Darryl J. Mohr, M.D.; Affirmance of Immediate Suspension Order, 34998-35020 [2012-14268]

Download as PDF srobinson on DSK4SPTVN1PROD with NOTICES 34998 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices www.usitc.gov). The public record for this investigation may be viewed on the Commission’s electronic docket (EDIS) at https://edis.usitc.gov. SUPPLEMENTARY INFORMATION: Background.—These investigations are being instituted in response to a petition filed on June 5, 2012, by CP Kelco US, Atlanta, GA. Participation in the investigations and public service list.—Persons (other than petitioners) wishing to participate in the investigations as parties must file an entry of appearance with the Secretary to the Commission, as provided in sections 201.11 and 207.10 of the Commission’s rules, not later than seven days after publication of this notice in the Federal Register. Industrial users and (if the merchandise under investigation is sold at the retail level) representative consumer organizations have the right to appear as parties in Commission antidumping investigations. The Secretary will prepare a public service list containing the names and addresses of all persons, or their representatives, who are parties to this investigation upon the expiration of the period for filing entries of appearance. Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and BPI service list.—Pursuant to section 207.7(a) of the Commission’s rules, the Secretary will make BPI gathered in this investigation available to authorized applicants representing interested parties (as defined in 19 U.S.C. 1677(9)) who are parties to the investigations under the APO issued in the investigation, provided that the application is made not later than seven days after the publication of this notice in the Federal Register. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO. Conference.—The Commission’s Director of Investigations has scheduled a conference in connection with this investigation for 9:30 a.m. on June 26, 2012, at the U.S. International Trade Commission Building, 500 E Street SW., Washington, DC. Requests to appear at the conference should be filed with the Office of the Secretary (William.bishop@usitc.gov and Sharon.bellamy@usitc.gov) on or before June 22, 2012. Parties in support of the imposition of antidumping duties in these investigations and parties in opposition to the imposition of such duties will each be collectively allocated one hour within which to make an oral presentation at the conference. A nonparty who has VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 testimony that may aid the Commission’s deliberations may request permission to present a short statement at the conference. Written submissions.—As provided in sections 201.8 and 207.15 of the Commission’s rules, any person may submit to the Commission on or before June 29, 2012, a written brief containing information and arguments pertinent to the subject matter of the investigations. Parties may file written testimony in connection with their presentation at the conference no later than three days before the conference. If briefs or written testimony contain BPI, they must conform with the requirements of sections 201.6, 207.3, and 207.7 of the Commission’s rules. Please be aware that the Commission’s rules with respect to electronic filing have been amended. The amendments took effect on November 7, 2011. See 76 FR 61937 (Oct. 6, 2011) and the newly revised Commission’s Handbook on E-Filing, available on the Commission’s Web site at https://edis.usitc.gov. In accordance with sections 201.16(c) and 207.3 of the rules, each document filed by a party to the investigation must be served on all other parties to the investigation (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service. Authority: This investigation is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.12 of the Commission’s rules. By order of the Commission. Issued: June 6, 2012. Lisa R. Barton, Acting Secretary to the Commission. [FR Doc. 2012–14158 Filed 6–11–12; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 10–58] Darryl J. Mohr, M.D.; Affirmance of Immediate Suspension Order On January 20, 2011, Administrative Law Judge (ALJ) Timothy D. Wing issued the attached recommended decision (also ALJ). Thereafter, Respondent filed exceptions to the decision. Having reviewed the entire record including the ALJ’s recommended PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 decision1 and Respondent’s exceptions, I have decided to adopt the ALJ’s rulings, findings of fact and conclusions of law, except as noted below.2 However, because Respondent’s registration expired shortly after the ALJ issued his decision and Respondent did not file a renewal application, I reject the ALJ’s recommendation that I revoke his registration and deny any pending application.3 While there is neither a registration, nor an application, to act upon, I affirm the immediate suspension order. In his exceptions, Respondent contends that the ALJ’s decision should be rejected because it is based on an unsupported assumption that ‘‘Respondent [can] not be trusted to avoid repeating his mistakes.’’ Exc. at 2. Respondent further contends that the State Board has placed him on probation and imposed various conditions, including that within six months of the State Order, he ‘‘attend an 1 All citations to the ALJ’s decision are to the slip opinion as issued on January 20, 2011. 2 The ALJ found that Respondent materially falsified his January 2008 renewal application by failing to disclose that in 2001, the Arizona Medical Board had placed him on probation based on his having prescribed Viagra to an FDA undercover agent without having conducted a physical examination and determining whether the drug was clinically indicated or contraindicated for the patient. See ALJ at 37; see also GX 2, at 3–4. The State Board also found that Respondent had been named as a defendant in a lawsuit brought by the Attorney General of Illinois which had alleged that he engaged ‘‘in the use of electronic internet communication for the prescribing and dispensing of prescription medications’’ in violation of the Illinois Consumer Fraud and Deceptive Business Practices Act; Pharmacy Practice Act of 1987, and Medical Practice Act of 1987; Respondent accepted a settlement in which he did not admit to any illegality ‘‘but agreed not to engage in the internet prescribing or dispensing of prescription medication in Illinois.’’ GX 2, at 3–4. The State did not, however, suspend or revoke his medical license. Viagra is not, however, a controlled substance and the Government did not offer any evidence that Respondent had engaged in the internet prescribing of controlled substances. Moreover, the Government did not offer any evidence explaining why Respondent’s Internet prescribing of Viagra was ‘‘capable of influencing the decision’’ of the Agency as to whether to grant his application. See Scott C. Bickman, 76 FR 17694, 17701 (2011) (quoting Kungys v. United States, 485 U.S. 759, 770 (1988) (other citations omitted)). Nor did the Government cite to any decision of this Agency holding that an application for registration may be denied on the ground that the applicant had prescribed a noncontrolled substance inappropriately. Accordingly, while Respondent falsified his application, the falsification was not material. I thus do not adopt the ALJ’s finding that Respondent materially falsified his renewal application. 3 Both the Government and Respondent nonetheless maintain that this case is not moot under the collateral consequences doctrine. See Gov. Note. Regarding Resp.’s DEA Registration, at 1–2 (citing William Lockridge, 71 FR 77,791 (2006)); Resp. Exceptions at 2 n.1. Neither party explains what collateral consequences attach in this case. E:\FR\FM\12JNN1.SGM 12JNN1 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices srobinson on DSK4SPTVN1PROD with NOTICES intensive education program regarding medical recordkeeping and the prescribing of controlled substances,’’ and that upon completion of the program, he submit his charts to a Board-approved contractor who is to review his documentation and prescribing practices. Id. at 3. In Respondent’s view, the ALJ’s finding that he did not accept responsibility for his misconduct is erroneous because the ALJ placed excessive weight on Respondent’s failure to implement the monitoring program required by the Board’s Order. Id. at 4. According to Respondent, the ALJ erroneously assumed that he was required to have ‘‘the monitoring program * * * up and running as of the time of the hearing’’ when the Board’s Order does not require ‘‘that the monitoring itself would * * * take place until after he had completed the PACE education program.’’ Id. Respondent further maintains that he cannot be faulted for failing to implement the monitoring program because the ‘‘program was to assess prescribing and documentation in the context of [his] prescribing [of] controlled substances,’’ which he is unable to do because his registration was immediately suspended. Id. However, subsequent to the ALJ’s issuance of his decision, on February 25, 2011, the Arizona Medical Board issued to Respondent an Interim Order For Practice Restriction And Consent To The Same. I take Official Notice of the Board’s Order.4 Therein, the Board found that Respondent had failed to complete ‘‘either the PACE prescribing course or the Pace medical recordkeeping course.’’ Interim Order, at 2. The Board further found ‘‘that a practice restriction is needed in order to protect the public.’’ Id. The Board therefore placed Respondent ‘‘on a practice restriction that prohibits him from prescribing, administering, or dispensing any Controlled Substances until he applies to the Board and receives permission to do so.’’ Id. at 3. Accordingly, Respondent no longer has authority under Arizona law to prescribe controlled substances and is 4 Under the Administrative Procedure Act (APA), an agency ‘‘may take official notice of facts at any stage in a proceeding-even in the final decision.’’ U.S. Dept. of Justice, Attorney General’s Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and DEA’s regulations, Respondent is ‘‘entitled on timely request, to an opportunity to show to the contrary.’’ 5 U.S.C. 556(e); see also 21 CFR 1316.59(e). Respondent can dispute the facts of which I take official notice by filing a properly supported motion for reconsideration within twenty days of service of this Order, which shall begin on the date it is mailed. VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 not entitled to be registered under the Controlled Substances Act. See 21 U.S.C. 802(21) (‘‘[t]he term ‘practitioner’ means a physician * * * licensed, registered, or otherwise permitted, by * * * the jurisdiction in which he practices * * * to * * * dispense * * * a controlled substance in the course of professional practice’’). See also id. § 823(f) (The Attorney General shall register practitioners * * * to dispense * * * controlled substances * * * if the applicant is authorized to dispense * * * controlled substances under the laws of the State in which he practices.’’); id. § 824(a)(3) (authorizing the revocation of a registration ‘‘upon a finding that the registrant * * * has had his State license or registration suspended [or] revoked * * * and is no longer authorized by State law to engage in the * * * distribution [or] dispensing of controlled substances’’). Thus, even if Respondent had filed a renewal application and prevailed in this proceeding, he would not be entitled to be registered. See, e.g., Jovencio L. Raneses, M.D., 75 FR 11563 (2010). Moreover, even assuming that Respondent intends to remain in professional practice, cf. Resp. Exc. n.1., contrary to Respondent’s understanding and notwithstanding the collateral consequences doctrine, his challenge to the ALJ’s finding that he did not accept responsibility for his misconduct is now moot. As DEA’s case law makes clear, the issue of whether a registrant has accepted responsibility for his misconduct and has demonstrated that he will not engage in future misconduct is in play in only two circumstances: (1) In determining whether a registrant’s continued registration is consistent with the public interest, see 21 U.S.C. 824(a)(4); and (2) in determining whether granting an applicant’s application for registration is consistent with the public interest. Id. § 823(f). However, where, as here, a registrant allows his registration to expire, and does not file a renewal application, there is neither a registration nor an application to act upon and the issue of whether a registrant’s continued registration is consistent with the public interest is off the table. Ronald J. Reigel, 63 FR 67132, 67133 (1998). While this Agency has recognized that because an immediate suspension order involves the exercise of summary process, it is reviewable in a proceeding under 21 U.S.C. 824, even where collateral consequences exist, review of the order is limited to challenging its factual and legal basis. Whether a former registrant has accepted responsibility for his PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 34999 misconduct has no bearing on the validity of the suspension order. As the ALJ found (and as the Government’s Expert testified), Respondent prescribed narcotic controlled substances to the two undercover patients even though he did not obtain a patient history or perform a bona fide physical exam during any of the four undercover visits, ALJ at 48, notwithstanding that Arizona law explicitly provides that it is ‘‘[u]nprofessional conduct’’ to ‘‘fail[] or refus[e] to maintain adequate records on a patient’’ or to ‘‘[p]rescrib[e], dispens[e] or furnish[] a prescription medication * * * to a person unless the licensee first conducts a physical examination of that person or has previously established a doctor-patient relationship.’’ Id. at 52 (quoting Ariz. Rev. Stat. § 32–1401(27)(e) & (ss)). As the Government’s Expert testified, Respondent’s records for the two undercover patients ‘‘showed no substantiation for a diagnosis, a plan, or a treatment with opioid medication.’’ Id. at 48 (quoting Tr. 416). Indeed, at their initial visits, both undercover patients had indicated on their intake form (‘‘Opioid Flow Sheet) that they had a pain level of ‘‘0’’ on a scale of 0 to 10. GX 15, at 2 (K.R. visit of 11/13/09); GX 16, at 2 (B.K. visit of 11/18/09).5 Respondent did not discuss a treatment plan with either undercover patient. Moreover, there is ample evidence establishing that Respondent knew that the undercover officers were not legitimate patients but were seeking the controlled substances to abuse them. At her first visit, K.R. told Respondent that she had been using her father’s Percocet and did not make any claim of being in pain in her conversation with Respondent. GX 21, at 144. During K.R.’s visit, Respondent told her that ‘‘[t]he only place you can get these medications from is me,’’ which K.R. then acknowledged with ‘‘o.k.’’ GX 21, at 147. Respondent then stated: ‘‘You 5 With respect to the undercover visitors, Respondent asserted that this did not give reason for concern because ‘‘0’’ on the flow sheet indicated that this was their pain score ‘‘with medications.’’ Resp. Proposed Findings of Fact and Conclusion of Law, at 7 (¶ 22) & 10 (¶ 34). During K.R.’s visit, Respondent asked her how long it had been since she had taken medication. GX 21, at 144. In response, K.R. stated that she had used her father’s Percocet and that it had been several weeks since she had done so. GX 21, at 142–45. K.R. did not represent that she was currently in pain. See id. What is obvious is that no matter what number on the pain scale was circled, this form would always provide justification to prescribe controlled substances. If, as in K.R.’s visit, the patient circled ‘‘0,’’ Respondent could claim that this was because of the medications the patient was on. Notably, during the visit, Respondent did not ask K.R. to rate her pain level without medications. E:\FR\FM\12JNN1.SGM 12JNN1 srobinson on DSK4SPTVN1PROD with NOTICES 35000 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices can’t, you go, you can’t go to me and then another doctor and another doctor cause they you’re gonna, it’s all computerized, so your gonna get redflagged and they’re gonna call you a drug addict and a doctor shopper and then all of a sudden no pharmacy is gonna give you any medication.’’ Id. Respondent was also well aware of the ‘‘high street value’’ of both Percocet and OxyContin. Id. at 147–48. While Respondent did a superficial examination, noting that ‘‘I’m gonna poke you. I gotta find something out about ya,’’ he had already agreed to write a prescription for K.R. Id. at 150– 51. As this interaction demonstrates, Respondent knew that K.R. was not a legitimate patient but needed to find something to justify the prescription he had already agreed to issue. Moreover, while during the visit, K.R. had stated that she had used Percocet (which contains only 5 mg of oxycodone) or even oxycodone 10 mg, Respondent gave her a prescription for seventy tablets of oxycodone 30 mg. See GX 21, at 144; Tr. 207. As for the first visit of B.K. (the second undercover patient), Respondent, immediately upon introducing himself, stated: ‘‘Obviously you’re looking for pain medication. What did you do?’’ GX 22, at 159. When Respondent then asked B.K. to state the location of his pain, B.K. stated: ‘‘You name it’’ and added that he had ‘‘basically, you know general pain.’’ Id. at 159–60. When Respondent asked if he had been in an auto accident, B.K. stated that he had been ‘‘[p]robably a couple years’’ ago. Id. Respondent then asked B.K. ‘‘what kind of medication are you looking to get?’’ Id. at 161. B.K. stated ‘‘well Oxy. Probably thirties’’ and added that he got them ‘‘wherever I can.’’ Id. When Respondent asked how B.K. got ‘‘started on oxycodones,’’ B.K. answered ‘‘[o]h just general pain’’ and ‘‘achiness.’’ Id. Respondent then suggested that there were ‘‘other medications to take except a schedule II narcotic’’; B.K. answered: ‘‘[w]ell that was available to me.’’ Id. Manifesting his recognition that B.K. was not a legitimate patient, Respondent then stated that ‘‘the issue is * * * that I can’t write for pain medication unless I have proof of injury. * * * You’re not giving me proof of injury, you’re just telling me you, you ache all over.’’ Id. To this B.K. replied: ‘‘Right.’’ Id. Respondent then stated: I mean there’s other medications that you can take. Uh, you’ve never even been on, or whatever you’re doing if you’re buying this off the street, and I don’t care whether you are or not, I have patients that do that. Uh, but basically that’s why they’re coming VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 because they’re very expensive on the street, plus they need to be evaluated and find out what their problem is. Uh, but for me just to write a script * * * for a patient that walks in the door and says, ‘‘I’m just having general pain’’ that doesn’t work. I mean there’s no way I’m going to lose my license. Id. at 162. While Respondent told B.K. that he was going to have to find another doctor, he then explained that: the point is, I can’t write you a prescription for medication at this level without any proof of injury. So, if you’re having pain, you know I can certainly give you something less than the Percocet. I can give you some Vicodin, I can give you some Darvocet, I can give you some Tyonol[sic] three’s, but to give you this level * * * drug is, no, that’s out. Id. After B.K. stated ‘‘ok,’’ Respondent added that ‘‘[i]f you want a lesser drug I’d be more than happy to write it for you. * * * But that’s up to you.’’ Id. B.K. stated ‘‘[t]hat’d be great’’ and Respondent asked him if he had ever been on Vicodin, Darvocet or Tylenol Three. Id. When B.K. told Respondent that he had previously ‘‘been on the strongest Vicodin * * * the 10–325,’’ Respondent offered to write the prescription and give B.K. a thirty-day supply (120 tablets), even though he acknowledged that B.K. ‘‘got no * * * chronic pain syndrome’’ and ‘‘no etiology.’’ Id. at 162–63. When B.K. then asked Respondent whether he could get another appointment, Respondent agreed that B.K. could ‘‘come back’’ on December 23rd even though he had no ‘‘proof of injury.’’ Id. at 165. Respondent then told B.K. that he was giving him the medication ‘‘because you’re telling me you’re having pain’’ (even though B.K. never identified any specific area of pain) and told him that he would have to find himself ‘‘a primary care physician.’ ’’ Id. at 166. Respondent gave B.K. a prescription for 120 Vicodin 10/ 325, a highly abused schedule III narcotic. Tr. 255; see also 21 CFR 1308.13(e)(1). On December 23rd, B.K. returned to Respondent. Shortly after the visit commenced, B.K. stated that he was ‘‘not better’’ and Respondent stated that he was going to give him the medication, but that he did not think that B.K. would ‘‘find anybody that’s really gonna give you these narcotic medications just because you’re stating that you’re not better.’’ GX 23, at 171. While Respondent recommended that B.K. get insurance and see a rheumatologist and stated that he would give B.K. another prescription for 120 Vicodin 10/325 but was discharging him, B.K. asked Respondent if he could PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 come back if he was able to get ‘‘[p]roof of an injury.’’ Id. at 172. Respondent then stated that because B.K. did not ‘‘have proof of injury * * * at this point you couldn’t come back to me and say well all of a sudden I’ve got an injury I forgot about’’ because ‘‘that tells me you’re lying to me.’’ Id. at 172–73. Respondent then stated that ‘‘I’m not gonna write you narcotics knowing that you’ve already told me that there’s nothing wrong with you.’’ Id. at 173. Respondent then told B.K. that he would have to go see a rheumatologist and get checked out. Id. Notwithstanding his acknowledgment that there was nothing wrong with B.K., Respondent then wrote B.K. another prescription for 120 Vicodin 10/325 before discharging him. The Government’s Expert reviewed Respondent’s medical records for K.R. and B.K., the audiotapes of their initial visits, the video tape of B.K.’s second visit, and the available transcripts.6 GX 18, at 1. The Government’s Expert concluded that both K.R. and B.K. ‘‘portrayed drug seeking individuals, with 0/10 pain, [and] with no documentation through past records, present records, radiologic studies, or physical examination of any condition warranting treatment with opioid medication.’’ Id. at 3. Continuing, the Expert found that ‘‘[t]he Medical Records are inadequate, inaccurate, representing falsifications and omissions, with no proper history and physical, no documentation of pathology that would warrant treatment with opioids, with fabricated details in an attempt to substantiate opioid prescriptions.’’ Id. at 4. The Expert also explained that ‘‘[t]here is no 120 day window, as mentioned by [Respondent], that allows opioid prescribing without past records and documentation.’’ Id.; see also Tr. 431. The Expert further opined that Respondent’s prescribing of controlled substances to both undercover patients lacked a ‘‘legitimate medical purpose.’’ Tr. 431. I agree. Based on the record, I conclude that Respondent’s prescribing of controlled substances to the undercover patients went ‘‘beyond the bounds of any legitimate medical practice,’’ United States v. McIver, 470 F.3d 550, 559 (4th Cir. 2006), and ‘‘completely betrayed any semblance of legitimate medical treatment.’’ United States v. Feingold, 454 F.3d 1001, 1010 (9th Cir. 2006). At the hearing, Respondent offered testimony only in regards to his prescribing to K.R. Tr. 761. Respondent 6 Due to an equipment malfunction, there was no recording of K.R.’s second visit. E:\FR\FM\12JNN1.SGM 12JNN1 srobinson on DSK4SPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices asserted that he had examined K.R. and she had told him that she had pain in her back. Id. However, as the ALJ found, Respondent had already agreed to write a prescription (which he did for 70 tablets of oxycodone 30 mg, a schedule II controlled substance) before he did his ‘‘exam.’’ ALJ at 49. Moreover, K.R. had told him she was getting Percocet from her father (and not from a physician) and never stated that she had pain (other than after he poked her), let alone pain that would support prescribing a schedule II narcotic. Tr. 406. (testimony of Government’s Expert discussing titration and adjustment of dosage). K.R. made a second visit to Respondent at which she again obtained a prescription for 70 tablets of oxycodone 30 mg, even though she again made no representation that she had pain and Respondent did not perform a physical exam or take a history. Tr. 218–20. However, Respondent offered no testimony as to why he prescribed to her at this visit. Moreover, Respondent offered no testimony addressing his medical justification for prescribing Vicodin 10/ 325 7 to B.K. at either visit. It is well settled that the Agency can draw an adverse inference from a respondent’s failure ‘‘to testify in response to probative evidence offered against’’ him. See Baxter v. Palmigiano, 425 U.S. 308, 316 (1976); see also United States v. Solano-Godines, 120 F.3d 957, 962 (9th Cir. 1997) (‘‘In civil proceedings * * * the Fifth Amendment does not forbid fact finders from drawing adverse inferences against a party who refuses to testify.’’). Based on Respondent’s failure to address why he prescribed to K.R. at her second visit, and B.K. at both of his visits, it is appropriate to draw the adverse inference that Respondent knowingly prescribed controlled substances to both B.K. and K.R. without a legitimate medical purpose. While in his testimony Respondent asserted that when he opened his pain practice, he did not ‘‘comprehend the deceit of many of my patients to get narcotics,’’ and that ‘‘[a]s time progressed, I learned more about pain management,’’ and started ‘‘doing better documentation, drug screening, * * * appropriate physical testing, better validation and proof of injury,’’ Tr. at 756–57, the undercover visits make clear that Respondent knowingly diverted controlled substances. Notably, when the State sanctioned Respondent based on his prescribing of Viagra, the 7 Vicodin is a schedule III narcotic, which contains hydrocodone. VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 State found that his doing so ‘‘without first conducting a physical examination’’ constituted ‘‘unprofessional conduct’’ under Arizona law. GX 2, at 3–4. Yet Respondent prescribed to both undercover officers without performing a physical examination (other than to perform a cursory physical examination on K.R. to, in his words, ‘‘find something out about ya,’’ after he had already agreed to write the prescription). Accordingly, this is not a case of a ‘‘naive or gullible’’ practitioner who did not intentionally prescribe to drug abusers and who has since learned from his mistakes and reformed his practices.8 See Paul J. Caragine, Jr., 63 FR 51592, 51601 (1998). Based on the above, I find that Respondent knowingly diverted controlled substances by issuing prescriptions outside of the usual course of profession practice and which lacked a legitimate medical purpose to the two undercover officers. 21 CFR 1306.04(a). This finding is sufficient to support the conclusion that Respondent committed acts which rendered the continuance of his then-existing registration ‘‘inconsistent with the public interest’’ and ‘‘an imminent danger to public health and safety,’’ and thus supported the suspension of his registration pursuant to 21 U.S.C. 824(d).9 I therefore affirm the Order of Immediate Suspension. Order Pursuant to the authority vested in me by 21 U.S.C. 824, as well as 28 CFR 0.100(b), I order that the Order of Immediate Suspension issued to Darryl J. Mohr, M.D., be, and it hereby is, affirmed. This Order is effective immediately. Dated: June 2, 2012. Michele M. Leonhart, Administrator. Dedra S. Curteman, Esq., for the Government Mary Baluss, Esq., for the Respondent Recommended Ruling, Findings of Fact, Conclusions of Law and Decision of the Administrative Law Judge Introduction Timothy D. Wing, Administrative Law Judge. This proceeding is an 8 Respondent also takes exception to the weight which the ALJ gave to the hearsay statements made by two of his patients (J.G. and L.W.) to the Task Force Officers. However, the statements have no bearing on the issue of whether Respondent’s prescriptions to the undercover officers complied with Federal law. I therefore do not consider the exception. 9 Respondent did not challenge the imminent danger finding at any point in this proceeding. PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 35001 adjudication pursuant to the Administrative Procedure Act, 5 U.S.C. § 551 et seq., to determine whether the Drug Enforcement Administration (DEA) should revoke a physician’s Certificate of Registration (COR) as a practitioner. Without this registration the practitioner, Respondent Darryl J. Mohr, M.D. (Respondent), of Phoenix, Arizona, will be unable to lawfully possess, prescribe, dispense or otherwise handle controlled substances in the course of his practice. On May 25, 2010, the Deputy Administrator, DEA, issued an Order to Show Cause and Immediate Suspension of Registration (OSC/IS), immediately suspending Respondent’s DEA COR and giving Respondent notice to show cause why the DEA should not revoke his COR pursuant to 21 U.S.C. § 824(a)(1), on grounds that his continued registration would be inconsistent with the public interest as that term is used in 21 U.S.C. §§ 824(a)(4), 823(f) and 823(g)(2)(E)(i). In substance, the OSC/IS alleges that: Respondent is registered with DEA as a practitioner in Schedules II–V under DEA COR BM2040498 at Access 2 Care Family Medical Center, 4607 North 12th Street, Phoenix, Arizona 85014; that COR BM2040498 expires by its terms on January 31, 2011; that pursuant to the Drug Addiction Treatment Act (DATA), Respondent is authorized to treat no more than thirty narcotic dependent patients at any one time with Schedule III–V narcotic controlled substances; that Respondent materially falsified his applications for renewal of his DEA COR on January 26, 2005, and January 29, 2008, by answering ‘‘no’’ to the liability questions despite the fact that his state medical license was suspended on November 27, 2001, in violation of 21 U.S.C. § 843(a)(4); and that Respondent prescribes and dispenses inordinate amounts of controlled substances, primarily hydrocodone compounds, Schedule III controlled substances, among others, under circumstances where Respondent knows or should know the prescriptions are not for legitimate medical purposes or are issued outside the course of usual professional practice. (ALJ Ex. 1.) The OSC/IS includes the following specific allegations: Family Practice and Pain Management recommends that patients fill their prescriptions at one pharmacy, Community Pharmacy (in various locations) and often provides a coupon for patients’ use. On November 27, 2009, Respondent’s patient, E:\FR\FM\12JNN1.SGM 12JNN1 srobinson on DSK4SPTVN1PROD with NOTICES 35002 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices ‘‘[MC],’’ 1 died at [MC]’s home from ‘‘Combined Drug Toxicity.’’ Three days before [MC]’s death, on November 24, 2009, Respondent prescribed [MC] 150 oxycodone 30 mg tablets, 70 alprazolam 2 mg tablets and 35 amphetamine salts 30 mg tablets. [MC] filled the prescription on the same day at the Community Pharmacy located at 17233 N. Holmes Blvd., Suite 1615, Phoenix, Arizona 85053. Respondent also prescribed controlled substances in various amounts on October 20, 2009, September 16, 2009, August 17, 2009, July 22, 2009, June 25, 2009, and May 27, 2009. The drugs found near [MC]’s body and in [MC]’s system at the time of death were consistent with the controlled substances Respondent prescribed for [MC]. (ALJ Ex. 1.) The OSC/IS further alleges that on January 6, 2010, Respondent’s patient, ‘‘[CS],’’ died at [CS]’s home; that [CS] received prescriptions from Respondent as recently as December 31, 2009, when Respondent prescribed 90 oxycodone 15 mg tablets and 60 alprazolam 2 mg tablets; and that [CS] obtained prescriptions for controlled substances from Respondent on a monthly basis since December 2008. (ALJ Ex. 1.) In addition, the OSC/IS alleges that on February 10, 2010, B.R., a twenty-fouryear-old male, died of a possible overdose at his home; that at the time of Mr. B.R.’s death, the Phoenix Police Department found a blue medical bottle prescribed by Respondent to ‘‘[TR]’’ with a date of December 16, 2009, for alprazolam 2 mg; that law enforcement personnel conducted four undercover visits to Respondent’s office in November and December 2009; and that on these occasions Respondent prescribed controlled substances including Schedule II and III controlled substances to undercover law enforcement personnel with cursory or no medical examinations, without medical records and without a legitimate medical purpose in violation of 21 C.F.R. § 1306.04 and Ariz. Rev. Stat. §§ 32–1401(27)(a), (q) & (ss) (2010). (ALJ Ex. 1.) On June 23, 2010, in a letter dated June 21, 2010, Respondent, through counsel, timely filed a request for hearing on the allegations in the OSC/ IS. Following prehearing procedures, a hearing was held in Phoenix, Arizona, between September 21–23, 2010, and in Arlington, Virginia, on October 19, 2010, with the Government and Respondent both represented by counsel. Both parties called witnesses to testify and introduced documentary evidence. After the hearing, both parties filed proposed findings of fact, conclusions of law, and argument. All of the evidence and post-hearing submissions have been considered, and to the extent the parties’ proposed findings of fact have been adopted, they are substantively incorporated into those set forth below. 1 To protect patient privacy, initials are used in this Recommended Decision when referring to Respondent’s current and former patients. 2 As noted below, [CP] is also a patient of Respondent (Tr. 693), and her name is therefore redacted. VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 I. Issue Whether the record evidence establishes by substantial evidence that Respondent’s DEA COR should be revoked as inconsistent with the public interest as that term is used in 21 U.S.C. §§ 824(a)(4), 823(f) and 823(g)(2)(E)(i); and because Respondent materially falsified an application for DEA registration or renewal pursuant to 21 U.S.C. § 824(a)(1). II. Evidence and Incorporated Findings of Fact I find, by a preponderance of the evidence, the following facts: A. Background (a) Darryl J. Mohr, M.D. (Respondent) Respondent received his medical degree in 1970. (Transcript (Tr.) at 34.) After thirty years of working in other practitioners’ practices, Respondent opened his own practice on August 3, 2009. (Tr. 34–35, 39–40.) He has no certifications or training in pain management. (Tr. 36.) Respondent’s most recent previous practice was a family practice. (Tr. 35.) Respondent’s current practice entails approximately eighty percent pain management and twenty percent family care. (Tr. 35–36, 39.) Respondent is the only physician at his practice. (Tr. 40.) Each month he sees between 225 and 300 patients, or approximately three to four patients per hour, devoting fifteen minutes to each patient. (Tr. 36, 37.) Approximately eighty percent of Respondent’s patients are cash-only. (Tr. 38.) The average age range of his patients is twenty-seven to thirty-three. (Tr. 61.) (b) Respondent’s Employees Respondent began his new practice with ‘‘[CP],’’ 2 his sole employee at that time. (Tr. 38–39.) In November 2009 he began to train a receptionist named Ana. (Tr. 38.) Ana could not handle the patient load, and left after about two months. (Tr. 38, 39.) Respondent next PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 hired Erin Kelly, who also left after about two months. (Tr. 39.) In January 2010, Respondent hired ‘‘[SO]’’ to be his medical assistant. (Tr. 39.) [SO] is also a patient of Respondent. (Tr. 41.) Respondent pays a salary for [SO]’s work; he also prescribes [SO] controlled substances as a patient. (Tr. 41.) (c) Respondent’s Arizona State Medical License Respondent possesses a state medical license, but that license has been suspended in the past. (Tr. 85–86; see Gov’t Exs. 2 & 3.) (d) The Arizona Controlled Substances Prescription Monitoring Program (PMP) The Arizona PMP is a database maintained by the Arizona State Board of Pharmacy (Board of Pharmacy) since approximately April 2008. (Tr. 96–97, 124, 318.) Every pharmacy provides records of filled prescriptions for controlled substances, as well as information such as the prescribing doctor and DEA registration number. (Tr. 97.) The Board of Pharmacy collects data from pharmacies on a weekly basis, and there can be a lag of up to two weeks before data appears on a PMP report. (Tr. 153.) Checking the PMP allows a doctor to determine whether a patient is receiving prescriptions from multiple doctors. (Tr. 171.) The normal way to access the PMP is via the Internet. (Tr. 97.) Doctors simply provide their credentials and receive Internet and phone access. (Tr. 386.) B. The Evidence (a) The Government’s Witnesses Task Force Officer Jeremy Dean (TFO Dean) is a member of the Apache Junction Police Department and is currently assigned to the Phoenix field division of the DEA. He was the lead investigator on Respondent’s case. (Tr. 70–72.) He began as a task force officer in March 2009. (Tr. 120.) Before joining the DEA Task Force, which is responsible for investigating the diversion of legitimate pharmaceuticals to the illegitimate market, TFO Dean served for three years as a patrol officer at the Apache Junction Police Department and a large telecommunications company. (Tr. 71– 72.) Diversion Investigator Gary Linder (DI Linder) has worked as a DEA Diversion Investigator for approximately five years. (Tr. 176.) He previously served as a police officer for six years and received a bachelor’s degree in criminal justice. (Tr. 176.) Task Force Officer Mike Baldwin (TFO Baldwin) is a DEA Task Force E:\FR\FM\12JNN1.SGM 12JNN1 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices srobinson on DSK4SPTVN1PROD with NOTICES Officer and a detective with the city of Surprise. (Tr. 181–82.) He has been a Task Force Officer with the DEA for approximately one and one half years. (Tr. 182.) TFO Baldwin has worked for the Surprise Police Department for approximately nine years, investigating illicit drug use in many cases. (Tr. 184.) He received a bachelor’s degree in secondary education. (Tr. 184.) Task Force Officer ‘‘[JB]’’ 3 (TFO [JB]) is a Task Force Officer with DEA’s Tactical Diversion Squad in Phoenix. (Tr. 204.) She is employed by the City of Phoenix Police Department and has been a Task Force Officer since March 2009. (Tr. 204.) Before joining the Tactical Diversion Squad, TFO [JB] was a narcotics detective for the City of Phoenix Police Department for over twelve years, serving as a patrol officer and a field training officer. (Tr. 204.) Task Force Officer ‘‘[BK]’’ 4 (TFO [BK]) is a detective with the City of Peoria Police Department and a task force officer with the Phoenix field division of the DEA in the diversion area task force. (Tr. 252–53.) TFO [BK] has been a Task Force Officer since June 2009. He previously worked as a narcotics detective with the City of Peoria Police Department for four years. (Tr. 253.) He also worked for six years as a patrol officer. (Tr. 253–54.) TFO [BK] received a bachelor’s degree in psychology. (Tr. 254.) Intelligence Research Specialist Stone (IRS Stone) is a DEA Intelligence Research Specialist. (Tr. 302.) He is a pattern analyst, looking at data to discern trends. (Tr. 303.) IRS Stone has worked at DEA for nineteen years, following a career as an intelligence officer with the U.S. Army. (Tr. 302–03.) He received a bachelor’s degree in accounting. (Tr. 303.) The Government’s expert witness, Stephen Borowsky, M.D. (Dr. Borowsky), is a board-certified anesthesiologist,5 board-certified and recertified in pain medicine. (Tr. 378, 384.) His specialty is pain medicine and he is the founding president of the Arizona Pain Society. He belongs to regional, national and international 3 As noted below, TFO [JB] and TFO ‘‘[BK]’’ conducted undercover visits to Respondent’s office while posing as patients ‘‘[KR]’’ and ‘‘[BK].’’ Although they visited Respondent for the purpose of an investigation, TFO [JB] and TFO [BK] are nevertheless assumed, arguendo, to be patients of Respondent, and their privacy is protected in this Recommended Decision by the use of initials. See supra note 1. 4 Supra note 3. 5 Dr. Borowsky has previously submitted questions for the board certification in anesthesiology. (Tr. 384.) VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 societies for pain management. (Tr. 384– 85.) In addition to working at John C. Lincoln North Mountain Hospital and Phoenix Surgicenter, Dr. Borowsky also works at the U.S. Department of Veterans Affairs Hospital (VA) one day a week and teaches at the University of Arizona Medical School. He is a member of a group of physicians that conducts independent medical examinations. (Tr. 378.) He has worked in his specialty for thirty years. (Tr. 379.) Dr. Borowsky holds a degree in mechanical engineering from Drexel University and a medical degree from Temple University. He interned at Baystate Medical Center in Massachusetts, and served two years in the U.S. Public Health Service in the Indian Health Service in a remote reservation in South Dakota. (Tr. 379.) He completed his anesthesia residency at Beth Israel Hospital in Boston, and was simultaneously considered a Fellow at Harvard Medical School. He then served as a staff physician at Beth Israel and as an instructor at Harvard. (Tr. 379.) He began practicing pain medicine when he was appointed Assistant Clinical Professor of Anesthesia at Boston University. (Tr. 379.) Dr. Borowsky came to Phoenix in 1980, where he practiced anesthesia and was recruited to work at a pain program. (Tr. 380.) He has served on the staff of eleven area hospitals. (Tr. 380.) He is a Clinical Professor of Anesthesia at the University of Arizona College of Medicine, and served on several task forces for the Arizona Legislature on chronic pain. He also served on the task force from the Board of Pharmacy for establishing the PMP. (Tr. 381, 385–86.) He participated in the development of the PMP. (Tr. 386.) Dr. Borowsky currently cares for eighty to ninety patients and performs procedures at the VA and other locations. (Tr. 381.) He is co-chairman of the VA hospital’s Multidisciplinary Pain Committee. (Tr. 382.) He sees between ten and twenty patients, all of which are pain patients, on the one day per week he works at the VA hospital. (Tr. 382–83.) Dr. Borowsky is a lecturer in the area of pain management. He stays apprised of recent developments in the field by reading journals and Internet web sites, attending or holding conferences and communicating with other practitioners. (Tr. 387–88; see generally Gov’t Ex. 17.) (b) Respondent’s Witnesses In addition to his own testimony, Respondent presented testimony by his patient ‘‘[CM].’’ Respondent also PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 35003 presented testimony by his employees ‘‘[SO]’’ and [CP], who are current or former patients. Finally, Respondent presented testimony of ‘‘[RF],’’ the ´ fiancé of Respondent’s late patient ‘‘[CS].’’ (c) About the DEA Investigation of Respondent, Generally The DEA’s investigation of Respondent, which began in August of 2009, centered around: (1) Allegations that Respondent falsified his application for a DEA registration; (2) allegations that Respondent was practicing at an unregistered location; (3) allegations that Respondent was prescribing controlled substances outside of a normal, professional practice; and (4) a number of fatalities allegedly connected with Respondent’s prescribing practices. (Tr. 72–74.) TFO Dean testified that a federal search warrant was executed at Respondent’s medical practice in May 2010. (Tr. 115–16.) Items seized included medical records for approximately eight patients, controlled substances and financial documents. (Tr. 116.) DI G.L. testified that he served Respondent with the OSC/IS on May 26, 2010, at Respondent’s business, at 16601 North 40th Street, Suite 115 in Phoenix. (Tr. 177.) (d) Material Falsification of DEA Application As discussed in a later section of this Recommended Decision,6 there is uncertainty as to some of the details of Respondent’s history of registration with the DEA. Certain details, however, are clear and undisputed. Respondent presently holds DEA COR number BM2040498. (Tr. 78; Gov’t Ex. 1 at 2.) He applied to renew his COR on January 29, 2008. (Gov’t Ex. 1 at 2; see also Tr. 795.) On his 2008 renewal application, Respondent answered ‘‘no’’ to liability questions inquiring, in pertinent part, whether Respondent had ever had a state medical license suspended or placed on probation (see, e.g., Gov’t Ex. 28), notwithstanding the fact that the Arizona Medical Board had previously suspended Respondent’s medical license in 2001. (See Tr. 85–86, 760–61; Gov’t Ex. 28; Gov’t Ex. 3 at 4.) Respondent testified that he did not ‘‘really have a good answer’’ for why he said ‘‘no’’ on the renewal application, ‘‘other than I didn’t pay much attention to the wording.’’ (Tr. 760.) Respondent 6 See generally infra Section III.B (discussing ambiguities surrounding the dates of Respondent’s COR registration and renewal(s)). E:\FR\FM\12JNN1.SGM 12JNN1 35004 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices maintains that he ‘‘never tried to deceive anyone.’’ (Tr. 760–61.) Record evidence indicates that on October 23, 2000, the Arizona Medical Board issued a consent agreement and order. (Tr. 86–87; see Gov’t Ex. 2.) The consent agreement reprimanded Respondent for unprofessional conduct and required forty hours of continuing medical education in pharmacology. (Tr. 87; see Gov’t Ex. 2 at 4.) Moreover, on November 27, 2001, the Board placed Respondent’s medical license on probation.7 (Tr. 88; see Gov’t Ex. 3.) (e) Respondent’s Registered Location and Practice Location Respondent testified that his current practice location is 16601 North 40th Street, Suite 115, Phoenix Arizona 85032. (Tr. 34.) Respondent conceded that this location is not reflected on his DEA COR. (Tr. 35; see also Tr. 90.) Respondent’s COR reflects a registered address of ‘‘Access2care Family Medical Center, 4607 N. 12th Street, Phoenix, Arizona 85014.’’ (Gov’t Ex. 28.) Respondent explained that when he last filled out the application to renew his COR, he ‘‘was working at Access to Care, and that was a family practice.’’ 8 (Tr. 35.) Respondent failed to update his address when he moved to his new practice in August 2009. (Tr. 760.) Respondent testified he did not realize he had to notify DEA of the change in address in addition to notifying the Arizona Medical Board. (Tr. 760.) (f) Respondent’s Care as a Physician srobinson on DSK4SPTVN1PROD with NOTICES (1) Proof of Patient Identity Respondent testified that he requires every patient to provide identification, but leaves the type of identification up to his staff. (Tr. 47–48.) While somewhat credible, this testimony is rebutted by record evidence that Respondent’s staff permitted TFO [BK], posing as patient [BK], to see Respondent after producing only an ‘‘admin per se form,’’ despite the fact that Respondent’s staff stated 7 Respondent also conceded that the Arizona Medical Board recently placed his license on probation for two years, (Tr. 62), on August 11, 2010. (See Gov’t Ex. 27 at 4). Respondent stated that the Board required him to be monitored, and that he has signed a contract to employ monitors. Respondent equivocated, however, as to whether the monitoring program is currently in place. (Tr. 62–63, 67–68.) Because this probation occurred after Respondent applied to renew his COR in 2008, it is not relevant for purposes of the material falsification analysis. But compare infra Section III.D (discussing Respondent’s August 11, 2010 probation in light of the 21 U.S.C. § 823(f) public interest analysis). 8 The different spellings of Respondent’s former clinic, compare Tr. 35 (‘‘Access to Care’’), with Gov’t Ex. 28 (‘‘Access2care Family Medical Center’’), appear to reflect a typographical error in the transcript. VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 that the admin per se form was not an acceptable form of identification. (Tr. 258, 295–96.) On his second visit to Respondent, on December 23, 2009, TFO [BK] was again permitted to see Respondent, who prescribed controlled substances to TFO [BK] for a second time without verifying the patient’s identification. (Tr. 266–67.) (2) Proof of Injury The Government’s expert medical witness, Dr. Borowsky, opined that obtaining a patient’s medical history is critical to avoiding diversion and overdose, which are becoming widespread. (Tr. 396.) Indeed, Dr. Borowsky testified that the Arizona Medical Board requires that physicians maintain medical records for patients. (Tr. 418.) In his own pain management practice, every patient Dr. Borowsky sees is referred to him by another practitioner; he does not accept walkins. (Tr. 388–89.) Moreover, Dr. Borowsky reviews patients’ medical records before consulting with patients, ‘‘so I know whether this is an appropriate patient for me or whether it [sic] needs some other direction, so that we’re not wasting anybody’s time.’’ (Tr. 389, 404.) He refuses to see patients ‘‘unless there’s the proper documentation and radiologic studies that have been done. I’m not a primary [care] physician, and I want to make sure everything has been done before they get to me.’’ (Tr. 390.) He conceded, however, that when a patient needs testing, he orders testing. (Tr. 390.) Respondent’s employee [CP] testified that Respondent has had a policy of requiring proof of injury ‘‘[f]rom day one.’’ (Tr. 713.) Respondent’s testimony, however, shows otherwise. Respondent testified that in the past, because it could take three or four months to acquire a patient’s medical records (Tr. 42), Respondent would write prescriptions beginning once the patient signed release forms to permit Respondent to acquire her records. (Tr. 42–43.) Respondent explained that he did this as a ‘‘compassionate doctor.’’ (Tr. 42.) ‘‘I always required proof of injury. But I waited sometimes for the proof of injury to come in’’ and prescribed controlled substances in the interim. (Tr. 43–44; see also Tr. 45.) Respondent further testified that he began requiring proof of injury from pain management patients in December 2009 or January 2010. (Tr. 42.) Now that Respondent has ‘‘gotten more into the pain management process,’’ Respondent requires that every patient present proof of injury. (Tr. 42–44.) Proof of injury can take the form of MRIs, CTs, X-ray reports, reports from a previous doctor PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 or blood work, depending on the diagnosis. (Tr. 43, 46.) Respondent might accept a three-year-old MRI that shows significant disease. (Tr. 45.) In some cases, he has accepted a six-yearold MRI. (Tr. 46.) Respondent’s testimony that he has required proof of injury since December 2009 or January 2010 is called into question by record evidence that TFO [BK], posing as patient [BK], provided no medical records before or during his December 23, 2009 visit to Respondent, at which Respondent prescribed controlled substances. (Tr. 265–67.) Similarly, the record shows that Respondent prescribed controlled substances to TFO [JB] on December 18, 2009, without requiring any past medical records. (Tr. 219, 247.) Indeed, TFO [JB] testified that Respondent stated that ‘‘if he were to continue to prescribe to me, I would need to get proof of injury because he was in danger of losing his license.’’ (Tr. 220; see Tr. 244.) Moreover, ‘‘Respondent does not contest the fact that he prescribed to the two undercover agents without demanding previous medical records,’’ (Resp’t Br. at 39), explaining that ‘‘I’m a good doctor and that at times I found myself not being prepared to manage such difficult situations,’’ (Tr. 756.) I find by substantial evidence that during the relevant time period, Respondent did not consistently require proof of injury. (3) Physical Examination of Patients Dr. Borowsky testified that the Arizona Medical Board requires that physicians conduct a physical examination and patient history. (Tr. at 416.) An examination is important to show discrepancies and determine whether a patient is credibly in pain. (Tr. 397.) Dr. Borowsky testified on the importance of being skeptical, and that prescribing properly requires picking the right patient and monitoring the patient. (Tr. 397.) In his own pain management practice, Dr. Borowsky does not take vital records on every patient; it depends on the patient. (Tr. 391–92.) However, he does conduct physical examinations. (Tr. 393.) An examination of a patient with low back pain, for instance, would include directing the patient to walk both on her heels and on her toes. (Tr. 393.) Dr. Borowsky would direct the patient to sit and do straight leg-raising, ‘‘and if that was positive, ultimately, I would lay them down and look for continuing [sic] with a straight leg-raise to see if it was the same result.’’ (Tr. 393, see also Tr. 394.) Throughout the examination, Dr. Borowsky would watch for ‘‘non-organic findings, in E:\FR\FM\12JNN1.SGM 12JNN1 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices srobinson on DSK4SPTVN1PROD with NOTICES other words, non-physical findings like Waddell’s signs. One of those would be lightly pressing on somebody’s head, and if they respond by exclaiming that they have radiating leg pain, that’s not a physical finding that creates a credible picture.’’ (Tr. 394.) Respondent’s patients ‘‘[CM],’’ ‘‘[CP]’’ and ‘‘[RF]’’ each testified that Respondent examined them on their first visits. (Tr. 515, 567, 700.) In addition, Respondent testified that when he conducts physical examinations of patients, he does not use the Waddell’s signs test. Instead, his exams are ‘‘heel to toe, hip flexion, range of motion, reflexes.’’ (Tr. 48.) This testimony is undercut by record evidence that Respondent conducted no physical examination of TFO [BK] when the latter posed as patient [BK] on November 18, 2009, and December 23, 2009. (Tr. 258, 260, 267–68.) Respondent gave TFO [BK] prescriptions for controlled substances on both occasions. (Tr. 256, 265.) Moreover, Respondent failed to conduct a physical examination of TFO [JB] when the latter posed as patient [KR] on December 18, 2009. (Tr. 219.) Respondent gave TFO [JB] a prescription for controlled substances anyway. (Tr. 247.) In mitigation, the record reflects that during TFO [JB]’s November 13, 2009 undercover visit, Respondent did touch TFO [JB]’s back in several places, asked if it hurt and moved her right foot. (Tr. 215, 238–40.) This incident, however, occurred only as Respondent was starting to leave the examination room, after he had already told TFO [JB] of his decision to prescribe controlled substances. (Tr. 214–15, 246.) Moreover, Dr. Borowsky testified that Respondent’s purported examination in this regard was inadequate because Respondent’s statement ‘‘‘I’m poking you’ . . . is not a physical exam.’’ (See Tr. 421–22.) I find by substantial evidence that during the relevant time period, Respondent did not consistently conduct adequate physical examinations before prescribing controlled substances. (4) Patient Drug Screens Dr. Borowsky testified that in his own pain management practice, before prescribing a controlled substance, he orders patients to complete a urine drug test. (Tr. 392–93.) Respondent testified that he performs drug screens on ‘‘[e]very patient that walked through the door’’ at every appointment. (Tr. 46.) Under certain circumstances, however, when a patient with an opioid prescription tests negative for opiates, Respondent might VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 nevertheless prescribe controlled substances, such as, for example, if the patient loses the medication or forgets to take it. (Tr. 47.) The credibility of Respondent’s testimony that he performs drug screens on all patients is called into question by evidence that Respondent did not require undercover investigators posing as patients to complete drug screens on November 13, 2009 (Tr. 209), November 18, 2009 (Tr. 258), December 18, 2009 (Tr. 219) or December 23, 2009 (Tr. 267). This discrepancy, however, may be explained in part by Respondent’s testimony that he began conducting drug screens in February 2010. (Tr. 805; see generally Tr. 221, 616–17.) In any event, ‘‘Respondent . . . concedes that his willingness to prescribe based on office observation, examination and patient complaints was unwise.’’ (Resp’t Br. at 40.) (5) Referrals for Treatment by Specialists Dr. Borowsky testified that the Arizona Medical Board requires that physicians consult with specialists (Tr. 417) because ‘‘[m]ost of these problems involve areas that can be beyond the practitioner, even a pain management doctor, and it’s important to get the appropriate consultations . . . .’’ (Tr. 429.) Respondent testified that he makes referrals for psychiatric evaluation to patients with insurance. (Tr. 48.) For patients without insurance, Respondent asks them about their psychiatric treatment history. (Tr. 49.) Most of his patients lacking insurance cannot afford psychiatric treatment, ‘‘[b]ut I tell them they still need to go if the situation calls for it.’’ (Tr. 49.) Respondent’s testimony that he makes referrals is called into question by his failure to make a referral to TFO [BK], posing as patient [BK], notwithstanding Respondent’s stated concern that TFO [BK] might have fibromyalgia. (Gov’t Ex. 23 at 1.) (6) Respondent’s Use of the Arizona PMP Dr. Borowsky testified that it is the obligation of a doctor to check the PMP.9 (Tr. 386–87; accord Tr. 170 (testimony of TFO Dean).) When 9 Respondent argues that Dr. Borowsky used the term ‘‘obligation’’ ‘‘in the aspirational or hortatory sense.’’ (Resp’t Br. at 22 ¶ 106 (citing Tr. 479–80).) Respondent was given ample opportunity before, during and after the hearing in Phoenix, Arizona to present testimony by an expert witness of his choosing. Such testimony could have addressed, inter alia, whether an Arizona physician is obligated to consult the PMP. Respondent declined to call an expert witness. (Tr. 863.) Dr. Borowsky’s unqualified and fully credible testimony therefore stands unrebutted. PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 35005 prescribing controlled substances, however, Respondent did not initially consult the PMP. (Tr. 50.) Respondent explained that he did not initially know about the PMP, and ‘‘there were certain things I didn’t know about pain management.’’ (Tr. 50.) But once he was informed of the PMP, in approximately December 2009 or January or February of 2010, he did start to use it. (Tr. 50– 51.) This testimony is slightly undercut by Respondent’s statement to TFO [JB] on November 13, 2009, that ‘‘the only place you can get these medications is from me . . . it’s all computerized, so you’re gonna get red-flagged and they’re gonna call you a drug addict and a doctor shopper and then all of a sudden no pharmacy . . . is gonna give you any medication’’ (Gov’t Ex. 21 at 147; see also Tr. 213), which evinces Respondent’s knowledge of the PMP on that earlier date. Respondent also testified to relying on a pharmacy to check the PMP for him. (Tr. 51.) The pharmacy would call Respondent if a review of the PMP indicated ‘‘doctor shopping.’’ (Tr. 51.) ‘‘And if that were the case, every one of those patients got discharged.’’ (Tr. 52.) (7) Patient Treatment Plans Dr. Borowsky testified that the Arizona Medical Board requires that physicians document a treatment plan. (Tr. 417.) He opined that it is critical to document both patient treatment plans and informed consent to substantiate the basis for treating the patient and the patient’s diagnosis. (Tr. 399–400.) ‘‘[I]f it’s not in writing, others will assume that it was not done.’’ (Tr. 400.) Dr. Borowsky testified that in his own pain management practice, following the physical examination of a patient, he consults with the nurse case manager to develop a written plan of treatment. (Tr. 395.) Frequently, such a treatment plan would involve any of the following: physical therapy, psychology, referral to a psychiatrist and injection techniques such as epidural steroid injections or trigger-point injections. (Tr. 394–95.) Treatment could also involve medication management, such as opioids, narcotics, antiinflammatories, anti-convulsives, antidepressants and various medications along that line. (Tr. 394– 95.) Respondent testified that he formulates treatment plans in his mind for his patients. (Tr. 52.) Respondent’s testimony was unclear as to whether he reduces his treatment plans to writing. (See Tr. 52.) The testimony of DEA investigators posing as patients indicates that Respondent discussed no treatment plan before prescribing E:\FR\FM\12JNN1.SGM 12JNN1 35006 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices controlled substances on November 13, 2009 (Tr. 212) November 18, 2009 (Tr. 262) December 18, 2009 (Tr. 220) or December 23, 2009 (Tr. 269). Moreover, the patient files of TFO [JB], posing as [KR], and TFO [BK], posing as [BK], reveal no treatment plans.10 (Tr. 416; see also Gov’t Exs. 15 & 16.) srobinson on DSK4SPTVN1PROD with NOTICES (8) Informed Consent and Opioid Contract Dr. Borowsky testified that the Arizona Medical Board requires that physicians obtain informed consent from patients. (Tr. 417.) In his own pain management practice, Dr. Borowsky discusses the risks and benefits of medications he prescribes to patients. (Tr. 395.) He also directs patients to sign an informed consent agreement using a standard form that is readily available in pain management societies. (Tr. 399.) He said it is critical to discuss with patients the risks and benefits of medications, especially opioids. (Tr. 399.) Dr. Borowsky opined that it is critical to document treatment plans and informed consent to substantiate the basis for treating the patient and the patient’s diagnosis. (Tr. 399–400.) Although diagnoses can be vague after patients undergo various surgeries and treatments, there does ultimately need to be credibility and substantiation for a diagnosis. (Tr. 398.) Respondent testified that he has required patients to sign an opioid contract since December 2009 or January 2010, but he was not sure exactly when. (Tr. 55.) Before he began using his current opioid contract, Respondent used an ‘‘opioid flow sheet,’’ which ‘‘explained about taking the drugs, and being responsible for how you take the drugs and potential side effects, and so on and so forth.’’ (Tr. 55.) Respondent has an informed consent agreement in place as a part of the opioid contract. (Tr. 65.) Respondent took the language in the opioid contract from his previous clinic. (Tr. 65–66.) In contrast to Respondent’s testimony, TFO [BK] testified that Respondent did not discuss the risks and benefits of the controlled substances he prescribed to TFO [BK] on December 23, 2009. (Tr. 10 Respondent proposes that it is ‘‘not necessarily reasonable to expect an elaborate treatment plan for patients who have been advised to get diagnostics ([JB]) or to find a primary care doctor to provide evaluation, diagnostics and probably referral ([BK]).’’ (Resp’t Br. at 38 n.10.) Respondent was given ample opportunity before, during and after the hearing in Phoenix, Arizona to present testimony by an expert witness of his choosing. Such testimony could have addressed, inter alia, whether a treatment plan was called for in the case of TFO [JB] and TFO [BK]. Respondent declined to call an expert witness. (Tr. 863.) Dr. Borowsky’s unqualified and fully credible testimony therefore stands unrebutted. VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 269.) Nor did Respondent discuss the risks and benefits of the drugs he prescribed to TFO [JB] during her second visit in an undercover capacity on December 18, 2009. (Tr. 220.) Taken together, this testimony calls into question the extent to which Respondent consistently obtains informed consent from his patients. (9) Pain Scale Dr. Borowsky testified that in his own pain management practice, it is customary to have patients fill out a questionnaire that includes a pain diagram. He stated that ‘‘the coloring-in of the location of pain many times can give you a good idea of the diagnosis.’’ (Tr. 390.) His intake form also includes a pain scale ranging from zero to ten, as well as adjectives that patients can circle to describe their pain. (Tr. 390.) Dr. Borowsky conceded that under some circumstances, a patient circling zero on a pain scale might mean zero pain while on medication. (Tr. 430–31.) Respondent testified that he would prescribe controlled substances to a patient that indicated zero on the pain scale. (Tr. 59.) Indeed, TFO [JB], posing as patient [BK], indicated zero out of ten on a patient intake form on November 13, 2009 and again on December 18, 2009. (Tr. 208, 219, 223; see Gov’t Ex. 15 & 16.) Respondent prescribed controlled substances to TFO [JB] on both occasions. (Tr. 207, 211–12, 247.) Similarly, TFO [BK], posing as a patient on November 18, 2009, indicated zero out of ten on a pain scale. (Tr. 257; see Gov’t Ex. 16.) On his second undercover visit, on December 23, 2009, TFO [BK] left the pain scale blank. (Tr. 266; see Gov’t Ex. 16.) Respondent prescribed controlled substances to TFO [BK] in both instances. (Tr. 256, 265.) (g) Respondent’s Knowledge of Controlled Substances DI G.L. testified that when he served the OSC/IS on Respondent on May 26, 2010, Respondent asked DI G.L. ‘‘what a controlled substance was, and if Xanax was a controlled substance.’’ (Tr. 177–79.) DI G.L. replied that ‘‘Xanax was in fact a controlled substance, and if he needed to refer to anything else, he could go to [the DEA] Web site, and there would be a full list of controlled substances on the diversion Web site.’’ (Tr. 179.) DI G.L. testified that in his experience as a DEA investigator, DI G.L. had never encountered that question before. (Tr. 179.) (h) Quantity of Controlled Substances Prescribed Dr. Borowsky testified that when prescribing controlled substances, it is PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 appropriate to ‘‘start[] off with the lowest level of medication . . . If you start high, you can’t go back very easily, but if you start low, you can assess [the patient’s] response.’’ (Tr. 406.) He elaborated that ‘‘it’s not just the pain relief that you’re looking for. The goal . . . is not just pain relief, but improvement in function . . . .’’ (Tr. at 406.) Respondent testified that the average amount of oxycodone he prescribes is 30 mg, with the dosages running from ninety to one hundred and fifty, corresponding to three to five times per day. (Tr. 54.) Thirty milligrams is the highest dosage available of oxycodone. (Tr. 55.) (1) ‘‘Street Value’’ of Controlled Substances TFO [JB] noted that based on her experience as an investigator, the term ‘‘on the street,’’ in the context of controlled substances, means the controlled substances are received illegally, or from illegal means. (Tr. 213–14.) TFO Dean testified that ‘‘many of the drugs [Respondent] was prescribing were ending up in the illegitimate market, in the street market.’’ (Tr. 73.) Respondent acknowledged prescribing to patients when he knew the patients bought drugs on the street in the past. (Tr. 58.) He said patients subsequently ‘‘came to me because they didn’t want to continue breaking the law.’’ (Tr. 57.) When he sees such patients, he tells them not to buy on the street and only to get drugs from him. (Tr. 58.) Respondent testified that he did not personally know any patients who sell pills on the street, and that he immediately discharges any patient he discovers to be selling drugs. (Tr. 55– 56.) Respondent estimated that the amount of patients he discovers are selling constitutes less than one percent. (Tr. 56–57.) Yet Respondent also testified that between December 2009 and May 2010, he discharged 264 patients. (Tr. 757.) ‘‘The reasons were from selling drugs, using medications that weren’t prescribed by me, multiple doctor shopping, using the pharmacy monitoring program, use of illicit drugs and drug screens where they came positive for cocaine or methamphetamine . . ..’’ (Tr. 757.) Dr. Borowsky testified that he does not discuss the street value of medications with his patients. (Tr. 428.) Respondent stated that in general, he does not discuss street values of drugs with patients. (Tr. 59.) However, he conceded having done so in the past. (Tr. 59.) ‘‘I would tell them what my E:\FR\FM\12JNN1.SGM 12JNN1 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices srobinson on DSK4SPTVN1PROD with NOTICES patients tell me. I know nothing about street drugs per se. I repeat what I’ve heard from my patients.’’ (Tr. 59.) This testimony by Respondent stands in contrast to other record evidence that on November 13, 2009, Respondent told TFO [JB] that the drugs he prescribed to her possessed a high street value. He noted that the pills sold for about ten dollars per pill on the street and that OxyContin sold for forty dollars to eighty dollars on the street. (Tr. 213.) In mitigation, a transcript of that visit suggests that when Respondent discussed the street value of drugs with TFO [JB], he did so for the patient’s own protection: these medications . . . there’s a high street value for them. That’s number one. So it’s not a good idea for you to tell your friends that you’re taking these medications because [even] your mother will take them from you . . . These medications go for about ten dollars a pill on the street . . . what’s called oxycontins . . . go like anywhere from like 40 to 80 dollars a pill . . . So there’s a huge street value. People are always stealing them. So be careful. Uh because if you lose your medications, even if you have a police report, can’t get em. Once a month is all you can get. (Gov’t Ex. 21 at 147–48.) (2) Statistical Analysis of Respondent’s Prescribing Practices IRS Stone testified that he analyzed the PMP data on Respondent’s prescriptions. (Tr. 303.) He focused on the number of patients involved, the dates covered and the kinds and combinations of controlled substances Respondent prescribed. (Tr. 304.) Government Exhibit 14 consists of charts IRS Stone prepared on this basis. (Tr. 305; see Gov’t Ex. 14.) IRS Stone did not verify that the data he was given was correct before analyzing it, because he had no basis to do so. (Tr. 318.) The category ‘‘oxycodone’’ on the first chart of Government Exhibit 14 refers to drugs prescribed by Respondent in which oxycodone is the main ingredient, including Percocet, Endocet, OxyContin and 12 oxycodone 30s. (Tr. 306.) The category ‘‘benzodiazepine’’ in the same chart refers to drugs prescribed by Respondent in which benzodiazepine is an active ingredient, such as Klonopin, Xanax, alprazolam, clonazepam and lorazepam. (Tr. 306– 07.) The first chart indicates that between August 2009 and March 2010, Respondent wrote 9411 prescriptions. (Tr. 307.) The highest number of prescriptions was 5126, for oxycodone. (Tr. 307, 310.) The total tablet count was 681,590. (Tr. 310.) This amount VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 represents 54.47 percent of Respondent’s prescriptions and 71.08 percent of the tablets he prescribed. (Tr. 311.) The second highest number of prescriptions Respondent wrote between August 2009 and March 2010 was 3230, for benzodiazepine. (Tr. 307, 310.) The total tablet count was 208,318. (Tr. 310.) This amount represents 34.32 percent of Respondent’s prescriptions and 21.72 percent of the tablets he prescribed. (Tr. 311; see Gov’t Ex. 14 at 2.) The tablet counts noted above do not distinguish between tablets of various dosages. (Tr. 319.) The second chart of Government Exhibit 14 contains the number of prescriptions within each drug group, the number of tablets prescribed within that drug group and the average number of tablets per prescription. (Tr. 307–08.) For instance, when Respondent prescribed hydrocodone, he did so with an average of one-hundred and ten tablets per prescription. (Tr. 309.) This average prescription indicates a patient taking a prescription more than three times per day during a month of thirty days. (Tr. 309.) The prescription average for oxycodone was one-hundred and thirty-three. (Tr. 310.) The third chart identifies how many of Respondent’s patients received various drugs between August 2009 and March 2010. (Tr. 311–14.) According to information IRS Stone received from the PMP, the age group in Arizona that received the highest number of prescriptions for controlled substances was the fifty to fifty-nine age group. (See Tr. 491 (correcting mistake in witness’s prior testimony, see Tr. 317).) (3) [JG] and Diversion TFO Baldwin testified to an interview he conducted with ‘‘[JG].’’ (Tr. 184.) [JG] was twenty nine or thirty years old at the time of the interview. (Tr. 189.) [JG] said she was addicted to oxycodone, and that she visits Respondent on a monthly basis and pays cash. (Tr. 185.) She has her prescriptions filled at Community Pharmacy, at 29th Avenue and Bell Road. (Tr. 186.) That location is ten miles away from Respondent’s office; to get from Respondent’s office to that location, one passes by many other pharmacies on the way. (Tr. 186.) TFO Baldwin testified that [JG] said she goes to that particular location of Community Pharmacy because it has the cheapest price in town, because it always has her stock on-hand and because Respondent directed her to go there. (Tr. 186.) TFO Baldwin has heard that Community Pharmacy has ‘‘the cheapest cash prices. That’s how they advertise.’’ (Tr. 197.) PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 35007 TFO Baldwin testified that [JG] said that she and her boyfriend sell their pills to pay their bills. (Tr. 187.) She and her boyfriend go to Respondent because a friend of hers had said: ‘‘Hey, this doctor can give you the hook up.’’ (Tr. 187, 197.) TFO Baldwin testified that he understood that to mean that without a lot of questions asked, a person can get the medications that they seek. (Tr. 187.) TFO Baldwin testified that he asked [JG] if Respondent knew that she was selling her pills, and her response was that ‘‘he should know because half the patients in there are just like me.’’ (Tr. 196.) TFO Baldwin further testified that [JG] said that fifty percent of Respondent’s patients are getting pills for no medical reason. (Tr. 187.) (4) [LW] and Diversion TFO [JB] testified that she talked with ‘‘[LW],’’ one of Respondent’s patients, at a pharmacy on November 13, 2009. (Tr. 216.) TFO [JB] knew [LW] was a patient of Respondent because they saw one another in Respondent’s waiting room. (Tr. 244.) [LW] said she was taking oxycodone 30, and that she was addicted. (Tr. 216.) She usually took five pills per day; she used to sell part of her prescription on the street but now needs to take all of them to avoid withdrawal. (Tr. 217.) [LW] said she sent several patients to Respondent to get prescriptions to sell on the street. (Tr. 217.) [LW] told TFO [JB] that Respondent had never asked [LW] for proof of injury, nor did she provide any, but that he had recently begun to ask patients for proof of injury. (Tr. 217.) (5) Pharmacists Questioning Respondent’s Prescribing Practices Respondent testified that a pharmacist has never questioned his prescribing of controlled substances. (Tr. 61.) On multiple occasions, however, pharmacists have contacted Respondent to ensure a prescription was valid. (Tr. 66.) In such situations, Respondent asked the pharmacist to fax him the suspicious prescription, and Respondent advised whether it was his own handwriting. (Tr. 66–67.) Contrary to Respondent’s testimony that a pharmacist has never questioned Respondent’s prescribing of controlled substances (see Tr. 61), the testimony of TFO Dean and an August 10, 2009 letter by pharmacist S.G. (see Gov’t Ex. 4) suggest otherwise. (See also Tr. 168.) TFO Dean testified that the official investigation of Respondent began when pharmacist S.G. contacted TFO Dean because he was suspicious of Respondent’s prescribing practices. (Tr. E:\FR\FM\12JNN1.SGM 12JNN1 srobinson on DSK4SPTVN1PROD with NOTICES 35008 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices 73.) S.G. told TFO Dean that Respondent ‘‘had a large number of customers at his pharmacy who all were receiving similar prescriptions, usually oxycodone and alprazolam, and that many of them seemed to be organized in some sort of group, as they were all using the same physical prescription discount card.’’ (Tr. 74.) Directly contradicting Respondent’s testimony, TFO Dean testified that S.G. contacted Respondent and expressed his suspicion that some of Respondent’s patients were diverting drugs. (Tr. 74.) According to TFO Dean, Respondent replied to S.G. that all the prescriptions in question were legitimate. (Tr. 75.) TFO Dean testified that S.G. said Respondent told S.G. a story about a previous practice where Respondent had worked, where Respondent had prescribed to a family of ten patients, but only two of them needed their medications. (Tr. 75.) On cross examination, TFO Dean said S.G. did not indicate where or when this story was said to have occurred, other than at a previous employer of Respondent. (Tr. 132–33.) TFO Dean testified that Respondent told this story to S.G. in response to S.G.’s suspicions. (Tr. 168.) In his testimony, Respondent denied that such a family existed, and denied prescribing to any such family. (Tr. 774– 76.) TFO Dean stated that following his conversation with S.G., TFO Dean asked S.G. in late July or early August 2009 to formalize in a letter what they had talked about. (Tr. 124–25.) The record reflects a letter from S.G. to the DEA dated August 10, 2009. (Gov’t Ex. 4; see Tr. 76.) TFO Dean testified on cross examination as to how S.G. connected an individual prescription by Respondent to concerns of diversion. For one thing, the amounts of some prescriptions were similar. Moreover, S.G. noted that patients were using the same physical prescription discount card because it was creased in a particular way. (Tr. 128.) S.G. told TFO Dean that S.G. followed patients out into the parking lot and saw them exchange cash with someone in a vehicle. (Tr. 128.) S.G. said he and his staff ‘‘would see them go outside— they’d come inside often, ask how much their prescriptions were going to be, go out to a vehicle, receive cash from the driver, walk back in. [They would p]ay with that cash, and go back and get in a vehicle and leave.’’ (Tr. 126–29, 130, 168.) TFO Dean did not recall whether S.G. said he had told Respondent about following the patients into the parking lot. (Tr. 130.) On redirect examination, VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 TFO Dean testified that TFO Dean did not inform Respondent of his suspicions relating to the parking lot story, but that S.G. did. (Tr. 168.) (i) Undercover Visits to Respondent, Generally Pursuant to a federal warrant executed on Respondent’s medical practice in May 2010, law enforcement officers seized medical files under the names of [BK] and [KR]. (Tr. 116.) These files are patient records associated with four undercover visits by two undercover law enforcement officers. (Tr. 118–19; see Gov’t Ex. 15 & 16.) Law enforcement officers made audio or video recordings of three of these undercover visits.11 (Tr. 118–19.) TFO Dean monitored all of the undercover visits via audio receiver. (Tr. 119.) (j) Undercover Visits to Respondent by TFO [JB], AKA ‘‘[KR]’’ TFO [JB] testified that on November 13, 2009, and December 18, 2009, she visited Respondent in an undercover capacity, posing as patient ‘‘[KR],’’ and Respondent gave her prescriptions for 70 oxycodone 30 mg. (Tr. 205–06, 211, 221.) (1) TFO [JB] Undercover Visit of November 13, 2009 During her first undercover visit to Respondent’s office, posing as ‘‘[KR],’’ TFO [JB] possessed a functioning recording device. (Tr. 206–07, 230; see Gov’t Exs. 21 & 24.) TFO [JB] filled out a patient intake form and paid seventy dollars in cash. (Tr. 208.) The patient intake form included a pain scale of zero to ten for ‘‘pain score on medications,’’ on which TFO [JB] marked ‘‘zero,’’ indicating no pain. (Tr. 208, 223.) TFO [JB] did not provide medical records. (Tr. 208.) The consultation with Respondent lasted ten minutes, and Respondent also took a phone call during that time. (Tr. 207; see Gov’t Ex. 21 at 145.) When Respondent entered the examination room, Respondent asked who sent TFO [JB] to him. (Tr. 210; Gov’t Ex. 21 at 142.) He then stated that he was going to flirt with TFO [JB], because he flirts with his good-looking patients. (Tr. 210; Gov’t Ex. 21 at 143.) After approximately the third time he said this to her, she responded ‘‘Oh, that’s fine.’’ (Tr. 236; Gov’t Ex. 21 at 143.) Respondent asked if TFO [JB] was single, and whether she had ever been out with a doctor. (Tr. 214; Gov’t Ex. 21 at 148.) He told her that she was 11 TFO [JB]’s recording device malfunctioned during the December 18, 2009 undercover visit. (Tr. 218.) PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 attractive, and that she was single, and that he was single. (Tr. 215; Gov’t Ex. 21 at 148–50.) TFO [JB] testified that Respondent made her feel uncomfortable (Tr. 234, 246), and that she was not sure whether he was joking or not. (Tr. 234.) This had never occurred in her investigation of other doctors. (Tr. 246.) The examination room contained an examination table, but no instruments. (Tr. 209.) No one checked her vital signs, such as her pulse, heart rate, height, weight or blood pressure. (Tr. 208–09.) She did not submit a urinalysis for drug screening. (Tr. 209.) TFO [JB] said Respondent did not give her a physical, neurological or musculoskeletal examination. (Tr. 212.) He asked if she had had an MRI; she said she had not and Respondent recommended she go to Simon Med, which would give her a discount. (Tr. 212; Gov’t Ex. 21 at 144, 146.) TFO [JB] did not say she had any pain. (Tr. 210, 245; see e.g., Gov’t Ex. 21 at 143.) She said she had been taking her father’s Percocet ‘‘to feel good, or better.’’ (Tr. 211; see Gov’t Ex. 21 at 144.) She said she had not seen a doctor in a few years. (Tr. 210; Gov’t Ex. 21 at 143.) Respondent then asked how TFO [JB] hurt her back, even though TFO [JB] never said her back hurt. (Tr. 210, 245; Gov’t Ex. 21 at 143.) TFO [JB] explained that Respondent coached her, and when he said ‘‘lower back?’’ she agreed. (Tr. 210–11; Gov’t Ex. 21 at 145; see also Tr. at 233.) Respondent did not discuss a treatment plan with TFO [JB], nor did he discuss the risks and benefits of the controlled substances he ultimately gave her. (Tr. 212; see generally Gov’t Ex. 21.) Although Respondent initially said he would prescribe oxycodone 15 mg, he ultimately prescribed oxycodone 30 mg 70 tablets, representing a little more than one month’s supply. (Tr. 207, 211– 12; see also Gov’t Ex. 21 at 146.) As Respondent started to leave the examination room, and after he had already told TFO [JB] that he would write her a prescription, he turned back and asked TFO [JB] to roll over on the examination table onto her stomach. (Tr. 214–15, 246; Gov’t Ex. 21 at 150.) TFO [JB] told Respondent she did not need an examination. (Tr. 215.) Respondent replied: ‘‘An exam? . . . No. I’m gonna poke you. I gotta find something out about ya . . . let me know whether that causes you pain.’’ (Gov’t Ex. 21 at 151. See generally Tr. 215.) He then had her roll over, touched her back in several places, asked if it hurt and moved her right foot. (Tr. 215, 238–40.) TFO [JB] testified that she told him there was no pain. (Tr. 215.) On cross examination, E:\FR\FM\12JNN1.SGM 12JNN1 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices srobinson on DSK4SPTVN1PROD with NOTICES however, she conceded that she had said ‘‘Oh, yes, that does’’ when he poked a part of her back. (Tr. 238; Gov’t Ex. 21 at 151.) TFO [JB] explained that Respondent’s touch startled her. (Tr. 239, 248.) She felt very uncomfortable when Respondent asked her to roll onto her stomach and found the whole visit unnerving. (Tr. 247.) TFO [JB] testified that Respondent stated that the prescription he gave her had high street value. (Tr. 213; Gov’t Ex. 21 at 147.) Particularly, the pills he was giving her went for ten dollars each on the street; OxyContins went for forty to eighty dollars on the street. (Tr. 213; Gov’t Ex. 21 at 147.) Respondent also said she ‘‘could only get the medication from him because it was electronically tracked, and I could be labeled a doctor shopper, or a drug user, or drug addict, and then I wouldn’t be able to get the mediation [sic] anymore.’’ (Tr. 213; see Gov’t Ex. 21 at 147 (‘‘medication’’).) The transcript of the visit provides some context for these remarks, and also evinces a degree of concern by Respondent for TFO [JB]’s wellbeing. these medications . . . there’s a high street value for them . . . So it’s not a good idea for you to tell your friends that you’re taking these medications because [even] your mother will take them from you . . . People are always stealing them. So be careful. Uh because if you lose your medications, even if you have a police report, can’t get em. Once a month is all you can get. (Gov’t Ex. 21 at 147–48.) TFO [JB] testified that Respondent’s staff recommended Community Pharmacy, located about five miles away from Respondent’s office, which had a five-dollar coupon. (Tr. 216.) She had never encountered pharmacy coupons offered in any other doctor’s office. (Tr. 247.) (2) TFO [JB] Undercover Visit of December 18, 2009 TFO [JB] returned to Respondent’s office on December 18, 2009. (Tr. 218.) Although her recording device malfunctioned that day, the transmitter functioned properly. (Tr. 218.) TFO [JB] did not tell Respondent or indicate on any paperwork during the second visit that she had pain. (Tr. 218– 19.) She again marked zero on the pain scale. (Tr. 219.) Respondent completed no physical, neurological or musculoskeletal examination of TFO [JB]. (Tr. 219.) TFO [JB] did not submit any medical records, nor did she submit a urinalysis for drug testing. (Tr. 219.) Respondent asked if TFO [JB] had an MRI; she said no. Respondent answered that ‘‘if he were to continue to prescribe to me, I would need to get proof of VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 injury because he was in danger of losing his license.’’ (Tr. 220; see Tr. 244.) But Respondent prescribed controlled substances to TFO [JB] on her second visit anyway. (Tr. 247.) Respondent said he had noted that TFO [JB] was taking fifteen-mg oxycodone. (Tr. 221.) TFO [JB] corrected him and said Respondent had actually given her thirty-mg oxycodone on the previous visit. (Tr. 221.) Respondent replied ‘‘Well, I wrote 15 milligrams in the chart, but I sometimes make mistakes.’’ (Tr. 221.) Respondent gave TFO [JB] a second prescription identical to the first: Another prescription for 70 tablets of oxycodone 30 mg. (Tr. 218.) Respondent did not discuss a treatment plan, nor did he discuss the risks and benefits of the drugs he prescribed to TFO [JB] during her second visit. (Tr. 220.) Respondent said he was in debt due to the day-to-day cost of operating his office. (Tr. 220.) He said he intended to raise the office visit fee to eighty dollars per visit, to cover the cost of the urinalysis testing he was going to begin, and to help with his own debt. (Tr. 221.) Respondent also stated that some of his patients used to get their drugs on the street. (Tr. 221.) 35009 During his first undercover visit to Respondent, TFO [BK] used a functioning recording device. (Tr. 256– 57.) The interaction with Respondent lasted approximately five to ten minutes. (Tr. 257.) TFO [BK] filled out an intake form and indicated zero out of ten on a pain scale, with zero meaning ‘‘no pain.’’ (Tr. 257.) As part of the intake process, TFO [BK] provided an admin per se form that indicated his driver’s license had been taken away due to a DUI.12 (Tr. 258.) Respondent’s office staff told TFO [BK] that the admin per se form was not an acceptable form of identification, but Respondent saw him anyway.13 (Tr. 258, 295–96.) He paid cash and did not provide medical records during the intake process. (Tr. 258.) TFO [BK] described the examination room as approximately eight by eight feet with an examination table, chair and desk, but no medical equipment. (Tr. 259.) When Respondent entered the room, he told TFO [BK] ‘‘[o]bviously you’re here looking for pain medication,’’ (Gov’t Ex. 22 at 159), and asked what TFO [BK] did that he needed it. (Tr. 259–60.) TFO [BK] said Respondent went on to suggest several reasons, including back and arm pain. (Tr. 260.) TFO [BK] did not respond with a specific reason, but just said ‘‘you name it,’’ and also ‘‘general pain.’’ (Tr. 260.) Respondent then said there would need to be a specific reason, and suggested a motor vehicle accident. (Tr. 260–61.) TFO [BK] agreed to a motor vehicle accident. (Tr. 261.) Respondent then stated that TFO [BK] would need to produce proof of injury. (Tr. 261.) TFO [BK] testified that Respondent recommended that TFO [BK] go to Simon Med, where he could get a discount on an MRI. (Tr. 262.) This testimony is called into question by other evidence of record. As Respondent notes (Resp’t Br. at 10), the audio recording and the transcript of the November 18, 2009 visit are devoid of any discussion of Simon Med or an MRI. (See Gov’t Ex. 22 & Gov’t Ex. 25 at track one.) One possible explanation is that a number of sections of the recording are inaudible, with corresponding blank spaces appearing in the transcript. Even so, TFO [BK] testified at hearing that he listened to the recording and that it accurately reflects what occurred during the visit. (Tr. 270.) Accordingly, I do not assign any weight to TFO [BK]’s assertion that Respondent recommended Simon Med to him. The remaining testimony of TFO [BK], however, is otherwise internally consistent and credible, and does appear to be corroborated by other record evidence.14 TFO [BK] further testified that Respondent asked TFO [BK] what kind of medication he wanted. TFO [BK] responded that he wanted ‘‘oxy 30s,’’ or oxycodone 30-milligram pain medication. Respondent asked where TFO [BK] got oxy 30s; TFO [BK] responded that he was getting them wherever he could. (Tr. 261.) During the meeting, Respondent sat approximately four to six feet away from 12 DEA prepared the admin per se form for this undercover purpose. (Tr. 258.) 13 Respondent’s staff asked: ‘‘[D]o you have any kind of photo id with your picture on it?’’ (Gov’t Ex. 23 at 157). I therefore reject Respondent’s assertion that ‘‘in November new patient [BK] was not asked for his ID.’’ (Resp’t Br. at 13 ¶ 50.) 14 But see infra note 15 (discussing the TFO [BK]’s testimony as to Simon Med during his second visit). (k) Undercover Visits to Respondent by TFO [BK], AKA ‘‘[BK]’’ TFO [BK] testified that on November 18, 2009, and December 23, 2009, he visited Respondent’s office in an undercover capacity, posing as patient ‘‘[BK],’’ and Respondent gave him prescriptions for 120 Vicodin 10/325 mg on each visit. (Tr. 255–56, 265; see Gov’t Exs. 16, 22, 23, 25 & 26.) (1) TFO [BK] Undercover Visit of November 18, 2009 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\12JNN1.SGM 12JNN1 35010 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices srobinson on DSK4SPTVN1PROD with NOTICES TFO [BK] and never came any closer. (Tr. 260.) No one took TFO [BK]’s pulse, heart rate, height, weight or blood pressure. (Tr. 258.) Nor did TFO [BK] submit a urinalysis for drug testing. (Tr. 258.) Respondent conducted no physical, neurological, musculoskeletal or other examination of TFO [BK]. (Tr. 260, 262.) Respondent gave TFO [BK] a prescription for 120 Vicodin 10/325 mg, a hydrocodone/acetaminophen compound and Schedule II narcotic. (Tr. 256.) The quantity was enough for thirty-five days. (Tr. 256.) Respondent did not discuss the medication’s risks and benefits. (Tr. 262.) TFO [BK] testified that Respondent told him that Respondent has some patients who get drugs off the street, and ‘‘I don’t care whether you are or not, I have patients that do that . . . .’’ (Gov’t Ex. 22 at 162.) Respondent told TFO [BK] that it is more expensive to buy drugs off the street. Therefore, some of Respondent’s patients come to him to be evaluated and obtain prescriptions at a lower price. (Tr. 263.) TFO [BK] testified that the people present in Respondent’s waiting room were in their twenties and thirties and appeared sleepy. (Tr. 259, 284.) TFO [BK] estimated observing between fifteen and twenty patients. (Tr. 284.) He did not notice any outward signs of chronic pain. (Tr. 259.) Respondent recommended that TFO [BK] fill his prescription at Community Pharmacy, located approximately thirteen miles away. There was a coupon for Community Pharmacy in the lobby. (Tr. 264.) (2) TFO [BK] Undercover Visit of December 23, 2009 On December 23, 2009, TFO [BK] provided no identification whatsoever, nor did he provide medical records, but Respondent nevertheless allowed him a second office visit. (Tr. 266–67.) TFO [BK] possessed a functioning audio and video recording device and transmitter. (Tr. 264–65.) The visit lasted between five and ten minutes. (Tr. 266.) TFO [BK] brought no proof of injury to the second visit. (Tr. 266.) He filled out intake forms, leaving the pain scale blank. (Tr. 266.) On cross examination, TFO [BK] agreed that circling ‘‘zero’’ indicated ‘‘with medication, no pain.’’ (Tr. 281.) He also told Respondent that he was obtaining medication ‘‘here and there.’’ (Tr. 282; see Gov’t Ex. 23.) He told Respondent he was experiencing ‘‘general pain.’’ (Tr. 285.) The transcript of the visit corroborates that Respondent suggested to TFO [BK] options in terms where his pain might stem from. (Gov’t Ex. 23 at 171; Tr. 297.) The evidence VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 supports TFO [BK]’s assertion that ‘‘I followed [Respondent] down the road I was led.’’ (Tr. 287.) Respondent told TFO [BK] that he would need to obtain proof of injury. (Tr. 268, 285.) As with the first visit, TFO [BK] testified that Respondent recommended getting a discount MRI at Simon Med. Also as with the first visit, this testimony is inconsistent with other record evidence.15 (Tr. 268.) TFO [BK] testified that during the second visit, Respondent prescribed the same prescription as at the first visit: 120 count Vicodin 10/325 mg. (Tr. 265.) Vicodin is a controlled substance. (Tr. 298.) On cross examination, TFO [BK] conceded that while he had requested ‘‘Oxy 30s . . . I got [a lesser strength].’’ (Tr. 283.) TFO [BK] filled the second prescription at Community Pharmacy. (Tr. 269.) Respondent did not discuss a treatment plan, nor did he discuss the risks and benefits of the medication he prescribed to TFO [BK]. (Tr. 269.) No one took TFO [BK]’s vital signs, nor did TFO [BK] submit a urinalysis for drug testing. (Tr. 267.) Neither Respondent nor his staff conducted a physical, neurological or musculoskeletal examination of TFO [BK], and Respondent again sat four to six feet away from him throughout the course of the meeting. (Tr. 267–68.) (l) Dr. Borowsky’s Evaluation Regarding Undercover Visits to Respondent The Government’s expert witness, Dr. Borowsky, reviewed Respondent’s records relating to the undercover visits discussed above by TFO [JB] and TFO [BK], to determine whether Respondent complied with the standard of care in prescribing opioids. (Tr. at 408, 410.) In evaluating Respondent’s conduct, Dr. Borowsky relied on the Arizona Medical Board Guidelines for the Use of Controlled Substances for the Treatment of Chronic Pain. He also relied on the Model Policy for the Use of Controlled Substances for the Treatment of Pain, published by the Federation of State Medical Boards. (Tr. 411–13.) Dr. Borowsky found that Respondent’s evaluation and treatment was nearly identical for both patients, and ‘‘[t]he medical records showed no substantiation for a diagnosis, a plan, or a treatment with opioid medication 15 As Respondent notes (Resp’t Br. at 11 ¶ 37), TFO [BK]’s testimony about Simon Med is inconsistent with the transcript and recording of the second visit, which contain no reference to Simon Med. (Gov’t Exs. 23 & 26.) I do not assign any weight to TFO [BK]’s testimony about Simon Med. I find, however, TFO [BK]’s other testimony to be generally credible and internally consistent. See supra text at note 14 (discussing similar issue). PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 . . ..’’ (Tr. 416.) He further found that both patients presented as drug-seeking individuals due to their lack of insurance, complaints of zero pain on a pain scale, and lack of background history or documentation to support any claims of pain. (Tr. 418–19.) He testified that Respondent failed to acquire patient histories and that Respondent’s documentation was both ‘‘inappropriate’’ and ‘‘inadequate.’’ (Tr. 421, 430.) Moreover, he testified that Respondent did not conduct any physical examination of TFO [BK] at either visit. (See Tr. 421–22.) With respect to TFO [JB], he found that Respondent did not conduct a physical examination on one visit, and that for the other visit Respondent’s statement that ‘‘I’m poking you’’ did not constitute an adequate physical examination. (Tr. at 421–22.) Respondent moreover failed to conduct neurological or musculoskeletal examinations. (Tr. 422– 23.) Respondent did not document an adequate treatment plan or plan for periodic review for either patient. (Tr. 424–28.) Respondent did not perform urinalysis or other drug screens on either patient. (Tr. 428.) Nor did he access the Arizona PMP. (Tr. 428.) Respondent did not consult with specialists. (Tr. 428.) In sum, Dr. Borowsky credibly found that Respondent’s prescription of controlled substances to TFO [BK] and TFO [JB] were not issued for a legitimate medical purpose. (See Tr. at 431.) (m) Deaths of Three Individuals (1) [CS] Respondent’s patient [CS] was born on June 26, 1968, and died on January 6, 2010. (Tr. 105; Gov’t Ex. 8.) A PMP report shows that Respondent prescribed controlled substances to [CS] starting in approximately August 2008, with the most recent prescription on December 31, 2009 for 90 oxycodone 15 mg and 60 alprazolam 2 mg. (Tr. 106– 07; Gov’t Ex. 9.) The oxycodone prescription was filled on New Year’s Eve; the alprazolam prescription was filled on January 2, 2010. (Tr. 107.) The PMP report indicates that Respondent saw [CS] monthly. (Tr. 108.) According to an autopsy report, a bottle of oxycodone was found near [CS]’s body. (Gov’t Ex. 10 at 2.) Respondent had recently prescribed oxycodone to [CS]. (Tr. 109.) The autopsy report listed the cause of death as ‘‘Intoxication due to the combined effects of multiple prescription medications including oxycodone.’’ (Gov’t Ex. 10 at 1; Tr. 109.) TFO Dean testified that he did not know the colors of various pills listed in E:\FR\FM\12JNN1.SGM 12JNN1 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices srobinson on DSK4SPTVN1PROD with NOTICES the police report as present when [CS] died: calcium, folic acid, CVS vitamins, vitamin D and zinc. (Tr. 150–51.) Even carisoprodol, which is usually white, can be a different color depending on the brand. (Tr. 151; see generally Tr. 152; Gov’t Ex 8 & 9.) TFO Dean testified that Respondent was one of several doctors prescribing medication for [CS] shortly before her death, based on the PMP report. (Tr. 156; see Gov’t Ex. 9.) Indeed, TFO Dean testified that Respondent was not the only doctor prescribing oxycodone and hydrocodone to [CS]. (Tr. 157–58; see Gov’t Ex. 9 at 69.) TFO Dean testified that a patient who receives prescriptions for the same controlled substance from multiple doctors is an indication of diversion. (Tr. 170–71.) ´ [RF], Respondent’s patient and fiancé of [CS], testified about the circumstances of [CS]’s death. Having known [CS] since 2006 and being generally aware of [CS]’s many medical problems, [RF] testified that he found it impossible that Respondent had anything to do with [CS]’s death. (Tr. 550–53, 555–56.) In the weeks before her death, [CS] suffered an injury to her ileostomy wound for which she did not seek treatment. (Tr. 558, 575.) On the day [CS] died, [RF] testified that [RF] did not see her take any medication nor does he recall seeing a bottle of oxycodone near [CS] when she died. (Tr. 561–62.) [RF] also testified that Respondent is a good doctor and that he did not observe anything unusual in Respondent’s practice. (Tr. 566, 569.) I find [RF]’s testimony credible. His testimony was internally consistent and the witness was able to recall factual events with a reasonable level of certainty. (2) B.R. B.R. was born on February 14, 1985, and died on February 10, 2010. (Tr. 111, Gov’t Ex. 11.) Investigators at the time of death found medications that Respondent prescribed. (Tr. 111.) In particular, investigators found a blue medication bottle with prescription number C255226 prescribed to Respondent’s patient ‘‘[TR],’’ filled December 16, 2009, for alprazolam 2 mg tablets. (Tr. 112.) They also found two and one half white tablets imprinted with ‘‘G3722,’’ which is consistent with an alprazolam two milligram tablet. (Tr. 112.) A PMP report reveals that Respondent wrote an alprazolam prescription to [TR] on November 19, 2009, which was filled on December 16, 2009. (Tr. 114; Gov’t Ex. 12.) An autopsy of Mr. B.R.’s body revealed the presence of alprazolam. (Tr. 115; Gov’t Ex. 15.) VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 On cross examination, TFO Dean conceded that neither he nor any agent interviewed Respondent’s patient, [TR], at the time of Mr. B.R.’s death. (Tr. 164.) However, ‘‘[h]e spoke with someone recently.’’ (Tr. 164.) TFO Dean said he believed [TR] is no longer a patient of Respondent and stated that [TR] acquired prescriptions for controlled substances after Respondent’s DEA COR was suspended. (Tr. 165–66.) (3) [MC] On November 27, 2009, [MC] was found dead in his house with foam coming out of his mouth. (Tr. 101, 137; Gov’t Ex. 5.) Prescription bottles with Respondent’s name on them were found near his body. (Tr. 101.) A PMP report confirmed that Respondent prescribed controlled substances to [MC]. (Tr. 98, 101; Gov’t Ex. 5.) In particular, [MC] ‘‘received prescriptions for amphetamine salts in a 30-milligram tablet, oxycodone in a 30milligram tablet. Also alprazolam in a two-milligram tablet.’’ (Tr. 99.) On November 24, 2009, just days before he died, [MC] received ‘‘70 alprazolam two-milligram tablets, 150 oxycodone 30-milligram tablets, and 35 amphetamine salt 30-milligram tablets.’’ (Tr. 99–100.) These prescriptions constituted only minor variations from what Respondent prescribed to [MC] in the past. (Tr. 100.) Substances present in [MC]’s blood at death included oxycodone metabolites, amphetamine, alprazolam and nordiazepam. (Tr. 103; Gov’t Ex. 7.) TFO Dean testified that these substances were consistent with Respondent’s prescriptions. (Tr. 103.) On cross examination, TFO Dean conceded that Respondent did not prescribe the diazepam. (Tr. 148; see Gov’t Ex. 6.) Indeed, the PMP report did not show that [MC] had received diazepam, a controlled substance, from any doctor. (Tr. 148–49.) [MC]’s house contained evidence that he abused cocaine or other drugs. (See Tr. 137–38.) There was a square piece of mirror on the armoire, with white powder residue and a red straw, and a credit card with white powder residue on it. (Tr. 141.) TFO Dean testified that this was consistent with both cocaine and also with smashing and snorting oxycodone and alprazolam. (Tr. 141– 42.) Alprazolam is commonly snorted. (Tr. 142.) TFO Dean testified that he did not know what the white powdery substance in the bedroom was. (Tr. 142.) In addition, the bedroom armoire contained several plastic baggies containing a white powdery residue that TFO Dean testified was consistent with drug sales and storage. (Tr. 142–43.) The PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 35011 small digital scales and syringes found near [MC] were also consistent with drug distribution. (Tr. 144.) TFO Dean testified that the substances in the white plastic baggies could have been a variety of substances, including substances Respondent did not prescribe. (Tr. 143.) Moreover, the white powdery substance was never tested. (Tr. 143.) TFO Dean conceded that the plastic baggies could have been the source of the white powder on the armoire. (Tr. 144.) TFO Dean did not know when the bottles and partially used blister pack found near [MC] at death had been used. (Tr. 138.) TFO Dean also conceded that the police report of [MC]’s death was unclear as to whether any medication remained in the bottles labeled oxycodone 30 mg, alprazolam or amphetamine salts. (Tr. 139–40.) TFO Dean also testified to being unfamiliar with a number of drugs that the police report listed as present near [MC]’s body: biobolt, undecyclenate and eltrenam. (Tr. 144–45.) The police report indicated that one of the drugs was indicated ‘‘for veterinary use,’’ which led TFO Dean to speculate it was not prescribed to an individual for his own use. (Tr. 145.) TFO Dean also conceded that [MC]’s housemates told the police that [MC] had some injuries. (Tr. 146.) Referring to the PMP report for [MC] (see Gov’t Ex. 6), TFO Dean indicated that a prescription for Suboxone was prescribed by Michael Warren Carlton and not by Respondent. (Tr. 146.) III. The Parties’ Contentions A. Government The Government argues that Dr. Borowsky’s testimony, which was unrebutted, establishes by a preponderance of the evidence that Respondent failed to act within the bounds of professional practice and issued controlled substances without a legitimate medical purpose, in contravention of the law, such as 21 C.F.R. § 1306.04 (2010). (Gov’t Br. 23.) The Government also highlights Dr. Borowsky’s testimony. Analyzing whether Respondent conformed to Arizona practice standards, Dr. Borowsky testified that Respondent’s medical records demonstrated no substantiation for a diagnosis plan or treatment with opioid medication. (Tr. 416.) Dr. Borowsky opined that Respondent’s evaluation and treatment of undercover agents TFO [JB] and TFO [BK] posing as patients who exhibited drug-seeking behavior (Tr. 416; Gov’t Ex. 18 at 130), ‘‘was identical and exhibited no adherence to the Guidelines for Treatment of Chronic E:\FR\FM\12JNN1.SGM 12JNN1 35012 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices srobinson on DSK4SPTVN1PROD with NOTICES Pain from the Arizona Medical Board.’’ (Gov’t Ex. 18 at 130.) With Respect to TFO [BK], for instance, Dr. Borowsky testified that Respondent should not have prescribed 120 Vicodin 10 mg. (Tr. 421.) Moreover, the Government argues that Respondent performed no patient monitoring, indicated by the lack of drug screens or access to the Arizona PMP. (Gov’t Ex. 18 at 130.) Respondent did not take a patient history, perform a physical examination, execute a treatment plan, provide informed consent and a treatment agreement, consult with specialists or maintain adequate and accurate medical records. (Gov’t Ex. 18 at 130–31.) The Government also argues that Respondent has failed to accept responsibility for his actions. (Gov’t Br. at 26.) The Government notes that Respondent has failed to admit specific wrongdoing, and has merely made a blanket assertion of ‘‘shortcomings.’’ The Government finally argues that because the Government has made a prima facie case, the burden of proof shifts to Respondent, and Respondent has failed to demonstrate he will not engage in future misconduct. B. Respondent Respondent argues in defense that he ¨ is naıve. (Tr. 24.) While he concedes he was casual about documentation (see Tr. 24, 28–29), he argues he is not indifferent to drug abuse and diversion and has no state convictions. (Tr. 24.) Respondent argues that opening a new practice in August of 2009 was a ‘‘learning experience’’ (Tr. 25), which was a ‘‘work in progress period.’’ (Tr. 28.) Respondent argues that, over time, he has sought to improve his practice standards. For instance, Respondent terminated over 250 patients for failing drug screens or failing to produce health records. (Tr. 27; see generally Tr. 752.) Additionally, Respondent has accepted the Arizona Medical Board’s requirement that he establish a monitoring program for his documentation. (Tr. 29.) Moreover, Respondent has started dictating his reports. (Tr. 28.) In any event, Respondent denies that the care of his patients was substandard. (Tr. 28.) He moreover argues that except as confirmed by the recordings and transcripts of TFO [BK]’s undercover visits, the testimony of TFO [BK] is not credible. (Resp’t Br. at 11 ¶ 41.) In addition, Respondent contends that ‘‘no reasonable conclusion can be drawn from the fact of [the] numbers or frequencies’’ of controlled substances that Respondent prescribed. (Resp’t Br. at 32.) Finally, Respondent argues that VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 there is no causal connection between Respondent’s prescribing practices and the deaths of [CS], B.R. and [MC]. (Tr. 27.) III. Discussion and Conclusions A. The Applicable Statutory and Regulatory Provisions The Controlled Substances Act (CSA) provides that any person who dispenses (including prescribing) a controlled substance must obtain a registration issued by the DEA in accordance with applicable rules and regulations.16 ‘‘A separate registration shall be required at each principal place of business or professional practice where the applicant . . . dispenses controlled substances.’’ 17 DEA regulations provide that any registrant may apply to modify his registration to change his address but such modification shall be handled in the same manner as an application for registration.18 ‘‘A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner’’ with a corresponding responsibility on the pharmacist who fills the prescription.19 It is unlawful for any person to possess a controlled substance unless that substance was obtained pursuant to a valid prescription from a practitioner acting in the course of his professional practice.20 In addition, I conclude that the reference in 21 U.S.C. § 823(f)(5) to ‘‘other conduct which may threaten the public health and safety’’ would as a matter of statutory interpretation logically encompass the factors listed in § 824(a).21 In an action to revoke or deny a registrant’s application for a DEA COR, the DEA has the burden of proving that the requirements for granting registration are not satisfied.22 The burden of proof shifts to Respondent once the Government has made its prima facie case.23 16 21 U.S.C. § 822(a)(2). U.S.C. § 822(e). 18 21 C.F.R. § 1301.51 (2010). 19 21 C.F.R. § 1306.04(a). 20 21 U.S.C. § 844(a). 21 See Kuen H. Chen, M.D., 58 Fed. Reg. 65,401, 65,402 (DEA 1993). 22 See 21 C.F.R. § 1301.44(d) (2010). 23 Medicine Shoppe—Jonesborough, 73 Fed. Reg. 364, 380 (DEA 2008); see also Thomas E. Johnston, 45 Fed. Reg. 72,311, 72,311 (DEA 1980). 17 21 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 B. Material Falsification of Application The CSA, at 21 U.S.C. § 824(a)(1), provides, insofar as pertinent to this proceeding, that the Deputy Administrator may revoke a registration if an applicant or registrant ‘‘has materially falsified any application filed pursuant to or required by this subchapter or subchapter II of this chapter.’’ The evidence reflects that Respondent falsified his applications for renewal of his DEA registration on at least one occasion, by answering ‘‘no’’ to the liability questions, notwithstanding the fact that Respondent had previously had his medical license suspended in 2001. TFO Dean testified in substance that his investigation revealed Respondent falsified his application because the Arizona Medical Board previously investigated and suspended Respondent’s medical license. (Tr. 85– 86.) Respondent testified that he did not ‘‘really have a good answer’’ for why he said ‘‘no’’ on the re-registration form, ‘‘other than I didn’t pay much attention to the wording.’’ Respondent maintained that he ‘‘never tried to deceive anyone.’’ (Tr. 760–61.) The evidence also includes a September 21, 2010 sworn certification by Richard A. Boyd, Chief, DEA Registration and Support Section, stating in substance that he is the DEA official charged with custody and control of all documents relative to registration of practitioners, among others. Mr. Boyd certified that DEA registration ‘‘BM2040498 was assigned to [Respondent] on October 4, 1998, that the last two renewals of this registration were issued to [Respondent] on January 29, 2005, at the address of Access2care Family Medical Center, 4607 N. 12th Street, Phoenix, Arizona 85014.’’ (Gov’t Ex. 28.) (emphasis supplied). Mr. Boyd further certified that Respondent answered ‘‘background questions’’ to include: ‘‘3. Has the applicant ever had a state professional license or controlled substance registration revoked, suspended, denied, restricted, or place [sic] on probation, or is any such action pending? ‘No’.’’ (Id.) The evidence also includes a June 30, 2010 sworn certification from Mr. Boyd, certifying that DEA registration ‘‘BM2040498 was assigned to [Respondent] on or before October 04, 1989 . . . [and the] last renewal of this registration was on January 29, 2008. . . . ’’ (Gov’t Ex. 1.) (emphasis supplied). The evidence further includes a DEA Master Information Report for DEA Number BM2040498, reflecting a registration date of October E:\FR\FM\12JNN1.SGM 12JNN1 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices srobinson on DSK4SPTVN1PROD with NOTICES 10, 1989, and last renewal date of January 29, 2008. (Gov’t Ex. 1 at 2.) Neither the testimony at hearing nor the post-hearing briefs addressed the date discrepancies between the two certifications, nor is it entirely apparent from the record evidence exactly what the correct dates should be. For example, the September 21, 2010 sworn certification indicates an assignment of registration on October 4, 1998, and then states the last two renewals were issued on January 29, 2005. Clearly the last two renewals were unlikely to both have been issued on the same date, which is also consistent with Respondent’s testimony that he believes he last renewed his registration in 2008. (Tr. 795.) The information contained within the DEA Master Information Report is also consistent with Respondent’s recollection. There is also an unexplained discrepancy regarding the registration assignment date, with one date listed as October 4, 1998 (Gov’t Ex. 28) and the second listed as ‘‘on or before October 04, 1989,’’ (Gov’t Ex. 1 at 2.) Again, the DEA Master Information Report (Gov’t Ex. 1 at 2) suggests that the ten-year discrepancy between the initial registration dates listed in the two certifications may simply be a typographical error, but speculating on possible reasons for the errors offers little assurance about the reliability of either certification. The issue of dates is certainly material, because the premise of the false statement allegation rests on when Respondent was first subject to a suspension that could serve as the predicate for a false statement. The record establishes that Respondent’s first relevant suspension occurred in 2001. (See Gov’t Ex. 3 at 4.) I find the inconsistencies and apparent errors in the two DEA certifications discussed above of sufficient consequence to preclude their use as substantial evidence for purposes of relevant dates.24 Accordingly, I do not assign any weight to Mr. Boyd’s June 30, 2010 (Gov’t Ex. 1 at 1) or September 21, 2010 (Gov’t Ex. 28) certifications with regard to information as to Respondent’s registration or re-registration dates. The remaining record evidence, including the DEA Master Information 24 I also note there is significant Agency precedent taking official notice of records of the Agency, to include filing of renewal applications. See, e.g. East Main Street Pharmacy, 75 Fed. Reg. 66,149, 66,152 (DEA 2010). The errors evidenced in the instant record, however, undermine any use of official notice to clarify this issue, because the record does not reveal whether the errors are due to preparation of the sworn certifications or whether the record checks of agency data on different dates produce different results. VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 Report (Gov’t Ex. 1 at 2) and Respondent’s testimony, does support a finding by substantial evidence that on one occasion in January 2008 Respondent materially falsified his application for re-registration, by failing to acknowledge a prior adverse action against his state medical license. A DEA COR may be revoked based on an unintentional falsification of an application, ‘‘but lack of intent to deceive is a relevant consideration in determining whether a registrant or applicant should possess a DEA registration.’’ Rosalind A. Cropper, M.D., 66 Fed. Reg. 41,040, 41,048 (DEA 2001). The unrebutted record evidence reflects that on November 6, 2000, the Arizona Medical Board issued Respondent a Letter of Reprimand, a $5,000.00 fine and forty hours of continuing medical education (CME), among other restrictions. (Gov’t Ex. 2 at 4.) On December 6, 2001, the same entity entered an order suspending Respondent’s medical license for a period of twelve months, but stayed the suspension during a probationary period. (Gov’t Ex. 3 at 4.) The gravamen of Respondent’s misconduct was an instance of Respondent prescribing without first conducting a physical examination or establishing a physicianpatient relationship with an undercover agent. Respondent’s history of state action regarding his medical license, as set forth below in further detail,25 was sufficiently significant that he could not under any reasonable circumstances have answered the relevant background question in the negative. Respondent’s brief explanation of the issue, including a claim of lack of intent to deceive, is not credible. Respondent’s failure to disclose the relevant information was material because it had ‘‘a natural tendency to influence, or was capable of influencing’’ the decision to renew Respondent’s registration. Gilbert Eugene Johnson, M.D., 74 Fed. Reg. 65,663, 65,665 (DEA 2010). In fact, DEA renewed Respondent’s registration in January 2008, a decision that relied in part on Respondent’s false statement. Accordingly, I find the Government has met its burden of proving a violation of Section 824(a)(1), see 21 CFR § 1301.44(d) (2010), placing the burden on Respondent to show that despite his material false statement, revoking his registration would be contrary to the public interest. Medicine Shoppe— Jonesborough, 73 Fed. Reg. 364, 380 (DEA 2008); see also Thomas E. Johnston, 45 Fed. Reg. 72,311, 72,311 (DEA 1980). I further find that for 25 Infra PO 00000 Section III.D. Frm 00081 Fmt 4703 reasons set forth below, revoking Respondent’s COR is in the public interest and substantial evidence supports revocation of Respondent’s COR on the material falsification ground alone. C. The Public Interest Standard The CSA, at 21 U.S.C. § 824(a)(4), provides, insofar as pertinent to this proceeding, that the Deputy Administrator may revoke a COR if she finds that the continued registration would be inconsistent with the public interest as that term is used in 21 U.S.C. § 823(f). Pursuant to 21 U.S.C. § 823(f), the Deputy Administrator may deny an application for a DEA COR if she determines that such registration would be inconsistent with the public interest. In determining the public interest, the Deputy Administrator is required to consider the following factors: (1) The recommendation of the appropriate state licensing board or professional disciplinary authority. (2) The applicant’s experience in dispensing, or conducting research, with respect to 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. As a threshold matter, the factors specified in Section 823(f) are to be considered in the disjunctive: the Deputy Administrator may properly rely on any one or a combination of those factors, and give each factor the weight she deems appropriate, in determining whether a registration should be revoked or an application for registration denied. See David H. Gillis, M.D., 58 Fed. Reg. 37,507, 37,508 (DEA 1993); see also D & S Sales, 71 Fed. Reg. 37,607, 37,610 (DEA 2006); Joy’s Ideas, 70 Fed. Reg. 33,195, 33,197 (DEA 2005); Henry J. Schwarz, Jr., M.D., 54 Fed. Reg. 16,422, 16,424 (DEA 1989). Additionally, in an action to revoke a registrant’s COR, the DEA has the burden of proving that the requirements for revocation are satisfied.26 The burden of proof shifts to the registrant once the Government has made its prima facie case. 26 21 Sfmt 4703 35013 E:\FR\FM\12JNN1.SGM CFR § 1301.44(e) (2010). 12JNN1 35014 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices srobinson on DSK4SPTVN1PROD with NOTICES D. The Factors to Be Considered Factors 1 and 3: The Recommendation of the Appropriate State Licensing Board or Professional Disciplinary Authority and Conviction Record Under Federal or State Laws Relating to the Manufacture, Distribution or Dispensing of Controlled Substances In this case, regarding Factor One, it is undisputed that Respondent currently holds a valid medical license in the State of Arizona, but Respondent’s medical license has been the subject of state disciplinary action in the past. On November 6, 2000, the Arizona Medical Board, pursuant to a consent order, issued Respondent a Letter of Reprimand, a $5,000.00 fine and forty hours of CME, among other restrictions. (Gov’t Ex. 2 at 4.) The stipulated findings of fact included an instance of Respondent prescribing without first conducting a physical examination or establishing a physician-patient relationship with an undercover agent of the Food and Drug Administration. (Gov’t Ex. 2.) On December 6, 2001, the Board entered an order suspending Respondent for a period of twelve months, which was stayed during a probationary period. Respondent was further required to complete the requirements of the November 6, 2000 Board order. (Gov’t Ex. 3.) On August 11, 2010, pursuant to a consent order, the Board issued Respondent a Letter of Reprimand and two years’ probation with terms and conditions to include Board preapproved monitoring (periodic chart reviews) by a contractor. (Gov’t Ex. 27 at 4–5.) The Board action was initiated ‘‘after receiving a complaint regarding Respondent’s care and treatment of five patients. During the Board’s investigation, five patient charts were reviewed and deviations were found in all five.’’ (Gov’t Ex. 27 at 1.) The Board concluded Respondent’s conduct constituted ‘‘unprofessional conduct pursuant to A.R.S. § 32–1401(27)(e) (‘[f]ailing or refusing to maintain adequate records on a patient.’) and A.R.S. § 32–1401(27)(q) (‘[a]ny conduct or practice that is or might be harmful or dangerous to the health of the patient or the public.’).’’ (Id. at 4.) The most recent action by the Arizona Medical Board reflects a determination that Respondent, notwithstanding findings of unprofessional conduct, can be entrusted with a medical license subject to probationary terms and conditions. While not dispositive,27 this 27 Mortimer B. Levin, D.O., 55 Fed. Reg. 8209, 8210 (DEA 1990) (finding DEA maintains separate oversight responsibility and statutory obligation to VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 action by the Arizona Medical Board does weigh against a finding that Respondent’s continued registration would be inconsistent with the public interest. See Robert A. Leslie, M.D., 68 Fed. Reg. 15,227, 15,230 (DEA 2003) (under Factor One, prior suspension of respondent’s state medical license held not dispositive where state license currently under no restrictions). Regarding Factor Three, there is no evidence that Respondent has ever been convicted under any federal or state law relating to the manufacture, distribution or dispensing of controlled substances. I therefore find that this factor, although not dispositive, weighs against a finding that Respondent’s continued registration would be inconsistent with the public interest. Factors 2 and 4: Respondent’s Experience in Handling Controlled Substances; and Compliance With Applicable State, Federal or Local Laws Relating to Controlled Substances (a) Respondent’s Registered Location Federal law requires every person who dispenses (including prescribing) any controlled substance to obtain a registration from the Attorney General.28 Additionally, a separate registration must be obtained for each principal place of practice where a registrant dispenses controlled substances and a registrant must report any change of address by applying to modify his or her registration to change his or her address, which shall be treated as an application for registration.29 The Code of Federal Regulations delineates the procedures a registrant must follow to request a change in registered address.30 In this case, the undisputed evidence indicates that Respondent’s DEA registered address is ‘‘Access2care Family Medical Center, 4607 N. 12th Street, Phoenix, Arizona 85014.’’ (Gov’t Ex. 28.) In or about August 2009, Respondent moved from that location to his current practice at 16601 N. 40th Street, Suite 115, Phoenix, Arizona. (Tr. 36, 90.) Respondent testified that he was unaware that he had to notify DEA when he moved to his new office. (Tr. 760.) In mitigation, Respondent explained that ‘‘I called the Arizona Medical Board and gave them my change of address. I didn’t know that I had to do anything more than that.’’ (Tr. 760.) make independent determination whether to grant registration). 28 21 U.S.C. § 822(a)(2). 29 21 U.S.C. §§ 822(e), 827(g); 21 C.F.R. § 1301.51 (2010). 30 See 21 C.F.R. § 1301.51 (2010). PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 Respondent’s failure to properly request a change in registered location does not appear to have been done with intent to deceive, given the unrebutted testimony that Respondent notified the Arizona Medical Board of the change. It does, however, demonstrate Respondent’s lack of compliance with applicable DEA regulations, weighing in favor of a finding that Respondent’s continued registration would be inconsistent with the public interest. (b) Deceased Patients [MC] and [CS]; B.R. The evidence at hearing included information related to the deaths of two of Respondent’s patients: [MC], who died on November 27, 2009; [CS], who died on January 6, 2010; and a nonpatient, B.R., who died on February 10, 2010, in possession of a prescription issued to Respondent’s patient [TR]. (Tr. 93.) The documentary evidence with regard to patient [MC] consists of a police report, a PMP report for [MC], and an autopsy report. (Gov’t Exs. 5–7.) The autopsy report lists the cause of death as accidental ‘‘combined drug toxicity.’’ (Gov’t Ex. 7.) The findings of a toxicological report noted positive findings for the presence of: oxycodone, noroxycodone, oxymorphone, amphetamine, alprazolam and nordiazepam. (Gov’t Ex. 7 at 6.) A Phoenix Police Department report noted that [MC] was found dead in his bedroom at home on November 27, 2009, and that located in an adjacent nightstand were three empty prescription bottles for oxycodone, alprazolam and cephalexin, with prescription labels in Respondent’s name, dated between June 2009 and October 2009. (Gov’t Ex. 5.) A partially used fifteen-count ‘‘blister pack’’ for omifin with two blisters remaining was also found. (See Tr. 128.) Also found at the foot of [MC]’s bed were prescriptions bearing Respondent’s name dated November 24, 2009, for oxycodone, alprazolam and amphetamine salt. (Tr. 139–40.) Additionally, an empty prescription bottle of carisoprodol in Respondent’s name was noted.31 (Gov’t Ex. 5 at 7.) The police report also noted that on top of an armoire in the bedroom rested a mirror with white powder residue, along with a red straw and credit card. (Tr. 137–8, 141.) Inside the armoire were numerous small plastic bags, several of which contained white 31 The spelling in the police report of Respondent’s name as ‘‘Dr. Moher,’’ (see Gov’t Ex. 5 at 7), appears to be a typographical error. E:\FR\FM\12JNN1.SGM 12JNN1 srobinson on DSK4SPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices powder residue and digital scales, among other items. (Tr. 142–43.) TFO Dean testified that he did not participate in the investigation pertaining to [MC]’s death, other than having a few conversations with detectives at the Phoenix Police Department. (Tr. 95.) TFO Dean further testified that he was unaware of what the white powdery substance was, but the items found in the bedroom were consistent with buying, selling and storing drugs. (Tr. 143.) TFO Dean also opined that the mirror, white powder residue, straw and credit card were consistent with drug use, common to cocaine use and ‘‘also common to the process of smashing up oxycodone or alprazolam, and using those to snort drugs.’’ (Tr. 141–42.) TFO Dean also testified that the PMP report confirmed that Respondent prescribed controlled substances to [MC] just prior to [MC]’s death, but the report did not reflect any prior prescriptions for diazepam. (Tr. 148–49.) The documentary evidence with regard to patient [CS] consists of a police report, a prescription history report and an autopsy report. (Gov’t Exs. 8–10.) The January 8, 2010 autopsy report found cause of death to be ‘‘[i]ntoxication due to the combined effects of multiple prescription medications including oxycodone.’’ (Gov’t Ex. 10 at 1.) The report also noted a history of Crohn’s disease and depression, and a ‘‘bottle of oxycodone, found in close proximity to her, appeared to have been taken at an accelerated rate.’’ (Id. at 2.) A PMP history report covering the time period January 1, 2008 to March 8, 2010, reflects that [CS] was prescribed multiple controlled substances by multiple practitioners, including Respondent. (Gov’t Ex. 9.) A Tempe, Arizona Police Department report dated January 6, 2010, reflects that [CS] was found unresponsive at home by her ´ fiancé, [RF]. (Gov’t Ex. 8 at 2.) It further notes that [CS] suffered from numerous medical conditions including Crohn’s disease, and had been complaining of a fever and hip pain. (Gov’t Ex. 8 at 2.) Contrary to the autopsy report, the police report does not reflect any notations regarding a bottle of oxycodone found in close proximity to [CS] or evidence that it was taken at an accelerated rate. (Tr. 161. Compare Gov’t Ex. 10 at 2, with Gov’t Ex. 8.) Respondent presented the testimony ´ of [CS]’s fiancé, [RF], regarding the circumstances of [CS]’s death. [RF] testified in substance that he had known [CS] since 2006, and is himself a patient of Respondent. (Tr. 550–51.) [RF] testified to a number of medical VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 problems that [CS] had experienced and found it impossible that Respondent’s care had anything to do with her death. (Tr. 552–53, 555–56.) [RF] testified that [CS] had been ‘‘unusually sick’’ a couple of weeks prior to her death and that she had had an altercation with a police officer, to include an injury to her ileostomy wound. (Tr. 558.) [RF] testified that [CS] did not seek any medical attention as a result of the altercation. (Tr. 556, 575.) [RF] further testified that on the day of [CS]’s death he did not see her take any medications and does not recall seeing a bottle of oxycodone anywhere in proximity to [CS] at the time of her death. (Tr. 561– 62.) [RF] also testified that in his experience Respondent is a good doctor, and he has not observed anything unusual at Respondent’s practice. (Tr. 566, 569.) The documentary evidence regarding the death of B.R. on February 10, 2010, includes a police report, an autopsy report and a PMP report for prescriptions issued to [TR]. (Gov’t Exs. 11–13.) The evidence at hearing reflected that Mr. B.R. was not a patient of Respondent, but an empty medication bottle bearing prescription number C255226 and prescribed by Respondent to patient [TR] on December 16, 2009, for 70 alprazolam 32 2 mg tablets was found near Mr. B.R.’s body. (Tr. 112.) Other items found in the vicinity included empty beer bottles, short straws, a rolled up one dollar bill with white residue inside and a plastic baggie containing two and one half pills, identified in the police report as alprazolam 2 mg tablets. (Gov’t Ex. 11; Tr. 93, 112–13.) A PMP report for patient [TR] reflects a prescription for 70 alprazolam 2 mg tablets written by Respondent on November 19, 2009, with a fill date of December 16, 2009. (Gov’t Ex. 12.) A February 11, 2010 autopsy report for B.R. listed the cause of death as accidental acute opiate, benzodiazepine and alcohol intoxication. (Gov’t Ex. 13.) Respondent argues that the Government has not proven by a preponderance of the evidence that the deaths of two patients and a third person stem from Respondent’s prescribing practices.33 In fact, no evidence was presented at hearing involving any of the foregoing patients’ medical files, nor did either party offer testimony or other evidence of specific facts surrounding Respondent’s prescribing practices with regard to 32 Alprazolam is a benzodiazepine and Schedule IV depressant. See 21 C.F.R. § 1308.14(c) (2010); infra note 46. 33 Resp’t Br. at 33–37. PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 35015 patients [TR], [CS] or [MC]. The expert testimony offered at hearing related to only the patient records of two law enforcement undercover agents posing as patients. I find that the Government has not established by a preponderance of the evidence that Respondent’s prescribing practices caused the foregoing deaths. For example, the evidence relating to the death of patient [CS] and the linkage to one oxycodone prescription cited in an autopsy report was directly contradicted by the sworn testimony of [RF], corroborated by the relevant police report. (Compare Gov’t Ex. 10 at 2, with Tr. 561–62, and Gov’t Ex. 8.) In the case of patient [MC], there is evidence that the cause of death was accidental and due to a combination of drugs, (Gov’t Ex. 7 at 1), and other evidence found in the vicinity of [MC]’s body is consistent with the buying, selling and storage of drugs, (Tr. 143). Yet there was no evidence or testimony offered at hearing related to Respondent’s prescribing or treatment of patient [MC]. The evidence regarding patient [TR] and the death of Mr. B.R. is even more tenuous in terms of linking the cause of death to Respondent’s prescribing practices. With regard to all three decedents, there is no evidence of record, such as, for example, relevant medical files, sufficient to determine and evaluate Respondent’s prescribing practices with regard to the three deaths. Making a finding that Respondent’s prescribing practices caused the deaths of these decedents, therefore, would require engaging in pure speculation. ‘‘Speculation is, of course, no substitute for evidence, and a decision based on speculation is not supported by substantial evidence.’’ White ex rel. Smith v. Apfel, 167 F.3d 369, 375 (7th Cir. 1999) (citing Erhardt v. Sec’y, DHS, 969 F.2d 534, 538 (7th Cir. 1992)). I find there is insufficient evidence to conclude that Respondent’s prescribing practices caused the deaths of these decedents. This finding weighs against a finding that Respondent’s continued registration would be inconsistent with the public interest. Although the evidence regarding the foregoing decedents does not support a finding that Respondent’s prescribing practices caused their deaths, the evidence with regard to patient [MC] does reflect varying degrees of drug misuse or acts of diversion by Respondent’s patient, at least as of November 2009. I find this evidence is consistent with other record evidence, including Respondent’s testimony, that Respondent’s prescribing practices during the same time period were significantly deficient in terms of E:\FR\FM\12JNN1.SGM 12JNN1 35016 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices srobinson on DSK4SPTVN1PROD with NOTICES properly supervising his patients to prevent them from abusing or diverting controlled substances. (c) Respondent’s Prescribing Practices The OSC/IS alleged that Respondent prescribes and dispenses inordinate amounts of controlled substances, primarily hydrocodone compounds, Schedule III controlled substances, among others, under circumstances where Respondent knows or should know the prescriptions are not for legitimate medical purposes or are issued outside the course of usual professional practice. (ALJ Ex. 1.) To be effective, and lawful, a prescription for a controlled substance ‘‘must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice . . . An order purporting to be a prescription issued not in the usual course of professional treatment . . . is not a prescription . . . and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.’’ 34 Revocation of an existing registration under the public interest standard of 21 U.S.C. § 823(f) is not limited to practitioners who intentionally violate the prescription requirement, but also includes a ‘‘practitioner’s failure to properly supervise her patients to prevent them from personally abusing controlled substances or selling them to others . . .’’ Jeri Hassman, M.D., 75 Fed. Reg. 8194, 8227 (DEA 2010). A practitioner must also ‘‘have established a bona fide doctor-patient relationship with the individual for whom the prescription is written.’’ Mohammed F. Abdel-Hameed, M.D., 66 Fed. Reg. 61,366, 61,369 (DEA 2009). As to the issue of a bona fide doctor-patient relationship, the CSA looks to state law in determining whether a physician has established a valid doctor-patient relationship. United Prescription Servs., Inc., 72 Fed. Reg. 50,397, 50,407 (DEA 2007). The evidence at hearing regarding Respondent’s prescribing practices included testimony from Dr. Stephen Borowsky, offered by the Government as an expert in pain management. Dr. Borowsky’s testimony and related written report (Gov’t Ex. 18) centered on his review of two patient files (Gov’t Ex. 15 & 16) involving four undercover law enforcement visits to Respondent in November and December 2009. (See also Gov’t Exs. 17 & 18.) Dr. Borowsky’s 34 21 C.F.R. § 1306.04(a) (2010). VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 experience includes board certification in pain medicine, among other specialties, and includes approximately thirty years of experience. (Tr. 378–79.) Dr. Borowsky has practiced in Arizona since 1980 and he has served on several task forces for the Arizona Legislature related to chronic pain. Additionally, Dr. Borowsky participated in the development of Arizona’s Prescription Monitoring Program and at the time of hearing was involved in the care of approximately twenty pain patients per week on the one day per week that he saw pain patients. (Tr. 382–86.) Although Respondent timely objected to the witness’s qualifications ‘‘as a pain management expert in the primary care level,’’ (Tr. 395–96), I have evaluated his testimony as an expert witness in pain management. Dr. Borowsky is clearly qualified to testify as an expert with regard to the standard of care and treatment of patients with pain management issues, based on his education, training and experience over thirty years. Dr. Borowsky’s testimony at hearing was internally consistent and fully credible. Dr. Borowsky testified in substance on direct examination that prior to being contacted by DEA he had no familiarity with Respondent. (Tr. 408). Dr. Borowsky further testified that he was asked to review two patient files in the name of [KR] and [BK] to determine how the records fit with established guidelines for prescribing opiates. (Tr. 410; see Gov’t Exs. 15 & 16.) The evidence also included a written report prepared by Dr. Borowsky discussing his findings and opinion on review of the two patient files. (Gov’t Ex. 18.) Dr. Borowsky next testified to his conclusions regarding the [KR] and [BK] medical files, corresponding to undercover visits by TFO [JB] and TFO [BK]. With regard to both files, Dr. Borowsky’s concluded that the ‘‘records showed no substantiation for a diagnosis, a plan, or a treatment with opioid medication . . . .’’ (Tr. 416.) Additionally, Dr. Borowsky opined that Respondent obtained no patient history in either case and conducted no appropriate physical examination. (Tr. 418–22.) Dr. Borowsky further opined that Respondent issued prescriptions for controlled substances to both patients without a legitimate medical purpose. (Tr. 431.) On cross examination, Dr. Borowsky testified that over the past ten years perceptions of pain management have changed. (Tr. 435.) The term pseudoaddiction means a patient is undertreated with medication and may appear drug seeking, but really requires more medication. (Tr. 435–36.) Dr. PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 Borowsky further testified that treatment of a pseudo-addict requires a rational understanding of the situation rather than just prescribing more medication. (Tr. 437.) Dr. Borowsky also testified that he routinely uses drug screens when prescribing controlled substances (Tr. 440) and only takes cases by referral. (Tr. 445.) Within the standard of care for prescribing opioids, he advised, there is room for individual decisions. (Tr. 458–59.) The testimony from two undercover law enforcement agents, TFO [JB] and TFO [BK], who posed as patients [KR] and [BK], was fully consistent with Dr. Borowsky’s findings. For example, TFO [JB] testified in substance that she met with Respondent at his office for an initial medical appointment on November 13, 2009, and again on December 18, 2009. During the November 13, 2009 initial visit, TFO [JB], posing as patient [KR], met with Respondent for approximately ten minutes, which included Respondent taking a telephone call. (Tr. 207.) TFO [JB] testified that she had marked zero for pain on a patient intake form and at no time during the visit was her pulse, heart rate, height, weight or blood pressure checked, nor was she given a urinalysis drug screen. (Tr. 209–09, 223.) TFO [JB] further testified that Respondent did not discuss a treatment plan, and the only incident arguably consisting of a physical examination occurred at the end of the visit, after Respondent had already indicated his decision to prescribe controlled substances.35 (Tr. 214–15, 246.) The physical examination, such as it was, consisted of asking TFO [JB] to lie on her stomach after which Respondent proceeded to touch her back in several places, ask if it hurt and move her right foot and ankle.36 (Tr. 215.) As a result of the visit, Respondent prescribed 70 35 Because Respondent had already decided to prescribe controlled substances before he palpitated TFO [JB]’s back, I reject Respondent’s argument that Respondent should be credited on the grounds that he did not give TFO [JB] a prescription ‘‘until after the examination . . . .’’ (Resp’t Br. at 8 ¶ 27.) 36 There is also evidence relating to a sexual harassment claim against Respondent, (see, e.g., Tr. 62, 67, 217), and Respondent’s ‘‘flirting’’ and related conduct with patients such as TFO [JB] (see, e.g., Tr. 210, 214–15, 234–36, 246), [JG] (see Tr. 188–89, 198) and [LW] (see Tr. 217). See generally Tr. 264. Respondent and other witnesses testified in substance that Respondent ‘‘flirts’’ with many patients, as a ‘‘joke,’’ which is how he puts patients ‘‘at ease.’’ Inasmuch as this issue was not sufficiently noticed in the OSC/IS, and given its tenuous relevance to the central issues alleged in this case, I do not make any specific factual findings or conclusions with regard to the conflicting testimony. See, e.g., CBS Wholesale Distribs., 74 Fed. Reg. 36,746, 36, 749 (DEA 2009) (discussing notice requirements before relying on given fact in revoking DEA COR). E:\FR\FM\12JNN1.SGM 12JNN1 srobinson on DSK4SPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices oxycodone 30 mg tablets. In partial mitigation, Respondent gave TFO [JB] a warning, in an apparent effort to encourage TFO [JB] to protect herself from theft: these medications . . . there’s a high street value for them . . . it’s not a good idea for you to tell your friends that you’re taking these medications because [even] your mother will take them from you . . . oxycontins . . . go like anywhere from like 40 to 80 dollars a pill . . . So there’s a huge street value. People are always stealing them. So be careful. Uh because if you lose your medications, even if you have a police report, can’t get em. Once a month is all you can get. (Gov’t Ex. 21 at 147–48.) In addition, Respondent’s statement that ‘‘once a month is all you get’’ (Id.) is evidence that Respondent did take some steps to manage his patients and guide them away from abuse or diversion. Similar to the testimony of TFO [JB], TFO [BK] testified in substance that he met with Respondent on November 18, 2009, and again on December 23, 2009, posing as patient [BK]. On his initial office visit, which lasted approximately five to ten minutes, TFO [BK] marked zero for pain on an intake form. (Tr. 257.) Additionally, TFO [BK] provided no prior medical records. (Tr. 258.) TFO [BK] further testified that during the visit he received no examination of any kind, and Respondent gave him a prescription for 120 Vicodin 10–325 tablets. (Tr. 256, 258, 267.) The testimony of TFO [JB] and TFO [BK], as summarized above, was internally consistent, corroborated by objective evidence including recordings and related transcripts, and I find it fully credible.37 This testimony and evidence is moreover consistent with the opinion testimony of Dr. Borowsky. Respondent’s behavior during the undercover visits bears heavily upon whether his continued registration would be inconsistent with the public interest. Respondent’s conduct during the second undercover visit by TFO [BK] tends to show that Respondent recognized it would be improper to issue a prescription to TFO [BK] without proof of injury or past medical records.38 (See Tr. 287, 290; see also Gov’t Ex. 22 at 162 (transcribing Respondent’s statement that TFO [BK] should seek another doctor).) Respondent even offered to refund TFO 37 As noted above, I do not assign any weight to TFO [BK]’s assertions that Respondent suggested he go to Simon Med. See supra text at notes 14 & 15. 38 Respondent also failed to require medical records before prescribing controlled substances to TFO [JB]. (Tr. 219, 247.) VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 [BK]’s money, stating that ‘‘I’m not going to write you narcotics knowing that you’ve already told me that there’s nothing wrong with you.’’ (Gov’t Ex. 23 at 173; Tr. 287–88, 294.) Nevertheless, Respondent issued TFO [BK] a second prescription for controlled substances anyway. The fact that Respondent terminated TFO [BK] as a patient that same day (Tr. 295) evinces Respondent’s recognition that he acted improperly in prescribing controlled substances to TFO [BK]. Moreover, the transcript of TFO [BK]’s second visit to Respondent suggests that Respondent’s professed concerns regarding proof of injury were motivated less by a desire to prevent the diversion of controlled substances than by his concern that he might lose his license. (Gov’t Ex. 23; see also Tr. 299.) At hearing, counsel for Respondent focused on Respondent’s apparent concern for TFO [BK]’s wellbeing, indicating the need for a referral to a primary care physician to test for serious medical conditions (see Tr. 289– 91), and Respondent’s statement that Respondent was just ‘‘giving you a chance to get over this pain . . ..’’ (Gov’t Ex. 22 at 165; see also Tr. 289.) Respondent’s sincerity, however, is undercut by the fact that he never made any such referrals to TFO [BK]. (Tr. 299–300.) The evidence at hearing also included a document referred to as the Arizona Medical Board Guidelines for the Use of Controlled Substances for the Treatment of Chronic Pain (Guidelines),39 as well as a second document entitled Model Policy for the Use of Controlled Substances for the Treatment of Pain (Model Policy). (Gov’t Exs. 19 & 20.) Dr. Borowsky testified that he relied on both documents in preparing his written report. The Guidelines reflect a substantive policy statement that is advisory only, developed by the Arizona Medical Board pursuant to Arizona statutory authority. (Gov’t Ex. 19 at 1.) The standards reflected in the Guidelines include a pain assessment, treatment plan, ongoing assessment, consultation and documentation, as well as counting and destroying medication, among other guidance. (Id.) Additionally, the Guidelines exhort physicians to comply with all 39 At hearing, counsel for Respondent suggested during cross examination that in 2004 the Arizona Medical Board adopted ‘‘not [a] materially, hugely different—but a different set of Guidelines from the one that [the Government] presented . . . .’’ (Tr. 474.) But this statement by counsel is not testimony, and in any event, counsel did not produce any alternative version of the Guidelines. PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 35017 applicable laws in the prescribing and dispensing of controlled substances. Under Arizona law, for instance, grounds for disciplinary action include ‘‘[u]nprofessional conduct’’ further defined as ‘‘[f]ailing or refusing to maintain adequate records on a patient’’ or ‘‘[p]rescribing, dispensing or furnishing a prescription medication . . . to a person unless the licensee first conducts a physical examination of that person or has previously established a doctor-patient relationship.’’ 40 Ariz. Rev. Stat. §§ 32–1401(27)(e) & (ss). There is substantial evidence of record that Respondent’s prescribing practices during the relevant time periods were contrary to applicable Arizona law. Respondent’s testimony at hearing did not significantly contradict the foregoing evidence. In fact, Respondent concedes in his post-hearing brief that ‘‘his practice documentation and patient screening/compliance monitoring needed improvement’’ from September 2009 through early January 2010.41 Respondent maintains, in essence, that because he acknowledges his past misconduct and has been making improvements to his practice between January 2010 and the date of his immediate suspension, Respondent’s DEA registration would not be inconsistent with the public interest. Respondent testified in substance that he has been practicing medicine for approximately thirty years, working as a family practitioner for someone else. (Tr. 40.) In August 2009, Respondent opened his own solo-family practice, seeing approximately 200–300 patients per month. (Tr. 36, 37.) Respondent further testified that he does not have any training or certifications in pain management. (Tr. 36.) Respondent admitted that there were certain things he did not know about pain 40 The OSC/IS alleges violations of Ariz. Rev. Stat. §§ 32–1401(27)(a), (q) and (ss). Moreover, the parties addressed the issue of unprofessional conduct at hearing. (See, e.g., Tr. 87, 93; Gov’t Ex. 2.) In any event, I take official notice of Ariz. Rev. Stat. § 32–1401(27). Under the Administrative Procedure Act (APA), an agency ‘‘may take official notice of facts at any stage in a proceeding—even in the final decision.’’ U.S. Dept. of Justice, Attorney General’s Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and DEA’s regulations, Respondent is ‘‘entitled on timely request, to an opportunity to show to the contrary.’’ 5 U.S.C. § 556(e); 21 C.F.R. § 1316.59(e); see, e.g., R & M Sales Co., 75 Fed. Reg. 78,734, 78,736 n.7 (DEA 2010). Respondent can dispute the facts of which I take official notice by filing a properly supported motion for reconsideration within twenty days of service of this Recommended Decision, which shall begin on the date it is mailed. See, e.g., Joseph Gaudio, M.D., 74 Fed. Reg. 10,083, 10,088 (DEA 2009) (granting Respondent opportunity to dispute officially noticed facts within fifteen days of service). 41 Resp’t Br. 30–31. E:\FR\FM\12JNN1.SGM 12JNN1 srobinson on DSK4SPTVN1PROD with NOTICES 35018 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices management, but once informed of these things, he began making improvements in or around December 2009 to January 2010. (Tr. 51). Respondent further testified that after starting his new practice he began to realize the difficulty of managing pain patients ‘‘finding it difficult to comprehend the deceit of many’’ patients. (Tr. 756.) As a result of these efforts, Respondent testified that during a period of from December of ‘09 until May of 2010, I tried to rid my practice of patients that were potential drug seekers as best I could. And in the process, I discharged 264 patients. The reasons were from selling drugs, using medications that weren’t prescribed by me, multiple doctor shopping, using the pharmacy monitoring program, use of illicit drugs and drug screens where they came positive for cocaine or methamphetamine, and tried my best to make sure that my patients were compliant with the treatment plan that they were under. (Tr. 757.) The evidence also included the testimony of TFO Baldwin, who credibly testified to an interview with [JG], who admitted that she is addicted to drugs, primarily oxycodone, and sees Respondent on a monthly basis. [JG] also admitted that she and her boyfriend ‘‘do sell their pills to pay their bills, get gas, etcetera.’’ (Tr. 187.) On cross examination, TFO Baldwin further testified that he did not specifically ask [JG] if she told Respondent she was selling her medications. When asked if Respondent knew, however, [JG] responded that Respondent ‘‘should know’’ because ‘‘half the patients in there are just like me.’’ (Tr. 196.) I find the statements attributed to [JG] to be generally credible, because they are consistent in part with other credible evidence, including Respondent’s testimony. That said, TFO Baldwin did not elicit a specific time frame during direct or cross examination as to when the statement from [JG] was taken, or the time frame that [JG] interacted with Respondent. TFO Baldwin’s testimony regarding [JG] therefore provides some weight, but not full weight, in favor of a finding under Factors Two and Four that Respondent’s continued registration would be inconsistent with the public interest. The Government further presented testimony from IRS Stone relating to an analysis of Respondent’s prescribing from August 1, 2009 to March 31, 2009. The evidence of record also includes three charts prepared by IRS Stone summarizing information received from the Board of Pharmacy pertaining to prescriptions for controlled substances VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 issued by Respondent. (Gov’t Ex. 14; Tr. 303–04.) The first chart reflects a total number of prescriptions written by Respondent during the stated time period to be 9411, including 5126 prescriptions for oxycodone and 3230 for benzodiazepine. The second chart provided a more detailed breakdown by percentage and tablet count, finding 681,590 tablets of oxycodone prescribed and 208,318 tablets of benzodiazepine prescribed during the relevant eightmonth time period. The third chart analyzes the prescription numbers by patients, rather than drugs. (See generally Gov’t Ex. 14 at 1–3.) No other testimony or evidence was offered at hearing to provide context for the numbers of prescriptions and tablets issued by Respondent, or any reference point for past prescribing by Respondent; nor did either party offer evidence of comparative prescribing practices of similarly situated pain management practitioners. The evidence does support by substantial evidence the allegation in the OSC/IS that Respondent dispensed ‘‘primarily hydrocodone compounds,’’ among others. Beyond that, however, the record evidence does not provide sufficient comparative analysis to support by substantial evidence the allegation in the OSC/IS that Respondent prescribed and dispensed ‘‘inordinate amounts of controlled substances.’’ In the absence of a methodology including a base-line or other reliable comparative number, IRS Stone’s numbers standing alone do not prove by a preponderance of the evidence that Respondent prescribed and dispensed inordinate amounts of controlled substances. See Mr. Checkout North Texas, 75 Fed. Reg. 4418, 4422 (DEA 2010) (finding that an unreliable methodology is not substantial evidence that respondent distributed excessive quantities of listed chemicals); see also CBS Wholesale Distributors, 74 Fed. Reg. 36,746, 36,749 (DEA 2009) (rejecting allegation that respondent sold excessive quantities of ephedrine products where Government expert did not provide ‘‘the underlying documentation necessary to support this critical component of his testimony’’). Respondent’s conduct during the relevant time period with regard to factors Two and Four weigh heavily in favor of revocation. Respondent’s admission that he was not aware of the difficulties relating to pain management, and that once informed, began to take corrective steps, understates the evidence. Dr. Borowsky, the only expert witness to testify in this case, concluded after reviewing two of Respondent’s patient files relating to four undercover visits, that Respondent prescribed PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 controlled substances without a legitimate medical purpose. (Tr. 431.) The absence of documentation, including a diagnosis, plan or physical examination, formed in part the basis for Dr. Borowsky’s opinion. (Tr. 416, 418–19, 421, 430.) Additionally, the fact that Respondent discharged over 250 patients between December 2009 and May 2010 for reasons such as ‘‘doctor shopping,’’ ‘‘selling drugs’’ and ‘‘use of illicit drugs,’’ among other reasons (see e.g., Tr. 752, 757), is fully consistent with a finding that Respondent’s experience in handling controlled substances and compliance with applicable law was substantially deficient on numerous occasions.42 ‘‘A practitioner’s failure to properly supervise her patients to prevent them from personally abusing controlled substances or selling them to others constitutes conduct ‘inconsistent with the public interest’ and can support the denial of an application or the revocation of an existing registration.’’ Jeri Hassman, M.D., 75 Fed. Reg. 8194, 8227 (DEA 2010). Under agency precedent, in the absence of a credible explanation by the practitioner, as few as two incidents of diversion are sufficient to revoke a registration. Alan H. Olefsky, M.D., 57 Fed. Reg. 928, 929 (DEA 1992). In this case, Respondent maintains he began making changes to his practice in late 2009 and early 2010. Respondent testified that he learned about the PMP from the owners of a pharmacy in late 2009 and began implementing the monitoring in January 2010. (Tr. 768.) He testified that he implemented drug screening in February 2010. (Tr. 805.) Respondent’s testimony on cross examination was only partially credible and at times inconsistent. For example, with regard to patient ‘‘[SH]’’ Respondent testified that he found the patient ‘‘compliant’’ notwithstanding a negative urine test for a prescribed controlled substance. (Resp’t Ex. 5 at 34; Tr. 806, 818–19.) Respondent explained that by ‘‘compliant’’ one must ‘‘look at it in a different light . . . you do have relapses. It’s part of the management of a patient.’’ (Tr. 819–19.) Respondent provided no credible explanation for the lack of a subsequent drug screen. There is additional evidence of record reflecting inconsistencies with regard to Respondent’s claim that he made substantial improvements to his practice but further elaboration is unnecessary. The weight of the evidence as a whole demonstrates that under Factors Two 42 Evidence of diversion by Respondent’s patients [MC] (see Tr. 137–38, 141–44) and [TR] (see Tr. 12, 14; Gov’t Ex. 12) bolsters this conclusion. E:\FR\FM\12JNN1.SGM 12JNN1 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices srobinson on DSK4SPTVN1PROD with NOTICES and Four, Respondent’s continued registration would be inconsistent with the public interest. Factor 5: Such Other Conduct Which May Threaten the Public Health and Safety As to factor five, ‘‘Respondent’s lack of candor and inconsistent explanations’’ may serve as a basis for denial of a registration. John Stanford Noell, M.D., 59 Fed. Reg. 47,359, 47,361 (DEA 1994). Additionally, where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for his or her actions and demonstrate that he or she will not engage in future misconduct. Patrick W. Stodola, 74 Fed. Reg. 20,727, 20,734 (DEA 2009).43 Also, ‘‘[c]onsideration of the deterrent effect of a potential sanction is supported by the CSA’s purpose of protecting the public interest.’’ Joseph Gaudio, M.D., 74 Fed. Reg. 10,083, 10,094 (DEA 2009). As an initial matter, I find that with the exceptions and inconsistencies noted above,44 Respondent has displayed at least some degree of candor before this tribunal. For instance, he has acknowledged his failure to update the address of his current practice location with the DEA. (Tr. 760, 795.) Moreover, Respondent at times conceded that his practice documentation and patient compliance monitoring needed improvement. This degree of candor, however, does not equate to a complete acceptance of responsibility for the full range of his misconduct embraced within the Government’s prima facie case. Respondent testified at hearing that he is ‘‘sorry for the shortcomings’’ and requests that he be allowed to ‘‘continue with the medical management of uncomplicated pain patients.’’ (Tr. 758; see also Resp’t Br. at 43.) But Respondent’s testimony as a whole demonstrates that he does not fully accept responsibility for his actions nor has he demonstrated that he will not engage in future misconduct. Notably, at the time of hearing, due to stated financial difficulty, Respondent was ‘‘in the process’’ of putting in place the monitoring program required by the Arizona Medical Board. (Tr. 63; see Gov’t Ex. 27 at 4.) A more compelling demonstration of acceptance of responsibility might have included a 43 See also Hoxie v. DEA, 419 F.3d 477, 484 (6th Cir. 2005) (decision to revoke registration ‘‘consistent with the DEA’s view of the importance of physician candor and cooperation.’’) 44 For example, I found Respondent’s testimony regarding the material falsification of his application for renewal of his DEA COR not to be credible. Supra Section III.B. VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 showing that a monitoring program is firmly in place. Instead, the absence of such a program required by order of the Arizona Medical Board, raises concerns that Respondent may engage in future misconduct. In any event, Respondent’s interactions with undercover investigators posing as patients highlight the risks to the public were Respondent’s COR to be reinstated. The theme that emerges from these undercover visits is Respondent’s awareness of diversion potential coupled with an indifference to diversion. For example, TFO [BK] testified, and a transcript corroborates, that Respondent told TFO [BK] that Respondent has some patients who get drugs off the street, and ‘‘I don’t care whether you are [one of them] or not, I have patients that do that . . . .’’ (Gov’t Ex. 22 at 162.) Even construed in a light most favorable to Respondent, this testimony evinces an indifference to diversion that is fundamentally at odds with the requirements and purpose of the CSA. The record further reflects that Respondent told TFO [BK] that it is more expensive to buy drugs off the street than at a pharmacy, and that therefore, some of Respondent’s patients come to him to be evaluated and obtain prescriptions at a lower price. (Tr. 263.) This statement by Respondent demonstrates an acceptance, if not an outright facilitation, of diversion. Under agency precedent, revocation of an existing registration under the public interest standard of 21 U.S.C. § 823(f) may be founded upon a ‘‘practitioner’s failure to properly supervise her patients to prevent them from personally abusing controlled substances or selling them to others . . .’’ Jeri Hassman, M.D., 75 Fed. Reg. 8194, 8227 (DEA 2010). Respondent’s statements, especially his statement that he did not care if patients bought drugs off the street (Gov’t Ex. 22 at 162), constitutes a failure by Respondent ‘‘to properly supervise . . . patients to prevent them from personally abusing controlled substances or selling them to others . . . .’’ Hassman, 75 Fed. Reg. at 8227. More troubling still is that indications of Respondent’s indifference to or outright facilitation of diversion are corroborated by other evidence of record, including statements attributable to [LW] (see Tr. 217) (indicating that Respondent never asked patient [LW] for proof of injury before prescribing controlled substances, and that [LW] sent several patients to Respondent to get prescriptions to sell on the street), and [JG] (see Tr. 187, 196) (indicating that patient [JG] routinely sells pills on PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 35019 the street, and that ‘‘half the patients in [Respondent’s practice] are just like me’’). Moreover, Respondent’s interactions with TFO [JB] and TFO [BK] indicate an awareness of and indifference to Respondent’s failures to comply with Arizona standards of professional medical practice. For example, TFO [JB] testified that on the second occasion that Respondent prescribed controlled substances to TFO [JB] without requiring proof of injury or patient medical records, Respondent stated that ‘‘if he were to continue to prescribe to me, I would need to get proof of injury because he was in danger of losing his license.’’ (Tr. 220; see Tr. 244.) Even if I were to fully credit Respondent’s testimony that his act of prescribing controlled substances without proof of injury or medical documentation was founded upon Respondent’s compassion for his patients, Respondent’s conduct would nevertheless constitute a departure from the Arizona standards of practice identified by Dr. Borowsky and supported by documentary evidence. The record also reflects that during the same undercover visit by TFO [JB], Respondent said he noted that TFO [JB] was taking oxycodone 15 mg. (Tr. 221.) TFO [JB] corrected him and said Respondent had actually given her oxycodone 30 mg on the previous visit. (Tr. 221.) Respondent replied ‘‘Well, I wrote 15 milligrams in the chart, but I sometimes make mistakes.’’ (Tr. 221.) In light of the testimony that thirty milligrams is the highest available dosage of oxycodone (Tr. 55), Respondent’s candid and cavalier attitude toward prescribing and recordkeeping constitutes a violation of Arizona medical standards in addition to presenting a risk of diversion. See, e.g., Ariz. Rev. Stat. §§ 32–1401(27)(e) & (q).45 Making matters worse, the unrebutted testimony of DI Linder indicates that as late as May 26, 2010, Respondent was unaware that Xanax, a benzodiazepine and Schedule IV 45 Although the OSC/IS alleged violations of Ariz. Rev. Stat. § 32–1401(27)(a), (q) & (ss), it did not explicitly allege a violation of § 32–1401(27)(e) (‘‘Failing or refusing to maintain adequate records on a patient.’’). Nevertheless, the Government’s prehearing statement alleged that Respondent violated his standard of care by ‘‘failing to take adequate medical histories or no medical histories [and], by failing to collecting [sic] previous medical records . . . .’’ (Gov’t PHS at 4.) I find this language adequate to apprise Respondent that this allegation would be litigated and considered. See CBS Wholesale Distribs., 74 Fed. Reg. 36,746, 36,749–50 (DEA 2009). Alternatively, even without considering § 32–1401(27)(e), I would still find that Factor Five favors recommending revocation of Respondent’s COR under 21 U.S.C. § 823(f). E:\FR\FM\12JNN1.SGM 12JNN1 35020 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices depressant,46 was a controlled substance. (Tr. 178–79 (‘‘He asked me what a controlled substance was, and whether Xanax was a controlled substance.’’).) Respondent testified that he commonly prescribes Xanax. (Tr. 778–79.) There is additional record evidence reflecting Respondent’s attitude toward diversion and his course of compliance with Arizona medical standards but further elaboration is unnecessary. As to all of these incidents, Respondent’s testimony at hearing that his motivation ‘‘was first and foremost the well-being of my patients,’’ (Tr. 757), is availing, to a point. But Respondent’s prepared testimony at hearing does not counter the more substantial weight properly given to his candid, un-coached remarks and behaviors toward undercover investigators posing as patients. These remarks and behaviors are telling, and I find substantial evidence that Respondent will engage in future misconduct if allowed to maintain his registration. In sum, Factor Five weighs in favor of a finding that Respondent’s continued registration would be inconsistent with the public interest. srobinson on DSK4SPTVN1PROD with NOTICES IV. Conclusion and Recommendation I find that a balancing of the foregoing public interest factors supports a finding that the Government has established a prima facie case in support of revocation of Respondent’s registration, or denial of an application for registration.47 I conclude by a preponderance of the evidence that the Government has proved independent grounds for revoking Respondent’s COR pursuant to 21 U.S.C. § 824(a)(1), and alternatively, that the balance of the other factors in this case weighs heavily in favor of a finding that Respondent’s registration would be inconsistent with the public interest under 21 U.S.C. § 823(f). Once DEA has made its prima facie case for revocation, the burden then shifts to the respondent to show that, 46 Alprazolam is a controlled substance. 21 C.F.R. § 1308.14(c) (2010). I take official notice that Xanax is a trade name for alprazolam. Respondent can dispute the facts of which I take official notice by filing a properly supported motion for reconsideration within twenty days of service of this Recommended Decision, which shall begin on the date it is mailed. See supra note 40. See generally Joseph Gaudio, M.D., 74 Fed. Reg. 10,083, 10,088 (DEA 2009). 47 Respondent all but concedes as much, arguing that ‘‘Respondent is well aware that the Presiding Administrative Law Judge is likely to determine that the government has made a prima facie case against him. That having been acknowledged, the record supports by a preponderance of the evidence a finding that his continued registration is not inconsistent with the public interest.’’ (Resp’t Br. 31.) VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 given the totality of the facts and circumstances in the record, revoking the registrant’s registration would not be appropriate. Morall v. DEA, 412 F.3d 165, 174 (D.C. Cir. 2005); Humphreys v. DEA, 96 F.3d 658, 661 (3d Cir. 1996); Shatz v. United States Dep’t of Justice, 873 F.2d 1089, 1091 (8th Cir. 1989); Thomas E. Johnston, 45 Fed. Reg. 72,311, 72,311 (DEA 1980). Additionally, where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for his or her actions and demonstrate that he or she will not engage in future misconduct. Patrick W. Stodola, 74 Fed. Reg. 20,727, 20,735 (DEA 2009). Also, ‘‘[c]onsideration of the deterrent effect of a potential sanction is supported by the CSA’s purpose of protecting the public interest.’’ Joseph Gaudio, M.D., 74 Fed. Reg. 10,083, 10,094 (DEA 2009). An agency’s choice of sanction will be upheld unless unwarranted in law or without justification in fact. A sanction must be rationally related to the evidence of record and proportionate to the error committed. See Morall v. DEA, 412 F.3d 165, 181 (D.C. Cir. 2005) (sanction will be upheld unless unwarranted in law or without justification in fact). Finally, an ‘‘agency rationally may conclude that past performance is the best predictor of future performance.’’ Alra Laboratories, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995). The evidence as a whole demonstrates that Respondent has not credibly accepted responsibility for his actions, or presented evidence that could reasonably support a finding that he will not engage in future misconduct. Accordingly, Respondent has failed to rebut the Government’s prima facie case. I therefore recommend that Respondent’s DEA COR be revoked and any pending applications for renewal denied. Dated: January 20, 2011 Timothy D. Wing Administrative Law Judge [FR Doc. 2012–14268 Filed 6–11–12; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances Notice of Application Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration under this Section to a bulk manufacturer of a controlled substance in schedule I or II, and prior PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 to issuing a regulation under 21 U.S.C. 952(a)(2) authorizing the importation of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing. Therefore, in accordance with 21 CFR 1301.34(a), this is notice that on October 6, 2011, Arizona Department of Corrections, ASPC–Florence, 1305 E. Butte Avenue Florence, Arizona 85132, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of Pentobarbital (2270), a basic class of controlled substance listed in schedule II. The facility intends to import the above listed controlled substance for legitimate use. Supplies of this particular controlled substance are inadequate and are not available in the form needed within the current domestic supply of the United States. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic class of controlled substance may file comments or objections to the issuance of the proposed registration, and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43, and in such form as prescribed by 21 CFR 1316.47. Any such comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive Springfield, Virginia 22152; and must be filed no later than [insert date 30 days from date of publication]. This procedure is to be conducted simultaneously with, and independent of, the procedures described in 21 CFR 1301.34(b), (c), (d), (e), and (f). As noted in a previous notice published in the Federal Register on September 23, 1975, 40 FR 43745–46, all applicants for registration to import a basic class of any controlled substance in schedule I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a), 21 U.S.C. 823(a), and 21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied. E:\FR\FM\12JNN1.SGM 12JNN1

Agencies

[Federal Register Volume 77, Number 113 (Tuesday, June 12, 2012)]
[Notices]
[Pages 34998-35020]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14268]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 10-58]


Darryl J. Mohr, M.D.; Affirmance of Immediate Suspension Order

    On January 20, 2011, Administrative Law Judge (ALJ) Timothy D. Wing 
issued the attached recommended decision (also ALJ). Thereafter, 
Respondent filed exceptions to the decision.
    Having reviewed the entire record including the ALJ's recommended 
decision\1\ and Respondent's exceptions, I have decided to adopt the 
ALJ's rulings, findings of fact and conclusions of law, except as noted 
below.\2\ However, because Respondent's registration expired shortly 
after the ALJ issued his decision and Respondent did not file a renewal 
application, I reject the ALJ's recommendation that I revoke his 
registration and deny any pending application.\3\ While there is 
neither a registration, nor an application, to act upon, I affirm the 
immediate suspension order.
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    \1\ All citations to the ALJ's decision are to the slip opinion 
as issued on January 20, 2011.
    \2\ The ALJ found that Respondent materially falsified his 
January 2008 renewal application by failing to disclose that in 
2001, the Arizona Medical Board had placed him on probation based on 
his having prescribed Viagra to an FDA undercover agent without 
having conducted a physical examination and determining whether the 
drug was clinically indicated or contraindicated for the patient. 
See ALJ at 37; see also GX 2, at 3-4. The State Board also found 
that Respondent had been named as a defendant in a lawsuit brought 
by the Attorney General of Illinois which had alleged that he 
engaged ``in the use of electronic internet communication for the 
prescribing and dispensing of prescription medications'' in 
violation of the Illinois Consumer Fraud and Deceptive Business 
Practices Act; Pharmacy Practice Act of 1987, and Medical Practice 
Act of 1987; Respondent accepted a settlement in which he did not 
admit to any illegality ``but agreed not to engage in the internet 
prescribing or dispensing of prescription medication in Illinois.'' 
GX 2, at 3-4. The State did not, however, suspend or revoke his 
medical license.
     Viagra is not, however, a controlled substance and the 
Government did not offer any evidence that Respondent had engaged in 
the internet prescribing of controlled substances. Moreover, the 
Government did not offer any evidence explaining why Respondent's 
Internet prescribing of Viagra was ``capable of influencing the 
decision'' of the Agency as to whether to grant his application. See 
Scott C. Bickman, 76 FR 17694, 17701 (2011) (quoting Kungys v. 
United States, 485 U.S. 759, 770 (1988) (other citations omitted)). 
Nor did the Government cite to any decision of this Agency holding 
that an application for registration may be denied on the ground 
that the applicant had prescribed a non-controlled substance 
inappropriately. Accordingly, while Respondent falsified his 
application, the falsification was not material. I thus do not adopt 
the ALJ's finding that Respondent materially falsified his renewal 
application.
    \3\ Both the Government and Respondent nonetheless maintain that 
this case is not moot under the collateral consequences doctrine. 
See Gov. Note. Regarding Resp.'s DEA Registration, at 1-2 (citing 
William Lockridge, 71 FR 77,791 (2006)); Resp. Exceptions at 2 n.1. 
Neither party explains what collateral consequences attach in this 
case.
     
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    In his exceptions, Respondent contends that the ALJ's decision 
should be rejected because it is based on an unsupported assumption 
that ``Respondent [can] not be trusted to avoid repeating his 
mistakes.'' Exc. at 2. Respondent further contends that the State Board 
has placed him on probation and imposed various conditions, including 
that within six months of the State Order, he ``attend an

[[Page 34999]]

intensive education program regarding medical recordkeeping and the 
prescribing of controlled substances,'' and that upon completion of the 
program, he submit his charts to a Board-approved contractor who is to 
review his documentation and prescribing practices. Id. at 3.
    In Respondent's view, the ALJ's finding that he did not accept 
responsibility for his misconduct is erroneous because the ALJ placed 
excessive weight on Respondent's failure to implement the monitoring 
program required by the Board's Order. Id. at 4. According to 
Respondent, the ALJ erroneously assumed that he was required to have 
``the monitoring program * * * up and running as of the time of the 
hearing'' when the Board's Order does not require ``that the monitoring 
itself would * * * take place until after he had completed the PACE 
education program.'' Id. Respondent further maintains that he cannot be 
faulted for failing to implement the monitoring program because the 
``program was to assess prescribing and documentation in the context of 
[his] prescribing [of] controlled substances,'' which he is unable to 
do because his registration was immediately suspended. Id.
    However, subsequent to the ALJ's issuance of his decision, on 
February 25, 2011, the Arizona Medical Board issued to Respondent an 
Interim Order For Practice Restriction And Consent To The Same. I take 
Official Notice of the Board's Order.\4\ Therein, the Board found that 
Respondent had failed to complete ``either the PACE prescribing course 
or the Pace medical recordkeeping course.'' Interim Order, at 2. The 
Board further found ``that a practice restriction is needed in order to 
protect the public.'' Id. The Board therefore placed Respondent ``on a 
practice restriction that prohibits him from prescribing, 
administering, or dispensing any Controlled Substances until he applies 
to the Board and receives permission to do so.'' Id. at 3.
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    \4\ Under the Administrative Procedure Act (APA), an agency 
``may take official notice of facts at any stage in a proceeding-
even in the final decision.'' U.S. Dept. of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and 
DEA's regulations, Respondent is ``entitled on timely request, to an 
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21 
CFR 1316.59(e). Respondent can dispute the facts of which I take 
official notice by filing a properly supported motion for 
reconsideration within twenty days of service of this Order, which 
shall begin on the date it is mailed.
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    Accordingly, Respondent no longer has authority under Arizona law 
to prescribe controlled substances and is not entitled to be registered 
under the Controlled Substances Act. See 21 U.S.C. 802(21) (``[t]he 
term `practitioner' means a physician * * * licensed, registered, or 
otherwise permitted, by * * * the jurisdiction in which he practices * 
* * to * * * dispense * * * a controlled substance in the course of 
professional practice''). See also id. Sec.  823(f) (The Attorney 
General shall register practitioners * * * to dispense * * * controlled 
substances * * * if the applicant is authorized to dispense * * * 
controlled substances under the laws of the State in which he 
practices.''); id. Sec.  824(a)(3) (authorizing the revocation of a 
registration ``upon a finding that the registrant * * * has had his 
State license or registration suspended [or] revoked * * * and is no 
longer authorized by State law to engage in the * * * distribution [or] 
dispensing of controlled substances''). Thus, even if Respondent had 
filed a renewal application and prevailed in this proceeding, he would 
not be entitled to be registered. See, e.g., Jovencio L. Raneses, M.D., 
75 FR 11563 (2010).
    Moreover, even assuming that Respondent intends to remain in 
professional practice, cf. Resp. Exc. n.1., contrary to Respondent's 
understanding and notwithstanding the collateral consequences doctrine, 
his challenge to the ALJ's finding that he did not accept 
responsibility for his misconduct is now moot. As DEA's case law makes 
clear, the issue of whether a registrant has accepted responsibility 
for his misconduct and has demonstrated that he will not engage in 
future misconduct is in play in only two circumstances: (1) In 
determining whether a registrant's continued registration is consistent 
with the public interest, see 21 U.S.C. 824(a)(4); and (2) in 
determining whether granting an applicant's application for 
registration is consistent with the public interest. Id. Sec.  823(f). 
However, where, as here, a registrant allows his registration to 
expire, and does not file a renewal application, there is neither a 
registration nor an application to act upon and the issue of whether a 
registrant's continued registration is consistent with the public 
interest is off the table. Ronald J. Reigel, 63 FR 67132, 67133 (1998). 
While this Agency has recognized that because an immediate suspension 
order involves the exercise of summary process, it is reviewable in a 
proceeding under 21 U.S.C. 824, even where collateral consequences 
exist, review of the order is limited to challenging its factual and 
legal basis. Whether a former registrant has accepted responsibility 
for his misconduct has no bearing on the validity of the suspension 
order.
    As the ALJ found (and as the Government's Expert testified), 
Respondent prescribed narcotic controlled substances to the two 
undercover patients even though he did not obtain a patient history or 
perform a bona fide physical exam during any of the four undercover 
visits, ALJ at 48, notwithstanding that Arizona law explicitly provides 
that it is ``[u]nprofessional conduct'' to ``fail[] or refus[e] to 
maintain adequate records on a patient'' or to ``[p]rescrib[e], 
dispens[e] or furnish[] a prescription medication * * * to a person 
unless the licensee first conducts a physical examination of that 
person or has previously established a doctor-patient relationship.'' 
Id. at 52 (quoting Ariz. Rev. Stat. Sec.  32-1401(27)(e) & (ss)).
    As the Government's Expert testified, Respondent's records for the 
two undercover patients ``showed no substantiation for a diagnosis, a 
plan, or a treatment with opioid medication.'' Id. at 48 (quoting Tr. 
416). Indeed, at their initial visits, both undercover patients had 
indicated on their intake form (``Opioid Flow Sheet) that they had a 
pain level of ``0'' on a scale of 0 to 10. GX 15, at 2 (K.R. visit of 
11/13/09); GX 16, at 2 (B.K. visit of 11/18/09).\5\ Respondent did not 
discuss a treatment plan with either undercover patient.
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    \5\ With respect to the undercover visitors, Respondent asserted 
that this did not give reason for concern because ``0'' on the flow 
sheet indicated that this was their pain score ``with medications.'' 
Resp. Proposed Findings of Fact and Conclusion of Law, at 7 (] 22) & 
10 (] 34). During K.R.'s visit, Respondent asked her how long it had 
been since she had taken medication. GX 21, at 144. In response, 
K.R. stated that she had used her father's Percocet and that it had 
been several weeks since she had done so. GX 21, at 142-45. K.R. did 
not represent that she was currently in pain. See id.
     What is obvious is that no matter what number on the pain scale 
was circled, this form would always provide justification to 
prescribe controlled substances. If, as in K.R.'s visit, the patient 
circled ``0,'' Respondent could claim that this was because of the 
medications the patient was on. Notably, during the visit, 
Respondent did not ask K.R. to rate her pain level without 
medications.
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    Moreover, there is ample evidence establishing that Respondent knew 
that the undercover officers were not legitimate patients but were 
seeking the controlled substances to abuse them. At her first visit, 
K.R. told Respondent that she had been using her father's Percocet and 
did not make any claim of being in pain in her conversation with 
Respondent. GX 21, at 144. During K.R.'s visit, Respondent told her 
that ``[t]he only place you can get these medications from is me,'' 
which K.R. then acknowledged with ``o.k.'' GX 21, at 147. Respondent 
then stated: ``You

[[Page 35000]]

can't, you go, you can't go to me and then another doctor and another 
doctor cause they you're gonna, it's all computerized, so your gonna 
get red-flagged and they're gonna call you a drug addict and a doctor 
shopper and then all of a sudden no pharmacy is gonna give you any 
medication.'' Id. Respondent was also well aware of the ``high street 
value'' of both Percocet and OxyContin. Id. at 147-48.
    While Respondent did a superficial examination, noting that ``I'm 
gonna poke you. I gotta find something out about ya,'' he had already 
agreed to write a prescription for K.R. Id. at 150-51. As this 
interaction demonstrates, Respondent knew that K.R. was not a 
legitimate patient but needed to find something to justify the 
prescription he had already agreed to issue. Moreover, while during the 
visit, K.R. had stated that she had used Percocet (which contains only 
5 mg of oxycodone) or even oxycodone 10 mg, Respondent gave her a 
prescription for seventy tablets of oxycodone 30 mg. See GX 21, at 144; 
Tr. 207.
    As for the first visit of B.K. (the second undercover patient), 
Respondent, immediately upon introducing himself, stated: ``Obviously 
you're looking for pain medication. What did you do?'' GX 22, at 159. 
When Respondent then asked B.K. to state the location of his pain, B.K. 
stated: ``You name it'' and added that he had ``basically, you know 
general pain.'' Id. at 159-60. When Respondent asked if he had been in 
an auto accident, B.K. stated that he had been ``[p]robably a couple 
years'' ago. Id.
    Respondent then asked B.K. ``what kind of medication are you 
looking to get?'' Id. at 161. B.K. stated ``well Oxy. Probably 
thirties'' and added that he got them ``wherever I can.'' Id. When 
Respondent asked how B.K. got ``started on oxycodones,'' B.K. answered 
``[o]h just general pain'' and ``achiness.'' Id. Respondent then 
suggested that there were ``other medications to take except a schedule 
II narcotic''; B.K. answered: ``[w]ell that was available to me.'' Id. 
Manifesting his recognition that B.K. was not a legitimate patient, 
Respondent then stated that ``the issue is * * * that I can't write for 
pain medication unless I have proof of injury. * * * You're not giving 
me proof of injury, you're just telling me you, you ache all over.'' 
Id. To this B.K. replied: ``Right.'' Id.
    Respondent then stated:

    I mean there's other medications that you can take. Uh, you've 
never even been on, or whatever you're doing if you're buying this 
off the street, and I don't care whether you are or not, I have 
patients that do that. Uh, but basically that's why they're coming 
because they're very expensive on the street, plus they need to be 
evaluated and find out what their problem is. Uh, but for me just to 
write a script * * * for a patient that walks in the door and says, 
``I'm just having general pain'' that doesn't work. I mean there's 
no way I'm going to lose my license.

Id. at 162.
    While Respondent told B.K. that he was going to have to find 
another doctor, he then explained that:

the point is, I can't write you a prescription for medication at 
this level without any proof of injury. So, if you're having pain, 
you know I can certainly give you something less than the Percocet. 
I can give you some Vicodin, I can give you some Darvocet, I can 
give you some Tyonol[sic] three's, but to give you this level * * * 
drug is, no, that's out.

Id.
    After B.K. stated ``ok,'' Respondent added that ``[i]f you want a 
lesser drug I'd be more than happy to write it for you. * * * But 
that's up to you.'' Id. B.K. stated ``[t]hat'd be great'' and 
Respondent asked him if he had ever been on Vicodin, Darvocet or 
Tylenol Three. Id. When B.K. told Respondent that he had previously 
``been on the strongest Vicodin * * * the 10-325,'' Respondent offered 
to write the prescription and give B.K. a thirty-day supply (120 
tablets), even though he acknowledged that B.K. ``got no * * * chronic 
pain syndrome'' and ``no etiology.'' Id. at 162-63.
    When B.K. then asked Respondent whether he could get another 
appointment, Respondent agreed that B.K. could ``come back'' on 
December 23rd even though he had no ``proof of injury.'' Id. at 165. 
Respondent then told B.K. that he was giving him the medication 
``because you're telling me you're having pain'' (even though B.K. 
never identified any specific area of pain) and told him that he would 
have to find himself ``a primary care physician.' '' Id. at 166. 
Respondent gave B.K. a prescription for 120 Vicodin 10/325, a highly 
abused schedule III narcotic. Tr. 255; see also 21 CFR 1308.13(e)(1).
    On December 23rd, B.K. returned to Respondent. Shortly after the 
visit commenced, B.K. stated that he was ``not better'' and Respondent 
stated that he was going to give him the medication, but that he did 
not think that B.K. would ``find anybody that's really gonna give you 
these narcotic medications just because you're stating that you're not 
better.'' GX 23, at 171. While Respondent recommended that B.K. get 
insurance and see a rheumatologist and stated that he would give B.K. 
another prescription for 120 Vicodin 10/325 but was discharging him, 
B.K. asked Respondent if he could come back if he was able to get 
``[p]roof of an injury.'' Id. at 172. Respondent then stated that 
because B.K. did not ``have proof of injury * * * at this point you 
couldn't come back to me and say well all of a sudden I've got an 
injury I forgot about'' because ``that tells me you're lying to me.'' 
Id. at 172-73. Respondent then stated that ``I'm not gonna write you 
narcotics knowing that you've already told me that there's nothing 
wrong with you.'' Id. at 173. Respondent then told B.K. that he would 
have to go see a rheumatologist and get checked out. Id. 
Notwithstanding his acknowledgment that there was nothing wrong with 
B.K., Respondent then wrote B.K. another prescription for 120 Vicodin 
10/325 before discharging him.
    The Government's Expert reviewed Respondent's medical records for 
K.R. and B.K., the audiotapes of their initial visits, the video tape 
of B.K.'s second visit, and the available transcripts.\6\ GX 18, at 1. 
The Government's Expert concluded that both K.R. and B.K. ``portrayed 
drug seeking individuals, with 0/10 pain, [and] with no documentation 
through past records, present records, radiologic studies, or physical 
examination of any condition warranting treatment with opioid 
medication.'' Id. at 3. Continuing, the Expert found that ``[t]he 
Medical Records are inadequate, inaccurate, representing falsifications 
and omissions, with no proper history and physical, no documentation of 
pathology that would warrant treatment with opioids, with fabricated 
details in an attempt to substantiate opioid prescriptions.'' Id. at 4. 
The Expert also explained that ``[t]here is no 120 day window, as 
mentioned by [Respondent], that allows opioid prescribing without past 
records and documentation.'' Id.; see also Tr. 431. The Expert further 
opined that Respondent's prescribing of controlled substances to both 
undercover patients lacked a ``legitimate medical purpose.'' Tr. 431.
---------------------------------------------------------------------------

    \6\ Due to an equipment malfunction, there was no recording of 
K.R.'s second visit.
---------------------------------------------------------------------------

    I agree. Based on the record, I conclude that Respondent's 
prescribing of controlled substances to the undercover patients went 
``beyond the bounds of any legitimate medical practice,'' United States 
v. McIver, 470 F.3d 550, 559 (4th Cir. 2006), and ``completely betrayed 
any semblance of legitimate medical treatment.'' United States v. 
Feingold, 454 F.3d 1001, 1010 (9th Cir. 2006).
    At the hearing, Respondent offered testimony only in regards to his 
prescribing to K.R. Tr. 761. Respondent

[[Page 35001]]

asserted that he had examined K.R. and she had told him that she had 
pain in her back. Id. However, as the ALJ found, Respondent had already 
agreed to write a prescription (which he did for 70 tablets of 
oxycodone 30 mg, a schedule II controlled substance) before he did his 
``exam.'' ALJ at 49. Moreover, K.R. had told him she was getting 
Percocet from her father (and not from a physician) and never stated 
that she had pain (other than after he poked her), let alone pain that 
would support prescribing a schedule II narcotic. Tr. 406. (testimony 
of Government's Expert discussing titration and adjustment of dosage).
    K.R. made a second visit to Respondent at which she again obtained 
a prescription for 70 tablets of oxycodone 30 mg, even though she again 
made no representation that she had pain and Respondent did not perform 
a physical exam or take a history. Tr. 218-20. However, Respondent 
offered no testimony as to why he prescribed to her at this visit. 
Moreover, Respondent offered no testimony addressing his medical 
justification for prescribing Vicodin 10/325 \7\ to B.K. at either 
visit.
---------------------------------------------------------------------------

    \7\ Vicodin is a schedule III narcotic, which contains 
hydrocodone.
---------------------------------------------------------------------------

    It is well settled that the Agency can draw an adverse inference 
from a respondent's failure ``to testify in response to probative 
evidence offered against'' him. See Baxter v. Palmigiano, 425 U.S. 308, 
316 (1976); see also United States v. Solano-Godines, 120 F.3d 957, 962 
(9th Cir. 1997) (``In civil proceedings * * * the Fifth Amendment does 
not forbid fact finders from drawing adverse inferences against a party 
who refuses to testify.''). Based on Respondent's failure to address 
why he prescribed to K.R. at her second visit, and B.K. at both of his 
visits, it is appropriate to draw the adverse inference that Respondent 
knowingly prescribed controlled substances to both B.K. and K.R. 
without a legitimate medical purpose.
    While in his testimony Respondent asserted that when he opened his 
pain practice, he did not ``comprehend the deceit of many of my 
patients to get narcotics,'' and that ``[a]s time progressed, I learned 
more about pain management,'' and started ``doing better documentation, 
drug screening, * * * appropriate physical testing, better validation 
and proof of injury,'' Tr. at 756-57, the undercover visits make clear 
that Respondent knowingly diverted controlled substances. Notably, when 
the State sanctioned Respondent based on his prescribing of Viagra, the 
State found that his doing so ``without first conducting a physical 
examination'' constituted ``unprofessional conduct'' under Arizona law. 
GX 2, at 3-4. Yet Respondent prescribed to both undercover officers 
without performing a physical examination (other than to perform a 
cursory physical examination on K.R. to, in his words, ``find something 
out about ya,'' after he had already agreed to write the prescription). 
Accordingly, this is not a case of a ``naive or gullible'' practitioner 
who did not intentionally prescribe to drug abusers and who has since 
learned from his mistakes and reformed his practices.\8\ See Paul J. 
Caragine, Jr., 63 FR 51592, 51601 (1998).
---------------------------------------------------------------------------

    \8\ Respondent also takes exception to the weight which the ALJ 
gave to the hearsay statements made by two of his patients (J.G. and 
L.W.) to the Task Force Officers. However, the statements have no 
bearing on the issue of whether Respondent's prescriptions to the 
undercover officers complied with Federal law. I therefore do not 
consider the exception.
---------------------------------------------------------------------------

    Based on the above, I find that Respondent knowingly diverted 
controlled substances by issuing prescriptions outside of the usual 
course of profession practice and which lacked a legitimate medical 
purpose to the two undercover officers. 21 CFR 1306.04(a). This finding 
is sufficient to support the conclusion that Respondent committed acts 
which rendered the continuance of his then-existing registration 
``inconsistent with the public interest'' and ``an imminent danger to 
public health and safety,'' and thus supported the suspension of his 
registration pursuant to 21 U.S.C. 824(d).\9\ I therefore affirm the 
Order of Immediate Suspension.
---------------------------------------------------------------------------

    \9\ Respondent did not challenge the imminent danger finding at 
any point in this proceeding.
---------------------------------------------------------------------------

Order

    Pursuant to the authority vested in me by 21 U.S.C. 824, as well as 
28 CFR 0.100(b), I order that the Order of Immediate Suspension issued 
to Darryl J. Mohr, M.D., be, and it hereby is, affirmed. This Order is 
effective immediately.

    Dated: June 2, 2012.
Michele M. Leonhart,
Administrator.
Dedra S. Curteman, Esq., for the Government
Mary Baluss, Esq., for the Respondent

Recommended Ruling, Findings of Fact, Conclusions of Law and Decision 
of the Administrative Law Judge

Introduction

    Timothy D. Wing, Administrative Law Judge. This proceeding is an 
adjudication pursuant to the Administrative Procedure Act, 5 U.S.C. 
Sec.  551 et seq., to determine whether the Drug Enforcement 
Administration (DEA) should revoke a physician's Certificate of 
Registration (COR) as a practitioner. Without this registration the 
practitioner, Respondent Darryl J. Mohr, M.D. (Respondent), of Phoenix, 
Arizona, will be unable to lawfully possess, prescribe, dispense or 
otherwise handle controlled substances in the course of his practice.
    On May 25, 2010, the Deputy Administrator, DEA, issued an Order to 
Show Cause and Immediate Suspension of Registration (OSC/IS), 
immediately suspending Respondent's DEA COR and giving Respondent 
notice to show cause why the DEA should not revoke his COR pursuant to 
21 U.S.C. Sec.  824(a)(1), on grounds that his continued registration 
would be inconsistent with the public interest as that term is used in 
21 U.S.C. Sec. Sec.  824(a)(4), 823(f) and 823(g)(2)(E)(i).
    In substance, the OSC/IS alleges that: Respondent is registered 
with DEA as a practitioner in Schedules II-V under DEA COR BM2040498 at 
Access 2 Care Family Medical Center, 4607 North 12th Street, Phoenix, 
Arizona 85014; that COR BM2040498 expires by its terms on January 31, 
2011; that pursuant to the Drug Addiction Treatment Act (DATA), 
Respondent is authorized to treat no more than thirty narcotic 
dependent patients at any one time with Schedule III-V narcotic 
controlled substances; that Respondent materially falsified his 
applications for renewal of his DEA COR on January 26, 2005, and 
January 29, 2008, by answering ``no'' to the liability questions 
despite the fact that his state medical license was suspended on 
November 27, 2001, in violation of 21 U.S.C. Sec.  843(a)(4); and that 
Respondent prescribes and dispenses inordinate amounts of controlled 
substances, primarily hydrocodone compounds, Schedule III controlled 
substances, among others, under circumstances where Respondent knows or 
should know the prescriptions are not for legitimate medical purposes 
or are issued outside the course of usual professional practice. (ALJ 
Ex. 1.)
    The OSC/IS includes the following specific allegations: Family 
Practice and Pain Management recommends that patients fill their 
prescriptions at one pharmacy, Community Pharmacy (in various 
locations) and often provides a coupon for patients' use. On November 
27, 2009, Respondent's patient,

[[Page 35002]]

``[MC],'' \1\ died at [MC]'s home from ``Combined Drug Toxicity.'' 
Three days before [MC]'s death, on November 24, 2009, Respondent 
prescribed [MC] 150 oxycodone 30 mg tablets, 70 alprazolam 2 mg tablets 
and 35 amphetamine salts 30 mg tablets. [MC] filled the prescription on 
the same day at the Community Pharmacy located at 17233 N. Holmes 
Blvd., Suite 1615, Phoenix, Arizona 85053. Respondent also prescribed 
controlled substances in various amounts on October 20, 2009, September 
16, 2009, August 17, 2009, July 22, 2009, June 25, 2009, and May 27, 
2009. The drugs found near [MC]'s body and in [MC]'s system at the time 
of death were consistent with the controlled substances Respondent 
prescribed for [MC]. (ALJ Ex. 1.)
---------------------------------------------------------------------------

    \1\ To protect patient privacy, initials are used in this 
Recommended Decision when referring to Respondent's current and 
former patients.
---------------------------------------------------------------------------

    The OSC/IS further alleges that on January 6, 2010, Respondent's 
patient, ``[CS],'' died at [CS]'s home; that [CS] received 
prescriptions from Respondent as recently as December 31, 2009, when 
Respondent prescribed 90 oxycodone 15 mg tablets and 60 alprazolam 2 mg 
tablets; and that [CS] obtained prescriptions for controlled substances 
from Respondent on a monthly basis since December 2008. (ALJ Ex. 1.)
    In addition, the OSC/IS alleges that on February 10, 2010, B.R., a 
twenty-four-year-old male, died of a possible overdose at his home; 
that at the time of Mr. B.R.'s death, the Phoenix Police Department 
found a blue medical bottle prescribed by Respondent to ``[TR]'' with a 
date of December 16, 2009, for alprazolam 2 mg; that law enforcement 
personnel conducted four undercover visits to Respondent's office in 
November and December 2009; and that on these occasions Respondent 
prescribed controlled substances including Schedule II and III 
controlled substances to undercover law enforcement personnel with 
cursory or no medical examinations, without medical records and without 
a legitimate medical purpose in violation of 21 C.F.R. Sec.  1306.04 
and Ariz. Rev. Stat. Sec. Sec.  32-1401(27)(a), (q) & (ss) (2010). (ALJ 
Ex. 1.)
    On June 23, 2010, in a letter dated June 21, 2010, Respondent, 
through counsel, timely filed a request for hearing on the allegations 
in the OSC/IS. Following prehearing procedures, a hearing was held in 
Phoenix, Arizona, between September 21-23, 2010, and in Arlington, 
Virginia, on October 19, 2010, with the Government and Respondent both 
represented by counsel. Both parties called witnesses to testify and 
introduced documentary evidence. After the hearing, both parties filed 
proposed findings of fact, conclusions of law, and argument. All of the 
evidence and post-hearing submissions have been considered, and to the 
extent the parties' proposed findings of fact have been adopted, they 
are substantively incorporated into those set forth below.

I. Issue

    Whether the record evidence establishes by substantial evidence 
that Respondent's DEA COR should be revoked as inconsistent with the 
public interest as that term is used in 21 U.S.C. Sec. Sec.  824(a)(4), 
823(f) and 823(g)(2)(E)(i); and because Respondent materially falsified 
an application for DEA registration or renewal pursuant to 21 U.S.C. 
Sec.  824(a)(1).

II. Evidence and Incorporated Findings of Fact

    I find, by a preponderance of the evidence, the following facts:

A. Background

(a) Darryl J. Mohr, M.D. (Respondent)

    Respondent received his medical degree in 1970. (Transcript (Tr.) 
at 34.) After thirty years of working in other practitioners' 
practices, Respondent opened his own practice on August 3, 2009. (Tr. 
34-35, 39-40.) He has no certifications or training in pain management. 
(Tr. 36.)
    Respondent's most recent previous practice was a family practice. 
(Tr. 35.) Respondent's current practice entails approximately eighty 
percent pain management and twenty percent family care. (Tr. 35-36, 
39.)
    Respondent is the only physician at his practice. (Tr. 40.) Each 
month he sees between 225 and 300 patients, or approximately three to 
four patients per hour, devoting fifteen minutes to each patient. (Tr. 
36, 37.) Approximately eighty percent of Respondent's patients are 
cash-only. (Tr. 38.) The average age range of his patients is twenty-
seven to thirty-three. (Tr. 61.)

(b) Respondent's Employees

    Respondent began his new practice with ``[CP],'' \2\ his sole 
employee at that time. (Tr. 38-39.) In November 2009 he began to train 
a receptionist named Ana. (Tr. 38.) Ana could not handle the patient 
load, and left after about two months. (Tr. 38, 39.) Respondent next 
hired Erin Kelly, who also left after about two months. (Tr. 39.)
---------------------------------------------------------------------------

    \2\ As noted below, [CP] is also a patient of Respondent (Tr. 
693), and her name is therefore redacted.
---------------------------------------------------------------------------

    In January 2010, Respondent hired ``[SO]'' to be his medical 
assistant. (Tr. 39.) [SO] is also a patient of Respondent. (Tr. 41.) 
Respondent pays a salary for [SO]'s work; he also prescribes [SO] 
controlled substances as a patient. (Tr. 41.)

(c) Respondent's Arizona State Medical License

    Respondent possesses a state medical license, but that license has 
been suspended in the past. (Tr. 85-86; see Gov't Exs. 2 & 3.)

(d) The Arizona Controlled Substances Prescription Monitoring Program 
(PMP)

    The Arizona PMP is a database maintained by the Arizona State Board 
of Pharmacy (Board of Pharmacy) since approximately April 2008. (Tr. 
96-97, 124, 318.) Every pharmacy provides records of filled 
prescriptions for controlled substances, as well as information such as 
the prescribing doctor and DEA registration number. (Tr. 97.) The Board 
of Pharmacy collects data from pharmacies on a weekly basis, and there 
can be a lag of up to two weeks before data appears on a PMP report. 
(Tr. 153.) Checking the PMP allows a doctor to determine whether a 
patient is receiving prescriptions from multiple doctors. (Tr. 171.) 
The normal way to access the PMP is via the Internet. (Tr. 97.) Doctors 
simply provide their credentials and receive Internet and phone access. 
(Tr. 386.)

B. The Evidence

(a) The Government's Witnesses

    Task Force Officer Jeremy Dean (TFO Dean) is a member of the Apache 
Junction Police Department and is currently assigned to the Phoenix 
field division of the DEA. He was the lead investigator on Respondent's 
case. (Tr. 70-72.) He began as a task force officer in March 2009. (Tr. 
120.) Before joining the DEA Task Force, which is responsible for 
investigating the diversion of legitimate pharmaceuticals to the 
illegitimate market, TFO Dean served for three years as a patrol 
officer at the Apache Junction Police Department and a large 
telecommunications company. (Tr. 71-72.)
    Diversion Investigator Gary Linder (DI Linder) has worked as a DEA 
Diversion Investigator for approximately five years. (Tr. 176.) He 
previously served as a police officer for six years and received a 
bachelor's degree in criminal justice. (Tr. 176.)
    Task Force Officer Mike Baldwin (TFO Baldwin) is a DEA Task Force

[[Page 35003]]

Officer and a detective with the city of Surprise. (Tr. 181-82.) He has 
been a Task Force Officer with the DEA for approximately one and one 
half years. (Tr. 182.) TFO Baldwin has worked for the Surprise Police 
Department for approximately nine years, investigating illicit drug use 
in many cases. (Tr. 184.) He received a bachelor's degree in secondary 
education. (Tr. 184.)
    Task Force Officer ``[JB]'' \3\ (TFO [JB]) is a Task Force Officer 
with DEA's Tactical Diversion Squad in Phoenix. (Tr. 204.) She is 
employed by the City of Phoenix Police Department and has been a Task 
Force Officer since March 2009. (Tr. 204.) Before joining the Tactical 
Diversion Squad, TFO [JB] was a narcotics detective for the City of 
Phoenix Police Department for over twelve years, serving as a patrol 
officer and a field training officer. (Tr. 204.)
---------------------------------------------------------------------------

    \3\ As noted below, TFO [JB] and TFO ``[BK]'' conducted 
undercover visits to Respondent's office while posing as patients 
``[KR]'' and ``[BK].'' Although they visited Respondent for the 
purpose of an investigation, TFO [JB] and TFO [BK] are nevertheless 
assumed, arguendo, to be patients of Respondent, and their privacy 
is protected in this Recommended Decision by the use of initials. 
See supra note 1.
---------------------------------------------------------------------------

    Task Force Officer ``[BK]'' \4\ (TFO [BK]) is a detective with the 
City of Peoria Police Department and a task force officer with the 
Phoenix field division of the DEA in the diversion area task force. 
(Tr. 252-53.) TFO [BK] has been a Task Force Officer since June 2009. 
He previously worked as a narcotics detective with the City of Peoria 
Police Department for four years. (Tr. 253.) He also worked for six 
years as a patrol officer. (Tr. 253-54.) TFO [BK] received a bachelor's 
degree in psychology. (Tr. 254.)
---------------------------------------------------------------------------

    \4\ Supra note 3.
---------------------------------------------------------------------------

    Intelligence Research Specialist Stone (IRS Stone) is a DEA 
Intelligence Research Specialist. (Tr. 302.) He is a pattern analyst, 
looking at data to discern trends. (Tr. 303.) IRS Stone has worked at 
DEA for nineteen years, following a career as an intelligence officer 
with the U.S. Army. (Tr. 302-03.) He received a bachelor's degree in 
accounting. (Tr. 303.)
    The Government's expert witness, Stephen Borowsky, M.D. (Dr. 
Borowsky), is a board-certified anesthesiologist,\5\ board-certified 
and re-certified in pain medicine. (Tr. 378, 384.) His specialty is 
pain medicine and he is the founding president of the Arizona Pain 
Society. He belongs to regional, national and international societies 
for pain management. (Tr. 384-85.)
---------------------------------------------------------------------------

    \5\ Dr. Borowsky has previously submitted questions for the 
board certification in anesthesiology. (Tr. 384.)
---------------------------------------------------------------------------

    In addition to working at John C. Lincoln North Mountain Hospital 
and Phoenix Surgicenter, Dr. Borowsky also works at the U.S. Department 
of Veterans Affairs Hospital (VA) one day a week and teaches at the 
University of Arizona Medical School. He is a member of a group of 
physicians that conducts independent medical examinations. (Tr. 378.) 
He has worked in his specialty for thirty years. (Tr. 379.)
    Dr. Borowsky holds a degree in mechanical engineering from Drexel 
University and a medical degree from Temple University. He interned at 
Baystate Medical Center in Massachusetts, and served two years in the 
U.S. Public Health Service in the Indian Health Service in a remote 
reservation in South Dakota. (Tr. 379.) He completed his anesthesia 
residency at Beth Israel Hospital in Boston, and was simultaneously 
considered a Fellow at Harvard Medical School. He then served as a 
staff physician at Beth Israel and as an instructor at Harvard. (Tr. 
379.) He began practicing pain medicine when he was appointed Assistant 
Clinical Professor of Anesthesia at Boston University. (Tr. 379.)
    Dr. Borowsky came to Phoenix in 1980, where he practiced anesthesia 
and was recruited to work at a pain program. (Tr. 380.) He has served 
on the staff of eleven area hospitals. (Tr. 380.) He is a Clinical 
Professor of Anesthesia at the University of Arizona College of 
Medicine, and served on several task forces for the Arizona Legislature 
on chronic pain. He also served on the task force from the Board of 
Pharmacy for establishing the PMP. (Tr. 381, 385-86.) He participated 
in the development of the PMP. (Tr. 386.)
    Dr. Borowsky currently cares for eighty to ninety patients and 
performs procedures at the VA and other locations. (Tr. 381.) He is co-
chairman of the VA hospital's Multidisciplinary Pain Committee. (Tr. 
382.) He sees between ten and twenty patients, all of which are pain 
patients, on the one day per week he works at the VA hospital. (Tr. 
382-83.)
    Dr. Borowsky is a lecturer in the area of pain management. He stays 
apprised of recent developments in the field by reading journals and 
Internet web sites, attending or holding conferences and communicating 
with other practitioners. (Tr. 387-88; see generally Gov't Ex. 17.)

(b) Respondent's Witnesses

    In addition to his own testimony, Respondent presented testimony by 
his patient ``[CM].'' Respondent also presented testimony by his 
employees ``[SO]'' and [CP], who are current or former patients. 
Finally, Respondent presented testimony of ``[RF],'' the fiancé
of Respondent's late patient ``[CS].''

(c) About the DEA Investigation of Respondent, Generally

    The DEA's investigation of Respondent, which began in August of 
2009, centered around: (1) Allegations that Respondent falsified his 
application for a DEA registration; (2) allegations that Respondent was 
practicing at an unregistered location; (3) allegations that Respondent 
was prescribing controlled substances outside of a normal, professional 
practice; and (4) a number of fatalities allegedly connected with 
Respondent's prescribing practices. (Tr. 72-74.)
    TFO Dean testified that a federal search warrant was executed at 
Respondent's medical practice in May 2010. (Tr. 115-16.) Items seized 
included medical records for approximately eight patients, controlled 
substances and financial documents. (Tr. 116.)
    DI G.L. testified that he served Respondent with the OSC/IS on May 
26, 2010, at Respondent's business, at 16601 North 40th Street, Suite 
115 in Phoenix. (Tr. 177.)

(d) Material Falsification of DEA Application

    As discussed in a later section of this Recommended Decision,\6\ 
there is uncertainty as to some of the details of Respondent's history 
of registration with the DEA. Certain details, however, are clear and 
undisputed. Respondent presently holds DEA COR number BM2040498. (Tr. 
78; Gov't Ex. 1 at 2.) He applied to renew his COR on January 29, 2008. 
(Gov't Ex. 1 at 2; see also Tr. 795.) On his 2008 renewal application, 
Respondent answered ``no'' to liability questions inquiring, in 
pertinent part, whether Respondent had ever had a state medical license 
suspended or placed on probation (see, e.g., Gov't Ex. 28), 
notwithstanding the fact that the Arizona Medical Board had previously 
suspended Respondent's medical license in 2001. (See Tr. 85-86, 760-61; 
Gov't Ex. 28; Gov't Ex. 3 at 4.) Respondent testified that he did not 
``really have a good answer'' for why he said ``no'' on the renewal 
application, ``other than I didn't pay much attention to the wording.'' 
(Tr. 760.) Respondent

[[Page 35004]]

maintains that he ``never tried to deceive anyone.'' (Tr. 760-61.)
---------------------------------------------------------------------------

    \6\ See generally infra Section III.B (discussing ambiguities 
surrounding the dates of Respondent's COR registration and 
renewal(s)).
---------------------------------------------------------------------------

    Record evidence indicates that on October 23, 2000, the Arizona 
Medical Board issued a consent agreement and order. (Tr. 86-87; see 
Gov't Ex. 2.) The consent agreement reprimanded Respondent for 
unprofessional conduct and required forty hours of continuing medical 
education in pharmacology. (Tr. 87; see Gov't Ex. 2 at 4.) Moreover, on 
November 27, 2001, the Board placed Respondent's medical license on 
probation.\7\ (Tr. 88; see Gov't Ex. 3.)
---------------------------------------------------------------------------

    \7\ Respondent also conceded that the Arizona Medical Board 
recently placed his license on probation for two years, (Tr. 62), on 
August 11, 2010. (See Gov't Ex. 27 at 4). Respondent stated that the 
Board required him to be monitored, and that he has signed a 
contract to employ monitors. Respondent equivocated, however, as to 
whether the monitoring program is currently in place. (Tr. 62-63, 
67-68.) Because this probation occurred after Respondent applied to 
renew his COR in 2008, it is not relevant for purposes of the 
material falsification analysis. But compare infra Section III.D 
(discussing Respondent's August 11, 2010 probation in light of the 
21 U.S.C. Sec.  823(f) public interest analysis).
---------------------------------------------------------------------------

(e) Respondent's Registered Location and Practice Location

    Respondent testified that his current practice location is 16601 
North 40th Street, Suite 115, Phoenix Arizona 85032. (Tr. 34.) 
Respondent conceded that this location is not reflected on his DEA COR. 
(Tr. 35; see also Tr. 90.) Respondent's COR reflects a registered 
address of ``Access2care Family Medical Center, 4607 N. 12th Street, 
Phoenix, Arizona 85014.'' (Gov't Ex. 28.) Respondent explained that 
when he last filled out the application to renew his COR, he ``was 
working at Access to Care, and that was a family practice.'' \8\ (Tr. 
35.) Respondent failed to update his address when he moved to his new 
practice in August 2009. (Tr. 760.) Respondent testified he did not 
realize he had to notify DEA of the change in address in addition to 
notifying the Arizona Medical Board. (Tr. 760.)
---------------------------------------------------------------------------

    \8\ The different spellings of Respondent's former clinic, 
compare Tr. 35 (``Access to Care''), with Gov't Ex. 28 
(``Access2care Family Medical Center''), appear to reflect a 
typographical error in the transcript.
---------------------------------------------------------------------------

(f) Respondent's Care as a Physician

(1) Proof of Patient Identity

    Respondent testified that he requires every patient to provide 
identification, but leaves the type of identification up to his staff. 
(Tr. 47-48.) While somewhat credible, this testimony is rebutted by 
record evidence that Respondent's staff permitted TFO [BK], posing as 
patient [BK], to see Respondent after producing only an ``admin per se 
form,'' despite the fact that Respondent's staff stated that the admin 
per se form was not an acceptable form of identification. (Tr. 258, 
295-96.) On his second visit to Respondent, on December 23, 2009, TFO 
[BK] was again permitted to see Respondent, who prescribed controlled 
substances to TFO [BK] for a second time without verifying the 
patient's identification. (Tr. 266-67.)

(2) Proof of Injury

    The Government's expert medical witness, Dr. Borowsky, opined that 
obtaining a patient's medical history is critical to avoiding diversion 
and overdose, which are becoming widespread. (Tr. 396.) Indeed, Dr. 
Borowsky testified that the Arizona Medical Board requires that 
physicians maintain medical records for patients. (Tr. 418.) In his own 
pain management practice, every patient Dr. Borowsky sees is referred 
to him by another practitioner; he does not accept walk-ins. (Tr. 388-
89.) Moreover, Dr. Borowsky reviews patients' medical records before 
consulting with patients, ``so I know whether this is an appropriate 
patient for me or whether it [sic] needs some other direction, so that 
we're not wasting anybody's time.'' (Tr. 389, 404.) He refuses to see 
patients ``unless there's the proper documentation and radiologic 
studies that have been done. I'm not a primary [care] physician, and I 
want to make sure everything has been done before they get to me.'' 
(Tr. 390.) He conceded, however, that when a patient needs testing, he 
orders testing. (Tr. 390.)
    Respondent's employee [CP] testified that Respondent has had a 
policy of requiring proof of injury ``[f]rom day one.'' (Tr. 713.) 
Respondent's testimony, however, shows otherwise. Respondent testified 
that in the past, because it could take three or four months to acquire 
a patient's medical records (Tr. 42), Respondent would write 
prescriptions beginning once the patient signed release forms to permit 
Respondent to acquire her records. (Tr. 42-43.) Respondent explained 
that he did this as a ``compassionate doctor.'' (Tr. 42.) ``I always 
required proof of injury. But I waited sometimes for the proof of 
injury to come in'' and prescribed controlled substances in the 
interim. (Tr. 43-44; see also Tr. 45.)
    Respondent further testified that he began requiring proof of 
injury from pain management patients in December 2009 or January 2010. 
(Tr. 42.) Now that Respondent has ``gotten more into the pain 
management process,'' Respondent requires that every patient present 
proof of injury. (Tr. 42-44.) Proof of injury can take the form of 
MRIs, CTs, X-ray reports, reports from a previous doctor or blood work, 
depending on the diagnosis. (Tr. 43, 46.) Respondent might accept a 
three-year-old MRI that shows significant disease. (Tr. 45.) In some 
cases, he has accepted a six-year-old MRI. (Tr. 46.)
    Respondent's testimony that he has required proof of injury since 
December 2009 or January 2010 is called into question by record 
evidence that TFO [BK], posing as patient [BK], provided no medical 
records before or during his December 23, 2009 visit to Respondent, at 
which Respondent prescribed controlled substances. (Tr. 265-67.) 
Similarly, the record shows that Respondent prescribed controlled 
substances to TFO [JB] on December 18, 2009, without requiring any past 
medical records. (Tr. 219, 247.) Indeed, TFO [JB] testified that 
Respondent stated that ``if he were to continue to prescribe to me, I 
would need to get proof of injury because he was in danger of losing 
his license.'' (Tr. 220; see Tr. 244.) Moreover, ``Respondent does not 
contest the fact that he prescribed to the two undercover agents 
without demanding previous medical records,'' (Resp't Br. at 39), 
explaining that ``I'm a good doctor and that at times I found myself 
not being prepared to manage such difficult situations,'' (Tr. 756.) I 
find by substantial evidence that during the relevant time period, 
Respondent did not consistently require proof of injury.

(3) Physical Examination of Patients

    Dr. Borowsky testified that the Arizona Medical Board requires that 
physicians conduct a physical examination and patient history. (Tr. at 
416.) An examination is important to show discrepancies and determine 
whether a patient is credibly in pain. (Tr. 397.) Dr. Borowsky 
testified on the importance of being skeptical, and that prescribing 
properly requires picking the right patient and monitoring the patient. 
(Tr. 397.)
    In his own pain management practice, Dr. Borowsky does not take 
vital records on every patient; it depends on the patient. (Tr. 391-
92.) However, he does conduct physical examinations. (Tr. 393.) An 
examination of a patient with low back pain, for instance, would 
include directing the patient to walk both on her heels and on her 
toes. (Tr. 393.) Dr. Borowsky would direct the patient to sit and do 
straight leg-raising, ``and if that was positive, ultimately, I would 
lay them down and look for continuing [sic] with a straight leg-raise 
to see if it was the same result.'' (Tr. 393, see also Tr. 394.) 
Throughout the examination, Dr. Borowsky would watch for ``non-organic 
findings, in

[[Page 35005]]

other words, non-physical findings like Waddell's signs. One of those 
would be lightly pressing on somebody's head, and if they respond by 
exclaiming that they have radiating leg pain, that's not a physical 
finding that creates a credible picture.'' (Tr. 394.)
    Respondent's patients ``[CM],'' ``[CP]'' and ``[RF]'' each 
testified that Respondent examined them on their first visits. (Tr. 
515, 567, 700.) In addition, Respondent testified that when he conducts 
physical examinations of patients, he does not use the Waddell's signs 
test. Instead, his exams are ``heel to toe, hip flexion, range of 
motion, reflexes.'' (Tr. 48.) This testimony is undercut by record 
evidence that Respondent conducted no physical examination of TFO [BK] 
when the latter posed as patient [BK] on November 18, 2009, and 
December 23, 2009. (Tr. 258, 260, 267-68.) Respondent gave TFO [BK] 
prescriptions for controlled substances on both occasions. (Tr. 256, 
265.) Moreover, Respondent failed to conduct a physical examination of 
TFO [JB] when the latter posed as patient [KR] on December 18, 2009. 
(Tr. 219.) Respondent gave TFO [JB] a prescription for controlled 
substances anyway. (Tr. 247.)
    In mitigation, the record reflects that during TFO [JB]'s November 
13, 2009 undercover visit, Respondent did touch TFO [JB]'s back in 
several places, asked if it hurt and moved her right foot. (Tr. 215, 
238-40.) This incident, however, occurred only as Respondent was 
starting to leave the examination room, after he had already told TFO 
[JB] of his decision to prescribe controlled substances. (Tr. 214-15, 
246.) Moreover, Dr. Borowsky testified that Respondent's purported 
examination in this regard was inadequate because Respondent's 
statement ```I'm poking you' . . . is not a physical exam.'' (See Tr. 
421-22.) I find by substantial evidence that during the relevant time 
period, Respondent did not consistently conduct adequate physical 
examinations before prescribing controlled substances.

(4) Patient Drug Screens

    Dr. Borowsky testified that in his own pain management practice, 
before prescribing a controlled substance, he orders patients to 
complete a urine drug test. (Tr. 392-93.)
    Respondent testified that he performs drug screens on ``[e]very 
patient that walked through the door'' at every appointment. (Tr. 46.) 
Under certain circumstances, however, when a patient with an opioid 
prescription tests negative for opiates, Respondent might nevertheless 
prescribe controlled substances, such as, for example, if the patient 
loses the medication or forgets to take it. (Tr. 47.)
    The credibility of Respondent's testimony that he performs drug 
screens on all patients is called into question by evidence that 
Respondent did not require undercover investigators posing as patients 
to complete drug screens on November 13, 2009 (Tr. 209), November 18, 
2009 (Tr. 258), December 18, 2009 (Tr. 219) or December 23, 2009 (Tr. 
267). This discrepancy, however, may be explained in part by 
Respondent's testimony that he began conducting drug screens in 
February 2010. (Tr. 805; see generally Tr. 221, 616-17.) In any event, 
``Respondent . . . concedes that his willingness to prescribe based on 
office observation, examination and patient complaints was unwise.'' 
(Resp't Br. at 40.)

(5) Referrals for Treatment by Specialists

    Dr. Borowsky testified that the Arizona Medical Board requires that 
physicians consult with specialists (Tr. 417) because ``[m]ost of these 
problems involve areas that can be beyond the practitioner, even a pain 
management doctor, and it's important to get the appropriate 
consultations . . . .'' (Tr. 429.) Respondent testified that he makes 
referrals for psychiatric evaluation to patients with insurance. (Tr. 
48.) For patients without insurance, Respondent asks them about their 
psychiatric treatment history. (Tr. 49.) Most of his patients lacking 
insurance cannot afford psychiatric treatment, ``[b]ut I tell them they 
still need to go if the situation calls for it.'' (Tr. 49.)
    Respondent's testimony that he makes referrals is called into 
question by his failure to make a referral to TFO [BK], posing as 
patient [BK], notwithstanding Respondent's stated concern that TFO [BK] 
might have fibromyalgia. (Gov't Ex. 23 at 1.)

(6) Respondent's Use of the Arizona PMP

    Dr. Borowsky testified that it is the obligation of a doctor to 
check the PMP.\9\ (Tr. 386-87; accord Tr. 170 (testimony of TFO Dean).) 
When prescribing controlled substances, however, Respondent did not 
initially consult the PMP. (Tr. 50.) Respondent explained that he did 
not initially know about the PMP, and ``there were certain things I 
didn't know about pain management.'' (Tr. 50.) But once he was informed 
of the PMP, in approximately December 2009 or January or February of 
2010, he did start to use it. (Tr. 50-51.) This testimony is slightly 
undercut by Respondent's statement to TFO [JB] on November 13, 2009, 
that ``the only place you can get these medications is from me . . . 
it's all computerized, so you're gonna get red-flagged and they're 
gonna call you a drug addict and a doctor shopper and then all of a 
sudden no pharmacy . . . is gonna give you any medication'' (Gov't Ex. 
21 at 147; see also Tr. 213), which evinces Respondent's knowledge of 
the PMP on that earlier date.
---------------------------------------------------------------------------

    \9\ Respondent argues that Dr. Borowsky used the term 
``obligation'' ``in the aspirational or hortatory sense.'' (Resp't 
Br. at 22 ] 106 (citing Tr. 479-80).) Respondent was given ample 
opportunity before, during and after the hearing in Phoenix, Arizona 
to present testimony by an expert witness of his choosing. Such 
testimony could have addressed, inter alia, whether an Arizona 
physician is obligated to consult the PMP. Respondent declined to 
call an expert witness. (Tr. 863.) Dr. Borowsky's unqualified and 
fully credible testimony therefore stands unrebutted.
---------------------------------------------------------------------------

    Respondent also testified to relying on a pharmacy to check the PMP 
for him. (Tr. 51.) The pharmacy would call Respondent if a review of 
the PMP indicated ``doctor shopping.'' (Tr. 51.) ``And if that were the 
case, every one of those patients got discharged.'' (Tr. 52.)

(7) Patient Treatment Plans

    Dr. Borowsky testified that the Arizona Medical Board requires that 
physicians document a treatment plan. (Tr. 417.) He opined that it is 
critical to document both patient treatment plans and informed consent 
to substantiate the basis for treating the patient and the patient's 
diagnosis. (Tr. 399-400.) ``[I]f it's not in writing, others will 
assume that it was not done.'' (Tr. 400.)
    Dr. Borowsky testified that in his own pain management practice, 
following the physical examination of a patient, he consults with the 
nurse case manager to develop a written plan of treatment. (Tr. 395.) 
Frequently, such a treatment plan would involve any of the following: 
physical therapy, psychology, referral to a psychiatrist and injection 
techniques such as epidural steroid injections or trigger-point 
injections. (Tr. 394-95.) Treatment could also involve medication 
management, such as opioids, narcotics, anti-inflammatories, anti-
convulsives, antidepressants and various medications along that line. 
(Tr. 394-95.)
    Respondent testified that he formulates treatment plans in his mind 
for his patients. (Tr. 52.) Respondent's testimony was unclear as to 
whether he reduces his treatment plans to writing. (See Tr. 52.) The 
testimony of DEA investigators posing as patients indicates that 
Respondent discussed no treatment plan before prescribing

[[Page 35006]]

controlled substances on November 13, 2009 (Tr. 212) November 18, 2009 
(Tr. 262) December 18, 2009 (Tr. 220) or December 23, 2009 (Tr. 269). 
Moreover, the patient files of TFO [JB], posing as [KR], and TFO [BK], 
posing as [BK], reveal no treatment plans.\10\ (Tr. 416; see also Gov't 
Exs. 15 & 16.)
---------------------------------------------------------------------------

    \10\ Respondent proposes that it is ``not necessarily reasonable 
to expect an elaborate treatment plan for patients who have been 
advised to get diagnostics ([JB]) or to find a primary care doctor 
to provide evaluation, diagnostics and probably referral ([BK]).'' 
(Resp't Br. at 38 n.10.) Respondent was given ample opportunity 
before, during and after the hearing in Phoenix, Arizona to present 
testimony by an expert witness of his choosing. Such testimony could 
have addressed, inter alia, whether a treatment plan was called for 
in the case of TFO [JB] and TFO [BK]. Respondent declined to call an 
expert witness. (Tr. 863.) Dr. Borowsky's unqualified and fully 
credible testimony therefore stands unrebutted.
---------------------------------------------------------------------------

(8) Informed Consent and Opioid Contract

    Dr. Borowsky testified that the Arizona Medical Board requires that 
physicians obtain informed consent from patients. (Tr. 417.) In his own 
pain management practice, Dr. Borowsky discusses the risks and benefits 
of medications he prescribes to patients. (Tr. 395.) He also directs 
patients to sign an informed consent agreement using a standard form 
that is readily available in pain management societies. (Tr. 399.) He 
said it is critical to discuss with patients the risks and benefits of 
medications, especially opioids. (Tr. 399.) Dr. Borowsky opined that it 
is critical to document treatment plans and informed consent to 
substantiate the basis for treating the patient and the patient's 
diagnosis. (Tr. 399-400.) Although diagnoses can be vague after 
patients undergo various surgeries and treatments, there does 
ultimately need to be credibility and substantiation for a diagnosis. 
(Tr. 398.)
    Respondent testified that he has required patients to sign an 
opioid contract since December 2009 or January 2010, but he was not 
sure exactly when. (Tr. 55.) Before he began using his current opioid 
contract, Respondent used an ``opioid flow sheet,'' which ``explained 
about taking the drugs, and being responsible for how you take the 
drugs and potential side effects, and so on and so forth.'' (Tr. 55.) 
Respondent has an informed consent agreement in place as a part of the 
opioid contract. (Tr. 65.) Respondent took the language in the opioid 
contract from his previous clinic. (Tr. 65-66.)
    In contrast to Respondent's testimony, TFO [BK] testified that 
Respondent did not discuss the risks and benefits of the controlled 
substances he prescribed to TFO [BK] on December 23, 2009. (Tr. 269.) 
Nor did Respondent discuss the risks and benefits of the drugs he 
prescribed to TFO [JB] during her second visit in an undercover 
capacity on December 18, 2009. (Tr. 220.) Taken together, this 
testimony calls into question the extent to which Respondent 
consistently obtains informed consent from his patients.

(9) Pain Scale

    Dr. Borowsky testified that in his own pain management practice, it 
is customary to have patients fill out a questionnaire that includes a 
pain diagram. He stated that ``the coloring-in of the location of pain 
many times can give you a good idea of the diagnosis.'' (Tr. 390.) His 
intake form also includes a pain scale ranging from zero to ten, as 
well as adjectives that patients can circle to describe their pain. 
(Tr. 390.) Dr. Borowsky conceded that under some circumstances, a 
patient circling zero on a pain scale might mean zero pain while on 
medication. (Tr. 430-31.) Respondent testified that he would prescribe 
controlled substances to a patient that indicated zero on the pain 
scale. (Tr. 59.) Indeed, TFO [JB], posing as patient [BK], indicated 
zero out of ten on a patient intake form on November 13, 2009 and again 
on December 18, 2009. (Tr. 208, 219, 223; see Gov't Ex. 15 & 16.) 
Respondent prescribed controlled substances to TFO [JB] on both 
occasions. (Tr. 207, 211-12, 247.) Similarly, TFO [BK], posing as a 
patient on November 18, 2009, indicated zero out of ten on a pain 
scale. (Tr. 257; see Gov't Ex. 16.) On his second undercover visit, on 
December 23, 2009, TFO [BK] left the pain scale blank. (Tr. 266; see 
Gov't Ex. 16.) Respondent prescribed controlled substances to TFO [BK] 
in both instances. (Tr. 256, 265.)

(g) Respondent's Knowledge of Controlled Substances

    DI G.L. testified that when he served the OSC/IS on Respondent on 
May 26, 2010, Respondent asked DI G.L. ``what a controlled substance 
was, and if Xanax was a controlled substance.'' (Tr. 177-79.) DI G.L. 
replied that ``Xanax was in fact a controlled substance, and if he 
needed to refer to anything else, he could go to [the DEA] Web site, 
and there would be a full list of controlled substances on the 
diversion Web site.'' (Tr. 179.) DI G.L. testified that in his 
experience as a DEA investigator, DI G.L. had never encountered that 
question before. (Tr. 179.)

(h) Quantity of Controlled Substances Prescribed

    Dr. Borowsky testified that when prescribing controlled substances, 
it is appropriate to ``start[] off with the lowest level of medication 
. . . If you start high, you can't go back very easily, but if you 
start low, you can assess [the patient's] response.'' (Tr. 406.) He 
elaborated that ``it's not just the pain relief that you're looking 
for. The goal . . . is not just pain relief, but improvement in 
function . . . .'' (Tr. at 406.)
    Respondent testified that the average amount of oxycodone he 
prescribes is 30 mg, with the dosages running from ninety to one 
hundred and fifty, corresponding to three to five times per day. (Tr. 
54.) Thirty milligrams is the highest dosage available of oxycodone. 
(Tr. 55.)

(1) ``Street Value'' of Controlled Substances

    TFO [JB] noted that based on her experience as an investigator, the 
term ``on the street,'' in the context of controlled substances, means 
the controlled substances are received illegally, or from illegal 
means. (Tr. 213-14.) TFO Dean testified that ``many of the drugs 
[Respondent] was prescribing were ending up in the illegitimate market, 
in the street market.'' (Tr. 73.)
    Respondent acknowledged prescribing to patients when he knew the 
patients bought drugs on the street in the past. (Tr. 58.) He said 
patients subsequently ``came to me because they didn't want to continue 
breaking the law.'' (Tr. 57.) When he sees such patients, he tells them 
not to buy on the street and only to get drugs from him. (Tr. 58.)
    Respondent testified that he did not personally know any patients 
who sell pills on the street, and that he immediately discharges any 
patient he discovers to be selling drugs. (Tr. 55-56.) Respondent 
estimated that the amount of patients he discovers are selling 
constitutes less than one percent. (Tr. 56-57.) Yet Respondent also 
testified that between December 2009 and May 2010, he discharged 264 
patients. (Tr. 757.) ``The reasons were from selling drugs, using 
medications that weren't prescribed by me, multiple doctor shopping, 
using the pharmacy monitoring program, use of illicit drugs and drug 
screens where they came positive for cocaine or methamphetamine . . 
..'' (Tr. 757.)
    Dr. Borowsky testified that he does not discuss the street value of 
medications with his patients. (Tr. 428.) Respondent stated that in 
general, he does not discuss street values of drugs with patients. (Tr. 
59.) However, he conceded having done so in the past. (Tr. 59.) ``I 
would tell them what my

[[Page 35007]]

patients tell me. I know nothing about street drugs per se. I repeat 
what I've heard from my patients.'' (Tr. 59.) This testimony by 
Respondent stands in contrast to other record evidence that on November 
13, 2009, Respondent told TFO [JB] that the drugs he prescribed to her 
possessed a high street value. He noted that the pills sold for about 
ten dollars per pill on the street and that OxyContin sold for forty 
dollars to eighty dollars on the street. (Tr. 213.) In mitigation, a 
transcript of that visit suggests that when Respondent discussed the 
street value of drugs with TFO [JB], he did so for the patient's own 
protection:

these medications . . . there's a high street value for them. That's 
number one. So it's not a good idea for you to tell your friends that 
you're taking these medications because [even] your mother will take 
them from you . . . These medications go for about ten dollars a pill 
on the street . . . what's called oxycontins . . . go like anywhere 
from like 40 to 80 dollars a pill . . . So there's a huge street value. 
People are always stealing them. So be careful. Uh because if you lose 
your medications, even if you have a police report, can't get em. Once 
a month is all you can get. (Gov't Ex. 21 at 147-48.)

(2) Statistical Analysis of Respondent's Prescribing Practices

    IRS Stone testified that he analyzed the PMP data on Respondent's 
prescriptions. (Tr. 303.) He focused on the number of patients 
involved, the dates covered and the kinds and combinations of 
controlled substances Respondent prescribed. (Tr. 304.) Government 
Exhibit 14 consists of charts IRS Stone prepared on this basis. (Tr. 
305; see Gov't Ex. 14.) IRS Stone did not verify that the data he was 
given was correct before analyzing it, because he had no basis to do 
so. (Tr. 318.)
    The category ``oxycodone'' on the first chart of Government Exhibit 
14 refers to drugs prescribed by Respondent in which oxycodone is the 
main ingredient, including Percocet, Endocet, OxyContin and 12 
oxycodone 30s. (Tr. 306.) The category ``benzodiazepine'' in the same 
chart refers to drugs prescribed by Respondent in which benzodiazepine 
is an active ingredient, such as Klonopin, Xanax, alprazolam, 
clonazepam and lorazepam. (Tr. 306-07.)
    The first chart indicates that between August 2009 and March 2010, 
Respondent wrote 9411 prescriptions. (Tr. 307.) The highest number of 
prescriptions was 5126, for oxycodone. (Tr. 307, 310.) The total tablet 
count was 681,590. (Tr. 310.) This amount represents 54.47 percent of 
Respondent's prescriptions and 71.08 percent of the tablets he 
prescribed. (Tr. 311.)
    The second highest number of prescriptions Respondent wrote between 
August 2009 and March 2010 was 3230, for benzodiazepine. (Tr. 307, 
310.) The total tablet count was 208,318. (Tr. 310.) This amount 
represents 34.32 percent of Respondent's prescriptions and 21.72 
percent of the tablets he prescribed. (Tr. 311; see Gov't Ex. 14 at 2.) 
The tablet counts noted above do not distinguish between tablets of 
various dosages. (Tr. 319.)
    The second chart of Government Exhibit 14 contains the number of 
prescriptions within each drug group, the number of tablets prescribed 
within that drug group and the average number of tablets per 
prescription. (Tr. 307-08.) For instance, when Respondent prescribed 
hydrocodone, he did so with an average of one-hundred and ten tablets 
per prescription. (Tr. 309.) This average prescription indicates a 
patient taking a prescription more than three times per day during a 
month of thirty days. (Tr. 309.) The prescription average for oxycodone 
was one-hundred and thirty-three. (Tr. 310.)
    The third chart identifies how many of Respondent's patients 
received various drugs between August 2009 and March 2010. (Tr. 311-
14.) According to information IRS Stone received from the PMP, the age 
group in Arizona that received the highest number of prescriptions for 
controlled substances was the fifty to fifty-nine age group. (See Tr. 
491 (correcting mistake in witness's prior testimony, see Tr. 317).)

(3) [JG] and Diversion

    TFO Baldwin testified to an interview he conducted with ``[JG].'' 
(Tr. 184.) [JG] was twenty nine or thirty years old at the time of the 
interview. (Tr. 189.) [JG] said she was addicted to oxycodone, and that 
she visits Respondent on a monthly basis and pays cash. (Tr. 185.) She 
has her prescriptions filled at Community Pharmacy, at 29th Avenue and 
Bell Road. (Tr. 186.) That location is ten miles away from Respondent's 
office; to get from Respondent's office to that location, one passes by 
many other pharmacies on the way. (Tr. 186.) TFO Baldwin testified that 
[JG] said she goes to that particular location of Community Pharmacy 
because it has the cheapest price in town, because it always has her 
stock on-hand and because Respondent directed her to go there. (Tr. 
186.) TFO Baldwin has heard that Community Pharmacy has ``the cheapest 
cash prices. That's how they advertise.'' (Tr. 197.)
    TFO Baldwin testified that [JG] said that she and her boyfriend 
sell their pills to pay their bills. (Tr. 187.) She and her boyfriend 
go to Respondent because a friend of hers had said: ``Hey, this doctor 
can give you the hook up.'' (Tr. 187, 197.) TFO Baldwin testified that 
he understood that to mean that without a lot of questions asked, a 
person can get the medications that they seek. (Tr. 187.) TFO Baldwin 
testified that he asked [JG] if Respondent knew that she was selling 
her pills, and her response was that ``he should know because half the 
patients in there are just like me.'' (Tr. 196.)
    TFO Baldwin further testified that [JG] said that fifty percent of 
Respondent's patients are getting pills for no medical reason. (Tr. 
187.)

(4) [LW] and Diversion

    TFO [JB] testified that she talked with ``[LW],'' one of 
Respondent's patients, at a pharmacy on November 13, 2009. (Tr. 216.) 
TFO [JB] knew [LW] was a patient of Respondent because they saw one 
another in Respondent's waiting room. (Tr. 244.) [LW] said she was 
taking oxycodone 30, and that she was addicted. (Tr. 216.) She usually 
took five pills per day; she used to sell part of her prescription on 
the street but now needs to take all of them to avoid withdrawal. (Tr. 
217.)
    [LW] said she sent several patients to Respondent to get 
prescriptions to sell on the street. (Tr. 217.) [LW] told TFO [JB] that 
Respondent had never asked [LW] for proof of injury, nor did she 
provide any, but that he had recently begun to ask patients for proof 
of injury. (Tr. 217.)

(5) Pharmacists Questioning Respondent's Prescribing Practices

    Respondent testified that a pharmacist has never questioned his 
prescribing of controlled substances. (Tr. 61.) On multiple occasions, 
however, pharmacists have contacted Respondent to ensure a prescription 
was valid. (Tr. 66.) In such situations, Respondent asked the 
pharmacist to fax him the suspicious prescription, and Respondent 
advised whether it was his own handwriting. (Tr. 66-67.)
    Contrary to Respondent's testimony that a pharmacist has never 
questioned Respondent's prescribing of controlled substances (see Tr. 
61), the testimony of TFO Dean and an August 10, 2009 letter by 
pharmacist S.G. (see Gov't Ex. 4) suggest otherwise. (See also Tr. 
168.)
    TFO Dean testified that the official investigation of Respondent 
began when pharmacist S.G. contacted TFO Dean because he was suspicious 
of Respondent's prescribing practices. (Tr.

[[Page 35008]]

73.) S.G. told TFO Dean that Respondent ``had a large number of 
customers at his pharmacy who all were receiving similar prescriptions, 
usually oxycodone and alprazolam, and that many of them seemed to be 
organized in some sort of group, as they were all using the same 
physical prescription discount card.'' (Tr. 74.)
    Directly contradicting Respondent's testimony, TFO Dean testified 
that S.G. contacted Respondent and expressed his suspicion that some of 
Respondent's patients were diverting drugs. (Tr. 74.) According to TFO 
Dean, Respondent replied to S.G. that all the prescriptions in question 
were legitimate. (Tr. 75.) TFO Dean testified that S.G. said Respondent 
told S.G. a story about a previous practice where Respondent had 
worked, where Respondent had prescribed to a family of ten patients, 
but only two of them needed their medications. (Tr. 75.) On cross 
examination, TFO Dean said S.G. did not indicate where or when this 
story was said to have occurred, other than at a previous employer of 
Respondent. (Tr. 132-33.) TFO Dean testified that Respondent told this 
story to S.G. in response to S.G.'s suspicions. (Tr. 168.) In his 
testimony, Respondent denied that such a family existed, and denied 
prescribing to any such family. (Tr. 774-76.)
    TFO Dean stated that following his conversation with S.G., TFO Dean 
asked S.G. in late July or early August 2009 to formalize in a letter 
what they had talked about. (Tr. 124-25.) The record reflects a letter 
from S.G. to the DEA dated August 10, 2009. (Gov't Ex. 4; see Tr. 76.)
    TFO Dean testified on cross examination as to how S.G. connected an 
individual prescription by Respondent to concerns of diversion. For one 
thing, the amounts of some prescriptions were similar. Moreover, S.G. 
noted that patients were using the same physical prescription discount 
card because it was creased in a particular way. (Tr. 128.)
    S.G. told TFO Dean that S.G. followed patients out into the parking 
lot and saw them exchange cash with someone in a vehicle. (Tr. 128.) 
S.G. said he and his staff ``would see them go outside--they'd come 
inside often, ask how much their prescriptions were going to be, go out 
to a vehicle, receive cash from the driver, walk back in. [They would 
p]ay with that cash, and go back and get in a vehicle and leave.'' (Tr. 
126-29, 130, 168.)
    TFO Dean did not recall whether S.G. said he had told Respondent 
about following the patients into the parking lot. (Tr. 130.) On 
redirect examination, TFO Dean testified that TFO Dean did not inform 
Respondent of his suspicions relating to the parking lot story, but 
that S.G. did. (Tr. 168.)

(i) Undercover Visits to Respondent, Generally

    Pursuant to a federal warrant executed on Respondent's medical 
practice in May 2010, law enforcement officers seized medical files 
under the names of [BK] and [KR]. (Tr. 116.) These files are patient 
records associated with four undercover visits by two undercover law 
enforcement officers. (Tr. 118-19; see Gov't Ex. 15 & 16.)
    Law enforcement officers made audio or video recordings of three of 
these undercover visits.\11\ (Tr. 118-19.) TFO Dean monitored all of 
the undercover visits via audio receiver. (Tr. 119.)
---------------------------------------------------------------------------

    \11\ TFO [JB]'s recording device malfunctioned during the 
December 18, 2009 undercover visit. (Tr. 218.)
---------------------------------------------------------------------------

(j) Undercover Visits to Respondent by TFO [JB], AKA ``[KR]''

    TFO [JB] testified that on November 13, 2009, and December 18, 
2009, she visited Respondent in an undercover capacity, posing as 
patient ``[KR],'' and Respondent gave her prescriptions for 70 
oxycodone 30 mg. (Tr. 205-06, 211, 221.)

(1) TFO [JB] Undercover Visit of November 13, 2009

    During her first undercover visit to Respondent's office, posing as 
``[KR],'' TFO [JB] possessed a functioning recording device. (Tr. 206-
07, 230; see Gov't Exs. 21 & 24.) TFO [JB] filled out a patient intake 
form and paid seventy dollars in cash. (Tr. 208.) The patient intake 
form included a pain scale of zero to ten for ``pain score on 
medications,'' on which TFO [JB] marked ``zero,'' indicating no pain. 
(Tr. 208, 223.) TFO [JB] did not provide medical records. (Tr. 208.)
    The consultation with Respondent lasted ten minutes, and Respondent 
also took a phone call during that time. (Tr. 207; see Gov't Ex. 21 at 
145.) When Respondent entered the examination room, Respondent asked 
who sent TFO [JB] to him. (Tr. 210; Gov't Ex. 21 at 142.) He then 
stated that he was going to flirt with TFO [JB], because he flirts with 
his good-looking patients. (Tr. 210; Gov't Ex. 21 at 143.) After 
approximately the third time he said this to her, she responded ``Oh, 
that's fine.'' (Tr. 236; Gov't Ex. 21 at 143.) Respondent asked if TFO 
[JB] was single, and whether she had ever been out with a doctor. (Tr. 
214; Gov't Ex. 21 at 148.) He told her that she was attractive, and 
that she was single, and that he was single. (Tr. 215; Gov't Ex. 21 at 
148-50.) TFO [JB] testified that Respondent made her feel uncomfortable 
(Tr. 234, 246), and that she was not sure whether he was joking or not. 
(Tr. 234.) This had never occurred in her investigation of other 
doctors. (Tr. 246.)
    The examination room contained an examination table, but no 
instruments. (Tr. 209.) No one checked her vital signs, such as her 
pulse, heart rate, height, weight or blood pressure. (Tr. 208-09.) She 
did not submit a urinalysis for drug screening. (Tr. 209.) TFO [JB] 
said Respondent did not give her a physical, neurological or 
musculoskeletal examination. (Tr. 212.) He asked if she had had an MRI; 
she said she had not and Respondent recommended she go to Simon Med, 
which would give her a discount. (Tr. 212; Gov't Ex. 21 at 144, 146.)
    TFO [JB] did not say she had any pain. (Tr. 210, 245; see e.g., 
Gov't Ex. 21 at 143.) She said she had been taking her father's 
Percocet ``to feel good, or better.'' (Tr. 211; see Gov't Ex. 21 at 
144.) She said she had not seen a doctor in a few years. (Tr. 210; 
Gov't Ex. 21 at 143.) Respondent then asked how TFO [JB] hurt her back, 
even though TFO [JB] never said her back hurt. (Tr. 210, 245; Gov't Ex. 
21 at 143.) TFO [JB] explained that Respondent coached her, and when he 
said ``lower back?'' she agreed. (Tr. 210-11; Gov't Ex. 21 at 145; see 
also Tr. at 233.)
    Respondent did not discuss a treatment plan with TFO [JB], nor did 
he discuss the risks and benefits of the controlled substances he 
ultimately gave her. (Tr. 212; see generally Gov't Ex. 21.) Although 
Respondent initially said he would prescribe oxycodone 15 mg, he 
ultimately prescribed oxycodone 30 mg 70 tablets, representing a little 
more than one month's supply. (Tr. 207, 211-12; see also Gov't Ex. 21 
at 146.)
    As Respondent started to leave the examination room, and after he 
had already told TFO [JB] that he would write her a prescription, he 
turned back and asked TFO [JB] to roll over on the examination table 
onto her stomach. (Tr. 214-15, 246; Gov't Ex. 21 at 150.) TFO [JB] told 
Respondent she did not need an examination. (Tr. 215.) Respondent 
replied: ``An exam? . . . No. I'm gonna poke you. I gotta find 
something out about ya . . . let me know whether that causes you 
pain.'' (Gov't Ex. 21 at 151. See generally Tr. 215.) He then had her 
roll over, touched her back in several places, asked if it hurt and 
moved her right foot. (Tr. 215, 238-40.) TFO [JB] testified that she 
told him there was no pain. (Tr. 215.) On cross examination,

[[Page 35009]]

however, she conceded that she had said ``Oh, yes, that does'' when he 
poked a part of her back. (Tr. 238; Gov't Ex. 21 at 151.) TFO [JB] 
explained that Respondent's touch startled her. (Tr. 239, 248.) She 
felt very uncomfortable when Respondent asked her to roll onto her 
stomach and found the whole visit unnerving. (Tr. 247.)
    TFO [JB] testified that Respondent stated that the prescription he 
gave her had high street value. (Tr. 213; Gov't Ex. 21 at 147.) 
Particularly, the pills he was giving her went for ten dollars each on 
the street; OxyContins went for forty to eighty dollars on the street. 
(Tr. 213; Gov't Ex. 21 at 147.) Respondent also said she ``could only 
get the medication from him because it was electronically tracked, and 
I could be labeled a doctor shopper, or a drug user, or drug addict, 
and then I wouldn't be able to get the mediation [sic] anymore.'' (Tr. 
213; see Gov't Ex. 21 at 147 (``medication'').) The transcript of the 
visit provides some context for these remarks, and also evinces a 
degree of concern by Respondent for TFO [JB]'s wellbeing.

these medications . . . there's a high street value for them . . . So 
it's not a good idea for you to tell your friends that you're taking 
these medications because [even] your mother will take them from you . 
. . People are always stealing them. So be careful. Uh because if you 
lose your medications, even if you have a police report, can't get em. 
Once a month is all you can get. (Gov't Ex. 21 at 147-48.)
    TFO [JB] testified that Respondent's staff recommended Community 
Pharmacy, located about five miles away from Respondent's office, which 
had a five-dollar coupon. (Tr. 216.) She had never encountered pharmacy 
coupons offered in any other doctor's office. (Tr. 247.)

(2) TFO [JB] Undercover Visit of December 18, 2009

    TFO [JB] returned to Respondent's office on December 18, 2009. (Tr. 
218.) Although her recording device malfunctioned that day, the 
transmitter functioned properly. (Tr. 218.)
    TFO [JB] did not tell Respondent or indicate on any paperwork 
during the second visit that she had pain. (Tr. 218-19.) She again 
marked zero on the pain scale. (Tr. 219.) Respondent completed no 
physical, neurological or musculoskeletal examination of TFO [JB]. (Tr. 
219.) TFO [JB] did not submit any medical records, nor did she submit a 
urinalysis for drug testing. (Tr. 219.) Respondent asked if TFO [JB] 
had an MRI; she said no. Respondent answered that ``if he were to 
continue to prescribe to me, I would need to get proof of injury 
because he was in danger of losing his license.'' (Tr. 220; see Tr. 
244.)
    But Respondent prescribed controlled substances to TFO [JB] on her 
second visit anyway. (Tr. 247.) Respondent said he had noted that TFO 
[JB] was taking fifteen-mg oxycodone. (Tr. 221.) TFO [JB] corrected him 
and said Respondent had actually given her thirty-mg oxycodone on the 
previous visit. (Tr. 221.) Respondent replied ``Well, I wrote 15 
milligrams in the chart, but I sometimes make mistakes.'' (Tr. 221.) 
Respondent gave TFO [JB] a second prescription identical to the first: 
Another prescription for 70 tablets of oxycodone 30 mg. (Tr. 218.) 
Respondent did not discuss a treatment plan, nor did he discuss the 
risks and benefits of the drugs he prescribed to TFO [JB] during her 
second visit. (Tr. 220.)
    Respondent said he was in debt due to the day-to-day cost of 
operating his office. (Tr. 220.) He said he intended to raise the 
office visit fee to eighty dollars per visit, to cover the cost of the 
urinalysis testing he was going to begin, and to help with his own 
debt. (Tr. 221.) Respondent also stated that some of his patients used 
to get their drugs on the street. (Tr. 221.)

(k) Undercover Visits to Respondent by TFO [BK], AKA ``[BK]''

    TFO [BK] testified that on November 18, 2009, and December 23, 
2009, he visited Respondent's office in an undercover capacity, posing 
as patient ``[BK],'' and Respondent gave him prescriptions for 120 
Vicodin 10/325 mg on each visit. (Tr. 255-56, 265; see Gov't Exs. 16, 
22, 23, 25 & 26.)

(1) TFO [BK] Undercover Visit of November 18, 2009

    During his first undercover visit to Respondent, TFO [BK] used a 
functioning recording device. (Tr. 256-57.) The interaction with 
Respondent lasted approximately five to ten minutes. (Tr. 257.) TFO 
[BK] filled out an intake form and indicated zero out of ten on a pain 
scale, with zero meaning ``no pain.'' (Tr. 257.)
    As part of the intake process, TFO [BK] provided an admin per se 
form that indicated his driver's license had been taken away due to a 
DUI.\12\ (Tr. 258.) Respondent's office staff told TFO [BK] that the 
admin per se form was not an acceptable form of identification, but 
Respondent saw him anyway.\13\ (Tr. 258, 295-96.) He paid cash and did 
not provide medical records during the intake process. (Tr. 258.)
---------------------------------------------------------------------------

    \12\ DEA prepared the admin per se form for this undercover 
purpose. (Tr. 258.)
    \13\ Respondent's staff asked: ``[D]o you have any kind of photo 
id with your picture on it?'' (Gov't Ex. 23 at 157). I therefore 
reject Respondent's assertion that ``in November new patient [BK] 
was not asked for his ID.'' (Resp't Br. at 13 ] 50.)
---------------------------------------------------------------------------

    TFO [BK] described the examination room as approximately eight by 
eight feet with an examination table, chair and desk, but no medical 
equipment. (Tr. 259.) When Respondent entered the room, he told TFO 
[BK] ``[o]bviously you're here looking for pain medication,'' (Gov't 
Ex. 22 at 159), and asked what TFO [BK] did that he needed it. (Tr. 
259-60.) TFO [BK] said Respondent went on to suggest several reasons, 
including back and arm pain. (Tr. 260.) TFO [BK] did not respond with a 
specific reason, but just said ``you name it,'' and also ``general 
pain.'' (Tr. 260.) Respondent then said there would need to be a 
specific reason, and suggested a motor vehicle accident. (Tr. 260-61.) 
TFO [BK] agreed to a motor vehicle accident. (Tr. 261.) Respondent then 
stated that TFO [BK] would need to produce proof of injury. (Tr. 261.)
    TFO [BK] testified that Respondent recommended that TFO [BK] go to 
Simon Med, where he could get a discount on an MRI. (Tr. 262.) This 
testimony is called into question by other evidence of record. As 
Respondent notes (Resp't Br. at 10), the audio recording and the 
transcript of the November 18, 2009 visit are devoid of any discussion 
of Simon Med or an MRI. (See Gov't Ex. 22 & Gov't Ex. 25 at track one.) 
One possible explanation is that a number of sections of the recording 
are inaudible, with corresponding blank spaces appearing in the 
transcript. Even so, TFO [BK] testified at hearing that he listened to 
the recording and that it accurately reflects what occurred during the 
visit. (Tr. 270.) Accordingly, I do not assign any weight to TFO [BK]'s 
assertion that Respondent recommended Simon Med to him. The remaining 
testimony of TFO [BK], however, is otherwise internally consistent and 
credible, and does appear to be corroborated by other record 
evidence.\14\
---------------------------------------------------------------------------

    \14\ But see infra note 15 (discussing the TFO [BK]'s testimony 
as to Simon Med during his second visit).
---------------------------------------------------------------------------

    TFO [BK] further testified that Respondent asked TFO [BK] what kind 
of medication he wanted. TFO [BK] responded that he wanted ``oxy 30s,'' 
or oxycodone 30-milligram pain medication. Respondent asked where TFO 
[BK] got oxy 30s; TFO [BK] responded that he was getting them wherever 
he could. (Tr. 261.)
    During the meeting, Respondent sat approximately four to six feet 
away from

[[Page 35010]]

TFO [BK] and never came any closer. (Tr. 260.) No one took TFO [BK]'s 
pulse, heart rate, height, weight or blood pressure. (Tr. 258.) Nor did 
TFO [BK] submit a urinalysis for drug testing. (Tr. 258.) Respondent 
conducted no physical, neurological, musculoskeletal or other 
examination of TFO [BK]. (Tr. 260, 262.)
    Respondent gave TFO [BK] a prescription for 120 Vicodin 10/325 mg, 
a hydrocodone/acetaminophen compound and Schedule II narcotic. (Tr. 
256.) The quantity was enough for thirty-five days. (Tr. 256.) 
Respondent did not discuss the medication's risks and benefits. (Tr. 
262.)
    TFO [BK] testified that Respondent told him that Respondent has 
some patients who get drugs off the street, and ``I don't care whether 
you are or not, I have patients that do that . . . .'' (Gov't Ex. 22 at 
162.) Respondent told TFO [BK] that it is more expensive to buy drugs 
off the street. Therefore, some of Respondent's patients come to him to 
be evaluated and obtain prescriptions at a lower price. (Tr. 263.)
    TFO [BK] testified that the people present in Respondent's waiting 
room were in their twenties and thirties and appeared sleepy. (Tr. 259, 
284.) TFO [BK] estimated observing between fifteen and twenty patients. 
(Tr. 284.) He did not notice any outward signs of chronic pain. (Tr. 
259.)
    Respondent recommended that TFO [BK] fill his prescription at 
Community Pharmacy, located approximately thirteen miles away. There 
was a coupon for Community Pharmacy in the lobby. (Tr. 264.)

(2) TFO [BK] Undercover Visit of December 23, 2009

    On December 23, 2009, TFO [BK] provided no identification 
whatsoever, nor did he provide medical records, but Respondent 
nevertheless allowed him a second office visit. (Tr. 266-67.) TFO [BK] 
possessed a functioning audio and video recording device and 
transmitter. (Tr. 264-65.) The visit lasted between five and ten 
minutes. (Tr. 266.)
    TFO [BK] brought no proof of injury to the second visit. (Tr. 266.) 
He filled out intake forms, leaving the pain scale blank. (Tr. 266.) On 
cross examination, TFO [BK] agreed that circling ``zero'' indicated 
``with medication, no pain.'' (Tr. 281.) He also told Respondent that 
he was obtaining medication ``here and there.'' (Tr. 282; see Gov't Ex. 
23.) He told Respondent he was experiencing ``general pain.'' (Tr. 
285.) The transcript of the visit corroborates that Respondent 
suggested to TFO [BK] options in terms where his pain might stem from. 
(Gov't Ex. 23 at 171; Tr. 297.) The evidence supports TFO [BK]'s 
assertion that ``I followed [Respondent] down the road I was led.'' 
(Tr. 287.)
    Respondent told TFO [BK] that he would need to obtain proof of 
injury. (Tr. 268, 285.) As with the first visit, TFO [BK] testified 
that Respondent recommended getting a discount MRI at Simon Med. Also 
as with the first visit, this testimony is inconsistent with other 
record evidence.\15\ (Tr. 268.)
---------------------------------------------------------------------------

    \15\ As Respondent notes (Resp't Br. at 11 ] 37), TFO [BK]'s 
testimony about Simon Med is inconsistent with the transcript and 
recording of the second visit, which contain no reference to Simon 
Med. (Gov't Exs. 23 & 26.) I do not assign any weight to TFO [BK]'s 
testimony about Simon Med. I find, however, TFO [BK]'s other 
testimony to be generally credible and internally consistent. See 
supra text at note 14 (discussing similar issue).
---------------------------------------------------------------------------

    TFO [BK] testified that during the second visit, Respondent 
prescribed the same prescription as at the first visit: 120 count 
Vicodin 10/325 mg. (Tr. 265.) Vicodin is a controlled substance. (Tr. 
298.) On cross examination, TFO [BK] conceded that while he had 
requested ``Oxy 30s . . . I got [a lesser strength].'' (Tr. 283.) TFO 
[BK] filled the second prescription at Community Pharmacy. (Tr. 269.)
    Respondent did not discuss a treatment plan, nor did he discuss the 
risks and benefits of the medication he prescribed to TFO [BK]. (Tr. 
269.) No one took TFO [BK]'s vital signs, nor did TFO [BK] submit a 
urinalysis for drug testing. (Tr. 267.) Neither Respondent nor his 
staff conducted a physical, neurological or musculoskeletal examination 
of TFO [BK], and Respondent again sat four to six feet away from him 
throughout the course of the meeting. (Tr. 267-68.)

(l) Dr. Borowsky's Evaluation Regarding Undercover Visits to Respondent

    The Government's expert witness, Dr. Borowsky, reviewed 
Respondent's records relating to the undercover visits discussed above 
by TFO [JB] and TFO [BK], to determine whether Respondent complied with 
the standard of care in prescribing opioids. (Tr. at 408, 410.) In 
evaluating Respondent's conduct, Dr. Borowsky relied on the Arizona 
Medical Board Guidelines for the Use of Controlled Substances for the 
Treatment of Chronic Pain. He also relied on the Model Policy for the 
Use of Controlled Substances for the Treatment of Pain, published by 
the Federation of State Medical Boards. (Tr. 411-13.)
    Dr. Borowsky found that Respondent's evaluation and treatment was 
nearly identical for both patients, and ``[t]he medical records showed 
no substantiation for a diagnosis, a plan, or a treatment with opioid 
medication . . ..'' (Tr. 416.) He further found that both patients 
presented as drug-seeking individuals due to their lack of insurance, 
complaints of zero pain on a pain scale, and lack of background history 
or documentation to support any claims of pain. (Tr. 418-19.) He 
testified that Respondent failed to acquire patient histories and that 
Respondent's documentation was both ``inappropriate'' and 
``inadequate.'' (Tr. 421, 430.) Moreover, he testified that Respondent 
did not conduct any physical examination of TFO [BK] at either visit. 
(See Tr. 421-22.) With respect to TFO [JB], he found that Respondent 
did not conduct a physical examination on one visit, and that for the 
other visit Respondent's statement that ``I'm poking you'' did not 
constitute an adequate physical examination. (Tr. at 421-22.) 
Respondent moreover failed to conduct neurological or musculoskeletal 
examinations. (Tr. 422-23.) Respondent did not document an adequate 
treatment plan or plan for periodic review for either patient. (Tr. 
424-28.) Respondent did not perform urinalysis or other drug screens on 
either patient. (Tr. 428.) Nor did he access the Arizona PMP. (Tr. 
428.) Respondent did not consult with specialists. (Tr. 428.)
    In sum, Dr. Borowsky credibly found that Respondent's prescription 
of controlled substances to TFO [BK] and TFO [JB] were not issued for a 
legitimate medical purpose. (See Tr. at 431.)

(m) Deaths of Three Individuals

(1) [CS]

    Respondent's patient [CS] was born on June 26, 1968, and died on 
January 6, 2010. (Tr. 105; Gov't Ex. 8.) A PMP report shows that 
Respondent prescribed controlled substances to [CS] starting in 
approximately August 2008, with the most recent prescription on 
December 31, 2009 for 90 oxycodone 15 mg and 60 alprazolam 2 mg. (Tr. 
106-07; Gov't Ex. 9.) The oxycodone prescription was filled on New 
Year's Eve; the alprazolam prescription was filled on January 2, 2010. 
(Tr. 107.) The PMP report indicates that Respondent saw [CS] monthly. 
(Tr. 108.)
    According to an autopsy report, a bottle of oxycodone was found 
near [CS]'s body. (Gov't Ex. 10 at 2.) Respondent had recently 
prescribed oxycodone to [CS]. (Tr. 109.) The autopsy report listed the 
cause of death as ``Intoxication due to the combined effects of 
multiple prescription medications including oxycodone.'' (Gov't Ex. 10 
at 1; Tr. 109.)
    TFO Dean testified that he did not know the colors of various pills 
listed in

[[Page 35011]]

the police report as present when [CS] died: calcium, folic acid, CVS 
vitamins, vitamin D and zinc. (Tr. 150-51.) Even carisoprodol, which is 
usually white, can be a different color depending on the brand. (Tr. 
151; see generally Tr. 152; Gov't Ex 8 & 9.)
    TFO Dean testified that Respondent was one of several doctors 
prescribing medication for [CS] shortly before her death, based on the 
PMP report. (Tr. 156; see Gov't Ex. 9.) Indeed, TFO Dean testified that 
Respondent was not the only doctor prescribing oxycodone and 
hydrocodone to [CS]. (Tr. 157-58; see Gov't Ex. 9 at 69.) TFO Dean 
testified that a patient who receives prescriptions for the same 
controlled substance from multiple doctors is an indication of 
diversion. (Tr. 170-71.)
    [RF], Respondent's patient and fiancé of [CS], testified 
about the circumstances of [CS]'s death. Having known [CS] since 2006 
and being generally aware of [CS]'s many medical problems, [RF] 
testified that he found it impossible that Respondent had anything to 
do with [CS]'s death. (Tr. 550-53, 555-56.) In the weeks before her 
death, [CS] suffered an injury to her ileostomy wound for which she did 
not seek treatment. (Tr. 558, 575.) On the day [CS] died, [RF] 
testified that [RF] did not see her take any medication nor does he 
recall seeing a bottle of oxycodone near [CS] when she died. (Tr. 561-
62.) [RF] also testified that Respondent is a good doctor and that he 
did not observe anything unusual in Respondent's practice. (Tr. 566, 
569.) I find [RF]'s testimony credible. His testimony was internally 
consistent and the witness was able to recall factual events with a 
reasonable level of certainty.

(2) B.R.

    B.R. was born on February 14, 1985, and died on February 10, 2010. 
(Tr. 111, Gov't Ex. 11.) Investigators at the time of death found 
medications that Respondent prescribed. (Tr. 111.) In particular, 
investigators found a blue medication bottle with prescription number 
C255226 prescribed to Respondent's patient ``[TR],'' filled December 
16, 2009, for alprazolam 2 mg tablets. (Tr. 112.) They also found two 
and one half white tablets imprinted with ``G3722,'' which is 
consistent with an alprazolam two milligram tablet. (Tr. 112.)
    A PMP report reveals that Respondent wrote an alprazolam 
prescription to [TR] on November 19, 2009, which was filled on December 
16, 2009. (Tr. 114; Gov't Ex. 12.) An autopsy of Mr. B.R.'s body 
revealed the presence of alprazolam. (Tr. 115; Gov't Ex. 15.)
    On cross examination, TFO Dean conceded that neither he nor any 
agent interviewed Respondent's patient, [TR], at the time of Mr. B.R.'s 
death. (Tr. 164.) However, ``[h]e spoke with someone recently.'' (Tr. 
164.) TFO Dean said he believed [TR] is no longer a patient of 
Respondent and stated that [TR] acquired prescriptions for controlled 
substances after Respondent's DEA COR was suspended. (Tr. 165-66.)

(3) [MC]

    On November 27, 2009, [MC] was found dead in his house with foam 
coming out of his mouth. (Tr. 101, 137; Gov't Ex. 5.) Prescription 
bottles with Respondent's name on them were found near his body. (Tr. 
101.) A PMP report confirmed that Respondent prescribed controlled 
substances to [MC]. (Tr. 98, 101; Gov't Ex. 5.)
    In particular, [MC] ``received prescriptions for amphetamine salts 
in a 30-milligram tablet, oxycodone in a 30-milligram tablet. Also 
alprazolam in a two-milligram tablet.'' (Tr. 99.) On November 24, 2009, 
just days before he died, [MC] received ``70 alprazolam two-milligram 
tablets, 150 oxycodone 30-milligram tablets, and 35 amphetamine salt 
30-milligram tablets.'' (Tr. 99-100.) These prescriptions constituted 
only minor variations from what Respondent prescribed to [MC] in the 
past. (Tr. 100.)
    Substances present in [MC]'s blood at death included oxycodone 
metabolites, amphetamine, alprazolam and nordiazepam. (Tr. 103; Gov't 
Ex. 7.) TFO Dean testified that these substances were consistent with 
Respondent's prescriptions. (Tr. 103.) On cross examination, TFO Dean 
conceded that Respondent did not prescribe the diazepam. (Tr. 148; see 
Gov't Ex. 6.) Indeed, the PMP report did not show that [MC] had 
received diazepam, a controlled substance, from any doctor. (Tr. 148-
49.)
    [MC]'s house contained evidence that he abused cocaine or other 
drugs. (See Tr. 137-38.) There was a square piece of mirror on the 
armoire, with white powder residue and a red straw, and a credit card 
with white powder residue on it. (Tr. 141.) TFO Dean testified that 
this was consistent with both cocaine and also with smashing and 
snorting oxycodone and alprazolam. (Tr. 141-42.) Alprazolam is commonly 
snorted. (Tr. 142.) TFO Dean testified that he did not know what the 
white powdery substance in the bedroom was. (Tr. 142.)
    In addition, the bedroom armoire contained several plastic baggies 
containing a white powdery residue that TFO Dean testified was 
consistent with drug sales and storage. (Tr. 142-43.) The small digital 
scales and syringes found near [MC] were also consistent with drug 
distribution. (Tr. 144.) TFO Dean testified that the substances in the 
white plastic baggies could have been a variety of substances, 
including substances Respondent did not prescribe. (Tr. 143.) Moreover, 
the white powdery substance was never tested. (Tr. 143.) TFO Dean 
conceded that the plastic baggies could have been the source of the 
white powder on the armoire. (Tr. 144.)
    TFO Dean did not know when the bottles and partially used blister 
pack found near [MC] at death had been used. (Tr. 138.) TFO Dean also 
conceded that the police report of [MC]'s death was unclear as to 
whether any medication remained in the bottles labeled oxycodone 30 mg, 
alprazolam or amphetamine salts. (Tr. 139-40.)
    TFO Dean also testified to being unfamiliar with a number of drugs 
that the police report listed as present near [MC]'s body: biobolt, 
undecyclenate and eltrenam. (Tr. 144-45.) The police report indicated 
that one of the drugs was indicated ``for veterinary use,'' which led 
TFO Dean to speculate it was not prescribed to an individual for his 
own use. (Tr. 145.) TFO Dean also conceded that [MC]'s housemates told 
the police that [MC] had some injuries. (Tr. 146.) Referring to the PMP 
report for [MC] (see Gov't Ex. 6), TFO Dean indicated that a 
prescription for Suboxone was prescribed by Michael Warren Carlton and 
not by Respondent. (Tr. 146.)

III. The Parties' Contentions

A. Government

    The Government argues that Dr. Borowsky's testimony, which was 
unrebutted, establishes by a preponderance of the evidence that 
Respondent failed to act within the bounds of professional practice and 
issued controlled substances without a legitimate medical purpose, in 
contravention of the law, such as 21 C.F.R. Sec.  1306.04 (2010). 
(Gov't Br. 23.)
    The Government also highlights Dr. Borowsky's testimony. Analyzing 
whether Respondent conformed to Arizona practice standards, Dr. 
Borowsky testified that Respondent's medical records demonstrated no 
substantiation for a diagnosis plan or treatment with opioid 
medication. (Tr. 416.) Dr. Borowsky opined that Respondent's evaluation 
and treatment of undercover agents TFO [JB] and TFO [BK] posing as 
patients who exhibited drug-seeking behavior (Tr. 416; Gov't Ex. 18 at 
130), ``was identical and exhibited no adherence to the Guidelines for 
Treatment of Chronic

[[Page 35012]]

Pain from the Arizona Medical Board.'' (Gov't Ex. 18 at 130.) With 
Respect to TFO [BK], for instance, Dr. Borowsky testified that 
Respondent should not have prescribed 120 Vicodin 10 mg. (Tr. 421.)
    Moreover, the Government argues that Respondent performed no 
patient monitoring, indicated by the lack of drug screens or access to 
the Arizona PMP. (Gov't Ex. 18 at 130.) Respondent did not take a 
patient history, perform a physical examination, execute a treatment 
plan, provide informed consent and a treatment agreement, consult with 
specialists or maintain adequate and accurate medical records. (Gov't 
Ex. 18 at 130-31.)
    The Government also argues that Respondent has failed to accept 
responsibility for his actions. (Gov't Br. at 26.) The Government notes 
that Respondent has failed to admit specific wrongdoing, and has merely 
made a blanket assertion of ``shortcomings.'' The Government finally 
argues that because the Government has made a prima facie case, the 
burden of proof shifts to Respondent, and Respondent has failed to 
demonstrate he will not engage in future misconduct.

B. Respondent

    Respondent argues in defense that he is na[iuml]ve. (Tr. 24.) While 
he concedes he was casual about documentation (see Tr. 24, 28-29), he 
argues he is not indifferent to drug abuse and diversion and has no 
state convictions. (Tr. 24.) Respondent argues that opening a new 
practice in August of 2009 was a ``learning experience'' (Tr. 25), 
which was a ``work in progress period.'' (Tr. 28.) Respondent argues 
that, over time, he has sought to improve his practice standards. For 
instance, Respondent terminated over 250 patients for failing drug 
screens or failing to produce health records. (Tr. 27; see generally 
Tr. 752.) Additionally, Respondent has accepted the Arizona Medical 
Board's requirement that he establish a monitoring program for his 
documentation. (Tr. 29.) Moreover, Respondent has started dictating his 
reports. (Tr. 28.) In any event, Respondent denies that the care of his 
patients was substandard. (Tr. 28.) He moreover argues that except as 
confirmed by the recordings and transcripts of TFO [BK]'s undercover 
visits, the testimony of TFO [BK] is not credible. (Resp't Br. at 11 ] 
41.) In addition, Respondent contends that ``no reasonable conclusion 
can be drawn from the fact of [the] numbers or frequencies'' of 
controlled substances that Respondent prescribed. (Resp't Br. at 32.) 
Finally, Respondent argues that there is no causal connection between 
Respondent's prescribing practices and the deaths of [CS], B.R. and 
[MC]. (Tr. 27.)

III. Discussion and Conclusions

A. The Applicable Statutory and Regulatory Provisions

    The Controlled Substances Act (CSA) provides that any person who 
dispenses (including prescribing) a controlled substance must obtain a 
registration issued by the DEA in accordance with applicable rules and 
regulations.\16\ ``A separate registration shall be required at each 
principal place of business or professional practice where the 
applicant . . . dispenses controlled substances.'' \17\ DEA regulations 
provide that any registrant may apply to modify his registration to 
change his address but such modification shall be handled in the same 
manner as an application for registration.\18\
---------------------------------------------------------------------------

    \16\ 21 U.S.C. Sec.  822(a)(2).
    \17\ 21 U.S.C. Sec.  822(e).
    \18\ 21 C.F.R. Sec.  1301.51 (2010).
---------------------------------------------------------------------------

    ``A prescription for a controlled substance to be effective must be 
issued for a legitimate medical purpose by an individual practitioner 
acting in the usual course of his professional practice. The 
responsibility for the proper prescribing and dispensing of controlled 
substances is upon the prescribing practitioner'' with a corresponding 
responsibility on the pharmacist who fills the prescription.\19\ It is 
unlawful for any person to possess a controlled substance unless that 
substance was obtained pursuant to a valid prescription from a 
practitioner acting in the course of his professional practice.\20\ In 
addition, I conclude that the reference in 21 U.S.C. Sec.  823(f)(5) to 
``other conduct which may threaten the public health and safety'' would 
as a matter of statutory interpretation logically encompass the factors 
listed in Sec.  824(a).\21\
---------------------------------------------------------------------------

    \19\ 21 C.F.R. Sec.  1306.04(a).
    \20\ 21 U.S.C. Sec.  844(a).
    \21\ See Kuen H. Chen, M.D., 58 Fed. Reg. 65,401, 65,402 (DEA 
1993).
---------------------------------------------------------------------------

    In an action to revoke or deny a registrant's application for a DEA 
COR, the DEA has the burden of proving that the requirements for 
granting registration are not satisfied.\22\ The burden of proof shifts 
to Respondent once the Government has made its prima facie case.\23\
---------------------------------------------------------------------------

    \22\ See 21 C.F.R. Sec.  1301.44(d) (2010).
    \23\ Medicine Shoppe--Jonesborough, 73 Fed. Reg. 364, 380 (DEA 
2008); see also Thomas E. Johnston, 45 Fed. Reg. 72,311, 72,311 (DEA 
1980).
---------------------------------------------------------------------------

B. Material Falsification of Application

    The CSA, at 21 U.S.C. Sec.  824(a)(1), provides, insofar as 
pertinent to this proceeding, that the Deputy Administrator may revoke 
a registration if an applicant or registrant ``has materially falsified 
any application filed pursuant to or required by this subchapter or 
subchapter II of this chapter.''
    The evidence reflects that Respondent falsified his applications 
for renewal of his DEA registration on at least one occasion, by 
answering ``no'' to the liability questions, notwithstanding the fact 
that Respondent had previously had his medical license suspended in 
2001. TFO Dean testified in substance that his investigation revealed 
Respondent falsified his application because the Arizona Medical Board 
previously investigated and suspended Respondent's medical license. 
(Tr. 85-86.) Respondent testified that he did not ``really have a good 
answer'' for why he said ``no'' on the re-registration form, ``other 
than I didn't pay much attention to the wording.'' Respondent 
maintained that he ``never tried to deceive anyone.'' (Tr. 760-61.)
    The evidence also includes a September 21, 2010 sworn certification 
by Richard A. Boyd, Chief, DEA Registration and Support Section, 
stating in substance that he is the DEA official charged with custody 
and control of all documents relative to registration of practitioners, 
among others. Mr. Boyd certified that DEA registration ``BM2040498 was 
assigned to [Respondent] on October 4, 1998, that the last two renewals 
of this registration were issued to [Respondent] on January 29, 2005, 
at the address of Access2care Family Medical Center, 4607 N. 12th 
Street, Phoenix, Arizona 85014.'' (Gov't Ex. 28.) (emphasis supplied). 
Mr. Boyd further certified that Respondent answered ``background 
questions'' to include: ``3. Has the applicant ever had a state 
professional license or controlled substance registration revoked, 
suspended, denied, restricted, or place [sic] on probation, or is any 
such action pending? `No'.'' (Id.)
    The evidence also includes a June 30, 2010 sworn certification from 
Mr. Boyd, certifying that DEA registration ``BM2040498 was assigned to 
[Respondent] on or before October 04, 1989 . . . [and the] last renewal 
of this registration was on January 29, 2008. . . . '' (Gov't Ex. 1.) 
(emphasis supplied). The evidence further includes a DEA Master 
Information Report for DEA Number BM2040498, reflecting a registration 
date of October

[[Page 35013]]

10, 1989, and last renewal date of January 29, 2008. (Gov't Ex. 1 at 
2.)
    Neither the testimony at hearing nor the post-hearing briefs 
addressed the date discrepancies between the two certifications, nor is 
it entirely apparent from the record evidence exactly what the correct 
dates should be. For example, the September 21, 2010 sworn 
certification indicates an assignment of registration on October 4, 
1998, and then states the last two renewals were issued on January 29, 
2005. Clearly the last two renewals were unlikely to both have been 
issued on the same date, which is also consistent with Respondent's 
testimony that he believes he last renewed his registration in 2008. 
(Tr. 795.) The information contained within the DEA Master Information 
Report is also consistent with Respondent's recollection. There is also 
an unexplained discrepancy regarding the registration assignment date, 
with one date listed as October 4, 1998 (Gov't Ex. 28) and the second 
listed as ``on or before October 04, 1989,'' (Gov't Ex. 1 at 2.) Again, 
the DEA Master Information Report (Gov't Ex. 1 at 2) suggests that the 
ten-year discrepancy between the initial registration dates listed in 
the two certifications may simply be a typographical error, but 
speculating on possible reasons for the errors offers little assurance 
about the reliability of either certification.
    The issue of dates is certainly material, because the premise of 
the false statement allegation rests on when Respondent was first 
subject to a suspension that could serve as the predicate for a false 
statement. The record establishes that Respondent's first relevant 
suspension occurred in 2001. (See Gov't Ex. 3 at 4.) I find the 
inconsistencies and apparent errors in the two DEA certifications 
discussed above of sufficient consequence to preclude their use as 
substantial evidence for purposes of relevant dates.\24\
---------------------------------------------------------------------------

    \24\ I also note there is significant Agency precedent taking 
official notice of records of the Agency, to include filing of 
renewal applications. See, e.g. East Main Street Pharmacy, 75 Fed. 
Reg. 66,149, 66,152 (DEA 2010). The errors evidenced in the instant 
record, however, undermine any use of official notice to clarify 
this issue, because the record does not reveal whether the errors 
are due to preparation of the sworn certifications or whether the 
record checks of agency data on different dates produce different 
results.
---------------------------------------------------------------------------

    Accordingly, I do not assign any weight to Mr. Boyd's June 30, 2010 
(Gov't Ex. 1 at 1) or September 21, 2010 (Gov't Ex. 28) certifications 
with regard to information as to Respondent's registration or re-
registration dates.
    The remaining record evidence, including the DEA Master Information 
Report (Gov't Ex. 1 at 2) and Respondent's testimony, does support a 
finding by substantial evidence that on one occasion in January 2008 
Respondent materially falsified his application for re-registration, by 
failing to acknowledge a prior adverse action against his state medical 
license. A DEA COR may be revoked based on an unintentional 
falsification of an application, ``but lack of intent to deceive is a 
relevant consideration in determining whether a registrant or applicant 
should possess a DEA registration.'' Rosalind A. Cropper, M.D., 66 Fed. 
Reg. 41,040, 41,048 (DEA 2001). The unrebutted record evidence reflects 
that on November 6, 2000, the Arizona Medical Board issued Respondent a 
Letter of Reprimand, a $5,000.00 fine and forty hours of continuing 
medical education (CME), among other restrictions. (Gov't Ex. 2 at 4.) 
On December 6, 2001, the same entity entered an order suspending 
Respondent's medical license for a period of twelve months, but stayed 
the suspension during a probationary period. (Gov't Ex. 3 at 4.) The 
gravamen of Respondent's misconduct was an instance of Respondent 
prescribing without first conducting a physical examination or 
establishing a physician-patient relationship with an undercover agent.
    Respondent's history of state action regarding his medical license, 
as set forth below in further detail,\25\ was sufficiently significant 
that he could not under any reasonable circumstances have answered the 
relevant background question in the negative. Respondent's brief 
explanation of the issue, including a claim of lack of intent to 
deceive, is not credible. Respondent's failure to disclose the relevant 
information was material because it had ``a natural tendency to 
influence, or was capable of influencing'' the decision to renew 
Respondent's registration. Gilbert Eugene Johnson, M.D., 74 Fed. Reg. 
65,663, 65,665 (DEA 2010). In fact, DEA renewed Respondent's 
registration in January 2008, a decision that relied in part on 
Respondent's false statement.
---------------------------------------------------------------------------

    \25\ Infra Section III.D.
---------------------------------------------------------------------------

    Accordingly, I find the Government has met its burden of proving a 
violation of Section 824(a)(1), see 21 CFR Sec.  1301.44(d) (2010), 
placing the burden on Respondent to show that despite his material 
false statement, revoking his registration would be contrary to the 
public interest. Medicine Shoppe--Jonesborough, 73 Fed. Reg. 364, 380 
(DEA 2008); see also Thomas E. Johnston, 45 Fed. Reg. 72,311, 72,311 
(DEA 1980). I further find that for reasons set forth below, revoking 
Respondent's COR is in the public interest and substantial evidence 
supports revocation of Respondent's COR on the material falsification 
ground alone.

C. The Public Interest Standard

    The CSA, at 21 U.S.C. Sec.  824(a)(4), provides, insofar as 
pertinent to this proceeding, that the Deputy Administrator may revoke 
a COR if she finds that the continued registration would be 
inconsistent with the public interest as that term is used in 21 U.S.C. 
Sec.  823(f).
    Pursuant to 21 U.S.C. Sec.  823(f), the Deputy Administrator may 
deny an application for a DEA COR if she determines that such 
registration would be inconsistent with the public interest. In 
determining the public interest, the Deputy Administrator is required 
to consider the following factors:
    (1) The recommendation of the appropriate state licensing board or 
professional disciplinary authority.
    (2) The applicant's experience in dispensing, or conducting 
research, with respect to 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.
    As a threshold matter, the factors specified in Section 823(f) are 
to be considered in the disjunctive: the Deputy Administrator may 
properly rely on any one or a combination of those factors, and give 
each factor the weight she deems appropriate, in determining whether a 
registration should be revoked or an application for registration 
denied. See David H. Gillis, M.D., 58 Fed. Reg. 37,507, 37,508 (DEA 
1993); see also D & S Sales, 71 Fed. Reg. 37,607, 37,610 (DEA 2006); 
Joy's Ideas, 70 Fed. Reg. 33,195, 33,197 (DEA 2005); Henry J. Schwarz, 
Jr., M.D., 54 Fed. Reg. 16,422, 16,424 (DEA 1989). Additionally, in an 
action to revoke a registrant's COR, the DEA has the burden of proving 
that the requirements for revocation are satisfied.\26\ The burden of 
proof shifts to the registrant once the Government has made its prima 
facie case.
---------------------------------------------------------------------------

    \26\ 21 CFR Sec.  1301.44(e) (2010).

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

[[Page 35014]]

D. The Factors to Be Considered

Factors 1 and 3: The Recommendation of the Appropriate State Licensing 
Board or Professional Disciplinary Authority and Conviction Record 
Under Federal or State Laws Relating to the Manufacture, Distribution 
or Dispensing of Controlled Substances

    In this case, regarding Factor One, it is undisputed that 
Respondent currently holds a valid medical license in the State of 
Arizona, but Respondent's medical license has been the subject of state 
disciplinary action in the past. On November 6, 2000, the Arizona 
Medical Board, pursuant to a consent order, issued Respondent a Letter 
of Reprimand, a $5,000.00 fine and forty hours of CME, among other 
restrictions. (Gov't Ex. 2 at 4.) The stipulated findings of fact 
included an instance of Respondent prescribing without first conducting 
a physical examination or establishing a physician-patient relationship 
with an undercover agent of the Food and Drug Administration. (Gov't 
Ex. 2.) On December 6, 2001, the Board entered an order suspending 
Respondent for a period of twelve months, which was stayed during a 
probationary period. Respondent was further required to complete the 
requirements of the November 6, 2000 Board order. (Gov't Ex. 3.)
    On August 11, 2010, pursuant to a consent order, the Board issued 
Respondent a Letter of Reprimand and two years' probation with terms 
and conditions to include Board pre-approved monitoring (periodic chart 
reviews) by a contractor. (Gov't Ex. 27 at 4-5.) The Board action was 
initiated ``after receiving a complaint regarding Respondent's care and 
treatment of five patients. During the Board's investigation, five 
patient charts were reviewed and deviations were found in all five.'' 
(Gov't Ex. 27 at 1.) The Board concluded Respondent's conduct 
constituted ``unprofessional conduct pursuant to A.R.S. Sec.  32-
1401(27)(e) (`[f]ailing or refusing to maintain adequate records on a 
patient.') and A.R.S. Sec.  32-1401(27)(q) (`[a]ny conduct or practice 
that is or might be harmful or dangerous to the health of the patient 
or the public.').'' (Id. at 4.)
    The most recent action by the Arizona Medical Board reflects a 
determination that Respondent, notwithstanding findings of 
unprofessional conduct, can be entrusted with a medical license subject 
to probationary terms and conditions. While not dispositive,\27\ this 
action by the Arizona Medical Board does weigh against a finding that 
Respondent's continued registration would be inconsistent with the 
public interest. See Robert A. Leslie, M.D., 68 Fed. Reg. 15,227, 
15,230 (DEA 2003) (under Factor One, prior suspension of respondent's 
state medical license held not dispositive where state license 
currently under no restrictions).
---------------------------------------------------------------------------

    \27\ Mortimer B. Levin, D.O., 55 Fed. Reg. 8209, 8210 (DEA 1990) 
(finding DEA maintains separate oversight responsibility and 
statutory obligation to make independent determination whether to 
grant registration).
---------------------------------------------------------------------------

    Regarding Factor Three, there is no evidence that Respondent has 
ever been convicted under any federal or state law relating to the 
manufacture, distribution or dispensing of controlled substances. I 
therefore find that this factor, although not dispositive, weighs 
against a finding that Respondent's continued registration would be 
inconsistent with the public interest.

Factors 2 and 4: Respondent's Experience in Handling Controlled 
Substances; and Compliance With Applicable State, Federal or Local Laws 
Relating to Controlled Substances

(a) Respondent's Registered Location

    Federal law requires every person who dispenses (including 
prescribing) any controlled substance to obtain a registration from the 
Attorney General.\28\ Additionally, a separate registration must be 
obtained for each principal place of practice where a registrant 
dispenses controlled substances and a registrant must report any change 
of address by applying to modify his or her registration to change his 
or her address, which shall be treated as an application for 
registration.\29\ The Code of Federal Regulations delineates the 
procedures a registrant must follow to request a change in registered 
address.\30\
---------------------------------------------------------------------------

    \28\ 21 U.S.C. Sec.  822(a)(2).
    \29\ 21 U.S.C. Sec. Sec.  822(e), 827(g); 21 C.F.R. Sec.  
1301.51 (2010).
    \30\ See 21 C.F.R. Sec.  1301.51 (2010).
---------------------------------------------------------------------------

    In this case, the undisputed evidence indicates that Respondent's 
DEA registered address is ``Access2care Family Medical Center, 4607 N. 
12th Street, Phoenix, Arizona 85014.'' (Gov't Ex. 28.) In or about 
August 2009, Respondent moved from that location to his current 
practice at 16601 N. 40th Street, Suite 115, Phoenix, Arizona. (Tr. 36, 
90.) Respondent testified that he was unaware that he had to notify DEA 
when he moved to his new office. (Tr. 760.) In mitigation, Respondent 
explained that ``I called the Arizona Medical Board and gave them my 
change of address. I didn't know that I had to do anything more than 
that.'' (Tr. 760.)
    Respondent's failure to properly request a change in registered 
location does not appear to have been done with intent to deceive, 
given the unrebutted testimony that Respondent notified the Arizona 
Medical Board of the change. It does, however, demonstrate Respondent's 
lack of compliance with applicable DEA regulations, weighing in favor 
of a finding that Respondent's continued registration would be 
inconsistent with the public interest.

(b) Deceased Patients [MC] and [CS]; B.R.

    The evidence at hearing included information related to the deaths 
of two of Respondent's patients: [MC], who died on November 27, 2009; 
[CS], who died on January 6, 2010; and a non-patient, B.R., who died on 
February 10, 2010, in possession of a prescription issued to 
Respondent's patient [TR]. (Tr. 93.)
    The documentary evidence with regard to patient [MC] consists of a 
police report, a PMP report for [MC], and an autopsy report. (Gov't 
Exs. 5-7.) The autopsy report lists the cause of death as accidental 
``combined drug toxicity.'' (Gov't Ex. 7.) The findings of a 
toxicological report noted positive findings for the presence of: 
oxycodone, noroxycodone, oxymorphone, amphetamine, alprazolam and 
nordiazepam. (Gov't Ex. 7 at 6.) A Phoenix Police Department report 
noted that [MC] was found dead in his bedroom at home on November 27, 
2009, and that located in an adjacent nightstand were three empty 
prescription bottles for oxycodone, alprazolam and cephalexin, with 
prescription labels in Respondent's name, dated between June 2009 and 
October 2009. (Gov't Ex. 5.) A partially used fifteen-count ``blister 
pack'' for omifin with two blisters remaining was also found. (See Tr. 
128.) Also found at the foot of [MC]'s bed were prescriptions bearing 
Respondent's name dated November 24, 2009, for oxycodone, alprazolam 
and amphetamine salt. (Tr. 139-40.) Additionally, an empty prescription 
bottle of carisoprodol in Respondent's name was noted.\31\ (Gov't Ex. 5 
at 7.) The police report also noted that on top of an armoire in the 
bedroom rested a mirror with white powder residue, along with a red 
straw and credit card. (Tr. 137-8, 141.) Inside the armoire were 
numerous small plastic bags, several of which contained white

[[Page 35015]]

powder residue and digital scales, among other items. (Tr. 142-43.)
---------------------------------------------------------------------------

    \31\ The spelling in the police report of Respondent's name as 
``Dr. Moher,'' (see Gov't Ex. 5 at 7), appears to be a typographical 
error.
---------------------------------------------------------------------------

    TFO Dean testified that he did not participate in the investigation 
pertaining to [MC]'s death, other than having a few conversations with 
detectives at the Phoenix Police Department. (Tr. 95.) TFO Dean further 
testified that he was unaware of what the white powdery substance was, 
but the items found in the bedroom were consistent with buying, selling 
and storing drugs. (Tr. 143.) TFO Dean also opined that the mirror, 
white powder residue, straw and credit card were consistent with drug 
use, common to cocaine use and ``also common to the process of smashing 
up oxycodone or alprazolam, and using those to snort drugs.'' (Tr. 141-
42.) TFO Dean also testified that the PMP report confirmed that 
Respondent prescribed controlled substances to [MC] just prior to 
[MC]'s death, but the report did not reflect any prior prescriptions 
for diazepam. (Tr. 148-49.)
    The documentary evidence with regard to patient [CS] consists of a 
police report, a prescription history report and an autopsy report. 
(Gov't Exs. 8-10.) The January 8, 2010 autopsy report found cause of 
death to be ``[i]ntoxication due to the combined effects of multiple 
prescription medications including oxycodone.'' (Gov't Ex. 10 at 1.) 
The report also noted a history of Crohn's disease and depression, and 
a ``bottle of oxycodone, found in close proximity to her, appeared to 
have been taken at an accelerated rate.'' (Id. at 2.) A PMP history 
report covering the time period January 1, 2008 to March 8, 2010, 
reflects that [CS] was prescribed multiple controlled substances by 
multiple practitioners, including Respondent. (Gov't Ex. 9.) A Tempe, 
Arizona Police Department report dated January 6, 2010, reflects that 
[CS] was found unresponsive at home by her fiancé, [RF]. (Gov't 
Ex. 8 at 2.) It further notes that [CS] suffered from numerous medical 
conditions including Crohn's disease, and had been complaining of a 
fever and hip pain. (Gov't Ex. 8 at 2.) Contrary to the autopsy report, 
the police report does not reflect any notations regarding a bottle of 
oxycodone found in close proximity to [CS] or evidence that it was 
taken at an accelerated rate. (Tr. 161. Compare Gov't Ex. 10 at 2, with 
Gov't Ex. 8.)
    Respondent presented the testimony of [CS]'s fiancé, [RF], 
regarding the circumstances of [CS]'s death. [RF] testified in 
substance that he had known [CS] since 2006, and is himself a patient 
of Respondent. (Tr. 550-51.) [RF] testified to a number of medical 
problems that [CS] had experienced and found it impossible that 
Respondent's care had anything to do with her death. (Tr. 552-53, 555-
56.) [RF] testified that [CS] had been ``unusually sick'' a couple of 
weeks prior to her death and that she had had an altercation with a 
police officer, to include an injury to her ileostomy wound. (Tr. 558.) 
[RF] testified that [CS] did not seek any medical attention as a result 
of the altercation. (Tr. 556, 575.) [RF] further testified that on the 
day of [CS]'s death he did not see her take any medications and does 
not recall seeing a bottle of oxycodone anywhere in proximity to [CS] 
at the time of her death. (Tr. 561-62.) [RF] also testified that in his 
experience Respondent is a good doctor, and he has not observed 
anything unusual at Respondent's practice. (Tr. 566, 569.)
    The documentary evidence regarding the death of B.R. on February 
10, 2010, includes a police report, an autopsy report and a PMP report 
for prescriptions issued to [TR]. (Gov't Exs. 11-13.) The evidence at 
hearing reflected that Mr. B.R. was not a patient of Respondent, but an 
empty medication bottle bearing prescription number C255226 and 
prescribed by Respondent to patient [TR] on December 16, 2009, for 70 
alprazolam \32\ 2 mg tablets was found near Mr. B.R.'s body. (Tr. 112.) 
Other items found in the vicinity included empty beer bottles, short 
straws, a rolled up one dollar bill with white residue inside and a 
plastic baggie containing two and one half pills, identified in the 
police report as alprazolam 2 mg tablets. (Gov't Ex. 11; Tr. 93, 112-
13.) A PMP report for patient [TR] reflects a prescription for 70 
alprazolam 2 mg tablets written by Respondent on November 19, 2009, 
with a fill date of December 16, 2009. (Gov't Ex. 12.) A February 11, 
2010 autopsy report for B.R. listed the cause of death as accidental 
acute opiate, benzodiazepine and alcohol intoxication. (Gov't Ex. 13.)
---------------------------------------------------------------------------

    \32\ Alprazolam is a benzodiazepine and Schedule IV depressant. 
See 21 C.F.R. Sec.  1308.14(c) (2010); infra note 46.
---------------------------------------------------------------------------

    Respondent argues that the Government has not proven by a 
preponderance of the evidence that the deaths of two patients and a 
third person stem from Respondent's prescribing practices.\33\ In fact, 
no evidence was presented at hearing involving any of the foregoing 
patients' medical files, nor did either party offer testimony or other 
evidence of specific facts surrounding Respondent's prescribing 
practices with regard to patients [TR], [CS] or [MC]. The expert 
testimony offered at hearing related to only the patient records of two 
law enforcement undercover agents posing as patients. I find that the 
Government has not established by a preponderance of the evidence that 
Respondent's prescribing practices caused the foregoing deaths. For 
example, the evidence relating to the death of patient [CS] and the 
linkage to one oxycodone prescription cited in an autopsy report was 
directly contradicted by the sworn testimony of [RF], corroborated by 
the relevant police report. (Compare Gov't Ex. 10 at 2, with Tr. 561-
62, and Gov't Ex. 8.) In the case of patient [MC], there is evidence 
that the cause of death was accidental and due to a combination of 
drugs, (Gov't Ex. 7 at 1), and other evidence found in the vicinity of 
[MC]'s body is consistent with the buying, selling and storage of 
drugs, (Tr. 143). Yet there was no evidence or testimony offered at 
hearing related to Respondent's prescribing or treatment of patient 
[MC]. The evidence regarding patient [TR] and the death of Mr. B.R. is 
even more tenuous in terms of linking the cause of death to 
Respondent's prescribing practices.
---------------------------------------------------------------------------

    \33\ Resp't Br. at 33-37.
---------------------------------------------------------------------------

    With regard to all three decedents, there is no evidence of record, 
such as, for example, relevant medical files, sufficient to determine 
and evaluate Respondent's prescribing practices with regard to the 
three deaths. Making a finding that Respondent's prescribing practices 
caused the deaths of these decedents, therefore, would require engaging 
in pure speculation. ``Speculation is, of course, no substitute for 
evidence, and a decision based on speculation is not supported by 
substantial evidence.'' White ex rel. Smith v. Apfel, 167 F.3d 369, 375 
(7th Cir. 1999) (citing Erhardt v. Sec'y, DHS, 969 F.2d 534, 538 (7th 
Cir. 1992)). I find there is insufficient evidence to conclude that 
Respondent's prescribing practices caused the deaths of these 
decedents. This finding weighs against a finding that Respondent's 
continued registration would be inconsistent with the public interest.
    Although the evidence regarding the foregoing decedents does not 
support a finding that Respondent's prescribing practices caused their 
deaths, the evidence with regard to patient [MC] does reflect varying 
degrees of drug misuse or acts of diversion by Respondent's patient, at 
least as of November 2009. I find this evidence is consistent with 
other record evidence, including Respondent's testimony, that 
Respondent's prescribing practices during the same time period were 
significantly deficient in terms of

[[Page 35016]]

properly supervising his patients to prevent them from abusing or 
diverting controlled substances.

(c) Respondent's Prescribing Practices

    The OSC/IS alleged that Respondent prescribes and dispenses 
inordinate amounts of controlled substances, primarily hydrocodone 
compounds, Schedule III controlled substances, among others, under 
circumstances where Respondent knows or should know the prescriptions 
are not for legitimate medical purposes or are issued outside the 
course of usual professional practice. (ALJ Ex. 1.)
    To be effective, and lawful, a prescription for a controlled 
substance ``must be issued for a legitimate medical purpose by an 
individual practitioner acting in the usual course of his professional 
practice . . . An order purporting to be a prescription issued not in 
the usual course of professional treatment . . . is not a prescription 
. . . and the person knowingly filling such a purported prescription, 
as well as the person issuing it, shall be subject to the penalties 
provided for violations of the provisions of law relating to controlled 
substances.'' \34\
---------------------------------------------------------------------------

    \34\ 21 C.F.R. Sec.  1306.04(a) (2010).
---------------------------------------------------------------------------

    Revocation of an existing registration under the public interest 
standard of 21 U.S.C. Sec.  823(f) is not limited to practitioners who 
intentionally violate the prescription requirement, but also includes a 
``practitioner's failure to properly supervise her patients to prevent 
them from personally abusing controlled substances or selling them to 
others . . .'' Jeri Hassman, M.D., 75 Fed. Reg. 8194, 8227 (DEA 2010). 
A practitioner must also ``have established a bona fide doctor-patient 
relationship with the individual for whom the prescription is 
written.'' Mohammed F. Abdel-Hameed, M.D., 66 Fed. Reg. 61,366, 61,369 
(DEA 2009). As to the issue of a bona fide doctor-patient relationship, 
the CSA looks to state law in determining whether a physician has 
established a valid doctor-patient relationship. United Prescription 
Servs., Inc., 72 Fed. Reg. 50,397, 50,407 (DEA 2007).
    The evidence at hearing regarding Respondent's prescribing 
practices included testimony from Dr. Stephen Borowsky, offered by the 
Government as an expert in pain management. Dr. Borowsky's testimony 
and related written report (Gov't Ex. 18) centered on his review of two 
patient files (Gov't Ex. 15 & 16) involving four undercover law 
enforcement visits to Respondent in November and December 2009. (See 
also Gov't Exs. 17 & 18.) Dr. Borowsky's experience includes board 
certification in pain medicine, among other specialties, and includes 
approximately thirty years of experience. (Tr. 378-79.) Dr. Borowsky 
has practiced in Arizona since 1980 and he has served on several task 
forces for the Arizona Legislature related to chronic pain. 
Additionally, Dr. Borowsky participated in the development of Arizona's 
Prescription Monitoring Program and at the time of hearing was involved 
in the care of approximately twenty pain patients per week on the one 
day per week that he saw pain patients. (Tr. 382-86.) Although 
Respondent timely objected to the witness's qualifications ``as a pain 
management expert in the primary care level,'' (Tr. 395-96), I have 
evaluated his testimony as an expert witness in pain management. Dr. 
Borowsky is clearly qualified to testify as an expert with regard to 
the standard of care and treatment of patients with pain management 
issues, based on his education, training and experience over thirty 
years. Dr. Borowsky's testimony at hearing was internally consistent 
and fully credible.
    Dr. Borowsky testified in substance on direct examination that 
prior to being contacted by DEA he had no familiarity with Respondent. 
(Tr. 408). Dr. Borowsky further testified that he was asked to review 
two patient files in the name of [KR] and [BK] to determine how the 
records fit with established guidelines for prescribing opiates. (Tr. 
410; see Gov't Exs. 15 & 16.) The evidence also included a written 
report prepared by Dr. Borowsky discussing his findings and opinion on 
review of the two patient files. (Gov't Ex. 18.)
    Dr. Borowsky next testified to his conclusions regarding the [KR] 
and [BK] medical files, corresponding to undercover visits by TFO [JB] 
and TFO [BK]. With regard to both files, Dr. Borowsky's concluded that 
the ``records showed no substantiation for a diagnosis, a plan, or a 
treatment with opioid medication . . . .'' (Tr. 416.) Additionally, Dr. 
Borowsky opined that Respondent obtained no patient history in either 
case and conducted no appropriate physical examination. (Tr. 418-22.) 
Dr. Borowsky further opined that Respondent issued prescriptions for 
controlled substances to both patients without a legitimate medical 
purpose. (Tr. 431.)
    On cross examination, Dr. Borowsky testified that over the past ten 
years perceptions of pain management have changed. (Tr. 435.) The term 
pseudo-addiction means a patient is undertreated with medication and 
may appear drug seeking, but really requires more medication. (Tr. 435-
36.) Dr. Borowsky further testified that treatment of a pseudo-addict 
requires a rational understanding of the situation rather than just 
prescribing more medication. (Tr. 437.) Dr. Borowsky also testified 
that he routinely uses drug screens when prescribing controlled 
substances (Tr. 440) and only takes cases by referral. (Tr. 445.) 
Within the standard of care for prescribing opioids, he advised, there 
is room for individual decisions. (Tr. 458-59.)
    The testimony from two undercover law enforcement agents, TFO [JB] 
and TFO [BK], who posed as patients [KR] and [BK], was fully consistent 
with Dr. Borowsky's findings. For example, TFO [JB] testified in 
substance that she met with Respondent at his office for an initial 
medical appointment on November 13, 2009, and again on December 18, 
2009. During the November 13, 2009 initial visit, TFO [JB], posing as 
patient [KR], met with Respondent for approximately ten minutes, which 
included Respondent taking a telephone call. (Tr. 207.) TFO [JB] 
testified that she had marked zero for pain on a patient intake form 
and at no time during the visit was her pulse, heart rate, height, 
weight or blood pressure checked, nor was she given a urinalysis drug 
screen. (Tr. 209-09, 223.) TFO [JB] further testified that Respondent 
did not discuss a treatment plan, and the only incident arguably 
consisting of a physical examination occurred at the end of the visit, 
after Respondent had already indicated his decision to prescribe 
controlled substances.\35\ (Tr. 214-15, 246.) The physical examination, 
such as it was, consisted of asking TFO [JB] to lie on her stomach 
after which Respondent proceeded to touch her back in several places, 
ask if it hurt and move her right foot and ankle.\36\ (Tr. 215.) As a 
result of the visit, Respondent prescribed 70

[[Page 35017]]

oxycodone 30 mg tablets. In partial mitigation, Respondent gave TFO 
[JB] a warning, in an apparent effort to encourage TFO [JB] to protect 
herself from theft:
---------------------------------------------------------------------------

    \35\ Because Respondent had already decided to prescribe 
controlled substances before he palpitated TFO [JB]'s back, I reject 
Respondent's argument that Respondent should be credited on the 
grounds that he did not give TFO [JB] a prescription ``until after 
the examination . . . .'' (Resp't Br. at 8 ] 27.)
    \36\ There is also evidence relating to a sexual harassment 
claim against Respondent, (see, e.g., Tr. 62, 67, 217), and 
Respondent's ``flirting'' and related conduct with patients such as 
TFO [JB] (see, e.g., Tr. 210, 214-15, 234-36, 246), [JG] (see Tr. 
188-89, 198) and [LW] (see Tr. 217). See generally Tr. 264. 
Respondent and other witnesses testified in substance that 
Respondent ``flirts'' with many patients, as a ``joke,'' which is 
how he puts patients ``at ease.'' Inasmuch as this issue was not 
sufficiently noticed in the OSC/IS, and given its tenuous relevance 
to the central issues alleged in this case, I do not make any 
specific factual findings or conclusions with regard to the 
conflicting testimony. See, e.g., CBS Wholesale Distribs., 74 Fed. 
Reg. 36,746, 36, 749 (DEA 2009) (discussing notice requirements 
before relying on given fact in revoking DEA COR).

these medications . . . there's a high street value for them . . . it's 
not a good idea for you to tell your friends that you're taking these 
medications because [even] your mother will take them from you . . . 
oxycontins . . . go like anywhere from like 40 to 80 dollars a pill . . 
. So there's a huge street value. People are always stealing them. So 
be careful. Uh because if you lose your medications, even if you have a 
police report, can't get em. Once a month is all you can get.
    (Gov't Ex. 21 at 147-48.) In addition, Respondent's statement that 
``once a month is all you get'' (Id.) is evidence that Respondent did 
take some steps to manage his patients and guide them away from abuse 
or diversion.
    Similar to the testimony of TFO [JB], TFO [BK] testified in 
substance that he met with Respondent on November 18, 2009, and again 
on December 23, 2009, posing as patient [BK]. On his initial office 
visit, which lasted approximately five to ten minutes, TFO [BK] marked 
zero for pain on an intake form. (Tr. 257.) Additionally, TFO [BK] 
provided no prior medical records. (Tr. 258.) TFO [BK] further 
testified that during the visit he received no examination of any kind, 
and Respondent gave him a prescription for 120 Vicodin 10-325 tablets. 
(Tr. 256, 258, 267.)
    The testimony of TFO [JB] and TFO [BK], as summarized above, was 
internally consistent, corroborated by objective evidence including 
recordings and related transcripts, and I find it fully credible.\37\ 
This testimony and evidence is moreover consistent with the opinion 
testimony of Dr. Borowsky.
---------------------------------------------------------------------------

    \37\ As noted above, I do not assign any weight to TFO [BK]'s 
assertions that Respondent suggested he go to Simon Med. See supra 
text at notes 14 & 15.
---------------------------------------------------------------------------

    Respondent's behavior during the undercover visits bears heavily 
upon whether his continued registration would be inconsistent with the 
public interest. Respondent's conduct during the second undercover 
visit by TFO [BK] tends to show that Respondent recognized it would be 
improper to issue a prescription to TFO [BK] without proof of injury or 
past medical records.\38\ (See Tr. 287, 290; see also Gov't Ex. 22 at 
162 (transcribing Respondent's statement that TFO [BK] should seek 
another doctor).) Respondent even offered to refund TFO [BK]'s money, 
stating that ``I'm not going to write you narcotics knowing that you've 
already told me that there's nothing wrong with you.'' (Gov't Ex. 23 at 
173; Tr. 287-88, 294.) Nevertheless, Respondent issued TFO [BK] a 
second prescription for controlled substances anyway. The fact that 
Respondent terminated TFO [BK] as a patient that same day (Tr. 295) 
evinces Respondent's recognition that he acted improperly in 
prescribing controlled substances to TFO [BK].
---------------------------------------------------------------------------

    \38\ Respondent also failed to require medical records before 
prescribing controlled substances to TFO [JB]. (Tr. 219, 247.)
---------------------------------------------------------------------------

    Moreover, the transcript of TFO [BK]'s second visit to Respondent 
suggests that Respondent's professed concerns regarding proof of injury 
were motivated less by a desire to prevent the diversion of controlled 
substances than by his concern that he might lose his license. (Gov't 
Ex. 23; see also Tr. 299.)
    At hearing, counsel for Respondent focused on Respondent's apparent 
concern for TFO [BK]'s wellbeing, indicating the need for a referral to 
a primary care physician to test for serious medical conditions (see 
Tr. 289-91), and Respondent's statement that Respondent was just 
``giving you a chance to get over this pain . . ..'' (Gov't Ex. 22 at 
165; see also Tr. 289.) Respondent's sincerity, however, is undercut by 
the fact that he never made any such referrals to TFO [BK]. (Tr. 299-
300.)
    The evidence at hearing also included a document referred to as the 
Arizona Medical Board Guidelines for the Use of Controlled Substances 
for the Treatment of Chronic Pain (Guidelines),\39\ as well as a second 
document entitled Model Policy for the Use of Controlled Substances for 
the Treatment of Pain (Model Policy). (Gov't Exs. 19 & 20.) Dr. 
Borowsky testified that he relied on both documents in preparing his 
written report. The Guidelines reflect a substantive policy statement 
that is advisory only, developed by the Arizona Medical Board pursuant 
to Arizona statutory authority. (Gov't Ex. 19 at 1.) The standards 
reflected in the Guidelines include a pain assessment, treatment plan, 
ongoing assessment, consultation and documentation, as well as counting 
and destroying medication, among other guidance. (Id.) Additionally, 
the Guidelines exhort physicians to comply with all applicable laws in 
the prescribing and dispensing of controlled substances.
---------------------------------------------------------------------------

    \39\ At hearing, counsel for Respondent suggested during cross 
examination that in 2004 the Arizona Medical Board adopted ``not [a] 
materially, hugely different--but a different set of Guidelines from 
the one that [the Government] presented . . . .'' (Tr. 474.) But 
this statement by counsel is not testimony, and in any event, 
counsel did not produce any alternative version of the Guidelines.
---------------------------------------------------------------------------

    Under Arizona law, for instance, grounds for disciplinary action 
include ``[u]nprofessional conduct'' further defined as ``[f]ailing or 
refusing to maintain adequate records on a patient'' or 
``[p]rescribing, dispensing or furnishing a prescription medication . . 
. to a person unless the licensee first conducts a physical examination 
of that person or has previously established a doctor-patient 
relationship.'' \40\ Ariz. Rev. Stat. Sec. Sec.  32-1401(27)(e) & (ss). 
There is substantial evidence of record that Respondent's prescribing 
practices during the relevant time periods were contrary to applicable 
Arizona law.
---------------------------------------------------------------------------

    \40\ The OSC/IS alleges violations of Ariz. Rev. Stat. 
Sec. Sec.  32-1401(27)(a), (q) and (ss). Moreover, the parties 
addressed the issue of unprofessional conduct at hearing. (See, 
e.g., Tr. 87, 93; Gov't Ex. 2.) In any event, I take official notice 
of Ariz. Rev. Stat. Sec.  32-1401(27). Under the Administrative 
Procedure Act (APA), an agency ``may take official notice of facts 
at any stage in a proceeding--even in the final decision.'' U.S. 
Dept. of Justice, Attorney General's Manual on the Administrative 
Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). 
In accordance with the APA and DEA's regulations, Respondent is 
``entitled on timely request, to an opportunity to show to the 
contrary.'' 5 U.S.C. Sec.  556(e); 21 C.F.R. Sec.  1316.59(e); see, 
e.g., R & M Sales Co., 75 Fed. Reg. 78,734, 78,736 n.7 (DEA 2010). 
Respondent can dispute the facts of which I take official notice by 
filing a properly supported motion for reconsideration within twenty 
days of service of this Recommended Decision, which shall begin on 
the date it is mailed. See, e.g., Joseph Gaudio, M.D., 74 Fed. Reg. 
10,083, 10,088 (DEA 2009) (granting Respondent opportunity to 
dispute officially noticed facts within fifteen days of service).
---------------------------------------------------------------------------

    Respondent's testimony at hearing did not significantly contradict 
the foregoing evidence. In fact, Respondent concedes in his post-
hearing brief that ``his practice documentation and patient screening/
compliance monitoring needed improvement'' from September 2009 through 
early January 2010.\41\ Respondent maintains, in essence, that because 
he acknowledges his past misconduct and has been making improvements to 
his practice between January 2010 and the date of his immediate 
suspension, Respondent's DEA registration would not be inconsistent 
with the public interest.
---------------------------------------------------------------------------

    \41\ Resp't Br. 30-31.
---------------------------------------------------------------------------

    Respondent testified in substance that he has been practicing 
medicine for approximately thirty years, working as a family 
practitioner for someone else. (Tr. 40.) In August 2009, Respondent 
opened his own solo-family practice, seeing approximately 200-300 
patients per month. (Tr. 36, 37.) Respondent further testified that he 
does not have any training or certifications in pain management. (Tr. 
36.) Respondent admitted that there were certain things he did not know 
about pain

[[Page 35018]]

management, but once informed of these things, he began making 
improvements in or around December 2009 to January 2010. (Tr. 51). 
Respondent further testified that after starting his new practice he 
began to realize the difficulty of managing pain patients ``finding it 
difficult to comprehend the deceit of many'' patients. (Tr. 756.) As a 
result of these efforts, Respondent testified that during a period of 
from December of `09 until May of 2010, I tried to rid my practice of 
patients that were potential drug seekers as best I could. And in the 
process, I discharged 264 patients. The reasons were from selling 
drugs, using medications that weren't prescribed by me, multiple doctor 
shopping, using the pharmacy monitoring program, use of illicit drugs 
and drug screens where they came positive for cocaine or 
methamphetamine, and tried my best to make sure that my patients were 
compliant with the treatment plan that they were under.
(Tr. 757.)
    The evidence also included the testimony of TFO Baldwin, who 
credibly testified to an interview with [JG], who admitted that she is 
addicted to drugs, primarily oxycodone, and sees Respondent on a 
monthly basis. [JG] also admitted that she and her boyfriend ``do sell 
their pills to pay their bills, get gas, etcetera.'' (Tr. 187.) On 
cross examination, TFO Baldwin further testified that he did not 
specifically ask [JG] if she told Respondent she was selling her 
medications. When asked if Respondent knew, however, [JG] responded 
that Respondent ``should know'' because ``half the patients in there 
are just like me.'' (Tr. 196.) I find the statements attributed to [JG] 
to be generally credible, because they are consistent in part with 
other credible evidence, including Respondent's testimony. That said, 
TFO Baldwin did not elicit a specific time frame during direct or cross 
examination as to when the statement from [JG] was taken, or the time 
frame that [JG] interacted with Respondent. TFO Baldwin's testimony 
regarding [JG] therefore provides some weight, but not full weight, in 
favor of a finding under Factors Two and Four that Respondent's 
continued registration would be inconsistent with the public interest.
    The Government further presented testimony from IRS Stone relating 
to an analysis of Respondent's prescribing from August 1, 2009 to March 
31, 2009. The evidence of record also includes three charts prepared by 
IRS Stone summarizing information received from the Board of Pharmacy 
pertaining to prescriptions for controlled substances issued by 
Respondent. (Gov't Ex. 14; Tr. 303-04.) The first chart reflects a 
total number of prescriptions written by Respondent during the stated 
time period to be 9411, including 5126 prescriptions for oxycodone and 
3230 for benzodiazepine. The second chart provided a more detailed 
breakdown by percentage and tablet count, finding 681,590 tablets of 
oxycodone prescribed and 208,318 tablets of benzodiazepine prescribed 
during the relevant eight-month time period. The third chart analyzes 
the prescription numbers by patients, rather than drugs. (See generally 
Gov't Ex. 14 at 1-3.)
    No other testimony or evidence was offered at hearing to provide 
context for the numbers of prescriptions and tablets issued by 
Respondent, or any reference point for past prescribing by Respondent; 
nor did either party offer evidence of comparative prescribing 
practices of similarly situated pain management practitioners. The 
evidence does support by substantial evidence the allegation in the 
OSC/IS that Respondent dispensed ``primarily hydrocodone compounds,'' 
among others. Beyond that, however, the record evidence does not 
provide sufficient comparative analysis to support by substantial 
evidence the allegation in the OSC/IS that Respondent prescribed and 
dispensed ``inordinate amounts of controlled substances.'' In the 
absence of a methodology including a base-line or other reliable 
comparative number, IRS Stone's numbers standing alone do not prove by 
a preponderance of the evidence that Respondent prescribed and 
dispensed inordinate amounts of controlled substances. See Mr. Checkout 
North Texas, 75 Fed. Reg. 4418, 4422 (DEA 2010) (finding that an 
unreliable methodology is not substantial evidence that respondent 
distributed excessive quantities of listed chemicals); see also CBS 
Wholesale Distributors, 74 Fed. Reg. 36,746, 36,749 (DEA 2009) 
(rejecting allegation that respondent sold excessive quantities of 
ephedrine products where Government expert did not provide ``the 
underlying documentation necessary to support this critical component 
of his testimony'').
    Respondent's conduct during the relevant time period with regard to 
factors Two and Four weigh heavily in favor of revocation. Respondent's 
admission that he was not aware of the difficulties relating to pain 
management, and that once informed, began to take corrective steps, 
understates the evidence. Dr. Borowsky, the only expert witness to 
testify in this case, concluded after reviewing two of Respondent's 
patient files relating to four undercover visits, that Respondent 
prescribed controlled substances without a legitimate medical purpose. 
(Tr. 431.) The absence of documentation, including a diagnosis, plan or 
physical examination, formed in part the basis for Dr. Borowsky's 
opinion. (Tr. 416, 418-19, 421, 430.) Additionally, the fact that 
Respondent discharged over 250 patients between December 2009 and May 
2010 for reasons such as ``doctor shopping,'' ``selling drugs'' and 
``use of illicit drugs,'' among other reasons (see e.g., Tr. 752, 757), 
is fully consistent with a finding that Respondent's experience in 
handling controlled substances and compliance with applicable law was 
substantially deficient on numerous occasions.\42\ ``A practitioner's 
failure to properly supervise her patients to prevent them from 
personally abusing controlled substances or selling them to others 
constitutes conduct `inconsistent with the public interest' and can 
support the denial of an application or the revocation of an existing 
registration.'' Jeri Hassman, M.D., 75 Fed. Reg. 8194, 8227 (DEA 2010).
---------------------------------------------------------------------------

    \42\ Evidence of diversion by Respondent's patients [MC] (see 
Tr. 137-38, 141-44) and [TR] (see Tr. 12, 14; Gov't Ex. 12) bolsters 
this conclusion.
---------------------------------------------------------------------------

    Under agency precedent, in the absence of a credible explanation by 
the practitioner, as few as two incidents of diversion are sufficient 
to revoke a registration. Alan H. Olefsky, M.D., 57 Fed. Reg. 928, 929 
(DEA 1992). In this case, Respondent maintains he began making changes 
to his practice in late 2009 and early 2010. Respondent testified that 
he learned about the PMP from the owners of a pharmacy in late 2009 and 
began implementing the monitoring in January 2010. (Tr. 768.) He 
testified that he implemented drug screening in February 2010. (Tr. 
805.) Respondent's testimony on cross examination was only partially 
credible and at times inconsistent. For example, with regard to patient 
``[SH]'' Respondent testified that he found the patient ``compliant'' 
notwithstanding a negative urine test for a prescribed controlled 
substance. (Resp't Ex. 5 at 34; Tr. 806, 818-19.) Respondent explained 
that by ``compliant'' one must ``look at it in a different light . . . 
you do have relapses. It's part of the management of a patient.'' (Tr. 
819-19.) Respondent provided no credible explanation for the lack of a 
subsequent drug screen.
    There is additional evidence of record reflecting inconsistencies 
with regard to Respondent's claim that he made substantial improvements 
to his practice but further elaboration is unnecessary. The weight of 
the evidence as a whole demonstrates that under Factors Two

[[Page 35019]]

and Four, Respondent's continued registration would be inconsistent 
with the public interest.

Factor 5: Such Other Conduct Which May Threaten the Public Health and 
Safety

    As to factor five, ``Respondent's lack of candor and inconsistent 
explanations'' may serve as a basis for denial of a registration. John 
Stanford Noell, M.D., 59 Fed. Reg. 47,359, 47,361 (DEA 1994). 
Additionally, where a registrant has committed acts inconsistent with 
the public interest, the registrant must accept responsibility for his 
or her actions and demonstrate that he or she will not engage in future 
misconduct. Patrick W. Stodola, 74 Fed. Reg. 20,727, 20,734 (DEA 
2009).\43\ Also, ``[c]onsideration of the deterrent effect of a 
potential sanction is supported by the CSA's purpose of protecting the 
public interest.'' Joseph Gaudio, M.D., 74 Fed. Reg. 10,083, 10,094 
(DEA 2009).
---------------------------------------------------------------------------

    \43\ See also Hoxie v. DEA, 419 F.3d 477, 484 (6th Cir. 2005) 
(decision to revoke registration ``consistent with the DEA's view of 
the importance of physician candor and cooperation.'')
---------------------------------------------------------------------------

    As an initial matter, I find that with the exceptions and 
inconsistencies noted above,\44\ Respondent has displayed at least some 
degree of candor before this tribunal. For instance, he has 
acknowledged his failure to update the address of his current practice 
location with the DEA. (Tr. 760, 795.) Moreover, Respondent at times 
conceded that his practice documentation and patient compliance 
monitoring needed improvement.
---------------------------------------------------------------------------

    \44\ For example, I found Respondent's testimony regarding the 
material falsification of his application for renewal of his DEA COR 
not to be credible. Supra Section III.B.
---------------------------------------------------------------------------

    This degree of candor, however, does not equate to a complete 
acceptance of responsibility for the full range of his misconduct 
embraced within the Government's prima facie case. Respondent testified 
at hearing that he is ``sorry for the shortcomings'' and requests that 
he be allowed to ``continue with the medical management of 
uncomplicated pain patients.'' (Tr. 758; see also Resp't Br. at 43.) 
But Respondent's testimony as a whole demonstrates that he does not 
fully accept responsibility for his actions nor has he demonstrated 
that he will not engage in future misconduct. Notably, at the time of 
hearing, due to stated financial difficulty, Respondent was ``in the 
process'' of putting in place the monitoring program required by the 
Arizona Medical Board. (Tr. 63; see Gov't Ex. 27 at 4.) A more 
compelling demonstration of acceptance of responsibility might have 
included a showing that a monitoring program is firmly in place. 
Instead, the absence of such a program required by order of the Arizona 
Medical Board, raises concerns that Respondent may engage in future 
misconduct.
    In any event, Respondent's interactions with undercover 
investigators posing as patients highlight the risks to the public were 
Respondent's COR to be reinstated. The theme that emerges from these 
undercover visits is Respondent's awareness of diversion potential 
coupled with an indifference to diversion. For example, TFO [BK] 
testified, and a transcript corroborates, that Respondent told TFO [BK] 
that Respondent has some patients who get drugs off the street, and ``I 
don't care whether you are [one of them] or not, I have patients that 
do that . . . .'' (Gov't Ex. 22 at 162.) Even construed in a light most 
favorable to Respondent, this testimony evinces an indifference to 
diversion that is fundamentally at odds with the requirements and 
purpose of the CSA.
    The record further reflects that Respondent told TFO [BK] that it 
is more expensive to buy drugs off the street than at a pharmacy, and 
that therefore, some of Respondent's patients come to him to be 
evaluated and obtain prescriptions at a lower price. (Tr. 263.) This 
statement by Respondent demonstrates an acceptance, if not an outright 
facilitation, of diversion. Under agency precedent, revocation of an 
existing registration under the public interest standard of 21 U.S.C. 
Sec.  823(f) may be founded upon a ``practitioner's failure to properly 
supervise her patients to prevent them from personally abusing 
controlled substances or selling them to others . . .'' Jeri Hassman, 
M.D., 75 Fed. Reg. 8194, 8227 (DEA 2010). Respondent's statements, 
especially his statement that he did not care if patients bought drugs 
off the street (Gov't Ex. 22 at 162), constitutes a failure by 
Respondent ``to properly supervise . . . patients to prevent them from 
personally abusing controlled substances or selling them to others . . 
. .'' Hassman, 75 Fed. Reg. at 8227. More troubling still is that 
indications of Respondent's indifference to or outright facilitation of 
diversion are corroborated by other evidence of record, including 
statements attributable to [LW] (see Tr. 217) (indicating that 
Respondent never asked patient [LW] for proof of injury before 
prescribing controlled substances, and that [LW] sent several patients 
to Respondent to get prescriptions to sell on the street), and [JG] 
(see Tr. 187, 196) (indicating that patient [JG] routinely sells pills 
on the street, and that ``half the patients in [Respondent's practice] 
are just like me'').
    Moreover, Respondent's interactions with TFO [JB] and TFO [BK] 
indicate an awareness of and indifference to Respondent's failures to 
comply with Arizona standards of professional medical practice. For 
example, TFO [JB] testified that on the second occasion that Respondent 
prescribed controlled substances to TFO [JB] without requiring proof of 
injury or patient medical records, Respondent stated that ``if he were 
to continue to prescribe to me, I would need to get proof of injury 
because he was in danger of losing his license.'' (Tr. 220; see Tr. 
244.) Even if I were to fully credit Respondent's testimony that his 
act of prescribing controlled substances without proof of injury or 
medical documentation was founded upon Respondent's compassion for his 
patients, Respondent's conduct would nevertheless constitute a 
departure from the Arizona standards of practice identified by Dr. 
Borowsky and supported by documentary evidence.
    The record also reflects that during the same undercover visit by 
TFO [JB], Respondent said he noted that TFO [JB] was taking oxycodone 
15 mg. (Tr. 221.) TFO [JB] corrected him and said Respondent had 
actually given her oxycodone 30 mg on the previous visit. (Tr. 221.) 
Respondent replied ``Well, I wrote 15 milligrams in the chart, but I 
sometimes make mistakes.'' (Tr. 221.) In light of the testimony that 
thirty milligrams is the highest available dosage of oxycodone (Tr. 
55), Respondent's candid and cavalier attitude toward prescribing and 
recordkeeping constitutes a violation of Arizona medical standards in 
addition to presenting a risk of diversion. See, e.g., Ariz. Rev. Stat. 
Sec. Sec.  32-1401(27)(e) & (q).\45\ Making matters worse, the 
unrebutted testimony of DI Linder indicates that as late as May 26, 
2010, Respondent was unaware that Xanax, a benzodiazepine and Schedule 
IV

[[Page 35020]]

depressant,\46\ was a controlled substance. (Tr. 178-79 (``He asked me 
what a controlled substance was, and whether Xanax was a controlled 
substance.'').) Respondent testified that he commonly prescribes Xanax. 
(Tr. 778-79.)
---------------------------------------------------------------------------

    \45\ Although the OSC/IS alleged violations of Ariz. Rev. Stat. 
Sec.  32-1401(27)(a), (q) & (ss), it did not explicitly allege a 
violation of Sec.  32-1401(27)(e) (``Failing or refusing to maintain 
adequate records on a patient.''). Nevertheless, the Government's 
prehearing statement alleged that Respondent violated his standard 
of care by ``failing to take adequate medical histories or no 
medical histories [and], by failing to collecting [sic] previous 
medical records . . . .'' (Gov't PHS at 4.) I find this language 
adequate to apprise Respondent that this allegation would be 
litigated and considered. See CBS Wholesale Distribs., 74 Fed. Reg. 
36,746, 36,749-50 (DEA 2009). Alternatively, even without 
considering Sec.  32-1401(27)(e), I would still find that Factor 
Five favors recommending revocation of Respondent's COR under 21 
U.S.C. Sec.  823(f).
    \46\ Alprazolam is a controlled substance. 21 C.F.R. Sec.  
1308.14(c) (2010). I take official notice that Xanax is a trade name 
for alprazolam. Respondent can dispute the facts of which I take 
official notice by filing a properly supported motion for 
reconsideration within twenty days of service of this Recommended 
Decision, which shall begin on the date it is mailed. See supra note 
40. See generally Joseph Gaudio, M.D., 74 Fed. Reg. 10,083, 10,088 
(DEA 2009).
---------------------------------------------------------------------------

    There is additional record evidence reflecting Respondent's 
attitude toward diversion and his course of compliance with Arizona 
medical standards but further elaboration is unnecessary. As to all of 
these incidents, Respondent's testimony at hearing that his motivation 
``was first and foremost the well-being of my patients,'' (Tr. 757), is 
availing, to a point. But Respondent's prepared testimony at hearing 
does not counter the more substantial weight properly given to his 
candid, un-coached remarks and behaviors toward undercover 
investigators posing as patients. These remarks and behaviors are 
telling, and I find substantial evidence that Respondent will engage in 
future misconduct if allowed to maintain his registration. In sum, 
Factor Five weighs in favor of a finding that Respondent's continued 
registration would be inconsistent with the public interest.

IV. Conclusion and Recommendation

    I find that a balancing of the foregoing public interest factors 
supports a finding that the Government has established a prima facie 
case in support of revocation of Respondent's registration, or denial 
of an application for registration.\47\ I conclude by a preponderance 
of the evidence that the Government has proved independent grounds for 
revoking Respondent's COR pursuant to 21 U.S.C. Sec.  824(a)(1), and 
alternatively, that the balance of the other factors in this case 
weighs heavily in favor of a finding that Respondent's registration 
would be inconsistent with the public interest under 21 U.S.C. Sec.  
823(f).
---------------------------------------------------------------------------

    \47\ Respondent all but concedes as much, arguing that 
``Respondent is well aware that the Presiding Administrative Law 
Judge is likely to determine that the government has made a prima 
facie case against him. That having been acknowledged, the record 
supports by a preponderance of the evidence a finding that his 
continued registration is not inconsistent with the public 
interest.'' (Resp't Br. 31.)
---------------------------------------------------------------------------

    Once DEA has made its prima facie case for revocation, the burden 
then shifts to the respondent to show that, given the totality of the 
facts and circumstances in the record, revoking the registrant's 
registration would not be appropriate. Morall v. DEA, 412 F.3d 165, 174 
(D.C. Cir. 2005); Humphreys v. DEA, 96 F.3d 658, 661 (3d Cir. 1996); 
Shatz v. United States Dep't of Justice, 873 F.2d 1089, 1091 (8th Cir. 
1989); Thomas E. Johnston, 45 Fed. Reg. 72,311, 72,311 (DEA 1980).
    Additionally, where a registrant has committed acts inconsistent 
with the public interest, the registrant must accept responsibility for 
his or her actions and demonstrate that he or she will not engage in 
future misconduct. Patrick W. Stodola, 74 Fed. Reg. 20,727, 20,735 (DEA 
2009). Also, ``[c]onsideration of the deterrent effect of a potential 
sanction is supported by the CSA's purpose of protecting the public 
interest.'' Joseph Gaudio, M.D., 74 Fed. Reg. 10,083, 10,094 (DEA 
2009). An agency's choice of sanction will be upheld unless unwarranted 
in law or without justification in fact. A sanction must be rationally 
related to the evidence of record and proportionate to the error 
committed. See Morall v. DEA, 412 F.3d 165, 181 (D.C. Cir. 2005) 
(sanction will be upheld unless unwarranted in law or without 
justification in fact). Finally, an ``agency rationally may conclude 
that past performance is the best predictor of future performance.'' 
Alra Laboratories, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995).
    The evidence as a whole demonstrates that Respondent has not 
credibly accepted responsibility for his actions, or presented evidence 
that could reasonably support a finding that he will not engage in 
future misconduct. Accordingly, Respondent has failed to rebut the 
Government's prima facie case. I therefore recommend that Respondent's 
DEA COR be revoked and any pending applications for renewal denied.

    Dated: January 20, 2011
Timothy D. Wing
Administrative Law Judge
[FR Doc. 2012-14268 Filed 6-11-12; 8:45 am]
BILLING CODE 4410-09-P

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