the 
plausible deniability that comes from walking into a practice as a 
locum tenens with no preparation can act as a shield to insulate a 
practitioner from consequences for failing to execute the 
responsibilities of a DEA registration in deterring diversion. . . . 
[A] sanction that falls short of revocation here . . . would 
communicate to the regulated community that there is no meaningful 
consequence to handing out powerful medications based on little more 
than small talk.'' Id. at 93.
    The CALJ also concluded that Respondent's misconduct ``does not 
present a picture of a lack of due care borne of a harried physician 
keeping up with the demands of practice, or an isolated blunder that 
has its genesis in lack of training; but rather, . . . measured, 
calculated decisions to issue powerful controlled substances backed up 
by little more than incomplete charts, vague answers, and casual banter 
and made in the face of talk of trading drugs and the street value of 
the medications.'' Id. Continuing, the CALJ explained that ``[f]or a 
DEA registrant, the answer to a deficit of records and questionable 
patient responses cannot be to prescribe anyway and sort matters out at 
some future date.'' Id. at 93-94. The CALJ thus concluded that 
Respondent's misconduct ``was sufficiently egregious to merit the 
sanction of revocation.'' Id. The CALJ recommended that Respondent's 
registration be revoked and that any pending application for renewal be 
denied. Id.
    Neither party filed exceptions to the CALJ's Recommended Decision. 
Thereafter, the CALJ forwarded the record to my Office for Final Agency 
Action.
    Having considered the record in its entirety, I adopt the CALJ's 
factual findings including his credibility determinations, his 
conclusions of law, and his recommendation that I revoke Respondent's 
registration and deny any pending application to renew his 
registration. I make the following factual findings.

Findings of Fact

    Respondent is a medical doctor licensed by the Michigan Board of 
Medicine. While on December 13, 2016, the Board summarily suspended 
Respondent's medical license, on February 16, 2017 (eight days after 
the CALJ issued his Recommended Decision and well before the record was 
forward to my Office), the Board's Disciplinary Subcommittee and the 
Board entered into a Consent Order and Stipulation with Respondent.\2\ 
Under the Consent Order, the Board found ``that the allegations of fact 
contained in the complaint are true and that Respondent has violated 
section 16221(a) of the Public Health code.'' Id. at 2.
---------------------------------------------------------------------------

    \2\ I take official notice of the Consent Order and Stipulation 
entered by Respondent with the Board on February 16, 2017. See 5 
U.S.C. 556(e). The parties are entitled to refute the findings based 
on the Consent Order and Stipulation by filing a properly supported 
motion for reconsideration within 10 business days of the issuance 
of this decision. It is further noted that while the CALJ's order 
directing the parties to ``provide timely updates to this tribunal 
regarding any developments'' pertaining to the status of 
Respondent's state license lapsed upon issuance of the Recommended 
Decision, ALJ Ex. 29, it is perplexing that neither party notified 
this Office that the summary suspension had been dissolved on 
February 16, 2017.
---------------------------------------------------------------------------

    As a consequence, the Board placed Respondent on probation for a 
period of two years from the effective date of the Order. Id. As one of 
the terms of the Consent Order, Respondent agreed that he ``shall not 
obtain, possess, prescribe, dispense or administer any drug designated 
as a controlled substance under the Public Health Code or its 
counterpart in federal law except in a hospital or other institutional 
setting.'' Id. In addition to imposing a variety of additional 
probationary terms, the Board fined Respondent $7,500. Id. at 5. The 
parties, however, also agreed to the dissolution of the summary 
suspension. Id. at 1.
    Respondent also previously held DEA Certificate of Registration No. 
FS2592005, pursuant to which he was authorized to dispense controlled 
substances in schedules II through V, at the registered address of 
29193 Northwestern Hwy., Suite 571, Southfield, Michigan. R.D. 3 
(Stipulation of Fact No. 1). The expiration date of this registration 
was February 28, 2017. Id. According to the registration records of 
this Agency, of which I also take official notice, Respondent did not 
submit a renewal application until March 16, 2017, after the expiration 
date of his registration. I therefore find that Respondent's renewal 
application was untimely and that his registration expired on February 
28, 2017. See 21 CFR 1301.36(i). I further find, however, that 
Respondent's March 16, 2017 application remains pending before the 
Agency.\3\ See Paul Volkman, 73 FR 30641, 30644 (2008), pet. for rev. 
denied, Volkman v. DEA, 567 F.3d 215, 225 (6th Cir. 2009).
---------------------------------------------------------------------------

    \3\ The parties are also entitled to refute the findings with 
respect to Respondent's registration status and application by 
filing a properly supported motion for reconsideration within 10 
business days of the issuance of this decision.
---------------------------------------------------------------------------

The Investigation of Respondent

    This investigation arose out of the investigation of another 
physician (Dr. Vora), who, the Chief of Police of Gladwin, Michigan 
suspected was issuing prescriptions that lacked a legitimate medical 
purpose. Tr. 37. Because the physicians in the town knew local police 
officers \4\ and the officers could not ``do any undercover work,'' an 
officer with the Gladwin Police Department contacted James

[[Page 18884]]

Howell, an investigator for Michigan Blue Cross/Blue Shield 
(hereinafter, BC) who the Chief had met at a state drug diversion 
conference, as they had ``the tools to do'' undercover work. Id. at 21. 
Mr. Howell (hereinafter, BCI 1 \5\) agreed to assist the Gladwin Police 
by performing undercover visits to Dr. V's clinic; Jill Kraczon, a 
second BC Investigator (hereinafter, BCI 2 \6\) also made several 
visits to the clinic.
---------------------------------------------------------------------------

    \4\ According to the Chief of the Gladwin Police Department, the 
Department has four full-time officers and six part-time officers. 
Tr. 21.
    \5\ Mr. Howell (BCI 1) had previously been employed by the 
Lincoln Park, Michigan Police Department for twenty-three years, 
where he did ``all type[s] of police work including uniform patrol, 
detective work, undercover work, [and] violent crime 
investigations,'' retiring with the rank of lieutenant. Tr. 58. He 
testified that he had ``attended a basic drug diversion school'' 
which ``was put on by the National Association of Drug Diversion 
Investigators,'' as well as ``over 40 hours of training in other 
drug diversion seminars.'' Id. at 58-59.
    \6\ Ms. Kraczon (BCI 2) testified that prior to working for BC 
she had been a police officer with the Lansing Police Department for 
16 years and that she had done undercover work for the last three 
years of her employment with the Department which included ``over 
prescribing doctor cases.'' Tr. 190. She also testified that she had 
professional training with the National Association of Drug 
Diversion Investigators, as well as in-house training with Blue 
Cross, and had ``done over 100 undercovers at Blue Cross.'' Id.
---------------------------------------------------------------------------

BCI 1's Visits

    Using the name of James Howard, on November 10, 2014, BCI 1 made 
his first visit to the clinic. There, he completed an authorization for 
the release of his records from one Dr. Lindsay, a ``Controlled 
Substances Management Agreement,'' a Medical History Form (on which he 
did not check any of the symptoms but did list Xanax as a medication he 
was currently taking), as well as other forms including one on which he 
noted that the reason for his visit was ``refills.'' GX 10, at 14, 16-
17, 19-20.
    At this visit, BCI I saw Dr. Vora. GX 10, at 5-6. Dr. Vora created 
a visit note which documented BCI 1's chief complaints as including 
anxiety, back pain, and back stiffness; the note also listed vital 
signs, a history, a review of systems and various physical examination 
findings. Id. at 5. However, the physical exam section contained no 
findings as to the Investigator's back. Id. Nor were there any findings 
as to the Investigator's psychiatric condition.
    As the treatment plan, Dr. Vora simply noted ``Follow Up'' and 
``After 1 month(s).'' Id. at 5-6. Although the progress note for this 
visit does not list any prescriptions, the patient file includes copies 
of prescriptions issued by Dr. Vora to BCI 1for 60 Norco 7.5 mg and 60 
Xanax 0.5 mg which are dated ``11-10-14.'' Id. at 21. BCI 1's patient 
file also includes a copy of a report from the Michigan Automated 
Prescription System dated ``10/20/2014.'' Id. at 23. It shows that 
James Howard had obtained alprazolam from four different providers, 
including one in Marquette, one in Detroit, and two with different 
addresses in Flint; the report also shows that one of the providers 
from Flint had also prescribed amphetamines to Howard. Id.
    On December 15, 2014, BCI 1 again saw Dr. Vora, who noted that the 
former's ``[p]roblem [l]ist'' included both back pain and anxiety (both 
with an onset date of ``12/15/2014''), as well as generalized anxiety 
disorder and lumbar paraspinal muscle spasm. Id. at 3. In the Review of 
Systems section of the visit note, Dr. Vora made negative findings \7\ 
except for with respect to ``lower back pain'' and ``endocrinology 
anxiety.'' Id.
---------------------------------------------------------------------------

    \7\ These negative findings included ``Psychiatry depression.'' 
GX 10, at 3.
---------------------------------------------------------------------------

    In the physical examination section, Dr. Vora documented findings 
of ``lumbar spine point tenderness,'' ``TTP L/S spine, pain with 
flexion/extension[,] Negative SLR [straight leg raise], No weakness 
with Toe/Heel walk b/l).'' Id. at 4. Dr. Vora listed diagnoses of 
generalized anxiety disorder and lumbar paraspinal muscle spasm. Id. 
His treatment plan included an X-Ray of the Investigator's lumbar 
spine, a recommendation to BCI 1 to ice his back for 20 minutes two to 
three times per day, and four prescriptions, including for 60 Norco 
7.5/325 mg, 60 Xanax .5 mg, and two non-controlled drugs. Id.
    On January 12, 2015, BCI 1 again saw Dr. Vora. Id. at 1. In the 
Review of Systems section of the visit note, Dr. Vora indicated the 
existence of musculoskeletal joint pain, muscle pain, lower back pain, 
back pain, and endocrinology anxiety. Id. However, in contrast to the 
previous visit note, there are no physical exam findings related to the 
Investigator's back pain. Id. at 1-2. Nor are there any findings 
related to BCI 1's anxiety. Id. Although the Treatment Plan section of 
the visit lists Zithromax Z-Pak as having been prescribed at this 
visit, it does not list any controlled substances as having been 
prescribed on this date. Id. at 2. Nonetheless, both Norco and Xanax 
are listed in the visit note under the ``Reconciled Medications'' and 
the patient file includes two prescriptions that were copied onto the 
same page: One for 66 Xanax (pill strength unclear) and one for 66 
Norco 7.5/325 mg.\8\ Id. at 10.
---------------------------------------------------------------------------

    \8\ While only the full date of the Norco prescription is clear, 
the year of the Xanax prescription is listed as ``15,'' and both 
prescriptions were written on Dr. Vora's prescription forms. GX 10, 
at 10. Respondent was the only other physician seen by the 
Investigator at this clinic in 2015.
---------------------------------------------------------------------------

    On February 19, 2015, BCI 1 returned to the clinic where he finally 
saw Respondent. After checking in and waiting for two hours, BCI 1 was 
required to provide a urine sample for drug testing after which he was 
taken to an exam room where a medical assistant took his blood pressure 
and told him to wait for Respondent. Tr. 66, 69.
    Respondent entered the exam room and after he and BCI 1 exchanged 
pleasantries, Respondent asked: ``what brings you here? What hurts 
you?'' to which BCI 1 replied that he had come back for refills'' and 
had ``been seeing Dr. Vora here.'' GX 3, at 5. Respondent then asked 
BCI 1 what he was ``getting the medication for?'' Id. BCI 1 stated: ``I 
take Norco for my back and I take Xanax on the weekends,'' prompting 
Respondent to ask: ``Okay so you have back pain and some anxiety?'' Id. 
BCI 1 replied, ``I guess.'' Id.
    Respondent asked BCI 1 when his other doctor was ``going to be 
here,'' to which the latter stated that he didn't know. Id. at 5-6. 
Respondent then asked BCI 1 why he needed a Z-Pak (Zithromax) and if he 
had had an infection?; BCI 1 answered that he ``didn't get one,'' 
prompting Respondent to ask: ``You didn't take it-any? Because it 
says.'' Id. at 6. BCI 1 answered that while he ``saw some paperwork for 
that,'' he ``didn't get it,'' stated that he was ``cool,'' and denied 
that he was sick. Id.
    BCI 1 then asked Respondent if he was taking over for Dr. Vora. Id. 
Respondent replied that he did not know, that it was his ``first time'' 
at the clinic and ``in this area ever,'' that he was from East 
Lansing,'' and that the Gladwin area was very rural and a lot 
different. Id. at 6-7.
    After determining the Investigator's age (44), Respondent asked BCI 
1 how long he had had back pain; the latter answered: ``probably ten 
years. Mostly just stiff.'' Id. at 7. Respondent then asked BCI 1 if he 
got ``any muscle spasms with the pain?'' Id. BCI 1 replied: ``I don't 
know. It[ ] gets like tight . . . so I don't know. I don't know--I 
don't know what the word is for that. Stiff.'' Id.
    After a discussion about Respondent's being left-handed, Respondent 
asked the Investigator: ``[d]o you ever have to walk with a limp 
because your pain gets so bad?'' Id. at 8. BCI 1 replied that ``I strut 
a little bit. Does that count?'' and added that ``I got a little flavor 
to my stroll.'' Id. Respondent then asked BCI 1 if he had ever fallen, 
BCI 1 answered in the affirmative, whether he ``had any loss of

[[Page 18885]]

muscle strength?'' to which BCI 1 stated that he was ``just getting 
older'' and was not ``a young buck,'' followed by his asking Respondent 
``are you a back doctor?'' Id. Respondent answered that he ``actually 
[does] procedures'' and ``reads MRI'' and ``CT scans.'' Id. at 8-9.
    Respondent then asked BCI 1 to stand up, turn around, and ``point 
to one spot in your back that hurts the most?'' Id. BCI 1 pointed to 
the small of his lower back, about two inches above his tail bone, Tr. 
164-65, and stated: ``[m]ostly just stiff. Right there.'' GX 3, at 9. 
Id.
    BCI 1 testified that when this occurred he was wearing outdoor 
winter clothing which he did not take off.\9\ Tr. 73. BCI 1 also 
testified that Respondent did not palpate the area of his back that he 
pointed to, and that neither he nor Respondent lifted up the clothing 
that he was wearing. Id. at 175.
---------------------------------------------------------------------------

    \9\ While the video reflects the presence of an item of clothing 
which BCI 1 brought with him and which he was not wearing during his 
visit with Respondent, BCI 1 testified that ``normally,'' he wears 
multiple layers and that ``[d]uring the exam, I had a hooded 
sweatshirt and some type of coat [or vest] over it.'' Tr. 174.
---------------------------------------------------------------------------

    Respondent asked if the pain ``shot anywhere'' or ``is it just 
localized?'' GX 3, at 9. BCI 1 stated that ``[i]t's localized.'' Id. 
Respondent then had BCI 1 hold out his arms, and as Respondent held the 
top of BCI 1's arms, Tr. 166-67, he had BCI 1 push up and then push 
down. GX 3, at 9. Notably, as he performed these tests, Respondent did 
not ask BCI 1 if either one caused pain and BCI 1 did not complain that 
either test caused pain. Id.; see also GX 3, Video 5, at 14:48:06-12. 
Thereafter, Respondent told BCI 1 to have a seat and asked if he smoked 
or used marijuana; BCI 1 answered ``[n]ope'' to both questions. GX 3, 
at 9.
    Next, Respondent asked BCI 1 if he was a social drinker. Id. BCI 1 
answered in the affirmative and added: ``That's why I take the Xanax. 
Because when I do that it keeps me from drinking too much moonshine on 
the weekends.'' Id. BCI 1 then asked Respondent if he ``like[d] 
moonshine''; Respondent answered in the negative and added that he 
``heard its very strong.'' Id. BCI 1 agreed and said: ``But, y[ou] 
know, if I take those Xanax[,] I'm cool with it.'' Id.
    Respondent asked BCI 1 what he did on the weekends ``[a]round 
here?'' BCI 1 replied: ``Yeah. I go--I leave. I go to East Lansing with 
you and kick it at the club. Nah. There's not a lot going on. I like 
outdoors stuff myself.'' Id. at 9-10. Respondent and BCI 1 then 
discussed a variety of topics including hunting, whether Respondent 
would be coming to the clinic on a ``steady'' basis, where else 
Respondent worked, where BCI 1 had lived, and the traffic in the 
Washington, DC area, where Respondent had done his residency. Id. at 
10-12.
    Respondent told BCI 1 that he was going to prescribe an 
``additional medication for [his] muscle spasm[,] Soma,'' prompting the 
latter to say ``[p]erfect.'' Id. at 12. Respondent then asked BCI 1 if 
he had high blood pressure or diabetes; the latter answered ``No'' to 
both questions. Id.
    After a lengthy discussion of the recent Super Bowl, the 
conversation turned to whether Respondent had any other offices and 
worked for himself. Id. at 12-14. Respondent answered that he worked in 
East Lansing and that he was ``on a contract'' and ``share[d] in the 
profits,'' after which he turned to discussing the hassle of getting 
insurance companies to pay for medication. Id. at 14. While BCI 1 said 
that he had not ``had that problem'' but had ``heard about it,'' 
Respondent replied that ``[i]ts crazy'' and ``[t]hose guys are making 
bank.'' Id.
    Continuing, Respondent added that ``I'd imagine these scripts right 
here that you are going to get would be like 6 or 7 hundred dollars. 
You know the pharmaceutical company are [sic] making bank.'' Id. BCI 1 
commented: ``Big cheese involved in that, ain[']t there?'' Id. 
Respondent answered: ``Right,'' prompting BCI 1 to state: ``Wonder why 
that is. They're worth a lot of money on the street.'' Id. Respondent 
then explained: ``That's the whole point. They're pure. You know there 
is nothing cut down about them. So when you're selling them--its like 
you know--the person buying--legit.'' Id.
    BCI 1 replied ``Right[,] Yeah,'' and Respondent added: ``Its not 
cut or anything like that. That's one reason.'' Id. at 15. BCI 1 then 
noted: ``Well, it's a little safer to do it that way. You know what I 
mean,'' prompting Respondent to say ``Right.'' Id.
    BCI 1 then told Respondent that ``[a] couple of time I ran out of 
pills'' and had to ``trade with my neighbor.'' Id. Respondent remarked: 
``You did? Was it an equal trade?'' to which BCI 1 answered: ``Yeah. It 
was--like I just asked Dr. Vora for a couple extra. . . . And then I 
just gave them back to old boy.'' Id. Respondent stated ``okay,'' and 
BCI 1 stated: ``So we're cool. He wrote it for 66. I said I don't think 
they will fill that[.] [H]e said oh yeah they'll fill it for me. They 
did. Do they fill odd numbers like that? They did for me.'' Id.
    Respondent replied: ``Yeah. I mean they can fill it. He probably 
should have maybe said 65,'' prompting BCI 1 to say ``Oh.'' Id. 
Laughing, Respondent stated: ``66 you know, 65, 70, you know, something 
like that. But 66 what's that about?'' Id. BCI 1 then stated: ``Yeah. 
Because I can't be paying--buying them on the street. You know what I 
mean?'' Id. Respondent stated ``Right'' and BCI 1 stated: ``that's why 
I got good--this insurance I got is the whip. . . . I got Blue Cross. I 
figure I'd use it.'' Id. Respondent replied: ``Right. They'll pay for 
it,'' and BCI 1 stated that he would use the insurance ``while I can.'' 
Id.
    Respondent stated ``okay'' and added: ``So what I did is I re-wrote 
your Xanax, your Norco and your--and Soma.'' Id. BCI 1 replied: 
``Sweet. Thanks doctor,'' after which Respondent and BCI 1 discussed 
the timing of his next appointment (``in a month'') and the visit 
ended. Id. at 15-16.
    In the progress note for this visit, Respondent wrote in the 
``subjective'' section that BCI 1 had ``DDD [degenerative disc disease] 
for approximately 10 years. Pt does have associated muscle spasm.'' GX 
10, at 31. Respondent also noted physical exam findings which included: 
``Slight limp that favors RLE [Right Lower Extremity],'' ``Moderate 
point tenderness to low back that is localized,'' ``Good muscle tone, 
``5/5 Muscle Strength,'' ``CN IV--XII intact,'' and ``Oriented x 3.'' 
Id. Respondent noted diagnoses of ``DDD,'' ``Etoh'' or Ethyl Alcohol,'' 
and ``Anxiety.'' Id.
    The visit note lists three prescriptions: (1) 65 dosage units of 
Norco (hydrocodone and acetaminophen) 7.5/325 mg; (2) 60 dosage units 
of Xanax 0.5 mg; and (3) 30 dosage units of Soma (carisoprodol) 350 mg. 
Id. The Investigator's patient file contains copies of each of these 
prescriptions. Id. at 29-30. Respondent did not include BCI 1's address 
on the prescriptions. See id; see also GX 4, at 1-3.
    The patient file also includes the lab report for the urine sample 
provided by BCI 1 at this visit. Id. at 24-25. While the urine sample 
was not received by the lab until February 23, 2015 and the test 
results were not certified until the next day, BCI 1 was negative for 
every drug listed on the result form, including alprazolam and 
hydrocodone, which had been prescribed to him by Dr. Vora at the 
previous visit. Id. at 24-25; 10.
    On March 19, 2015, BCI 1 returned to the clinic and again saw 
Respondent. Tr. 81. After completing various forms and providing 
another urine sample, BCI 1 was taken to an exam room. Id. at 84.
    Upon Respondent's entering the room, he and BCI 1 greeted each 
other, engaged in a short discussion of the

[[Page 18886]]

NCAA basketball tournament, after which, Respondent asked: ``So how has 
everything been going with your pain?'' GX 5, at 3-4. BCI 1 replied: 
``Great. Yup everything is cool.'' Id. at 4. Respondent said ``Ok[,] 
alright,'' and BCI 1 stated: ``I just pretty much need refills. I am 
easy. You got a special on old people today it looks like. Problem is I 
am one of them.'' Id.
    Respondent directed BCI 1 to ``just walk back and forth for me'' 
and told him to ``just point to where it hurts in your back.'' Id. BCI 
1 stated that ``I just got stiffness pretty much like right down 
there,'' and pointed to a spot about two inches above his tailbone in 
the middle of his back. Tr. 181. Respondent then asked: ``Does it go to 
your leg or anything?'' and BCI 1 replied: ``No just like . . . you 
know.'' GX 5, at 4.
    Respondent had BCI 1 hold out his arms and had BCI 1 push up and 
down. Id. Here again, Respondent did not ask BCI 1 if either test 
caused pain and BCI 1 did not complain that either test caused pain. 
Id. Instead, upon completion of this test, Respondent asked: ``so how 
would you rate your pain on a scale of 1-10 today?'' Id. BCI 1 replied: 
``I am good today. I am good today.'' Id.
    Respondent then told BCI 1 that he was ``going to just refill [his] 
prescriptions'' to which BCI 1 replied: ``Ok that is perfect. Straight. 
I am good then.'' Id. Respondent stated: ``Yeah you are good.'' Id. BCI 
1 thanked Respondent and said he would see him in a month, and after 
Respondent determined that BCI 1 had provided a urine sample, the visit 
ended. Id.
    Respondent wrote in the subjective section of the visit note that 
BCI 1 had ``DDD For approximately 10 yrs'' and that ``Pt has associated 
muscle spasm [with] lbp'' or lower back pain. Id. at 32. In the note's 
physical exam section, Respondent documented findings which included 
``[w]alks [with] a slight limp that Favors RLE,'' ``Moderate point 
tenderness to low back that is localized,'' ``CN [illegible]--XII 
intact,'' ``5/5 Muscle Strength,'' ``good muscle tone,'' ``2+ pulses 
throughout,'' ``2/2 reflexes Full ROM.'' Id.
    As for his diagnoses, Respondent noted: ``DDD--Lumbar,'' ``Etoh,'' 
``Anxiety,'' and ``Muscle Spasm.'' Id. Respondent also documented the 
issuance of prescriptions for 65 dosage units of Norco 7.5/325 mg, 60 
Xanax 0.5 mg, and 30 Soma 350 mg. Id. While the patient file includes 
copies of only the Xanax and Soma prescriptions, see generally GX 10, 
the Government submitted a separate exhibit which contains a copy of 
all three prescriptions issued by Respondent at this visit including 
the Norco prescription. See GX 6, at 1-3. Respondent also failed to 
include BCI 1's address on these prescriptions. See id.

BCI 2's Visit to the Clinic

    Using the name Noelle Garcia, the second BC Investigator also made 
several visits to Dr. Vora's clinic. At her first visit (January 21, 
2015), BCI 2 completed various forms including a medical history form 
on which she did not check any symptoms or conditions but listed Norco, 
Ambien and Xanax as medications she was currently taking. GX 11, at 10. 
Her file also includes a Michigan Automated Prescription System report 
(dated ``1/12/2015''), which shows that Noelle Garcia, whose residence 
was reported as being in Grand Rapids, had last obtained controlled 
substance prescriptions eight months earlier on May 13, 2014 from a 
Nurse Practitioner in Flint. Id. at 15. The report also showed that the 
prescriptions were for 60 hydrocodone/apap 5/325 mg, 60 alprazolam .25 
mg, and 30 zolpidem 5 mg. Id.
    At the visit, BCI 2 saw Dr. Vora, who documented in the visit note 
that she:

[p]resents with complaints of chronic back pain, anxiety and 
inability to sleep through a night. States has been taking Norco, 
Ambien and Xanax for years. States that her back pain fluctuates and 
today rates pain 0/10. States has tried physical therapy and states 
it helped temporarily and would like referral to physical therapy 
again, has not seen PT in over three years. Denies seeking therapy 
for anxiety but would like referral to physical therapy again, has 
not seen PT in over three years. Denies seeking therapy for anxiety 
but would like referral to speak so something, stating that anxiety 
stems from ``struggling for change.''

GX 11, at 1. The visit note further lists BCI 2's problems as 
``anxiety,'' ``Chronic lumbar pain,'' ``Sleep-wake disorder,'' ``GAD 
(generalized anxiety disorder),'' ``Chronic pain,'' and ``Sleep 
disorder,'' and states that BCI 2 ``needs refills on Norco[,] Ambien 
and Xanax.'' Id.
    In the visit note, Dr. Vora documented negative findings for every 
item, including lower back pain. Id. Dr. Vora also documented a variety 
of physical exam findings and made diagnoses of generalized anxiety 
disorder, chronic pain and sleep disorder. While Dr. Vora prescribed 
only a seven-day supply of Motrin 800 mg (a non-controlled substance), 
he made the following additional notes in the ``Treatment Plan'' 
section of the visit note.

    First, with respect to BCI 2's ``[h]istory of chronic lumbar 
pain,'' he documented: States in the past was prescribed Norco for 
pain by a provider in Flint. Has not been prescribed medication in 
over four months and has been ``borrowing from a friend.'' Referral 
to Pain Clinic for treatment of chronic pain. Referral to physical 
therapy. 7 days of 800 mg Motrin prescribed.

Id. at 2. Second, with respect to BCI 2's anxiety, Dr. Vora documented: 
``States that in the past was prescribed Xanax by a provider in Flint 
MI[.] Has not had filled prescription in over four months. States has 
been borrowing from a friend. Referral to MidMichigan Mental Health for 
evaluation and recommendation of treatment.'' Id.
    Two days later, BCI 2 was seen by the Pain Clinic (which shared the 
building or adjoined Dr. Vora's clinic) and completed additional forms 
including a Pain Clinic History Questionnaire and a Narcotic Agreement. 
Id. at 23-24 (Pain Hx form); id. at 26 (Narcotic Agreement). On this 
form, BCI 2 indicated that her ``pain problem'' was an old injury and 
that on a ``0 to 10 pain scale,'' her pain was presently a ``0'' but 
was ``[u]sually a ``4'' and ranged from ``0-4.'' Id. She noted that her 
pain was decreased by medication and that her current medications, 
which she listed as Norco 5/325 mg, Ambien 5 mg and Xanax .25 mg were 
``very good.'' Id. at 23. She also circled numerous medications that 
she had tried, indicated that she had previously had physical therapy, 
and that she had not seen ``any neurologist, neurosurgeon, orthopedic 
surgeons or any other pain physicians.'' Id. While she admitted to 
using alcohol, she denied marijuana use. Id. at 24. Notably, BCI 2 did 
not indicate on the form the location of her pain, how long she had 
suffered it, nor any activity which increased it. See id. at 23.
    According to the visit note, BCI 2 was seen by Dr. R., who 
documented that she complained of ``[p]ain in the lumbar spine.'' Id. 
at 16. Dr. R. noted that BCI 2 ``fell off a horse 10 years ago and 
since then has had pain in her right lumbar area''; she also noted that 
``PT didn't help'' and that ``she has not been considered for spinal 
interventions or seen by a surgeon.'' Id. Dr. R. conducted a review of 
various symptoms, documenting under ``[m]usculoskeletal'' that BCI 2 
had ``[n]o joint pain, redness or swelling'' but had ``[l]umbar back 
pain.'' Id.
    Dr. R. also documented that she performed a physical exam. In her 
findings as to the ``musculoskeletal'' portion, Dr. R. noted 
``tenderness in lumbar spine, no pain on ROM [range of motion] of 
lumbar spine, pinprick intact b/l lower extremities, 4/5 strength b/l 
lower extremities, [D]TR 2+ lower extremities.'' Id. Dr. R. made a 
diagnosis of ``[l]umbar facet pain.'' Id. As for her

[[Page 18887]]

plan, Dr. R. listed ``[o]btain updated MRI of lumbar spine,'' 
``consider LMBB,'' and issued prescriptions for 60 Norco 5/325 mg, 30 
Ambien 5 mg with four refills, and 60 Xanax 0.25 mg, also with four 
refills. Id. See also id. at 28 (copies of each prescription).
    On February 20, 2015, BCI 2 returned to the Pain Clinic and again 
saw Dr. R. In the visit note, Dr. R. documented that ``[p]atient is 
having good pain control on Norco. Did not get MRI.'' Id. at 18; see 
also id. at 29. Under review of systems, Dr. R. documented that ``[a]ll 
14 systems within normal limits.'' Id. at 18. Dr. R.'s physical exam 
findings included ``tenderness in lumbar spine, pinprick intact, some 
pain on ROM of spine[,] 5/5 strength in upper and lower extremities.'' 
Id. Dr. R noted the same diagnosis as before of lumbar facet pain. Id. 
Her plan included having BCI 2 get an MRI of her lumbar spine, 
``try[ing] [S]oma this month instead of Norco,'' and ``consider spinal 
interventions.'' Id.
    BCI 2's patient file contains copies of two prescriptions issued 
this date: one for 120 du of Soma 350 mg, the other for five du of 
Norco 5/325. Id. at 30. The file also includes a signed order by Dr. R. 
for an MRI of BCI 2's lumbar spine; the form lists the date and time of 
the appointment as ``3/5'' at ``10:30 a.m.'' Id. at 31.
    BCI 2's patient file also includes a lab report which shows that 
BCI 2 provided a urine sample at her February 20, 2015 visit. Id. at 
32. According to the report, the specimen was received by the lab on 
February 26, 2015 and the results, which were negative for all drugs 
including those prescribed to her at the previous visit (Norco 
(hydrocodone) and Xanax (alprazolam)). Id. The report further indicates 
that BCI 2's sample failed validity tests and lists a urine creatinine 
level (27 mg/dl) below the reference range (37-300 mg/dl). Id. at 32-
33.
    On March 19, 2015, BCI 2 returned to the clinic and saw Respondent. 
Tr. 191-92. After providing a urine sample, BCI 2 was taken to an exam 
room, and after a short wait, Respondent entered the room. Id. at 194. 
Respondent and BCI 2 exchanged pleasantries, after which Respondent 
asked: ``so tell me what's going on?'' GX 7, at 2. BCI 2 stated that 
she was ``just here for refills,'' prompting Respondent to state: ``Ok. 
Alright and how are you feeling?'' Id. BCI 2 replied: ``I feel great 
today. It's awesome outside.'' Id. Respondent noted that he had 
``[g]one outside pretty early this morning'' and that ``it was like 
barely light out,'' prompting BCI 2 to state that ``[t]hat's too early 
to start work.'' Id.
    Respondent then asked BCI 2: ``[t]ell me how you, you been doing?'' 
Id. BCI 2 answered: ``actually I have been doing really good I have no 
complaints.'' Id. Respondent replied: ``Ok well that's what I like to 
hear. You know, you know that's a good thing.'' Id. BCI 2 then noted 
that there were ``a lot of chairs in this room'' and this ``makes it 
look like an intervention,'' prompting Respondent to comment: ``Right, 
Right. One of those, you know surprise interventions. Families about to 
show up.'' Id. In response, BCI 2 stated that she ``was about to see, 
like a camera man and relatives. Why are you here for pain pills?'' Id. 
at 3.
    Respondent then asked: ``what's going on. Now where is it hurting 
you the most?'' Id. BCI 2 replied: ``Right, lower right but umm. No we 
are good[.] I don't want to bug you. Right, lower right.'' Id. Next, 
Respondent asked BCI 2 to ``stand up for'' him and ``[p]oint to right 
where it is real quick.'' Id. BCI 2 stood up, pointed to her right 
lower hip area about three inches from her spine, Tr. 285,\10\ and said 
``[u]mm right here.'' GX 7, at 3.
---------------------------------------------------------------------------

    \10\ BCI 2 also described this area as her ``lower right back.'' 
Tr. 213.
---------------------------------------------------------------------------

    Respondent acknowledged the location to which BCI 2 had pointed and 
asked ``does it shoot to like your hip or like your leg?'' Id. BCI 2 
responded: ``Ummm. No it just stays there. But umm like right now I 
have like nothing. I feel good. I have good days and bad.'' Id. 
Respondent then had BCI 2 hold out her arms, placed his hands on her 
arms, Tr. 213, and directed her to press up and press down, id., after 
which he asked: ``[d]oes it ever cause you to limp?'' GX 7, at 3; see 
also Tr. 213. BCI 2 answered ``[n]o.'' GX 7, at 3.
    Respondent had BCI 2 ``[w]alk towards the wall and back,'' after 
which he asked if she was ``a smoker.'' Id. BCI 2 said ``no'' and asked 
if she ``look[ed] like one,'' prompting Respondent to say: ``No, you 
look . . . That's one of those medical questions. Just in case.'' Id. 
BCI 2 then asked if she ``ha[d] more refills than I am supposed too?'' 
Id. Respondent answered: ``No. . . . [N]ot at all'' and asked ``And how 
long have you had the pain? And how old are you now?'' Id. After BCI 2 
said she was ``41,'' Respondent told her she could ``sit down'' and 
asked: ``How long have you had the lower back pain.'' Id. BCI 2 
replied: ``Uh god for over 10 years,'' and Respondent asked: ``how did 
it start?'' and ``[w]as it [an] injury?'' Id. BCI 2 answered that she 
``fell off of a horse,'' and Respondent said ``ok.'' Id.
    BCI 2 then said: ``And umm. Actually everything was fine though and 
I wasn't sure but I had the MRI but there was . . . there is nothing 
wrong, nothing broken, X-rays and all that stuff.'' Id. at 4. 
Respondent asked her when she had last had an MRI, and BCI 2 answered 
that she was ``actually going today at 2 p.m.'' Id. Respondent then 
asked: ``MRI of what? Your spine?'' and BCI 2 replied: ``Yep yep, cause 
doctor [R.] wanted me to get one and umm. So it's actually today at 
2.'' Id.
    Respondent asked BCI 2 ``do you get `muscle spasms?''; BCI 2 said 
``nope.'' Id. Respondent then asked: ``And when does it hurt the 
most?'' Id. BCI 2 answered: ``Sometimes on occasion like when my alarm 
clock goes off in the morning and I am totally dead asleep and I'll 
twist to shut off my alarm . . . That's when it kind of screws it up.'' 
Id. Respondent said ``ok,'' and BCI 2 added: ``But I haven't had that 
happen in a very long time like literally I have been really doing 
well.'' Id.
    Respondent asked if she had ``lost any flexibility or anything like 
that?'' Id. BCI 2 answered that she did not ``think so.'' Id.
    Respondent then asked BCI 2 if she had any allergies. Id. BCI 2 
answered: ``Nope. She [Dr. R.] put me on Soma,'' prompting Respondent 
to comment that he saw that and Dr. R. ``put you on quite a bit.'' Id. 
Respondent then told BCI 2 that ``I will give you some Norco and I'll 
give you some Soma but I will only give you Soma for like twice a 
day.'' Id. BCI 2 said ``ok,'' and Respondent repeated ``[t]wice a day 
but I will give you some Norcos,'' and asked BCI 2 if she ``ha[d] any 
questions.'' Id. After Respondent confirmed that BCI 2 had given a 
urine sample the visit ended. Id. at 4-5. Consistent with Respondent's 
statement, the evidence shows that Respondent issued to BCI 2 
prescriptions for 60 Norco (hydrocodone/apap) 5/325 mg. and 60 Soma 
(carisoprodol) 350 mg. GX 8, at 1-2. Respondent did not include BCI 2's 
address on either prescription. See id.
    In the subjective section of the visit note, Respondent wrote; 
``LBP x 10 yrs [secondary] to falling off a horse.'' GX 11, at 35. As 
for his physical exam findings, he documented: ``[p]oint tenderness to 
[right] lower back, shoots to left hip,'' ``Full ROM,'' ``slight 
limp,'' ``5/5 Muscle strength,'' ``Good Muscle tone,'' ``CN II-XII 
intact,'' ``2+ pulses throughout,'' ``oriented x 3,'' and ``2/2 
reflexes.'' Id. As for his diagnoses, he listed ``LBP x 10 yrs,'' 
``spasm,'' ``[Oslash] Smoking,'' and ``Abnormal Gait periodically.'' 
Id.

The Government's Expert's Testimony

    The Government called Carl W. Christensen, M.D. and Ph.D., as an

[[Page 18888]]

Expert witness in pain management and the standard of care applicable 
in Michigan to general practitioners treating patients who complain of 
pain. Tr. 350-51. Following voir dire, the CALJ accepted Dr. 
Christensen as an expert in these areas and the CALJ ultimately found 
his testimony generally credible. R.D. at 40-41.
    Dr. Christensen holds a Bachelor of Arts in Biology from Wayne 
State University (W.S.U.), which he obtained in 1977, as well as both a 
Doctor of Medicine and Doctor of Biochemistry from the W.S.U. School of 
Medicine, which he obtained in 1979 and 1985, respectively. GX 12, at 
1-2. While much of his initial professional experience was in the 
specialty of obstetrics and gynecology, in 2002, Dr. Christensen began 
working with another physician who specialized in treating pregnant 
heroin addicts and became Board Certified in Addiction Medicine; he 
also testified that he has been practicing chronic pain medicine 
``since.'' Tr. 350; see also GX 12, at 9. His professional experience 
includes serving as Director of Addiction Medicine Services, Detroit 
Medical Center, and as Medical Director of both the Dawn Farm Treatment 
Center in Ypsilanti, Michigan, and Spera Detox Center in Ann Arbor, 
Michigan. GX 12, at 5. He is a member and Distinguished Fellow of the 
American Society of Addiction Medicine, a member and former President 
of the Michigan Society of Addiction Medicine, and a member of the 
American Academy of Pain Management. Id. at 7. Dr. Christensen holds a 
current Michigan Medical License and Michigan Controlled Substance 
License, as well as a current DEA registration and DATA-Waiver 
Identification Number for treating patient with buprenorphine. Id. at 
8. Dr. Christensen is also ``one of two speakers employed by the 
Michigan State Medical Society to teach safe opioid practices . . . to 
local medical societies.'' Tr. 354; see also id. at 361-62 (discussing 
Risk Evaluation Mitigation Strategy lectures, in which he discusses the 
``safe prescribing of all opioids, including the new CDC . . . FDA 
guidelines'').
    Dr. Christensen testified that his practice primarily involves 
treating patients who are already taking controlled substances and who 
have been referred to him because the medication is no longer 
effective, the patient's physician suspects the patient is misusing or 
abusing the medication, or the patient needs to be prepared for 
surgery. Id. at 353. He also testified that he ``do[es] pain medication 
management'' and that he ``manage[s] pain medications and associated 
medications, such as sedatives, muscle relaxers, and any medication 
that may interfere with pain management.'' Id. at 355.
    On voir dire, Dr. Christensen acknowledged that he is not board 
certified in pain management because he does not do interventional pain 
management and that he does not believe he is eligible to sit for that 
board's examination. Id. at 357-58. However, he testified that he does 
take patients without referrals who are addicted to pain medication, 
and that ``probably over half'' of his patients are patients who are 
being treated solely for pain. Id. at 360-61.
    Also, on cross-examination, Dr. Christensen acknowledged that he 
had previously testified in court in two pain-related cases for the 
government. Id. at 484-85. He testified that since 2012, he has 
reviewed ``between 10 and 20'' cases total for the government, and that 
in approximately two-thirds of these matters, he rendered an opinion 
that supported the government allegations.\11\ Id. at 485-86. He also 
testified that he has reviewed one case on behalf of a physician 
accused of improper prescribing and rendered an opinion that ``was 
positive for the physician'' and that case ``was dismissed.'' Id. at 
486.
---------------------------------------------------------------------------

    \11\ Dr. Christensen also testified as to his hourly rate for 
both reviewing cases and testifying in court, as well as various 
functions he performs for Blue Cross/Blue Shield which include 
serving on the Medicare Drug Utilization Review Committee. Tr. 487-
88.
---------------------------------------------------------------------------

Dr. Christensen's Testimony on the Standard of Care

    Dr. Christensen testified that as a general matter, the standard of 
care requires that a patient present a complaint, after which ``the 
first thing [a] physician should do is take a history,'' id. at 489, 
which is ``relevant to [the] complaint.'' Id. at 365. The physician 
should then do ``a physical examination that deals with that 
complaint.'' Id.; see also id. at 489. After the exam, the physician 
may need to do lab work and diagnostic tests ``depending upon . . . the 
specific complaint . . . . [a]nd then make a diagnosis and offer a plan 
of treatment.'' Id. at 365; see also id. at 489-90. Dr. Christensen 
acknowledged, however, that a physician may not be able to do 
diagnostic and lab tests at the initial visit but that these tests can 
be ordered. Id. at 367-68. He also testified that while a treatment 
plan should be offered, the plan may need to wait until the diagnosis 
is confirmed through testing. Id. at 490.
    In taking the history of a pain patient, Dr. Christensen testified 
that he uses and teaches medical students to use a mnemonic called 
``OLD CARTS.'' Id. at 373-74. He further testified that the steps set 
forth by this mnemonic constitute the standard of care in Michigan. Id. 
at 374. Dr. Christensen explained the questions pertinent to each 
letter as follows: O, the onset of the pain (when it began); L, the 
location of the pain; D, the duration of the pain; C, the character of 
pain (i.e., whether it is dull, squeezing, burning, or shooting); A, 
factors that aggravate the pain; R, factors that relieve the pain; T, 
timing or what brings the pain on; S, the severity of the pain. Id. at 
373-74. He further explained that as part of this process, the standard 
of care requires the assessment of the patient's functional or activity 
level with the pain. Id. at 374.
    With respect to a chronic pain patient, who would be a patient 
``who has had pain for more than four to six months,'' Dr. Christensen 
would be concerned about the patient's psychiatric history as anxiety 
or depression ``can dramatically affect [a patient's] pain level.'' Id. 
at 368. Dr. Christensen would also want to know if a patient has a 
substance abuse problem and ``do an addiction evaluation to find out if 
there was also a co-occurring or a primary substance abuse problem.'' 
Id. Dr. Christensen further explained that he ``would want to know what 
surgeries [the patient] had in the past and what procedures had been 
done.'' Id.
    Dr. Christensen explained that once a physician makes a diagnosis 
of chronic pain and determines the patient's underlying condition, a 
treatment plan is offered to the patient. Id. at 369. He testified that 
on a return visit, the physician would focus on the patient's chief 
complaint, a review of systems, and the history of the patient's 
present illness, the latter involving asking the patient ``how the 
pain's affecting you?'' ``how strong the pain is?'' ``does it 
radiate?'' and ``what makes it worse and what make it better?'' Id. at 
370. Dr. Christensen testified that the physician ``would then be 
involved primarily in medical decision-making, which means . . . 
look[ing] at the level of risk that the patient has,'' and that ``in 
chronic pain management[,] . . . using a controlled substance [is] 
consider[ed] to be moderate risk.'' Id. The physician would also ``look 
at the amount of information that [the physician] need[s] or the 
information that [the physician] ha[s]'' and ``the number of problems 
that the

[[Page 18889]]

patient has'' and formulate a treatment plan.\12\ Id.
---------------------------------------------------------------------------

    \12\ With respect to how a physician should evaluate whether to 
continue prescribing controlled substances after a patient's initial 
visit, Dr. Christensen testified as to the use of what he called 
``the five As'' to assess the patient. Id. at 370. Dr. Christensen 
explained that these involve: (1) Assessing the level of 
``analgesia'' or pain level; (2) asking the patient about his/her 
activity or ``functional level''; (3) asking ``about adverse 
effects, which for opioids typically consist of . . . constipation, 
sweating, [and] swelling''; (4) looking for aberrant behavior such 
as use of illicit drugs or the failure to use prescribed drugs by 
conducting drug screens and obtaining MAPS reports to look for 
doctor shopping; and (5) looking at how the drugs ``affect'' the 
patient and how the patient appears and behaves during the visit. 
Id. at 370-72. Dr. Christensen testified that findings as to the 
five As should be documented every time. Id. at 373.
     Yet on cross-examination, Dr. Christensen answered ``no'' when 
asked: ``[t]here's no absolute standard of care requirement to go 
through these five As, right?'' Tr. 506.
---------------------------------------------------------------------------

    Asked on cross-examination whether his OLD CARTS + ``sets the 
minimum standard of care,'' Dr. Christensen testified that ``[t]his 
applies to [the] history of present illness, which depending upon the 
level of the visit requires a certain number of elements depending on 
the visit.'' Id. at 506. He further agreed that OLD CARTS ``is a 
helpful mnemonic'' that helps a physician ``remember the types of 
things to ask that meet that standard.'' Id.
    The Government also asked Dr. Christensen whether the standard of 
care is different when ``a physician is acting as a locum tenens 
physician or is in a group practice?'' Id. at 375. Dr. Christensen 
testified that ``the standard of care is the same whether somebody is 
in a solo practice, a group practice, a hospital practice, or locum 
tenens. You're held to the same standards of care in the practice of 
medicine, and the underlying ethical principles are still the same.'' 
Id.
    Turning to BCI I's first visit with Respondent (February 19, 2015), 
Dr. Christensen testified that the former's statement that ``I just 
came back for refills'' raised a red flag that he was just seeking 
medication ``and has no other complaint.'' Id. at 376. As for BCI I's 
statement that ``I take Norco for my back, and I take Xanax on the 
weekends,'' Dr. Christensen testified that this raised a red flag that 
the patient was either misusing or diverting controlled substances. Id. 
at 377. Dr. Christensen also noted that the statement ``I take Xanax on 
the weekends . . . does not appear to be someone who's complaining 
about an anxiety diagnosis who's being prescribed Xanax for a 
documented anxiety disorder.'' Id. at 379. Dr. Christensen further 
found concerning the statement ``I take Norco for my back,'' because 
while ``back pain is one possible explanation,'' BCI 1 did not 
specifically complain of back pain, and while BCI 1 may have meant 
that, it may also ``be a sign of somebody who is self-medicating.'' Id. 
at 379-80.
    With respect to BCI 1's seeking Xanax, Dr. Christensen testified 
that ``a reasonable practitioner . . . would want to know'' if there 
had been a diagnosis of anxiety disorder, who ``made the diagnosis,'' 
and what treatments had been tried. Id. at 381. With respect to BCI 1's 
seeking Norco, Dr. Christensen explained that he would ``want to know 
the same thing,'' including what the diagnosis was, what medications 
had been tried, ``and who made the diagnosis.'' Id.
    Dr. Christensen also testified that the combination of drugs that 
BCI 1 claimed to be taking, i.e., Norco and Xanax, was also a concern 
because ``[t]hey are both controlled substances'' and are 
``synergistic,'' in that ``[t]hey are much more euphoric when taken 
together.'' Id. Dr. Christensen explained that this combination of 
controlled substances would cause concern as to the ``underlying 
diagnosis'' in that the ``primary diagnosis is chemical dependence 
rather than a combination of moderate to severe back pain and a 
documented anxiety disorder.'' Id. at 382; see also id. at 406 
(testimony of Dr. Christensen: ``[F]rom this visit, it would appear 
that the diagnosis of back pain and anxiety is in doubt. There's a 
strong possibility of another diagnosis, which would be chemical 
dependency, and that would mean that you would not be prescribing these 
medications. And, again, I would recommend referral to a substance 
abuse specialist.'').
    Next, Dr. Christensen testified that BCI I's statement that his 
back was ``[m]ostly just stiff'' is ``not an indication for prescribing 
Norco'' (hydrocodone). Id. at 383. As for the physical exam Respondent 
performed, Dr. Christensen testified that BCI 1 stated that his pain 
did not shoot anywhere and was localized, which means it ``is more 
likely to be joint or musculoskeletal pain.'' Id. at 386. Dr. 
Christensen then explained that the tests Respondent performed in which 
he held BCI 1's arms and had him push up and push down ``is a test for 
the cervical and upper thoracic nerves essentially in the neck.'' Id. 
Dr. Christensen noted, however, that BCI 1 complained of lower back 
pain and that this test was not appropriate for evaluating lower back 
pain. Id.; see also id. at 390.
    Asked what the standard of care required of Respondent after he had 
BCI 1 point to where his pain was, Dr Christensen acknowledged that 
this was ``a return visit for this patient.'' Id. at 386. Dr. 
Christensen explained, however, that ``if a physical examination were 
to be done as part of the . . . visit, then you would want to check for 
tenderness and spasm in that area,'' and that this would be done either 
by ``push[ing] on the patient's back or hav[ing] the patient push on 
their [sic] back and tell you if it hurts.'' Id. at 386-87. Dr. 
Christensen subsequently testified that a reasonable practitioner would 
put his hands on the patient's back and feel for tenderness and for a 
muscle spasm. Id. at 387. As for whether a physician could properly 
check for tenderness or spasm if the patient is wearing clothing, Dr. 
Christensen testified that ``[i]t would be difficult'' but ``you could 
check for tenderness if you pushed hard enough.'' Id. Dr. Christensen 
testified, however, that he did not ``believe that you could test for 
spasm'' if the patient was wearing clothing. Id.; see also id. at 389.
    As for the scope of an appropriate physical exam for evaluating 
lower back pain, Dr. Christensen testified that ``at a minimum'' a 
reasonable practitioner ``would check for flexion and extension,'' id. 
at 391, which involves seeing ``[h]ow far [a patient] can bend over 
before [he/she] has[s] moderate to severe pain'' and ``how far can they 
lean back.'' Id. at 390.\13\
---------------------------------------------------------------------------

    \13\ Dr. Christensen identified other tests including ``checking 
for side to side motion,'' doing a straight leg raise test if the 
patient complains of radiation, checking muscle strength in the 
lower extremities by having the patient push in and push out, 
checking the lower extremities for edema, checking the reflexes in 
the lower extremities, and if there is a neurological complaint of 
numbness or pain, ``check[ing] for touch and sensation and pain in 
the bottom or the top . . . of the feet.'' Tr. 390.
---------------------------------------------------------------------------

    Dr. Christensen again testified that on a return visit, a physical 
exam is not required and the physician can rely on the history and the 
medical decision-making. Id. at 391. Asked by the CALJ if he would have 
expected to see ``these tests . . . documented in the initial exam'' or 
would have ``just looked for the diagnosis,'' Dr. Christensen answered 
that ``if this was a return visit for the patient and I was seeing the 
patient for the first time, I would hopefully find these things in the 
initial examination and the reasons for the diagnosis in the initial 
examination.'' Id. at 392. On further questioning as to whether, under 
such circumstances, he would be looking in the chart for documentation 
of various tests to support a diagnosis before he prescribed controlled 
substances, Dr. Christensen answered: ``If the diagnosis is in 
question, if the initial evaluation did not document this, I would want 
to confirm

[[Page 18890]]

the diagnosis before I prescribed controlled substances.'' Id. at 393.
    As for BCI 1's statement that his back was ``mostly just stiff,'' 
Dr. Christensen acknowledged that there could be ``multiple reasons for 
it'' such as ``joint disease,'' ``deconditioning,'' ``central pain 
syndrome,'' or an ``underlying medical condition.'' Id. at 389. Dr. 
Christensen nonetheless testified that he would ``[n]ot automatically'' 
equate stiffness with a complaint of pain and that to connect the two, 
the patient would also have to complain of pain. Id. at 389-90.
    Addressing BCI 1's statement that he took Xanax ``[b]ecause when I 
do that it keeps me from drinking too much moonshine on the weekends,'' 
Dr. Christensen noted that drinking and taking Xanax is ``a potentially 
lethal combination. And if you add [h]ydrocodone, it's even more 
dangerous.'' Id. at 394. He explained that ``[t]he combination of 
alcohol and benzodiazepines, [such as] Xanax, increases [the] chance of 
respiratory depression,'' and that when you ``throw in an opiate . . . 
like [h]ydrocodone,'' the combination is ``even more dangerous.'' Id. 
Continuing, Dr. Christensen testified that ``[i]f somebody told me they 
were drinking on the weekends and there was a prescription for Xanax, 
[he] would be very concerned.'' Id. He added that drinking is ``a 
contraindication to'' Xanax, and because ``the ethical principle here 
is do no harm[,] [he] would not prescribe . . . Xanax.'' Id. at 395.
    Asked by the CALJ if this was his personal standard or the standard 
of care in Michigan, Dr. Christensen explained that because the FDA 
warning label strongly recommends against the use of alcohol when 
taking this medication, if the physician believes the patient is 
``going to continue drinking,'' ``the standard of care is not to 
prescribe the medication.'' Id. at 396. Dr. Christensen then testified 
that ``with that statement'' (presumably BCI 1's statement), a 
reasonable general practitioner would refer the patient to an addiction 
specialist or counselor and not prescribe the medication. Id. at 396-
397.
    Dr. Christensen also found concerning Respondent's prescribing of 
Soma (carisoprodol) to BCI 1. Id. at 397. Dr. Christensen explained 
that carisoprodol ``is now a controlled substance based on its abuse 
potential'' and that with respect to BCI 1, ``you've got somebody who 
admits to alcohol use, who is prescribed Xanax, and now you're adding a 
third sedation which also increased the risk of accidents and overdose 
and death.'' Id. at 397-98. Dr. Christensen then testified that the 
combination of hydrocodone, Xanax, and Soma ``is commonly known as the 
holy trinity,'' which is ``a very euphoric combination, and [is] 
dangerous because you're mixing two sedatives together'' as well as 
hydrocodone, which creates ``the additive effect on respiratory 
depression.'' Id. at 398-99.
    With respect to Respondent`s statement that he was prescribing 
carisoprodol for BCI I's muscle spasms, GX 3, at 12, Dr. Christensen 
testified that he ``didn't see any diagnosis of muscle spasms'' and 
that a physician would diagnose a patient as suffering from spasms by 
palpating the patient's back. Tr. 399. According to Dr. Christensen, 
Respondent did not do this. Id.
    Turning to the colloquy between Respondent and BCI 1 regarding the 
value of the drugs on the street, see GX 3, at 14-15, Dr. Christensen 
opined that this raised a concern because BCI 1 ``did not initially 
raise it but was engaging in a discussion of diversion'' and yet 
Respondent was ``prescribing him controlled substances.'' Id. at 400-
01. Dr. Christensen further testified that in response to this 
conversation, a physician acting in accordance with the Michigan 
standard of care would need to ``make sure that there was an opioid 
agreement'' with the patient and ``to reinforce the opioid agreement 
and to monitor'' the patient ``or correct use'' by doing urine drug 
screening. Id. at 402.
    Next, the Government asked Dr. Christensen whether concerns were 
raised by the colloquy during which BCI 1 stated that ``a couple of 
times'' he had ``r[un] out of pills'' and had to ``trade'' with his 
neighbor, Respondent asked if it was ``an equal trade,'' and BCI I 
added that he had asked Dr. Vora ``for a couple [of] extra'' pills'' 
and that Dr. Vora had given him a couple of extra pills which he had 
given back to his neighbor. Tr. 402-03; GX 3, at 15. Dr. Christensen 
testified that the patient ``is admitting to diversion'' and that a 
physician must explain to the patient that this is illegal and that the 
patient ``ha[d] signed an opioid agreement'' and that ``according to 
the . . . agreement . . . if this occurs [the patient] will not be able 
to receive controlled substances.'' Id. at 403. Dr. Christensen further 
testified that, ``at a minimum,'' a reasonable practitioner would 
explain that the opioid agreement prohibits trading and selling pills, 
``and that if it were to happen, [the physician] would not be able to 
prescribe him medications anymore.'' Id. at 405. He also testified that 
based on the transcript, the standard of care would require referral to 
an addiction specialist. Id. at 406.
    Turning to BCI 1's patient file, Dr. Christensen testified that the 
November 10, 2014 medical history form was largely ``blank, including 
[the section pertinent to] muscle, joint and bone.'' Id. at 410. Dr. 
Christensen testified that ``[i]f you are getting a history and this 
isn't complete, you have to verify it independently'' and that a 
physician ``would be responsible for confirming the portion of the 
history and exam that dealt with your treatment plan, especially if it 
included controlled medications.'' Id. at 410-11. Dr. Christensen then 
testified that he ``would look at the remainder of the file, which 
would be Dr. [Vora's] initial electronic medical record.'' Id. Dr. 
Christensen noted, however, that this record was also missing 
information, and that a reasonable practitioner would have to 
``[o]btain the information'' and the missing history ``if you are going 
to prescribe controlled substances.'' Id. at 411-12. With respect to 
the form which asked various questions about BCI 1's family history and 
which were not answered, GX 10, at 19, Dr. Christensen testified that 
the standard of care required obtaining this information because ``[i]f 
you are treating the patient for back pain and . . . ruling out 
substances abuse'' by the patient, ``a family history of psychiatric or 
substance use disorders is important.'' Tr. 413; see also id. at 551 
(testimony of Dr. Christensen agreeing that a physician ``would want to 
look through the . . . medical record to see if . . . a proper history 
[was] conducted and . . . fill in the gaps from what the patient failed 
to report on [his] questionnaire'').\14\
---------------------------------------------------------------------------

    \14\ As for the history listed by Dr. Vora at the December 15, 
2014 visit, which included both a social history and diet history, 
Dr. Christensen testified that there was ``no mention . . . of [the] 
presence or absence . . . of drug or alcohol use.'' Tr. 552. While 
Dr. Christensen acknowledged that BCI 1's self-report of alcohol use 
and Respondent's questioning BCI 1 as to whether he used marijuana 
rendered the history complete, Dr. Christensen expressed skepticism 
as to whether either Dr. Vora at the December 15, 2015 visit or Ms. 
S.A. (the person listed on the EMR as having reviewed BCI 1's Social 
History and Consumption/Diet) at the January 12, 2015 visit had 
actually done so. Id. at 553. When asked if ``it would be fair to 
assume that there were two separate people who looked at the 
patient's history,'' he replied: ``I believe it indicated that two 
different log-ons checked off that box'' and ``I don't know that it 
indicates they ever reviewed the history with the patient.'' Id.
---------------------------------------------------------------------------

    As found above, BCI 1's file also contained a MAPS report. GX 10, 
at 23. Dr. Christensen found it notable that the report showed that BCI 
1 had gotten four different prescriptions for Xanax and one 
prescription for amphetamines and that some of the providers, those 
whose offices were in Detroit and Marquette, were ``400 miles apart.'' 
Id.

[[Page 18891]]

at 413-14. Dr. Christensen testified that the ``high geographic 
distance between providers'' and the ``multiple providers'' are ``signs 
of doctor shopping'' and ``diversion or misuse.'' Id. at 414.
    Turning to Respondent's progress note for the visit, Dr. 
Christensen noted that while it documented a complaint of ``associated 
muscle spasm,'' BCI 1 had ``complained of stiffness,'' which ``is a 
symptom.'' Id. at 415. Dr. Christensen testified that ``spasm is a 
physical finding'' which ``would need to be corroborated later on in 
the examination'' by ``palpation,'' but according to the testimony of 
BCI 1, Respondent never touched him and thus could not possibly have 
diagnosed BCI 1 as having a muscle spasm. Id. at 415-16.
    As for the other exam findings in this visit note, Dr. Christensen 
testified that he ``didn't see documentation of [a] complaint of point 
tenderness.'' Id. at 417. Dr. Christensen acknowledged that he had no 
``way of knowing whether [BCI 1] had a limp that you couldn't see on 
the video'' and that ``[h]is muscle tone in the upper extremities may 
have been excellent.'' Id. As for the notation that ``CN IV-XII 
intact,'' Dr. Christensen testified that video did not show that 
Respondent did the various cranial nerve tests as documented in the 
note. Id. at 417-19.
    After noting Respondent's diagnoses of degenerative disc disease, 
positive ETOH, and anxiety, and the three prescriptions (Norco 7.5/325, 
SOMA 350, and Xanax .5), Dr. Christensen then opined that based on his 
review of the video, the transcript and the medical file, Respondent's 
prescription for Norco was inappropriate as ``[t]here was no 
documentation of moderate to moderately severe pain.'' Id. at 419-20. 
There was also the ``concern[ ] about another underlying diagnosis,'' 
i.e., substance abuse, ``that would have mandated either a referral or 
not writing the prescription.'' Id. at 420.
    Dr. Christensen opined that the Xanax prescription was ``not 
appropriate'' because the drug is ``contraindicated in somebody who is 
actively drinking.'' Id. Dr. Christensen also noted that he ``did not 
see any documentation of an anxiety diagnosis.'' Id.
    Dr. Christensen also opined that the Soma prescription was ``not 
appropriate.'' Id. He explained that this drug is ``indicated for 
short-term treatment of muscle spasms,'' but that ``there is no 
documentation of this'' condition. Id. Dr. Christensen further 
explained that Soma was ``contraindicated with this patient's 
history.'' Id. He then opined that each of the three prescriptions 
Respondent issued at BCI 1's first visit was not issued for a 
legitimate medical purpose and in the usual course of professional 
practice. Id. at 425-26.
    Turning to BCI 1's second visit (Mar. 19, 2015), Dr. Christensen 
noted that when Respondent asked BCI 1 about his pain, the latter 
responded that ``everything is cool,'' and that ``there's no pain 
level.'' Id. at 428. He also noted that BCI 1 complained only of 
stiffness, that BCI 1denied having pain that radiated down his leg, and 
that when Respondent asked BCI 1 to rate his pain level on a 1-10 
scale, BCI 1 replied that he was ``good today.'' Id. at 428-29. Dr. 
Christensen opined that BCI 1's response when asked to rate his pain on 
the numeric scale was ``a non-responsive . . . and . . . an evasive 
answer, which can be signs of drug-seeking behavior.'' Id. at 431.
    Dr. Christensen opined that this ``was a negative evaluation for 
moderate to moderately severe pain.'' Id. at 429. Dr. Christensen also 
testified that a reasonable practitioner ``would have asked [BCI 1] 
about [his] functional level. . . . He would have asked about side 
effects. . . . And he would have . . . inquired about any aberrant 
behaviors.'' Id. He further testified that whether BCI 1's second visit 
was evaluated either on the basis of ``face-to-face time,'' which was 
under two minutes, or ``by complexity,'' this was not an adequate 
evaluation. Id. at 431. While Dr. Christensen noted that at a return 
visit, only two of the three components of a history, physical, and 
medical decisionmaking must be performed, he opined that if the 
adequacy of the evaluations was based on its ``complexity,'' there was 
not ``enough of an examination . . . to allow the medical decision-
making.'' Id.
    As noted above, the subjective section of the visit note repeats 
nearly verbatim the subjective notes written in the February 19 visit 
note in that it states: ``44 y/o WM c DDD For approximately 10 yrs. Pt 
has associate muscle spasm c LBP.'' GX 10, at 32; see also Tr. 432. Dr. 
Christensen testified that the subjective section of the visit note 
``appears to be a repeat of the history from the previous 
examination.'' Tr. 432. Dr. Christensen noted, however, that while it 
is allowable to repeat the history from a previous examination, 
``there's no additional information from the visit that occurred'' and 
nothing occurred at this visit to substantiate what was written in the 
subjective section of the note. Id. at 432-33.
    Dr. Christensen further testified that neither the video nor the 
transcript provide evidence that Respondent performed the tests 
necessary to make several of the findings he documented in the note's 
physical exam section. Dr. Christensen specifically identified the 
findings of ``moderate point tenderness to low back,'' ``cranial nerves 
2 through 12 intact,'' ``2+ pulses throughout,'' \15\ and ``2/2 
reflexes'' as not supported by tests. Id at 433-35. Dr. Christensen 
also testified that with the exception of the diagnosis of Etoh, which 
was based on BCI 1's admission that he used alcohol, there was no 
documentation of findings to support the diagnoses of degenerative disc 
disease in the lumbar area, anxiety, and muscle spasm. Id. at 447; see 
also GX 10, at 32.
---------------------------------------------------------------------------

    \15\ With respect to this notation, Dr. Christensen testified 
that the notation ``that the pulses are normal throughout . . . 
implies the upper and lower extremities.'' Tr. 434. He then 
explained that to make this finding, ``[y]ou check typically for the 
radial pulse in both wrists and either the posterior tibia, which is 
behind your ankle, or the dorsalis pedis pulse, which is in the 
front of, the top of your foot.'' Id. at 435.
---------------------------------------------------------------------------

    Noting the prescriptions for Norco and Xanax that were issued by 
Dr. Vora at BCI 1's January 12, 2015 visit, the Government asked Dr. 
Christensen whether the results of the urine drug screen administered 
on February 19, 2015, which were negative for these drugs, were 
aberrational. Tr. 439-441. Dr. Christensen noted, however, that the 
prescriptions were for a one-month supply and the drug screen was 
administered five weeks after the prescriptions were issued. Dr. 
Christensen testified that while it is possible the drugs should still 
show up in the urine screen even if BCI 1 has stopped taking the drugs 
one week earlier, ``[t]here's no definite answer that I can give'' 
because these results may have been caused by ``run[ning] out of 
medications, which is legitimate.'' Id. at 440-41. Dr. Christensen 
testified that the standard of care required repeating the drug screen 
and doing so ``at a time when the patient is taking the medications to 
see what happens'' as well to consult with the patient. Id. at 441-42. 
Although Respondent repeated the drug screen at the second visit, he 
did not address the results with BCI 1. See GX 10, at 34. While Dr. 
Christensen further testified that the standard of care required that 
Respondent document how he addressed the test result, there is no such 
documentation in the March 19 visit note. Tr. 443-444; see also GX 10, 
at 32.
    With respect to each of the three prescriptions (65 Norco 7.5/325 
mg, 60 Xanax 0.5 mg, and 30 Soma 350 mg) issued by Respondent to BCI 1 
at this visit, Dr. Christensen opined that the prescriptions lacked a 
legitimate medical purpose. Tr. 448.

[[Page 18892]]

    Dr. Christensen also testified about BCI 2's March 19, 2015 visit 
with Respondent. As found above, after an exchange of pleasantries, BCI 
2 stated that she was ``[j]ust here for refills'' and answered his 
question ``how are you feeling,'' stating: ``I feel great today.'' Tr. 
449. When further asked by Respondent to ``tell me how you have been 
doing,'' BCI 2 replied: ``actually, I've been doing really good. I have 
no complaints.'' Id.
    With respect to this exchange, Dr. Christensen testified that BCI 
2's statement that she had ``no complaints . . . by itself does not 
mean anything.'' Id. at 450. Continuing, Dr. Christensen explained that 
``there's no identification yet if she's been taking the medication and 
if the medication is the reason . . . for how she feels. And, again, 
[BCI 2] states, `I'm just here for refills.' '' Id.
    Dr. Christensen testified that a practitioner acting under the 
standard of care would follow up this exchange by ``ask[ing] if [the 
patient has] been taking the medications, . . . then ask[ing] about 
pain level, activity level, side effects, and mak[ing] inquiries about 
are they [sic] having any problem with aberrant behavior, are they 
[sic] running out early.'' Id. Dr. Christensen then testified that none 
of this was done. Id.
    Addressing the portion of the colloquy in which Respondent asked 
BCI 2 ``where is it hurting the most'' and BCI 2 replied ``[r]ight, 
lower right but . . . no, we are good,'' Dr. Christensen testified that 
while BCI 2 ``identifie[d] a location . . . again, there's no direct 
answer.'' Id. at 450-51. As for the physical exam Respondent performed 
(after BCI 2 pointed to her lower back near her right hip) which 
involved having BCI 2 hold out her arms and press up and down as he 
held them, Dr. Christensen again testified that this ``tests for upper 
extremity strength and integrity of the nerves in the neck and upper 
thoracic areas, which is the upper back'' and would have no value in 
evaluating a rear right hip issue. Id.
    As found above, after BCI 2 denied that she got muscle spasms, 
Respondent asked ``when does it hurt most,'' and BCI 2 replied that 
``sometimes,'' when she was asleep, she would ``twist to shut [her] 
alarm off'' and ``screw[ ] it up,'' but this had not ``happen[ed] in a 
very long time'' and she had ``been really doing well.'' GX 7, at 4. 
Regarding this exchange, Dr. Christensen testified that ``[t]here's no 
documentation of a moderate or higher pain level other than being stiff 
in the morning when you wake up. There's no discussion of whether or 
not this is due to her pain medications.'' Tr. 454. Dr. Christensen 
then opined that a reasonable practitioner would ask a patient who said 
she was not having any pain if she was taking her pain medications and 
then evaluate based on the answer. Id. at 455. Dr. Christensen noted 
that there was no indication in the transcript that Respondent asked 
this question. Id.
    Dr. Christensen further noted that nothing was checked on the 
medical history form filled in by BCI 2 with respect to any symptoms of 
muscle, joint or bone pain even though she presented with ``potential 
complaints of back pain'' and that this should have prompted a 
discussion between Respondent and her. Id. at 456. Dr. Christensen 
further testified that a reasonable ``practitioner is responsible for 
obtaining the history, so . . . he or she would need to ask the 
patients the questions directly'' and fill in the blanks. Id. at 457.
    As for the drugs (Norco, Ambien, and Xanax) which BCI 2 listed on 
the medical history form as her current medications, see GX 11, at 10, 
Dr. Christensen again observed ``that Norco and Xanax is a potentially 
dangerous combination and a patient who is prescribed these or taking 
these, I'm concerned about another underlying diagnosis,'' that being 
dependence. Tr. 457-58. Dr. Christensen further explained that while 
Ambien ``is not technically a benzodiazepine . . . it is very similar 
and its side effects'' and risks are similar to those of 
benzodiazepines. Id. at 457. Dr. Christensen testified that this drug 
combination raises concern as to why it ``is being prescribed or 
taken'' and a practitioner would ``need to confirm that there was a 
legitimate medical diagnosis for it and not another underlying 
diagnosis, such as dependence.'' Id. at 458.
    Turning to the family history form (GX 11, at 12) on which BCI 2 
noted that the reason for her visit was ``Refills--Norco, Ambien[,] 
Xanax,'' Dr. Christensen testified that this explanation is not one 
that he would typically expect a patient to provide at a first visit, 
id. at 462-63, and that ``[a] practitioner would need to be concerned 
that someone was drug seeking'' and visiting the doctor ``simply to get 
the medications,'' especially given the combination of drugs. Id. at 
458. Moreover, even after the CALJ questioned whether the concern would 
exist if it was not the patient's first visit to the practice, but was 
the first visit with the doctor, Dr. Christensen explained that ``[i]f 
you are going to prescribe a controlled substance, the practitioner 
needs to confirm the diagnosis.'' Id. at 460.
    As for the Pain Clinic History Questionnaire completed by BCI 2, 
Dr. Christensen noted that there was no ``description circled for the 
pain,'' and nothing was ``circled for what'' increased the pain'' and 
for how the pain made her feel. Id. at 461; see also GX 11, at 23. He 
observed that while her ``pain level is listed as 0 to 4,'' there was 
no notation as to whether this was with medication or without 
medication. Id. at 461. He also noted that the location of the pain was 
not circled. Id. Dr. Christensen further observed that various sections 
of the form, including BCI 2's work history, domestic situation, and 
family history were left blank. Id. at 462.
    Turning to the next page of the form, Dr. Christensen noted that 
while BCI 2 had indicated that she used alcohol, there was no 
discussion as to ``how much [she was] drinking,'' because depending 
upon ``the amount and the frequency, it will put [the patient] at risk 
of increased side effects and risks from the combination of medications 
they're currently taking.'' Id. Dr. Christensen further noted that the 
standard of care requires a physician to obtain this information. Id. 
at 462.
    Addressing the note Respondent wrote for this visit, Dr. 
Christensen took issue with the adequacy of the subjective section, 
observing that it contained no notations about BCI 2's ``pain level, 
[her] medications, any side effects, [and] any problems with 
medications.'' Id. at 464; see also GX 11, at 35. As for the physical 
exam findings documented by Respondent, Dr. Christensen identified 
multiple findings which the video and transcript show did not occur. 
Tr. 464-65.
    With respect to his finding of point tenderness to BCI 2's right 
lower back, Dr. Christensen noted that ``the investigator said she was 
good and she was great and there was no problem.'' Id. at 464. He also 
reiterated his earlier testimony that point tenderness would be 
evaluated by palpating the patient and asking if it hurt or not; Dr. 
Christensen testified that he did not see that this occurred at this 
visit. Id. at 464-65. As for Respondent finding that BCI 2's pain 
``shoots to left hip,'' consistent with the evidence, Dr. Christensen 
testified that he did not ``believe that she complained about any 
radiation to the hip.'' Id. at 465; see also GX 7, at 1-5. With respect 
to Respondent's finding of ``Full RoM,'' Dr. Christensen testified that 
while ``she did abduct and adduct her upper extremities . . . [t]here 
was no other testing of range of motion that I saw either in the upper 
or lower extremities.'' Id. Finally, while Respondent also made 
findings of ``CN II-XII intact,'' ``2+ pulses throughout,''

[[Page 18893]]

and ``2/2 reflexes,'' he did not see evidence that Respondent performed 
the tests used to make these findings. Id. at 465-66; see also GX 11, 
at 35.
    Dr. Christensen reiterated his earlier testimony that on a repeat 
visit, the standard of care does not require a physical examination. 
Tr. 366. However, he further testified that a physical exam for a 
complaint of back pain would involve ``check[ing] for spasm in the 
lower back by palpation,'' checking both flexion and extension of the 
lower back, ``check[ing] the gait,'' and ``check[ing] the strength and 
reflexes in the lower extremities.'' Id. As for the items listed as 
Respondent's impression, Dr. Christensen acknowledged that while there 
was documentation of lower back pain based on BCI 2's statement that 
she fell off a horse 10 years ago as well as that she was a non-smoker, 
there was no documentation to support the diagnosis of spasm or an 
abnormal gait periodically. Id. at 467.
    Dr. Christensen further observed that BCI 2's March 19, 2015 drug 
test produced several aberrational results. These included that she 
tested positive for THC and tested negative for Ambien and Xanax which 
had been prescribed with four refills at BCI 2's January 23, 2015 
visit. Id. at 471; see also GX 11, at 37-38. He also testified that BCI 
2 should have tested positive for Soma as this was prescribed to her at 
the February 20, 2015 visit. Id. at 471-72. Dr. Christensen 
acknowledged, however, that the March 19, 2015 test results were not 
available to Respondent on that date. Id. at 472.
    Dr. Christensen then opined that the Norco and Soma prescriptions 
issued to BCI 2 on March 19, 2015 were not issued for a legitimate 
medical purpose. Id. at 473. Dr. Christensen further noted that because 
BCI 2's Xanax prescription had four refills, with Respondent's 
prescribing to her, she had current prescriptions for Norco, Xanax, 
Soma and Ambien, and that this ``combination of sedatives'' increases 
the patient's risk level and is ``a highly addictive . . . and . . . 
dangerous combination.'' Id. at 474.
    On cross-examination, Dr. Christensen admitted that on the morning 
of his testimony, he had prescribed methadone to one of his pain 
management patients electronically and without either speaking with or 
seeing the patient. Tr. 475-76, 478. Dr. Christensen testified, 
however, that this patient has severe lumbar stenosis, that he has been 
on the same drug for eight years, that he sees the patient every 60 
days, and that in between visits, the patient provides a urine drug 
screen two weeks before his prescription is reissued and a MAPS report 
is run on the day his prescription is due for renewal. Id. at 479. Dr. 
Christensen then explained that it is okay to simply issue a ``refill'' 
\16\ if a ``patient is stable,'' the drug screens and MAPS reports are 
confirmatory, there is no evidence of aberrant behavior, and the 
patient is ``not experiencing undue adverse side effects.'' Id.
---------------------------------------------------------------------------

    \16\ While called a refill, this was actually a new 
prescription.
---------------------------------------------------------------------------

    Dr. Christensen subsequently acknowledged that performing two of 
the three items (of history, physical examination, and medical 
decisionmaking) is not strictly required to prescribe controlled 
substances each month under the standard of care and that determining 
the past diagnosis and whether ``the patient is well managed on the 
medication . . . are two of the requirements'' of the standard of care. 
Id. at 481. He also acknowledged that Respondent's encounters with both 
undercovers were follow-up visits and that Respondent was not obligated 
to do all three things that are done at an initial visit but that he 
needed to verify that another physician had done these things. Id. at 
490-91. Dr. Christensen explained, however, that whether it is okay to 
trust another physician's diagnosis ``would depend on what the 
record[s] showed'' and that he ``would want to see evidence of a 
pertinent examination'' by the other physician if he was to 
``prescrib[e] a controlled substance for a history of back pain.'' Id. 
at 492; see also id. at 529-30.
    After Dr. Christensen reiterated that a physician ``need[s] to make 
sure that it [the prescription] is for a legitimate medical purpose,'' 
Respondent's counsel asked him ``[w]here is that standard that you've 
said is the standard of care enumerated?'' Id. at 493. Dr. Christensen 
then asked to ``see the MCL,'' apparently referring to the Michigan 
Compiled Laws setting forth the ``good faith'' standard for prescribing 
controlled substances and testified:

    So it says that the prescribing is done . . . in the regular 
course of professional treatment by an individual who is under 
treatment by the practitioner for a condition other than the 
individual's physical or psychological dependence upon an addiction 
to a controlled substance.
    So I need to confirm, I believe the standard of care is you need 
to confirm that this is not an addictive disorder when you are 
seeing this combination of controlled substances being prescribed.

Id. at 493-94.
    Then asked ``where it is enumerated that the standard requires you 
to not trust the diagnosis of an initial physician when you're 
conducting a follow-up visit,'' Dr. Christensen answered that the 
Michigan pain guidelines ``state that an examination shall be 
performed'' and that when he ``reviewed Dr. Vora's records, I did not 
see any musculoskeletal examination except for noting edema.'' Id. at 
494.
    Dr. Christensen acknowledged that there was a plus mark next to 
both lower back pain and endocrinology anxiety in the review of systems 
section of the note created by Dr. Vora for BCI 1's December 15, 2014 
visit. Id. at 495 (discussing GX 10, at 3-4). He acknowledged that Dr. 
Vora's note contained various physical exam findings pertinent to BCI's 
1 back, including that he had ``lumbar spine point tenderness'' and 
another notation indicated ``tenderness to palpation,'' thus indicating 
that Dr. Vora had palpated the spine and found it tender. Id. at 497, 
530-31. Dr. Christensen also acknowledged that Dr. Vora's note 
documented ``Pain with Flexion/Extension,'' thus indicating that BCI 1 
``was asked to flex and extend [his] back''; he also testified that 
other notations indicated that Dr. Vora did other tests including a 
straight leg raise test, a toe heel walk, and that he palpated and did 
range of motion testing on various parts of BCI 1's spine. Id. at 497-
500, 530. Dr. Christensen then conceded that if all of these tests were 
done, this would be an appropriate physical examination of a patient 
complaining of lower back pain on a ``follow-up visit.'' \17\ Id. at 
500, 530-31.
---------------------------------------------------------------------------

    \17\ Notably, Dr. Vora's note for BCI 1's November visit 
contains no physical examination findings pertinent to BCI 1's back. 
See GX 10, at 5-6. However, Dr. Christensen was not asked whether 
these findings reflect the performance of an appropriate physical 
examination for an initial visit.
---------------------------------------------------------------------------

    While Dr. Christensen testified that a finding of lumbar spine 
tenderness would ``assist with a determination of back pain,'' he added 
that back pain is a symptom even though it has its own billing code and 
that it is not a real diagnosis which would involve determining the 
cause of the pain. Id. at 500-01. He acknowledged that in some cases 
back pain could be caused by neuropathy and that there may be no 
physical manifestation of an injury such as on radiology exams (MRI or 
X-rays) or other physical findings. Id. at 501.
    Dr. Christensen also acknowledged that a patient's complaint of 
pain is an important indicator of whether he/she has pain and that this 
``should be taken as part of the history.'' Id. at 502. However, asked 
hypothetically whether a physician should believe a patient when a 
patient complains of high level

[[Page 18894]]

of pain (nine out of 10) which cannot be verified by imaging or a 
physical exam, he answered that this ``depends on the rest of the 
history and examination.'' Id. Dr. Christensen then agreed that the 
existence or non-existence of aberrant behavior would be a factor in 
whether a physician should believe such a patient. Id. at 503.
    Turning to the undercover visits, Respondent's counsel questioned 
Dr. Christensen regarding Respondent's engaging in the various steps 
set forth by the OLD CARTS mnemonic. Dr. Christensen acknowledged that 
Respondent asked both BCIs to identify the location of their pain (the 
L in OLDCARTS) at their initial visits with him. Id. at 506-07. As for 
the onset of the pain, Dr. Christensen disagreed with the suggestion of 
Respondent's counsel that Respondent's question (``So how long have you 
had low back pain?'') and BCI 1's answer (``Probably 10 years. Mostly 
just stiff.''), was an indication of the onset of BCI's pain, 
explaining that this exchange simply addressed the pain's duration; 
however, Dr. Christensen acknowledged that onset and duration are only 
different if the pain had gone away and returned. Id. at 508-09, 511. 
Asked if BCI 1's statement about back stiffness ``could also mean there 
is some pain,'' Dr. Christensen replied: ``it could mean there is 
almost anything associated with it.'' Id. at 510.
    Turning to the character of the pain (the C in OLD CARTS), while 
Dr. Christensen acknowledged that Respondent's question (``Is the pain 
shooting or localized'') was designed to question whether one type of 
pain existed, he did ``not necessarily'' agree that Respondent 
satisfied this element, explaining that if BCI 1 had ``complained of 
only shooting pain, then it would.'' Id. at 511-12. However, Dr. 
Christensen acknowledged that BCI 1 had stated that the pain was 
localized. Id.
    As for the aggravating or associated factors (the A in OLD CARTS), 
Respondent's counsel asked Dr. Christensen if he saw ``an indication in 
this visit that the patient made a statement about what makes [his] 
pain worse?'' Id. Dr. Christensen testified that he would need ``to go 
back over the,'' at which point, Respondent's counsel interrupted and 
stated: ``No need to go back over it.'' Id.
    Then asked if the questions embodied in the OLD CARTS mnemonic are 
``enumerated in the Michigan guidelines . . . for the use of controlled 
substance for the treatment of pain,'' Dr. Christensen initially 
testified to his belief that ``if you go through the entire document,'' 
those questions ``are in there.'' Id. at 513. However, asked if he 
believed ``all of the [OLD CARTS] elements are met in the Michigan 
guidelines,'' Dr. Christensen answered: ``No, I believe they refer to 
the four As actually.'' Id. Dr. Christensen then disagreed with 
Respondent's counsel that ``OLD CARTS isn't in the Michigan standard,'' 
explaining that he ``believe[s] [that the] history of present illness 
is, which is what we're referring to'' and that some of the elements 
are in the standard. Id.
    Turning to BCI 1's statement at his first visit with Respondent 
(``I take Norco for my back and Xanax on the weekends''), Dr. 
Christensen adhered to his earlier testimony that the combination of 
Norco and Xanax was concerning, as was his statement that he took Xanax 
on the weekends. Id. at 513-14. While Dr. Christensen acknowledged that 
the statement ``can be interpreted that Norco is for back pain,'' he 
noted that BCI 1's statement ``doesn't specify that'' and that 
additional questions to ``confirm that'' were necessary. Id. at 514. 
While Dr. Christensen acknowledged that Respondent did engage in 
further questioning when he asked BCI 1 ``so you have back pain and 
some anxiety,'' he disagreed with the suggestion of Respondent's 
counsel that BCI 1's answer of ``I guess'' was confirmation that the 
latter had pain, characterizing the answer as ``evasive'' and subject 
to ``many'' possible interpretations. Id. at 515.
    As for BCI 1's statement that he took Xanax because it kept him 
``from drinking too much moonshine on the weekends,'' GX 3, at 9, Dr. 
Christensen acknowledged that Dr. Vora's January 12, 2015 visit note 
(GX 10, at 2) lists anxiety as a diagnosis. Tr. 516. Dr. Christensen 
also acknowledged that it is ``okay to trust medical documentation of a 
physician if . . . the elements of a diagnosis are met.'' Id. Dr. 
Christensen disagreed with the suggestion that BCI 1's earlier 
statement that ``I take Xanax on the weekends'' could ``refer to the 
patient having increased periods of anxiety because of whatever he does 
on the weekend,'' explaining that he did not know and would need to do 
``appropriate questioning'' to reach this conclusion. Id. at 517. Dr. 
Christensen also testified that while the medical record lists a 
diagnosis of anxiety, he was ``not agreeing with any diagnosis of 
anxiety.'' Id.
    Asked whether it is ``ever appropriate to simply cut . . . off'' a 
person who has been ``on Xanax for a long period of time,'' Dr. 
Christensen testified that it does not depend on the time the patient 
has been on the drug, but rather, ``[i]t depends on the situation.'' 
Id. at 518. Continuing, Dr. Christensen testified that ``[i]f somebody 
is mixing Xanax with another medication that is lethal, the patient 
should be referred immediately, but the medication, the prescription 
should not be continued.'' Id. Then asked if a physician ``might want 
to consider cutting that patient off'' where ``the harm of taking . . . 
Xanax and the other substance is greater than the potential harm for 
withdrawal from Xanax,'' Dr. Christensen answered ``[y]es'' and added 
that ``if somebody's taking Xanax on the weekend, there is no physical 
dependence to Xanax.'' Id.
    Referring to BCI 1's statement that a couple of times he had run 
out of pills and traded with his neighbor, Dr. Christensen did not 
agree that this statement ``indicate[d] that the patient was 
consistently using the Xanax in a manner that he actually ran out of 
his pills prior to the end of the prescription,'' noting that BCI 1 did 
not ``specify which medication he's talking about.'' Id. at 520. While 
Dr. Christensen acknowledged that a patient going through alcohol 
withdrawal could suffer delirium tremens and be treated with 
benzodiazepines such as Xanax, he disagreed that BCI 1's statement that 
``I take Xanax because it keeps me from drinking too much moonshine'' 
was a reference to his using Xanax to address ``withdrawal from 
alcoholism [sic].'' Id. at 521-22.
    Still later on cross-examination, Dr. Christensen testified with 
respect to BCI 1's acknowledgment of having traded pills, that a 
patient's admission of diversion is ``not an automatic reason to 
discharge'' the patient and that ``you have to review the opioid 
agreement, let [the patient] know that this will not be tolerated, and 
monitor [the patient] more closely.'' Id. at 547. Dr. Christensen 
acknowledged that conducting urine drugs screens would be one of the 
things to do to monitor the patient more closely but that various 
guidelines including the Michigan guidelines do not require monthly 
drug screens. Id. at 547-48.
    On further questioning as to the significance of BCI 1's statement 
about running out and trading pills, Respondent's counsel asked Dr. 
Christensen if this conduct could be explained by pseudo-addiction, 
which Respondent's counsel explained involved a patient engaging in 
aberrant behaviors because of under-treatment of this condition and not 
necessarily because of abuse or addiction. Id. at 549. While Dr. 
Christensen testified that pseudo-addiction occurs ``[i]n very rare 
cases'' and ``[p]rimarily in cancer patients,'' and that ``[i]t's 
possible'' this

[[Page 18895]]

could happen ``[i]f a patient had uncontrolled pain,'' when asked 
whether this could explain BCI 1's statement about trading narcotics 
with a neighbor, he answered: ``None of which I have seen.'' Id. at 
549-51.
    Turning to the physical exam Respondent performed on BCI 1, Dr. 
Christensen testified that the arm adduction and abduction tests do 
``not determine pain'' but ``determine normal function'' in the upper 
spine and neck areas. Id. at 524. While Dr. Christensen acknowledged 
that a patient ``may have more difficulty exerting resistance if they 
have increased pain,'' he further explained that ``[t]he primary reason 
for doing that is to assess for damage, whether there's stenosis 
there.'' Id. at 524-25. He testified that this test is not used to 
determine ``a lack of function due to pain,'' explaining that ``[y]ou 
can have somebody who has give-away pain who can't tolerate the test at 
all. But when you perform what [Respondent] did, you're primarily 
assessing whether . . . there's [an] injury to the spinal nerves and 
spinal cord at that area.'' Id. at 525.
    After recounting Dr. Christensen's testimony that the straight leg 
raise test is used to diagnose pain in the lower back, Respondent's 
counsel asked him if he was ``saying that you can't use a test like 
that to determine back pain in the upper extremities.'' Id. After 
clarifying that Respondent's counsel was referring to the straight leg 
test, Dr. Christensen explained that ``the straight leg test pulls on 
the sciatic nerve, which comes out of the bottom of the spinal cord.'' 
Id. Respondent's counsel then asked: ``Isn't it possible that pushing 
down on the arms could be a test for referred pain from the lower back 
to the upper spine?'' Id. at 525-26. Dr. Christensen answered that 
there is a test (the Waddell Test) which involves ``push[ing] on 
various parts of the body, and if the patient complains of pain all 
over . . . it's felt to be psychosomatic pain.'' Id.
    Dr. Christensen also rejected the suggestion of Respondent's 
counsel that the abduction test on BCI 1's arms would have shown an 
inconsistency with his complaint of only lower back pain if BCI 1 had 
given up resisting and complained of pain. Id. at 526-27. As he 
explained, Respondent did not ask BCI 1 if the test ``was painful.'' 
Id. at 527. Nor did BCI 1 complain that the test was painful. GX 3, at 
9. Dr. Christensen further rejected the suggestion of Respondent's 
counsel that that this test could be a sign of malingering by BCI 1. 
Tr. 527.
    Respondent's counsel asked Dr. Christensen what the standard of 
care requires for a physical exam of a patient who complains of 
localized lower back pain. Id. at 528. Dr. Christensen testified that 
he ``would check for tenderness,'' ``for spasm actually next to the 
spine,'' and ``test for range of motion.'' Id. When Respondent's 
counsel asked if a physical exam is needed on a follow-up visit if the 
first exam was sufficient, Dr. Christensen testified that ``[i]f you 
are doing a physical exam as part of your office visit, then that [sic] 
would be the elements that I would do for low back pain.'' Id. at 529.
    Respondent's counsel then revisited his earlier questioning 
regarding the physical examination documented by Dr. Vora in his 
December 15, 2014 visit note, with Dr. Christensen again acknowledging 
that the note documented that the various elements of an appropriate 
physical exam had been performed. Id. at 530-31. Dr. Christensen 
acknowledged that a second physician can reasonably rely on a medical 
record created by another physician who did a full and complete 
physical exam, provided that ``a diagnosis is confirmed'' and there is 
no indication that the first physician has not ``been truthful in his 
medical documentation.'' Id. at 531-32. While Dr. Christensen testified 
that when he ``see[s] a[n] electronic medical record like this that 
shows a complete visit, I'm always suspicious,'' he added that ``that's 
not a standard of care issue.'' Id. at 533. Subsequently, he agreed 
that ``if a physical exam was noted in the record, you wouldn't need to 
reconfirm the diagnosis.'' Id. at 534.
    Dr. Christensen acknowledged that based on his review of the case, 
he did not know whether Respondent actually saw the urinalysis results. 
Id. However, he acknowledged that Respondent could not have seen BCI 
2's March 19 test results and that her previous test result (Feb. 19, 
2015) was below the level of detection. Id. at 534-36.
    Dr. Christensen also acknowledged that the documentation by Dr. R. 
of her January 23, 2015 examination of BCI 2 reflected an 
``appropriate'' musculoskeletal examination in that it involved 
identifying if there were spasms, checking for tenderness, and testing 
the range of motion of the lumbar spine. Id. at 537-38.
    Dr. Christensen agreed that Dr. R.'s decision to order an MRI was a 
reasonable step to confirm her diagnosis of lower back pain and that 
patients ``occasionally'' do not get their MRI done before their next 
visit. Id. at 539-40. Dr. Christensen then acknowledged that it was 
reasonable for Respondent ``to trust'' the medical records created by 
Dr. R. for BCI 2's January 23 and February 20 visits. Id. at 540. He 
agreed that Dr. R. had issued to BCI 2 prescriptions for Norco, 
carisoprodol, and Xanax at these visits. Id. at 540-41. He acknowledged 
that there is no specific standard as to how often a physician should 
run a MAPS report and that this ``depends on the patient.'' Id. at 541-
42. Dr. Christensen also testified that the MAPS report in BCI 2's 
file, which showed that she had last obtained Xanax from a Nurse 
Practitioner eight months earlier, was actually obtained prior to Dr. 
R.'s issuance of the prescriptions on January 23, 2015. Id. at 544.
    While Respondent's counsel then suggested that based on the MAPS 
report and Dr. R.'s February 20 note, Respondent ``would have no 
indication that [BCI 2] had an outstanding prescription for Xanax at 
[the] time'' of her March 19 visit with him, Dr. Christensen testified 
that Respondent would know without running another MAPS report if ``the 
prescriptions were in the chart'' or if ``he asked the patient.'' Id. 
at 545. Dr. Christensen added that he ``saw no indication that 
[Respondent] asked her what medications she was taking.'' Id. at 545. 
And on questioning by the CALJ, Dr. Christensen testified that Dr. R.'s 
January 23, 2015 visit note (GX 11, at 16) documented that the Xanax 
prescription she wrote that date provided four refills and that 
Respondent ``would know that [BCI 2] was also taking Xanax.'' Id. at 
546.
    Asked by Respondent's counsel whether, based on ``a review of her 
history and her MAPS report,'' BCI 2 ``appeared to be a doctor 
shopper,'' Dr. Christensen testified: ``she [did] not appear to have 
legitimate pain complaints and [was] seeking Norco and Xanax and 
Ambien.'' Id. at 555. Respondent's counsel then asked whether ``it was 
reasonable for [Respondent] to prescribe [to her] based on her MAPS 
report and her prior history?'' Id. While Dr. Christensen acknowledged 
that the MAPS report did not show that BCI 2 was engaged in doctor 
shopping and that this was not a red flag, he then explained: 
``[e]xcept that she presented requesting refills and there was no sign 
that she was getting medication.'' Id. at 556.
    Observing that in the note for BCI 2's January 21, 2015 visit, Dr. 
Vora had written that his treatment plan included a referral for a 
mental health evaluation (GX11, at 14), Respondent's counsel asked Dr. 
Christensen if ``a referral like that would be for the purpose of 
treating potential addiction?'' Id. at 558. Dr. Christensen testified 
``[n]ot necessarily, no,'' and after reading the contents of

[[Page 18896]]

the note, added: ``It doesn't say whether it's for addiction or 
anxiety.'' Id. at 558-59. While Dr. Christensen acknowledged that 
``[i]t's possible'' that the referral was made because BCI 2 was 
engaged in ``drug-seeking behavior,'' this was ``[n]ot necessarily'' 
the case. Id.
    Dr. Christensen agreed that both Norco 5 mg and 7.5 mg are 
indicated for moderate to severe pain, and that on a pain scale, 
moderate pain is pain above 4. Id. at 559-60. Asked if the pain level 
which BCI 2 noted on her pain history questionnaire as the usual level 
of her pain (``4'' on a 0 to 10 scale) should not be considered as 
``moderate pain,'' Dr. Christensen initially said ``yes'' but agreed 
that there is no universal agreement as to that standard. Id. at 561. 
He then acknowledged that it would be okay to prescribe Norco to 
someone complaining of pain at a level of 4, but that would be the 
minimum level for prescribing the drug. Id.
    Noting that BCI 2's pain history questionnaire indicated that her 
present pain was at the ``0'' level and that her pain was decreased by 
``medication,'' Dr. Christensen disagreed that it would ``be fair to 
assume'' that Norco was the reason for her experiencing ``0 pain.'' Id. 
at 562. He testified that this was ``not necessarily'' the case, noting 
that ``when she said everything is great, we don't know that that's 
because of her pain medication.'' \18\ Id. Dr. Christensen acknowledged 
that ``[i]t's possible'' that BCI 2's statement to Respondent that 
``I'm good today'' was ``an indication that she's being well managed on 
her pain . . . with medication.'' Id. at 563-64. Dr. Christensen 
disagreed, however, with the suggestion of Respondent's counsel that it 
was ``not unreasonable for [Respondent] to conclude that that statement 
means my current regime is appropriate.'' Id. at 564. As he further 
testified: ``For a physician not to bother asking someone how much 
medication they're taking? Reasonable? . . . I'm sorry, sir, but I 
don't think it's reasonable for an interviewer to completely ignore 
asking, are you taking your medication? How much medication are you 
taking? It's missing.'' Id.
---------------------------------------------------------------------------

    \18\ Dr. Christensen correctly observed that BCI 2's pain 
history questionnaire was not dated. Tr. 563. While Dr. Christensen 
testified that the document was used by Dr. R., he did not know if 
it was completed before BCI 2's first or second visit with Dr. R. 
Id.
---------------------------------------------------------------------------

    As for BCI 2's response (``Uh, just here for refills'') to 
Respondent's question (``so tell me what's going on?''), GX 7, at 2, 
Dr. Christensen acknowledged that BCI 2's answer could potentially be 
``an indication that she is taking her medication and needs refills.'' 
\19\ Tr. 566. Apparently interpreting the question as asking whether 
BCI 2 was taking the medications as prescribed, Dr. Christensen 
disagreed that this was a reasonable conclusion. Id. at 566-67. As he 
explained: ``How much? . . . I will stand by my statement [that] it's 
inappropriate for a physician to ignore asking whether or not someone's 
taking their medication as prescribed, especially if there's been a 
change in the pain level.'' Id. at 567. In response to a similar 
question by Respondent's counsel, Dr. Christensen testified that ``I 
believe that's insufficient information to assume they're [sic] taking 
the medication according to the prescribed schedule.'' Id.
---------------------------------------------------------------------------

    \19\ Respondent's counsel's question simply asked: ``Is that to 
you an indication that she is taking her medication and needs 
refills of those medications?'' Tr. 566. He did not ask if BCI 2's 
statement was an indication that she was taking her medication as 
prescribed. Id.
---------------------------------------------------------------------------

    Asked how often a physical exam is required of a patient the same 
age as BCI 2 (41) who complains of back pain and was receiving Norco 
and ``the more dangerous things have been ruled out,'' Dr. Christensen 
testified that DEA regulations require a visit ``every 90 days for a 
schedule II medication'' such as Norco.\20\ Id. at 568. Dr. Christensen 
then testified that under DEA regulations, Respondent was not even 
required to conduct a visit with BCI 2 if she had previously received a 
prescription for Norco. Id. However, when then asked whether requiring 
the visit was ``[o]ver and above what [he] believe[s] is required [by] 
the standard of care in Michigan,'' Dr. Christensen testified that ``my 
interpretation of this patient is apparently different than 
[Respondent's], so I can't confirm your question.'' Id. at 569.
---------------------------------------------------------------------------

    \20\ DEA's regulation does not, however, specify how often a 
patient who is being prescribed schedule II controlled substances 
must return for an office visit. See 21 CFR 1306.12. Rather, the 
regulation allows an individual practitioner to ``issue multiple 
prescriptions authorizing the patient to receive up to a 90-day 
supply of a Schedule II'' drug provided various conditions are met. 
Id. Sec.  1306.12(b)(1). Indeed, the regulation states that 
``[n]othing in [it] shall be construed as mandating or encouraging 
individual practitioners to issue multiple prescriptions or to see 
their patients only once every 90 days when prescribing Schedule II 
controlled substances. Rather, individual practitioners must 
determine on their own, based on sound medical judgment, and in 
accordance with established medical standards, whether it is 
appropriate to issue multiple prescriptions and how often to see 
their patients when doing so.'' Id. Sec.  1306.12(b)(2).
---------------------------------------------------------------------------

    Asked by the CALJ if there is ``a different standard that prevails 
in Michigan than the one that's in the DEA regulations in regards to 
the requirement of a visit,'' Dr. Christensen testified that he 
believed ``the DEA prescriber manual . . . does give the 90-day 
interval as a requirement but also recommends that the visit be more 
frequent.'' Id. Then asked by the CALJ if Michigan's standard requires 
more frequent visits than every 90 days, Dr. Christensen testified: ``I 
don't believe we have a standard.'' Id.
    Respondent's counsel then asked if it would have been ``okay for 
[Respondent] to prescribe controlled substances for a patient such as 
[BCI 2], assuming all the information you know about her, and not see 
her for 90 days?'' Id. at 569-70. After clarifying that Respondent's 
counsel was referring to the information available at BCI 2's visit 
with Respondent, Dr. Christensen testified: ``at that time, if you 
schedule a 90-day return visit and her urine drug screen came up 
negative for prescribed medications, you would need--I believe it would 
be appropriate to intervene.'' Id. at 570. Dr. Christensen testified 
that this would involve having her come back ``about a week later'' and 
doing a pill count. Id. Dr. Christensen then agreed that Respondent did 
not have the results of the March 19 drug test available to him \21\ 
``[a]t the time of the visit.'' Id.
---------------------------------------------------------------------------

    \21\ However, the results of the February 20 drug test, which 
was negative for all drugs including those that had previously been 
prescribed to her, would have been available on the date of BCI 2's 
visit, although Respondent claimed that he still did not have access 
to the results.
---------------------------------------------------------------------------

    On cross-examination, Respondent's counsel also questioned Dr. 
Christensen regarding his direct testimony questioning Respondent's 
notation in the visit note that ``[p]ain shoots to left hip.'' Id. at 
571 (GX 11, at 35). As Dr. Christensen testified, the Investigator 
testified that when asked by Respondent ``to point to where it is real 
quick,'' (GX 7, at 3), she pointed to her lower right hip area and not 
her left hip. Tr. 285; see also id. at 572.
    Respondent's counsel then asked: ``this statement here, shoots to 
left hip, if somebody's complaining of back pain, but when they're 
asked where it hurts and it manifests itself on the hip side, would 
that appear to you that the pain is shooting from one area to another 
area?'' Id. at 572. Dr. Christensen testified: ``If they complained of 
pain in both areas.'' Id. Then asked if ``that would be consistent with 
shooting pain,'' Dr. Christensen testified: ``If they said it was 
shooting. You could have pain in two separate locations. The shooting 
pain typically refers to nerve irritation or injury.'' Id. However, as 
found above, BCI 2 did not complain of shooting pain but said ``it just 
stays there.'' GX 7, at 3.

[[Page 18897]]

    On re-direct, Dr. Christensen testified that Respondent's 
prescribing of 60 Norco and 60 Soma to BCI 2 was a departure from Dr. 
R.'s treatment plan which she instituted at the February visit, and 
that while there was some discussion as to why Respondent reduced the 
Soma prescription, there was ``no discussion'' as to why he increased 
the Norco prescription. Id. at 576. Dr. Christensen explained that the 
standard of care in Michigan includes ``the principle of informed 
consent'' and that this ``require[s] [that] if you're making a major 
change in a controlled substance, . . . to discuss it, [and] why you're 
recommending it.'' Id. at 577. Dr. Christensen testified that he found 
no evidence in the video that there was any discussion as to why 
Respondent increased the Norco. Id. He also testified that it appeared 
that Respondent was ``ignoring the planned taper by Dr. [R.]'' and that 
Respondent was trading an ``increase'' in the Norco prescription for a 
``decrease'' in the Soma. Id.
    While on re-cross, Dr. Christensen agreed that Respondent's 
decreasing of the Soma prescription was reasonable and this drug has an 
analgesic effect ``in short-term treatment,'' he testified that 
increasing BCI 2's Norco prescription ``to maintain the analgesic 
effect'' was not ``a rational therapeutic choice.'' Id. at 580. Then 
asked if he would rather have BCI 2 ``on Norco only and not Soma or 
Soma only and not Norco,'' Dr. Christensen answered ``[n]either.'' Id. 
at 580-81.

Respondent's Case

    Respondent testified on his own behalf and called two other 
witnesses. The first of these was Dr. Carla Scott, a physician who is 
the medical director for the Wayne County Juvenile Detention Facility. 
Tr. 592. Dr. Scott, who did residencies in both internal medicine and 
pediatrics and is board certified in pediatrics, testified that her 
duties involve overseeing the facility's Health Services Department, 
including its Mental Health Department, and that the facility has a 
psychiatrist, two psychologists, three social workers, and two 
contractor physicians. Id. at 593-94. Dr. Scott also testified that she 
had ``worked as a professor for a year at Baylor.'' Id. at 593.
    Dr. Scott testified that when she first moved back to Detroit she 
had worked at an outpatient public health clinic for ``[a]bout nine or 
10 months, '' id. at 595, but had left because she did not like the way 
the clinic practiced medicine, as ``[t]hey really expected physicians 
to just pass out drugs'' as ``they got paid per capita'' and ``the more 
patients you saw, the faster you saw them, the more money the clinic 
made.'' Id. at 596. She explained that ``they felt like I spent too 
much time with the patients'' and because the clinic ``push[ed] the 
doctors to . . . just keep the patients coming in . . . we had a lot of 
patients there who were just drug-seeking.'' Id. at 596-97. She 
testified that she was ``threatened several times'' and ``had to have 
people removed from the clinic because'' she was not ``going to write 
the scripts.'' Id. at 597. Dr. Scott also testified that she ``clearly 
. . . learned something'' about identifying drug-seeking behavior, but 
acknowledged that ``I can't say that I was an expert.'' Id.
    Dr. Scott testified that she went to medical school with Respondent 
and that they ``were pretty good friends'' until their residencies led 
them to go their ``separate ways.'' Id. at 598. Dr. Scott testified 
that she did not ``hear from [Respondent] for like 25 years,'' at which 
point Respondent called and asked her to supervise him pursuant to an 
order of the Michigan Medical Board.\22\ Id. As Dr. Scott did not have 
any available positions, Respondent worked at the detention center as a 
volunteer. Id. According to Dr. Scott, the letter she received from the 
Board after she agreed to supervise Respondent ``was really vague'' as 
to what this entailed, so Dr. Scott asked him where else he was working 
and asked to see some of his patient charts. Id. at 599.
---------------------------------------------------------------------------

    \22\ Respondent had been accepted for a fellowship at Johns 
Hopkins but was required to have a permanent license and list the 
license number on the application. Tr. 628. According to Respondent, 
he then had only a temporary educational license so he listed his 
roommate's license number. Id. While Respondent did receive a 
permanent license, he was sanctioned for falsifying his application. 
Id. at 628-30; see also id. at 601-02. Respondent testified that he 
``made a severe error in judgment'' and that he ``was dishonest on 
[his] application to Johns Hopkins.'' Id. at 628.
---------------------------------------------------------------------------

    Respondent told Dr. Scott ``that he had opened up his own private 
pain clinic,'' which sent Dr. Scott's ``antennas up . . . because [she] 
ha[s] an issue about narcotics.'' Id. Dr. Scott asked to see these 
files and also went over to see his pain clinic. Id. Dr. Scott 
testified that she reviewed Respondent's charts and that after she 
fired one of the detention center's physicians, she hired Respondent as 
a part-time contractor. Id. at 603. Dr. Scott testified that her 
supervision began around April 2014 and lasted for one year, after 
which she wrote a letter to the Board. Id. at 604-05. She testified 
that she reviewed about 10 of his pain clinic charts, and that all of 
these charts were for patients who were receiving controlled 
substances. Id. at 605.
    While Dr. Scott also reviewed hundreds of charts maintained by 
Respondent in the course of his employment at the detention center, she 
acknowledged that ``not a lot of these'' involve patients on controlled 
substances as ``we give out little to no narcotics at the . . . 
detention facility.'' Id. at 606. She subsequently testified that 
controlled substances for pain were ``probably less than five 
percent,'' and ``might even be less than two percent'' of the drugs 
that are prescribed at the detention facility. Id. at 607. While Dr. 
Scott testified that ``we have a lot of kids on'' controlled substances 
for psychiatric conditions, those prescriptions are ``always done by 
the psychiatrist'' unless the ``psychiatrist is absent'' and ``they're 
always reviewed.'' Id.
    Dr. Scott testified that she ``did not have any problems with the'' 
the 10 charts she reviewed from Respondent's private pain clinic. Id. 
at 610. She did, however, ``talk to him about . . . making sure that he 
. . . sent people to physical therapy, and he already was.'' Id. Dr. 
Scott also testified that Respondent showed her that ``they had to 
bring in films'' and ``different things''; Dr. Scott did not, however, 
clarify what these ``different things'' involved. Id.
    Asked what she was looking for in reviewing Respondent's charts, 
Dr. Scott testified:

. . . just that as a physician that someone gave him a good reason 
why they needed narcotics and that he had a plan in place on how to 
get them off narcotics, that there were . . . other modalities 
offered to people, that you talked to them about other things that 
they could do for pain control, that you made sure that, because . . 
. pain is nebulous. It's very difficult. I mean, you can tell me 
you're in pain, but . . . how do I know that you really are?
    So you, as a physician, you're going to have to try to figure 
out how, you know, this person's saying they're in pain . . . so 
what are the best steps in terms of getting them out of pain . . . . 
and what kind, what other kinds of things can you do besides give 
them pills. And that's what I wanted to see.

Id. at 610-11. Dr. Scott also testified that she never had an issue 
with Respondent's charting of his treatment of patients at the 
detention facility. Id. at 611. However, Dr. Scott offered no testimony 
to even establish that Respondent treated any of the detention 
facility's patients with narcotics.\23\ Id.
---------------------------------------------------------------------------

    \23\ Dr. Scott also testified that Respondent had an 
``excellent'' work ethic at the detention facility, that she ``would 
like for him to continue to be an employee,'' and that he is 
``providing a valuable service to the community.'' Id. at 611-12. 
None of this testimony is relevant in the public interest 
determination. See Gregory Owens, 74 FR 36751, 36756-57 (2009).
---------------------------------------------------------------------------

    Next, Respondent called Ms. Tyanna Clemmons. Id. at 613. Ms. 
Clemmons

[[Page 18898]]

testified that she is a Certified Nursing Assistant and that she worked 
as Respondent's office manager at a clinic he owned in Flint, Michigan 
from March through July 2016. Id. at 616-17.
    Ms. Clemmons testified that her duties involved ``scheduling 
patients, collecting documentation for patients,'' and managing the 
patient files. Id. at 617-18. Asked what type of documentation she 
would see in the patient files, she testified that ``all of our 
patients had to have imaging studies.'' Id. at 618. She also testified 
that ``[w]e had the patients sign their consent forms,'' that she 
``would contact [the patient's] previous doctor to receive their 
documentation,'' and that Respondent ``always reviewed'' these records 
``to see . . . what was exactly going on with the patient.'' Id. at 
619.
    Ms. Clemmons testified that the patients would undergo monthly 
urinalysis testing, that Respondent reviewed each drug test result, and 
that there was one patient, who tested positive for cocaine and was 
discharged by Respondent. Id. at 619-20. Asked how she knew that 
Respondent reviewed the drug test results, Ms. Clemmons testified: 
``Because I specifically gave them to [Respondent]. He would have them 
inside of his file . . . [and] he always reviewed his files before his 
examination.'' Id. at 620.
    Ms. Clemmons testified that Respondent would see ``about 10'' 
patients a day and that he would spend ``[r]oughly about 30 minutes'' 
with the patients, although the amount of time per visit varied and was 
``[s]ometimes maybe 15 minutes, sometime maybe 45 minutes.'' Id. at 
621. She also testified that a MAPS report would be obtained for every 
visit by a patient and that ``every time'' the report indicated that a 
patient was engaged in doctor shopping, the patient would be 
discharged. Id. at 622-23. Finally, she testified that patients were 
given referrals for ``outpatient therapy, chiropractors and . . . home 
care services.'' Id.
    Finally, Respondent testified on his own behalf. Id. at 624-700. 
Respondent testified that he received his undergraduate degree from the 
University of Michigan and his medical degree from Wayne State 
University. Id. at 624. Following medical school, Respondent did both 
an internship and a residency in radiology at Howard University 
Hospital. Id. at 625. He also did a fellowship in interventional 
radiology at the Detroit Medical Center and in neuroradiology at the 
University of Arizona. Id. Respondent testified that his neuroradiology 
fellowship involved interpreting MRIs of the brain, face, neck and 
spine and that he was ``taught to evaluate pain pumps, kyphoplasty, 
vertebroplasty, nerve blocks, facet blocks, blood patches, [and] SI 
joint injections.'' Id. at 625. As for his fellowship in interventional 
radiology, Respondent testified that ``you get taught in pain 
management as far as facet blocks, epidural injections, nerve blocks, 
[and] pain pump evaluations.'' Id. at 627. He also testified that while 
he is board eligible, he is not board certified. Id.
    Subsequently, Respondent testified that prescribing narcotics was 
``[p]art of the training in each of [his] fellowships . . . because 
that's pain management.'' Id. at 647. Respondent also testified that he 
has had significant training in pain management. Id. at 648. He further 
testified that he has ``a few months'' of experience doing office-based 
pain management. Id. at 652.
    Respondent testified that notwithstanding the earlier sanctions 
that were imposed on his medical licenses, all of his licenses are now 
``free and clear'' with ``no restrictions.'' Id. at 631. Describing his 
work at the juvenile detention facility, Respondent testified that it 
involved doing physicals and minor procedures and ``not that much'' 
prescribing of narcotics. Id. Continuing, Respondent offered vague 
testimony that ``the anti-psychotics, stuff like that, I would say it's 
10 to 20 percent because . . . the psychiatrists might not be there.'' 
Id. Respondent did not, however, identify what specific ``anti-
psychotics'' he prescribed, and thus, there is no evidence as to 
whether this prescribing involved any drugs that are controlled 
substances.
    Moving on to the allegations of the Show Cause Order, Respondent 
testified that in January 2015, he started doing locum tenens work for 
a company called Michigan Healthcare. Id. at 633. Respondent did one or 
two shifts at Michigan Healthcare before taking on locum tenens work at 
Dr. Vora's office.\24\ Id. at 634.
---------------------------------------------------------------------------

    \24\ Respondent testified that he became aware of the position 
at Dr. Vora's office through Michigan Healthcare. Tr. 635.
---------------------------------------------------------------------------

    Respondent testified that he understood his work at Dr. Vora's 
office would involve ``just see[ing] patients and that I'd be doing 
procedures since I have been fellowship trained.'' Id. at 635. He 
testified that he was not informed that he would specifically be seeing 
pain management patients. Id. Rather, he explained: ``The setup that it 
was supposed to be was that I'd go to Dr. Vora, Dr. Vora would set up 
[the] patient, and then I would see patients, because it was done 
through, at least the patient list was done through Dr. Vora's officer 
manager and the office manager at Michigan Healthcare.'' Id. Respondent 
testified that he worked ``two or three'' days total at Dr. Vora's 
practice. Id.
    Respondent testified that his first day at Dr. Vora's practice was 
February 19, 2015, the day he saw BCI 1. Id. at 636. Respondent 
testified that ``[p]rior to showing up'' on that morning, he had no 
communication with either Dr. Vora or his staff other than a 
conversation he had ``on the way to Gladwin'' (the location of the 
office), when ``all [he] was told was that he was going to have some 
patients and . . . see patients.'' Id. at 636-37. He testified that he 
had ``zero'' opportunity to review the patient charts prior to arriving 
at the office and did not know how many patients he would see until he 
arrived and was provided with ``a patient list'' of 25 patients by the 
office manager. Id. at 637-38.
    Respondent denied that he had access to the urine drug screen, 
stating that he did not ``have access through the EMR'' (the electronic 
medical records), because ``something was going on with [the office's] 
computer system.'' Id. at 638-39. Respondent testified: ``What Dr. 
Vora, his staff would do would give me these printouts of the charts 
and I would, you know, request.'' Continuing, Respondent testified: ``I 
had at the very least to have the MAPS, but I said I also need the 
urinalysis in order to see what's going on with the patients and to . . 
. have what I would think is a complete access to the medical 
records.'' \25\ Id. Respondent further testified that he did not know 
if anyone could access the urine drug screen reports.\26\ Id. at 639.
---------------------------------------------------------------------------

    \25\ Respondent also maintained that after his first day, he 
told the staff that he ``wanted to have access to the urinalysis'' 
and ``access to the[ ] full . . . EMR.'' Tr. 687. He also wanted 
``advance knowledge of which patients [he] would be seeing'' and 
``to have the MAPS there prior to . . . coming to the office.'' Id. 
Respondent testified that when he showed up on March 19, 2015, his 
instructions ``were not'' followed. Id.
     However, later during cross-examination, Respondent testified 
that ``for every patient I got [a] MAPS'' and ``[b]efore I saw any 
patient I was able to get the MAPS'' without specifying that he got 
MAPS reports only on March 19, 2015. Id. at 692. While on cross-
examination, Respondent reiterated that the UDSs were missing when 
asked what else was missing ``apart from the urinalysis records,'' 
``I didn't think anything was missing off of the top of my head . . 
. .'' Id. at 693.
    \26\ Respondent also testified that he was told that he would 
have access to the urine drug screens ``either later on that day or 
even the next visit.'' Tr. 639.
---------------------------------------------------------------------------

    Asked whether he had ``any discussions with Dr. Vora prior to 
walking in for [his] first patient,'' Respondent initially testified: 
``[z]ero . . . [o]ther than that he introduced

[[Page 18899]]

himself to me.'' Id. However, when then asked by his counsel if Dr. 
Vora said ``anything about his prior treatment of the patients or a 
---------------------------------------------------------------------------
care plan,'' Respondent testified:

    Oh, yeah. He said that all the patients that I was receiving he 
had seen, he had established a patient management plan, and that he 
would, because they were his patients, that he would prefer that if 
there was [sic] any drastic changes that I'd discuss them with him.

Id.
    As for why he did not refuse to see the patients until he could see 
their urine drug screen results, Respondent explained:

    Well, initially, number one, they're established patients. 
Number two is that it's not necessarily a requirement to have urine 
drug screens every time you see the patient. Therefore . . . you can 
have . . . you have judgment. It's up to me to decide whether okay, 
I'll see this patient, or it is definitely a . . . requirement for 
me to have the urine screens.

Id. at 640.
    As for how he knew that the patients were established patients, 
Respondent testified that the office manager gave him ``printouts of 
the patient's prior history . . . what he had decided to treat.'' Id. 
Respondent testified that he took ``into account the patients' medical 
records and prior history.'' Id. Asked what he was looking at based on 
the videos which show him flipping through pages during BCI 1's visits 
and looking at a tablet during BCI 2's visit, Respondent testified 
that:

[t]he second time I came, and I think that's with [BCI 2], it was 
all mixed up. It was that I got part of the medical records [that] 
were given to me through the printout that [the] office manager gave 
me, and then . . . I had limited access via . . . my computer, but 
because it was not the computer established with [the] EMR, I can 
[sic] only get access to certain areas of the patients' medical 
records.

Id. at 641. Respondent then testified that ``the paper was the prior 
medical history as far as that goes'' for BCI 1 and the tablet had 
``some additional information on him.'' Id.
    Addressing BCI 1's first visit, Respondent testified that he 
``definitely'' recalled the visit and that ``[i]t was very memorable'' 
as ``the language that he was using was inappropriate. . . . I don't 
think that anybody talks to their physician, yeah, brother, yeah, you 
know, in a hot month he's going to be back. I think that no one talks 
like that, number one.'' Id. at 642. Respondent then explained that 
this language elicited this reaction because Gladwin, Michigan ``is 
like Leesburg[,] [Virginia] 40 or 50 years ago. So, when I go to 
Gladwin, it's like I am a sore thumb standing out.'' Id. at 642-43.
    Asked by the CALJ what he meant by that, Respondent testified: ``I 
mean there are no African-American people there, period.'' Id. at 643. 
Then asked by his counsel if he was ``suggesting that [he was] treated 
differently because of [his] race by'' BCI 1, Respondent answered: 
``There's no other way I could say it because I can't see him saying 
those things if I were not African-American.'' Id.
    Asked by his counsel what he was ``feeling about some of the 
statements he made and whether . . . he was cooperating as a patient 
with'' him, Respondent testified that the ``main thing'' was ``to try 
to connect [with the patient] on a human level.'' Id. Continuing, 
Respondent explained that ``you want to talk to the patient, you want 
to let them know that you're a regular person, you're there to take 
care of them, you're there to help them out. You're no different than 
they are. So you want to initially just establish a rapport with the 
patient.'' Id. at 643-44. Respondent further explained that:

[i]f they [sic] feel comfortable with you, then they [sic] can feel 
comfortable accepting what you advise them to do, your orders, 
whatever it may be. But if they [sic] feel that you are coming from 
a condescending type of attitude and you're there to bigfoot them, 
them . . . they [sic] might not be as receptive to following your 
plan.

Id. at 644.
    Addressing some of the dialogue at BCI 1's first visit with him, 
Respondent was asked to explain ``[w]hat [was] going through [his] mind 
when'' BCI 1 said that ``I take Norco for my back and I take Xanax on 
the weekends.'' Id. Respondent testified:

    Multiple things. You know, I'm thinking that he was taking the 
Norco for his back pain. The Xanax is, which was for anxiety which 
was previously diagnosed from Dr. Vora's records, and that's my 
impression of that. I would think, . . . anybody would--I don't 
think it's unreasonable to say that when he says I'm taking Norco 
for my back that it's for back pain. I don't think that's 
unreasonable.

Id. at 644-45.
    As for his subsequent question to BCI 1 (``Okay, so you have back 
pain, some anxiety?''), Respondent explained that, in his mind, he 
viewed BCI 1's answer of ``I guess,'' ``as an affirmative answer'' to 
his question, and that BCI 1was confirming the diagnoses of back pain 
and anxiety which were documented in the patient record. Id. at 645. 
Respondent also testified that prior to asking these questions, he had 
looked through the medical record and noticed both diagnoses, id. at 
645, and that he believed the diagnoses were substantiated as he had no 
other reason to believe that the medical records were not legitimate as 
far as that goes.'' Id. at 645-46.
    On questioning by the CALJ, Respondent testified that he knew 
``[z]ero'' about Dr. Vora before going to the clinic and ``[t]hat's the 
way locums works.'' Id. at 646. The CALJ then asked Respondent if it 
was clear to him ``after [he] started seeing patients that [he was] 
doing pain management?'' Id. at 646-47. Respondent answered:

    At that time, I went specifically to Dr. Vora and I said this is 
not really what I had signed up for, was just to see pain patients. 
You know, however, as a matter of professional courtesy, I said 
okay, you know, I'll do this, but this is not what I signed up for. 
I want to do something else. This is not for me per se.

Id. at 647.
    Suggesting that Respondent ``almost want[ed] to have it both ways'' 
in that ``[o]n the one hand,'' he was claiming that he ``didn't 
understand anything about this and . . . didn't know what to look for 
and . . . didn't have . . . access to the records[,] [b]ut on the other 
hand . . . talked about [his] extensive training . . . in the science 
of pain management,'' the CALJ asked ``which one is it?'' Id. at 649. 
Respondent answered: ``when you say access, that is like EMR . . . 
Electronic Medical Record. That is something that you have to have a 
password for. So I am reliant upon somebody else to provide those for 
me as far as that goes. And as far as my fellowship training, pain is 
just part of that. It's not the only thing about interventional 
radiology or neuroradiology.'' Id. at 649-50.
    After Respondent acknowledged that as an interventional radiologist 
he would not perform a procedure (such as an epidural) in a complex 
case without the necessary tools, the CALJ again asked Respondent to 
explain why, given his training on prescribing opioids, he was willing 
to prescribe pain medication without ``more access'' to the medical 
records. Id. at 650-51. Respondent answered:

    . . . This is the way it works. With pain management, first, you 
have to go conservative . . . . You can go three months and you can 
see a patient and not perform a procedure. So that's not 
unreasonable. It's not unreasonable for a physician to see a patient 
for three months, and then after that three months, if they're just 
getting medication, you have to ask them if they want or if they are 
amenable to a procedure.
    So it's not like you--because that's not the way medicine works. 
You first start out conservatively. Then after you start out 
conservatively, if the pain is not being controlled, it's over three 
to four months,

[[Page 18900]]

then you offer them a procedure. If they are not amenable to the 
procedure, you are supposed to discharge or refer them to another 
physician or not see them. It's their choice really.

Id. at 651-52.
    Returning to the dialog of BCI 1's first visit, Respondent 
testified that when he asked how long BCI 1 had his lower back pain and 
BCI 1 said ``Uh, probably 10 years,'' he believed that BCI 1 ``has 
chronic back pain, degenerative disc disease,'' that this is ``the most 
common low back pain diagnosis,'' and that he took BCI 1's statement 
``as an affirmative.'' Id. at 653. Then asked what BCI 1's statement 
``[m]ostly just stiff'' meant to him, Respondent answered:

    The thing when you're evaluating a patient, and again, this 
patient, he's stating that he's having difficulty reading. You do 
not want patients coming in using medical terminology. You want them 
to describe it. If they start using medical terminology during the 
office visit, you can get suspicious that they're either Googling it 
or they're trying to, you know, skew their answers to make it seem 
like they have these certain illnesses.

Id. at 653-54. Respondent added that ``mostly just stiff . . . means 
back pain'' to him. Id. at 654.
    As for his questioning BCI 1 as to whether he had ``any muscle 
spasms with the pain'' and BCI 1's response to the effect that ``[i]t 
gets tight . . . so I don't know . . . I don't know what the word is 
for that. Stiff,'' Respondent testified that ``[t]o me, when you say 
tight . . . that it would be indicative of muscle spasm.'' Id. 
Respondent further explained that ``[t]here's various ways that people 
describe . . . low back pain and that's one of them, in addition to 
muscle spasm.'' Id. at 654-55. Respondent also asserted that BCI 1's 
failure to deny muscles spasms also played into his belief that he had 
muscle spasms. Id. at 655.
    As for his asking BCI 1 if he ``ever ha[s] to walk with a limp 
because [his] pain gets so bad,'' Respondent explained that ``you want 
to know the degree of pain, if it's causing him a lifestyle type of 
change. You're trying to measure how severe the pain is.'' Id. As for 
BCI 1's answer (``No, I strut a little bit. Does that count?''), 
Respondent answered that he considered ``the language that he's using . 
. . strut. I would consider that a limp . . . at the very least 
abnormality of his gait.'' Id. As for why someone would answer his 
question this way, Respondent testified: ``[a]gain, I'm trying to get 
to know the patient. You know, for him, with him. I just took it as 
that he did walk with . . . he had abnormality of his gait.'' Id. at 
655-56.
    Addressing his asking BCI 1 if he had ever fallen and BCI 1's 
response (``I'm a grown-ass man. Yeah, I've fallen.''), Respondent 
testified that ``it's very difficult to determine what he's trying to 
say. However, when someone says that they have fallen, to me, that 
means muscle weakness.'' Id. Respondent then recited BCI 1's answer to 
his question as to whether the latter had lost muscle strength (``I 
mean, just getting older, what not. I don't know how you, you know.''), 
and Respondent's counsel asked if he felt ``like the patient in this 
case was being evasive or answering your questions in a straight-up 
manner?'' Id. at 656. Respondent answered: ``[t]here are multiple 
things that are going through my mind. Number one, I think he's trying 
to overcompensate. He's using a lot of slang. . . .'' Id.
    Asked by the CALJ what he meant by his use of the term 
``overcompensate,'' Respondent testified: ``Like I don't think that 
he's used to seeing somebody like myself . . . evaluate him.'' Id. at 
657. Then asked by the CALJ what he meant by ``somebody like 
yourself,'' Respondent answered: ``An African-American. I don't think 
that he's . . . I just can't see a person who comes to a doctor's 
office using the language that he does.'' Id. at 657. Respondent then 
testified that he had issues with his race while at the Gladwin office 
as ``[t]here were times that some of the patients did not want me to 
touch them. So, you know, there's nothing I can do about that as far as 
that goes, so it can be, you know.'' Id. Continuing, Respondent 
testified that ``[t]he only reason why I could deduce is that . . . I'm 
African-American.'' Id. Respondent then testified that patients had not 
only said that they did not want him to touch him but also that they 
``don't like black people.'' Id. Asked when he encountered these 
persons, Respondent testified that ``it happened twice. It happened 
right before [BCI 2], and then it happened . . . two or three patients 
prior to seeing [BCI 1] . . . [t]he second time.'' Id. at 658.
    Respondent did not, however, assert that either BCI 1 or BCI 2 
acted in this fashion. While Respondent further testified that this had 
an effect on how he interacted with patients, he then explained that 
this led him to ``want to . . . instill trust in the patients that I 
know what I'm doing and that I'm there to help them.'' Id.
    As for the portion of BCI 1's first visit when Respondent asked the 
former to stand up and point to the part of his back that hurts the 
most, Respondent asserted that ``he had his coat on his arm'' and that 
he did not ``believe'' that BCI 1's testimony that he was wearing a 
coat during the physical exam ``to be credible.'' Id. at 658-59. 
Respondent also maintained that BCI 1 ``had some type of a thick shirt 
on'' and ``when I asked him to turn around, I lifted up his shirt and 
then I pressed on his back.'' Id. at 659. Respondent then reiterated 
that he ``personally press[ed] on [BCI 1's] back'' and testified that 
when he did so, he ``was feeling tightness, feeling . . . whether he 
was going to elicit some pain. That's it. Muscle tone, spasm.'' Id.
    As found above, as BCI 1 pointed to his back, he stated ``[m]ostly 
just stiff.'' GX 3, at 9. Respondent testified that he took this 
statement ``as pain.'' Tr. 659. Respondent then explained that he asked 
BCI 1 if his pain shot anywhere or was localized because he ``wanted to 
see if [BCI 1] had any nerve symptoms'' which would indicate ``[t]hat 
he ha[d] radiculopathy'' or ``degenerative disc disease.'' Id. at 660.
    As also found above, BCI 1 said that his pain was localized. GX 3, 
at 9. Respondent testified that this statement ``could mean a lot of 
things,'' including ``that he had a herniated disc,'' that ``it could 
be a degenerative disc, or it could be a narrowing of his 
neuroforamina.'' Tr. 660. Respondent then testified that ``[y]ou can 
feel a herniated disc'' but not degenerative disc disease with your 
finger. Id. at 660-61.
    Respondent further testified that BCI 1's ``prior medical records'' 
showed that he had been referred to radiology. Id. at 660-61. However, 
while the ``Orders'' section of Dr. Vora's progress note for BCI 1's 
December 15, 2014 visit contain the notations ``Radiology'' and 
``lumbar spine,'' GX 10, at 3, there is no radiology report in BCI 1's 
patient file.\27\ See generally GX 10.
---------------------------------------------------------------------------

    \27\ Respondent also testified that ``you can'' see degenerative 
disc disease on an X-ray. Tr. 661. Respondent did not, however, 
testify that he reviewed either an X-ray or radiology report at 
either of BCI 1's visits.
---------------------------------------------------------------------------

    As for the abduction/adduction test he performed, Respondent 
explained that his purpose was to determine muscle strength and 
referred pain, which he explained that ``many times, if you lift up 
your arms, you also have to contract your low back, and sometimes that 
can lead to referred pain.'' Id. at 661-62. However, as the video 
shows, when Respondent performed this test on BCI 1, he did not ask if 
it caused pain and BCI 1 made no comment to the effect that it caused 
him pain.\28\ See GX 3, at 9; see also GX 3, Video 5, at 14:48:06-12.
---------------------------------------------------------------------------

    \28\ Likewise, when Respondent performed this test at BCI 1's 
second visit, he did not ask BCI 1 if it caused pain and BCI 1 did 
not complain that it caused pain. GX 5, at 4.

---------------------------------------------------------------------------

[[Page 18901]]

    Respondent testified that he asked Respondent if he smoked because 
``many times cigarette smokers . . . can have a problem with healing'' 
and ``if you're planning on doing a procedure, you want them to cease 
smoking.'' Id. at 662. As for why he asked BCI 1 if he used marijuana, 
Respondent explained that if BCI 1 had acknowledged marijuana use, you 
would want to know if he was certified by a physician and had been 
prescribed medical marijuana as well as to ``get a general history of 
his use of narcotics and drugs.'' Id. at 662-63.
    Next, Respondent explained that he asked BCI 1 about his drinking 
because BCI 1 said ``he's on Xanax and he does it on the weekends, and 
he relates it to his drinking.'' Id. at 663. Respondent then explained 
that ``Dr. Vora had established a pain management plan for him,'' and 
``reading through the notes . . . it [the reason for Xanax] could have 
been twofold, that he was worried about his anxiety, which was 
documented that he had anxiety, or he could have worried about whether 
he was going to go into DTs if he stopped drinking.'' Id. Respondent 
testified that he agreed with Dr. Christensen's statement that it is 
sometime appropriate to prescribe benzodiazepines to prevent delirium 
tremens. Id. at 663-64. Respondent also testified that, in his mind, 
BCI 1's statement that he took Xanax to keep him from drinking too much 
on the weekends meant that BCI 1 ``is not educated on . . . his medical 
condition,'' that ``[h]e doesn't really know what's going on,'' and 
that ``Dr. Vora has not told him exactly that he's on his Xanax for not 
only his anxiety but also for the potential of going into DTs.'' Id. at 
664. Respondent added: ``And that's how I viewed reading the medical 
record.'' Id.
    However, on cross-examination, Respondent testified that he did not 
create a plan to address BCI 1's drinking, because ``in [his] opinion, 
the plan was already enacted by Dr. Vora'' and that plan ``was giving 
the Xanax for both the possibility of DTs and the anxiety that that was 
documented in [the] prior notes.'' Id. at 690. Respondent denied that 
he left the issue ``unaddressed,'' explaining that his ``impression . . 
. was that if he felt that he was going into withdrawals [sic] he would 
take the Xanax.'' Id. at 691-92. Respondent admitted, however, that he 
never asked Dr. Vora if this was his plan. Id. at 692.
    As for why he prescribed carisoprodol to BCI 1, Respondent 
testified that ``in his prior medical records, he was getting Baclofen 
. . . a muscle relaxant. That's the reason why I had given him the 
Soma.'' Id. Respondent then acknowledged that while Baclofen treats 
muscle spasms, it is not a controlled substance. Id. at 665.
    Next, Respondent offered his explanation regarding BCI 1's 
statement that ``[t]hey're worth a lot of money on the street'' and his 
response of ``[t]hat's the whole point. They're pure. You know there is 
nothing cut down about them. So when you're selling them--its like you 
know--the person buying--legit.'' Id. at 665-666 (citing GX3, at 14). 
Asked what his reason was for engaging in this conversation, Respondent 
maintained: ``Well, it's just like educating him, you know, what is 
going on, why people are seeking this drug. It's not like I'm trying to 
tell him to go out and sell his drugs.'' Id. at 666. Then asked whether 
BCI I ``ever admit[ted] to [him] at any point during the interaction 
that he was diverting his controlled substances,'' Respondent answered: 
``No. Let's see.'' Id.
    As for what action Respondent felt was necessary after BCI 1's 
subsequent admission that he had traded drugs with his neighbor, 
Respondent testified that ``number one, you want to treat them, you 
want to give them a chance to be able to rectify their behavior as far 
as that goes. And if he continued with that, I would have just 
discharged him.'' Id. As for how he would have determined if BCI I had 
continued this behavior, Respondent answered: ``Number one, I would 
have, you know, inquired about that. And I would have seen, you know, 
as far as the MAPS, whatever he's taking in the MAPS.'' Id. at 667.
    The CALJ then asked Respondent why he discussed the street value of 
the drugs that he was prescribing to BCI 1. Id. Initially, Respondent 
testified that ``it was an inappropriate conversation'' but that he 
``was really trying to be accepted, trying to relate to the patient. It 
was a mistake.'' Id. Pressed on the issue, Respondent testified: 
``Again, it's like, I mean, I can honestly just say that I just wanted 
for him to feel comfortable for me. It was wrong. I admit that. It was 
something that I should not have said.'' Id.
    Asked by the CALJ whether he ``wanted to be [BCI 1's] friend,'' 
Respondent answered ``[y]es'' and added that he ``wanted'' BCI 1 to 
``trust'' and ``like'' him and ``to be able to say that this guy cares 
about me, he wants to help me.'' Id. at 668. Then asked by the CALJ 
``if you wanted him to be your friend, why would you tell him that he 
could sell his drugs on the street for a lot of money,'' Respondent 
answered: ``I wasn't telling him to sell the drugs.'' Id. The CALJ then 
said: ``You just told him what the value was,'' prompting Respondent's 
counsel to object that the question was argumentative in that it's 
``premise . . . assumed that he was educating him on how to sell drugs 
on the street.'' Id. at 669. While the CALJ overruled the objection, he 
did not pursue this line of questioning. Id.
    Respondent subsequently testified that he, and not BCI 1, had 
engaged in the conversation about the street value of the drugs. Id. at 
670. However, he then revised his testimony to state: ``The thing I was 
trying to convey when I look at my statement is that I mention the 
pharmaceutical companies. And . . . I'd say most physicians feel that 
the pharmaceutical companies are . . . getting rich off the patients 
like himself. And that's why I said that.'' Id. at 670-71. Respondent 
then maintained that when he stated that ``these scripts . . . that you 
are going to get would be like 6 or 7 hundred dollars. You know the 
pharmaceutical company are making bank,'' he was referring to the 
pharmaceutical value and not the street value. Id.
    Addressing the note he prepared for BCI 1's first visit, Respondent 
testified that he wrote that Respondent had degenerative disc disease 
for approximately ten years because BCI 1 ``had it [low back pain] for 
10 years'' and ``[i]t would be consistent with degenerative disc 
disease of his low back.'' Id. at 671. As for why he noted that BCI 1 
had associated muscle spasm, Respondent explained that BCI 1 ``was 
getting Baclofen. So the mere fact that he's getting Baclofen from his 
prior medical records, I would say that the Baclofen which is for 
muscle spasm.'' Id. at 672. Respondent also maintained that ``[t]he 
physical exam that Dr. Vora gave and . . . my examination'' were other 
reasons why he thought BCI 1 could have been getting Baclofen. Id.
    As for the notation that BCI 1 walked with a ``slight limp,'' 
Respondent testified that ``to me, it looked like he walked with a 
limp.'' Id. As for why he noted ``moderate point tenderness,'' 
Respondent maintained that ``when I palpated or pushed on his lower 
back, I thought that he had moderate point tenderness that was 
localized.'' Id. Respondent also maintained that he read Dr. Vora's 
medical records for BCI I and ``agreed with his management and I was 
just going to continue that until I got to know the patient better.'' 
Id. at 673.
    After stating his diagnoses and noting that BCI 1 ``was previously 
diagnosed with'' anxiety, Respondent explained that he continued the 
Norco and Xanax prescriptions ``[f]or the reasons that I previously 
mentioned'' and that BCI 1

[[Page 18902]]

``had documented anxiety and I was worried about him going into DTs.'' 
Id.
    Turning to BCI 1's second visit, as found above, after exchanging 
pleasantries, Respondent asked: ``So how is everything been going with 
your pain?'' and BCI 1 replied: ``[g]reat, yup, everything is cool?'' 
GX 5, at 4; Tr. 674. Respondent testified that, in his mind, BCI 1's 
answer meant ``that the regimen or the plan of his management is 
working. You want the patient to not have any back pain, or you don't 
want them to, or the pain to be more tolerable.'' Tr. 674. Respondent 
also testified that he asked BCI 1 to walk back and forth to see if he 
had a limp and that he ``noticed a limp.'' Id.
    As for why Respondent had BCI 1 point to where it hurt in his back, 
Respondent testified that he did this ``[j]ust to gauge . . . the level 
of his back pain and to see if he had any muscle tightness, the tone, 
to see if it shot anywhere, if he had any progression of his disease.'' 
Id. Respondent maintained that at this point, he palpated BCI 1's back, 
and when asked if he did it through BCI 1's clothing, Respondent 
testified that ``[w]hat I would do is I'd lift the back of his shirt up 
and then I'd push on his back.'' Id. at 675.
    As for BCI 1's statement that ``I got stiffness pretty much like 
right down there,'' GX 5, at 4, Respondent explained that he 
interpreted this as ``he has back pain. I'm specifically asking him 
about back pain. I'm, you know, asking him about that and, to me, when 
he responds, to me, that means that he has low back pain.'' Tr. 675. As 
for why he performed the arm adduction and abduction tests, Respondent 
again testified that he did these tests ``to see if he had referred 
pain, to check out his upper body musculature, and to see if he had 
good muscle tone. Id.
    As found above, Respondent then asked BCI 1 to ``rate [his] pain on 
a scale of one to ten today''; BCI 1 responded: ``I am good today. I am 
good today.'' GX 5, at 4. Asked why he still prescribed medications to 
BCI 1 ``even though he's just failed to give you a pain score,'' 
Respondent explained:

    Well, number one, pain waxes and wanes. So he has had this 
chronic pain for 10 years. This might be just a time that when he 
comes into the office he might have just taken his medication, that 
he's okay.
    Usually . . . if the patient takes the medication prior to 
coming to the office . . . he won't have as much pain.

Tr. 676.
    Next, Respondent testified that on March 19, 2015, he still ``did 
not'' have access to the urine drugs screens because ``[t]hey still 
were saying that there was a computer issue.'' Id. Respondent 
maintained that he complained about his lack of access to the urine 
drug screens and ``said that I needed to have these and that . . . 
that's part of the treatment for the patient.'' Id. at 676-77. As for 
why he just did not refuse to see patients that day, Respondent 
explained that ``it's not a requirement necessarily to have the 
urinalysis, but . . . for him, but the key to me about that is to make 
sure that I eventually do get it.'' Id. at 677. Respondent, however, 
testified that he never saw a urinalysis test result for BCI I. Id. at 
678.
    Noting Dr. Christensen's testimony that BCI 1's second visit with 
Respondent ``was only about two minutes,'' Respondent's counsel asked 
him why it was ``so brief.'' Id. at 677. Respondent testified that he 
``had a[n] incident with a patient prior to [BCI 1], and . . . I'm a 
human being . . . as far as that goes,'' and that the incident involved 
``a patient that did not want me to examine her'' because of his race. 
Id. Asked why this would affect his treatment of BCI 1, Respondent 
answered: ``Well, I mean, again, it's hard to describe when somebody 
doesn't think of you as an equal, and that affects you.'' Id. 
Respondent then asserted that ``[j]ust in general from just the 
language that [BCI 1] used during the examination,'' he did not feel 
like BCI 1 was treating him ``as an equal.'' Id. at 678.
    Addressing Dr. Christensen's testimony that he did not see evidence 
that Respondent did a cranial nerves examination yet documented having 
done so in the March 19 visit note, Respondent's counsel asked: ``[w]hy 
put down in the record that his CN were intact . . . ?'' Id. Respondent 
answered:

    Okay. First of all, you can indirectly evaluate the cranial 
nerves. Like the facial nerve, if he has a facial palsy . . . one 
his cheeks is [sic] droopy, or his eyelid is not, it's like droopy 
also, that is indication of an abnormality of one of the cranial 
nerves. If he . . . has speech patterns similar to somebody who is 
deaf, that would be indicative of a cranial nerve issue. So that's 
why. That's it. So you don't necessarily have to, in order to say 
that the cranial nerves are intact, to directly palpate.

Id. at 679.
    As found above, Respondent also documented in the March 19 visit 
note ``2+ pulses throughout'' and Dr. Christensen testified that 
neither the video nor the transcript show that Respondent took BCI 1's 
pulses. GX 10, at 32; Tr. 433-35. Asked why he made the notation, 
Respondent testified: ``On the radial pulse is the pulses in the wrist. 
Now, when I have the patient lift up their arms, I'm at the same time 
pinching their wrist and I'm feeling their pulse.'' Tr. 678-79.
    As for BCI 2, Respondent testified that he reviewed her medical 
file including the records created by both Dr. Vora and Dr. R. prior to 
treating her and that he had no reason to not believe the statements in 
her medical record. Id. at 680. He further testified that he ``reviewed 
[Dr. R.'s] physical and . . . what she gave the patient'' and the pain 
clinic history questionnaire. Id. at 681.
    As found above, after exchanging pleasantries, Respondent asked BCI 
2 ``to tell [him] what's going on'' and she replied: ``just here for 
refills.'' Id. Asked what BCI 2's response indicated to him, Respondent 
testified: ``I mean, it's subjective as far as that goes, it's 
depending on, you know, I perceive it as that she came in to get her 
examination and that she was coming in there to have her pain 
evaluated.'' Id. at 681-82. Respondent also testified that BCI 2's 
statement that ``I feel great today'' meant to him ``that she's saying 
to me that the management that she's getting is working.'' Id.
    Respondent then testified that he believed that he knew BCI 2's 
pain score from her previous visit with Dr. R. and that based on the 
Pain Clinic History Questionnaire, he believed her pain was ``at least 
a 4,'' which was the rating BCI 2 listed on the form as her usual pain 
level. Id. at 683; see also GX 11, at 23.
    As for his decision to increase the Norco and decrease the Soma 
from the quantities prescribed by Dr. R., Respondent testified that 
``she was getting 120 of the Soma,'' and in his opinion, that was ``too 
high.'' Id. at 683. Respondent further testified that ``Soma can be an 
anti-anxiety medication'' and ``can cause you to become drowsy,'' and 
that, in his understanding, ``the most that you can prescribe within a 
30-day period is 90'' and ``she's overmedicated.'' Id. Respondent 
further maintained that he ``looked at the MAPS and the MAPS said that 
she had gotten Xanax the prior month. And that, since I was seeing her, 
I was not going to write the prescription for Xanax.'' Id. at 683-84. 
Respondent added that he ``didn't notice a refill'' in the MAPS report 
and that he ``didn't realize you could get refills.'' Id. at 684.
    Respondent's counsel then pointed out that ``the MAPS report 
doesn't show the prescription by Dr. [R.] for Xanax'' and asked if he 
``look[ed] at another MAPS report somewhere?'' Id. Respondent 
testified: ``No, I thought that that was the whole point. I wasn't 
going to, no matter what, I wasn't going to prescribe her Xanax.'' Id.
    As for why he increased BCI 2's Norco, Respondent testified: ``that 
the

[[Page 18903]]

reason why she's on such a high dose of Soma is that she's trying to 
control the pain through the Soma, and I just thought that, in my 
judgment, that was too much to be giving her at that time.'' Id. 
Respondent then testified that he thought BCI 2's Soma prescription was 
dangerous, ``so [he] decreased it to 60 and . . . increased the Norco 
to 60, which she prior had been getting from Dr [R].'' Id. at 685. 
Respondent also maintained that he was aware that Dr. R. had previously 
reduced BCI 2's Norco prescription to 5 dosage units. Id.
    Respondent was then asked by his counsel why he increased the Norco 
prescription ``if [he] saw that the other doctor had prescribed less?'' 
Id. Respondent answered:

    Well, the point being was that generally you want to, if you're 
going to wean a patient off of a medication, again, it's unique to 
each patient, but you can wean like 10 percent a week, 10 percent a 
month, but you have to gauge, or the patient has to be monitored. . 
. . And with that, I wanted to make sure that her pain was under 
control.

Id.
    Respondent further testified that after his first day in Dr. Vora's 
office, he tried to contact a psychiatrist because ``many of these 
patients needed to be followed for the Xanax, for the anti-anxiety 
diagnosis.'' Id. at 685-86. Respondent testified that there was ``no 
one'' in the phonebook for Gladwin and while he ``Google[d] 
psychiatrists in'' other cities, ``[t]here's this big procedure when 
you're trying to get a patient to see a psychiatrist'' which involves 
``arrang[ing] an appointment with the psychologist'' who evaluates 
whether the patient needs to see a psychiatrist. Id. at 686. Respondent 
testified that he made these phone calls because he ``wasn't going to 
continue to see the patients that were on Xanax'' and ``did not want to 
keep prescribing Xanax.'' Id.
    Respondent also testified that because his instructions regarding 
obtaining access to the EMR and the urine drug screen results were not 
followed, he ``told them that I cannot do this anymore.'' Id. at 687. 
Asked if he ``recognize[d] . . . that there were some deficiencies in 
how [he] treated the patients at Dr. Vora's office,'' Respondent 
answered ``yes.'' Id. at 688. As for what he could ``do better,'' 
Respondent said ``cut down the number of patients,'' ``make sure'' he 
had ``full access to all the records,'' ``make sure that everything was 
set up for, you know, I needed to offer them you know, procedures,'' 
and to ``let the patients know that there was going to be an African-
American there and that if they didn't want to come, that's their 
choice.'' Id. at 688-89. Respondent also testified that he is no longer 
working as a locum tenens because he has not found a ``satisfactory'' 
job. Id. at 689. He then explained that ``I want to do radiology'' and 
``I do not really want to do pain management. . . . But right now the 
only thing that's open is pain management.'' Id. Asked if it is his 
``desire to ever engage in office-based pain management treatment 
again,'' Respondent answered: ``That's not my goal at all.'' Id.
    On cross-examination, the Government asked Respondent why he 
``still prescribed a 30-day supply of controlled substances'' rather 
than ``a lesser day . . . supply'' at each of the three undercover 
visits ``given [his] uncomfortableness with not having [the] urinalysis 
results.'' Id. at 693. Respondent answered: ``[f]irst of all, you can 
never just have the patient go cold turkey for any type of narcotic.'' 
Id. Government counsel reminded Respondent that he ``didn't say cold 
turkey'' and he had ``said a lesser number.'' Id. Respondent answered:

    So what would they, if I'm not going to be there or they're not 
going to be seen for a month, what would they do--from my 
standpoint, this is rhetorical, is that if you do give a lesser 
amount . . . they run out. Then they're going to self-medicate if 
they run out and they don't have access. And then if the patient 
runs out, they go into withdrawals, they might be driving, then they 
might cross the median, they could kill somebody. So that's my 
concern of like saying okay, I'm going to just give you 10.''

Id. at 693-94.
    When the Government suggested that Respondent could have ``had the 
patient return or . . . could have phoned in the additional pills 
later,'' Respondent testified that ``[y]ou can't phone in Norco'' and 
that ``he'd go in[to] withdrawal from the Norco.'' Id. at 694. 
Respondent then testified that he ``would have to weigh the costs and 
the benefits'' and that if ``a patient has been on it for an extended 
period of time and then you decide to just stop them, . . . they're 
going to have withdrawals.'' Id. After the Government asked if ``it 
would be too inconvenient for them to return,'' Respondent answered: 
``It's like this is--you guys know where you're at. It's Gladwin as far 
as that goes.'' Id. at 694-95. Then asked how hard it would be ``to get 
back to the doctor's office'' if ``only 3,000 people'' live in Gladwin, 
Respondent answered: ``It only takes one accident. That's it. I'm just 
saying for me, I just used my--I did not want patient to go into 
withdrawals. I didn't feel comfortable not giving him medication.'' Id. 
at 695.
    Addressing BCI 1's February 19, 2015 prescriptions, the Government 
asked Respondent whether he believed, at the time he issued each of the 
prescriptions, that the prescriptions were ``for a legitimate medical 
purpose within the usual course of professional practice and the 
Michigan standard of practice?'' Id. Respondent generally testified 
that he did believe the prescriptions were lawful, although he 
acknowledged that ``[i]t was a mistake'' to prescribe Soma to BCI 1. 
Id. at 696. Respondent then explained that by this, he meant that he 
``wasn't as aware of the holy trinity''; he further explained that with 
the patients that ``I'd come in contact with, this holy trinity was not 
that . . . common for me . . . So I wasn't that familiar with that. So, 
when I wrote these out, I wrote it out in good faith. I was not as 
knowledgeable as I should have been.'' Id. at 696-97.
    While Respondent admitted that it was a mistake to prescribe Soma 
to BCI 1 because he was on a different non-controlled muscle relaxant, 
he again testified that if ``I had been more knowledgeable about the 
holy trinity, I would not have given him the Soma.'' Id. at 697. 
Respondent nonetheless believed that prescription was issued for a 
legitimate medical purpose and in the usual course of professional 
practice ``[b]ased on the medical records from Dr. Vora and his history 
he gave me.'' Id.
    Respondent offered testimony to the same effect with respect to the 
three prescriptions he issued to BCI 1 at the March 19, 2015 visit, 
testifying that he believed that he wrote the prescriptions ``in good 
faith'' and ``[b]ased on Dr. Vora's history, what he told me.'' Id. at 
698-99. While Respondent again admitted that the Soma prescription was 
a mistake, he testified that he ``wrote it under good faith,'' that ``I 
wasn't trying to write something that was illegal,'' and that ``I 
wasn't trying to have somebody get something that . . . they shouldn't 
have gotten.'' Id. at 699.
    Finally, Respondent testified that both the Norco and Soma 
prescriptions he issued to BCI 2 were for a legitimate medical purpose, 
and within both the usual course of professional practice and the 
Michigan Standard of Practice. Id. at 699-700.

Discussion

    Section 303(f) of the Controlled Substances Act (CSA) provides that 
``[t]he Attorney General may deny an application for [a practitioner's] 
registration . . . if the Attorney General determines that the issuance 
of such registration . . . would be inconsistent with the public 
interest.'' 21 U.S.C. 823(f). With respect to a practitioner, the Act 
requires the consideration of the

[[Page 18904]]

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.
    ``[T]hese factors are . . . considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that ``I 
may rely on any one or a combination of factors, and may give each 
factor the weight [I] deem [ ] appropriate in determining whether . . . 
an application for registration [should be] denied.'' Paul H. Volkman, 
73 FR 30630, 30641 (2008) (citing id.), pet. for rev. denied, Volkman 
v. DEA, 567 F.3d 215, 222 (6th Cir. 2009); see also MacKay v. DEA, 664 
F.3d 808, 816 (10th Cir. 2011); Hoxie v. DEA, 419 F.3d 477, 482 (6th 
Cir. 2005). Moreover, while I am required to consider each of the 
factors, I ``need not make explicit findings as to each one.'' MacKay, 
664 F.3d at 816 (quoting Volkman, 567 F.3d at 222 (quoting Hoxie, 419 
F.3d at 482)).\29\
---------------------------------------------------------------------------

    \29\ In short, this is not a contest in which score is kept; the 
Agency is not required to mechanically count up the factors and 
determine how many favor the Government and how many favor the 
registrant. Rather, it is an inquiry which focuses on protecting the 
public interest; what matters is the seriousness of the registrant's 
misconduct. Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, 
as the Tenth Circuit has recognized, findings under a single factor 
can support the revocation of a registration or the denial of an 
application. MacKay, 664 F.3d at 821.
---------------------------------------------------------------------------

    The Government has the burden of proving, by a preponderance of the 
evidence, that the requirements for denial of an application pursuant 
to 21 U.S.C. 823(f) are met. 21 CFR 1301.44(d). However, once the 
Government has made a prima facie showing that issuing a new 
registration to the applicant would be inconsistent with the public 
interest, an applicant must then present sufficient mitigating evidence 
to show why he can be entrusted with a new registration. Medicine 
Shoppe-Jonesborough, 73 FR 364, 387 (2008) (citing cases), pet. for 
rev. denied, 300 Fed. Appx. 409 (6th. Cir. 2008); see also MacKay, 664 
F.3d at 817.
    Having considered all of the factors, I find that the Government's 
evidence with respect to Factors Two and Four satisfies its prima facie 
burden of showing that granting Respondent's application would be 
inconsistent with the public interest.\30\ I further find that 
Respondent has failed to produce sufficient evidence to rebut the 
Government's prima facie case.
---------------------------------------------------------------------------

    \30\ As to Factor One, while on December 13, 2016, the Michigan 
Board imposed a summary suspension of Respondent's medical license, 
on February 16, 2017, the Board entered into a Consent Order and 
Stipulation which dissolved the summary suspension while limiting 
Respondent's authority to ``obtain, possess, prescribe, dispense or 
administer any . . . controlled substance . . . except in a hospital 
or other institutional setting.'' However, while Respondent does 
possess limited state authority as required to be registered under 
21 U.S.C. 823(f), the Board has not made a recommendation to the 
Agency in this matter. Moreover, as the Agency has long held, this 
partial restoration of Respondent's state authority is not 
dispositive of the public interest inquiry. See Mortimer Levin, 57 
FR 8680, 8681 (1992) (``[T]he Controlled Substances Act requires 
that the Administrator . . . make an independent determination [from 
that made by state officials] as to whether the granting of 
controlled substance privileges would be in the public interest.''). 
See also 21 U.S.C. 802(21) (defining ``the term `practitioner' [to] 
mean[ ] a . . . physician . . . or other person licensed, registered 
or otherwise permitted, by . . . the jurisdiction in which he 
practices . . . to distribute, dispense, [or] administer . . . a 
controlled substance in the course of professional practice'').
     To be sure, the Agency's case law contains some older decisions 
which can be read as giving more than nominal weight in the public 
interest determination to a State Board's decision (not involving a 
recommendation to DEA) either restoring or maintaining a 
practitioner's state authority to dispense controlled substances. 
See, e.g., Gregory D. Owens, 67 FR 50461, 50463 (2002) (expressing 
agreement with ALJ's conclusion that the board's placing dentist on 
probation instead of suspending or limiting his controlled substance 
authority ``reflects favorably upon [his] retaining his . . . 
[r]egistration, and upon DEA's granting of [his] pending renewal 
application''); Vincent J. Scolaro, 67 FR 42060, 42065 (2002) 
(concurring with ALJ's ``conclusion that'' state board's 
reinstatement of medical license ``with restrictions'' established 
that ``[b]oard implicitly agrees that the [r]espondent is ready to 
maintain a DEA registration upon the terms set forth in'' its 
order).
     Of note, these cases cannot be squared with the Agency's 
longstanding holding that ``[t]he Controlled Substances Act requires 
that the Administrator . . . make an independent determination [from 
that made by state officials] as to whether the granting of 
controlled substance privileges would be in the public interest.'' 
Levin, 57 FR at 8681. Indeed, neither of these cases even 
acknowledged the existence of Levin, let alone attempted to 
reconcile the weight it gave the state board's action with Levin. 
While in other cases, the Agency has given some weight to a Board's 
action in allowing a practitioner to retain his state authority even 
in the absence of an express recommendation, see Tyson Quy, 78 FR 
47412, 47417 (2013), the Agency has repeatedly held that a 
practitioner's retention of his/her state authority is not 
dispositive of the public interest inquiry. See, e.g., Paul Weir 
Battershell, 76 FR 44359, 44366 (2011) (citing Edmund Chein, 72 FR 
6580, 6590 (2007), pet. for rev. denied, Chein v. DEA, 533 F.3d 828 
(D.C. Cir. 2008)).
     As 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.
     As for Factor Five, the Government made no allegations that 
implicate Factor Five. Nor did it claim that Respondent's false 
testimony on certain issues implicates Factor Five.
---------------------------------------------------------------------------

Factors Two and Four--Respondent's Experience in Dispensing Controlled 
Substances and Record of Compliance With Applicable Controlled 
Substance Laws

    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 . . . .'').\31\
---------------------------------------------------------------------------

    \31\ As the CALJ noted, the Government did not cite this 
provision in the Show Cause Order or in its post-hearing brief. 
R.D., at 73-74. I find, however, that this provision imposes the 
same standard as 21 CFR 1306.04(a).
---------------------------------------------------------------------------

    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

[[Page 18905]]

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'').\32\
---------------------------------------------------------------------------

    \32\ 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).
---------------------------------------------------------------------------

    The CALJ found that Respondent violated 21 CFR 1306.04(a) with 
respect to each of the prescriptions issued to both investigators. I 
agree. Even considering the evidence that Respondent practiced at the 
clinic on a locum tenens basis and that both investigators had 
previously been seen by other physicians at the clinic, who documented 
findings in the medical records that, in some respects, tended to 
support the diagnosis of conditions that may justify the prescribing of 
controlled substances, I nonetheless conclude that the weight of the 
evidence supports the conclusion that Respondent lacked a legitimate 
medical purpose and acted outside of the usual course of professional 
practice when he issued the prescriptions. 21 CFR 1306.04(a).

BCI 1's Prescriptions

    With respect to BCI 1's first visit, the CALJ credited Dr. 
Christensen's testimony that the combination of drugs that Respondent 
prescribed (Norco, Xanax and carisoprodol), otherwise known as the Holy 
Trinity, has both a very high abuse potential because of its 
``euphoric'' effects and creates a high risk of ``respiratory 
depression,'' especially in a patient who admits to drinking alcohol. 
Tr. 397-98. The CALJ also credited Dr. Christensen's testimony that, 
under the standard of care, the Investigator's admission of alcohol use 
required Respondent to not prescribe the Xanax.\33\ Tr. 395-96. While 
Respondent agreed with Dr. Christensen's testimony that prescribing 
Xanax is medically appropriate to prevent delirium tremens, a condition 
caused by withdrawal from alcohol, and testified that he was simply 
following Dr. Vora's plan, which he believed involved prescribing Xanax 
to both treat the Investigator's anxiety and to prevent DTs, Respondent 
admitted that he never asked Dr. Vora if he was prescribing Xanax for 
the latter purpose. Id. at 692.
---------------------------------------------------------------------------

    \33\ Dr. Christensen also testified that a physician in primary 
care should refer a patient who admits to alcohol use to an 
addiction specialist or counselor. Tr. 396. Dr. Christensen did not, 
however, testify as to whether the standard of care would require a 
pain management specialist to refer the patient, and, in any event, 
it is unclear whether Respondent should be treated as a primary care 
physician or as a pain management specialist.
---------------------------------------------------------------------------

    Moreover, even though Dr. Vora's progress notes list a diagnosis of 
anxiety, and Dr. Christensen testified that a physician can trust the 
medical documentation of another physician if

[[Page 18906]]

``the elements of a diagnosis are met,'' he did not agree ``with any 
diagnosis of anxiety.'' Id. at 516-17. Dr. Christensen also testified 
that BCI 1's statement that he ``take[s] Xanax on the weekends . . . 
does not appear to be [that of] someone who's complaining about an 
anxiety diagnosis who's being prescribed Xanax for a documented anxiety 
disorder.'' Id. at 379. And Dr. Christensen testified that if there was 
a diagnosis of anxiety disorder, ``a reasonable practitioner . . . 
would want to know'' what treatments had been tried. Id. at 381. 
However, Respondent made no such inquiry.
    As for Respondent's prescribing of carisoprodol at the first visit, 
a muscle relaxant which is also a schedule IV drug with sedative 
effects and Respondent's statements that he was going to prescribe this 
drug for muscle spasms, Dr. Christensen testified that muscle spasms 
would be diagnosed by palpating the patient but that he did not see 
evidence that Respondent had done so. Tr. 399. By contrast, Respondent, 
in addition to asserting that he interpreted BCI 1's statements that 
his back was stiff with the presence of muscle spasms, also testified 
that he lifted up BCI 1's shirt and palpated his back at this visit. 
Id. at 659. However, BCI 1 testified that neither he nor Respondent 
lifted up the clothing that he was wearing and Respondent never 
palpated his back. Id. at 175. Yet Respondent documented in the visit 
note a physical exam finding of ``[m]oderate point tenderness to low 
back.'' GX 10, at 31. Moreover, Respondent, at another point in his 
testimony, explained that he prescribed carisoprodol because Dr. Vora 
had previously prescribed Baclofen, a non-controlled muscle relaxant to 
BCI 1. Tr. 665. He also testified that the prescription was a 
``mistake.'' Id.
    Dr. Christensen opined that the Soma prescription was ``not 
appropriate.'' Id. at 420. He explained that the drug is ``indicated 
for short-term treatment of muscle spasms,'' but that ``there is no 
documentation of this'' condition. Id. Dr. Christensen further 
explained that Soma was ``contraindicated with this patient's 
history.'' Id.
    Notably, the CALJ found BCI 1's testimony ``fully credible'' as to 
all issues. R.D. 14 By contrast, the CALJ found Respondent's testimony 
on the issue of why he prescribed the carisoprodol, to be ``not just a 
little confusing'' and ``not convincing.'' Id. at 54. Based on the 
CALJ's credibility findings, I find that Respondent's testimony that he 
lifted up BCI's clothing and palpated BCI 1's back was false, that 
Respondent had no basis for documenting in the visit note a finding of 
moderate point tenderness, and that Respondent falsified BCI 1's 
medical record.
    Thus, notwithstanding that BCI 1's records showed that Dr. Vora had 
diagnosed him with muscle spasms and the somewhat ambiguous statements 
made by BCI 1 as to his condition, I conclude that the weight of the 
evidence supports the conclusion that Respondent acted outside of the 
usual course of professional practice and lacked a legitimate purpose 
when he prescribed carisoprodol to BCI 1. 21 CFR 1306.04(a). While Dr. 
Christensen testified that a physical exam is not required at a follow-
up visit and a subsequent physician can rely on a diagnosis of another 
physician if there is evidence that a pertinent examination had 
previously been performed, I reject Respondent's defense that he 
reasonably relied on the examinations as documented by Dr. Vora and 
that while ``we now know'' that Dr. Vora's records ``were largely 
false, Respondent had no indication that this was the case.'' See 
Resp.'s Post-Hrng. Br. 30.
    First, as found above, BCI 1 told Respondent that he had asked Dr. 
Vora for a couple of extra pills, and based on the statements 
Respondent made regarding the quantity of the prescriptions (66 pills 
for both Norco and Xanax) written by Vora, I find that Respondent 
clearly knew that Vora had given extra pills to BCI 1, thus calling 
into question the legitimacy of Vora's prescribing as well as his 
recordkeeping. Moreover, Respondent falsified the visit note to 
indicate a finding of moderate point tenderness, and in this 
proceeding, he falsely testified that he lifted up BCI 1's clothing and 
palpated his back. Unexplained by Respondent is why, if he reasonably 
relied on Vora's records and had ``no indication'' that they ``were 
largely false,'' he proceeded to create his own set of false physical 
exam findings and gave false testimony at the hearing. Indeed, 
Respondent's testimony and his falsification of BCI 1's visit note 
support the conclusion that Respondent did not merely make a mistake 
when he prescribed carisoprodol but that he knowingly diverted 
controlled substances when he prescribed the drug (as well as 
alprazolam and Norco) to BCI 1. 21 CFR 1306.04(a).
    As for the Norco prescription, Dr. Christensen noted that on his 
initial intake form, BCI 1 had listed ``refills'' as his reason for 
visit and that on the medical history form, BCI 1 did not check off any 
symptom listed on the form, let alone those that are relevant in 
assessing lower back pain. Tr. 410; see also GX 10, at 17, 19. He 
further explained that the standard of care required that Respondent 
obtain a family history of psychiatric and substance abuse disorders to 
rule out substance abuse as the reason BCI 1 was seeking medication. 
Id. at 413. While Dr. Christensen acknowledged that BCI 1 had been seen 
by Dr. Vora, he testified that if the medical record is incomplete, a 
subsequent physician must obtain the missing history which is relevant 
to the patient's complaint, especially if the treatment plan involves 
controlled substances. Id. at 411-12. See also id. at 489 (``the first 
thing you should do is take a history'' that is relevant to the 
complaint). Dr. Christensen also testified as to the various items, 
which under the standard of care in Michigan, should be addressed in 
taking a pain patient's history, including addressing the onset of the 
pain, the duration of the pain, factors that aggravate or relieve the 
pain, what brings the pain on, the severity of the pain, and how the 
pain affects the patient's function. Id. at 374.
    Notably, the visit notes created by Dr. Vora contained no 
discussion of these issues other than to note that the onset date of 
BCI 1's back pain was 12/15/2014. See GX 10, at 1 (Jan. 12, 2015 note); 
id. at 3 (Dec. 15, 2014 note); see also id. at 5 (Nov. 10, 2014 note 
which lists back pain and back stiffness as patient's complaint but no 
other information). Moreover, while Respondent proceeded to ask BCI 1 
as to how long he had back pain, whether he got muscle spasms with the 
pain, whether he walked with a limp, whether he had any loss of muscle 
strength, and whether the pain shot anywhere or was just localized, 
even when BCI 1's answers were ambiguous, Respondent accepted them with 
no further questioning. He did not ask questions that would clarify 
whether BCI 1's purported pain was caused by an injury, question BCI 1 
about any prior treatments he received, nor clarify what BCI 1 meant 
when he said he was mostly just stiff. And while Respondent asked BCI 1 
if he smoked, used marijuana, and was a social drinker, even after BCI 
1 replied that he took Xanax to keep from drinking too much on the 
weekends, Respondent asked no further questions to determine the extent 
of Respondent's alcohol use.
    As for Respondent's physical exam, it is acknowledged that Dr. 
Vora's visit note for BCI 1's December 15, 2014 visit documented the 
performance of a physical exam and that Dr. Christensen acknowledged 
that this would be an appropriate exam on a follow-up visit.\34\

[[Page 18907]]

However, even assuming that the findings documented in the December 
2014 visit note establish that Dr. Vora performed an appropriate 
physical exam, as well as acknowledging that a physical exam is not 
necessarily required at a follow-up visit and that a subsequent 
physician can rely on the medical record absent some indication that 
the record is not truthful, Respondent nonetheless documented various 
findings of a physical exam when the evidence shows he did not perform 
the tests necessary to make those findings. These include not only his 
finding of moderate point tenderness as well as his findings that BCI 
1's cranial nerves IV-XII were intact. Compare GX 10, at 31, with Tr. 
416 (testimony of Dr. Christensen noting no evidence of palpation of 
BCI 1's lower back) and id. at 417-19 (testimony of Dr. Christensen 
noting no evidence of testing of BCI 1's cranial nerves).
---------------------------------------------------------------------------

    \34\ As found above, Dr. Vora made no physical exam findings 
pertinent to BCI 1's complaint of back pain at his first visit (Nov. 
2014), and Dr. Christensen was not asked if the findings made by Dr. 
Vora in the December 2014 visit establish that an appropriate 
physical exam was performed as part of the initial evaluation of BCI 
1's complaint. For purposes of this discussion, I assume, without 
deciding, that the December 2014 physical exam findings establish 
that Dr. Vora performed an appropriate exam, whether the visit is 
viewed as an initial evaluation or a follow-up.
     I also assume, without deciding, that at the time he commenced 
his February 2015 locum tenens service at Dr. Vora's clinic and 
prior to his interaction with BCI 1, Respondent did not have 
sufficient information to conclude that Dr. Vora was not engaging in 
the legitimate practice of medicine. See Tr. 532 (testimony of Dr. 
Christensen that it was reasonable to trust Dr. Vora's documentation 
absent an indication that the records were not truthful).
---------------------------------------------------------------------------

    Moreover, even as to the tests Respondent did perform, Dr. 
Christensen's testimony suggests that Respondent was just going through 
the motions, as the arm abduction/adduction test he did do is not used 
to assess lower back pain but rather nerve issues in the thoracic and 
cervical spine. Id. at 386. Indeed, while Respondent asserted that his 
purpose in doing this test was to establish if BCI 1 had ``referred 
pain,'' id. at 661, he did not ask BCI 1 if it caused pain, and BCI 1 
did not complain that it caused pain at either visit. GX 3, at 9; GX 5, 
at 4.
    Thus, Respondent did not simply rely on Dr. Vora's physical exam 
findings but deemed it necessary to document his own false findings to 
support his decision to prescribe Norco to BCI 1. Respondent also gave 
false testimony when he asserted that he had actually palpated BCI 1. 
Moreover, the statements made at various points in his interaction with 
BCI 1 show that Respondent knew that BCI 1 was not a legitimate pain 
patient. These include:

    BCI 1's statement that he took Xanax because it kept him from 
drinking too much moonshine on the weekends;
    BCI 1's statement that the drugs he was getting from Respondent 
were ``worth a lot of money on the street'' and Respondent's 
explanation that this is because the drugs are ``pure'' and ``there 
is nothing cut down about them. So when you're selling them'' 
followed by BCI 1's statement that ``it's a little safer to do it 
that way'' and Respondent's acknowledgement that this was ``right''; 
\35\
---------------------------------------------------------------------------

    \35\ As for his statement that the prescriptions he was giving 
BCI 1 ``would be like 6 or 7 hundred dollars,'' Respondent initially 
testified that ``it was an inappropriate conversation'' but that he 
was ``trying to relate to the patient,'' only for him to claim that 
he ``wasn't telling him to sell the drugs'' and that he was trying 
to convey that it was ``the pharmaceutical companies'' that were 
``getting rich off the patients like himself.'' However, even were I 
to credit Respondent's latter explanation that he discussed the high 
prices of drugs as being caused by the drug companies making lots of 
money, his subsequent explanation to BCI 1 that the reason the drugs 
were worth a lot of money is because ``[t]hey're pure'' and ``there 
is nothing cut down about them,'' leaves no doubt that Respondent 
understood that BCI 1 was not a legitimate patient.
---------------------------------------------------------------------------

    BCI 1's statements that ``a couple of times'' he had ``r[u]n out 
of pills'' and had to ``trade with [his] neighbor,'' as well as his 
statement that he asked Dr. Vora ``for a couple extra'' pills which 
he gave back to his neighbor; \36\

    \36\ Of further note, while BCI 1 entered into a Controlled 
Substances Management Agreement, which prohibited him from sharing, 
selling or trading his medication, and Dr. Christensen testified 
that ``at a minimum,'' a reasonable practitioner would tell the 
patient that this is illegal and that if this was to happen again, 
the physician ``would not be able to prescribe'' any more controlled 
substances. Tr. 403, 406.
---------------------------------------------------------------------------

and after Respondent asked BCI 1 ``but 66'' [the quantity of Dr. 
Vora's previous Norco prescription] what's that about?''; BCI 1's 
statement that ``I can't be paying--buying them on the street.''

    As further evidence that Respondent knew that BCI 1 was likely 
engaged in either abuse or diversion of controlled substances, BCI 1's 
MAPS report \37\ showed that he had obtained alprazolam from four 
different prescribers, including prescribers whose offices were in 
Detroit and Marquette, 400 miles apart. GX 10, at 23. Notably, while 
Respondent testified that on his first day at the clinic, he did not 
have access to urine drug screen reports, he also testified that he 
would request and the staff ``would give'' him ``printouts of the 
charts''; he also testified that ``I had at the very least to have the 
MAPS.'' Tr. 638. At no point did Respondent deny that he had received 
BCI 1's MAPS report at the time of the first visit, nor did he offer 
testimony that he did not review BCI 1's MAPS report. As Dr. 
Christensen explained, the ``high geographic distance between [the] 
providers'' and the ``multiple providers'' listed on BCI 1's MAPS 
report are ``signs of doctor shopping'' and ``diversion or misuse.'' 
Id. at 414.
---------------------------------------------------------------------------

    \37\ The report was dated October 29, 2014. GX 10, at 23.
---------------------------------------------------------------------------

    Dr. Christensen opined that based on his review of the video, the 
transcript, and BCI 1's medical file, Respondent's issuance of the 
Norco prescription was inappropriate because ``[t]here was no 
documentation of moderate to moderately severe pain.'' Id. at 419-20. 
Dr. Christensen also explained that the evidence created ``concern 
about another underlying diagnosis,'' i.e., substance abuse, ``that 
would have mandated either a referral or not writing the [Norco] 
prescription.'' Id.
    Dr. Christensen thus opined, and the CALJ agreed, that none of the 
three prescriptions Respondent wrote for BCI 1 on February 19, 2015 
were issued for a legitimate medical purpose by a practitioner acting 
in the usual course of his professional practice. Tr. 425-26. I agree.
    As for BCI 1's second visit, as Dr. Christensen noted, when 
Respondent asked about his pain level, the former replied that 
``everything is cool.'' Tr. 428. Dr. Christensen also noted that when 
Respondent then asked BCI 1 to rate his pain on a 1-10 scale, BCI 1 
simply replied: ``I'm good today.'' Id. Dr. Christensen testified that 
these were ``non-responsive'' and ``evasive answer[s], which can be 
signs of drug-seeking behavior.'' Id. at 430-31.\38\
---------------------------------------------------------------------------

    \38\ I have considered Respondent's testimony that he 
interpreted BCI 1's answer to his question, ``[s]o how is everything 
going with your pain'' (``great, yup, everything is cool''), as 
meaning ``that the regimen or the plan of his management was 
working.'' Tr. 674. I have also considered Respondent's testimony 
that he interpreted BCI 1's answer--when asked to rate his pain on a 
scale of one to ten--of ``I am good today,'' as ``pain waxes and 
wanes'' and ``[t]his might be just a time when he comes into the 
office [and] he might have just taken his medication.'' Id. at 676.
     Even were I to consider this testimony without regard to the 
CALJ's findings that Respondent's testimony was generally not 
credible, which I decline to do, Respondent did not ask any further 
questions to probe why BCI 1 answered his questions as he did, nor 
ask BCI 1 when he last took his medication. Also, as Dr. Christensen 
testified, Respondent did not engage in anything close to a 
meaningful assessment of how the pain affected BCI 1's level of 
function, whether there were side effects, or ask about aberrant 
behavior. I thus find Respondent's testimony on these issues not 
credible.
     Respondent also explained that the reasons he made various 
comments to BCI 1 was because he felt the latter's comments to him 
were racially motivated and created a situation where he had to work 
to gain BCI1's trust. Tr. 658. He also testified that he encountered 
racial animus from several other patients. Id. The CALJ rejected 
Respondent's contention, noting that ``[t]here was no evidence of 
any tension in any of the three office visits in the video 
recordings or the transcripts'' and that this does not excuse his 
violations of federal law. R.D. at 84-85. I agree.
---------------------------------------------------------------------------

    Dr. Christensen further explained that a reasonable practitioner 
would have asked BCI 1 about his function level,

[[Page 18908]]

side effects of the medication, and inquired about any aberrant 
behaviors. Id. at 429. Yet none of this was done. Moreover, the entire 
interaction between BCI 1 and Respondent lasted less than two minutes, 
and while a physical exam is not necessarily required on a follow-up 
visit, Respondent nonetheless performed an exam. Significantly, his 
examination was limited to having BCI 1 walk back and forth and 
performing the arm abduction/adduction test, which as previously 
explained, tests for nerve damage in the thoracic and cervical spine 
and not nerve damage in the lower back. As Dr. Christensen explained, 
the examination was not adequate to support medical decision making and 
that this ``was a negative evaluation for moderate to moderately severe 
pain.'' Id. at 431, 429.
    Also, as Dr. Christensen explained, Respondent again falsified the 
visit note by documenting physical exam findings when he did not 
perform the tests necessary to make those findings. Id. at 433-35. Dr. 
Christensen specifically identified the findings of ``moderate point 
tenderness to low back,'' ``cranial nerves 2 through 12 intact,'' ``2+ 
pulses throughout,'' and ``2/2 reflexes'' as not supported by tests, 
and he further explained that there were no findings to support the 
diagnoses of degenerative disc disease in the lumbar area, anxiety, and 
muscle spasm. Id. at 447.
    While Respondent testified that he palpated BCI 1's back, here 
again, BCI 1 credibly testified that he did not do so. Moreover, as for 
Respondent's testimony that ``you can indirectly evaluate the cranial 
nerves'' by looking for facial palsy and if ``speech patterns [are] 
similar to somebody who is deaf,'' id. at 678-79, Dr. Christensen 
testified that an examination of a patient's cranial nerves is far more 
extensive than what Respondent claim is required. See id. at 417-19. As 
for Respondent's claim that he assessed BCI 1's radial pulse when he 
performed the arm abduction/adduction test by pinching his wrist, Dr. 
Christensen testified that a finding of ``2+ pulses throughout'' also 
requires testing of the pulse in the lower extremities. Id. at 434-35. 
There is, however, no evidence that Respondent touched BCI 1's lower 
extremities. While Respondent also documented findings of ``2/2 
reflexes'' and ``Full RoM,'' Respondent offered no testimony as to how 
he accomplished the tests necessary to make these findings and the 
video provides no evidence that he did so. Thus, the evidence shows 
that Respondent again falsified BCI 1's medical record when he 
documented findings that would support prescribing Norco and 
carisoprodol. Moreover, there are no findings in the March 19 (or the 
February 19) visit note that support a diagnosis of anxiety and the 
prescribing of alprazolam.
    Accordingly, based on the medical record, the video and transcript 
of the visit, Dr. Christensen's testimony, and the inferences to be 
drawn from Respondent's false testimony, I conclude that Respondent 
lacked a legitimate medical purpose and acted outside of the usual 
course of professional practice when he issued each of the three March 
19, 2015 prescriptions to BCI 1. 21 CFR 1306.04(a).

BCI 2's Prescriptions

    The CALJ also concluded that Respondent violated 21 CFR 1306.04(a) 
when he issued the Norco and Carisoprodol prescriptions to BCI 2. R.D. 
84. I agree.
    As found above, in responding to Respondent's instruction to tell 
him how she was doing and how she was feeling, BCI 2 stated that she 
was ``[j]ust here for refills,'' that she was ``feel[ing] great 
today,'' and ``actually,'' she had ``been doing really good'' and 
``ha[d] no complaints.'' GX 7, at 2. Dr. Christensen testified that the 
statement that she had ``no complaints'' did ``not mean anything'' and 
that Respondent did not determine whether BCI 2 had ``been taking the 
medication and if the medication is the reason . . . for how she 
feels.'' Tr. 450. According to Dr. Christensen's unrefuted testimony, 
under the standard of care, Respondent was required to follow-up this 
exchange by asking BCI 2 if she had ``been taking the medications,'' as 
well as by asking about her ``pain level, activity level, side 
effects,'' and inquire as to whether she was engaged in any aberrant 
behavior. Id.
    Dr. Christensen noted that BCI 2 denied that she had muscle spasms 
and when asked ``when does it hurt the most,'' her answer was that 
``sometimes'' when she was asleep and her alarm went off, she would 
twist to turn off her alarm and screw her back up, but that this had 
not ``happened in a very long time'' and she had ``been doing really 
well.'' Tr. 454. Dr. Christensen testified that this discussion did not 
support a finding ``of a moderate or higher pain level'' and that a 
reasonable practitioner would ask a patient who said she was not having 
pain if she was taking her medication and evaluate based on her answer. 
Id. at 454-55.
    Dr. Christensen noted that while BCI 2's records listed a complaint 
of lower back pain, she did not check any of the symptoms of muscle, 
joint or bone pain listed on the Medical History Form. Id. at 456; see 
also GX 11, at 10. He also observed that, on this form, she had listed 
Norco, Ambien, and Xanax as her current medications. He then explained 
that Norco and Xanax is a potentially dangerous combination and that 
Ambien causes side effects and creates risks similar to 
benzodiazepines, that this combination of drugs raises the concern as 
to why it ``is being prescribed or taken,'' and if ``there was a 
legitimate diagnosis for'' the prescriptions. Tr. 457-58.
    With respect to the pain clinic history questionnaire, Dr. 
Christensen noted that BCI 2 had listed her pain level as ranging from 
``0 to 4,'' but did not circle such items as its location, what made 
her pain worse, how the pain made her feel, and whether pain levels she 
listed were with or without medication. Id. at 461-62; see GX 11, at 
23. He further observed that while BCI 2 indicated on the form that she 
used alcohol, she did not provide any information as to the extent of 
her drinking. Id. at 462; GX 11, at 24. He then explained that, under 
the standard of care, Respondent was required to obtain this 
information because the amount of her drinking could increase the side 
effects and risks from the combination of drugs she was prescribed. Id. 
Notably, Respondent did not ask BCI 2 any question about her use of 
alcohol.
    Dr. Christensen further observed that Respondent documented various 
findings in the progress note even though the video evidence shows that 
he had no basis to do so. Specifically, Respondent made a finding of 
``point tenderness to right lower back,'' notwithstanding that he never 
palpated BCI 2. Tr. 464-65; GX 11, at 35. Dr. Christensen further noted 
that BCI 2 ``said she was good and she was great and there was no 
problem.'' Tr. 464.
    As for Respondent's finding that the pain ``shoots to left hip,'' 
Dr. Christensen testified that BCI 2 did not complain that her pain 
radiated or shot to her left hip, and, in fact, when BCI 2 was asked 
``to point to where it is,'' she pointed to her right hip area. Id. at 
465, 285, 572. Indeed, BCI 2 said that ``it just stays there.'' GX 7, 
at 3. As for Respondent's finding of ``Full Rom,'' while Dr. 
Christensen acknowledged that he performed the abduction/adduction test 
on BCI 2's arms, he did not perform any other range of motion testing. 
Tr. 465. Dr. Christensen also noted that Respondent did not perform the 
tests necessary to make his findings of ``CN II-XII intact,'' ``2+ 
pulses

[[Page 18909]]

throughout,'' \39\ and ``2/2 reflexes.'' Id. at 465-66. He further 
observed that while Respondent diagnosed BCI 2 as having muscle spasms, 
he did not palpate her and she specifically denied having spasms; he 
also noted that there was no documentation for his diagnosis of 
``abnormal gait periodically,'' and BCI 2 denied that the pain caused 
her to limp. Id. at 467; GX 7, at 3-4.
---------------------------------------------------------------------------

    \39\ For the same reasons that I rejected Respondent's testimony 
that he made this finding with respect to BCI 1 based on the arm 
abduction/adduction tests he performed, I reject it with respect to 
BCI 2 as well.
---------------------------------------------------------------------------

    As found above, on January 23, 2015, Dr. R. had issued BCI 2 
prescriptions for 30-day quantities of both Xanax and Ambien, with each 
prescription providing for four refills. Thus, when Respondent 
prescribed Norco and carisoprodol to BCI 2, she had current 
prescriptions for four different controlled substances. As Dr. 
Christensen explained, this combination of sedatives is ``a highly 
addictive and dangerous combination.'' Tr. 474.
    Respondent justified his prescribing, maintaining that he reviewed 
the medical records created by Dr. Vora and Dr. R., including the 
latter's ``physical and . . . what she gave the patient.'' Id. at 681. 
However, in the January 23, 2015 visit note, Dr. R. indicated that she 
was issuing both Ambien and Xanax prescriptions, each of which provided 
for four refills. Moreover, the prescriptions were in the file, each 
clearly indicated that four refills were authorized, and, in contrast 
to his testimony that the medical files did not contain the UDS 
results, Respondent made no claim that the prescriptions were not in 
the files.
    Moreover, while Dr. Christensen testified that that Dr. R.'s 
documentation of her January 23, 2015 examination reflected an 
appropriate examination based on BCI 2's complaint of lower back pain 
(as documented on her chart), notably, at BCI 2's Feb. 19 visit (which 
immediately preceded her visit with Respondent), Dr. R. had reduced the 
Norco prescription from 60 dosage units to five dosage units (a five-
day supply), doing what Dr. Christensen explained was ``a planned 
taper.'' Tr. 577; see also GX 11, at 30. Yet Respondent increased BCI 
2's Norco prescription back up to 60 dosage units even though BCI 2 
never once claimed that she was currently in pain and, indeed, made 
statements that she was ``feel[ing] great,'' that she had ``been doing 
really good'' and ``ha[d] no complaints,'' that ``like right now I have 
like nothing. I feel good. I have good days and bad,'' and even when 
she identified when it hurt her the most, she added: ``But I haven't 
had that happen in a very long time like literally I have been really 
doing well.''
    Although Dr. Christensen acknowledged that these statements could 
be an indication that BCI 2's condition was well managed with her 
medication, he explained that it was not reasonable for Respondent to 
conclude that her medication regimen was appropriate given that 
Respondent did not ask her if she was taking her medication and how 
much medication she was taking. Tr. 563-64. Moreover, while Respondent 
testified that he had reviewed what Dr. R. had prescribed to BCI 2, he 
did not issue the same prescriptions but rather increased her Norco 
prescription back up to 60 dosage units.
    As Dr. Christensen explained, while there was some discussion 
between Respondent and BCI 2 as to why he had decreased the 
carisoprodol prescription, there was no discussion between the two as 
to why he increased the Norco prescription. Id. at 576. Notably, Dr. 
Christensen explained that the standard of care in Michigan includes 
``the principle of informed consent,'' which requires a physician to 
explain why the physician is ``making a major change'' in a patient's 
controlled medications and the risks involved. Id. at 577. He testified 
that while Respondent's decision to decrease BCI 2's carisoprodol 
prescription was reasonable, it was ``not a rational therapeutic 
choice'' to increase her Norco ``to maintain the analgesic effect'' of 
her carisoprodol. Id. at 580. Indeed, he testified that BCI 2 should 
have been on ``neither'' drug. Id. at 580-81.
    As for why he increased BCI 2's Norco prescription, Respondent 
testified that he was aware that Dr. R. had previously reduced it to 
five dosage units, but that he ``wanted to make sure her pain was under 
control.'' Id. at 685. However, as found above, BCI 2 generally denied 
having pain and certainly denied having had recent pain. Moreover, 
Respondent did not ask her if she was even taking the medications that 
Dr. R. had prescribed, let alone assess how her pain affected her 
ability to function, whether she had side effects from the medications, 
and whether she was engaged in any aberrant behavior.\40\
---------------------------------------------------------------------------

    \40\ As found above, Respondent claimed that he was denied 
access to the urine drug screens at both visits, and thus, this 
means of determining if the patients were engaged in aberrant 
behavior was unavailable. Asked why he nonetheless prescribed 30-day 
quantities of narcotics such as hydrocodone, Respondent testified 
that ``you can never just have the patient go cold turkey for any 
type of narcotic'' and ``if the patient runs out, they [sic] go into 
withdrawals [sic].'' Tr. 693-94. Yet BCI 2 had been already tapered 
off of Norco by Dr. R.
---------------------------------------------------------------------------

    Dr. Christensen opined that Respondent lacked a legitimate medical 
purpose and acted outside of the usual course of professional practice 
in issuing the Norco and carisoprodol prescriptions to BCI 2. I agree. 
Based on Dr. Christensen's testimony that Respondent's evaluation was 
totally inadequate, his testimony that increasing the Norco 
prescription was not a rational therapeutic choice, that the 
combinations of drugs prescribed to BCI 2 was highly addictive and 
dangerous, and Respondent's falsification of the visit note to reflect 
various findings to support the prescribing of controlled substances 
when he failed to perform the necessary tests and BCI 2 made no 
complaint of pain, I conclude that the record as a whole supports the 
conclusion that Respondent did not simply engage in malpractice, but 
knowingly issued the prescriptions in violation of 21 CFR 1306.04(a).

Issuance of Prescriptions That Did Not Include the Patient's Address

    In addition to the violations of the CSA's prescription 
requirement, the record supports a finding that Respondent violated 21 
CFR 1306.05(a) when he failed to include the patient's address on each 
of the eight prescriptions at issue in this matter. Under this 
regulation, ``[a]ll prescriptions for controlled substances . . . shall 
bear the full name and address of the patient.'' Id. Sec.  1306.05(a). 
This regulation further provides that ``the prescribing practitioner is 
responsible in case the prescription does not conform in all essential 
respects to the law and regulations.'' Id. Sec.  1306.05(f). As found 
above, Respondent failed to include the patient's address on each of 
the eight prescriptions he issued to BCI 1 and BCI 2 and thus violated 
section 1306.05(a) as well.

Summary of Factors Two and Four

    As for Respondent's evidence of his experience as a dispenser of 
controlled substances, it includes the testimony of Dr. Scott that, 
pursuant to the order of the Michigan Board, she had supervised 
Respondent beginning around April 2014 for a period of one year, that 
she reviewed about 10 of his pain clinic patient charts, and that she 
``did not have any problems with'' them. Tr. 605, 610. Dr. Scott's 
testimony does not, however, refute the proof of the specific 
violations found above. Moreover, Dr. Scott's testimony suggests that 
the prescribing violations which have been proven on the record of this 
case occurred during the period in which

[[Page 18910]]

Respondent was under a Board-imposed probation. As for Respondent's 
prescribing at the detention facility, Dr. Scott offered no testimony 
that he has treated any of the facility's patients with narcotics and 
Respondent himself acknowledged that ``not that much'' of his work at 
the facility involves prescribing narcotics. Although Respondent also 
maintained that a small portion of his work at the facility involves 
prescribing ``anti-psychotics'' when psychiatrists are not at the 
facility, he offered no evidence that any of this prescribing involves 
controlled substances. Finally, while Respondent also testified that 
prescribing narcotics was part of his training in his fellowships, the 
manner in which he prescribed to the investigators suggests that he did 
not learn very much about the proper prescribing of controlled 
substances.\41\
---------------------------------------------------------------------------

    \41\ As for the testimony of Ms. Clemmons, she worked for 
Respondent for a brief period of time, and she offered only 
generalized testimony about procedures at his clinic which does not 
address the specific violations alleged in this matter.
---------------------------------------------------------------------------

    In any event, even assuming that Respondent has complied with 
federal law with respect to every other controlled substance 
prescription he has issued in the course of his professional career, 
Respondent's experience evidence does not refute my findings that he 
lacked a legitimate medical purpose and acted outside of the usual 
course of professional practice in issuing each of the eight different 
prescriptions and that he knowingly diverted controlled substances. See 
21 CFR 1306.04(a). I therefore conclude that the evidence with respect 
to Factors Two and Four establishes that Respondent ``has committed 
such acts as would render his registration . . . inconsistent with the 
public interest.'' 21 U.S.C. 824(a)(4).

Sanction

    Where, as here, the Government has established grounds to revoke a 
registration or deny an application, a respondent must then ``present[ 
] sufficient mitigating evidence'' to show why he can be entrusted with 
a new registration. Samuel S. Jackson, 72 FR 23848, 23853 (2007) 
(quoting Leo R. Miller, 53 FR 21931, 21932 (1988)). `` `Moreover, 
because ``past performance is the best predictor of future 
performance,'' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 
1995), [DEA] has repeatedly held that where [an applicant] has 
committed acts inconsistent with the public interest, the [applicant] 
must accept responsibility for [his] actions and demonstrate that [he] 
will not engage in future misconduct.' '' Jayam Krishna-Iyer, 74 FR 
459, 463 (2009) (quoting Medicine Shoppe, 73 FR 364, 387 (2008)); see 
also Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 
(2006); Cuong Tron Tran, 63 FR 64280, 64283 (1998); Prince George 
Daniels, 60 FR 62884, 62887 (1995).
    An applicant's acceptance of responsibility must be unequivocal. 
See Lon F. Alexander, 82 FR 49704, 49728 (2017) (collecting cases). 
Also, an applicant's candor during both an investigation and the 
hearing itself is an important factor to be considered in determining 
both whether he has accepted responsibility as well as the appropriate 
sanction. Michael S. Moore, 76 FR 45867, 45868 (2011); Robert F. Hunt, 
D.O., 75 FR 49995, 50004 (2010); see also Jeri Hassman, 75 FR 8194, 
8236 (2010) (quoting Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005) 
(``Candor during DEA investigations, regardless of the severity of the 
violations alleged, is considered by the DEA to be an important factor 
when assessing whether a physician's registration is consistent with 
the public interest[.]'')), pet. for rev. denied, 515 Fed. Appx. 667 
(9th Cir. 2013).
    While a registrant must accept responsibility for his misconduct 
and demonstrate that he will not engage in future misconduct in order 
to establish that his registration would be consistent with the public 
interest, DEA has repeatedly held that these are not the only factors 
that are relevant in determining the appropriate disposition of the 
matter. See, e.g., Joseph Gaudio, 74 FR 10083, 10094 (2009); Southwood 
Pharmaceuticals, Inc., 72 FR 36487, 36504 (2007). Obviously, the 
egregiousness and extent of an applicant's misconduct are significant 
factors in determining the appropriate sanction. See Jacobo Dreszer, 76 
FR 19386, 19387-88 (2011) (explaining that a respondent can ``argue 
that even though the Government has made out a prima facie case, his 
conduct was not so egregious as to warrant revocation''); Paul H. 
Volkman, 73 FR 30630, 30644 (2008); see also Paul Weir Battershell, 76 
FR 44359, 44369 (2011) (imposing six-month suspension, noting that the 
evidence was not limited to security and recordkeeping violations found 
at first inspection and ``manifested a disturbing pattern of 
indifference on the part of [r]espondent to his obligations as a 
registrant''); Gregory D. Owens, 74 FR 36751, 36757 n.22 (2009).
    So too, the Agency can consider the need to deter similar acts, 
both with respect to the respondent in a particular case and the 
community of registrants. See Gaudio, 74 FR at 10095 (quoting 
Southwood, 71 FR at 36503). Cf. McCarthy v. SEC, 406 F.3d 179, 188-89 
(2d Cir. 2005) (upholding SEC's express adoption of ``deterrence, both 
specific and general, as a component in analyzing the remedial efficacy 
of sanctions'').
    The CALJ found that Respondent has refused to accept responsibility 
for his misconduct. R.D. at 91. As the CALJ explained, ``[f]ar from 
offering an unequivocal acceptance of responsibility . . . Respondent 
offered excuses for his conduct that smacked more of contrivance than 
contrition.'' Id. Indeed, Respondent specifically denied that he 
violated 21 CFR 1306.04(a) with respect to any of the prescriptions. I 
therefore agree with the CALJ that Respondent has failed to accept 
responsibility for his misconduct.
    Given the egregious nature of his misconduct, which involves the 
knowing diversion of controlled substances, Respondent's failure to 
acknowledge his misconduct provides reason alone to conclude that he 
has not rebutted the Government's prima facie case.\42\ Indeed, this 
Agency has explained that because the knowing diversion of controlled 
substances strikes at the core of the CSA's purpose, the Agency will 
not grant an application (or continue a registration) where the 
evidence shows that a practitioner has engaged in even a single act of 
the knowing diversion of a controlled substance and the practitioner 
refuses to acknowledge his/her misconduct. See Samuel Mintlow, 80 FR 
3630, 3653 (2015) (citing Dewey C. MacKay, 75 FR 49956, 49977 (2010) 
(citing Krishna-Iyer, 74 FR 459, 463 (2009) and Alan H. Olefsky, 57 FR 
928, 928-29 (1992))). Moreover, while the Agency's interest in specific 
deterrence is not triggered (because I deny his application), the 
Agency's interest in deterring other practitioners who contemplate 
diverting controlled substances is manifest.
---------------------------------------------------------------------------

    \42\ Even had Respondent accepted responsibility, his evidence 
which is arguably relevant on the issue of remediation is not 
adequate to assure me that he can be entrusted with a registration. 
As found above, his evidence simply amounts to his promise to do 
better in the future and his non-binding desire that ``I do not 
really want to do pain management . . . But right now the only thing 
that's open is pain management.'' Tr. 688-89. Thus, his promise is 
no more than a ``goal.'' Id. at 689.
---------------------------------------------------------------------------

    I therefore conclude that granting Respondent's application for a 
registration ``would be inconsistent with the public interest.'' 21 
U.S.C. 823(f). Accordingly, I will order that his pending application 
be denied.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 
CFR 0.100(b),

[[Page 18911]]

I order that the application of Garrett Howard Smith, M.D., for a DEA 
Certificate of Registration as a practitioner, be, and it hereby is, 
denied. This Order is effective immediately.

    Dated: April 17, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-09020 Filed 4-27-18; 8:45 am]
 BILLING CODE 4410-09-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.