David A. Ruben, M.D.; Decision and Order, 38363-38388 [2013-15266]

Download as PDF Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices All comments must be submitted no later than thirty (30) days after the publication date of this notice. Comments may be submitted either by email or by mail: To submit comments: Send them to: By email ... pubcommentees.enrd@usdoj.gov. Assistant Attorney General, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044–7611. By mail ..... During the public comment period, the proposed Modification to the Consent Decree may be examined and downloaded at this Justice Department Web site: http://www.usdoj.gov/enrd/ Consent_Decrees.html. We will provide a paper copy of the proposed Modification to the Consent Decree upon written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044–7611. Please enclose a check or money order for $0.75 (25 cents per page reproduction cost) payable to the United States Treasury. Robert Brook, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. 2013–15243 Filed 6–25–13; 8:45 am] BILLING CODE 4410–15–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 11–39] mstockstill on DSK4VPTVN1PROD with NOTICES David A. Ruben, M.D.; Decision and Order On February 7, 2011, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause to David A. Ruben, M.D. (hereinafter, Respondent), of Tucson, Arizona. The Show Cause Order proposed the revocation of Respondent’s DEA Certificate of Registration, which authorizes him to dispense controlled substances as a practitioner, and the denial of any pending applications to renew or modify his registration, on the ground that his ‘‘continued registration is inconsistent with the public interest.’’ ALJ Ex. 1, at 1 (citing 21 U.S.C. 823(f) and 824(a)(4)). More specifically, the Show Cause Order alleged that between April 9 and June 6, 2008, two cooperating sources VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 (CS), who posed as patients, made four visits to Respondent’s office seeking controlled substances. Id. The Order further alleged that at each visit, Respondent issued the CSs prescriptions for schedule II controlled substances without performing a physical examination, without taking a medical history, without reviewing or obtaining any medical records or test results, and without providing a diagnosis. Id. at 1–2. The Order thus alleged that Respondent lacked ‘‘a legitimate medical purpose’’ and acted ‘‘outside of the usual course of professional practice’’ in issuing the prescriptions and thus violated both federal and state law. Id. at 1 (citing 21 CFR 1306.04(a); Ariz. Rev. Stat. § 32– 1401(27)(ss)). The Show Cause Order further alleged that on June 10, 2010, the Arizona Medical Board (AMB or Board) issued an order which found that Respondent had ‘‘deviated from the standard of care in [his] treatment of multiple patients from 2006 to early 2009.’’ Id. at 2. The Show Cause Order alleged that the AMB found that Respondent ‘‘[f]ail[ed] to perform adequate examinations/ evaluations prior to prescribing controlled substances’’; that he ‘‘[f]ailed to develop an adequate treatment plan prior to prescribing controlled substances’’; that he ‘‘[f]ailed to perform tests and assessments to confirm diagnoses and the necessity of treatment with controlled substances’’; that he ‘‘[f]ailed to obtain or review patients’ medical records’’; that he ‘‘[f]ailed to offer patients adjunct treatments that included non-controlled substances and/or physical therapy’’; that he ‘‘[f]ailed to address patients’ aberrant drug seeking behaviors’’; and that he ‘‘[f]ailed to address or investigate patients’ abnormal urinalysis results.’’ Id. The Show Cause Order further alleged that based on these findings, the AMB had barred Respondent ‘‘from prescribing, administering or dispensing any opioids for a period of one year.’’ Id. On March 28, 2011, Respondent requested an extension of time to respond to the Show Cause Order, which was unopposed by the Government. ALJ Ex. 2. The matter was then placed on the docket of the Office of Administrative Law Judges (ALJ) and assigned to ALJ Wing. While the ALJ initially denied Respondent’s request because neither party had established the date of service, on March 30, 2011, Respondent filed a Request for Reconsideration, which was also unopposed by the Government, and which showed that Respondent had not PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 38363 been served until February 25, 2008.1 ALJ Exs. 3 & 4. While Respondent sought an additional thirty days to respond to the Order to Show Cause, on April 1, 2011, the ALJ granted Respondent one additional week to do so. ALJ Ex. 5. On April 7, 2011, Respondent requested a hearing on the allegations. ALJ Ex. 6. Following pre-hearing procedures, the ALJ conducted a hearing in Phoenix, Arizona on January 10–12, 2012, at which both parties elicited the testimony of multiple witnesses and introduced various exhibits into the record. Following the hearing, both parties submitted briefs containing their proposed findings of fact, conclusions of law, and argument. Thereafter, the ALJ issued his Recommended Decision (hereinafter, cited at R.D.). Therein, the ALJ found that the Government had ‘‘established by substantial evidence a prima facie case that Respondent has committed acts inconsistent with the public interest between 2006 and 2009.’’ R.D. at 65. However, the ALJ further found that ‘‘Respondent has fully accepted responsibility for his past misconduct and credibly demonstrated that he will not engage in future misconduct.’’ Id. With respect to factor one—the recommendation of the state licensing board—the ALJ found that while Respondent currently has a valid Arizona medical license, he has twice been the subject of disciplinary action by the AMB, which found that he had engaged in ‘‘ ‘unprofessional conduct,’ ’’ as well as ‘‘ ‘any conduct or practice that is or might be harmful or dangerous to the health of the patient or the public. ’’’ R.D. at 47 (quoting Ariz. Rev. Stat. § 32– 1401(27)(q)). In addition, the ALJ found that Respondent had also committed unprofessional conduct by ‘‘ ‘failing or refusing to maintain adequate records on a patient.’ ’’ Id. (quoting Ariz. Rev. Stat. § 32–1401(27)(e)). However, because in August 2011, the AMB had fully restored Respondent’s prescribing privileges, the ALJ concluded that while not dispositive, the Board’s action ‘‘weigh[s] against a finding that Respondent’s continued registration subject to conditions would be inconsistent with the public interest.’’ Id. at 48. With respect to factor three— Respondent’s conviction record under federal and state laws relating to the manufacture, distribution, or dispensing of controlled substances—the ALJ noted 1 Notwithstanding of the date of the Show Cause Order, Respondent’s request was timely because the Order was not served until February 25, 2008, and the thirtieth day period for filing his request fell on a Sunday. E:\FR\FM\26JNN1.SGM 26JNN1 mstockstill on DSK4VPTVN1PROD with NOTICES 38364 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices that there was no evidence that Respondent has been convicted of such an offense. R.D. at 48. The ALJ thus concluded that while this factor is also not dispositive, it weighed against a finding that Respondent’s ‘‘registration would be inconsistent with the public interest.’’ Id. The ALJ then considered the evidence with respect to factors two— Respondent’s experience in dispensing controlled substances—and four— Respondent’s compliance with federal, state, and local laws relating to controlled substances—together. With regard to the allegation that Respondent had ‘‘deviated from the standard of care in [his] treatment of multiple patients from 2006 to early 2009,’’ the ALJ noted that the Government’s evidence ‘‘rested primarily on the findings by the Board in the 2009 Agreement and 2010 Order’’ and that the Government had offered ‘‘[n]o evidence in the form of patient charts or related medical expert testimony’’ in either its case-in-chief or in rebuttal of the testimony offered by Respondent and his expert witness. Id. at 49–50. However, the ALJ noted that the 2009 AMB Order found that between ‘‘November 17, 2006 and October 2007[,] ‘Respondent deviated from the standard of care by prescribing high dose opioids to DK without proper indications . . . [and] by failing to timely use objective measures, such as urine drug tests, to assess DK’s compliance with her treatment even after he was aware of her cocaine addiction.’ ’’ R.D. at 50. The ALJ further found that the 2010 AMB order ‘‘established that Respondent’s care and treatment of eleven patients . . . on various dates between 2006 and September 2009, constituted unprofessional conduct contrary to Ariz. Rev. Stat. § 32–1401(27)(e) and (q).’’ Id. The ALJ then noted some, but not all, of the specific findings made by the AMB with respect to the various patients. Id. at 50–51. With respect to the Board’s findings, the ALJ further found that Respondent testified ‘‘that he did not agree with all of the Board’s findings with regard to the 2009 Agreement, but otherwise agreed with the sanctioning imposed by the Board.’’ Id. at 53. With respect to the 2010 AMB order, the ALJ found that ‘‘Respondent credibly testified . . . that he agreed from a regulatory standpoint why the Board censured him, but disagreed with some of the specific factual findings.’’ Id. Based on the two AMB orders, the ALJ nonetheless concluded that ‘‘Respondent issued controlled substance prescriptions to multiple VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 patients . . . for other than a legitimate medical purpose and outside the usual course of professional practice in violation of applicable state and federal law.’’ Id. at 54–55 (citing 21 CFR 1306.04(a); Ariz. Rev. Stat. § 32– 1401(27)(a), (e), and (q)). However, the ALJ rejected the Government’s allegation based on the four visits of the two CSs, finding that Respondent ‘‘credibly testified’’ regarding his treatment of them, and that his testimony was ‘‘supported by patient files.’’ Id. at 56. In addition, the ALJ noted that Respondent’s Expert credibly testified that his prescribing to the two CSs was ‘‘ ‘well within the standard of care.’ ’’ Id. (quoting Tr. 618). The ALJ further found that Respondent had presented evidence of ‘‘more recent conduct’’ [which] weigh[s] significantly’’ in his ‘‘favor.’’ Id. at 60. More specifically, the ALJ noted that Respondent testified that he had been in compliance with the AMB’s Order, that he had ‘‘successfully completed’’ the one year suspension of his authority to prescribe opioids, and that there was no evidence that he ‘‘has not been fully compliant with state and federal law since the 2010 Order.’’ Id. Moreover, the ALJ noted Respondent’s evidence that he had made improvements in his controlled-substance prescribing practices since the 2010 Order. Id. Thus, the ALJ found that the Government had demonstrated that ‘‘Respondent’s prescribing practices and compliance with applicable state and federal law between 2006 and 2009 was inconsistent with the public interest’’ and supported a finding that his ‘‘continued registration would be inconsistent with the public interest, at least as of 2010.’’ Id. at 63. However, the ALJ further found ‘‘that Respondent’s recent positive improvements in his prescribing practices and compliance with applicable state and federal law weigh in [his] favor.’’ Id. As for factor five—such other conduct which may threaten public health and safety—the ALJ noted that the Government had not alleged, and the evidence did not support a finding that Respondent had engaged in ‘‘any ‘other conduct’ . . . that is inconsistent with the public interest.’’ Id. at 64. The ALJ then found that Respondent ‘‘ha[d] credibly accepted responsibility for his past misconduct,’’ explaining that ‘‘Respondent testified at various points that he acknowledged and accepted the Board’s disciplinary actions.’’ Id. Also noting the evidence as to Respondent’s efforts to improve his prescribing practices, the ALJ concluded that factor five supported ‘‘a finding that Respondent’s continued registration PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 would be consistent with the public interest.’’ Id. at 65. The ALJ thus concluded that Respondent had rebutted the Government’s prima facie case. Id. He then recommended that Respondent’s registration be continued and that any pending applications be renewed subject to two conditions: 1) that Respondent ‘‘comply with all of the terms and conditions specified in the’’ AMB’s June 2010 order, and 2) that ‘‘Respondent shall promptly forward to the DEA regional office any changes to the terms and conditions of his probation.’’ Id. at 65–66. The Government filed Exceptions to the R.D. Thereafter, the record was forwarded to me for Final Agency Action. Having considered the entire record, I adopt the ALJ’s finding that Respondent committed acts which were inconsistent with the public interest during the 2006 through 2009 time period. While I also accept the ALJ’s finding that Respondent has accepted responsibility for his misconduct and produced substantial evidence of various remedial measures he has implemented, I nonetheless reject the ALJ’s recommended sanction because the ALJ failed to consider both the egregiousness of the violations and the Agency’s interest in deterring similar misconduct by Respondent in the future as well as on the part of others. See, e.g., Joseph Gaudio, 74 FR 10083, 10094 (2009). The ALJ’s Rulings on the Government’s Motion in Limine To Exclude Evidence Before proceeding to make factual findings, a discussion of the ALJ’s ruling on the Government’s Motion in Limine To Exclude Evidence is warranted. During the course of the pre-hearing procedures, Respondent provided notice that he intended to call several physicians to testify, in part, regarding their review of the medical charts of those patients which were the subject of the AMB’s 2009 and 2010 orders. ALJ Ex. 46. Respondent also provided notice that he intended to introduce into evidence various letters written by these physicians based on their review of various patient charts which were reviewed by the AMB and discussed in the two orders. Id. Relevant to the Government’s motion, Respondent proffered Dr. Jennifer Schneider to testify that she had reviewed the medical charts of patients LP, WO, JF, JR, CJ, ML, AM, MF, DD, and SS, all of which were reviewed by the AMB’s consultant as part of the Board’s investigation. ALJ Ex. 9, at 5 (Resp. Prehearing Statement). Respondent further proffered that Dr. E:\FR\FM\26JNN1.SGM 26JNN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices Schneider ‘‘will explain that the AMB consultant had missed items in the charts for which Respondent was inaccurately criticized.’’ Id. Finally, Respondent proffered that Dr. Schneider ‘‘will testify in conformance with information about [Respondent] and Pain Management practices in Arizona in general as the author of Proposed Exhibits 4, 5, and 6.’’ Id. Respondent also proffered the testimony of Dr. Bennet Davis to ‘‘testify regarding his review of a chart involving patient DK and his review and evaluation of patient ML, who has a complex set of issues.’’ Id. Respondent further proffered that Dr. Davis would testify that, ‘‘[i]n his opinion, the AMB consultant did not properly define the standard of care for which Respondent was issued a reprimand per [the 2009] Consent Agreement,’’ and that Respondent adhered to a ‘reasonable standard [of] care in all aspects of treating . . . [DK].’ ’’ Id. at 5–6. Respondent also proffered that ‘‘Dr. Davis was able to synthesize his own evaluation and compare it with the notes and records provided by Respondent [and] will testify that Respondent met the standard of care in his evaluation of Respondent’s chart of ML.’’ Id. at 6. Finally, Respondent proffered the testimony of Dr. Kevin Goeta-Kreisler, who was to ‘‘explain that . . . he reviewed the complaints and the charts on patients ‘AL, KF, and JF.’ ’’ Id. Respondent further proffered that Dr. Goeta-Kreisler ‘‘will testify that he and Respondent both agreed that the early charting was ‘insufficient for another practitioner to assume continuity of the patients’ care’ even though the documentation met the standard of practice at the earlier time.’’ Id. Thereafter, the Government filed a motion in limine to exclude this evidence, arguing that ‘‘[t]he doctrine of res judicata bars the relitigation of the factual findings and conclusion of law of the prior proceedings before the AMB.’’ Motion in Limine to Exclude Evidence (ALJ Ex. 46, at 3). The Government argued that ‘‘[e]ach of Respondent’s proposed experts’ testimony and their [sic] related documentary evidence . . . are [sic] an attempt to relitigate the factual findings and conclusions of law by the AMB,’’ and therefore, ‘‘Respondent should be precluded from presenting such evidence.’’ Id. As support for its position, the Government cited numerous authorities, including cases of both federal and state courts and the Agency. See id. (citing Misischia v. Pirie, 60 F.3d 626, 629–30 (9th Cir. 1995); Marie Y. v. General Star Indem. VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 Co., 2 Cal. Rptr. 3d 135, 155 (Cal. Ct. App. 2003); Robert L. Dougherty, 76 FR 16823, 16830 (2011); Alan H. Olefsky, 76 FR 20025, 20031 (2011); Christopher Henry Lister, 75 FR 28068, 28069 (2010). Respondent opposed the motion on multiple grounds. See ALJ Ex. 47. More specifically, Respondent argued: (1) That the motion was untimely, id. at 1–2; (2) that the AMB Orders were the result of consent agreements, which stated that his ‘‘admissions are not intended or made for any other use, such as in the context of another state or federal government regulatory agency proceeding,’’ and that he ‘‘never agreed that all of the conduct set forth in the findings was accurate,’’ id. at 2–3; and (3) that DEA could not invoke the doctrine of res judicata because it was not a party to the consent agreements and was not in privity with the AMB. Id. at 4–5. The ALJ denied the Government’s motion for two reasons. First, noting that the Government had not filed its motion until approximately eight months after Respondent had provided notice as to its witnesses and their anticipated testimony, the ALJ held that the Government had not established good cause for the untimely filing of the motion. ALJ Ex. 48, at 2–3. Second, the ALJ held that because the Agency was not a party to the proceeding before the AMB, and the AMB did not consider the issue of whether Respondent’s DEA registration should be revoked under the public interest standard, the doctrine of res judicata could not be invoked to bar the introduction of the proposed testimony and reports. Id. at 3–4. However, the ALJ further noted that his ruling was ‘‘not intended to limit the parties from making evidentiary objections at the time the evidence is offered.’’ Id. at 4 n.3.2 As for the first of the ALJ’s reasons, the Agency’s regulations clearly grant the ALJ authority ‘‘to take all necessary action to avoid delay.’’ 21 CFR 1316.52. Moreover, this regulation provides that the ALJ ‘‘shall have all powers necessary to these ends, including (but not limited to) the power to . . . [r]eceive, rule on, exclude, or limit evidence.’’ Id. § 1316.52(f). This power clearly includes the authority to set reasonable time periods for the filing of motions. Given that the Government’s 2 Taking the ALJ at his word, throughout the proceeding, the Government made numerous objections to the testimony of several of Respondent’s witnesses (as well as the admission of several documents authored by the aforementioned physicians) asserting that various AMB findings were in error, including its findings as to what the standard of care required at the time he treated the patients who were the subject of the Board’s Orders. See Tr. 578, 591, 596, and 603. PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 38365 motion was filed eight months late, the Government’s motion was clearly untimely. However, notwithstanding that the motion was untimely, the ALJ considered it on the merits. Moreover, after the parties filed their respective prehearing statements, the ALJ clearly was aware that the Government intended to introduce the AMB Orders and that Respondent intended to challenge the validity of their findings. Indeed, on June 24, 2011, Respondent filed a motion to preclude the Government from introducing the two AMB Orders. See ALJ Ex. 20. Thus, even though the Government did not raise issue in its response to Respondent’s motion to preclude, the ALJ was obligated (and remained so throughout the proceeding) to apply the law of the Agency. Accordingly, the ALJ should have raised, sua sponte, the issue of whether the findings of the AMB Orders were entitled to preclusive effect.3 I therefore conclude that it is appropriate to consider whether the ALJ’s ruling on the merits was correct. While the ALJ correctly noted that the Agency has applied the doctrine of res judicata in proceedings brought under 21 U.S.C. 823 and 824, he then misapplied Agency precedent. To be sure, the application of res judicata itself requires that the parties in the subsequent proceeding be the same parties (or privies of the parties) in the earlier proceedings and that the proceedings involve the same claim. However, this Agency has also long held that the doctrine of collateral estoppel precludes a party from re-litigating adverse findings rendered against him in either a state board proceeding or a federal/state judicial proceeding.4 See 3 Under Agency regulations, at the hearing, the ALJ ‘‘shall admit only evidence that is competent [and] relevant.’’ 21 CFR 1316.59(a). If, as the Government argues, such evidence was barred by the doctrine of res judicata (or more precisely, collateral estoppel) the admission of such evidence was a violation of the above regulation. 4 While the Government argued that ‘‘[t]he doctrine of res judicata bars the relitigation of the factual findings and conclusions of law of the prior proceedings before the AMB,’’ ALJ Ex. 46, at 3, as the above passage (as well as other portions of its motion) made clear, it actually sought to invoke collateral estoppel against the Respondent. See also id. (quoting Marie Y. v. General Star Indem. Co., 2 Cal. Rptr. 3d 135, 155 (Cal. Ct. App. 2003) (‘‘When an administrative agency acts in a judicial capacity to resolve disputed issues of fact properly before it which the parties have had an adequate opportunity to litigate, its decision will collaterally estop a party to the proceeding from relitigating those issues.’’). As further support for its position, the Government cited Section 29 of the Restatement (Second) of Judgments. See id. Notably, this section is entitled ‘‘Issue Preclusion in Subsequent Litigation With Others.’’ E:\FR\FM\26JNN1.SGM Continued 26JNN1 38366 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices Robert L. Dougherty, 76 FR 16823, 16830–31 (2011); Robert A. Leslie, 60 FR 14004, 14005 (1995). Contrary to the ALJ’s misunderstanding, the Agency was not required to be a party or privy of a party in the AMB proceedings to collaterally estop Respondent from relitigating the findings of the AMB Orders.5 So too, that the State Board proceeding did not involve the same claim as this proceeding (whether Respondent’s registration is consistent with the public interest), does not preclude the Agency from relying on those findings of the Board which are relevant and material to the Agency’s public interest determination. While not addressed by the ALJ, Respondent argued that both of the AMB Orders were based upon consent agreements, which included the following clause: mstockstill on DSK4VPTVN1PROD with NOTICES All admissions made by Respondent are solely for final disposition of this matter and any subsequent related administrative proceedings or civil litigation involving the Board and the Respondent. Therefore, said admissions are not intended or made for any While in his ruling, the ALJ noted that ‘‘the Agency has stated that ‘the doctrine of res judicata bars the relitigation of the findings of the [state medical board]’s final order,’ ’’ ALJ Ex. 48 at 4 n.2 (quoting Dougherty, 76 FR at 16830), he then ‘‘declined to extend this dicta [sic] to the facts in the present case for the reasons discussed above.’’ Id. Contrary to the ALJ’s understanding, the passage in Dougherty was not a dictum but rather a holding, as the Agency’s decision relied on numerous findings of the state medical board’s order in support of its finding that Respondent had committed acts which rendered his registration inconsistent with the public interest and squarely rejected the physician’s attempts to relitigate the state board’s findings. See 76 FR at 16831. As I explained: All of Respondent’s testimony could have been, and should have been presented in the MBC proceeding. Here again, it is clear that Respondent is simply trying to relitigate the findings of the MBC proceeding. Having failed to establish that the MBC proceeding did not provide him with a full and fair opportunity to litigate these issues, the doctrine of res judicata precludes Respondent from relitigating them in this proceeding. Id. Thus, contrary to the ALJ’s reasoning, there was no dictum ‘‘to extend’’ but only a holding to apply; his reasons for ignoring Agency precedent reflect a fundamental misunderstanding of the differences between claim preclusion and issue preclusion. 5 As support for his reasoning, the ALJ also cited the Agency decision in Robert Raymond Reppy, 76 FR 61154, 61159–60 (2011), noting that the decision ‘‘refus[ed] to apply res judicata because, although a prior Agency decision was a final judgment on the merits, the respondent was not a party to the prior litigation.’’ ALJ Ex 48, at 3. The ALJ ignored, however, the fundamental difference between Reppy and this matter, that being that the Government sought preclusion against Dr. Reppy based on findings made in a matter involving the pharmacy for which he worked, and did so notwithstanding that he was not a party to the pharmacy’s proceeding. By contrast, here the Government seeks preclusion against Respondent based on findings made in a proceeding in which he was a party. VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 other use, such as in the context of another state or federal government regulatory agency proceeding. ALJ Ex. 47, at 2 (quoting GX Ex. 17, at 2 (2009 AMB Order) and GX 18, at 20– 21 (2010 AMB Order). Respondent argues that he ‘‘and his counsel had to consider whether there was a reasonable basis to conclude that there was at least some evidence that would lead to a conclusion that some of the allegations made would be sustained.’’ Id. He contends that ‘‘[h]e bargained for and received an agreement to enter each of these consent agreements, on the basis of that recognition, on his agreement that he would indeed follow the requirements of any discipline authorized as a result of the Agreement, but that outside of the required discipline set forth, the stated findings and conclusions could not be used in a non-AMB proceeding, including a ‘federal government regulatory agency proceeding[,]’ such as this one.’’ Id. at 2–3. Respondent further argues that he ‘‘never agreed that all of the conduct set forth in the findings was accurate,’’ and that both he and the AMB ‘‘agreed that [his] concessions there were not to be given substantive weight outside of the Arizona professional proceedings.’’ Id. at 3. In the 2010 Order, however, Respondent also ‘‘agree[d] not to contest the validity of the Findings of Fact and Conclusions of Law contained in the Order in any present or future administrative proceedings before the Board (or any other state agency in the State of Arizona, concerning the denial or issuance of any license or registration required by the state to engage in the practice or any business or profession.)’’ GX 18, at 20. Moreover, he also ‘‘voluntarily relinquishe[d] any rights to a hearing or judicial review in state or federal court on the matters alleged, or to challenge th[e] Order in its entirety as issued by the Board, and waive[d] any other cause of action related thereto or arising from said Order.’’ Id. Finally, he agreed that the ‘‘Order is a public record that will be publicly disseminated as a formal disciplinary action of the Board and will be reported to the National Practitioner’s Data Bank and on the Board’s Web site as a disciplinary action.’’ Id. at 21 (emphasis added). Likewise, the 2009 Order provided that ‘‘[b]y entering into this Consent Agreement, Respondent voluntarily relinquishes any rights to a hearing or judicial review in state or federal court on the matters alleged, or to challenge this Consent Agreement in its entirety as used by the Board, and waives any other cause of action related thereto or arising from said Consent Agreement.’’ GX 17, PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 at 1. Also, the 2009 Order provided that ‘‘[t]his Consent Agreement, or any part thereof, may be considered in any future disciplinary action against Respondent,’’ and that upon its approval and signing, was ‘‘a public record that will be publicly disseminated as a formal action of the Board’’ which would be reported to the National Practitioner’s Data Bank and on the AMB’s Web site. Id. at 1–2. Respondent does not contend that he lacked a full and fair opportunity to litigate the allegations that were the subject of the 2009 and 2010 Orders. And while both Orders were the result of consent agreements in which the findings were not actually litigated, the Supreme Court of Arizona has explained that even where a judgment has been entered by stipulation or consent, it ‘‘may be conclusive, with respect to one or more issues, if the parties have entered an agreement manifesting such intention.’’ Chaney Building Co., v. City of Tuscon, 716 P.2d 28, 30 (Ariz. 1986) (en banc) (citing Restatement (Second) of Judgments § 27 comment e).6 See also Gilbert v. BenAsher, 900 F.2d 1407, 1410 (9th Cir. 1990) (‘‘Arizona law permits a judgment by stipulation to ‘be conclusive . . . if the parties have entered an agreement manifesting such intention.’’’) (quoting Chaney, 716 P.2d at 30); Restatement (Second) of Judgments § 8.3. Here, both AMB Orders constitute formal disciplinary actions of the Board; their findings and legal conclusions were the basis for the sanctions which the AMB imposed on Respondent. Most significantly, the parties agreed that Respondent could not ‘‘contest the validity of the Findings of Fact and Conclusions of Law contained in the [2010] Order in any present or future administrative proceedings before the Board,’’ as well as in a proceeding before ‘‘any other state agency in the State of Arizona, concerning the denial or issuance of any license or registration required by the state to engage in the practice or any business or profession.’’ So too, Respondent agreed that he could not challenge any portion of either Order in the state or federal courts. Thus, notwithstanding that both AMB Orders were the result of consent agreements, it is clear that the parties agreed that the findings of fact and 6 Indeed, in Chaney, the Supreme Court of Arizona explained that even where parties stipulate to a dismissal, if the parties ‘‘intended the . . . dismissal to be binding as to certain factual issues, and if their intention was reflected in the dismissal, we would enforce the intent of the parties and collateral estoppel would apply.’’ 716 P.2d at 30 (citing James, Consent Judgments as Collateral Estoppel, 108 U. Pa. L. Rev. 173, 192 (1959)). E:\FR\FM\26JNN1.SGM 26JNN1 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices conclusions of law contained in them, were not subject to relitigation between Respondent and the Board. As for Respondent’s contention that ‘‘the stated findings and conclusions could not be used in a non-AMB proceeding,’’ ALJ Ex. 47, at 3, the 2010 Order itself expressly provided that it could be used in administrative proceedings brought by other Arizona agencies. GX 18, at 20. And as for his contention that he and the AMB agreed that his admissions were ‘‘not intended or made for any other use, such as in the context of another state or federal government regulatory agency proceeding,’’ Respondent cites no authority to support the proposition that he and the State can dictate to an Agency of the United States that it cannot give the same effect to the factual findings and legal conclusions as would exist in a subsequent state administrative proceeding.7 Cf. Howlett v. Rose, 496 U.S. 356, 371 (1990) (citing FERC v. Mississippi, 456 U.S. 742, 776 n.1 (1982) (opinion of O’Connor, J.) (‘‘State may not discriminate against federal causes of action’’)); U.S. Const. art. VI, cl. 2. Accordingly, I hold that the ALJ erred by failing to give preclusive effect to the factual findings and legal conclusions of the two AMB Orders.8 mstockstill on DSK4VPTVN1PROD with NOTICES Findings of Fact Respondent is the holder of a DEA Certificate of Registration, which authorizes him to dispense controlled substances in schedules II through V as a practitioner at the registered address 7 Nor is it even clear why the agreement’s language that ‘‘[a]ll admissions made by Respondent are solely for final disposition of this matter’’ and ‘‘said admissions are not intended or made for any other use,’’ should preclude this Agency from giving collateral estoppel effect to the Board’s factual findings and legal conclusions. Notably, the Board did not agree that its factual findings and legal conclusions were not entitled to preclusive effect in other proceedings; indeed, Respondent agreed that he could not contest the validity of the Board’s factual findings and legal conclusions in other Arizona administrative proceedings. Rather, the above quoted language states only that Respondent’s admissions were not intended for use in other proceedings. Notably, in his opposition to the Government’s motion, Respondent did not identify any factual findings in the two Orders which were based on his admissions. 8 As has been made clear in several agency decisions, even where the factual findings and legal conclusions of a state board order are not subject to relitigation, a respondent is entitled to argue whether those findings and legal conclusions also establish violations of federal laws and regulations, as well as whether those violations are sufficiently egregious to support the Government’s proposed sanction. So too, even where the factual findings and legal conclusions of a state board order are entitled to preclusive effect, a respondent is still entitled to put on evidence as to his/her acceptance of responsibility and remedial measures. See Robert L. Dougherty, 76 FR 16823, 16830 (2011). VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 of 2016 South 4th Avenue, Tucson, Arizona. GX 1, at 1. Respondent’s registration was due to expire on April 30, 2011, id.; however, on March 16, 2011, Respondent submitted a renewal application. GX 2. Because Respondent has timely submitted a renewal application, I find that Respondent’s registration has remained in effect pending the issuance of this Decision and Final Order. See 5 U.S.C. 558(c). Respondent is also the holder of a license to practice allopathic medicine in the State of Arizona. GX 18, at 1. Respondent holds board certifications from the American Board of Psychiatry and Neurology, the American Board of Child and Adolescent Psychiatry, American Board of Addiction Medicine, and the American Board of Pain Medicine. Tr. 802–03. The State Board Proceedings The 2009 AMB Order Respondent first came to the attention of the AMB, after DF, a Tucson area pharmacist, filed a complaint with the Board regarding Respondent’s issuance of an OxyContin prescription to DK in October 2007.9 Tr. 68–69. DF testified that he had received and filled prescriptions which Respondent had issued for OxyContin for patients who were participants in the Arizona Health Care Cost Containment System (AHCCS), the State’s Medicaid Program. Id. at 55. DF further testified that while OxyContin was not covered by AHCCS, Respondent’s prescriptions would, based on the ‘‘quantity and strength . . . cost in the neighborhood of $2,000 per month,’’ and yet the ‘‘the patient would pay cash.’’ Id. at 56–57. Moreover, even when DF ‘‘offered the generic, which was significantly less money, [Respondent’s] patients demanded the brand name’’ OxyContin and paid cash.10 Id. at 57. As for the quantity and strength of Respondent’s prescriptions, DF testified that ‘‘some of’’ them were for ‘‘the highest milligram strength, 80 milligrams,’’ with a dosing instruction to take ‘‘multiple tablets of that strength 9 At the time of the hearing, DF had been a pharmacist for twenty-nine years and had been appointed as the Assistant Director of Pharmacy for a major grocery chain in Arizona, and was responsible for supervising 43 pharmacies. Tr. 50– 51. He had also previously served for twelve years as a Pharmacy Manager for the same chain and for four years as the District Pharmacy Manager for the chain’s stores in southern Arizona. Id. at 52. 10 Several other pharmacists also testified to instances in which Respondent’s patients presented similar OxyContin prescriptions, turned down generics, and paid large sums of cash notwithstanding that they were on AHCCS. See Tr. 153–54 (testimony of NB); id. at 180–81 (testimony of WL). PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 38367 more frequently than was substantiated in the literature.’’ Id. Based on his ‘‘knowledge of prescribing practices of other physicians writing the same medications,’’ DF found the quantities to be ‘‘very excessive.’’ Id. In October 2007, DK presented a prescription issued by Respondent for 210 tablets of OxyContin 80mg, with a dosing instruction to take one tablet up to seven times per day. Id. at 64. DF testified that the dosing instruction was ‘‘totally outside of the literature and the general accepted prescribing practice for that medication,’’ id. at 65, because OxyContin is a sustained-release product which is typically taken every twelve hours, and at most every eight hours, and taking the drug every two hours ‘‘would lead to a blood level that could be dangerous.’’ Id. at 76. Accordingly, the prescription ‘‘prompted [DF] to call the doctor’s office to verify that the prescription was written correctly.’’ Id. at 65. However, when DF called Respondent’s office, the latter’s office manager told him that Respondent ‘‘refuses to speak to pharmacists.’’ Id. at 66. DF told the office manager that he wanted to know where Respondent ‘‘got the pharmacokinetics information that would support’’ the dosing interval and that he ‘‘was not going to fill the prescription until [he] spoke with’’ Respondent. Id. While DF made at least two phone calls regarding the prescription, Respondent did not speak with him. Id. at 67. Respondent eventually faxed a letter to DF stating that ‘‘OxyContin 80mg per day is the patient’s prescription dose. She is being monitored for plain [sic] & compliance. We will continue to prescribe as appropriate for the lowest dose, which meets her pain needs. We also expect politeness in communication.’’ RX 29, at 2; Tr. 67. In response, DF hand wrote a note on the fax, which he then faxed back: 7 times per day is not appropriate by anyone’s measure[.] We will no longer fill prescriptions under your name. Board of Medical Examiners and DEA will be notified. We will not help maintain an addiction. You are confusing firmness with impoliteness, and appropriate therapy with inappropriate therapy. RX 29, at 2; Tr. 68. Consistent with his note, DF instructed the pharmacists he supervised not to fill Respondent’s prescriptions and reported the incident to the AMB. Tr. 70. Respondent then called DF; during the conversation, DF related that Respondent’s office manager had stated that he refused to speak with pharmacists. Id. at 90. Respondent maintained that he ‘‘never directed his E:\FR\FM\26JNN1.SGM 26JNN1 38368 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES office manager to say that.’’ Id. DF asked Respondent if it ‘‘didn’t raise a red flag with him that [patients] were paying cash and demanding the brand name and that they were on AHCCCS,’’ and presumably ‘‘could not afford $2,000.00 a month for these medications?’’ Id. at 63. Respondent replied, ‘‘Well how do you know their family isn’t paying for it?’’ Id. DF stated that if he was paying for a family member’s prescription ‘‘that cost that much money, I would demand that they got the generic so I wasn’t spending that much money for it,’’ and then asked Respondent if this didn’t ‘‘raise a big red flag to you that they’re selling it on the street.’’ Id. at 63–64. Respondent ‘‘disregarded [DF’s] concerns and really had no response to that.’’ Id. at 64. Respondent also stated that many of his patients requested brand name drugs because generics were less effective. Id. at 106. DF and Respondent also discussed the dosing instruction on DK’s prescription, with Respondent telling DF that DK was taking two tablets, three times a day, and one tablet at night. Id. at 102. In response, DF told Respondent ‘‘that that is not the way the prescription is written and [that] for a pharmacist to fill a prescription with directions that are not indicative of . . . the doctor’s true intent . . . would be unethical and unprofessional.’’ Id. While DF recalled discussing drug ‘‘tolerance as a general principal,’’ he further told Respondent ‘‘the standard practice for pain control with a sustained release product . . . was to use an immediate release product to help with . . . breakthrough [pain] and not to simply increase’’ the dosing of the sustained release drug. Id. at 103. DF also testified that Respondent asserted that the medication was providing what appeared to be adequate pain relief to DK. Id. With respect to DK, the AMB conducted an investigation. GX 17, at 4. Thereafter, Respondent and the AMB entered into a consent agreement, pursuant to which he stipulated to certain findings of fact and conclusions of law. Id. at 1. Therein, the Board made the following findings of fact: 4. On November 17, 2006, DK first presented to Respondent through self-referral complaining of lower back pain and psychiatric issues. DK reported her current pain management medications as OxyContin, Oxycodone, Valium, and Paxil. DK also reported having imaging studies and x-rays done three years prior to her visit. Although Respondent requested at this first meeting and four times subsequently that DK provide him with her medical records and film, she did not comply until December, 2007. At this first visit, Respondent prescribed OxyContin and Valium at the reported doses and increased the Oxycodone dosage from the VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 reported dosage. Subsequently, Respondent prescribed medications on a monthly basis and in December 2006, he added Wellbutrin for increasing depression. Respondent did not obtain urine drug tests to monitor compliance before June 2008, or order additional testing to identify the source of DK’s pain. 5. On August 29, 2007, Respondent provided DK with early refills of OxyContin and Oxycodone, although he decreased the Oxycodone dosage. 6. On October 19, 2007, Respondent saw DK and a family member, who both insisted that DK was compliant with her treatment. Respondent then wrote DK her usual opioid prescriptions. However, later that day, Respondent received written documentation from another patient that DK was recently discharged from the care of another physician for violating a pain agreement. Respondent subsequently took appropriate measures in an attempt to prevent DK from filling the prescription he had written earlier that day. 7. Respondent later learned from the other provider that DK had tested positive for cocaine and Methadone (which was not prescribed to her). Respondent referred DK to Behavioral Health for substance abuse issues, but he continued to prescribe opiates to DK for her back pain. Further, Respondent continued to prescribe opiates to DK after he learned that she had successfully completed inpatient opioid detoxification. 8. The standard of care requires a physician to base new or continuing high dose opioid prescriptions for a self-referred, chronic pain management patient (who reports currently being prescribed high dose opioid medications) on proper indications, including previous medical records and verified previous prescriptions, and/or contact with the previous prescribing physician. 9. Respondent deviated from the standard of care by prescribing high dose opioids to DK without proper indications. 10. The standard of care when treating a chronic pain patient who has a known or suspected substance abuse problem is to utilize objective measures to monitor compliance. 11. Respondent deviated from the standard of care by failing to timely use objective measures, such as urine drug tests, to assess DK’s compliance with her treatment even after he was aware of her cocaine addiction. 12. As a result of Respondent’s conduct, DK might have suffered an accidental overdose resulting in respiratory depression, aspiration, brain damage, or death. In addition, Respondent’s inappropriate prescribing might have . . . perpetuated DK’s aberrant drug seeking and addiction. Id. at 4–5. Based on the above findings, the Board concluded that ‘‘[t]he conduct and circumstances described above constitute unprofessional conduct pursuant to’’ Ariz. Rev. Stat. § 32– 1401(27)(q), a provision which encompasses ‘‘[a]ny conduct or practice that is or might be harmful or dangerous to the health of the patient or the PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 public.’’ Id. at 6. The Board issued Respondent a reprimand and placed him on probation for one year, subject to several conditions, including that he take 15–20 hours of Continuing Medical Education in pain management; that he pay the Board’s administrative costs; and that he obey all federal, state and local laws and regulations ‘‘governing the practice of medicine.’’ Id. at 6–7. In addition, the conditions provided that the ‘‘Board staff or its agents shall conduct periodic chart reviews,’’ and that based on the reviews, ‘‘the Board may retain jurisdiction to take additional disciplinary or remedial action.’’ Id. at 6. After entering into the 2009 agreement, Respondent requested that Dr. Bennet E. Davis, M.D., President of the Pima County Medical Society Pain Working Group review the consent agreement. RX 8, at 4. Therein, Dr. Davis took issue with several of the AMB’s findings, specifically findings 8, 9, and 11. As set forth above, in findings number 8 and 9, the AMB found that in the case of ‘‘a self-referred, chronic pain management patient (who reports currently being prescribed high dose opioid medications),’’ the standard of care requires that a physician base the prescription ‘‘on proper indications, including previous medical records and verified previous prescriptions, and/or contact with the previous prescribing physician,’’ and that Respondent failed to do so. With respect to these findings, Dr. Davis asserted that the Board was applying a standard of care which ‘‘does not reflect the actual standard of care in the state of Arizona, nor in the community in which [Respondent] practices medicine,’’ but rather a standard which ‘‘reflects an ideal which is not achievable in reality.’’ Id. As for finding number 11, in which the Board found that Respondent deviated from the standard of care by failing to timely use objective measures, such as urine drug tests, to assess DK’s compliance with her treatment, even after he was aware of her cocaine addiction, Dr. Davis asserted that the Board’s finding ‘‘appears to have no basis in fact.’’ Id. Dr. Davis then opined that even ‘‘if it did, it would not reflect actual standard of care in the community in which [Respondent] practices medicine because the use of urine screening in pain medicine is an area of some controversy and consequently wide latitude must be given to practitioners.’’ Id. The short answer to these contentions is that the AMB is the expert agency entrusted under Arizona law with authority to determine ‘‘if a doctor of E:\FR\FM\26JNN1.SGM 26JNN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices medicine has engaged in unprofessional conduct or provided incompetent medical care.’’ Ariz. Rev. Stat. § 32– 1403(A)(2). See also id. § 32–1403(A) (‘‘The primary duty of the board is to protect the public from unlawful, incompetent, unqualified, impaired, or unprofessional practitioners of allopathic medicine through licensure, regulation and rehabilitation of the profession in this state.’’). Under Arizona law, eight of the Board’s twelve members must ‘‘be actively practicing medicine,’’ and ‘‘[e]ach doctor of medicine who is appointed to the board [must] have been a resident of this state and actively engaged in the practice of medicine as a licensed physician for at least the five years before appointment.’’ Id. § 32–1402(A) and (B). Respondent could have presented this evidence to the Board, but did not. Most significantly, to even entertain such evidence undermines fundamental values of federalism. As Gonzales v. Oregon makes clear, ‘‘[t]he structure and operation of the CSA presume and rely upon a functioning medical profession regulated under the States’ police powers.’’ Gonzales v. Oregon, 546 U.S. 243, 279 (2006). Where, as here, a state medical board has determined that a practitioner’s conduct violated the standard of care, its findings of fact and conclusions of law are not subject to relitigation before the Agency. Rather, the only question is whether those findings also establish whether a practitioner has committed acts which render his registration inconsistent with the public interest within the meaning of the CSA. With respect to DK, Respondent testified that he recognized the AMB’s criticism of his failure to get her records ‘‘originally.’’ Tr. 850–51. Indeed, other than a then-five year old MRI, which DK did not produce until more than a year after she had begun seeing Respondent and which had negative findings (see RX 30, at 11), Respondent did not obtain any records from DK’s prior treating physicians, notwithstanding that at the first visit, Respondent noted in his evaluation that ‘‘[h]er most recent treatment has been OxyContin 160 mg t.i.d. (three times a day) and oxycodone 30 mg two tablets, one to two times daily which she currently takes. She also takes Valium, 10mg. one p.o. at h.s.’’ RX 30, at 40.11 Respondent maintained, however, that: 11 Respondent also noted that DK ‘‘was previously treated with methadone, five to six years ago, and also received Percocet in the past. She has also a history of diazepam for muscle spasms.’’ See RX 30, at 40. Respondent also noted that DK had undergone physical therapy and ‘‘some psychiatric counseling.’’ Id. VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 There was a dilemma in obtaining her records. We asked many times and our option—the only option I saw available to us if she would not tell us or remember who she had seen in the past, was to fire her. And I felt, as I answered before, that she was a multiple diagnosed patient and that would be to her detriment and would be poor medical care. So I decided though she could not remember or give us the name or produce records, to continue her in my care based on my original examination of her, my history I took of her and her compliance. Tr. 851–52.12 Moreover, shortly after DF questioned the OxyContin 80 mg prescription (in early October 2007), Respondent was provided with a copy of a letter (dated 9–13–07) written by another physician (Dr. P.), which stated that Dr. P. had fired DK for breaking her pain contract, specifically citing DK’s use of cocaine and narcotics. RX 30, at 20. Respondent noted in DK’s record that the patient, who provided him with this letter, had observed that DK, who had recently stayed in the patient’s residence, had ‘‘not be[en] compliant with her medications,’’ and that this was corroborated by the reporting patient’s relative. Id. at 21. On October 19, 2007, Respondent sent out a Fax Net 13 cancelling the narcotic prescriptions he had issued to DK earlier that day. Id. at 19. However, the following month, he resumed prescribing both OxyContin and oxycodone to DK. Id. at 46. Respondent also noted in DK’s chart that his plan was ‘‘to contact Dr. [P’s] office, receive prior treatment information from [DK] and review this with prior providers, review this with [DK] before making a decision to continuing care for her. In the event, opioid medication care is not continued, she will be supported with detoxification medication and referral to appropriate treatment.’’ Respondent testified that he corroborated with DK’s previous physician that she had ‘‘violated the pain contract.’’ Tr. 844. However, he concluded that he ‘‘was her physician and she obviously needed additional care.’’ Id. According to Respondent, he told DK that ‘‘in order to continue treatment she would have to get 12 At the first visit, Respondent prescribed DK 180 tablets of OxyContin 80 mg as well as 180 tablets of oxycodone 30 mg. RX 30, at 40. Respondent issued monthly prescriptions to DK for both drugs, increasing the quantity of OxyContin 80 mg to 210 tablets after three months; he also issued monthly prescriptions of oxycodone 30 mg, which were typically for 180 tablets. Id. 13 A Fax Net is an Arizona State Board of Pharmacy form which is used by doctors and pharmacies to report such incidents as forged prescriptions, phony telephone prescriptions, doctor shopping, prescription pad thefts, and armed robberies. See RX 30, at 19. PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 38369 treatment at the Behavioral Health Center for this drug problem,’’ and that he ‘‘coordinated with Behavioral Health Center’’ and ‘‘required records back.’’ Id. at 844–45. Respondent then maintained that they ‘‘requested actually that I continue the care’’ as DK ‘‘continued to have pain and needed treatment for that and that was how we proceeded.’’ Id. at 845. Respondent then explained that he did not fire her at that point because: Abandoning her would have been unethical and immoral in my mind. She was—had multiple problems, including psychiatric. She had been apparently to two doctors previously. I felt that if I had fired her at that point, she would have gone looking for another doctor. She wouldn’t have gotten the care she needed. And that as long as she was willing to cooperate with a restructured treatment plan and supervision, it was my responsibility to care for her. Id. Respondent further maintained that ‘‘[a]fter we sent her to CODAC Behavioral Health, we continued to care for her at a lower dose. Communicated with them. She came back to us several months later for several more visits.’’ Id. at 848. Respondent continued to prescribe OxyContin and oxycodone to D.K. Indeed, he issued prescriptions for these drugs (as well as others) on a monthly basis on multiple occasions following her commencement of treatment at CODAC Behavioral Health, up to and including in March 2008, after which he stopped prescribing OxyContin but continued prescribing oxycodone 30mg and added methadone. RX 30, at 46–47. This continued through DK’s last visit, which occurred on August 27, 2008. Id. DK, however, had tested positive for cocaine on June 3, 2008. Id. at 3; Tr. 1013.14 14 While Respondent acknowledged that DK was prescribed 45 dosage units of oxycodone 30 mg on June 30, 2008, Tr. 1013, he then testified that: [m]y progress notes only go to June 4th, so I don’t know anything more than the record reflects that she was prescribed that. It may or may not have been me. My last progress note in this is June 4, 2008 and then there’s one additional note, August 27, ‘08 which has really no record except it was a rewrite for a methadone script. Tr. 1013. While on further questioning, Respondent again testified that he did not know whether he or another doctor wrote the script, he acknowledged that his office had continued to prescribe oxycodone to DK even after her positive test for cocaine. Tr. 1015. Notwithstanding his testimony that on June 4, 2008, DK ‘‘was given a three day supply of oxycodone, 40 to 60 milligrams a day, and then it was to be reduced,’’ id. at 1014, Respondent later acknowledged that between June 4 and August 27, 2008, DK’s oxycodone prescription was ‘‘increased’’ from 15–30 mg per day to thirty mg, twice a day. Id. at 1016. Respondent then maintained that RX 30, an exhibit he introduced into the record (and which was denominated as ‘‘Copy of DK Medical E:\FR\FM\26JNN1.SGM Continued 26JNN1 38370 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES As set forth above, the Board found that even after Respondent had referred DK for treatment for substance abuse, he continued to prescribe opiates to her for her back pain. Moreover, the Board found that Respondent continued to prescribe opiates to DK after he learned that she had successfully completed inpatient opioid detoxification.15 Of note, DK’s medical record contains the results of a single urine drug screen, which did not occur until June 3, 2008.16 Yet even after this screen showed that DK tested positive for cocaine, Respondent continued to prescribe to her. On cross-examination, Respondent testified that ‘‘we didn’t have all the perfect records.’’ Tr. 1027. However, he then asserted that DK ‘‘wouldn’t tell us or couldn’t tell what they were.’’ Id. When asked if he accepted the AMB’s judgment regarding his treatment of DK, Respondent testified that ‘‘I accept that I didn’t do a urine screen early on, which we would always do now.’’ Id. at 1028. As for the AMB’s findings that he failed to obtained DK’s records, Respondent testified that ‘‘I accept that I didn’t get old records, which we would handle as we handled,’’ id. whatever that means. As for the Board’s findings related to his continued prescribing to DK, even after he had referred her to substance abuse treatment and even after ‘‘she had completed inpatient opioid detoxification treatment,’’ (AMB Finding #7), Respondent testified that he did not accept the Board’s finding. Tr. 1028. According to Respondent, ‘‘they said I referred her to treatment and that was great that I followed her. She continued . . . to have pain and I did that treatment at much, much lower doses in conjunction with . . . her behavioral health center and at their request. So I think that was appropriate. Records in Possession of [Respondent],’’ was ‘‘apparently not’’ DK’s complete patient file, but rather only ‘‘the med log’’ as ‘‘the notes aren’t there that would explain in detail what was going on.’’ Id. at 1017. 15 According to the affidavit of Dr. Bennett Davis, Respondent’s medical record for DK included ‘‘notes from CODAC behavioral health clinic from 12–04–07 and 03–18–08.’’ RX 8, at 7. Strangely, the exhibit which Respondent submitted as DK’s medical record does not contain a note from CODAC dated 3–18–08. See generally RX 30. 16 A letter dated 10/09/08 from Respondent’s practice to another physician regarding DK’s request for medical records stated that ‘‘[s]he also tested positive for cocaine on two occasions. She was referred to Codac Behavioral Health for additional help and to our knowledge she did not complete treatment.’’ RX 30, at 1. While the log of DK’s prescriptions contains an entry for July 28, 2008, indicating that a urine drug screen was done on this date, DK’s patient record, as submitted into evidence, contains the test results of only the June 2008 drug screen. VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 But that’s [sic] everybody has differences of opinions.’’ Id. The 2010 AMB Order As set forth above, under the terms of the 2009 AMB order, Respondent was required ‘‘to participate in the periodic review of his patients’ charts.’’ GX 18, at 14; GX 17, at 6. The Board’s staff selected three charts at random and provided them to a medical consultant who reviewed them and ‘‘found deviations from the standard of care in each case,’’ as well as ‘‘medical recordkeeping issues.’’ GX 18, at 14. The 2010 AMB Order set forth extensive findings regarding three patients, JR, LP, and ML. Id. at 14–16. Based on several complaints the Board received regarding his treatment and care of multiple patients, the AMB initiated additional cases. See generally id. at 2–17. In its 2010 Order, the AMB made extensive findings regarding Respondent’s treatment of patients AL, KF, JF, DD, SS, AM, MF, ML, WO and CJ. See id. at 2–13, 17. Based on these findings, the AMB concluded that Respondent had engaged in unprofessional conduct, both by ‘‘[f]ailing or refusing to maintain adequate records on a patient,’’ and by engaging in ‘‘[a]ny conduct or practice that is or might be harmful or dangerous to the health of the patient or the public.’’ Id. at 17 (citing Ariz. Rev. Stat. §§ 32–1401(27)(e) and (q)).17 JR The Board found that Respondent treated JR for reported neck and back pain from July 2007 until September 2009. GX 18, at 14. No previous medical records were obtained prior to Respondent prescribing oxycodone, Xanax and Subutex. Id. Despite normal CT scans of JR’s head and neck on February 18, 2008, Respondent continued to prescribe oxycodone on numerous occasions until August 2009. Id. Respondent changed JR’s medication on several occasions without documenting his reasoning and refilled JR’s medication after he reported that it had been stolen. Id. According to the Board, when treating a patient for chronic pain, the standard of care requires a physician to obtain prior records pertaining to the past treatment of the patient, and to obtain 17 Under Ariz. Rev. Stat. § 32–1401(2), the term ‘‘‘[a]dequate records’ means legible medical records, produced by hand or electronically, containing, at a minimum, sufficient information to identify the patient, support the diagnosis, justify the treatment, accurately document the results, indicate advice and cautionary warnings provided to the patient and provide sufficient information for another practitioner to assume continuity of the patient’s care at any point in the course of treatment.’’ PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 any objective measures for the cause of pain. Id. The Board found that Respondent deviated from the standard of care because he did not obtain JR’s previous medical and/or treatment records prior to prescribing opioid medication for reported chronic pain, and that he failed to obtain objective measures for the cause of JR’s pain. Id. It further found that Respondent’s conduct could result in an overdose and/or perpetuation of drug seeking behavior and addiction. Id. The Board also found that Respondent’s records were inadequate because they failed to document a treatment plan and reasoning for high dose opioids in a patient with a history of substance abuse, lost/stolen medications and positive drug-screen findings. Id. at 15. Further, his records failed to adequately document the reasoning for, and the results of, his prescribing of Adderall.18 Id. LP The Board found that LP’s chart indicated that in August 2005, Respondent began treating LP for his reported history of chronic lower back 18 Regarding JR, as well as LP, CJ, WO and JF, Respondent’s Expert testified that she believed that Respondent was ‘‘practicing with skill and safety,’’ (as she had written in her June 7, 2010 letter to the AMB) in that ‘‘[t]he dosage he prescribed for the patients initially based on their symptoms, which of course are subjective, were reasonable. When he raised the doses subsequently, he did it in a careful manner, and he didn’t increase them sufficiently to risk the patient’s health. So I felt that he was skillful and he was taking into consideration the safety of the patient.’’ Tr. 592–93. Yet in her letter, Dr. Schneider noted ‘‘it is difficult at times to reconstruct his reasoning because his documentation, although typical of psychiatric patients, needs to be more detailed when dealing with chronic pain patients.’’ RX 4, at 1. And subsequently, Dr. Schneider testified that she ‘‘remember[ed] that I read some of [Respondent’s] records where he didn’t do a physical exam on the first visit and things like that.’’ Id. at 597. Thus, even if the Board’s findings were subject to relitigation in this proceeding, Dr. Schneider’s testimony provides no reason to reject the Board’s findings. Dr. Schneider also took issue with several of the AMB findings, asserting that in the case of one patient (AM), ‘‘the consultant alleged’’ that Respondent ‘‘did not get prior imaging studies’’ when ‘‘those records were in the chart’’; that in the case of MF, ‘‘the consultant alleged that [he] did not try alternative non-opioid treatment before initiating opioid treatment,’’ as well as that he did not get imaging studies when ‘‘a CT of the thorax was in the chart’’; and that ‘‘the consultant alleged’’ that he did not physically examine patient SS at the initial visit, when the results were in the chart. RX 4, at 2. Here again, Respondent could have raised these contentions with the Board. Moreover, even if the Board’s findings were subject to relitigation, the Board made findings with respect to fourteen patients. Thus, even if I were to place no weight on the Board’s findings with respect to these three patients, the Board’s findings were essentially unchallenged with respect to most of the other patients. E:\FR\FM\26JNN1.SGM 26JNN1 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices pain, DJD, musculoskeletal pain, chronic depression, PTSD, Lupus and ADD. Id. On the first as well as subsequent visits, Respondent prescribed OxyContin and oxycodone without obtaining past medical records. Id. The Board noted that objective data in the records such as x-rays were documented as normal; however, Respondent continued to treat LP with opioids and/or methadone through October 2009 without a documented treatment plan. Id. Respondent increased LP’s medications, as well as changed them at times without documented reasoning. Id. According to the Board, the standard of care when treating a patient for chronic pain requires a physician to obtain objective measures as to the cause of pain. Id. The Board found that Respondent deviated from the standard of care in that he continued to treat LP’s reported pain with high-dose opioid medications without obtaining objective measures as to the cause of the reported pain. Id. The Board further found that Respondent’s conduct could result in an overdose or perpetuation of drug seeking behavior and addiction. Id. at 16. The Board also noted that Respondent’s records were inadequate because they fail to adequately document the initial visit, treatment plan and reasoning for high dose opioids and changes in medications, in violation of Ariz. Rev. Stat. § 32– 1401(2). mstockstill on DSK4VPTVN1PROD with NOTICES ML The Board made findings pertaining to ML, a twenty-three year old male, as part of both the random chart review it conducted pursuant to the 2009 Order, as well as the case it opened following the receipt of a complaint regarding Respondent’s care and treatment of him.19 Id. at 9, 16. The Board found that in October 2006, Respondent diagnosed ML with spondylolisthesis based on his reported history and that he prescribed oxycodone, but that he did not perform a facet, sacroiliac joint, myofascial pain 19 This individual is not the same person as the confidential source who made undercover visits to Respondent on May 2 and June 6, 2008, and was also referred to by the initials ML. Respondent also elicited testimony from an individual with the same initials, who testified that he was treated by Respondent for spondylolisthesis. Tr. 464–94. The testimony of this individual suggests he may well have been the same ML as discussed in the AMB’s 2010 Order. Compare GX 18, at 9 (discussing ML’s treatment at methadone facility) with Tr. 474, 484–8 (ML testifying about his treatment by methadone program). The record does not, however, definitively establish if the ML who testified and the ML discussed in the AMB’s Order are one and the same. VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 or neural flexes examination on ML, nor did he test him for weakness or numbness. Id. at 9. The Board also found that Respondent did not order flexion extension films to assess spinal instability from spondylolisthesis or an MRI scan to assess for neural compression. Id. Moreover, in the course of its chart review, the Board found that there was an x-ray in the chart dated February 18, 2008, which stated: ‘‘NO evidence of spondylolisthesis.’’ Id. at 16. The Board found that in November 2007, Respondent documented that ML had, on his own, increased the oxycodone medication. Id. at 9. However, there was no documentation that Respondent cautioned ML to adhere to his dosing instructions. Id. The Board also found that from January through December 2007, Respondent prescribed multiple early refills of oxycodone, that he added hydrocodone to the regime in January but discontinued it in March without indication, and that from February through December 2008 Respondent prescribed multiple early refills of oxycodone.20 Id. It also found that in June 2008 Respondent was notified that ML was undergoing methadone treatment at a facility; however, Respondent he did not obtain ML’s medical records from that facility. Id. Next, the Board found that Respondent discharged ML from opioid therapy in January 2009, but restarted opioids in March 2009, without documenting an explanation. Id. Moreover, the Board found that even after he was placed on probation pursuant to the 2009 Order, ‘‘Respondent continued to prescribe high-dose opioids to ML for pain secondary to spondylolisthesis’’ until September 2009. Id. at 16. The Board noted that during the course of Respondent’s treatment of ML there was no further documentation that he performed any examinations prior to prescribing the medications, or that he obtained ML’s past medical records or diagnostic studies. Id. at 9–10. According to the Board, prior to initiating high dose opiate therapy, the standard of care requires a physician to perform an adequate exam for pain generators, obtain the patient’s past medical records and diagnostic studies, offer the patient adjunct treatments that include non-opioid medications and physical therapy, address aberrant drug seeking behaviors, and refrain from prescribing more than one month of Schedule II prescriptions at a time. Id. 20 Here again, Respondent’s Expert did not take issue this finding. Tr. 675. PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 38371 The Board found that Respondent deviated from the standard of care because he did not perform an adequate exam prior to initiating high dose opiate therapy, did not obtain ML’s past medical records and diagnostic studies, did not offer adjunct treatments, did not address ML’s aberrant drug-seeking behaviors, and did not refrain from prescribing more than one month of schedule II prescriptions at a time. Id. As it noted with the previously discussed patients, the Board also found that when treating a patient for chronic pain, the standard of care requires a physician to obtain objective measures as to the cause of pain. Id. at 16. The Board thus found that Respondent violated the standard of care by continuing to treat ML’s reported pain with high-dose opioids without obtaining objective measures for the cause of his pain, and that his conduct could result in the perpetuation of ML’s drug-seeking behavior/addiction or an overdose. Id. In addition, the Board found that there was potential for diversion or abuse of the oxycodone. Id. at 10. Finally, the Board found that ‘‘[a] physician is required to maintain adequate legible medical records containing, at a minimum, sufficient information to identify the patient, support the diagnosis, justify the treatment, accurately document the results, indicate [the] advice and cautionary warnings provided to the patient and provide sufficient information for another practitioner to assume continuity of the patient’s care at any point in the course of treatment.’’ Id. at 11 (citing Ariz. Rev. Stat. § 32– 1401(2)). The Board thus found that ‘‘Respondent’s records were inadequate[,] because there was no documentation that [he] performed any [neurologic] and musculoskeletal examinations prior to prescribing opioid therapy, no documentation that he cautioned ML to stay within the prescribing instructions, no documented rationale for re-starting opiates again later[,] and that [he] did not obtain ML’s medical records from the treatment facility or from his previous treating physicians.’’ Id. During the hearing, Respondent’s expert did not dispute the Board’s findings with respect to Respondent’s multiple early refills for ML. Tr. 675. She also did not dispute that notwithstanding that ML had tested positive for both marijuana and cocaine, as well as benzodiazepines which Respondent had not prescribed on previous visits, Respondent continued to prescribe oxycodone to him. Id. at 675–76. Nor did she dispute that ML E:\FR\FM\26JNN1.SGM 26JNN1 38372 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices had tested negative for oxycodone even though Respondent had prescribed the drug to him at the preceding visit. Id. at 677. While Dr. Schneider testified that there might be a valid reason why a short acting opioid might not turn up in a urine drug screen (depending upon when it was taken), she testified that the physician ‘‘need[s] to find out when the patient took their last dose so that you can find out if there’s some legitimate reasons for why they[sic] tested negative when one would have expected it to be positive.’’ Id. at 679. And notwithstanding that the ALJ allowed Respondent to relitigate the Board’s findings, Respondent offered no evidence as to whether ML had a legitimate reason for testing negative for oxycodone.21 mstockstill on DSK4VPTVN1PROD with NOTICES CJ Following its receipt of a complaint from a pharmacy alleging inappropriate prescribing by Respondent, the Board investigated his treatment of CJ. GX 18, at 17. The Board found that Respondent ‘‘prescribed large amounts of opioids to . . . CJ with an inadequate treatment plan,’’ and that he did so even though ‘‘CJ had a history of testing positive for [h]eroine [sic], [o]xycodone, [m]orphine and [c]ocaine.’’ Id. The Board also found that ‘‘on two occasions, CJ tested positive for narcotics that were not prescribed by Respondent.’’ Id. According to the Board, ‘‘[t]he standard of care is to develop an adequate treatment plan prior to prescribing opioids and to treat the patient’s substance abuse problem before treating pain.’’ Id. The Board found that Respondent violated this standard when he ‘‘prescribed opioids to CJ without an adequate treatment plan,’’ and that he ‘‘exposed the patient to possible drug overdose and drug diversion.’’ Id. AL The Board found that on November 6, 2006, AL, who was then an eighteen year old female, presented to Respondent complaining of moodiness and irritability. Id. at 2. Respondent diagnosed AL as having Attention Deficit Hyperactivity Disorder and prescribed Adderall (a schedule II stimulant) to her, but did not document the prescription in AL’s record. Id. The Board found that there was no documentation that Respondent 21 Nor did she dispute the Board findings that Respondent had continued to prescribe opioids to individuals with anomalous urine drug screens, such as where patients tested positive for drugs he had not prescribed or illicit street drugs, or had tested negative for drugs he had prescribed. Tr. 678–80. VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 performed an adequate psychiatric evaluation, which included ordering laboratory studies; that he had obtained her past medical records, her history of alcohol or substance abuse, and her psychiatric history; or that he performed a functional assessment to support his diagnosis and prescription. Id. The Board also found that there was no initial treatment plan documented in the record. Id. The Board further found that ‘‘[f]rom November 2006 through February 2009, Respondent provided AL with frequent, early and escalated doses of Adderall without documenting any rationale for doing so.’’ Id. Moreover, the Board found that ‘‘[o]n several occasions[,] AL attempted to refill her Adderall prescription early. There was, however, no documentation that Respondent investigated or addressed AL’s rationale for doing so. Id. Next, the Board further found that during the course of AL’s treatment, Respondent added Prozac, Cymbalta, Lorazepam, and Zoloft 22 to her medication regime but did not document his rationale for the medications or whether he discussed the risks and benefits of taking them. Id. There was also no documentation that he ordered any laboratory studies to support his continued prescribing of Adderall, or urine drug screens to determine whether AL was taking the medications as prescribed and/or any illicit substances. Id. Further, several of Respondent’s progress notes were illegible. Id. The Board found that the standard of care requires a psychiatrist to perform adequate psychiatric evaluations prior to commencing treatment, and that when prescribing Adderall, a physician is required to perform tests to confirm the diagnosis and the necessity of the medication, and to monitor the patient’s use of the medication. Id. at 3. The Board thus found that Respondent deviated from the standard of care in that he did not perform an adequate psychiatric evaluation of AL, he did not perform tests to confirm his diagnosis and the necessity of medication, and he did not monitor AL’s use of the medication. Id. The Board further found that there was no collateral information in AL’s record to support prescribing Adderall, which created a potential for misdiagnosis, addiction, abuse, misuse, overdose and diversion. Id. The Board also found that because no urine drug tests were performed, it was unknown whether AL was taking the medication 22 Of these drugs, only Lorazepam is controlled. See 21 CFR 1308.14(c). PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 as prescribed and/or whether she was utilizing illicit substances. Id. Finally, the Board found that Respondent’s records did not comply with Ariz. Rev. Stat. § 32–1401(2), because there was no documentation of the initial Adderall prescription, no documented initial treatment plan, the psychiatric evaluation was inadequate, there was no documented rationale for his prescribing of several medications, and several of his progress notes were illegible, including his use of nonstandard abbreviations.23 Id. KF The Board found that on March 25, 2008, Respondent began treating KF, a twenty-one year old female patient, who complained that she had ‘‘difficulty finishing tasks and focusing.’’ Id. at 4. Respondent prescribed Adderall to KF, yet ‘‘[t]here was no documentation that [he] obtained her past medical records or ordered any laboratory tests that would qualify KF for a diagnosis to support the use of Adderall.’’ Id. Respondent prescribed frequent early refills at several subsequent office visits without documenting any rationale for the refills. Id. Moreover, on November 4, 2008, Respondent increased KF’s dose of Adderall from 20 mg to 30 mg, without any rationale for the prescription. Id. There was no documentation that Respondent ordered any laboratory studies to support his continued prescribing of the drug, or any urine drug screens to determine whether KF was taking the medications as prescribed and/or any illicit substances; also, ‘‘several of Respondent’s progress notes were illegible.’’ Id. The Board found that the standard of care requires a psychiatrist to perform adequate psychiatric evaluations, and that Respondent deviated from the standard of care because he did not perform an adequate psychiatric evaluation. Id. The Board also found that the standard of care requires a physician who prescribes Adderall ‘‘to obtain prior medical records, perform tests to confirm the diagnosis and the necessity of the medication[,] and to monitor the patient’s use of the medication.’’ Id. The Board thus found that ‘‘Respondent deviated from the standard of care because he did not obtain prior medical records, perform tests to confirm the diagnosis and the necessity of the medication[,] and he 23 When asked about the Board’s finding that ‘‘Respondent provided AL with frequent early and escalated doses of Adderall,’’ Respondent’s Expert did not take issue with this finding. Tr. 668–69. E:\FR\FM\26JNN1.SGM 26JNN1 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices did not monitor KF’s use of the medication.’’ Id. The Board also found that ‘‘[t]here was no collateral information to support prescribing Adderall, creating a potential for misdiagnosis, addiction, abuse, misuse, overdose and diversion. Since no urine drug tests were performed it is unknown whether KF was taking the medication as prescribed and/or whether she was utilizing illicit substances.’’ Id. at 4–5. Finally, the Board found that Respondent’s records were inadequate because he did not obtain KF’s past medical records, did not document a physical examination prior to prescribing medications, did not document any rationale for the prescriptions, dosage escalations, additions of medication, that several of Respondent’s progress notes were illegible, and that he used non-standard abbreviations.24 Id. at 5 (citing Ariz. Rev. Stat. § 32–1401(2)). mstockstill on DSK4VPTVN1PROD with NOTICES JF The Board found that Respondent began treating patient JF, a nineteenyear old female patient in August 2007 for chronic pain, Attention Deficit Disorder and Obsessive Compulsive Disorder. Id. JF reported current prescriptions of OxyContin 40 mg and oxycodone 30 mg. Id. There was neither a documented physical examination nor laboratory studies, and Respondent did not obtain past medical records. Id. Respondent, however, prescribed 90 tablets of OxyContin 40 mg, 45 tablets of oxycodone 30 mg, and Requip to her. Id. The Board found that Respondent added Adderall to JF’s medication regime in October 2007, without documenting any rationale for the medication. Id. It also noted that during the course of JF’s treatment, she reported on multiple occasions damaged or stolen prescriptions, running out of medication, and that the pharmacy had refused to fill a prescription because of different handwriting. Id. However, Respondent continued to prescribe to her and escalated the doses of oxycodone and Adderall. Id. The Board further found that there was no documentation that Respondent ordered laboratory studies to support his continued prescribing of OxyContin, oxycodone, and Adderall, or that he did any urine drug screens to determine whether JF was taking the medications 24 Here again, Respondent’s Expert did not dispute the Board’s finding that Respondent provided AL with ‘‘frequent early refills of Adderall.’’ Tr. 669. She also did not ‘‘take issue with the fact that this dose was increased.’’ Id. at 670. VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 as prescribed and/or illicit substances. Id. at 5–6. In addition, there was no documentation that Respondent referred JF to a specialist for consultation. Id. at 6. The Board found that that the standard of care requires a psychiatrist to perform adequate psychiatric evaluations, and that Respondent deviated from the standard of care because he did not perform an adequate psychiatric evaluation for JF. Id. In addition, the Board found that when a physician prescribes Adderall, the standard of care requires that he perform tests to confirm the diagnosis and the necessity of the medication and to monitor the patient’s use of the medication, and that Respondent deviated from this standard because he prescribed the drug without performing tests to confirm the diagnosis and the necessity of the medication and did not monitor JF’s use of the medication. Id. Next, the Board found that when prescribing opioids for the treatment of chronic pain, the standard of care requires a physician to review previous diagnostic studies and interventions, assess the chronic pain complaint prior to initiating an opioid trial, appropriately monitor the patient’s use of the medication, and obtain appropriate therapeutic and laboratory test results that support the diagnosis. Id. The Board found that Respondent deviated from the standard of care because he did not review past medical records and he did not order appropriate tests or consultations for JF. Id. The Board further found that there was no collateral information to support prescribing Adderall, which created a potential for misdiagnosis, addiction, abuse, misuse, overdose and diversion, and that no urine drug tests were performed to determine whether JF was taking the medication as prescribed. Id. The Board also found that Respondent’s medical records for JF were inadequate because he did not obtain JF’s past medical records, did not document a physical examination prior to prescribing medications, did not document any rationale for prescriptions, dosage escalations, and additions of medication. Id. at 7. Further, it found that Respondent used non-standard abbreviations in his records. Id. (citing Ariz. Rev. Stat. § 32– 1401(2)). DD, SS, AM & MF The Board found that in 2008, Respondent treated patients DD, SS, AM and MF for chronic pain. Id. He prescribed medications that included OxyContin and oxycodone based on the PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 38373 patients’ reported history and complaints of chronic pain. Id. Yet the Board found that there was no documentation that Respondent obtained past medical records to confirm the patients’ diagnoses. Id. Moreover, the Board found that during the course of his treatment, Respondent provided early refills and escalated the patients’ doses of OxyContin and oxycodone, without documenting any rationale to support his diagnosis or prescribing. Id. The Board further found that Respondent ‘‘did not perform adequate physical examinations, obtain past medical records, or order diagnostic and laboratory studies.’’ Id. Also, there was no documentation that Respondent referred the patients to a specialist to confirm his continued prescribing of opioids, or that he performed any urine drug screens to determine whether the patients were taking the medications as prescribed and/or illicit substances. Id. The Board found that when prescribing opioids for the treatment of chronic pain, the standard of care ‘‘requires a physician to review past diagnostic studies and interventions, assess and confirm the chronic pain complaint prior to initiating an opioid trial, appropriately monitor the patient’s use of the medication, and obtain appropriate therapeutic and laboratory results that support the diagnosis. Id. at 8. The Board found that Respondent deviated from the standard of care because he did not review DD’s, SS’s, AM’s and MF’s past diagnostic studies and interventions, assess and confirm their chronic pain complaints prior to initiating an opioid trial, appropriately monitor their use of the medication, and obtain appropriate therapeutic and laboratory test results that supported his diagnoses of chronic pain. Id. The Board further found that there was no collateral information to support prescribing opioids to DD, SS, AM and MF, thus creating the potential for misdiagnosis, addiction, abuse, misuse, overdose and diversion, and that because no urine drug tests were performed, it was unknown whether they were taking the medication as prescribed and/or whether they were utilizing illicit substances. Id. Finally, the Board found that Respondent’s records for patients, DD, SS, AM, and MF were inadequate because he did not obtain past medical records, did not document adequate physical examinations or laboratory and diagnostic studies prior to prescribing medications, did not obtain any diagnostic studies to support his continued prescribing of medications, E:\FR\FM\26JNN1.SGM 26JNN1 38374 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES and did not document any rationale for prescriptions and dosage escalations.25 Id. at 8–9 (citing Ariz. Rev. Stat. § 32–1401(2)). WO The Board investigated a complaint regarding Respondent’s care and treatment of patient WO, a fifty-two year old male, for chronic pain syndrome. Id. at 11. Respondent assumed WO’s care in January 2008, at which time ‘‘WO was on [o]xycodone, [m]orphine [s]ulfate immediate release (MSIR) and Soma, which had been prescribed by his previous physician.’’ Id. The Board found that Respondent reviewed previous imaging studies, including a computed tomography scan of WO’s pelvis and abdomen that showed healed lower right lateral rib fractures, but no other abnormalities, and a cervical spine film that showed mild hypertrophic degenerative changes in the mid-cervical spine, but no other abnormalities. Id. The Board found that from WO’s initial visit until July 2009, Respondent continued to see WO and refill the prescriptions. Id. The Board found, however, that there was no documentation that he performed a neurological or musculoskeletal exam or ordered any imaging studies of WO’s lumbar spine or laboratory studies, prior to continuing the treatment of WO’s previous physician. Id. The Board also found that from March 2008 through December 2008, Respondent increased WO’s dosage of oxycodone 30 mg to six tablets per day. Id. at 12. Moreover, on May 30, 2008, Respondent added Morphine Sulfate (MS) Contin 30 mg for poor sleep, but subsequently increased the dose without documenting a rationale for the increase. Id. Yet there was no documentation that Respondent performed any physical examinations or obtained any radiologic studies to support his increased opioid prescribing. Id. Next, the Board found that in February 2009, Respondent discontinued prescribing MS Contin to WO and instead prescribed six tablets per day of morphine sulfate 30 mg to him. Id. The Board found that Respondent simultaneously increased WO’s oxycodone dose to eight tablets per day, yet did not document a rationale for the increase. Id. 25 When asked about the Board’s finding with respect to these four patients that ‘‘[d]uring the course of treatment Respondent provided early refills and escalated the patient doses,’’ Respondent’s Expert testified that she didn’t know whether or not it was appropriate for Respondent to increase the patients’ doses ‘‘because he didn’t document it.’’ Tr. 670–71. VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 In March 2009, Respondent performed a urine drug screen on WO; the screen was negative for oxycodone, but positive for methadone and codeine, which were not among his prescribed medications, as well as heroin. Id. At WO’s next visit, Respondent documented that he was aware of the positive drug screens. Id. The Board found however, that Respondent did not adequately investigate or address the abnormal results by either referring him to an addiction medicine specialist or discontinuing the opioid prescriptions. Id. The Board found that the standard of care requires a physician to perform an adequate work up of a patient prior to continuing treatment of the patient’s prior treating physician, to perform an adequate physical examination, and to obtain radiologic data to support the amount of opioid medications prescribed to the patient. Id. The Board found that Respondent deviated from the standard of care because he did not perform an adequate work-up and that the physical examination and radiologic data did not support the amount of opioid medications he prescribed to WO. Id. at 12–13. The Board also found that the standard of care requires a physician to adequately investigate or address a patient’s abnormal urine drug screen. Id. at 13. The Board found that Respondent deviated from the standard because he did not adequately investigate or address WO’s abnormal urine drug screen. Id. The Board further found that Respondent allowed WO to continue a pattern of illicit substance use and opioid misuse. Id. The Board found that that Respondent’s prescribing of 240 tablets of oxycodone per month also created a potential for misuse and diversion.26 Id. Finally, the Board found that Respondent’s records were inadequate because there was no documentation that he performed a neurological or musculoskeletal examination, ordered any imaging or lab studies prior to continuing the treatment, and there was no documented rational for his excessive prescribing of opioids. Id. (citing Ariz. Rev. Stat. § 32–1401(2)). Summary of the 2010 Order Based on its findings with respect to all of the patients, the Board found that Respondent committed unprofessional conduct by ‘‘failing or refusing to 26 The Board also found that ‘‘[t]he long-term use of Soma has the potential for habituation and misuse.’’ GX 18, at 13. However, at the time, Soma (carisoprodol) was not a controlled substance under federal law. PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 maintain adequate records on a patient,’’ Ariz. Rev. Stat. § 32– 1401(27)(e), as well as by engaging in ‘‘[a]ny conduct or practice that is or might be harmful or dangerous to the health of the patient or the public,’’ Ariz. Rev. Stat. § 32–1401(27)(q). GX 18, at 17. The Board issued Respondent a Decree of Censure and prohibited him ‘‘from prescribing, administering or dispensing any opioids for a period of one year.’’ Id. at 18. It also placed him on probation for two years; among the terms of the probation, Respondent was required ‘‘to complete the PACE prescribing course within 6 months of the effective date of this Order’’ and enter into a contract providing for quarterly chart reviews by a monitor. Id. Regarding the 2010 AMB Order, Respondent testified that the Board had reviewed 45 of his patient records and had not criticized his recordkeeping other than with respect to the thirteen that were the subject of the Order. Tr. 856–58. He asserted that the reason his recordkeeping was inadequate was because his ‘‘early training and practice was primarily in psychiatry’’ where ‘‘[t]he confidentiality of the patient is paramount,’’ such that his ‘‘[n]otes were often brief’’ and hit just ‘‘the main points’’ of the patient’s ‘‘main complaint, perhaps a mental status examination, the diagnosis and the plan.’’ Id. at 859–60. He then testified that ‘‘the main purpose of the record was to refresh your own memory and wasn’t necessarily always focused on outside review,’’ id. at 860, but that he was now ‘‘making every effort to make the record transparent to outside individuals, which was really not the standard of care or the practice for psychiatry.’’ Id. at 861. Respondent further testified that during the period in which the AMB was investigating his prescribing to D.K., he sought out assistance from other pain management physicians, studied for and took the board in Pain Medicine, read multiple textbooks and took online courses. Id. at 864. He also testified that he had complied with the 2010 Order’s practice restriction, which prohibited him from prescribing opioids, and that the restriction had been lifted. Id. at 870. As far as other measures he has undertaken since 2007, Respondent stated that his practice was now able to use the Arizona Controlled Substance Prescription Monitoring Program, that the office was now certified to do inoffice urine testing and that it was doing random urine screening, that the office was using the fax alert system, and that he was now placing ‘‘[a] very high priority’’ on calls from pharmacies. Id. E:\FR\FM\26JNN1.SGM 26JNN1 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES at 870–72. Respondent also stated that he had imposed an ‘‘internal kind of ceiling on opiate dosing,’’ and that ‘‘[w]e’re not a prescribing mill.’’ Id. 874, 877. Regarding the second AMB Order, Respondent testified that ‘‘there was a Board statement that no actual harm was found in any patient’’ and ‘‘no patients . . . were found to have been diverting substances.’’ Id. at 883. He then asserted that ‘‘[t]here was no potential addiction, which was perpetuated by my behavior, which is one of the claims.’’ Id. When asked whether he accepted the AMB’s criticism of his recordkeeping and care of his patients, Respondent testified: ‘‘Yes. I realize this is a difficult area and that I need to keep working to improve and I have and I will.’’ Id. at 884. Respondent then testified that ‘‘I accept the general criticism that there needs to be improvement of my care as I can do so’’ but that he did not agree with some of the specifics of the Order, as his Expert had testified. Id. The Undercover Visits The Government also introduced evidence that it sent two confidential sources (CS) into Respondent’s office to obtain controlled substances; each source performed two visits and obtained controlled substances at each visit. With respect to these visits, the Government introduced the recordings (and transcripts) of each visit, and the medical record for each CS. In addition, the Government elicited testimony from a Special Agent (S/A) who was involved in conducting the visits and debriefing the CSs after the visits. The Government did not, however, elicit testimony from an expert witness regarding whether Respondent had acted within the usual course of professional practice and with a legitimate medical purpose when he prescribed to the two CSs. Instead, it argues that the evidence shows that ‘‘on four occasions,’’ Respondent prescribed controlled substances to the CSs ‘‘without ever conducting a physical examination,’’ and that the prescriptions violated an Arizona Statute, which provides that it is ‘‘ ‘[u]nprofessional conduct’ ’’ 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,’ ’’ and therefore, the prescriptions violated 21 CFR 1306.04(a). Gov. Exceptions at 3 (quoting Ariz. Rev. Stat. §§ 32– 1401(27)(ss)). With respect to RL, the evidence showed that she visited Respondent on VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 April 9 and May 7, 2008, obtaining a prescription for 120 oxycodone 5 mg at the first visit and a prescription for 60 OxyContin 20 mg. at the second visit. See GXs 3 and 5. In addition, the S/A testified that during the debriefing of RL following her visit, RL said that ‘‘she told [Respondent] where she had pain’’ and that Respondent ‘‘asked a series of questions regarding exercise, sleep, family history, basically general medical questions as to how her life is, what her occupation is, what she does, is she stressed out, does she have anxiety, things of that nature.’’ Tr. 358. The S/ A further testified that RL did not provide any medical records to Respondent and that RL ‘‘said there was no physical examination.’’ Id. at 359. According to the transcript of the visit, RL complained of having hip pain which was caused by a fall. GX 11, at 2. Respondent asked RL a series of questions, including when she had fallen; whether her hips had been ok prior to the fall; whether she had had an x-ray or MRI, and whether the x-ray showed arthritis; whether the pain bothered her when she did various body movements and whether it went down her leg; how often she had the pain; whether it was a sharp or dull pain; whether she had any numbness; whether it impaired her ability to walk; whether it affected her ability to sleep, her appetite, her energy, and her mood; whether she had anxiety attacks; whether she drank alcohol; whether she had taken any medication for the pain and whether it had helped; whether her health was otherwise good; and whether her family had certain medical conditions. Id. at 3–8; 13–15; 18–22. Respondent also discussed various forms RL needed to complete, including one to describe her pain, his controlled substance contract, and a form regarding which pharmacy she was using. Id. at 25. Respondent then told RL that oxycodone and Percocet were ‘‘not refillable’’ and that the long-term effect of taking oxycodone could include constipation and affect her level of hormones. Id. at 29. Although the transcript corroborates some of RL’s hearsay statements (as related by the S/A), significantly, the transcript shows that early on in the visit, the following colloquy occurred: Respondent: Do you have any tenderness if, if you push on it like this? RL: Yeah. Respondent: Where does it hurt? Just when you push on it here? RL: Directly on it, yes. Id. at 6. While the above colloquy does not foreclose the possibility that PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 38375 Respondent may actually have palpated only his own hip and not RL’s, the Government had the burden of proof on the issue and produced no other evidence other than the conclusory testimony of the S/A regarding RL’s statement that Respondent did not perform a physical exam on her.27 With respect to the second CS (ML), the evidence showed that she saw Respondent on May 2, 2008 and June 6, 2008. GX 6, at 1; GX 8, at 1. At the first visit, Respondent prescribed 30 oxycodone 5 mg to ML, GX 6, at 1; at the second visit, Respondent prescribed both 30 oxycodone 5 mg and 30 morphine sulfate ER 15 mg. GX 8, at 1. According to the S/A, during the debriefing following her first visit, ML stated ‘‘that an evaluation was done with questions based on anxiety, sleep, her family history, [and] what her pain was. She said she had a pain in her shoulder due to her occupation.’’ Tr. 373. ML also told Respondent that she had undergone gastric bypass surgery and ‘‘how much weight she had lost.’’ Id. The S/A further testified that ML did not provide Respondent with any medical records on this visit, and when asked what type of physical examination Respondent had performed on her during the visit, ML answered: ‘‘[n]one.’’ Id. The transcript for the visit shows that after discussing her dental pain, ML complained of pain, stated that the pain was ‘‘right here’’ and that it was ‘‘really hurting . . . a lot!’’ GX 15, at 4. Respondent then asked if the pain was in the bone or ‘‘the joint here?’’ Id. ML stated that ‘‘it’s like a muscle type tissue or something.’’ Id. Respondent then asked ML to ‘‘point right there,’’ ML said, ‘‘[i]t, it hurts.’’ Id. at 4–5. Respondent suggested that ML should ‘‘maybe . . . get that injected’’ and asked ‘‘[w]hen did that start?’’ Id. at 5. ML stated that she didn’t remember when, or what she was doing when she started feeling the pain, and that she had to alter the position of her bra strap. Id. After discussing that Respondent was also a psychiatrist, Respondent suggested that ML see his colleague, Dr. Skinner, who ‘‘might be able to adjust that,’’ and asked if the pain went down 27 While the transcript for RL’s second visit contains no indication that Respondent physically examined her, and the S/A testified that RL stated that she was not physically examined on that occasion, see Tr. 367, the Arizona statute does not require that a physician physically examine his patient on each occasion that he prescribes a controlled substance to her. See Ariz. Rev. Stat. §§ 32–1401(27)(ss)). Nor did the Government offer any evidence that under the standard of care, a physician is required to perform a physical exam on each occasion that he prescribes. E:\FR\FM\26JNN1.SGM 26JNN1 mstockstill on DSK4VPTVN1PROD with NOTICES 38376 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices her arm. Id. at 5–6. ML replied in the affirmative and said it was ‘‘hard for’’ her because ‘‘what I do is on the phone.’’ Id. at 6. Respondent then suggested that ML use a headset so she could keep her ‘‘head up straight,’’ and asked, ‘‘how often does that hurt you?’’ Id. ML said the pain ‘‘comes and goes,’’ but that ‘‘it’s been about a month now that . . . it pulls.’’ Id. Respondent then said he would see if Dr. Skinner would be available to help ML and asked ‘‘what else is going on?’’ Id. ML then complained that ‘‘I get emotional’’ and ‘‘just stress out because I think people are looking at me’’; ML and Respondent then discussed ML’s efforts to lose weight and her having undergone a gastric bypass procedure. Id. at 7–9. Next, Respondent asked ML if she was ‘‘sleeping okay’’; ML replied that she had ‘‘a sleeping disorder’’ for which she took ‘‘some sleeping pills.’’ Id. at 9. Thereafter, Respondent asked ML ‘‘about [her] energy’’ (with ML stating that she fatigued easily), if she was ‘‘irritable or grouchy’’ (with ML answering in the affirmative), and whether ML had anxiety or panic attacks, (with ML saying just when she hurt). Id. at 10. Respondent again asked ML, ‘‘what hurts? It’s, it’s this area in your shoulder?’’ and ML replied ‘‘it’s the shoulder, my back.’’ Id. Respondent then asked ML if she had depression (with ML saying she did not think so), whether she drank alcohol (ML answering ‘‘no’’), what ML took to sleep (with ML saying she had ‘‘no idea’’), whether she took any other medications (with ML apparently answering that she took a drug for blood pressure), and whether she had ‘‘any other health problems’’ (with ML answering ‘‘no.’’). Id. at 11–12. Following this, Respondent asked ML a series of questions about her family, including whether her parents were still alive, whether she had siblings, whether she was married and had children, as well as where she was living, and the circumstances surrounding the death of her mother. Id. at 12–17. Respondent then asked ML if she had ever taken medication for anxiety or depression; ML replied that she had taken Lexapro for a while and that it had helped but that she didn’t have insurance and the drug was expensive. Id. at 17–18. ML added that the only drug she was presently taking were her ‘‘pain pills’’ and that they made her ‘‘feel better.’’ Id. at 18. When Respondent asked ML what she had taken in the past, the latter said that she had tried hydrocodone but was allergic to it, and that the only drug she thought she could take was oxycodone. Id. Respondent then asked how much oxycodone she could take; ML said she VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 could take one a day and that the drug ‘‘calm[ed her] down a lot,’’ but that she did not know how many milligrams the pills were. Id. at 18–19. ML then said she was just really nervous and explained that she worked as a phone sex operator and that she had previously worked as a financial counselor at a hospital. Id. at 20–22. Respondent asked ML who had previously given her pain medication; ML identified the name of a doctor and his practice. Id. at 22. Respondent then said he would see if Dr. Skinner was available and suggested that she might be able to ‘‘fix’’ ML’s injured area and added that he would get ML some prescriptions. Id. at 24. Respondent then found Dr. Skinner and brought her to see ML. Id. at 26. Respondent explained to Dr. Skinner that ML ‘‘ha[d] a crook on her neck,’’ which was ‘‘like a . . . [a] little rock in there.’’ Id. Notably, before Respondent completed this sentence, ML stated: ‘‘That right there!’’ Id. ML then complained that she could not move her arm very well and again said that she had to alter where she wore her bra strap. Id. Dr. Skinner then observed that ML’s shoulders were straight but that her ‘‘neck [wa]s out,’’ and after an unintelligible comment by Respondent, replied ‘‘I know.’’ Dr. Skinner then said that she would ‘‘rotate it to the right . . . and then to the left.’’ Id.at 27. ML asked if that was ‘‘from a muscle spasm?’’ Id. Dr. Skinner asked ML if she was ‘‘on the phone,’’ and after ML said that it was her ‘‘job,’’ Skinner stated: ‘‘Okay, listen to me. Don’t do that!’’ Id. Respondent and Dr. Skinner then discussed with ML that she needed to get a headset or some other device so that ML could keep her head upright while she was on the phone. Id. at 27– 28. ML then asked Dr. Skinner if she could ‘‘feel that?’’ Id. Dr. Skinner said ‘‘[y]eah,’’ and Respondent asked if there was something such as acupuncture’’ that could be useful. Id. at 28–29. Dr. Skinner then told ML not to ‘‘resist [her] pain’’ and explained that ‘‘it’s stuck because you keep your head in the wrong position’’ and that ML was ‘‘not going to be able to fix it, if [she] ke[pt] using [her] head, putting [her] head . . . that way.’’ Id. at 29. ML said ‘‘[a]h,’’ and Dr. Skinner stated: ‘‘Don’t resist it please.’’ Id. ML said ‘‘[o]kay,’’ and Dr. Skinner replied: ‘‘Just accept it, until I say move. You might need to come back . . . I think it’s going to take some time.’’ Id. ML said ‘‘now it’s starting to feel a little better’’; Skinner replied: ‘‘Yeah, it does,’’ and added ‘‘but if you resist it[,] it’s going to feel worse.’’ Id. at 30. PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 ML then asked if ‘‘it’s more[ ] like a mental thing?’’ Id. Dr. Skinner replied ‘‘[e]xactly,’’ and Respondent interjected: ‘‘[w]ell, your muscles are attached to your brain[,] [y]ou know?’’ Id. ML said ‘‘[o]h,’’ and Respondent added: ‘‘So your . . . brain has to let it . . . .’’ Id. Dr. Skinner then stated: ‘‘We got to release all that, so we can—and your neck is out of alignment. And I don’t know if anything—yeah, push your head against my hand and relax.’’ Id. After ML said ‘‘Ah,’’ Skinner said ‘‘[o]kay,’’ and added that ‘‘we’re going to have to work on it with acupuncture.’’ Id. ML said ‘‘okay,’’ and Respondent told ML that if she made an appointment with Dr. Skinner, she would ‘‘have it adjusted.’’ Id. at 30–31. Respondent then asked Skinner if acupuncture would be of any use, and Skinner said that ‘‘it helps it release it so.’’ Id. at 31. After Respondent, Skinner, and ML discussed her weight loss, Skinner left. Id. at 31–32. Respondent then told ML that he had various paperwork which had to be completed when he prescribed controlled substances, including his pain contract, a form that was sent to the patient’s pharmacy, and a form on which ML was to show the location of her pain and describe it. Id. at 32–33. He also told ML that she was expected to participate in the meetings of a monthly support group for his pain management patients. Id. at 34–37. Respondent then discussed with ML that all he was going to prescribe to her was oxycodone and asked if she had ever taken Percocet, a drug which combines oxycodone with Tylenol (acetaminophen). Id. at 38. ML said that she had taken Tylenol but it ‘‘ha[d] done nothing’’ for her, and after Respondent said that Percocet was a combination of the drugs, added that he would be giving ML oxycodone. Id. Respondent then explained that oxycodone had to be written every month. Id. at 39. After some small talk, the visit ended. Id. at 39–41. Here again, the evidence shows that Respondent did more than simply observe ML during the course of her first visit. Rather, the evidence shows that ML was palpated during the visit. In its Exceptions, the Government argues that ‘‘Respondent’s own expert (Dr. Schneider) testified that Respondent failed to conduct a physical examination of either [RL or ML] prior to issuing them prescriptions for controlled substances.’’ Exceptions at 3. As support for the contention, the Government cites various portions of Dr. Schneider’s testimony during crossexamination regarding both her review of RL’s and ML’s patient files and the E:\FR\FM\26JNN1.SGM 26JNN1 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES transcripts of the visits, as well as a May 27, 2011 letter she had written regarding Respondent’s treatment of RL and ML. Id. In the letter, Dr. Schneider noted that she had reviewed the charts of both RL and ML, as well as the transcripts of their visits.28 RX 23, at 1. On cross-examination, the Government questioned Dr. Schneider about various findings that Respondent had documented in RL’s record, including that her pulse was 70, that her respiration was 16, meaning that she was ‘‘breathing at 16 times per minute,’’ her hip flexion was 1 over 4 for her right hip and 3 over 4 for her left hip, and that her range of motion was fair. Tr. 635–36. The Government then asked Dr. Schneider to point to where in the transcript Respondent had measured RL’s pulse. Id. at 638. Dr. Schneider testified: ‘‘I don’t believe it is in there.’’ Id. Next, the Government asked Dr. Schneider where in the transcript Respondent had measured RL’s respiration. Id. Dr. Schneider replied: ‘‘I believe it’s not in the transcript.’’ Id.29 28 In the letter, Dr. Schneider wrote with respect to RL that Respondent ‘‘asked her about the quality of the pain, effect of exercise, what helps, diurnal course. He asked what she had tried and what medication worked. He asked about a history of alcohol or drug abuse. He obtained a social history. He did a physical and mental exam.’’ RX 23, at 1 (emphasis added). After discussing RL’s second visit, Dr. Schneider asserted that ‘‘[t]he transcripts were consistent with his chart notes,’’ and that Respondent ‘‘did a lot of things correctly, including excellent documentation, discussion with patient, asking about her past treatments for the pain problem, getting addiction history on first visit, dealing with her mental status, doing a physical exam on first visit, assessing and treating her smoking . . . , and talking with her about physical medicine options.’’ Id. So too with respect to M.L., Dr. Schneider wrote that Respondent ‘‘did a lot of things correctly, including excellent documentation, discussion with the patient, asking about her alcohol use, dealing with her mental status, doing a focused physical on first visit, referring her for physical medicine and psychotherapy group, and documenting his thinking and his plan.’’ Id. at 2 (emphasis added). 29 Regarding whether a physician is required to take a patient’s vital signs during a physical examination which is performed at a patient’s initial visit, Dr. Schneider testified: That’s usually done. Again, listening to heart and lungs in someone with low back pain is not really going to be all that helpful. It’s just sort of a tradition to do it, let’s say. So, yeah I would imagine you would get normal vital signs. And a lot of times the nurse does it, not the doctor so it doesn’t even come up in the discussion on the transcript because it was done even before the doctor comes into the office. And that’s actually the usual thing. That’s [the] rule rather than the exception, that the medical assistant does the vital signs. Tr. 664–65. Notably, in his testimony, Respondent did not maintain that an assistant or nurse took vital signs for him. Moreover, while Dr. Schneider testified that observing the patient was ‘‘part of the physical exam,’’ she then acknowledged that ‘‘[t]here are some things you need to do more directly; for example, you have to put your stethoscope on their VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 The Government then asked Dr. Schneider to point to where in the transcript Respondent had measure RL’s hip flexion; Dr. Schneider acknowledged: ‘‘It is not in there.’’ Id. Likewise, when asked in reference to Respondent’s documentation that RL was able to do a partial squat and bend at the waist, where in the transcript this had occurred, Dr. Schneider answered that ‘‘I probably won’t be able to find it.’’ Id. at 639. Turning to Dr. Schneider’s letter, in which she wrote that ‘‘[o]n April 9, 2008 Dr. Ruben conducted a physical and mental exam,’’ Dr. Schneider interrupted the Government counsel before the latter even asked a question, testifying: [Y]ou’re pointing out a discrepancy, right. And assuming, unless I spend a half hour looking through these records and seeing if I can find it, the physical exam, which I may not be able to, that would suggest that I made a mistake in writing that he did a physical exam on that visit. Id. at 640. Likewise, when asked about her having noted in her letter, that Respondent’s plan included obtaining an x-ray followed by a referral to an orthopedic surgeon, Dr. Schneider could not recall where in the transcript Respondent had told RL that she would need to get an x-ray. Id. at 641. Regarding his treatment of RL, Respondent testified that she was able to do a partial squat, which he determined by watching her sit down in a chair. Id. at 920. With regard to how he had determined RL’s pulse rate, Respondent testified: The pulse is determined by feeling the pulsation at the wrist. It’s easy to do when you shake hands. If you hold the handshake for three or four to five seconds, you can tell a pulse. If you’ve done it a lot, it’s fairly easy to tell within about ten to [fifteen percent] of what the pulse is. Pulses are not significant if—unless they are outside a couple of standard deviations. And you can tell that very quickly. If somebody is beating at 90 it only takes you, measuring with your fingertip two or three beats. If someone is beating at 30 and they’re still standing up, it doesn’t take long. Maybe a couple seconds. So I always shake hands with patients. I always hold their hand. Some of them may think it’s weird, but I’m taking their pulse. I’m feeling their body temperature. I’m feeling their muscular strength. . . . Now if I’m concerned about their pulse being something that I can’t really think is chest and listen to their lungs and heart. You can’t just look at them across the room and assess their heart function.’’ Id. at 713. While Dr. Schneider testified that taking a pulse does not necessarily require a conversation, to do so she ‘‘would take the patient’s hand and with my fingers on their radial artery and count up how many times I feel it over a 15 second period’’ and then multiply by four. Id. at 696. PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 38377 within the normal range, I may sit down and take their pulse for 15 seconds and sit there formally with them. Or if I can’t find their pulse easily. But most people you can—with some practice, you can pretty much find it. You can pretty much hold their hand and you have the pulse. Id. at 924–25. See also id. at 984 (testifying in response to Government’s question: ‘‘[h]ow long would a handshake last?,’’ that ‘‘[i]f you’re holding their hand it often can last the three or four second[s] needed to kind of evaluate the pulse’’); id. at 985–86 (testifying in response to Government’s question ‘‘what’s a normal pulse range for your three second handshake?,’’ that ‘‘[a]ll you need to assess, if you’re experienced at assessing, is a couple of beats’’ and then maintaining that ‘‘[i]t’s more the rhythm. You don’t have to actually count it. You can feel. If you feel two or three beats, you can really tell what—basically within ten—we’re only interested in seeing . . . if somebody is within normal range.’’). However, on further questioning as to whether he had determined R.L.’s pulse using his three-second handshake technique, Respondent testified: Yes. If that was how I did it. That’s—I was telling you that the three second handshake is one way to do it. I may have done it another way. I may have done it some other way but I would have touched the areas that would have given me the reading on the pulse. Id. at 987. As for how he determined RL’s rate of respiration, Respondent testified that ‘‘[y]ou can look at you or me, particularly if they don’t have covering on their upper chest as in summer. This was in May. And you can watch the respirations. You can tell the respirations again, with an observation of a very short time. You can look and watch.’’ Id. at 926. Respondent then stated that the ‘‘normal range for resting respirations is probably 14 to 17 or something like that,’’ and that ‘‘[i]f it’s not within a normal range, then you can do more definitive testing,’’ including ‘‘count[ing] them more clearly’’ and ‘‘listen[ing] to see if their lungs are clear.’’ Id. at 927. See also id. at 987– 88 (‘‘I can tell a respiratory rate just from watching a person at any point in an interview where you’re in the same room with them. Just by watching if their chest is moving.’’). As for his findings that RL was ‘‘[a]ble to do partial squat and bend at waist,’’ Respondent testified that this was essentially the chair test and that when ‘‘ladies put down their purse[,] [t]hey reach over for that[,] [t]hey reach for things[,] [a]ll that is information about their movement.’’ Id. at 928. On cross- E:\FR\FM\26JNN1.SGM 26JNN1 38378 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices examination, Respondent testified that he ‘‘may not have’’ asked RL to do a partial squat and ‘‘probably would not have’’ asked her to bend at her waist. Id. at 990. Respondent then testified that ‘‘[a]nd if it’s not here, I must have not asked it. But I gained the information through observation.’’ Id. And as for his finding that RL’s hip flexor was ‘‘R 1⁄4, L 3⁄4,’’ Respondent testified that ‘‘[f]our is a norm’’ and that ‘‘[i]t’s more of an average of what was going on.’’ Id. at 928. Continuing, Respondent explained: ‘‘You know, I might of [sic] observed as she sat down she favored—she flexed one side more than—sat one way rath[er]—and guarded on [one] side. So that would be an estimation of that.’’ Id. at 928–29. And regarding his finding RL’s ‘‘R hip tender with ROM [f]air,’’ Respondent testified: Range of motion is how the hip moves. How the leg moves. You can watch that from the gait. You watch that from the movement. Tender would mean that I put my hand on her hip and may have pushed. May have said, ‘‘is your pain here or is it[?]’’ Id. at 929. Later, when asked on crossexamination whether he had actually asked RL to move her left leg so that he could observe her range of motion, Respondent, explained that: mstockstill on DSK4VPTVN1PROD with NOTICES [o]ne of the tests I conduct is to have them walk in front of me . . . that shows me range of motion in their body. They move through the exam room. They sit. They stand. I shake their hands. I do all sorts of things that are range of motion tests. Id. at 991. On cross-examination, Respondent further testified that he did not do ‘‘a more formal physical exam’’ on RL, because he ‘‘felt [he] gathered sufficient information to meet the needs for her first visit to begin to treat her and make a diagnosis and to make a basis for prescribing the limited amounts of medication that she was receiving.’’ Id. at 982–83. Respondent then stated that he ‘‘didn’t perform more than what I did. But I told you—that’s true.’’ Id. at 983. Likewise, with respect to M.L., the Government established that Respondent made findings in her patient record that she had a pulse of 80 beats per minute, a respiration rate of 18 breaths a minute, that she ‘‘[h]a[s] decreased flexion and extension’’ in her head, that her cranial nerves were intact, that her grip for both hands was a 2⁄4, and that she moved ‘‘both arms in abduction and adduction.’’ Tr. 650–52; RX 2, at 2. The Government then asked Dr. Schneider where in the transcript there was evidence that Respondent had VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 performed these various tests. Tr. 653– 56. Dr. Schneider admitted that she did not see in the transcript where Respondent had taken M.L.’s pulse or measured her respiration. Id. at 653, 655. As for where Respondent had measured the extension and flexion of M.L.’s head, Dr. Schneider acknowledged that ‘‘[i]t’s not in there.’’ Id. at 653. However, Dr. Schneider then testified ‘‘that [it] is possible to tell from—sometimes from looking at a person.’’ Id. Dr. Schneider also acknowledged that the transcript contained no indication that Respondent had done ‘‘a formal’’ cranial nerve examination, nor measured M.L.’s grip. Id. at 653–54. As for where in the transcript there was evidence that Respondent had ML move her arms, Dr. Schneider answered: ‘‘[T]hat again, he may have seen just watching her.’’ Id. at 654. Next, the Government asked Dr. Schneider whether Respondent could rely on Dr. Skinner’s examination of ML. More specifically, the Government asked: Q. Okay. And in your experience, is it acceptable to replace your own physical examination of the patient with the examination of someone else in your office? A. That’s a good question and I don’t have an exact answer because that doesn’t often come up. I suppose if it’s someone else who’s skilled who is doing the physical exam that might be appropriate. I don’t know. Id. at 654–55.30 Next, the Government noted that in her letter, Dr. Schneider had stated that Respondent ‘‘did a focused physical exam on the first visit of’’ ML and asked Dr. Schneider ‘‘where in the transcript does [Respondent] conduct a focused physical of [ML] on this occasion?’’ 31 Id. 30 In discussing the various instances in which Dr. Schneider acknowledged that the transcripts of the undercover visits contained no indication that Respondent had performed various tests or discussed various matters with the patients which he documented in the medical records, the ALJ noted Dr. Schneider’s testimony that ‘‘parts of the written transcript were unintelligible.’’ R.D. 57 (citing Tr. 693–97). Dr. Schneider conceded, however, that she did not listen to the recordings. Tr. 711. Nor, apparently, did the ALJ listen to any of the recordings, as notwithstanding that they were part of the record, the R.D. contains no indication that he did so. However, my Office has listened to them and has concluded that none of the unintelligible parts are of sufficient duration to support the possibility that Respondent actually performed various tests or had various discussions which he documented in the patient records as having done but which did not appear in the transcripts. 31 Regarding what constitutes ‘‘a focused physical exam,’’ Dr. Schneider testified: It’s when you concentrate on one particular part of the body. So for example, if someone has back pain, you watch how they get up, you watch how PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 at 655–56. Dr. Schneider answered: ‘‘I don’t see it.’’ Id. at 656. And with regard to Dr. Schneider’s statement in her letter that Respondent ‘‘had excellent documentation of his treatment of’’ ML, Dr. Schneider acknowledged that her definition of excellent documentation does not include documenting findings ‘‘that were not actually discerned during the course of a visit.’’ 32 Id. Regarding ML, Respondent testified that he observed her gait and walking during his evaluation of her and that he did not do any formal test of her reflexes. Id. at 957. He further testified that he ‘‘could see that there was some difficulty she had with movement of her head, range of motion,’’ but that ‘‘she did not have any neurological findings that I could—from a review of [her] cranial nerves.’’ Id. at 958. Moreover, he acknowledged that he did not use any ‘‘instruments to measure her flexion of her head,’’ and that he had measured her grip by shaking her hands. Id. at 998–99. However, Respondent then stated that ‘‘there may have been some other way’’ he used to ‘‘sense[] her grip strength,’’ and that he ‘‘probably . . . t[ook] her hands in [his] hands.’’ Id. at 999. And as for whether he had asked ML to move her arms in abduction or adduction, Respondent testified that ‘‘I may have handed her something or in that sense made a prompt to move them or I may have just observed her in her natural moving around the room, sitting down, getting up, picking things up to do. It’s possible that I handed her something purposefully to see if she could reach. Sometimes I do that.’’ Id. at 1000. Respondent then testified that he did not know how he tested this, they sit down, you watch how they move, you watch how they pick up something and you can get some conclusions without doing a formal one. Ideally, you’d want to do a formal one, but it is possible to gather information from observing the patient. Tr. 664. 32 In its Exceptions, the Government also cites to its cross-examination of Dr. Schneider regarding the statements in her letter that, at ML’s second visit, Respondent performed ‘‘a focused physical exam’’ and that ML had ‘‘said her pain had decreased to 3/10 on [the] current dose.’’ Exceptions at 3–4 (citing Tr. 662–64); see also RX 23, at 2. When questioned about these statements in her letter, Dr. Schneider conceded that the transcript did not reflect that Respondent had done a focused physical exam, but added that ‘‘he could have been observing her as he talked with her.’’ Tr. 664. Dr. Schneider also acknowledged that the transcript contained no indication that ML had said her pain had decreased to three out of ten. Id. at 663. While in her letter, Dr. Schneider made no mention as to whether Respondent had tested ML’s grip at the second visit, Dr. Schneider acknowledged that the transcript contained no indication that he had tested ML’s grip even though he documented in the progress note having done so. Id. at 663; see also RX 2, at 1. E:\FR\FM\26JNN1.SGM 26JNN1 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices because he did not ‘‘remember specifically.’’ Id. Regarding the scope of the examination he performed on M.L., Respondent explained that: The focus on this patient was not a hip. It was neck and back. So the focused examination in my focus would have been on her mobility and her movements and her functions in that area. So that would be—I’d be looking at upper extremities. That there was no wasting of her arms. I could see her, I believe from this examination, I could see her arms and movement of her arms and movement of her head and again, we talked about how we can do pulse and we can do respirations. We talked about gait. That didn’t seem to be the main issue. Id. at 959. Respondent further explained that Dr. Skinner is a naturopath ‘‘who is very adept at diagnosing neck and shoulder injuries.’’ Id. at 963. He testified that he ‘‘brought her in to look at [ML] and give me a second opinion.’’ Id. Respondent then explained that: She put her hands on the patient. I put my hands on the patient. We were looking for muscle spasm. We were looking for range of motion and Dr. Skinner then probably did do some kind of stretching or some kind of manipulation to see if that would relieve some of the spasm which was probably in this patient’s neck. Id.33 mstockstill on DSK4VPTVN1PROD with NOTICES Discussion Section 304(a) of the Controlled Substances Act (CSA) provides that a registration to ‘‘dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render his registration under section 823 of this 33 The Government also introduced an affidavit from BO, a person who, in March 2009, saw Respondent for her depression. GX 19. In her affidavit, BO related that ‘‘[w]hile in the waiting room, I heard other patients speaking about oxycodone’’ and that ‘‘these other patients were exchanging information regarding which pharmacies had stock of certain dosages and in what quantities.’’ Id. at 1. Even assuming that BO’s affidavit bears substantial indicia of reliability (such that it could constitute substantial evidence), there is no evidence that Respondent was aware of this discussion. Moreover, while BO also related that she overheard a conversation between Respondent and an employee in which the former stated that ‘‘a pharmaceutical representative had just informed him that he could make a lot of money if he were to dispense medications directly from his office, because [he] would get a percentage of money from each prescription filled in-house,’’ even assuming that this constitutes an admission, it does not establish any wrongdoing. Id. at 2. Finally, while BO stated that Respondent gave her prescriptions for Ambien (zolpidem), a schedule IV controlled substance, as well as Cymbalta and Depakote, two non-controlled medications, the record does not establish that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in prescribing the Ambien. Id. at 2–3. VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 title inconsistent with the public interest as determined under such section.’’ 21 U.S.C. 824(a)(4) (emphasis added). With respect to a practitioner, the Act requires the consideration of the following factors in making the public interest determination: (1) The recommendation of the appropriate State licensing board or professional disciplinary authority. (2) The applicant’s experience in dispensing * * * controlled substances. (3) The applicant’s conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances. (4) Compliance with applicable State, Federal, or local laws relating to controlled substances. (5) Such other conduct which may threaten the public health and safety. Id. § 823(f). ‘‘[T]hese factors are . . . considered in the disjunctive.’’ Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I ‘‘may rely on any one or a combination of factors, and may give each factor the weight [I] deem[] appropriate in determining whether a registration should be revoked.’’ Id.; see also MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while I am required to consider each of the factors, I ‘‘need not make explicit findings as to each one.’’ MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482)).34 The Government has the burden of proving, by a preponderance of the evidence, that the requirements for revocation or suspension pursuant to 21 U.S.C. § 824(a) are met. 21 CFR 1301.44(e). However, ‘‘once the [G]overnment establishes a prima facie case showing a practitioner has committed acts which render his registration inconsistent with the public interest, the burden shifts to the practitioner to show why his continued registration would be consistent with the public interest.’’ MacKay, 664 F.3d at 817 (citing Medicine ShoppeJonesborough, 73 FR 364, 387 (2008) (citing cases)). Having considered all of the factors, I agree with the ALJ’s conclusion that the 34 In short, this is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest; what matters is the seriousness of the registrant’s misconduct. Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has recognized, findings under a single factor can support the revocation of a registration. MacKay, 664 F.3d at 821. PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 38379 Government’s evidence with respect to factors two (Respondent’s experience in dispensing controlled substances) and four (Respondent’s compliance with applicable controlled substance laws), establishes that Respondent has committed acts which render his registration inconsistent with the public interest.35 21 U.S.C. 824(a)(4). While I also agree with the ALJ’s conclusion that Respondent has accepted responsibility for his misconduct and put forward evidence as to his remedial measures, I reject the ALJ’s recommended sanction because the ALJ failed to consider the egregiousness of Respondent’s misconduct and the Agency’s interest in deterring others from engaging in similar acts. Accordingly, I will order that Respondent’s registration be suspended for a period of one year. Factors Two and Four—Respondent’s Experience in Dispensing Controlled Substances and Record of Compliance With Applicable Controlled Substance Laws Under a longstanding DEA regulation, a prescription for a controlled substance is not ‘‘effective’’ unless it is ‘‘issued for a legitimate medical purpose by an 35 As for factor one, the recommendation of the state licensing authority, the ALJ found that the AMB’s restoration of Respondent’s authority to prescribe opioids in August 2011, ‘‘[w]hile not dispositive . . . does weigh against a finding that Respondent’s continued registration would be inconsistent with the public interest.’’ R.D. at 48. Even assuming that the Board’s restoration constitutes a recommendation to the Agency that Respondent’s registration be continued, DEA has repeatedly held that while a practitioner’s possession of state authority constitutes an essential condition for maintaining a registration, see 21 U.S.C. §§ 802(21) & 823(f), it ‘‘ ‘is not dispositive of the public interest inquiry.’ ’’ George Mathew, 75 FR 66138, 66145 (2010), pet. for rev. denied Mathew v. DEA, No. 10–73480, slip op. at 5 (9th Cir., Mar. 16, 2012); see also Patrick W. Stodola, 74 FR 20727, 20730 n.16 (2009); Robert A. Leslie, 68 FR 15227, 15230 (2003). As the Agency has long held, ‘‘the Controlled Substances Act requires that the Administrator . . . make an independent determination [from that made by state officials] as to whether the granting of controlled substance privileges would be in the public interest.’’ Mortimer Levin, 57 FR 8680, 8681 (1992). Thus, this factor is not dispositive either for, or against, the continuation of Respondent’s registration. Paul Weir Battershell, 76 FR 44359, 44366 (2009) (citing Edmund Chein, 74 FR 6580, 6590 (2007), pet. for rev. denied Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008)). Regarding factor three, there is no evidence that Respondent has been convicted of an offense related to the manufacture, distribution or dispensing of controlled substances. However, as there are a number of reasons why a person may never be convicted of an offense falling under this factor, let alone be prosecuted for one, ‘‘the absence of such a conviction is of considerably less consequence in the public interest inquiry’’ and is thus not dispositive. Dewey C. MacKay, 75 FR 49956, 49973 (2010), pet. for rev. denied MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011). E:\FR\FM\26JNN1.SGM 26JNN1 mstockstill on DSK4VPTVN1PROD with NOTICES 38380 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices individual practitioner acting in the usual course of his professional practice.’’ 21 CFR 1306.04(a). Under the CSA, it is fundamental that a practitioner must establish a bonafide doctor-patient relationship in order to act ‘‘in the usual course of . . . professional practice’’ and to issue a prescription for a ‘‘legitimate medical purpose.’’ See United States v. Moore, 423 U.S. 122, 142–43 (1975); United States v. Lovern, 590 F.3d 1095, 1100– 01 (10th Cir. 2009); United States v. Smith, 573 F.3d 639, 657 (8th Cir. 2009); see also 21 CFR 1306.04(a) (‘‘an order purporting to be a prescription issued not in the usual course of professional treatment . . . is not a prescription within the meaning and intent of [21 U.S.C. 829] and . . . the person issuing it, shall be subject to the penalties provided for violations of the provisions of law related to controlled substances’’). As the Supreme Court has explained, ‘‘the prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, [it] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.’’ Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing Moore, 423 U.S. 122, 135, 143 (1975)). Both this Agency and the federal courts have held that ‘‘establishing a violation of the prescription requirement ‘requires proof that the practitioner’s conduct went ‘‘beyond the bounds of any legitimate medical practice, including that which would constitute civil negligence.’’ ’ ’’ Laurence T. McKinney, 73 FR 43260, 43266 (2008) (quoting United States v. McIver, 470 F.3d 550, 559 (4th Cir. 2006). See also United States v. Feingold, 454 F.3d 1001, 1010 (9th Cir. 2006) (‘‘[T]he Moore Court based its decision not merely on the fact that the doctor had committed malpractice, or even intentional malpractice, but rather on the fact that his actions completely betrayed any semblance of legitimate medical treatment.’’); Jack A. Danton, 76 FR 60900, 60904 (2011) (finding violations of 21 CFR 1306.04(a), in the absence of expert testimony, ‘‘where a physician has utterly failed to comply with multiple requirements of state law for evaluating her patients and determining whether controlled substances are medically indicated and thus has ‘‘‘completely betrayed any semblance of legitimate medical treatment’’’’’) (quoting McKinney, 73 FR at 43266 (quoting Feingold, 454 F.3d at 1010)). However, as the Agency has held in multiple cases, ‘‘the Agency’s authority VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 to deny an application [and] to revoke an existing registration . . . is not limited to those instances in which a practitioner intentionally diverts a controlled substance.’’ Bienvenido Tan, 76 FR 17673, 17689 (2011) (citing Paul J. Caragine, Jr., 63 FR 51592, 51601 (1998)); see also Dewey C. MacKay, 75 FR at 49974. As Caragine explained: ‘‘[j]ust because misconduct is unintentional, innocent, or devoid of improper motive, [it] does not preclude revocation or denial. Careless or negligent handling of controlled substances creates the opportunity for diversion and [can] justify’’ the revocation of an existing registration or the denial of an application for a registration. 63 FR at 51601. ‘‘Accordingly, under the public interest standard, DEA has authority to consider those prescribing practices of a physician, which, while not rising to the level of intentional or knowing misconduct, nonetheless create a substantial risk of diversion.’’ MacKay, 75 FR at 49974; see also Patrick K. Chau, 77 FR 36003, 36007 (2012). Likewise, ‘‘[a] practitioner who ignores the warning signs that [his] patients are either personally abusing or diverting controlled substances commits ‘acts inconsistent with the public interest,’ 21 U.S.C. § 824(a)(4), even if [he] is merely ¨ gullible or naıve.’’ Jayam Krishna-Iyer, 74 FR 459, 460 n.3 (2009); see also Chau, 77 FR at 36007 (holding that even if physician ‘‘did not intentionally divert controlled substances,’’ State Board Order ‘‘identified numerous instances in which [physician] recklessly prescribed controlled substances to persons who were likely engaged in either self-abuse or diversion’’ and that physician’s ‘‘repeated failure to obtain medical records for his patients, as well as to otherwise verify their treatment histories and other claims, created a substantial risk of diversion and abuse’’) (citing MacKay, 75 FR at 49974). In this matter, the Government alleged that Respondent violated the prescription requirement with respect to both the patients who were the subject of the AMB Orders and the undercover visitors. Notably, in his post-hearing brief, Respondent acknowledges that ‘‘the First and Second Consent Order establish violations of Arizona State law, as explained more fully in the Orders.’’ Resp’s. Proposed Findings of Fact, Conclusions of Law and Argument 33. Moreover, in his post-hearing brief, Respondent states that he ‘‘is prepared to concede that the Government established a prima facie case for revocation . . . on the basis of the portions of the Second Consent Order PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 . . . that he did not challenge for factual insufficiency.’’ Id. at 34. However, with respect to the first AMB Order, which involved his treatment of DK, while Respondent acknowledged that he ‘‘should have obtained past medical records sooner’’ and should have more carefully monitored her use of medication, he rejects other findings of the AMB. Id. at 38. The ALJ found that ‘‘Respondent issued controlled substance prescriptions to multiple patients referenced in the 2009 Agreement and 2010 Order for other than a legitimate medical purpose and outside the usual course of professional practice in violation of applicable state and federal law.’’ ALJ at 54–55 (citing 21 CFR 1306.04(a); Ariz. Rev. Stat. § 32– 1401(27)(a), (e) & (q)). Indeed, notwithstanding that the ALJ improperly allowed Respondent to challenge the Board’s findings both as to historical facts regarding his treatment of the various patients and the standard of care, Respondent’s evidence only addressed four of the patients. Thus, even were I to give weight to this evidence (which—like the ALJ—I do not), the Government’s evidence still establishes that Respondent committed violations of the prescription requirement with respect to numerous patients, as Respondent himself concedes. To be clear, the Board’s findings with respect to many of the patients establish not simply that Respondent ‘‘committed malpractice, or even intentional malpractice, but rather . . . that his actions completely betrayed any semblance of legitimate medical treatment,’’ Feingold, 454 F.3d at 1010, and thus, that he intentionally or knowingly diverted controlled substances. More specifically, the AMB found that the standard of care requires that when treating a patient for chronic pain, a physician must obtain prior records for the past treatment of the pain, as well as obtain any objective measures for the cause of pain, and that Respondent failed to do so. Also, the AMB found that Respondent failed to adequately document his reasoning for prescribing high dose opioids as well as other drugs he added, as well as his treatment plan. Moreover, even Respondent’s Expert acknowledged that in various instances, Respondent failed to perform a physical examination on the first visit, notwithstanding that Arizona law clearly required that he do so. Tr. 597– 98; see also Ariz. Rev. Stat. § 32– 1401(27)(ss) (deeming it ‘‘[u]nprofessional conduct’’ to ‘‘[p]rescrib[e], dispens[e], or furnish[] a E:\FR\FM\26JNN1.SGM 26JNN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices prescription medication . . . to a person unless the licensee first conducts a physical examination of that person or has previously established a doctorpatient relationship’’). The AMB also found that Respondent violated the standard of care because he prescribed high dose opioids without performing adequate physical exams. For example, with respect to ML, the AMB found that Respondent diagnosed him with spondylolisthesis based on ML’s report and prescribed oxycodone to him, but did not perform a facet, sacroiliac joint, myofascialpain or neural flexes examination, nor test him for weakness or numbness. The Board also found that Respondent did not order various tests such as flexion extension films or an MRI scan, and that he also failed to obtain ML’s past medical records and diagnostic studies. Most significantly, the Board found in ML’s chart an x-ray, dated eighteen months after Respondent diagnosed ML as having spondylolisthesis, which stated: ‘‘no evidence of spondylolisthesis.’’ Yet, notwithstanding that the x-ray contradicted his diagnosis and his failure to conduct necessary tests, the Board found that Respondent provided ML with multiple early refills of oxycodone from February through December 2008.36 Moreover, the Board found that while in June 2008, Respondent was notified that ML was undergoing methadone treatment at a facility, he did not obtain ML’s records from the facility. And while in January 2009, Respondent discharged ML from opioid therapy, two months later he resumed prescribing high does opioids without documenting an explanation. The Board also found that even after the 2009 Order placed Respondent on probation by the 2009 Order, he continued to prescribe high dose opioids to ML ‘‘for pain secondary to spondylolisthesis until September 2009.’’ In addition, Respondent’s Expert acknowledged that Respondent had continued to prescribe oxycodone to ML, notwithstanding several aberrant urine drug tests. See Tr. 675–77. For example, ML tested positive for cocaine, as well as benzodiazepines (twice) which Respondent had not prescribed to him on previous visits. Still another time, ML tested negative for oxycodone, 36 The Board also found that Respondent provided multiple early refills of oxycodone to ML during the period from January through December 2007. It further found that while in November 2007, Respondent had determined that ML had selfescalated his oxycodone dosing, Respondent did not document having cautioned ML to adhere to the dosing instructions. VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 notwithstanding that Respondent continually prescribed the drug to ML and even provided him with numerous early refills. As the AMB found, prior to initiating high dose opiate therapy, the standard of care requires a physician to perform an adequate exam for pain generators. Moreover, the AMB found that the standard of care requires that a physician obtain the patient’s past medical records and diagnostic studies, offer the patient adjunct treatments that include non-opioid medications and physical therapy, address aberrant drug seeking behaviors and refrain from prescribing more than one month of schedule II prescriptions at a time. The Board found that Respondent deviated from the standard of care because he did not perform an adequate exam prior to initiating high dose opiate therapy, he did not obtain ML’s past medical records and diagnostic studies, he did not offer adjunct treatments, he did not address ML’s aberrant drug-seeking behaviors, nor did he refrain from prescribing more than one month of schedule II prescriptions at a time.37 While the Board also found that Respondent violated Arizona law and committed unprofessional conduct by failing to maintain adequate records, the Board’s findings establish that Respondent did far more than fail to comply with recordkeeping requirements. Rather, the Board’s findings establish that Respondent’s prescribing of oxycodone to ML ‘‘‘completely betrayed any semblance of legitimate medical treatment’’’ and thus violated 21 CFR 1306.04(a). Danton, 76 FR 60900, 60904 (2011) (quoting McKinney, 73 FR at 43266 (quoting Feingold, 454 F.3d at 1010)). As the Supreme Court explained in Moore in upholding the criminal conviction of a physician for unlawfully distributing controlled substances under circumstance similar to those found by the Board: The evidence presented at trial was sufficient for the jury to find that respondent’s conduct exceeded the bounds of ‘professional practice.’ As detailed above, he gave inadequate physical examinations or none at all. He ignored the results of the tests he did make. He . . . took no precautions 37 The Board found that the standard of care when treating a patient for chronic pain is to obtain objective measures as to the cause of pain. 2010 Order, at 16. It found that Respondent violated the standard of care by continuing to treat ML’s reported pain with high-dose opioids without obtaining objective measures for the cause of his pain, and that his conduct could result in the perpetuation of ML’s drug-seeking behavior/ addiction or an overdose. Id. In addition, the Board found that there was potential for diversion or abuse of the oxycodone. Id. at 10. PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 38381 against . . . misuse and diversion. He did not regulate the dosage at all, prescribing as much and as frequently as the patient demanded. Moore, 423 U.S. at 142–43. Likewise, the Board found that Respondent prescribed multiple controlled substances including OxyContin 40 mg, oxycodone 30 mg and Adderall to JF for conditions including chronic pain, attention deficit disorder, and obsessive compulsive disorder. While JF reported at her first visit (August 31, 2007) that her current prescriptions were OxyContin 40 mg and oxycodone 30 mg, the Board found that he did not obtain her past medical records to confirm the diagnosis and her prescriptions; he also did not document having performed a physical examination. Yet he prescribed 90 tablets of OxyContin 40 mg and 45 tablets of oxycodone 30 mg to her. Moreover, in October 2007, Respondent added Adderall, another schedule II controlled substance, to her ‘‘medication regime without any rationale for the medication.’’ GX 18, at 5. The Board further found that on multiple occasions during the course of her treatment, JF reported that her prescriptions had been stolen or damaged, that she had run out of medication, and that a pharmacy had refused to fill a prescription because of different handwriting. Nonetheless, Respondent continued to prescribe the drugs and increased the doses of oxycodone and Adderall. As the Board found, there was no documentation that Respondent ordered any laboratory studies to support his continued prescribing of the three drugs. Nor was there any documentation that Respondent had JF undergo urine drug screens to determine if she ‘‘was taking the medication as prescribed and/or whether she was utilizing illicit substances.’’ Id. at 6. With respect to his prescribing of OxyContin and oxycodone to JF for the treatment of chronic pain, the Board found that the standard of care ‘‘requires a physician to review diagnostic studies and interventions, assess the chronic pain complaint prior to initiating an opioid trial, appropriately monitor the patient’s use of the medication, and obtain appropriate therapeutic and laboratory test results that support the diagnosis.’’ Id. The Board further found that ‘‘Respondent deviated from the standard care because he did not review past medical records and he did not order appropriate tests or consultations for JF.’’ Id. As for his treatment of JF’s psychiatric conditions, the Board found that E:\FR\FM\26JNN1.SGM 26JNN1 mstockstill on DSK4VPTVN1PROD with NOTICES 38382 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices Respondent ‘‘did not perform an adequate psychiatric evaluation’’ of her and thus ‘‘deviated from the standard of care.’’ Id. The Board also found that Respondent deviated from the standard care because he prescribed Adderall to JF without ‘‘perform[ing] tests to confirm the diagnosis and the necessity of the medication’’ and did not monitor her ‘‘use of the medication.’’ Id. And because ‘‘[t]here was no collateral information to support prescribing Adderall,’’ the Board concluded that this ‘‘creat[ed] a potential for misdiagnosis, addiction, abuse, misuse, overdose, and diversion.’’ Id. Finally, the Board found that Respondent’s records for JF ‘‘were inadequate because he did not obtain [her] past medical records, he did not document a physical examination prior to prescribing medications and he did not document any rationale for the prescriptions, dosage escalations, and additions of medication.’’ Id. at 7. Here again, the Board’s findings establish that Respondent’s prescribing of controlled substances to JF ‘‘‘completely betrayed any semblance of legitimate medical treatment’’’ and support the conclusion that he acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed schedule II opioids (OxyContin and oxycodone) and Adderall (a schedule II stimulant) to her. See 21 CFR 1306.04(a). Accordingly, I hold that Respondent knowingly diverted controlled substances to JF. Of similar consequence, the Board found that Respondent prescribed both OxyContin and oxycodone to patients DD, SS, AM, and MF ‘‘based on [their] reported history and complaints of chronic pain.’’ Id. at 7. Here again, the Board found that ‘‘[t]here was no documentation that Respondent obtained the patients’ past medical record to confirm the diagnoses,’’ that ‘‘he did not perform adequate physical examinations,’’ and that he did not ‘‘order diagnostic and laboratory studies.’’ Id. The Board further found that while ‘‘Respondent provided early refills and escalated the patients’ doses of [o]xycodone and OxyContin,’’ he neither ‘‘document[ed] a rationale to support his diagnosis or [his] prescribing.’’ Id. Nor did he ‘‘perform[] any urine drug screens to determine whether the[se] patients were taking the medications as prescribed and/or illicit substances.’’ Id. Here again, the Board found that ‘‘Respondent deviated from the standard of care because he did not review [the four patients’] past diagnostic studies VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 and interventions, assess and confirm their chronic pain complaints prior to initiating an opioid trial, appropriately monitor their use of the medication, or obtain appropriate therapeutic and laboratory test results to support his diagnoses of chronic pain.’’ Id. at 8. The Board further found that because ‘‘[t]here was no collateral information to support prescribing opioids to [the four patients],’’ Respondent ‘‘creat[ed] [the] potential for misdiagnosis, addiction, abuse, misuse, overdose, and diversion.’’ Id. Finally, the Board found that ‘‘Respondent’s records were inadequate because he did not obtain [the four patients’] past medical records; he did not document adequate physical examinations or laboratory and diagnostic studies prior to prescribing medications; he did not obtain any diagnostic studies to support his continued prescribing of medications[;] and he did not document any rationale for [the] prescriptions and dosage escalations.’’ Id. at 8–9. Here again, the Board’s findings with respect to these four patients establish more than that Respondent failed to keep adequate records. Rather, they establish that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed OxyContin and oxycodone to DD, SS, AM, and MF.38 21 CFR 1306.04(a). The Board also made findings regarding Respondent’s prescribing of Adderall to two patients (AL and KF) that establish violations of the prescription requirement. Specifically, the Board found that Respondent diagnosed AL with Attention Deficit Hyperactivity Disorder and prescribed Adderall to her. GX 18, at 2. The Board found, however, that Respondent deviated from the standard of care because he did not perform an adequate psychiatric evaluation of AL. Id. Moreover, the Board found that there was no documentation that Respondent obtained her past medical records, her history of alcohol or substances abuse, her psychiatric history or that he ‘‘perform[ed] a functional assessment to 38 Even if I were to give weight to Dr. Schneider’s testimony in which she maintained that the Board’s consultant made findings with respect to patients AM, MF and SS that were contradicted by the respective patient’s chart, I would still adopt the Board’s findings. As explained above, the AMB’s findings cited multiple ways in which Respondent deviated from the standard of care, and Respondent offers no argument as to why, even if the Board’s consultant may have overlooked several items, these errors would have materially affected the Board’s conclusions. And here again, Respondent could have, and should have, presented Dr. Schneider’s evaluation to the Board. PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 support the diagnosis and prescription.’’ Id. Respondent also failed to document a treatment plan. Id. The Board further found that over a twenty-seven month period, ‘‘Respondent provided AL with frequent, early and escalated doses of Adderall’’ but did not document a rationale for doing so. Id. And the Board found that ‘‘on several occasions[,] AL attempted to refill her Adderall prescription early,’’ yet Respondent did not document that he ‘‘investigated or addressed AL’s rationale for doing so.’’ Id. In addition, Respondent prescribed Lorazepam, a schedule IV benzodiazepine to AL, ‘‘without documenting a rationale for’’ doing so and that he did not ‘‘discuss[ ] the risks and benefits of taking’’ the drug. Id. Finally, the Board found that there ‘‘was no documentation that Respondent ordered any laboratory studies to support his continued prescribing of Adderall or any urine drug screens to determine whether AL was taking the medication as prescribed and/or illicit substances.’’ Id. Thus, in addition to finding that Respondent deviated from the standard of care because he failed to perform an adequate psychiatric evaluation of AL, the Board found that he committed an additional deviation ‘‘because he did not confirm the diagnosis and the necessity of the medication and he did not monitor AL’s use of the medication.’’ Id. at 3.39 These findings support the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed Adderall to AL. 21 CFR 1306.04(a). Likewise, with respect to KF, the Board found that Respondent prescribed Adderall to her, yet ‘‘[t]here was no documentation that [he] obtained her past medical record or ordered any laboratory tests that would qualify KF for a diagnosis to support the use of Adderall.’’ GX 18, at 4. Moreover, the Board found that ‘‘Respondent prescribed frequent early refills without documenting any rationale for the prescriptions,’’ and that he ‘‘increased KF’s dose from 20mg to 30 mg without any rationale’’ for doing so. Id. Also, the Board found that ‘‘[t]here was no documentation that Respondent ordered any laboratory studies to support his 39 Finally, the Board found that Respondent failed to maintain adequate records ‘‘because there was no documentation of the initial Adderall prescription, no documented initial plan of treatment, the psychiatric evaluation was inadequate, there was no documented rationale for his prescribing of several medications, and several of his progress notes were illegible.’’ GX 18, at 3. E:\FR\FM\26JNN1.SGM 26JNN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices continued prescribing of Adderall or any urine drug screens to determine whether KF was taking the medications as prescribed and/or any illicit substances.’’ Id. The Board thus found that ‘‘Respondent deviated from the standard care because he did not obtain prior medical records, perform tests to confirm the diagnosis and the necessity of the medication,’’ ‘‘did not perform an adequate psychiatric evaluation for KF,’’ and ‘‘did not monitor [her] use of the medication.’’ Id. The Board also found that because ‘‘[t]here was not collateral information to support prescribing Adderall,’’ Respondent ‘‘created [the] potential for misdiagnosis, addiction, abuse, misuse, overdose and diversion.’’ 40 Id. The Board’s findings thus also support the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in prescribing Adderall to KF. 21 CFR 1306.04(a). The Board also made extensive findings regarding Respondent’s prescribing of schedule II opioids to WO for the latter’s chronic pain over an eighteen-month period. GX 18, at 11–13. While WO had previously been treated by another physician, who prescribed to him both oxycodone and morphine sulfate, and Respondent reviewed several imaging studies, the Board found that the studies ‘‘did not support the amount of opioid medications [Respondent] prescribed to WO.’’ Id. at 11, 13. The Board also found that ‘‘[t]here was no documentation that Respondent performed a neurological or musculoskeletal examination or ordered any imaging studies of WO’s lumbar spine or laboratory studies prior to continuing the treatment of WO’s previous treating physician.’’ Id. at 11. Moreover, the Board found that Respondent both increased the dose of oxycodone and added an additional drug, MS Contin, the dose of which he also ‘‘subsequently increased,’’ and yet did not document having ‘‘performed any physical examinations or [having] obtained any radiological studies to support his increased opioid prescribing.’’ Id. at 12. Nor did he document ‘‘a rationale for the increase’’ in the MS Contin dosing. Id. The Board further found that later in his treatment of WO, Respondent further increased the dose of oxycodone ‘‘to eight tablets 40 Here again, the Board found that ‘‘Respondent’s records were inadequate because he did not obtain KF’s past medical records, he did not document a physical examination prior to prescribing medications, he did not document any rationale for prescriptions, dosage escalations, and additions of medication.’’ Id. at 5. VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 per day without documenting a rationale for the increase.’’ Id. Next, the Board found that approximately one month after the latter increase in WO’s oxycodone dosage, Respondent obtained a urine drug screen from WO. Id. However, the results were negative for oxycodone but positive for both methadone and codeine, even though Respondent had not prescribed either of the latter two drugs. Id. Moreover, WO’s drug screen was positive for heroin. Id. While the Board found that ‘‘Respondent documented that he was aware of the positive’’ test results, it further found that ‘‘he did not adequately investigate or address the abnormal results, which include referring WO to an addiction medicine specialist or discontinuing the opioid prescriptions.’’ Id. The Board thus also found that ‘‘Respondent allowed WO to continue a pattern of illicit substance use and opioid misuse.’’ Id. at 13. Accordingly, the Board found that Respondent ‘‘deviated from the standard of care’’ because ‘‘he did not perform an adequate workup of WO prior to continuing the treatment of his previous treating physician,’’ prescribed opioids in amounts that were not supported by ‘‘the physical examination and radiological data,’’ and ‘‘did not adequately investigate or address WO’s abnormal urine drug screens.’’’’ Id. at 12–13.41 Here again, the Board findings support the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in prescribing controlled substances to WO.42 21 CFR 1306.04(a). Finally, in the 2009 Order, the Board made extensive findings regarding Respondent’s prescribing to DK, a selfreferred patient who complained of lower back pain and psychiatric issues. GX 17, at 4. At her initial visit, DK reported that she was currently taking OxyContin 160 mg, three times per day; oxycodone 30 mg, two tablets, one to two times daily; and Valium; RX 30, at 40. She also reported that imaging studies and x-rays had been done three 41 The Board also found that Respondent failed to maintain adequate records ‘‘because there was no documentation that [he] performed neurological or musculoskeletal examination or ordered any imaging or laboratory studies prior to continuing the treatment and there was no documented rationale for his excessive prescribing of opioids.’’ GX 18, at 13. 42 It is noted that the Board faulted Respondent because he did not obtain imaging studies of WO’s lumbar spine. GX 18, at 11. My conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose is based on the totality of the Board’s findings and the multiple deviations of the standard of care which it found. PO 00000 Frm 00099 Fmt 4703 Sfmt 4703 38383 years earlier. Id. However, while at the initial visit, DK said she would provide her medical records, including these imaging studies, to Respondent, and Respondent asked her to do so on four additional visits, she did not comply for more than a year. Id.; see also GX 17, at 4. Regarding DK’s noncompliance, Respondent testified that she either ‘‘could not remember or give us the name [of her previous physician] or produce records.’’ Tr. 851–52; see also id. at 1027. Yet, notwithstanding her noncompliance, Respondent issued monthly prescriptions to DK for OxyContin 80 mg (initially for 180 tablets, but after several months, increasing to 210 tablets) and oxycodone 30 mg (typically 180 tablets). RX 30, at 40. This continued for nearly one year and until Respondent was notified that another physician had recently discharged her (in the prior month, no less) for violating her pain contract by using cocaine, as well as methadone which had not been prescribed to her. Indeed, only then did he take any action. Notably, Respondent failed to do any urine drug screens on DK from November 2006, when he first began prescribing to her, until June 3, 2008. According to the Board, under the standard of care, a physician who ‘‘continu[es] high dose opioid prescriptions for a self-referred, chronic pain management patient . . . who reports currently being prescribed high dose opioid medications,’’ must base the prescriptions ‘‘on proper indications, including previous medical records and verified previous prescriptions, and/or contact with the previous prescribing physician.’’ GX 17, at 5. The Board thus found that ‘‘Respondent deviated from the standard of care by prescribing high dose opioids to DK without proper indications.’’ Id. Also, the Board found that the standard of care requires that a physician ‘‘treating a chronic pain patient [with] known or suspected substance abuse problem . . . to utilize objective measures to monitor compliance.’’ Id. The Board thus also found that ‘‘Respondent deviated from the standard of care by failing to timely use objective measures, such as urine drug tests, to assess DK’s compliance with her treatment even after he was aware of her cocaine addiction.’’ Id. The deviations of the standard of care found by the Board are sufficient to support the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in E:\FR\FM\26JNN1.SGM 26JNN1 38384 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices prescribing OxyContin and oxycodone to DK.43 See 21 CFR 1306.04(a). The Undercover Patients mstockstill on DSK4VPTVN1PROD with NOTICES The ALJ concluded that the Government did not establish that the Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed controlled substances to RL and ML, the two undercover visitors. R.D. at 60. The Government takes exception to these findings, contending that ‘‘[t]he evidence . . . shows that, on four occasions, Respondent prescribed controlled substances to [ML and RL] without ever conducting a physical examination,’’ and thus the prescriptions were issued in violation of Ariz. Rev. Stat. § 32–1401(27)(ss), which provides that it is ‘‘unprofessional conduct’’ to prescribe ‘‘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,’’ and thus also violated federal law. Exceptions at 3 (also citing 21 CFR 1306.04(a)). As support for its contention, the Government cites the testimony of a Special Agent as to hearsay statements that were made by the two confidential sources to the effect that Respondent 43 While the Board faulted Respondent for his ‘‘continu[ing] to prescribe opiates to DK for her back pain’’ after she was referred to Behavioral Health, as well as his continued prescribing of opiates after ‘‘he learned that she had successfully completed inpatient opioid detoxification,’’ GX 17, at 5; the Board did not find that either course of conduct constituted a deviation from the standard of care. See id. Nor did the Government offer any expert testimony as to whether Respondent’s prescribing of opiates following DK’s referral to Behavioral Health or following her completion of inpatient opioid detoxification was within usual course of professional practice and lacked a legitimate medical purpose. As for Respondent’s continued prescribing to DK, notwithstanding that she purportedly could not remember the name of the physician who had previously (and likely was also continuing to prescribe to her), as well as her repeated failure to provide her medical records, the federal courts have held that knowledge can be inferred based on the ‘‘willful blindness’’ of a physician in ignoring various warning signs that a patient is either abusing or diverting drugs. United States v. Katz, 445 F.3d 1023, 1031 (8th Cir. 2006). See also United States v. Jewell, 532 U.S. 697, 702–704 (9th Cir. 1976) (discussing deliberate ignorance instructions, noting that ‘‘Courts of Appeals reviewing the sufficiency of evidence have approved the premise that ‘knowingly’ in criminal statutes is not limited to positive knowledge, but includes the state of mind of one who does not possess positive knowledge only because he consciously avoided it’’). Even if I believed that Respondent was merely ¨ naıve or gullible in his treatment of DK, which I do not, I would conclude that Respondent is so irresponsible as to raise grave doubts as to his fitness to hold a registration. VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 did not perform a physical examination on them. Id. (citations omitted). It also argues that ‘‘Respondent’s own expert testified that Respondent failed to conduct a physical examination of either CS1 or CS2 prior to issuing them prescriptions for controlled substances.’’ Id. (citations omitted). As for the hearsay statements of the confidential sources, the Government offered no evidence to support a finding that each statement is sufficiently reliable to constitute substantial evidence. See Carlos Gonzalez, 76 FR 63118, 63119 (2011) (citing various appellate decisions regarding factors which support a finding that hearsay statements are sufficiently reliable). And while Respondent’s Expert admitted that she did not see in the transcripts of the undercover visits where Respondent had performed a physical examination at either RL or ML’s first visit, as found above, I cannot ignore that the transcripts and recordings manifest that at each of the CS’s first visits, either Respondent (or Dr. Skinner) palpated them in the area of their body which was the source of their purported pain complaint. Thus, the testimony of Respondent’s Expert does not corroborate the hearsay statement of either RL or ML. It may be that the physical exams Respondent performed on RL and ML were totally inadequate to validly diagnose them as having a legitimate pain condition and to support the prescribing of controlled substances. However, while Arizona law requires that a physician perform a physical exam before he initially prescribes a drug, it does not set forth what is required to constitute an adequate examination. Moreover, while Respondent’s Expert repeatedly attempted to minimize his misconduct,44 thus suggesting a less 44 For example, in her letter of May 27, 2011, Dr. Schneider, in an apparent reference to the Board’s findings, characterized Respondent’s problematic practices as ‘‘past minor deficiencies.’’ RX 23, at 3. Likewise, in her testimony, she asserted that the Arizona Medical Board’s guidelines on using controlled substances to treat chronic pain were not even minimum standards but were aspirational and ‘‘to educate doctors.’’ Tr. 588. She further asserted that physicians were ‘‘being judged by standards of care that are current [but] that were not the standard of care at the time that those visits took place,’’ id. at 586, as if the standards had actually changed between the time Respondent prescribed to the patients identified in the two AMB Orders and the period during which the Board conducted its review. So too, when asked whether the standard of care requires a physician to obtain medical records before providing the first prescription, she asserted that she did not ‘‘think that most doctors actually get the records before providing a first prescription.’’ Id. at 589. While she then acknowledged that it was risky if patients ‘‘come in PO 00000 Frm 00100 Fmt 4703 Sfmt 4703 than objective portrayal on her part of Respondent’s prescribing practices, even were I to reject the ALJ’s credibility finding regarding her testimony that Respondent’s prescribing to the two CSs was ‘‘well within the standard of care,’’ I would still reject the Government’s contention because it had the burden of proving by substantial evidence that these four prescriptions violated 21 CFR 1306.04(a).45 Here, because the transcripts clearly showed that Respondent palpated (or observed Dr. Skinner palpate 46) the CSs, and the transcripts otherwise contain no statements by either the CSs or Respondent indicating that either CS was not a legitimate patient, expert testimony was required to show that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed controlled substances to the two CSs. Accordingly, I reject the Government’s exception and adopt the ALJ’s findings with respect to the undercover patients. Sanction Based on his findings that Respondent acted outside of the usual course of and what they want is super high doses, . . . it’s risky to let them walk out with a prescription in the absence of any documentation that they indeed were on that dose because that could be lethal,’’ she then added that ‘‘[t]he doses we’re talking about with [Respondent] were often minimal doses,’’ id., as if the amounts and dosages he prescribed to DK at her first visit were minimal. Finally, while Dr. Schneider noted that there were instances in which Respondent did not do a physical exam on the first visit, this, notwithstanding the requirements of Arizona law, see Ariz. Rev. Stat. § 32–1401(27)(ss), is, in her view, just one of the ‘‘things that could be improved’’ because Respondent ‘‘really need[s] education.’’ Tr. 598. 45 Put another way, it was not Respondent’s burden to prove that the prescriptions were lawful. Thus, in the absence of probative and reliable evidence that the prescriptions were unlawful, Respondent had no obligation to refute the charge. 46 The Government also asked Dr. Schneider as to whether Respondent could rely upon Dr. Skinner’s examination of ML. Dr. Schneider testified that she did not ‘‘have an exact answer because that doesn’t often come up. I suppose if it’s someone else who’s skilled who is doing the physical that might be appropriate.’’ Tr. 654–55. Dr. Schneider then added that she did not know. Id. at 655. However, it was the Government’s obligation to establish that under the standard of care, a physician cannot observe another physician examine a patient and rely on those observations as part of performing a physical exam and not Respondent’s obligation to show that it is within the standard of care. As for the Government’s contention that Respondent also failed to physically examine the CSs at their second visits, the Government offered no evidence that the standard of care requires that a physician perform a physical exam at each visit at which he prescribes a controlled substance. Indeed, the statute relied on by the Government suggests the opposite, as it permits prescribing where a physician ‘‘has previously established a doctor-patient relationship.’’ Ariz. Rev. Stat. § 32– 1401(27)(ss). E:\FR\FM\26JNN1.SGM 26JNN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices professional practice and lacked a legitimate medical purpose in prescribing controlled substances to numerous patients, the ALJ found that the Government had met its prima facie burden of showing that ‘‘Respondent has committed acts inconsistent with the public interest between 2006 and 2009.’’ R.D. at 65. However, based on his finding that Respondent had ‘‘credibly accepted responsibility for his past misconduct and demonstrated that he has implemented various corrective measures to ensure that his medical practice is consistent with the public interest,’’ id. at 64, the ALJ recommended that Respondent’s registration should be continued subject to the condition that he comply with all terms of the AMB’s 2010 Order and notify the DEA field office of any changes in the terms and conditions of the AMB’s 2010 Order. Id. at 65–66. Under Agency precedent, where, as here, ‘‘the Government has proved that a registrant has committed acts inconsistent with the public interest, a registrant must ‘ ‘‘present sufficient mitigating evidence to assure the Administrator that [he] can be entrusted with the responsibility carried by such a registration.’’ ’ ’’ Medicine ShoppeJonesborough, 73 FR 364, 387 (2008) (quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988)). ‘‘Moreover, because ‘past performance is the best predictor of future performance,’ ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.1995), [DEA] has repeatedly held that where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for [his] actions and demonstrate that [he] will not engage in future misconduct.’’ Medicine Shoppe, 73 FR at 387; see also Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006); Prince George Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v. DEA, 419 F.3d at 483 (‘‘admitting fault’’ is ‘‘properly consider[ed]’’ by DEA to be an ‘‘important factor[]’’ in the public interest determination). However, while a registrant must accept responsibility and demonstrate that he will not engage in future misconduct in order to establish that his/her continued registration is consistent with the public interest, DEA has repeatedly held these are not the only factors that are relevant in determining the appropriate sanction. See, e.g., Joseph Gaudio, 74 FR 10083, 10094 (2009); Southwood Pharmaceuticals, Inc., 72 FR 36487, 36504 (2007). Obviously, the egregiousness and extent of a VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 registrant’s misconduct are significant factors in determining the appropriate sanction. See Jacobo Dreszer, 76 FR 19386, 19387–88 (2011) (explaining that a respondent can ‘‘argue that even though the Government has made out a prima facie case, his conduct was not so egregious as to warrant revocation’’); Paul H. Volkman, 73 FR 30630, 30644 (2008); see also Paul Weir Battershell, 76 FR 44359, 44369 (2010) (imposing six-month suspension, noting that the evidence was not limited to security and recordkeeping violations found at first inspection and ‘‘manifested a disturbing pattern of indifference on the part of [r]espondent to his obligations as a registrant’’); Gregory D. Owens, 74 FR 36751, 36757 n.22 (2009). Moreover, as I have noted in several cases, ‘‘‘[n]either Jackson, nor any other agency decision, holds . . . that the Agency cannot consider the deterrent value of a sanction in deciding whether a registration should be [suspended or] revoked.’’’ Gaudio, 74 FR at 10094 (quoting Southwood, 72 FR at 36504 (2007)); see also Robert Raymond Reppy, 76 FR 61154, 61158 (2011); Michael S. Moore, 76 FR 45867, 45868 (2011). This is so, both with respect to the respondent in a particular case and the community of registrants. See Gaudio, 74 FR at 10095 (quoting Southwood, 71 FR at 36503). Cf. McCarthy v. SEC, 406 F.3d 179, 188–89 (2d Cir. 2005) (upholding SEC’s express adoptions of ‘‘deterrence, both specific and general, as a component in analyzing the remedial efficacy of sanctions’’). Thus, in Gaudio, ‘‘I explained that ‘even when a proceeding serves a remedial purpose, an administrative agency can properly consider the need to deter others from engaging in similar acts.’ ’’ 74 FR at 10094 (quoting Southwood, 72 FR at 36504) (citing Butz v. Glover Livestock Commission Co., Inc., 411 U.S. 182, 187–88 (1973)); cf. McCarthy, 406 F.3d at 189 (‘‘Although general deterrence is not, by itself, sufficient justification for expulsion or suspension, we recognize that it may be considered as part of the overall remedial inquiry.’’); Paz Securities, Inc., et al. v. SEC, 494 F.3d 1059, 1066 (D.C. Cir. 2007) (agreeing with McCarthy). In Gaudio, I further noted that the ‘‘[c]onsideration of the deterrent effect of a potential sanction is supported by the CSA’s purpose of protecting the public interest, see 21 U.S.C. § 801, and the broad grant of authority conveyed in the statutory text, which authorizes the [suspension or] revocation of a registration when a registrant ‘has committed such acts as would render [his] registration . . . inconsistent with PO 00000 Frm 00101 Fmt 4703 Sfmt 4703 38385 the public interest,’ id. § 824(a)(4), and [which] specifically directs the Attorney General to consider [‘such other conduct which may threaten public health and safety,’ id. § 823(f)].’’ 74 FR at 10094 (quoting Southwood, 72 FR at 36504).47 While noting that ‘‘[a]gency precedent has recognized the significance of a registrant’s remedial actions in continuing a registration,’’ R.D at 63, the ALJ entirely ignored the Southwood/ Gaudio line of authority. See id. at 63– 65. However, as these cases make clear, even where a registrant accepts responsibility and demonstrates that he has undertaken remedial measures, in determining the appropriate sanction, the Agency can still consider the need to deter both the particular registrant, as well as others, from engaging in similar acts. For example, in Gaudio, a case in which a physician was found to have recklessly dispensed controlled substances over the internet, I noted that ‘‘even were I to ignore that Respondent has not accepted responsibility for his misconduct, and credit his testimony that he does not intend to resume his internet practice, I would still conclude that a lengthy suspension of his registration is warranted.’’ 74 FR at 10095.48 I rejected the ALJ’s recommendation that I continue the physician’s registration, subject only to the condition that he not prescribe controlled substances over the internet, id. at 10094, and instead suspended the physician’s registration for a period of one year, holding that ‘‘the ALJ’s recommendation would not only ‘ignore how irresponsibly [the physician] acted’; it would also signal to others that one can ignore the law . . . and yet incur no consequence for having done 47 Unlike factors two (‘‘[t]he applicant’s experience in dispensing’’) and three (‘‘[t]he applicant’s conviction record’’), neither factor four (‘‘Compliance with applicable laws related to controlled substances’’) nor factor five (‘‘Such other conduct which may threaten public health and safety’’) contain the limiting words of ‘‘[t]he applicant.’’ As the Supreme Court has held, ‘‘[w]here Congress includes particular language in one section of a statute but omits it in another section of the same Act, it is generally presumed that Congress acts intentionally and purposely in the disparate inclusion or exclusion.’’ Russello v. United States, 464 U.S. 16, 23 (1983). Thus, the text of factors four and five suggest that these factors are not limited to assessing the applicant’s compliance with applicable laws and whether he has engaged in ‘‘such other conduct,’’ but rather authorize the Agency to also consider the effect of a sanction on inducing compliance with federal law by other practitioners. 48 I further required that as a condition of approving the physician’s application to renew his registration following the completion of his suspension, the physician was required to provide a sworn statement acknowledging his wrongdoing, and that without such an acknowledgement, his application would be denied. See 74 FR at 10095. E:\FR\FM\26JNN1.SGM 26JNN1 38386 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES so.’’ Id. at 10095 (quoting Southwood, 71 FR at 36503). I also noted that ‘‘this is not the message that should be sent to those who contemplate prescribing controlled substances in’’ the same unlawful manner as had the physician. Id. In Moore, the ALJ found that a physician had unlawfully possessed and manufactured four pounds of marijuana. 76 FR at 45867. While finding that the physician had ‘‘demonstrate[d] an acknowledgement that his actions were illegal,’’ id. at 45877, and had ‘‘credibly testified that he was in compliance with the terms of his [court-imposed] probation, as well as the terms of the [o]rder of’’ his state medical board, id. at 45876, the ALJ recommended that his registration be suspended, noting that ‘‘the agency has an interest in both assuring that the Respondent can be entrusted with the responsibilities attendant upon a [DEA] registrant and (notwithstanding the non-punitive nature of these proceedings) . . . in deterring others from similar acts.’’ Id. at 45877. On review, I ‘‘agree[d] with the ALJ that the Agency’s interest in deterring similar misconduct on the part of others warrant[ed] a substantial period of outright suspension.’’ Id. at 45868. However, I increased the length of the suspension from the ALJ’s recommendation of six months to one year, noting, in part, that ‘‘a six-month suspension [did not] sufficiently protect[ ] the Agency’s interest in deterring misconduct on the part of others.’’ Id. It is acknowledged that Respondent largely expressed his acceptance of the AMB’s concerns with various aspects of his prescribing practices.49 Moreover, 49 In support of its contention that Respondent does not accept responsibility for his misconduct, the Government contends that Respondent lacked candor in his testimony when he ‘‘attempted to explain away the inconsistencies between [the UCs’] medical records and the recordings/ transcripts of these visits by concocting a patently disingenuous story about how he conducted . . . physical examinations through silent observation and covert methods of discerning pulse, respiration, grip strength etc.’’ Exceptions at 6 (citing John Stanford Noell, 59 FR 47359, 47362 (1994)). As found above, when confronted with the evidence that he had documented in each UC’s medical record having taken their pulse while the transcript contains no indication that he had done so (at least in the typical way, see Tr.696), Respondent testified that he had determined the UC’s pulses by shaking their hands. Id. at 987. Notably, the Government does not contend that Respondent’s falsification of the UCs’ medical records is itself actionable misconduct which should be considered under factor five, and even if it had, falsification of a medical record (and whether there is a materiality requirement) is a question of state law. As for the Government’s contention that Respondent’s testimony shows that he does not accept responsibility for his misconduct VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 Respondent put on evidence of various improvements he had made in his prescribing practices.50 The ALJ also noted the testimony of Dr. Schneider, to the effect that Respondent was ‘‘doing much more careful documentation’’ and ‘‘was ordering older records and he . . . definitely changed the way he did things.’’ R.D. at 64 (citing Tr. 626); see also id. at 64–65 (citing affidavits of two physicians regarding improvements in charting and investigation of patient backgrounds). Yet Respondent’s evidence as to his reform efforts is undercut to a significant degree by the Board’s finding that, even after he had been placed on probation based on his prescribing to DK, he continued to prescribe high doses of opioids to ML without obtaining objective measures of ML’s pain (and indeed, did so notwithstanding that ML’s x-ray contradicted his diagnosis of spondylolisthesis).51 GX 18, at 16. Thus, I give Respondent’s evidence as to his remedial efforts substantially less weight than the ALJ did.52 in prescribing to the UCs, Respondent is not required to accept responsibility for misconduct which has not been proved on the record. Accordingly, while I conclude that Respondent’s testimony as to how he took the UCs’ pulses is ludicrous, I do not rely on it in setting the appropriate sanction. 50 Respondent testified that he had read four or five textbooks, taken on-line courses, and talked with other practitioners to make improvements to his charting and that his records are now more detailed and ‘‘transparent to outside individuals.’’ Tr. 861. In addition, Respondent testified that he does not ‘‘take patients without records if they’re possible to obtain,’’ and that ‘‘[i]f a patient comes and there are no records, particularly of high dose opiates, we might give them small doses and establish a record with them ourselves.’’ Id. at 852– 53. Also, Respondent testified that he is now using the Arizona prescription monitoring program to determine whether his patients are getting controlled substances from another provider. Id. at 853. Finally, Respondent testified that his practice now has ‘‘in-office urine testing’’ and he does ‘‘routine urine screenings . . . on a random basis,’’ that he has given an even ‘‘higher priority’’ to pharmacy calls,’’ and that ‘‘we will often call physicians . . . that we have records on to verify if we have any questions about dosing from another physician.’’ Id. at 872–73. 51 The AMB’s 2010 Order also identified several other patients, to whom Respondent continued to prescribe controlled substances in deviation of the standard of care, by failing to obtain prior records, obtain objective measures for the cause of pain, and address abnormal urine drug screens, and did so even after he had been placed on probation. See GX 18, at 11–13 (WO); id. at 14–15 (JR); id. at 15–16 (LP). 52 In discussing Respondent’s ‘‘improvements in his prescribing practices . . . since the Board’s actions,’’ R.D. 60, the ALJ also cited the testimony of two patients, WR and ML (neither of whom is a medical professional), explaining that they ‘‘credibly testified to their positive experiences in being treated by Respondent.’’ R.D. at 61; see also id. at 62 (discussing testimony of Dr. SF that Respondent’s care and treatment were ‘‘excellent’’). The term ‘‘positive experience’’ is not in the CSA, PO 00000 Frm 00102 Fmt 4703 Sfmt 4703 Nor does the ALJ’s recommended sanction reflect an appreciation for the egregiousness of the violations he found proved (and which I concur with). In short, proof that in issuing a prescription, a practitioner acted outside of the usual course of professional practice and lacked a legitimate medical purpose, establishes that the practitioner has engaged in an act of intentional or knowing diversion. Such conduct strikes at the CSA’s core purpose of preventing the abuse and diversion of controlled substances. See Jack A. Danton, 76 FR 60900, 60903 (2011); George Mathew, 75 FR 66138 (2010). Indeed, this Agency has revoked a practitioner’s registration upon proof of as few as two acts of intentional diversion and has further explained that proof of a single act of intentional diversion is sufficient to support the revocation of a registration. See MacKay, 75 FR at 49977 (citing Krishna-Iyer, 74 FR at 463 (citing Alan H. Olefsky, 57 FR 928, 928–29 (1992))). While Respondent’s misconduct would be egregious if it had been confined to a single patient, it was not. Rather, the Board’s findings establish that Respondent diverted controlled substances to at least ten patients, and that with respect to several of these patients, he did so over an extensive time period. and the ALJ’s conclusory discussion of WR’s and ML’s testimony offers little insight into what he understood the term to mean. Notably, neither patient offered testimony identifying specific changes in Respondent’s prescribing practices which occurred following either of the AMB’s orders. Thus, the testimony of WR and ML is not probative of the issue of whether Respondent has improved his prescribing practices. As for Dr. SF’s testimony that Respondent provided him with ‘‘excellent’’ treatment, while this Agency (as do the Federal courts) necessarily look to medical practice standards in assessing whether a physician who has prescribed controlled substances had a legitimate medical purpose and acted within the usual course of professional practice in doing so, DEA is charged with preventing the diversion of controlled substances and not with evaluating the adequacy of a physician’s medical treatment. Moreover, as I have previously noted, ‘‘[b]ecause under [the CSA], registration is limited to those who have authority to dispense controlled substances in the course of professional practice, and patients with legitimate medical conditions routinely seek treatment from licensed medical professionals, every registrant can undoubtedly point to an extensive body of legitimate prescribing over the course of [his] professional career.’’ See Krishna-Iyer, 74 FR at 463. It is acknowledged that Dr. SF testified that Respondent took a complete history, performed a physical examination, reviewed his rules for prescribing medication, as well as subsequently helped SF taper off of his medication. Tr. 782. Yet, Dr. SF did not see Respondent until six to nine months after the AMB issued the first order, Tr. 780, and was clearly a legitimate patient. While his testimony bolsters to a degree the other evidence as to Respondent’s change in his prescribing practices, it is of minimal probative value in assessing Respondent management of drug seeking patients. E:\FR\FM\26JNN1.SGM 26JNN1 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES Nor—not surprisingly given that the ALJ totally ignored the Agency case law—does the recommended sanction reflect an appreciation for the growing and serious problem of the diversion of prescription drugs by unscrupulous practitioners and the epidemic of prescription drug abuse.53 Indeed, adopting the ALJ’s recommendation— which simply requires Respondent to do what the State has already required him to do—would create a perverse incentive. In short, it would send the message that a practitioner can unlawfully distribute controlled substances until he/she gets caught, and as long as he/she then acknowledges wrongdoing and puts on evidence that he/she has reformed, he/she will get a slap on the wrist. This is the entirely wrong message to send to those practitioners who contemplate using their prescribing authority for illicit purposes. And even those practitioners who might fairly be described as ¨ gullible or naıve, should know that there are serious consequences if they prescribe controlled substances in a manner that does not comply with the accepted standards of professional practice.54 53 See Krishna-Iyer, 74 FR at 463 (quoting National Center on Addiction and Substance Abuse, Under the Counter: The Diversion and Abuse of Controlled Prescription Drugs in the U.S. 3 (2005) [hereinafter, Under the Counter]). As noted in Krishna-Iyer, ‘‘[t]he diversion of controlled substances has become an increasingly grave threat to this nation’s public health and safety. According to The National Center on Addiction and Substance Abuse (CASA), ‘[t]he number of people who admit abusing controlled prescription drugs increased from 7.8 million in 1992 to 15.1 million in 2003.’ ’’ 74 FR at 463 (quoting Under the Counter, at 3). CASA also found that ‘‘ ‘[a]pproximately six percent of the U.S. population (15.1 million people) admitted abusing controlled prescription drugs in 2003, 23 percent more than the combined number abusing cocaine (5.9 million), hallucinogens (4.0 million), inhalants (2.1 million) and heroin (328,000).’ ’’ Id. (quoting Under the Counter, at 3). Finally, CASA found that ‘‘‘[b]etween 1992 and 2003, there has been a . . . 140.5 percent increase in the self-reported abuse of prescription opioids,’’ and in the same period, the ‘‘abuse of controlled prescription drugs has been growing at a rate twice that of marijuana abuse, five times greater than cocaine abuse and 60 times greater than heroin abuse.’’ Id. (quoting Under the Counter, at 4). 54 As support for his recommendation, the ALJ also quoted from a letter of Dr. Schneider, in which she wrote: The goal of regulatory agencies needs to be (and is usually claimed to be) to improve the performance of physicians when a deficiency is noted, rather than prevent them from continuing to practice, thereby wasting their training and experience. [Respondent], like many pain management doctors, developed his knowledge of pain management on the job rather than through a formal training program. This is a rapidly evolving field, and its standards are evolving. [Respondent]’s skills continue to improve. I believe that at this point he is clearly able to practice pain management with sufficient skill and safety that he should be allowed to continue to do this. VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 RX 23, at 2–3. Whatever the State of Arizona has chosen, in the exercise of its sovereignty, as the goal of its Medical Board, Congress has directed this Agency to protect the public interest. See 21 U.S.C. §§ 823(f) and 824(a)(4). This charge necessarily contemplates not only deterring a diverter from continuing to do so, but also deterring other would be diverters from doing so. And notwithstanding Dr. Schneider’s view of the appropriate goal of a state medical board, here, the AMB concluded that Respondent’s prescribing of opioids was so deficient that it suspended his prescribing authority for one year. Indeed, while in this same paragraph, Dr. Schneider characterized Respondent’s prescribing practices as ‘‘minor deficiencies,’’ RX 23, at 3, the Board’s findings establish that, in numerous instances, Respondent violated the standard of care by: (1) Failing to perform physical examinations; (2) failing to perform adequate psychiatric evaluations; (3) not obtaining prior records; (4) failing to perform tests to confirm diagnoses and the need for controlled substances; (5) failing to conduct urine drug screens and monitor his patients’ compliance; (6) ignoring the results of drug tests which either showed that his patient was not taking drugs he prescribed or taking drugs he did not prescribe or street drugs; (7) providing early refills; (8) adding drugs to a patient’s medication regime and escalating the dosing of drugs without any rationale for doing so; and (9) prescribing large doses of opioids to a patient, who purportedly could not remember the name of her previous prescriber and who repeatedly failed to comply with instructions to bring in records from prior treating physicians. These findings were in addition to the Board’s findings that Respondent failed to maintain adequate records. If these are ‘‘minor deficiencies,’’ I would like to know what, in Dr. Schneider’s view, would constitute a major one. As for Dr. Schneider’s suggestion that Respondent’s misconduct should be excused because he ‘‘developed his knowledge of pain management on the job rather than through a formal training program,’’ on various occasions (November 1997, May 1999, and June 2003), the AMB published guidelines on the Use of Controlled Substances for the Treatment of Chronic Pain, which specifically addressed many of the problematic practices the Board identified in its review of Respondent’s prescribing practices, and which ‘‘clarif[ied] the principles of professional practice that are endorsed by the Board.’’ Arizona Medical Board, Use of Controlled Substances for the Treatment of Chronic Pain (Substantive Policy Statement # 7). Likewise, well before Respondent issued the prescriptions which were discussed in the AMB’s orders, federal courts had issued decisions upholding convictions for violating the prescription requirement based on conduct similar to Respondent’s. See, e.g., Moore, 423 U.S. at 142–43; United States v. Williams, 445 F.3d 1302, 1305 (11th Cir. 2006) (sustaining conviction for unlawful distribution noting, inter alia, expert’s testimony that physician ‘‘wrote prescriptions for patients on whom he performed no or very minimal physical examination,’’ ‘‘wrote prescriptions for patients whose toxicology screens . . . showed that they were not taking the prescribed drugs and were instead taking illegal drugs,’’ and ‘‘he frequently refilled prescriptions early and replaced ‘lost’ drugs’’); United States v. Tran Trong Cuong, 18 F.3d 1132, 1139 (4th Cir. 1994) (sustaining conviction for unlawful distribution noting, inter alia, that ‘‘[m]ost of the patients were given very superficial physical examinations and even after months of the same complaints of pain and the same prescriptions of drugs, they were not given more complete examinations, nor were they subjected to x-rays or blood analysis or referred to specialists in an effort to identify and correct the cause of the pain’’). Certainly, those who undertake to practice in a highly regulated profession cannot reasonably claim PO 00000 Frm 00103 Fmt 4703 Sfmt 4703 38387 I therefore reject the ALJ’s recommended sanction that Respondent’s registration be continued subject only to the condition that he comply with the AMB’s order (and notify the Agency of any changes to the order). Instead, while I will order that Respondent’s renewal application be granted, I will further order that his registration then be suspended for a period of one year. Moreover, as Respondent suggested in his post-hearing brief, the Agency ‘‘may wish to impose requirements of continued monitoring of his files and perhaps keeping a separate log for all medications.’’ Resp. Prop. Findings of Fact, Conclusions of Law and Argument, at 43. Accordingly, upon Respondent’s completion of his suspension, the following conditions shall be imposed on his registration. 1. Respondent shall keep a log of all controlled substance prescriptions he issues. Said log shall be maintained in chronological order, and shall list each patient by name, and include the name of the drug prescribed, the number of refills authorized, the strength of the dosage unit, the quantity, and the dosing instruction. Not later than ten days following the end of each month, Respondent shall provide the local DEA field office with a complete copy of the log for the preceding month. 2. Respondent shall agree to continued monitoring of his patient files, with the costs of said monitoring to be borne by him. Said monitor shall be board certified in pain management and licensed by the Arizona Medical Board. DEA retains final authority to accept or reject the selection of said monitor. Said monitor shall review no less than twenty patient files each quarter, which shall be selected by the monitor; the monitor’s selection of any patient file may not be challenged by Respondent. Respondent shall agree to fully cooperate with the monitor. 3. Respondent shall further consent to unannounced inspections of his registered location and to waive his right to require DEA personnel to obtain an administrative inspection warrant prior to conducting an inspection. 4. These conditions shall remain in effect for a period of two years following the completion of Respondent’s suspension. Said condition shall ignorance of the laws, regulations and standards applicable to the practice of their profession. Cf. United States v. Southern Union Co., 630 F.3d 17, 31 (1st Cir. 2010). Finally, given that Respondent testified that he read four or five textbooks to improve his understanding of applicable standards, one must wonder why he did not read these textbooks when he decided to commence treating patients for chronic pain. E:\FR\FM\26JNN1.SGM 26JNN1 38388 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices thereupon terminate upon Respondent’s completion of the two year period without violating any of the above terms. The violation of any of the above terms shall, however, subject, Respondent’s registration to an Order of Immediate Suspension. Order Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 28 CFR 0.100(b), I order that the application of David A. Ruben, M.D., to renew his Certificate of Registration as a practitioner, be, and it hereby is, granted subject to the conditions set forth above. I further order that Respondent’s Certificate of Registration be, and it hereby is, suspended for a period of one year to begin thirty days from the date of publication of this Order in the Federal Register. This Order is effectively immediately. Dated: June 18, 2013. Michele M. Leonhart, Administrator. [FR Doc. 2013–15266 Filed 6–25–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA–2006–0040] SGS North America, Inc. (Formerly SGS U.S. Testing Company, Inc.) Occupational Safety and Health Administration (OSHA), Labor. ACTION: Notice. AGENCY: This notice announces the application of SGS North America, Inc., for expansion of its recognition as a Nationally Recognized Testing Laboratory by the addition of one test site and the removal of one test site. This notice presents the Agency’s preliminary finding to grant this request. This notice also announces a voluntary modification of the NRTL scope of recognition of SGS North America, Inc., and formally reflects the name change from SGS U.S. Testing Company, Inc. This preliminary finding does not constitute an interim or temporary approval of this application. DATES: Submit comments, information, and documents in response to this notice, or requests for an extension of time to make a submission, on or before July 11, 2013. ADDRESSES: Submit comments by any of the following methods: 1. Electronically: Submit comments and attachments electronically at http:// mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 20:26 Jun 25, 2013 Jkt 229001 www.regulations.gov, which is the Federal eRulemaking Portal. Follow the instructions online for making electronic submissions. 2. Facsimile: If submissions, including attachments, are not longer than 10 pages, commenters may fax them to the OSHA Docket Office at (202) 693–1648. 3. Regular or express mail, hand delivery, or messenger (courier) service: Submit a copy of comments and any attachments to the OSHA Docket Office, Docket No. OSHA–2007–0039, Technical Data Center, Room N–2625, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone: (202) 693–2350 (TDY number: (877) 889–5627). Note that security procedures may result in significant delays in receiving comments and other written materials by regular mail. Contact the OSHA Docket Office for information about security procedures concerning delivery of materials by express delivery, hand delivery, or messenger service. The hours of operation for the OSHA Docket Office are 8:15 a.m.–4:45 p.m., e.t. 4. Instructions: All submissions must include the Agency name and the OSHA docket number (OSHA–2006–0040). OSHA will place all submissions, including any personal information provided, in the public docket without revision, and these submissions will be available online at http:// www.regulations.gov. 5. Docket: To read or download submissions or other material in the docket, go to http://www.regulations.gov or the OSHA Docket Office at the address above. All documents in the docket are listed in the http:// www.regulations.gov index; however, some information (e.g., copyrighted material) is not publicly available to read or download through the Web site. All submissions, including copyrighted material, are available for inspection and copying at the OSHA Docket Office. Contact the OSHA Docket Office for assistance in locating docket submissions. 6. Extension of comment period: Submit requests for an extension of the comment period on or before July 11, 2013 to the Office of Technical Programs and Coordination Activities, NRTL Program, Occupational Safety and Health Administration, U.S. Department of Labor, 200 Constitution Avenue NW., Room N–3655, Washington, DC 20210, or by fax to (202) 693–1644. FOR FURTHER INFORMATION CONTACT: David W. Johnson, Director, Office of Technical Programs and Coordination Activities, NRTL Program, Occupational PO 00000 Frm 00104 Fmt 4703 Sfmt 4703 Safety and Health Administration, U.S. Department of Labor, 200 Constitution Avenue NW., Room N–3655, Washington, DC 20210, or phone (202) 693–1973. SUPPLEMENTARY INFORMATION: I. Notice of Expansion Application The Occupational Safety and Health Administration (OSHA) is providing notice that SGS North America, Inc. (SGS) is applying for expansion of its current recognition as a Nationally Recognized Testing Laboratory (NRTL). SGS’s expansion request covers the addition of one additional test site. SGS’s also requests the removal of one test site from its NRTL scope of recognition. SGS informed OSHA of a change in name from SGS U.S. Testing Company, Inc. to SGS North America, Inc. (see Exhibit 1: SGS Application). This notice reflects that change. OSHA’s current scope of recognition for SGS is available at http://www.osha.gov/dts/ otpca/nrtl/sgs.html. OSHA recognition of an NRTL signifies that the organization meets the legal requirements specified in Section 1910.7 of Title 29, Code of Federal Regulations (29 CFR 1910.7). Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within its scope of recognition, and is not a delegation or grant of government authority. As a result of recognition, employers may use products approved by the NRTL to meet OSHA standards that require product testing and certification. The Agency processes applications by an NRTL for initial recognition, or for an expansion or renewal of this recognition, following requirements in Appendix A to 29 CFR 1910.7. This appendix requires that the Agency publish two notices in the Federal Register in processing an application. In the first notice, OSHA announces the application and provides its preliminary finding and, in the second notice, the Agency provides its final decision on the application. These notices set forth modifications of the NRTL’s scope of recognition. OSHA maintains an informational Web page for each NRTL that details the NRTL’s scope of recognition. These pages are available from the OSHA Web site at http:// www.osha.gov/dts/otpca/nrtl/ index.html. Each NRTL’s scope of recognition has three elements. The first element is the type of products the NRTL may test, with each type specified by its applicable test standard. The second element identifies the recognized site(s) E:\FR\FM\26JNN1.SGM 26JNN1

Agencies

[Federal Register Volume 78, Number 123 (Wednesday, June 26, 2013)]
[Notices]
[Pages 38363-38388]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15266]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 11-39]


David A. Ruben, M.D.; Decision and Order

    On February 7, 2011, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to David A. Ruben, M.D. (hereinafter, Respondent), of 
Tucson, Arizona. The Show Cause Order proposed the revocation of 
Respondent's DEA Certificate of Registration, which authorizes him to 
dispense controlled substances as a practitioner, and the denial of any 
pending applications to renew or modify his registration, on the ground 
that his ``continued registration is inconsistent with the public 
interest.'' ALJ Ex. 1, at 1 (citing 21 U.S.C. 823(f) and 824(a)(4)).
    More specifically, the Show Cause Order alleged that between April 
9 and June 6, 2008, two cooperating sources (CS), who posed as 
patients, made four visits to Respondent's office seeking controlled 
substances. Id. The Order further alleged that at each visit, 
Respondent issued the CSs prescriptions for schedule II controlled 
substances without performing a physical examination, without taking a 
medical history, without reviewing or obtaining any medical records or 
test results, and without providing a diagnosis. Id. at 1-2. The Order 
thus alleged that Respondent lacked ``a legitimate medical purpose'' 
and acted ``outside of the usual course of professional practice'' in 
issuing the prescriptions and thus violated both federal and state law. 
Id. at 1 (citing 21 CFR 1306.04(a); Ariz. Rev. Stat. Sec.  32-
1401(27)(ss)).
    The Show Cause Order further alleged that on June 10, 2010, the 
Arizona Medical Board (AMB or Board) issued an order which found that 
Respondent had ``deviated from the standard of care in [his] treatment 
of multiple patients from 2006 to early 2009.'' Id. at 2. The Show 
Cause Order alleged that the AMB found that Respondent ``[f]ail[ed] to 
perform adequate examinations/evaluations prior to prescribing 
controlled substances''; that he ``[f]ailed to develop an adequate 
treatment plan prior to prescribing controlled substances''; that he 
``[f]ailed to perform tests and assessments to confirm diagnoses and 
the necessity of treatment with controlled substances''; that he 
``[f]ailed to obtain or review patients' medical records''; that he 
``[f]ailed to offer patients adjunct treatments that included non-
controlled substances and/or physical therapy''; that he ``[f]ailed to 
address patients' aberrant drug seeking behaviors''; and that he 
``[f]ailed to address or investigate patients' abnormal urinalysis 
results.'' Id. The Show Cause Order further alleged that based on these 
findings, the AMB had barred Respondent ``from prescribing, 
administering or dispensing any opioids for a period of one year.'' Id.
    On March 28, 2011, Respondent requested an extension of time to 
respond to the Show Cause Order, which was unopposed by the Government. 
ALJ Ex. 2. The matter was then placed on the docket of the Office of 
Administrative Law Judges (ALJ) and assigned to ALJ Wing. While the ALJ 
initially denied Respondent's request because neither party had 
established the date of service, on March 30, 2011, Respondent filed a 
Request for Reconsideration, which was also unopposed by the 
Government, and which showed that Respondent had not been served until 
February 25, 2008.\1\ ALJ Exs. 3 & 4. While Respondent sought an 
additional thirty days to respond to the Order to Show Cause, on April 
1, 2011, the ALJ granted Respondent one additional week to do so. ALJ 
Ex. 5.
---------------------------------------------------------------------------

    \1\ Notwithstanding of the date of the Show Cause Order, 
Respondent's request was timely because the Order was not served 
until February 25, 2008, and the thirtieth day period for filing his 
request fell on a Sunday.
---------------------------------------------------------------------------

    On April 7, 2011, Respondent requested a hearing on the 
allegations. ALJ Ex. 6. Following pre-hearing procedures, the ALJ 
conducted a hearing in Phoenix, Arizona on January 10-12, 2012, at 
which both parties elicited the testimony of multiple witnesses and 
introduced various exhibits into the record. Following the hearing, 
both parties submitted briefs containing their proposed findings of 
fact, conclusions of law, and argument.
    Thereafter, the ALJ issued his Recommended Decision (hereinafter, 
cited at R.D.). Therein, the ALJ found that the Government had 
``established by substantial evidence a prima facie case that 
Respondent has committed acts inconsistent with the public interest 
between 2006 and 2009.'' R.D. at 65. However, the ALJ further found 
that ``Respondent has fully accepted responsibility for his past 
misconduct and credibly demonstrated that he will not engage in future 
misconduct.'' Id.
    With respect to factor one--the recommendation of the state 
licensing board--the ALJ found that while Respondent currently has a 
valid Arizona medical license, he has twice been the subject of 
disciplinary action by the AMB, which found that he had engaged in `` 
`unprofessional conduct,' '' as well as `` `any conduct or practice 
that is or might be harmful or dangerous to the health of the patient 
or the public. ''' R.D. at 47 (quoting Ariz. Rev. Stat. Sec.  32-
1401(27)(q)). In addition, the ALJ found that Respondent had also 
committed unprofessional conduct by `` `failing or refusing to maintain 
adequate records on a patient.' '' Id. (quoting Ariz. Rev. Stat. Sec.  
32-1401(27)(e)). However, because in August 2011, the AMB had fully 
restored Respondent's prescribing privileges, the ALJ concluded that 
while not dispositive, the Board's action ``weigh[s] against a finding 
that Respondent's continued registration subject to conditions would be 
inconsistent with the public interest.'' Id. at 48.
    With respect to factor three--Respondent's conviction record under 
federal and state laws relating to the manufacture, distribution, or 
dispensing of controlled substances--the ALJ noted

[[Page 38364]]

that there was no evidence that Respondent has been convicted of such 
an offense. R.D. at 48. The ALJ thus concluded that while this factor 
is also not dispositive, it weighed against a finding that Respondent's 
``registration would be inconsistent with the public interest.'' Id.
    The ALJ then considered the evidence with respect to factors two--
Respondent's experience in dispensing controlled substances--and four--
Respondent's compliance with federal, state, and local laws relating to 
controlled substances--together. With regard to the allegation that 
Respondent had ``deviated from the standard of care in [his] treatment 
of multiple patients from 2006 to early 2009,'' the ALJ noted that the 
Government's evidence ``rested primarily on the findings by the Board 
in the 2009 Agreement and 2010 Order'' and that the Government had 
offered ``[n]o evidence in the form of patient charts or related 
medical expert testimony'' in either its case-in-chief or in rebuttal 
of the testimony offered by Respondent and his expert witness. Id. at 
49-50.
    However, the ALJ noted that the 2009 AMB Order found that between 
``November 17, 2006 and October 2007[,] `Respondent deviated from the 
standard of care by prescribing high dose opioids to DK without proper 
indications . . . [and] by failing to timely use objective measures, 
such as urine drug tests, to assess DK's compliance with her treatment 
even after he was aware of her cocaine addiction.' '' R.D. at 50. The 
ALJ further found that the 2010 AMB order ``established that 
Respondent's care and treatment of eleven patients . . . on various 
dates between 2006 and September 2009, constituted unprofessional 
conduct contrary to Ariz. Rev. Stat. Sec.  32-1401(27)(e) and (q).'' 
Id. The ALJ then noted some, but not all, of the specific findings made 
by the AMB with respect to the various patients. Id. at 50-51.
    With respect to the Board's findings, the ALJ further found that 
Respondent testified ``that he did not agree with all of the Board's 
findings with regard to the 2009 Agreement, but otherwise agreed with 
the sanctioning imposed by the Board.'' Id. at 53. With respect to the 
2010 AMB order, the ALJ found that ``Respondent credibly testified . . 
. that he agreed from a regulatory standpoint why the Board censured 
him, but disagreed with some of the specific factual findings.'' Id.
    Based on the two AMB orders, the ALJ nonetheless concluded that 
``Respondent issued controlled substance prescriptions to multiple 
patients . . . for other than a legitimate medical purpose and outside 
the usual course of professional practice in violation of applicable 
state and federal law.'' Id. at 54-55 (citing 21 CFR 1306.04(a); Ariz. 
Rev. Stat. Sec.  32-1401(27)(a), (e), and (q)). However, the ALJ 
rejected the Government's allegation based on the four visits of the 
two CSs, finding that Respondent ``credibly testified'' regarding his 
treatment of them, and that his testimony was ``supported by patient 
files.'' Id. at 56. In addition, the ALJ noted that Respondent's Expert 
credibly testified that his prescribing to the two CSs was `` `well 
within the standard of care.' '' Id. (quoting Tr. 618).
    The ALJ further found that Respondent had presented evidence of 
``more recent conduct'' [which] weigh[s] significantly'' in his 
``favor.'' Id. at 60. More specifically, the ALJ noted that Respondent 
testified that he had been in compliance with the AMB's Order, that he 
had ``successfully completed'' the one year suspension of his authority 
to prescribe opioids, and that there was no evidence that he ``has not 
been fully compliant with state and federal law since the 2010 Order.'' 
Id. Moreover, the ALJ noted Respondent's evidence that he had made 
improvements in his controlled-substance prescribing practices since 
the 2010 Order. Id.
    Thus, the ALJ found that the Government had demonstrated that 
``Respondent's prescribing practices and compliance with applicable 
state and federal law between 2006 and 2009 was inconsistent with the 
public interest'' and supported a finding that his ``continued 
registration would be inconsistent with the public interest, at least 
as of 2010.'' Id. at 63. However, the ALJ further found ``that 
Respondent's recent positive improvements in his prescribing practices 
and compliance with applicable state and federal law weigh in [his] 
favor.'' Id.
    As for factor five--such other conduct which may threaten public 
health and safety--the ALJ noted that the Government had not alleged, 
and the evidence did not support a finding that Respondent had engaged 
in ``any `other conduct' . . . that is inconsistent with the public 
interest.'' Id. at 64. The ALJ then found that Respondent ``ha[d] 
credibly accepted responsibility for his past misconduct,'' explaining 
that ``Respondent testified at various points that he acknowledged and 
accepted the Board's disciplinary actions.'' Id. Also noting the 
evidence as to Respondent's efforts to improve his prescribing 
practices, the ALJ concluded that factor five supported ``a finding 
that Respondent's continued registration would be consistent with the 
public interest.'' Id. at 65.
    The ALJ thus concluded that Respondent had rebutted the 
Government's prima facie case. Id. He then recommended that 
Respondent's registration be continued and that any pending 
applications be renewed subject to two conditions: 1) that Respondent 
``comply with all of the terms and conditions specified in the'' AMB's 
June 2010 order, and 2) that ``Respondent shall promptly forward to the 
DEA regional office any changes to the terms and conditions of his 
probation.'' Id. at 65-66.
    The Government filed Exceptions to the R.D. Thereafter, the record 
was forwarded to me for Final Agency Action.
    Having considered the entire record, I adopt the ALJ's finding that 
Respondent committed acts which were inconsistent with the public 
interest during the 2006 through 2009 time period. While I also accept 
the ALJ's finding that Respondent has accepted responsibility for his 
misconduct and produced substantial evidence of various remedial 
measures he has implemented, I nonetheless reject the ALJ's recommended 
sanction because the ALJ failed to consider both the egregiousness of 
the violations and the Agency's interest in deterring similar 
misconduct by Respondent in the future as well as on the part of 
others. See, e.g., Joseph Gaudio, 74 FR 10083, 10094 (2009).

The ALJ's Rulings on the Government's Motion in Limine To Exclude 
Evidence

    Before proceeding to make factual findings, a discussion of the 
ALJ's ruling on the Government's Motion in Limine To Exclude Evidence 
is warranted. During the course of the pre-hearing procedures, 
Respondent provided notice that he intended to call several physicians 
to testify, in part, regarding their review of the medical charts of 
those patients which were the subject of the AMB's 2009 and 2010 
orders. ALJ Ex. 46. Respondent also provided notice that he intended to 
introduce into evidence various letters written by these physicians 
based on their review of various patient charts which were reviewed by 
the AMB and discussed in the two orders. Id.
    Relevant to the Government's motion, Respondent proffered Dr. 
Jennifer Schneider to testify that she had reviewed the medical charts 
of patients LP, WO, JF, JR, CJ, ML, AM, MF, DD, and SS, all of which 
were reviewed by the AMB's consultant as part of the Board's 
investigation. ALJ Ex. 9, at 5 (Resp. Prehearing Statement). Respondent 
further proffered that Dr.

[[Page 38365]]

Schneider ``will explain that the AMB consultant had missed items in 
the charts for which Respondent was inaccurately criticized.'' Id. 
Finally, Respondent proffered that Dr. Schneider ``will testify in 
conformance with information about [Respondent] and Pain Management 
practices in Arizona in general as the author of Proposed Exhibits 4, 
5, and 6.'' Id.
    Respondent also proffered the testimony of Dr. Bennet Davis to 
``testify regarding his review of a chart involving patient DK and his 
review and evaluation of patient ML, who has a complex set of issues.'' 
Id. Respondent further proffered that Dr. Davis would testify that, 
``[i]n his opinion, the AMB consultant did not properly define the 
standard of care for which Respondent was issued a reprimand per [the 
2009] Consent Agreement,'' and that Respondent adhered to a `reasonable 
standard [of] care in all aspects of treating . . . [DK].' '' Id. at 5-
6. Respondent also proffered that ``Dr. Davis was able to synthesize 
his own evaluation and compare it with the notes and records provided 
by Respondent [and] will testify that Respondent met the standard of 
care in his evaluation of Respondent's chart of ML.'' Id. at 6.
    Finally, Respondent proffered the testimony of Dr. Kevin Goeta-
Kreisler, who was to ``explain that . . . he reviewed the complaints 
and the charts on patients `AL, KF, and JF.' '' Id. Respondent further 
proffered that Dr. Goeta-Kreisler ``will testify that he and Respondent 
both agreed that the early charting was `insufficient for another 
practitioner to assume continuity of the patients' care' even though 
the documentation met the standard of practice at the earlier time.'' 
Id.
    Thereafter, the Government filed a motion in limine to exclude this 
evidence, arguing that ``[t]he doctrine of res judicata bars the 
relitigation of the factual findings and conclusion of law of the prior 
proceedings before the AMB.'' Motion in Limine to Exclude Evidence (ALJ 
Ex. 46, at 3). The Government argued that ``[e]ach of Respondent's 
proposed experts' testimony and their [sic] related documentary 
evidence . . . are [sic] an attempt to relitigate the factual findings 
and conclusions of law by the AMB,'' and therefore, ``Respondent should 
be precluded from presenting such evidence.'' Id. As support for its 
position, the Government cited numerous authorities, including cases of 
both federal and state courts and the Agency. See id. (citing Misischia 
v. Pirie, 60 F.3d 626, 629-30 (9th Cir. 1995); Marie Y. v. General Star 
Indem. Co., 2 Cal. Rptr. 3d 135, 155 (Cal. Ct. App. 2003); Robert L. 
Dougherty, 76 FR 16823, 16830 (2011); Alan H. Olefsky, 76 FR 20025, 
20031 (2011); Christopher Henry Lister, 75 FR 28068, 28069 (2010).
    Respondent opposed the motion on multiple grounds. See ALJ Ex. 47. 
More specifically, Respondent argued: (1) That the motion was untimely, 
id. at 1-2; (2) that the AMB Orders were the result of consent 
agreements, which stated that his ``admissions are not intended or made 
for any other use, such as in the context of another state or federal 
government regulatory agency proceeding,'' and that he ``never agreed 
that all of the conduct set forth in the findings was accurate,'' id. 
at 2-3; and (3) that DEA could not invoke the doctrine of res judicata 
because it was not a party to the consent agreements and was not in 
privity with the AMB. Id. at 4-5.
    The ALJ denied the Government's motion for two reasons. First, 
noting that the Government had not filed its motion until approximately 
eight months after Respondent had provided notice as to its witnesses 
and their anticipated testimony, the ALJ held that the Government had 
not established good cause for the untimely filing of the motion. ALJ 
Ex. 48, at 2-3. Second, the ALJ held that because the Agency was not a 
party to the proceeding before the AMB, and the AMB did not consider 
the issue of whether Respondent's DEA registration should be revoked 
under the public interest standard, the doctrine of res judicata could 
not be invoked to bar the introduction of the proposed testimony and 
reports. Id. at 3-4. However, the ALJ further noted that his ruling was 
``not intended to limit the parties from making evidentiary objections 
at the time the evidence is offered.'' Id. at 4 n.3.\2\
---------------------------------------------------------------------------

    \2\ Taking the ALJ at his word, throughout the proceeding, the 
Government made numerous objections to the testimony of several of 
Respondent's witnesses (as well as the admission of several 
documents authored by the aforementioned physicians) asserting that 
various AMB findings were in error, including its findings as to 
what the standard of care required at the time he treated the 
patients who were the subject of the Board's Orders. See Tr. 578, 
591, 596, and 603.
---------------------------------------------------------------------------

    As for the first of the ALJ's reasons, the Agency's regulations 
clearly grant the ALJ authority ``to take all necessary action to avoid 
delay.'' 21 CFR 1316.52. Moreover, this regulation provides that the 
ALJ ``shall have all powers necessary to these ends, including (but not 
limited to) the power to . . . [r]eceive, rule on, exclude, or limit 
evidence.'' Id. Sec.  1316.52(f). This power clearly includes the 
authority to set reasonable time periods for the filing of motions. 
Given that the Government's motion was filed eight months late, the 
Government's motion was clearly untimely.
    However, notwithstanding that the motion was untimely, the ALJ 
considered it on the merits. Moreover, after the parties filed their 
respective prehearing statements, the ALJ clearly was aware that the 
Government intended to introduce the AMB Orders and that Respondent 
intended to challenge the validity of their findings. Indeed, on June 
24, 2011, Respondent filed a motion to preclude the Government from 
introducing the two AMB Orders. See ALJ Ex. 20. Thus, even though the 
Government did not raise issue in its response to Respondent's motion 
to preclude, the ALJ was obligated (and remained so throughout the 
proceeding) to apply the law of the Agency. Accordingly, the ALJ should 
have raised, sua sponte, the issue of whether the findings of the AMB 
Orders were entitled to preclusive effect.\3\ I therefore conclude that 
it is appropriate to consider whether the ALJ's ruling on the merits 
was correct.
---------------------------------------------------------------------------

    \3\ Under Agency regulations, at the hearing, the ALJ ``shall 
admit only evidence that is competent [and] relevant.'' 21 CFR 
1316.59(a). If, as the Government argues, such evidence was barred 
by the doctrine of res judicata (or more precisely, collateral 
estoppel) the admission of such evidence was a violation of the 
above regulation.
---------------------------------------------------------------------------

    While the ALJ correctly noted that the Agency has applied the 
doctrine of res judicata in proceedings brought under 21 U.S.C. 823 and 
824, he then misapplied Agency precedent. To be sure, the application 
of res judicata itself requires that the parties in the subsequent 
proceeding be the same parties (or privies of the parties) in the 
earlier proceedings and that the proceedings involve the same claim. 
However, this Agency has also long held that the doctrine of collateral 
estoppel precludes a party from re-litigating adverse findings rendered 
against him in either a state board proceeding or a federal/state 
judicial proceeding.\4\ See

[[Page 38366]]

Robert L. Dougherty, 76 FR 16823, 16830-31 (2011); Robert A. Leslie, 60 
FR 14004, 14005 (1995). Contrary to the ALJ's misunderstanding, the 
Agency was not required to be a party or privy of a party in the AMB 
proceedings to collaterally estop Respondent from re-litigating the 
findings of the AMB Orders.\5\ So too, that the State Board proceeding 
did not involve the same claim as this proceeding (whether Respondent's 
registration is consistent with the public interest), does not preclude 
the Agency from relying on those findings of the Board which are 
relevant and material to the Agency's public interest determination.
---------------------------------------------------------------------------

    \4\ While the Government argued that ``[t]he doctrine of res 
judicata bars the relitigation of the factual findings and 
conclusions of law of the prior proceedings before the AMB,'' ALJ 
Ex. 46, at 3, as the above passage (as well as other portions of its 
motion) made clear, it actually sought to invoke collateral estoppel 
against the Respondent. See also id. (quoting Marie Y. v. General 
Star Indem. Co., 2 Cal. Rptr. 3d 135, 155 (Cal. Ct. App. 2003) 
(``When an administrative agency acts in a judicial capacity to 
resolve disputed issues of fact properly before it which the parties 
have had an adequate opportunity to litigate, its decision will 
collaterally estop a party to the proceeding from relitigating those 
issues.''). As further support for its position, the Government 
cited Section 29 of the Restatement (Second) of Judgments. See id. 
Notably, this section is entitled ``Issue Preclusion in Subsequent 
Litigation With Others.''
    While in his ruling, the ALJ noted that ``the Agency has stated 
that `the doctrine of res judicata bars the relitigation of the 
findings of the [state medical board]'s final order,' '' ALJ Ex. 48 
at 4 n.2 (quoting Dougherty, 76 FR at 16830), he then ``declined to 
extend this dicta [sic] to the facts in the present case for the 
reasons discussed above.'' Id. Contrary to the ALJ's understanding, 
the passage in Dougherty was not a dictum but rather a holding, as 
the Agency's decision relied on numerous findings of the state 
medical board's order in support of its finding that Respondent had 
committed acts which rendered his registration inconsistent with the 
public interest and squarely rejected the physician's attempts to 
relitigate the state board's findings. See 76 FR at 16831. As I 
explained:
    All of Respondent's testimony could have been, and should have 
been presented in the MBC proceeding. Here again, it is clear that 
Respondent is simply trying to relitigate the findings of the MBC 
proceeding. Having failed to establish that the MBC proceeding did 
not provide him with a full and fair opportunity to litigate these 
issues, the doctrine of res judicata precludes Respondent from 
relitigating them in this proceeding.
    Id. Thus, contrary to the ALJ's reasoning, there was no dictum 
``to extend'' but only a holding to apply; his reasons for ignoring 
Agency precedent reflect a fundamental misunderstanding of the 
differences between claim preclusion and issue preclusion.
    \5\ As support for his reasoning, the ALJ also cited the Agency 
decision in Robert Raymond Reppy, 76 FR 61154, 61159-60 (2011), 
noting that the decision ``refus[ed] to apply res judicata because, 
although a prior Agency decision was a final judgment on the merits, 
the respondent was not a party to the prior litigation.'' ALJ Ex 48, 
at 3. The ALJ ignored, however, the fundamental difference between 
Reppy and this matter, that being that the Government sought 
preclusion against Dr. Reppy based on findings made in a matter 
involving the pharmacy for which he worked, and did so 
notwithstanding that he was not a party to the pharmacy's 
proceeding. By contrast, here the Government seeks preclusion 
against Respondent based on findings made in a proceeding in which 
he was a party.
---------------------------------------------------------------------------

    While not addressed by the ALJ, Respondent argued that both of the 
AMB Orders were based upon consent agreements, which included the 
following clause:

    All admissions made by Respondent are solely for final 
disposition of this matter and any subsequent related administrative 
proceedings or civil litigation involving the Board and the 
Respondent. Therefore, said admissions are not intended or made for 
any other use, such as in the context of another state or federal 
government regulatory agency proceeding.

ALJ Ex. 47, at 2 (quoting GX Ex. 17, at 2 (2009 AMB Order) and GX 18, 
at 20-21 (2010 AMB Order). Respondent argues that he ``and his counsel 
had to consider whether there was a reasonable basis to conclude that 
there was at least some evidence that would lead to a conclusion that 
some of the allegations made would be sustained.'' Id. He contends that 
``[h]e bargained for and received an agreement to enter each of these 
consent agreements, on the basis of that recognition, on his agreement 
that he would indeed follow the requirements of any discipline 
authorized as a result of the Agreement, but that outside of the 
required discipline set forth, the stated findings and conclusions 
could not be used in a non-AMB proceeding, including a `federal 
government regulatory agency proceeding[,]' such as this one.'' Id. at 
2-3. Respondent further argues that he ``never agreed that all of the 
conduct set forth in the findings was accurate,'' and that both he and 
the AMB ``agreed that [his] concessions there were not to be given 
substantive weight outside of the Arizona professional proceedings.'' 
Id. at 3.
    In the 2010 Order, however, Respondent also ``agree[d] not to 
contest the validity of the Findings of Fact and Conclusions of Law 
contained in the Order in any present or future administrative 
proceedings before the Board (or any other state agency in the State of 
Arizona, concerning the denial or issuance of any license or 
registration required by the state to engage in the practice or any 
business or profession.)'' GX 18, at 20. Moreover, he also 
``voluntarily relinquishe[d] any rights to a hearing or judicial review 
in state or federal court on the matters alleged, or to challenge th[e] 
Order in its entirety as issued by the Board, and waive[d] any other 
cause of action related thereto or arising from said Order.'' Id. 
Finally, he agreed that the ``Order is a public record that will be 
publicly disseminated as a formal disciplinary action of the Board and 
will be reported to the National Practitioner's Data Bank and on the 
Board's Web site as a disciplinary action.'' Id. at 21 (emphasis 
added).
    Likewise, the 2009 Order provided that ``[b]y entering into this 
Consent Agreement, Respondent voluntarily relinquishes any rights to a 
hearing or judicial review in state or federal court on the matters 
alleged, or to challenge this Consent Agreement in its entirety as used 
by the Board, and waives any other cause of action related thereto or 
arising from said Consent Agreement.'' GX 17, at 1. Also, the 2009 
Order provided that ``[t]his Consent Agreement, or any part thereof, 
may be considered in any future disciplinary action against 
Respondent,'' and that upon its approval and signing, was ``a public 
record that will be publicly disseminated as a formal action of the 
Board'' which would be reported to the National Practitioner's Data 
Bank and on the AMB's Web site. Id. at 1-2.
    Respondent does not contend that he lacked a full and fair 
opportunity to litigate the allegations that were the subject of the 
2009 and 2010 Orders. And while both Orders were the result of consent 
agreements in which the findings were not actually litigated, the 
Supreme Court of Arizona has explained that even where a judgment has 
been entered by stipulation or consent, it ``may be conclusive, with 
respect to one or more issues, if the parties have entered an agreement 
manifesting such intention.'' Chaney Building Co., v. City of Tuscon, 
716 P.2d 28, 30 (Ariz. 1986) (en banc) (citing Restatement (Second) of 
Judgments Sec.  27 comment e).\6\ See also Gilbert v. Ben-Asher, 900 
F.2d 1407, 1410 (9th Cir. 1990) (``Arizona law permits a judgment by 
stipulation to `be conclusive . . . if the parties have entered an 
agreement manifesting such intention.''') (quoting Chaney, 716 P.2d at 
30); Restatement (Second) of Judgments Sec.  8.3.
---------------------------------------------------------------------------

    \6\ Indeed, in Chaney, the Supreme Court of Arizona explained 
that even where parties stipulate to a dismissal, if the parties 
``intended the . . . dismissal to be binding as to certain factual 
issues, and if their intention was reflected in the dismissal, we 
would enforce the intent of the parties and collateral estoppel 
would apply.'' 716 P.2d at 30 (citing James, Consent Judgments as 
Collateral Estoppel, 108 U. Pa. L. Rev. 173, 192 (1959)).
---------------------------------------------------------------------------

    Here, both AMB Orders constitute formal disciplinary actions of the 
Board; their findings and legal conclusions were the basis for the 
sanctions which the AMB imposed on Respondent. Most significantly, the 
parties agreed that Respondent could not ``contest the validity of the 
Findings of Fact and Conclusions of Law contained in the [2010] Order 
in any present or future administrative proceedings before the Board,'' 
as well as in a proceeding before ``any other state agency in the State 
of Arizona, concerning the denial or issuance of any license or 
registration required by the state to engage in the practice or any 
business or profession.'' So too, Respondent agreed that he could not 
challenge any portion of either Order in the state or federal courts. 
Thus, notwithstanding that both AMB Orders were the result of consent 
agreements, it is clear that the parties agreed that the findings of 
fact and

[[Page 38367]]

conclusions of law contained in them, were not subject to relitigation 
between Respondent and the Board.
    As for Respondent's contention that ``the stated findings and 
conclusions could not be used in a non-AMB proceeding,'' ALJ Ex. 47, at 
3, the 2010 Order itself expressly provided that it could be used in 
administrative proceedings brought by other Arizona agencies. GX 18, at 
20. And as for his contention that he and the AMB agreed that his 
admissions were ``not intended or made for any other use, such as in 
the context of another state or federal government regulatory agency 
proceeding,'' Respondent cites no authority to support the proposition 
that he and the State can dictate to an Agency of the United States 
that it cannot give the same effect to the factual findings and legal 
conclusions as would exist in a subsequent state administrative 
proceeding.\7\ Cf. Howlett v. Rose, 496 U.S. 356, 371 (1990) (citing 
FERC v. Mississippi, 456 U.S. 742, 776 n.1 (1982) (opinion of O'Connor, 
J.) (``State may not discriminate against federal causes of action'')); 
U.S. Const. art. VI, cl. 2. Accordingly, I hold that the ALJ erred by 
failing to give preclusive effect to the factual findings and legal 
conclusions of the two AMB Orders.\8\
---------------------------------------------------------------------------

    \7\ Nor is it even clear why the agreement's language that 
``[a]ll admissions made by Respondent are solely for final 
disposition of this matter'' and ``said admissions are not intended 
or made for any other use,'' should preclude this Agency from giving 
collateral estoppel effect to the Board's factual findings and legal 
conclusions. Notably, the Board did not agree that its factual 
findings and legal conclusions were not entitled to preclusive 
effect in other proceedings; indeed, Respondent agreed that he could 
not contest the validity of the Board's factual findings and legal 
conclusions in other Arizona administrative proceedings. Rather, the 
above quoted language states only that Respondent's admissions were 
not intended for use in other proceedings. Notably, in his 
opposition to the Government's motion, Respondent did not identify 
any factual findings in the two Orders which were based on his 
admissions.
    \8\ As has been made clear in several agency decisions, even 
where the factual findings and legal conclusions of a state board 
order are not subject to relitigation, a respondent is entitled to 
argue whether those findings and legal conclusions also establish 
violations of federal laws and regulations, as well as whether those 
violations are sufficiently egregious to support the Government's 
proposed sanction. So too, even where the factual findings and legal 
conclusions of a state board order are entitled to preclusive 
effect, a respondent is still entitled to put on evidence as to his/
her acceptance of responsibility and remedial measures. See Robert 
L. Dougherty, 76 FR 16823, 16830 (2011).
---------------------------------------------------------------------------

 Findings of Fact

    Respondent is the holder of a DEA Certificate of Registration, 
which authorizes him to dispense controlled substances in schedules II 
through V as a practitioner at the registered address of 2016 South 4th 
Avenue, Tucson, Arizona. GX 1, at 1. Respondent's registration was due 
to expire on April 30, 2011, id.; however, on March 16, 2011, 
Respondent submitted a renewal application. GX 2. Because Respondent 
has timely submitted a renewal application, I find that Respondent's 
registration has remained in effect pending the issuance of this 
Decision and Final Order. See 5 U.S.C. 558(c).
    Respondent is also the holder of a license to practice allopathic 
medicine in the State of Arizona. GX 18, at 1. Respondent holds board 
certifications from the American Board of Psychiatry and Neurology, the 
American Board of Child and Adolescent Psychiatry, American Board of 
Addiction Medicine, and the American Board of Pain Medicine. Tr. 802-
03.

The State Board Proceedings

The 2009 AMB Order

    Respondent first came to the attention of the AMB, after DF, a 
Tucson area pharmacist, filed a complaint with the Board regarding 
Respondent's issuance of an OxyContin prescription to DK in October 
2007.\9\ Tr. 68-69. DF testified that he had received and filled 
prescriptions which Respondent had issued for OxyContin for patients 
who were participants in the Arizona Health Care Cost Containment 
System (AHCCS), the State's Medicaid Program. Id. at 55. DF further 
testified that while OxyContin was not covered by AHCCS, Respondent's 
prescriptions would, based on the ``quantity and strength . . . cost in 
the neighborhood of $2,000 per month,'' and yet the ``the patient would 
pay cash.'' Id. at 56-57. Moreover, even when DF ``offered the generic, 
which was significantly less money, [Respondent's] patients demanded 
the brand name'' OxyContin and paid cash.\10\ Id. at 57.
---------------------------------------------------------------------------

    \9\ At the time of the hearing, DF had been a pharmacist for 
twenty-nine years and had been appointed as the Assistant Director 
of Pharmacy for a major grocery chain in Arizona, and was 
responsible for supervising 43 pharmacies. Tr. 50-51. He had also 
previously served for twelve years as a Pharmacy Manager for the 
same chain and for four years as the District Pharmacy Manager for 
the chain's stores in southern Arizona. Id. at 52.
    \10\ Several other pharmacists also testified to instances in 
which Respondent's patients presented similar OxyContin 
prescriptions, turned down generics, and paid large sums of cash 
notwithstanding that they were on AHCCS. See Tr. 153-54 (testimony 
of NB); id. at 180-81 (testimony of WL).
---------------------------------------------------------------------------

    As for the quantity and strength of Respondent's prescriptions, DF 
testified that ``some of'' them were for ``the highest milligram 
strength, 80 milligrams,'' with a dosing instruction to take ``multiple 
tablets of that strength more frequently than was substantiated in the 
literature.'' Id. Based on his ``knowledge of prescribing practices of 
other physicians writing the same medications,'' DF found the 
quantities to be ``very excessive.'' Id.
    In October 2007, DK presented a prescription issued by Respondent 
for 210 tablets of OxyContin 80mg, with a dosing instruction to take 
one tablet up to seven times per day. Id. at 64. DF testified that the 
dosing instruction was ``totally outside of the literature and the 
general accepted prescribing practice for that medication,'' id. at 65, 
because OxyContin is a sustained-release product which is typically 
taken every twelve hours, and at most every eight hours, and taking the 
drug every two hours ``would lead to a blood level that could be 
dangerous.'' Id. at 76.
    Accordingly, the prescription ``prompted [DF] to call the doctor's 
office to verify that the prescription was written correctly.'' Id. at 
65. However, when DF called Respondent's office, the latter's office 
manager told him that Respondent ``refuses to speak to pharmacists.'' 
Id. at 66. DF told the office manager that he wanted to know where 
Respondent ``got the pharmacokinetics information that would support'' 
the dosing interval and that he ``was not going to fill the 
prescription until [he] spoke with'' Respondent. Id. While DF made at 
least two phone calls regarding the prescription, Respondent did not 
speak with him. Id. at 67.
    Respondent eventually faxed a letter to DF stating that ``OxyContin 
80mg per day is the patient's prescription dose. She is being monitored 
for plain [sic] & compliance. We will continue to prescribe as 
appropriate for the lowest dose, which meets her pain needs. We also 
expect politeness in communication.'' RX 29, at 2; Tr. 67. In response, 
DF hand wrote a note on the fax, which he then faxed back:

    7 times per day is not appropriate by anyone's measure[.] We 
will no longer fill prescriptions under your name. Board of Medical 
Examiners and DEA will be notified. We will not help maintain an 
addiction. You are confusing firmness with impoliteness, and 
appropriate therapy with inappropriate therapy.

RX 29, at 2; Tr. 68.

    Consistent with his note, DF instructed the pharmacists he 
supervised not to fill Respondent's prescriptions and reported the 
incident to the AMB. Tr. 70. Respondent then called DF; during the 
conversation, DF related that Respondent's office manager had stated 
that he refused to speak with pharmacists. Id. at 90. Respondent 
maintained that he ``never directed his

[[Page 38368]]

office manager to say that.'' Id. DF asked Respondent if it ``didn't 
raise a red flag with him that [patients] were paying cash and 
demanding the brand name and that they were on AHCCCS,'' and presumably 
``could not afford $2,000.00 a month for these medications?'' Id. at 
63. Respondent replied, ``Well how do you know their family isn't 
paying for it?'' Id. DF stated that if he was paying for a family 
member's prescription ``that cost that much money, I would demand that 
they got the generic so I wasn't spending that much money for it,'' and 
then asked Respondent if this didn't ``raise a big red flag to you that 
they're selling it on the street.'' Id. at 63-64. Respondent 
``disregarded [DF's] concerns and really had no response to that.'' Id. 
at 64. Respondent also stated that many of his patients requested brand 
name drugs because generics were less effective. Id. at 106.
    DF and Respondent also discussed the dosing instruction on DK's 
prescription, with Respondent telling DF that DK was taking two 
tablets, three times a day, and one tablet at night. Id. at 102. In 
response, DF told Respondent ``that that is not the way the 
prescription is written and [that] for a pharmacist to fill a 
prescription with directions that are not indicative of . . . the 
doctor's true intent . . . would be unethical and unprofessional.'' Id. 
While DF recalled discussing drug ``tolerance as a general principal,'' 
he further told Respondent ``the standard practice for pain control 
with a sustained release product . . . was to use an immediate release 
product to help with . . . breakthrough [pain] and not to simply 
increase'' the dosing of the sustained release drug. Id. at 103. DF 
also testified that Respondent asserted that the medication was 
providing what appeared to be adequate pain relief to DK. Id.
    With respect to DK, the AMB conducted an investigation. GX 17, at 
4. Thereafter, Respondent and the AMB entered into a consent agreement, 
pursuant to which he stipulated to certain findings of fact and 
conclusions of law. Id. at 1. Therein, the Board made the following 
findings of fact:

    4. On November 17, 2006, DK first presented to Respondent 
through self-referral complaining of lower back pain and psychiatric 
issues. DK reported her current pain management medications as 
OxyContin, Oxycodone, Valium, and Paxil. DK also reported having 
imaging studies and x-rays done three years prior to her visit. 
Although Respondent requested at this first meeting and four times 
subsequently that DK provide him with her medical records and film, 
she did not comply until December, 2007. At this first visit, 
Respondent prescribed OxyContin and Valium at the reported doses and 
increased the Oxycodone dosage from the reported dosage. 
Subsequently, Respondent prescribed medications on a monthly basis 
and in December 2006, he added Wellbutrin for increasing depression. 
Respondent did not obtain urine drug tests to monitor compliance 
before June 2008, or order additional testing to identify the source 
of DK's pain.
    5. On August 29, 2007, Respondent provided DK with early refills 
of OxyContin and Oxycodone, although he decreased the Oxycodone 
dosage.
    6. On October 19, 2007, Respondent saw DK and a family member, 
who both insisted that DK was compliant with her treatment. 
Respondent then wrote DK her usual opioid prescriptions. However, 
later that day, Respondent received written documentation from 
another patient that DK was recently discharged from the care of 
another physician for violating a pain agreement. Respondent 
subsequently took appropriate measures in an attempt to prevent DK 
from filling the prescription he had written earlier that day.
    7. Respondent later learned from the other provider that DK had 
tested positive for cocaine and Methadone (which was not prescribed 
to her). Respondent referred DK to Behavioral Health for substance 
abuse issues, but he continued to prescribe opiates to DK for her 
back pain. Further, Respondent continued to prescribe opiates to DK 
after he learned that she had successfully completed inpatient 
opioid detoxification.
    8. The standard of care requires a physician to base new or 
continuing high dose opioid prescriptions for a self-referred, 
chronic pain management patient (who reports currently being 
prescribed high dose opioid medications) on proper indications, 
including previous medical records and verified previous 
prescriptions, and/or contact with the previous prescribing 
physician.
    9. Respondent deviated from the standard of care by prescribing 
high dose opioids to DK without proper indications.
    10. The standard of care when treating a chronic pain patient 
who has a known or suspected substance abuse problem is to utilize 
objective measures to monitor compliance.
    11. Respondent deviated from the standard of care by failing to 
timely use objective measures, such as urine drug tests, to assess 
DK's compliance with her treatment even after he was aware of her 
cocaine addiction.
    12. As a result of Respondent's conduct, DK might have suffered 
an accidental overdose resulting in respiratory depression, 
aspiration, brain damage, or death. In addition, Respondent's 
inappropriate prescribing might have . . . perpetuated DK's aberrant 
drug seeking and addiction.

Id. at 4-5.

    Based on the above findings, the Board concluded that ``[t]he 
conduct and circumstances described above constitute unprofessional 
conduct pursuant to'' Ariz. Rev. Stat. Sec.  32-1401(27)(q), a 
provision which encompasses ``[a]ny conduct or practice that is or 
might be harmful or dangerous to the health of the patient or the 
public.'' Id. at 6. The Board issued Respondent a reprimand and placed 
him on probation for one year, subject to several conditions, including 
that he take 15-20 hours of Continuing Medical Education in pain 
management; that he pay the Board's administrative costs; and that he 
obey all federal, state and local laws and regulations ``governing the 
practice of medicine.'' Id. at 6-7. In addition, the conditions 
provided that the ``Board staff or its agents shall conduct periodic 
chart reviews,'' and that based on the reviews, ``the Board may retain 
jurisdiction to take additional disciplinary or remedial action.'' Id. 
at 6.
    After entering into the 2009 agreement, Respondent requested that 
Dr. Bennet E. Davis, M.D., President of the Pima County Medical Society 
Pain Working Group review the consent agreement. RX 8, at 4. Therein, 
Dr. Davis took issue with several of the AMB's findings, specifically 
findings 8, 9, and 11.
    As set forth above, in findings number 8 and 9, the AMB found that 
in the case of ``a self-referred, chronic pain management patient (who 
reports currently being prescribed high dose opioid medications),'' the 
standard of care requires that a physician base the prescription ``on 
proper indications, including previous medical records and verified 
previous prescriptions, and/or contact with the previous prescribing 
physician,'' and that Respondent failed to do so. With respect to these 
findings, Dr. Davis asserted that the Board was applying a standard of 
care which ``does not reflect the actual standard of care in the state 
of Arizona, nor in the community in which [Respondent] practices 
medicine,'' but rather a standard which ``reflects an ideal which is 
not achievable in reality.'' Id.
    As for finding number 11, in which the Board found that Respondent 
deviated from the standard of care by failing to timely use objective 
measures, such as urine drug tests, to assess DK's compliance with her 
treatment, even after he was aware of her cocaine addiction, Dr. Davis 
asserted that the Board's finding ``appears to have no basis in fact.'' 
Id. Dr. Davis then opined that even ``if it did, it would not reflect 
actual standard of care in the community in which [Respondent] 
practices medicine because the use of urine screening in pain medicine 
is an area of some controversy and consequently wide latitude must be 
given to practitioners.'' Id.
    The short answer to these contentions is that the AMB is the expert 
agency entrusted under Arizona law with authority to determine ``if a 
doctor of

[[Page 38369]]

medicine has engaged in unprofessional conduct or provided incompetent 
medical care.'' Ariz. Rev. Stat. Sec.  32-1403(A)(2). See also id. 
Sec.  32-1403(A) (``The primary duty of the board is to protect the 
public from unlawful, incompetent, unqualified, impaired, or 
unprofessional practitioners of allopathic medicine through licensure, 
regulation and rehabilitation of the profession in this state.''). 
Under Arizona law, eight of the Board's twelve members must ``be 
actively practicing medicine,'' and ``[e]ach doctor of medicine who is 
appointed to the board [must] have been a resident of this state and 
actively engaged in the practice of medicine as a licensed physician 
for at least the five years before appointment.'' Id. Sec.  32-1402(A) 
and (B).
    Respondent could have presented this evidence to the Board, but did 
not. Most significantly, to even entertain such evidence undermines 
fundamental values of federalism. As Gonzales v. Oregon makes clear, 
``[t]he structure and operation of the CSA presume and rely upon a 
functioning medical profession regulated under the States' police 
powers.'' Gonzales v. Oregon, 546 U.S. 243, 279 (2006). Where, as here, 
a state medical board has determined that a practitioner's conduct 
violated the standard of care, its findings of fact and conclusions of 
law are not subject to relitigation before the Agency. Rather, the only 
question is whether those findings also establish whether a 
practitioner has committed acts which render his registration 
inconsistent with the public interest within the meaning of the CSA.
    With respect to DK, Respondent testified that he recognized the 
AMB's criticism of his failure to get her records ``originally.'' Tr. 
850-51. Indeed, other than a then-five year old MRI, which DK did not 
produce until more than a year after she had begun seeing Respondent 
and which had negative findings (see RX 30, at 11), Respondent did not 
obtain any records from DK's prior treating physicians, notwithstanding 
that at the first visit, Respondent noted in his evaluation that 
``[h]er most recent treatment has been OxyContin 160 mg t.i.d. (three 
times a day) and oxycodone 30 mg two tablets, one to two times daily 
which she currently takes. She also takes Valium, 10mg. one p.o. at 
h.s.'' RX 30, at 40.\11\ Respondent maintained, however, that:
---------------------------------------------------------------------------

    \11\ Respondent also noted that DK ``was previously treated with 
methadone, five to six years ago, and also received Percocet in the 
past. She has also a history of diazepam for muscle spasms.'' See RX 
30, at 40. Respondent also noted that DK had undergone physical 
therapy and ``some psychiatric counseling.'' Id.

    There was a dilemma in obtaining her records. We asked many 
times and our option--the only option I saw available to us if she 
would not tell us or remember who she had seen in the past, was to 
fire her. And I felt, as I answered before, that she was a multiple 
diagnosed patient and that would be to her detriment and would be 
poor medical care. So I decided though she could not remember or 
give us the name or produce records, to continue her in my care 
based on my original examination of her, my history I took of her 
---------------------------------------------------------------------------
and her compliance.

Tr. 851-52.\12\
---------------------------------------------------------------------------

    \12\ At the first visit, Respondent prescribed DK 180 tablets of 
OxyContin 80 mg as well as 180 tablets of oxycodone 30 mg. RX 30, at 
40. Respondent issued monthly prescriptions to DK for both drugs, 
increasing the quantity of OxyContin 80 mg to 210 tablets after 
three months; he also issued monthly prescriptions of oxycodone 30 
mg, which were typically for 180 tablets. Id.

    Moreover, shortly after DF questioned the OxyContin 80 mg 
prescription (in early October 2007), Respondent was provided with a 
copy of a letter (dated 9-13-07) written by another physician (Dr. P.), 
which stated that Dr. P. had fired DK for breaking her pain contract, 
specifically citing DK's use of cocaine and narcotics. RX 30, at 20. 
Respondent noted in DK's record that the patient, who provided him with 
this letter, had observed that DK, who had recently stayed in the 
patient's residence, had ``not be[en] compliant with her medications,'' 
and that this was corroborated by the reporting patient's relative. Id. 
at 21.
    On October 19, 2007, Respondent sent out a Fax Net \13\ cancelling 
the narcotic prescriptions he had issued to DK earlier that day. Id. at 
19. However, the following month, he resumed prescribing both OxyContin 
and oxycodone to DK. Id. at 46. Respondent also noted in DK's chart 
that his plan was ``to contact Dr. [P's] office, receive prior 
treatment information from [DK] and review this with prior providers, 
review this with [DK] before making a decision to continuing care for 
her. In the event, opioid medication care is not continued, she will be 
supported with detoxification medication and referral to appropriate 
treatment.''
---------------------------------------------------------------------------

    \13\ A Fax Net is an Arizona State Board of Pharmacy form which 
is used by doctors and pharmacies to report such incidents as forged 
prescriptions, phony telephone prescriptions, doctor shopping, 
prescription pad thefts, and armed robberies. See RX 30, at 19.
---------------------------------------------------------------------------

    Respondent testified that he corroborated with DK's previous 
physician that she had ``violated the pain contract.'' Tr. 844. 
However, he concluded that he ``was her physician and she obviously 
needed additional care.'' Id. According to Respondent, he told DK that 
``in order to continue treatment she would have to get treatment at the 
Behavioral Health Center for this drug problem,'' and that he 
``coordinated with Behavioral Health Center'' and ``required records 
back.'' Id. at 844-45. Respondent then maintained that they ``requested 
actually that I continue the care'' as DK ``continued to have pain and 
needed treatment for that and that was how we proceeded.'' Id. at 845.
    Respondent then explained that he did not fire her at that point 
because:

    Abandoning her would have been unethical and immoral in my mind. 
She was--had multiple problems, including psychiatric. She had been 
apparently to two doctors previously. I felt that if I had fired her 
at that point, she would have gone looking for another doctor. She 
wouldn't have gotten the care she needed. And that as long as she 
was willing to cooperate with a restructured treatment plan and 
supervision, it was my responsibility to care for her.

Id. Respondent further maintained that ``[a]fter we sent her to CODAC 
Behavioral Health, we continued to care for her at a lower dose. 
Communicated with them. She came back to us several months later for 
several more visits.'' Id. at 848.

    Respondent continued to prescribe OxyContin and oxycodone to D.K. 
Indeed, he issued prescriptions for these drugs (as well as others) on 
a monthly basis on multiple occasions following her commencement of 
treatment at CODAC Behavioral Health, up to and including in March 
2008, after which he stopped prescribing OxyContin but continued 
prescribing oxycodone 30mg and added methadone. RX 30, at 46-47. This 
continued through DK's last visit, which occurred on August 27, 2008. 
Id. DK, however, had tested positive for cocaine on June 3, 2008. Id. 
at 3; Tr. 1013.\14\
---------------------------------------------------------------------------

    \14\ While Respondent acknowledged that DK was prescribed 45 
dosage units of oxycodone 30 mg on June 30, 2008, Tr. 1013, he then 
testified that:
    [m]y progress notes only go to June 4th, so I don't know 
anything more than the record reflects that she was prescribed that. 
It may or may not have been me. My last progress note in this is 
June 4, 2008 and then there's one additional note, August 27, `08 
which has really no record except it was a rewrite for a methadone 
script.
    Tr. 1013. While on further questioning, Respondent again 
testified that he did not know whether he or another doctor wrote 
the script, he acknowledged that his office had continued to 
prescribe oxycodone to DK even after her positive test for cocaine. 
Tr. 1015.
     Notwithstanding his testimony that on June 4, 2008, DK ``was 
given a three day supply of oxycodone, 40 to 60 milligrams a day, 
and then it was to be reduced,'' id. at 1014, Respondent later 
acknowledged that between June 4 and August 27, 2008, DK's oxycodone 
prescription was ``increased'' from 15-30 mg per day to thirty mg, 
twice a day. Id. at 1016. Respondent then maintained that RX 30, an 
exhibit he introduced into the record (and which was denominated as 
``Copy of DK Medical Records in Possession of [Respondent],'' was 
``apparently not'' DK's complete patient file, but rather only ``the 
med log'' as ``the notes aren't there that would explain in detail 
what was going on.'' Id. at 1017.

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

[[Page 38370]]

    As set forth above, the Board found that even after Respondent had 
referred DK for treatment for substance abuse, he continued to 
prescribe opiates to her for her back pain. Moreover, the Board found 
that Respondent continued to prescribe opiates to DK after he learned 
that she had successfully completed inpatient opioid 
detoxification.\15\
---------------------------------------------------------------------------

    \15\ According to the affidavit of Dr. Bennett Davis, 
Respondent's medical record for DK included ``notes from CODAC 
behavioral health clinic from 12-04-07 and 03-18-08.'' RX 8, at 7. 
Strangely, the exhibit which Respondent submitted as DK's medical 
record does not contain a note from CODAC dated 3-18-08. See 
generally RX 30.
---------------------------------------------------------------------------

    Of note, DK's medical record contains the results of a single urine 
drug screen, which did not occur until June 3, 2008.\16\ Yet even after 
this screen showed that DK tested positive for cocaine, Respondent 
continued to prescribe to her.
---------------------------------------------------------------------------

    \16\ A letter dated 10/09/08 from Respondent's practice to 
another physician regarding DK's request for medical records stated 
that ``[s]he also tested positive for cocaine on two occasions. She 
was referred to Codac Behavioral Health for additional help and to 
our knowledge she did not complete treatment.'' RX 30, at 1. While 
the log of DK's prescriptions contains an entry for July 28, 2008, 
indicating that a urine drug screen was done on this date, DK's 
patient record, as submitted into evidence, contains the test 
results of only the June 2008 drug screen.
---------------------------------------------------------------------------

    On cross-examination, Respondent testified that ``we didn't have 
all the perfect records.'' Tr. 1027. However, he then asserted that DK 
``wouldn't tell us or couldn't tell what they were.'' Id. When asked if 
he accepted the AMB's judgment regarding his treatment of DK, 
Respondent testified that ``I accept that I didn't do a urine screen 
early on, which we would always do now.'' Id. at 1028. As for the AMB's 
findings that he failed to obtained DK's records, Respondent testified 
that ``I accept that I didn't get old records, which we would handle as 
we handled,'' id. whatever that means.
    As for the Board's findings related to his continued prescribing to 
DK, even after he had referred her to substance abuse treatment and 
even after ``she had completed inpatient opioid detoxification 
treatment,'' (AMB Finding 7), Respondent testified that he did 
not accept the Board's finding. Tr. 1028. According to Respondent, 
``they said I referred her to treatment and that was great that I 
followed her. She continued . . . to have pain and I did that treatment 
at much, much lower doses in conjunction with . . . her behavioral 
health center and at their request. So I think that was appropriate. 
But that's [sic] everybody has differences of opinions.'' Id.

The 2010 AMB Order

    As set forth above, under the terms of the 2009 AMB order, 
Respondent was required ``to participate in the periodic review of his 
patients' charts.'' GX 18, at 14; GX 17, at 6. The Board's staff 
selected three charts at random and provided them to a medical 
consultant who reviewed them and ``found deviations from the standard 
of care in each case,'' as well as ``medical recordkeeping issues.'' GX 
18, at 14. The 2010 AMB Order set forth extensive findings regarding 
three patients, JR, LP, and ML. Id. at 14-16.
    Based on several complaints the Board received regarding his 
treatment and care of multiple patients, the AMB initiated additional 
cases. See generally id. at 2-17. In its 2010 Order, the AMB made 
extensive findings regarding Respondent's treatment of patients AL, KF, 
JF, DD, SS, AM, MF, ML, WO and CJ. See id. at 2-13, 17. Based on these 
findings, the AMB concluded that Respondent had engaged in 
unprofessional conduct, both by ``[f]ailing or refusing to maintain 
adequate records on a patient,'' and by engaging in ``[a]ny conduct or 
practice that is or might be harmful or dangerous to the health of the 
patient or the public.'' Id. at 17 (citing Ariz. Rev. Stat. Sec. Sec.  
32-1401(27)(e) and (q)).\17\
---------------------------------------------------------------------------

    \17\ Under Ariz. Rev. Stat. Sec.  32-1401(2), the term 
```[a]dequate records' means legible medical records, produced by 
hand or electronically, containing, at a minimum, sufficient 
information to identify the patient, support the diagnosis, justify 
the treatment, accurately document the results, indicate advice and 
cautionary warnings provided to the patient and provide sufficient 
information for another practitioner to assume continuity of the 
patient's care at any point in the course of treatment.''
---------------------------------------------------------------------------

JR

    The Board found that Respondent treated JR for reported neck and 
back pain from July 2007 until September 2009. GX 18, at 14. No 
previous medical records were obtained prior to Respondent prescribing 
oxycodone, Xanax and Subutex. Id. Despite normal CT scans of JR's head 
and neck on February 18, 2008, Respondent continued to prescribe 
oxycodone on numerous occasions until August 2009. Id. Respondent 
changed JR's medication on several occasions without documenting his 
reasoning and refilled JR's medication after he reported that it had 
been stolen. Id.
    According to the Board, when treating a patient for chronic pain, 
the standard of care requires a physician to obtain prior records 
pertaining to the past treatment of the patient, and to obtain any 
objective measures for the cause of pain. Id. The Board found that 
Respondent deviated from the standard of care because he did not obtain 
JR's previous medical and/or treatment records prior to prescribing 
opioid medication for reported chronic pain, and that he failed to 
obtain objective measures for the cause of JR's pain. Id. It further 
found that Respondent's conduct could result in an overdose and/or 
perpetuation of drug seeking behavior and addiction. Id.
    The Board also found that Respondent's records were inadequate 
because they failed to document a treatment plan and reasoning for high 
dose opioids in a patient with a history of substance abuse, lost/
stolen medications and positive drug-screen findings. Id. at 15. 
Further, his records failed to adequately document the reasoning for, 
and the results of, his prescribing of Adderall.\18\ Id.
---------------------------------------------------------------------------

    \18\ Regarding JR, as well as LP, CJ, WO and JF, Respondent's 
Expert testified that she believed that Respondent was ``practicing 
with skill and safety,'' (as she had written in her June 7, 2010 
letter to the AMB) in that ``[t]he dosage he prescribed for the 
patients initially based on their symptoms, which of course are 
subjective, were reasonable. When he raised the doses subsequently, 
he did it in a careful manner, and he didn't increase them 
sufficiently to risk the patient's health. So I felt that he was 
skillful and he was taking into consideration the safety of the 
patient.'' Tr. 592-93. Yet in her letter, Dr. Schneider noted ``it 
is difficult at times to reconstruct his reasoning because his 
documentation, although typical of psychiatric patients, needs to be 
more detailed when dealing with chronic pain patients.'' RX 4, at 1. 
And subsequently, Dr. Schneider testified that she ``remember[ed] 
that I read some of [Respondent's] records where he didn't do a 
physical exam on the first visit and things like that.'' Id. at 597. 
Thus, even if the Board's findings were subject to relitigation in 
this proceeding, Dr. Schneider's testimony provides no reason to 
reject the Board's findings.
    Dr. Schneider also took issue with several of the AMB findings, 
asserting that in the case of one patient (AM), ``the consultant 
alleged'' that Respondent ``did not get prior imaging studies'' when 
``those records were in the chart''; that in the case of MF, ``the 
consultant alleged that [he] did not try alternative non-opioid 
treatment before initiating opioid treatment,'' as well as that he 
did not get imaging studies when ``a CT of the thorax was in the 
chart''; and that ``the consultant alleged'' that he did not 
physically examine patient SS at the initial visit, when the results 
were in the chart. RX 4, at 2.
    Here again, Respondent could have raised these contentions with 
the Board. Moreover, even if the Board's findings were subject to 
relitigation, the Board made findings with respect to fourteen 
patients. Thus, even if I were to place no weight on the Board's 
findings with respect to these three patients, the Board's findings 
were essentially unchallenged with respect to most of the other 
patients.
---------------------------------------------------------------------------

LP

    The Board found that LP's chart indicated that in August 2005, 
Respondent began treating LP for his reported history of chronic lower 
back

[[Page 38371]]

pain, DJD, musculoskeletal pain, chronic depression, PTSD, Lupus and 
ADD. Id. On the first as well as subsequent visits, Respondent 
prescribed OxyContin and oxycodone without obtaining past medical 
records. Id. The Board noted that objective data in the records such as 
x-rays were documented as normal; however, Respondent continued to 
treat LP with opioids and/or methadone through October 2009 without a 
documented treatment plan. Id. Respondent increased LP's medications, 
as well as changed them at times without documented reasoning. Id.
    According to the Board, the standard of care when treating a 
patient for chronic pain requires a physician to obtain objective 
measures as to the cause of pain. Id. The Board found that Respondent 
deviated from the standard of care in that he continued to treat LP's 
reported pain with high-dose opioid medications without obtaining 
objective measures as to the cause of the reported pain. Id. The Board 
further found that Respondent's conduct could result in an overdose or 
perpetuation of drug seeking behavior and addiction. Id. at 16.
    The Board also noted that Respondent's records were inadequate 
because they fail to adequately document the initial visit, treatment 
plan and reasoning for high dose opioids and changes in medications, in 
violation of Ariz. Rev. Stat. Sec.  32-1401(2).

ML

    The Board made findings pertaining to ML, a twenty-three year old 
male, as part of both the random chart review it conducted pursuant to 
the 2009 Order, as well as the case it opened following the receipt of 
a complaint regarding Respondent's care and treatment of him.\19\ Id. 
at 9, 16.
---------------------------------------------------------------------------

    \19\ This individual is not the same person as the confidential 
source who made undercover visits to Respondent on May 2 and June 6, 
2008, and was also referred to by the initials ML.
     Respondent also elicited testimony from an individual with the 
same initials, who testified that he was treated by Respondent for 
spondylolisthesis. Tr. 464-94. The testimony of this individual 
suggests he may well have been the same ML as discussed in the AMB's 
2010 Order. Compare GX 18, at 9 (discussing ML's treatment at 
methadone facility) with Tr. 474, 484-8 (ML testifying about his 
treatment by methadone program). The record does not, however, 
definitively establish if the ML who testified and the ML discussed 
in the AMB's Order are one and the same.
---------------------------------------------------------------------------

    The Board found that in October 2006, Respondent diagnosed ML with 
spondylolisthesis based on his reported history and that he prescribed 
oxycodone, but that he did not perform a facet, sacroiliac joint, 
myofascial pain or neural flexes examination on ML, nor did he test him 
for weakness or numbness. Id. at 9. The Board also found that 
Respondent did not order flexion extension films to assess spinal 
instability from spondylolisthesis or an MRI scan to assess for neural 
compression. Id. Moreover, in the course of its chart review, the Board 
found that there was an x-ray in the chart dated February 18, 2008, 
which stated: ``NO evidence of spondylolisthesis.'' Id. at 16.
    The Board found that in November 2007, Respondent documented that 
ML had, on his own, increased the oxycodone medication. Id. at 9. 
However, there was no documentation that Respondent cautioned ML to 
adhere to his dosing instructions. Id.
    The Board also found that from January through December 2007, 
Respondent prescribed multiple early refills of oxycodone, that he 
added hydrocodone to the regime in January but discontinued it in March 
without indication, and that from February through December 2008 
Respondent prescribed multiple early refills of oxycodone.\20\ Id. It 
also found that in June 2008 Respondent was notified that ML was 
undergoing methadone treatment at a facility; however, Respondent he 
did not obtain ML's medical records from that facility. Id.
---------------------------------------------------------------------------

    \20\ Here again, Respondent's Expert did not take issue this 
finding. Tr. 675.
---------------------------------------------------------------------------

    Next, the Board found that Respondent discharged ML from opioid 
therapy in January 2009, but restarted opioids in March 2009, without 
documenting an explanation. Id. Moreover, the Board found that even 
after he was placed on probation pursuant to the 2009 Order, 
``Respondent continued to prescribe high-dose opioids to ML for pain 
secondary to spondylolisthesis'' until September 2009. Id. at 16. The 
Board noted that during the course of Respondent's treatment of ML 
there was no further documentation that he performed any examinations 
prior to prescribing the medications, or that he obtained ML's past 
medical records or diagnostic studies. Id. at 9-10.
    According to the Board, prior to initiating high dose opiate 
therapy, the standard of care requires a physician to perform an 
adequate exam for pain generators, obtain the patient's past medical 
records and diagnostic studies, offer the patient adjunct treatments 
that include non-opioid medications and physical therapy, address 
aberrant drug seeking behaviors, and refrain from prescribing more than 
one month of Schedule II prescriptions at a time. Id. The Board found 
that Respondent deviated from the standard of care because he did not 
perform an adequate exam prior to initiating high dose opiate therapy, 
did not obtain ML's past medical records and diagnostic studies, did 
not offer adjunct treatments, did not address ML's aberrant drug-
seeking behaviors, and did not refrain from prescribing more than one 
month of schedule II prescriptions at a time. Id.
    As it noted with the previously discussed patients, the Board also 
found that when treating a patient for chronic pain, the standard of 
care requires a physician to obtain objective measures as to the cause 
of pain. Id. at 16. The Board thus found that Respondent violated the 
standard of care by continuing to treat ML's reported pain with high-
dose opioids without obtaining objective measures for the cause of his 
pain, and that his conduct could result in the perpetuation of ML's 
drug-seeking behavior/addiction or an overdose. Id. In addition, the 
Board found that there was potential for diversion or abuse of the 
oxycodone. Id. at 10.
    Finally, the Board found that ``[a] physician is required to 
maintain adequate legible medical records containing, at a minimum, 
sufficient information to identify the patient, support the diagnosis, 
justify the treatment, accurately document the results, indicate [the] 
advice and cautionary warnings provided to the patient and provide 
sufficient information for another practitioner to assume continuity of 
the patient's care at any point in the course of treatment.'' Id. at 11 
(citing Ariz. Rev. Stat. Sec.  32-1401(2)). The Board thus found that 
``Respondent's records were inadequate[,] because there was no 
documentation that [he] performed any [neurologic] and musculoskeletal 
examinations prior to prescribing opioid therapy, no documentation that 
he cautioned ML to stay within the prescribing instructions, no 
documented rationale for re-starting opiates again later[,] and that 
[he] did not obtain ML's medical records from the treatment facility or 
from his previous treating physicians.'' Id.
    During the hearing, Respondent's expert did not dispute the Board's 
findings with respect to Respondent's multiple early refills for ML. 
Tr. 675. She also did not dispute that notwithstanding that ML had 
tested positive for both marijuana and cocaine, as well as 
benzodiazepines which Respondent had not prescribed on previous visits, 
Respondent continued to prescribe oxycodone to him. Id. at 675-76. Nor 
did she dispute that ML

[[Page 38372]]

had tested negative for oxycodone even though Respondent had prescribed 
the drug to him at the preceding visit. Id. at 677. While Dr. Schneider 
testified that there might be a valid reason why a short acting opioid 
might not turn up in a urine drug screen (depending upon when it was 
taken), she testified that the physician ``need[s] to find out when the 
patient took their last dose so that you can find out if there's some 
legitimate reasons for why they[sic] tested negative when one would 
have expected it to be positive.'' Id. at 679. And notwithstanding that 
the ALJ allowed Respondent to relitigate the Board's findings, 
Respondent offered no evidence as to whether ML had a legitimate reason 
for testing negative for oxycodone.\21\
---------------------------------------------------------------------------

    \21\ Nor did she dispute the Board findings that Respondent had 
continued to prescribe opioids to individuals with anomalous urine 
drug screens, such as where patients tested positive for drugs he 
had not prescribed or illicit street drugs, or had tested negative 
for drugs he had prescribed. Tr. 678-80.
---------------------------------------------------------------------------

CJ

    Following its receipt of a complaint from a pharmacy alleging 
inappropriate prescribing by Respondent, the Board investigated his 
treatment of CJ. GX 18, at 17. The Board found that Respondent 
``prescribed large amounts of opioids to . . . CJ with an inadequate 
treatment plan,'' and that he did so even though ``CJ had a history of 
testing positive for [h]eroine [sic], [o]xycodone, [m]orphine and 
[c]ocaine.'' Id. The Board also found that ``on two occasions, CJ 
tested positive for narcotics that were not prescribed by Respondent.'' 
Id.
    According to the Board, ``[t]he standard of care is to develop an 
adequate treatment plan prior to prescribing opioids and to treat the 
patient's substance abuse problem before treating pain.'' Id. The Board 
found that Respondent violated this standard when he ``prescribed 
opioids to CJ without an adequate treatment plan,'' and that he 
``exposed the patient to possible drug overdose and drug diversion.'' 
Id.

AL

    The Board found that on November 6, 2006, AL, who was then an 
eighteen year old female, presented to Respondent complaining of 
moodiness and irritability. Id. at 2. Respondent diagnosed AL as having 
Attention Deficit Hyperactivity Disorder and prescribed Adderall (a 
schedule II stimulant) to her, but did not document the prescription in 
AL's record. Id. The Board found that there was no documentation that 
Respondent performed an adequate psychiatric evaluation, which included 
ordering laboratory studies; that he had obtained her past medical 
records, her history of alcohol or substance abuse, and her psychiatric 
history; or that he performed a functional assessment to support his 
diagnosis and prescription. Id. The Board also found that there was no 
initial treatment plan documented in the record. Id.
    The Board further found that ``[f]rom November 2006 through 
February 2009, Respondent provided AL with frequent, early and 
escalated doses of Adderall without documenting any rationale for doing 
so.'' Id. Moreover, the Board found that ``[o]n several occasions[,] AL 
attempted to refill her Adderall prescription early. There was, 
however, no documentation that Respondent investigated or addressed 
AL's rationale for doing so. Id.
    Next, the Board further found that during the course of AL's 
treatment, Respondent added Prozac, Cymbalta, Lorazepam, and Zoloft 
\22\ to her medication regime but did not document his rationale for 
the medications or whether he discussed the risks and benefits of 
taking them. Id. There was also no documentation that he ordered any 
laboratory studies to support his continued prescribing of Adderall, or 
urine drug screens to determine whether AL was taking the medications 
as prescribed and/or any illicit substances. Id. Further, several of 
Respondent's progress notes were illegible. Id.
---------------------------------------------------------------------------

    \22\ Of these drugs, only Lorazepam is controlled. See 21 CFR 
1308.14(c).
---------------------------------------------------------------------------

    The Board found that the standard of care requires a psychiatrist 
to perform adequate psychiatric evaluations prior to commencing 
treatment, and that when prescribing Adderall, a physician is required 
to perform tests to confirm the diagnosis and the necessity of the 
medication, and to monitor the patient's use of the medication. Id. at 
3. The Board thus found that Respondent deviated from the standard of 
care in that he did not perform an adequate psychiatric evaluation of 
AL, he did not perform tests to confirm his diagnosis and the necessity 
of medication, and he did not monitor AL's use of the medication. Id.
    The Board further found that there was no collateral information in 
AL's record to support prescribing Adderall, which created a potential 
for misdiagnosis, addiction, abuse, misuse, overdose and diversion. Id. 
The Board also found that because no urine drug tests were performed, 
it was unknown whether AL was taking the medication as prescribed and/
or whether she was utilizing illicit substances. Id.
    Finally, the Board found that Respondent's records did not comply 
with Ariz. Rev. Stat. Sec.  32-1401(2), because there was no 
documentation of the initial Adderall prescription, no documented 
initial treatment plan, the psychiatric evaluation was inadequate, 
there was no documented rationale for his prescribing of several 
medications, and several of his progress notes were illegible, 
including his use of non-standard abbreviations.\23\ Id.
---------------------------------------------------------------------------

    \23\ When asked about the Board's finding that ``Respondent 
provided AL with frequent early and escalated doses of Adderall,'' 
Respondent's Expert did not take issue with this finding. Tr. 668-
69.
---------------------------------------------------------------------------

KF

    The Board found that on March 25, 2008, Respondent began treating 
KF, a twenty-one year old female patient, who complained that she had 
``difficulty finishing tasks and focusing.'' Id. at 4. Respondent 
prescribed Adderall to KF, yet ``[t]here was no documentation that [he] 
obtained her past medical records or ordered any laboratory tests that 
would qualify KF for a diagnosis to support the use of Adderall.'' Id. 
Respondent prescribed frequent early refills at several subsequent 
office visits without documenting any rationale for the refills. Id. 
Moreover, on November 4, 2008, Respondent increased KF's dose of 
Adderall from 20 mg to 30 mg, without any rationale for the 
prescription. Id. There was no documentation that Respondent ordered 
any laboratory studies to support his continued prescribing of the 
drug, or any urine drug screens to determine whether KF was taking the 
medications as prescribed and/or any illicit substances; also, 
``several of Respondent's progress notes were illegible.'' Id.
    The Board found that the standard of care requires a psychiatrist 
to perform adequate psychiatric evaluations, and that Respondent 
deviated from the standard of care because he did not perform an 
adequate psychiatric evaluation. Id. The Board also found that the 
standard of care requires a physician who prescribes Adderall ``to 
obtain prior medical records, perform tests to confirm the diagnosis 
and the necessity of the medication[,] and to monitor the patient's use 
of the medication.'' Id. The Board thus found that ``Respondent 
deviated from the standard of care because he did not obtain prior 
medical records, perform tests to confirm the diagnosis and the 
necessity of the medication[,] and he

[[Page 38373]]

did not monitor KF's use of the medication.'' Id.
    The Board also found that ``[t]here was no collateral information 
to support prescribing Adderall, creating a potential for misdiagnosis, 
addiction, abuse, misuse, overdose and diversion. Since no urine drug 
tests were performed it is unknown whether KF was taking the medication 
as prescribed and/or whether she was utilizing illicit substances.'' 
Id. at 4-5.
    Finally, the Board found that Respondent's records were inadequate 
because he did not obtain KF's past medical records, did not document a 
physical examination prior to prescribing medications, did not document 
any rationale for the prescriptions, dosage escalations, additions of 
medication, that several of Respondent's progress notes were illegible, 
and that he used non-standard abbreviations.\24\ Id. at 5 (citing Ariz. 
Rev. Stat. Sec.  32-1401(2)).
---------------------------------------------------------------------------

    \24\ Here again, Respondent's Expert did not dispute the Board's 
finding that Respondent provided AL with ``frequent early refills of 
Adderall.'' Tr. 669. She also did not ``take issue with the fact 
that this dose was increased.'' Id. at 670.
---------------------------------------------------------------------------

JF

    The Board found that Respondent began treating patient JF, a 
nineteen-year old female patient in August 2007 for chronic pain, 
Attention Deficit Disorder and Obsessive Compulsive Disorder. Id. JF 
reported current prescriptions of OxyContin 40 mg and oxycodone 30 mg. 
Id. There was neither a documented physical examination nor laboratory 
studies, and Respondent did not obtain past medical records. Id. 
Respondent, however, prescribed 90 tablets of OxyContin 40 mg, 45 
tablets of oxycodone 30 mg, and Requip to her. Id.
    The Board found that Respondent added Adderall to JF's medication 
regime in October 2007, without documenting any rationale for the 
medication. Id. It also noted that during the course of JF's treatment, 
she reported on multiple occasions damaged or stolen prescriptions, 
running out of medication, and that the pharmacy had refused to fill a 
prescription because of different handwriting. Id. However, Respondent 
continued to prescribe to her and escalated the doses of oxycodone and 
Adderall. Id. The Board further found that there was no documentation 
that Respondent ordered laboratory studies to support his continued 
prescribing of OxyContin, oxycodone, and Adderall, or that he did any 
urine drug screens to determine whether JF was taking the medications 
as prescribed and/or illicit substances. Id. at 5-6. In addition, there 
was no documentation that Respondent referred JF to a specialist for 
consultation. Id. at 6.
    The Board found that that the standard of care requires a 
psychiatrist to perform adequate psychiatric evaluations, and that 
Respondent deviated from the standard of care because he did not 
perform an adequate psychiatric evaluation for JF. Id. In addition, the 
Board found that when a physician prescribes Adderall, the standard of 
care requires that he perform tests to confirm the diagnosis and the 
necessity of the medication and to monitor the patient's use of the 
medication, and that Respondent deviated from this standard because he 
prescribed the drug without performing tests to confirm the diagnosis 
and the necessity of the medication and did not monitor JF's use of the 
medication. Id.
    Next, the Board found that when prescribing opioids for the 
treatment of chronic pain, the standard of care requires a physician to 
review previous diagnostic studies and interventions, assess the 
chronic pain complaint prior to initiating an opioid trial, 
appropriately monitor the patient's use of the medication, and obtain 
appropriate therapeutic and laboratory test results that support the 
diagnosis. Id. The Board found that Respondent deviated from the 
standard of care because he did not review past medical records and he 
did not order appropriate tests or consultations for JF. Id.
    The Board further found that there was no collateral information to 
support prescribing Adderall, which created a potential for 
misdiagnosis, addiction, abuse, misuse, overdose and diversion, and 
that no urine drug tests were performed to determine whether JF was 
taking the medication as prescribed. Id. The Board also found that 
Respondent's medical records for JF were inadequate because he did not 
obtain JF's past medical records, did not document a physical 
examination prior to prescribing medications, did not document any 
rationale for prescriptions, dosage escalations, and additions of 
medication. Id. at 7. Further, it found that Respondent used non-
standard abbreviations in his records. Id. (citing Ariz. Rev. Stat. 
Sec.  32-1401(2)).

DD, SS, AM & MF

    The Board found that in 2008, Respondent treated patients DD, SS, 
AM and MF for chronic pain. Id. He prescribed medications that included 
OxyContin and oxycodone based on the patients' reported history and 
complaints of chronic pain. Id. Yet the Board found that there was no 
documentation that Respondent obtained past medical records to confirm 
the patients' diagnoses. Id. Moreover, the Board found that during the 
course of his treatment, Respondent provided early refills and 
escalated the patients' doses of OxyContin and oxycodone, without 
documenting any rationale to support his diagnosis or prescribing. Id.
    The Board further found that Respondent ``did not perform adequate 
physical examinations, obtain past medical records, or order diagnostic 
and laboratory studies.'' Id. Also, there was no documentation that 
Respondent referred the patients to a specialist to confirm his 
continued prescribing of opioids, or that he performed any urine drug 
screens to determine whether the patients were taking the medications 
as prescribed and/or illicit substances. Id.
    The Board found that when prescribing opioids for the treatment of 
chronic pain, the standard of care ``requires a physician to review 
past diagnostic studies and interventions, assess and confirm the 
chronic pain complaint prior to initiating an opioid trial, 
appropriately monitor the patient's use of the medication, and obtain 
appropriate therapeutic and laboratory results that support the 
diagnosis. Id. at 8.
    The Board found that Respondent deviated from the standard of care 
because he did not review DD's, SS's, AM's and MF's past diagnostic 
studies and interventions, assess and confirm their chronic pain 
complaints prior to initiating an opioid trial, appropriately monitor 
their use of the medication, and obtain appropriate therapeutic and 
laboratory test results that supported his diagnoses of chronic pain. 
Id. The Board further found that there was no collateral information to 
support prescribing opioids to DD, SS, AM and MF, thus creating the 
potential for misdiagnosis, addiction, abuse, misuse, overdose and 
diversion, and that because no urine drug tests were performed, it was 
unknown whether they were taking the medication as prescribed and/or 
whether they were utilizing illicit substances. Id.
    Finally, the Board found that Respondent's records for patients, 
DD, SS, AM, and MF were inadequate because he did not obtain past 
medical records, did not document adequate physical examinations or 
laboratory and diagnostic studies prior to prescribing medications, did 
not obtain any diagnostic studies to support his continued prescribing 
of medications,

[[Page 38374]]

and did not document any rationale for prescriptions and dosage 
escalations.\25\ Id. at 8-9 (citing Ariz. Rev. Stat. Sec.  32-1401(2)).
---------------------------------------------------------------------------

    \25\ When asked about the Board's finding with respect to these 
four patients that ``[d]uring the course of treatment Respondent 
provided early refills and escalated the patient doses,'' 
Respondent's Expert testified that she didn't know whether or not it 
was appropriate for Respondent to increase the patients' doses 
``because he didn't document it.'' Tr. 670-71.
---------------------------------------------------------------------------

WO

    The Board investigated a complaint regarding Respondent's care and 
treatment of patient WO, a fifty-two year old male, for chronic pain 
syndrome. Id. at 11. Respondent assumed WO's care in January 2008, at 
which time ``WO was on [o]xycodone, [m]orphine [s]ulfate immediate 
release (MSIR) and Soma, which had been prescribed by his previous 
physician.'' Id.
    The Board found that Respondent reviewed previous imaging studies, 
including a computed tomography scan of WO's pelvis and abdomen that 
showed healed lower right lateral rib fractures, but no other 
abnormalities, and a cervical spine film that showed mild hypertrophic 
degenerative changes in the mid-cervical spine, but no other 
abnormalities. Id. The Board found that from WO's initial visit until 
July 2009, Respondent continued to see WO and refill the prescriptions. 
Id. The Board found, however, that there was no documentation that he 
performed a neurological or musculoskeletal exam or ordered any imaging 
studies of WO's lumbar spine or laboratory studies, prior to continuing 
the treatment of WO's previous physician. Id.
    The Board also found that from March 2008 through December 2008, 
Respondent increased WO's dosage of oxycodone 30 mg to six tablets per 
day. Id. at 12. Moreover, on May 30, 2008, Respondent added Morphine 
Sulfate (MS) Contin 30 mg for poor sleep, but subsequently increased 
the dose without documenting a rationale for the increase. Id. Yet 
there was no documentation that Respondent performed any physical 
examinations or obtained any radiologic studies to support his 
increased opioid prescribing. Id.
    Next, the Board found that in February 2009, Respondent 
discontinued prescribing MS Contin to WO and instead prescribed six 
tablets per day of morphine sulfate 30 mg to him. Id. The Board found 
that Respondent simultaneously increased WO's oxycodone dose to eight 
tablets per day, yet did not document a rationale for the increase. Id.
    In March 2009, Respondent performed a urine drug screen on WO; the 
screen was negative for oxycodone, but positive for methadone and 
codeine, which were not among his prescribed medications, as well as 
heroin. Id. At WO's next visit, Respondent documented that he was aware 
of the positive drug screens. Id. The Board found however, that 
Respondent did not adequately investigate or address the abnormal 
results by either referring him to an addiction medicine specialist or 
discontinuing the opioid prescriptions. Id.
    The Board found that the standard of care requires a physician to 
perform an adequate work up of a patient prior to continuing treatment 
of the patient's prior treating physician, to perform an adequate 
physical examination, and to obtain radiologic data to support the 
amount of opioid medications prescribed to the patient. Id. The Board 
found that Respondent deviated from the standard of care because he did 
not perform an adequate work-up and that the physical examination and 
radiologic data did not support the amount of opioid medications he 
prescribed to WO. Id. at 12-13.
    The Board also found that the standard of care requires a physician 
to adequately investigate or address a patient's abnormal urine drug 
screen. Id. at 13. The Board found that Respondent deviated from the 
standard because he did not adequately investigate or address WO's 
abnormal urine drug screen. Id.
    The Board further found that Respondent allowed WO to continue a 
pattern of illicit substance use and opioid misuse. Id. The Board found 
that that Respondent's prescribing of 240 tablets of oxycodone per 
month also created a potential for misuse and diversion.\26\ Id. 
Finally, the Board found that Respondent's records were inadequate 
because there was no documentation that he performed a neurological or 
musculoskeletal examination, ordered any imaging or lab studies prior 
to continuing the treatment, and there was no documented rational for 
his excessive prescribing of opioids. Id. (citing Ariz. Rev. Stat. 
Sec.  32-1401(2)).
---------------------------------------------------------------------------

    \26\ The Board also found that ``[t]he long-term use of Soma has 
the potential for habituation and misuse.'' GX 18, at 13. However, 
at the time, Soma (carisoprodol) was not a controlled substance 
under federal law.
---------------------------------------------------------------------------

Summary of the 2010 Order

    Based on its findings with respect to all of the patients, the 
Board found that Respondent committed unprofessional conduct by 
``failing or refusing to maintain adequate records on a patient,'' 
Ariz. Rev. Stat. Sec.  32-1401(27)(e), as well as by engaging in 
``[a]ny conduct or practice that is or might be harmful or dangerous to 
the health of the patient or the public,'' Ariz. Rev. Stat. Sec.  32-
1401(27)(q). GX 18, at 17. The Board issued Respondent a Decree of 
Censure and prohibited him ``from prescribing, administering or 
dispensing any opioids for a period of one year.'' Id. at 18. It also 
placed him on probation for two years; among the terms of the 
probation, Respondent was required ``to complete the PACE prescribing 
course within 6 months of the effective date of this Order'' and enter 
into a contract providing for quarterly chart reviews by a monitor. Id.
    Regarding the 2010 AMB Order, Respondent testified that the Board 
had reviewed 45 of his patient records and had not criticized his 
recordkeeping other than with respect to the thirteen that were the 
subject of the Order. Tr. 856-58. He asserted that the reason his 
recordkeeping was inadequate was because his ``early training and 
practice was primarily in psychiatry'' where ``[t]he confidentiality of 
the patient is paramount,'' such that his ``[n]otes were often brief'' 
and hit just ``the main points'' of the patient's ``main complaint, 
perhaps a mental status examination, the diagnosis and the plan.'' Id. 
at 859-60. He then testified that ``the main purpose of the record was 
to refresh your own memory and wasn't necessarily always focused on 
outside review,'' id. at 860, but that he was now ``making every effort 
to make the record transparent to outside individuals, which was really 
not the standard of care or the practice for psychiatry.'' Id. at 861.
    Respondent further testified that during the period in which the 
AMB was investigating his prescribing to D.K., he sought out assistance 
from other pain management physicians, studied for and took the board 
in Pain Medicine, read multiple textbooks and took online courses. Id. 
at 864. He also testified that he had complied with the 2010 Order's 
practice restriction, which prohibited him from prescribing opioids, 
and that the restriction had been lifted. Id. at 870.
    As far as other measures he has undertaken since 2007, Respondent 
stated that his practice was now able to use the Arizona Controlled 
Substance Prescription Monitoring Program, that the office was now 
certified to do in-office urine testing and that it was doing random 
urine screening, that the office was using the fax alert system, and 
that he was now placing ``[a] very high priority'' on calls from 
pharmacies. Id.

[[Page 38375]]

at 870-72. Respondent also stated that he had imposed an ``internal 
kind of ceiling on opiate dosing,'' and that ``[w]e're not a 
prescribing mill.'' Id. 874, 877.
    Regarding the second AMB Order, Respondent testified that ``there 
was a Board statement that no actual harm was found in any patient'' 
and ``no patients . . . were found to have been diverting substances.'' 
Id. at 883. He then asserted that ``[t]here was no potential addiction, 
which was perpetuated by my behavior, which is one of the claims.'' Id. 
When asked whether he accepted the AMB's criticism of his recordkeeping 
and care of his patients, Respondent testified: ``Yes. I realize this 
is a difficult area and that I need to keep working to improve and I 
have and I will.'' Id. at 884. Respondent then testified that ``I 
accept the general criticism that there needs to be improvement of my 
care as I can do so'' but that he did not agree with some of the 
specifics of the Order, as his Expert had testified. Id.

The Undercover Visits

    The Government also introduced evidence that it sent two 
confidential sources (CS) into Respondent's office to obtain controlled 
substances; each source performed two visits and obtained controlled 
substances at each visit. With respect to these visits, the Government 
introduced the recordings (and transcripts) of each visit, and the 
medical record for each CS. In addition, the Government elicited 
testimony from a Special Agent (S/A) who was involved in conducting the 
visits and debriefing the CSs after the visits.
    The Government did not, however, elicit testimony from an expert 
witness regarding whether Respondent had acted within the usual course 
of professional practice and with a legitimate medical purpose when he 
prescribed to the two CSs. Instead, it argues that the evidence shows 
that ``on four occasions,'' Respondent prescribed controlled substances 
to the CSs ``without ever conducting a physical examination,'' and that 
the prescriptions violated an Arizona Statute, which provides that it 
is `` `[u]nprofessional conduct' '' 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,' '' and 
therefore, the prescriptions violated 21 CFR 1306.04(a). Gov. 
Exceptions at 3 (quoting Ariz. Rev. Stat. Sec. Sec.  32-1401(27)(ss)).
    With respect to RL, the evidence showed that she visited Respondent 
on April 9 and May 7, 2008, obtaining a prescription for 120 oxycodone 
5 mg at the first visit and a prescription for 60 OxyContin 20 mg. at 
the second visit. See GXs 3 and 5. In addition, the S/A testified that 
during the debriefing of RL following her visit, RL said that ``she 
told [Respondent] where she had pain'' and that Respondent ``asked a 
series of questions regarding exercise, sleep, family history, 
basically general medical questions as to how her life is, what her 
occupation is, what she does, is she stressed out, does she have 
anxiety, things of that nature.'' Tr. 358. The S/A further testified 
that RL did not provide any medical records to Respondent and that RL 
``said there was no physical examination.'' Id. at 359.
    According to the transcript of the visit, RL complained of having 
hip pain which was caused by a fall. GX 11, at 2. Respondent asked RL a 
series of questions, including when she had fallen; whether her hips 
had been ok prior to the fall; whether she had had an x-ray or MRI, and 
whether the x-ray showed arthritis; whether the pain bothered her when 
she did various body movements and whether it went down her leg; how 
often she had the pain; whether it was a sharp or dull pain; whether 
she had any numbness; whether it impaired her ability to walk; whether 
it affected her ability to sleep, her appetite, her energy, and her 
mood; whether she had anxiety attacks; whether she drank alcohol; 
whether she had taken any medication for the pain and whether it had 
helped; whether her health was otherwise good; and whether her family 
had certain medical conditions. Id. at 3-8; 13-15; 18-22. Respondent 
also discussed various forms RL needed to complete, including one to 
describe her pain, his controlled substance contract, and a form 
regarding which pharmacy she was using. Id. at 25. Respondent then told 
RL that oxycodone and Percocet were ``not refillable'' and that the 
long-term effect of taking oxycodone could include constipation and 
affect her level of hormones. Id. at 29.
    Although the transcript corroborates some of RL's hearsay 
statements (as related by the S/A), significantly, the transcript shows 
that early on in the visit, the following colloquy occurred:

    Respondent: Do you have any tenderness if, if you push on it 
like this?
    RL: Yeah.
    Respondent: Where does it hurt? Just when you push on it here?
    RL: Directly on it, yes.

Id. at 6.

    While the above colloquy does not foreclose the possibility that 
Respondent may actually have palpated only his own hip and not RL's, 
the Government had the burden of proof on the issue and produced no 
other evidence other than the conclusory testimony of the S/A regarding 
RL's statement that Respondent did not perform a physical exam on 
her.\27\
---------------------------------------------------------------------------

    \27\ While the transcript for RL's second visit contains no 
indication that Respondent physically examined her, and the S/A 
testified that RL stated that she was not physically examined on 
that occasion, see Tr. 367, the Arizona statute does not require 
that a physician physically examine his patient on each occasion 
that he prescribes a controlled substance to her. See Ariz. Rev. 
Stat. Sec. Sec.  32-1401(27)(ss)). Nor did the Government offer any 
evidence that under the standard of care, a physician is required to 
perform a physical exam on each occasion that he prescribes.
---------------------------------------------------------------------------

    With respect to the second CS (ML), the evidence showed that she 
saw Respondent on May 2, 2008 and June 6, 2008. GX 6, at 1; GX 8, at 1. 
At the first visit, Respondent prescribed 30 oxycodone 5 mg to ML, GX 
6, at 1; at the second visit, Respondent prescribed both 30 oxycodone 5 
mg and 30 morphine sulfate ER 15 mg. GX 8, at 1.
    According to the S/A, during the debriefing following her first 
visit, ML stated ``that an evaluation was done with questions based on 
anxiety, sleep, her family history, [and] what her pain was. She said 
she had a pain in her shoulder due to her occupation.'' Tr. 373. ML 
also told Respondent that she had undergone gastric bypass surgery and 
``how much weight she had lost.'' Id. The S/A further testified that ML 
did not provide Respondent with any medical records on this visit, and 
when asked what type of physical examination Respondent had performed 
on her during the visit, ML answered: ``[n]one.'' Id.
    The transcript for the visit shows that after discussing her dental 
pain, ML complained of pain, stated that the pain was ``right here'' 
and that it was ``really hurting . . . a lot!'' GX 15, at 4. Respondent 
then asked if the pain was in the bone or ``the joint here?'' Id. ML 
stated that ``it's like a muscle type tissue or something.'' Id. 
Respondent then asked ML to ``point right there,'' ML said, ``[i]t, it 
hurts.'' Id. at 4-5. Respondent suggested that ML should ``maybe . . . 
get that injected'' and asked ``[w]hen did that start?'' Id. at 5. ML 
stated that she didn't remember when, or what she was doing when she 
started feeling the pain, and that she had to alter the position of her 
bra strap. Id.
    After discussing that Respondent was also a psychiatrist, 
Respondent suggested that ML see his colleague, Dr. Skinner, who 
``might be able to adjust that,'' and asked if the pain went down

[[Page 38376]]

her arm. Id. at 5-6. ML replied in the affirmative and said it was 
``hard for'' her because ``what I do is on the phone.'' Id. at 6. 
Respondent then suggested that ML use a headset so she could keep her 
``head up straight,'' and asked, ``how often does that hurt you?'' Id. 
ML said the pain ``comes and goes,'' but that ``it's been about a month 
now that . . . it pulls.'' Id. Respondent then said he would see if Dr. 
Skinner would be available to help ML and asked ``what else is going 
on?'' Id. ML then complained that ``I get emotional'' and ``just stress 
out because I think people are looking at me''; ML and Respondent then 
discussed ML's efforts to lose weight and her having undergone a 
gastric bypass procedure. Id. at 7-9.
    Next, Respondent asked ML if she was ``sleeping okay''; ML replied 
that she had ``a sleeping disorder'' for which she took ``some sleeping 
pills.'' Id. at 9. Thereafter, Respondent asked ML ``about [her] 
energy'' (with ML stating that she fatigued easily), if she was 
``irritable or grouchy'' (with ML answering in the affirmative), and 
whether ML had anxiety or panic attacks, (with ML saying just when she 
hurt). Id. at 10. Respondent again asked ML, ``what hurts? It's, it's 
this area in your shoulder?'' and ML replied ``it's the shoulder, my 
back.'' Id.
    Respondent then asked ML if she had depression (with ML saying she 
did not think so), whether she drank alcohol (ML answering ``no''), 
what ML took to sleep (with ML saying she had ``no idea''), whether she 
took any other medications (with ML apparently answering that she took 
a drug for blood pressure), and whether she had ``any other health 
problems'' (with ML answering ``no.''). Id. at 11-12. Following this, 
Respondent asked ML a series of questions about her family, including 
whether her parents were still alive, whether she had siblings, whether 
she was married and had children, as well as where she was living, and 
the circumstances surrounding the death of her mother. Id. at 12-17. 
Respondent then asked ML if she had ever taken medication for anxiety 
or depression; ML replied that she had taken Lexapro for a while and 
that it had helped but that she didn't have insurance and the drug was 
expensive. Id. at 17-18. ML added that the only drug she was presently 
taking were her ``pain pills'' and that they made her ``feel better.'' 
Id. at 18. When Respondent asked ML what she had taken in the past, the 
latter said that she had tried hydrocodone but was allergic to it, and 
that the only drug she thought she could take was oxycodone. Id. 
Respondent then asked how much oxycodone she could take; ML said she 
could take one a day and that the drug ``calm[ed her] down a lot,'' but 
that she did not know how many milligrams the pills were. Id. at 18-19. 
ML then said she was just really nervous and explained that she worked 
as a phone sex operator and that she had previously worked as a 
financial counselor at a hospital. Id. at 20-22.
    Respondent asked ML who had previously given her pain medication; 
ML identified the name of a doctor and his practice. Id. at 22. 
Respondent then said he would see if Dr. Skinner was available and 
suggested that she might be able to ``fix'' ML's injured area and added 
that he would get ML some prescriptions. Id. at 24. Respondent then 
found Dr. Skinner and brought her to see ML. Id. at 26.
    Respondent explained to Dr. Skinner that ML ``ha[d] a crook on her 
neck,'' which was ``like a . . . [a] little rock in there.'' Id. 
Notably, before Respondent completed this sentence, ML stated: ``That 
right there!'' Id. ML then complained that she could not move her arm 
very well and again said that she had to alter where she wore her bra 
strap. Id.
    Dr. Skinner then observed that ML's shoulders were straight but 
that her ``neck [wa]s out,'' and after an unintelligible comment by 
Respondent, replied ``I know.'' Dr. Skinner then said that she would 
``rotate it to the right . . . and then to the left.'' Id.at 27. ML 
asked if that was ``from a muscle spasm?'' Id. Dr. Skinner asked ML if 
she was ``on the phone,'' and after ML said that it was her ``job,'' 
Skinner stated: ``Okay, listen to me. Don't do that!'' Id. Respondent 
and Dr. Skinner then discussed with ML that she needed to get a headset 
or some other device so that ML could keep her head upright while she 
was on the phone. Id. at 27-28. ML then asked Dr. Skinner if she could 
``feel that?'' Id. Dr. Skinner said ``[y]eah,'' and Respondent asked if 
there was something such as acupuncture'' that could be useful. Id. at 
28-29.
    Dr. Skinner then told ML not to ``resist [her] pain'' and explained 
that ``it's stuck because you keep your head in the wrong position'' 
and that ML was ``not going to be able to fix it, if [she] ke[pt] using 
[her] head, putting [her] head . . . that way.'' Id. at 29. ML said 
``[a]h,'' and Dr. Skinner stated: ``Don't resist it please.'' Id. ML 
said ``[o]kay,'' and Dr. Skinner replied: ``Just accept it, until I say 
move. You might need to come back . . . I think it's going to take some 
time.'' Id. ML said ``now it's starting to feel a little better''; 
Skinner replied: ``Yeah, it does,'' and added ``but if you resist it[,] 
it's going to feel worse.'' Id. at 30.
    ML then asked if ``it's more[ ] like a mental thing?'' Id. Dr. 
Skinner replied ``[e]xactly,'' and Respondent interjected: ``[w]ell, 
your muscles are attached to your brain[,] [y]ou know?'' Id. ML said 
``[o]h,'' and Respondent added: ``So your . . . brain has to let it . . 
. .'' Id.
    Dr. Skinner then stated: ``We got to release all that, so we can--
and your neck is out of alignment. And I don't know if anything--yeah, 
push your head against my hand and relax.'' Id. After ML said ``Ah,'' 
Skinner said ``[o]kay,'' and added that ``we're going to have to work 
on it with acupuncture.'' Id. ML said ``okay,'' and Respondent told ML 
that if she made an appointment with Dr. Skinner, she would ``have it 
adjusted.'' Id. at 30-31. Respondent then asked Skinner if acupuncture 
would be of any use, and Skinner said that ``it helps it release it 
so.'' Id. at 31. After Respondent, Skinner, and ML discussed her weight 
loss, Skinner left. Id. at 31-32.
    Respondent then told ML that he had various paperwork which had to 
be completed when he prescribed controlled substances, including his 
pain contract, a form that was sent to the patient's pharmacy, and a 
form on which ML was to show the location of her pain and describe it. 
Id. at 32-33. He also told ML that she was expected to participate in 
the meetings of a monthly support group for his pain management 
patients. Id. at 34-37.
    Respondent then discussed with ML that all he was going to 
prescribe to her was oxycodone and asked if she had ever taken 
Percocet, a drug which combines oxycodone with Tylenol (acetaminophen). 
Id. at 38. ML said that she had taken Tylenol but it ``ha[d] done 
nothing'' for her, and after Respondent said that Percocet was a 
combination of the drugs, added that he would be giving ML oxycodone. 
Id. Respondent then explained that oxycodone had to be written every 
month. Id. at 39. After some small talk, the visit ended. Id. at 39-41.
    Here again, the evidence shows that Respondent did more than simply 
observe ML during the course of her first visit. Rather, the evidence 
shows that ML was palpated during the visit.
    In its Exceptions, the Government argues that ``Respondent's own 
expert (Dr. Schneider) testified that Respondent failed to conduct a 
physical examination of either [RL or ML] prior to issuing them 
prescriptions for controlled substances.'' Exceptions at 3. As support 
for the contention, the Government cites various portions of Dr. 
Schneider's testimony during cross-examination regarding both her 
review of RL's and ML's patient files and the

[[Page 38377]]

transcripts of the visits, as well as a May 27, 2011 letter she had 
written regarding Respondent's treatment of RL and ML. Id. In the 
letter, Dr. Schneider noted that she had reviewed the charts of both RL 
and ML, as well as the transcripts of their visits.\28\ RX 23, at 1.
---------------------------------------------------------------------------

    \28\ In the letter, Dr. Schneider wrote with respect to RL that 
Respondent ``asked her about the quality of the pain, effect of 
exercise, what helps, diurnal course. He asked what she had tried 
and what medication worked. He asked about a history of alcohol or 
drug abuse. He obtained a social history. He did a physical and 
mental exam.'' RX 23, at 1 (emphasis added). After discussing RL's 
second visit, Dr. Schneider asserted that ``[t]he transcripts were 
consistent with his chart notes,'' and that Respondent ``did a lot 
of things correctly, including excellent documentation, discussion 
with patient, asking about her past treatments for the pain problem, 
getting addiction history on first visit, dealing with her mental 
status, doing a physical exam on first visit, assessing and treating 
her smoking . . . , and talking with her about physical medicine 
options.'' Id.
     So too with respect to M.L., Dr. Schneider wrote that 
Respondent ``did a lot of things correctly, including excellent 
documentation, discussion with the patient, asking about her alcohol 
use, dealing with her mental status, doing a focused physical on 
first visit, referring her for physical medicine and psychotherapy 
group, and documenting his thinking and his plan.'' Id. at 2 
(emphasis added).
---------------------------------------------------------------------------

    On cross-examination, the Government questioned Dr. Schneider about 
various findings that Respondent had documented in RL's record, 
including that her pulse was 70, that her respiration was 16, meaning 
that she was ``breathing at 16 times per minute,'' her hip flexion was 
1 over 4 for her right hip and 3 over 4 for her left hip, and that her 
range of motion was fair. Tr. 635-36.
    The Government then asked Dr. Schneider to point to where in the 
transcript Respondent had measured RL's pulse. Id. at 638. Dr. 
Schneider testified: ``I don't believe it is in there.'' Id. Next, the 
Government asked Dr. Schneider where in the transcript Respondent had 
measured RL's respiration. Id. Dr. Schneider replied: ``I believe it's 
not in the transcript.'' Id.\29\
---------------------------------------------------------------------------

    \29\ Regarding whether a physician is required to take a 
patient's vital signs during a physical examination which is 
performed at a patient's initial visit, Dr. Schneider testified:
     That's usually done. Again, listening to heart and lungs in 
someone with low back pain is not really going to be all that 
helpful. It's just sort of a tradition to do it, let's say. So, yeah 
I would imagine you would get normal vital signs. And a lot of times 
the nurse does it, not the doctor so it doesn't even come up in the 
discussion on the transcript because it was done even before the 
doctor comes into the office. And that's actually the usual thing. 
That's [the] rule rather than the exception, that the medical 
assistant does the vital signs.
    Tr. 664-65. Notably, in his testimony, Respondent did not 
maintain that an assistant or nurse took vital signs for him.
     Moreover, while Dr. Schneider testified that observing the 
patient was ``part of the physical exam,'' she then acknowledged 
that ``[t]here are some things you need to do more directly; for 
example, you have to put your stethoscope on their chest and listen 
to their lungs and heart. You can't just look at them across the 
room and assess their heart function.'' Id. at 713. While Dr. 
Schneider testified that taking a pulse does not necessarily require 
a conversation, to do so she ``would take the patient's hand and 
with my fingers on their radial artery and count up how many times I 
feel it over a 15 second period'' and then multiply by four. Id. at 
696.
---------------------------------------------------------------------------

    The Government then asked Dr. Schneider to point to where in the 
transcript Respondent had measure RL's hip flexion; Dr. Schneider 
acknowledged: ``It is not in there.'' Id. Likewise, when asked in 
reference to Respondent's documentation that RL was able to do a 
partial squat and bend at the waist, where in the transcript this had 
occurred, Dr. Schneider answered that ``I probably won't be able to 
find it.'' Id. at 639.
    Turning to Dr. Schneider's letter, in which she wrote that ``[o]n 
April 9, 2008 Dr. Ruben conducted a physical and mental exam,'' Dr. 
Schneider interrupted the Government counsel before the latter even 
asked a question, testifying:

    [Y]ou're pointing out a discrepancy, right. And assuming, unless 
I spend a half hour looking through these records and seeing if I 
can find it, the physical exam, which I may not be able to, that 
would suggest that I made a mistake in writing that he did a 
physical exam on that visit.

Id. at 640. Likewise, when asked about her having noted in her letter, 
that Respondent's plan included obtaining an x-ray followed by a 
referral to an orthopedic surgeon, Dr. Schneider could not recall where 
in the transcript Respondent had told RL that she would need to get an 
x-ray. Id. at 641.
    Regarding his treatment of RL, Respondent testified that she was 
able to do a partial squat, which he determined by watching her sit 
down in a chair. Id. at 920. With regard to how he had determined RL's 
pulse rate, Respondent testified:

    The pulse is determined by feeling the pulsation at the wrist. 
It's easy to do when you shake hands. If you hold the handshake for 
three or four to five seconds, you can tell a pulse. If you've done 
it a lot, it's fairly easy to tell within about ten to [fifteen 
percent] of what the pulse is. Pulses are not significant if--unless 
they are outside a couple of standard deviations. And you can tell 
that very quickly. If somebody is beating at 90 it only takes you, 
measuring with your fingertip two or three beats. If someone is 
beating at 30 and they're still standing up, it doesn't take long. 
Maybe a couple seconds. So I always shake hands with patients. I 
always hold their hand. Some of them may think it's weird, but I'm 
taking their pulse. I'm feeling their body temperature. I'm feeling 
their muscular strength. . . .
    Now if I'm concerned about their pulse being something that I 
can't really think is within the normal range, I may sit down and 
take their pulse for 15 seconds and sit there formally with them. Or 
if I can't find their pulse easily. But most people you can--with 
some practice, you can pretty much find it. You can pretty much hold 
their hand and you have the pulse.

Id. at 924-25. See also id. at 984 (testifying in response to 
Government's question: ``[h]ow long would a handshake last?,'' that 
``[i]f you're holding their hand it often can last the three or four 
second[s] needed to kind of evaluate the pulse''); id. at 985-86 
(testifying in response to Government's question ``what's a normal 
pulse range for your three second handshake?,'' that ``[a]ll you need 
to assess, if you're experienced at assessing, is a couple of beats'' 
and then maintaining that ``[i]t's more the rhythm. You don't have to 
actually count it. You can feel. If you feel two or three beats, you 
can really tell what--basically within ten--we're only interested in 
seeing . . . if somebody is within normal range.'').
    However, on further questioning as to whether he had determined 
R.L.'s pulse using his three-second handshake technique, Respondent 
testified:

    Yes. If that was how I did it. That's--I was telling you that 
the three second handshake is one way to do it. I may have done it 
another way. I may have done it some other way but I would have 
touched the areas that would have given me the reading on the pulse.

Id. at 987.

    As for how he determined RL's rate of respiration, Respondent 
testified that ``[y]ou can look at you or me, particularly if they 
don't have covering on their upper chest as in summer. This was in May. 
And you can watch the respirations. You can tell the respirations 
again, with an observation of a very short time. You can look and 
watch.'' Id. at 926. Respondent then stated that the ``normal range for 
resting respirations is probably 14 to 17 or something like that,'' and 
that ``[i]f it's not within a normal range, then you can do more 
definitive testing,'' including ``count[ing] them more clearly'' and 
``listen[ing] to see if their lungs are clear.'' Id. at 927. See also 
id. at 987-88 (``I can tell a respiratory rate just from watching a 
person at any point in an interview where you're in the same room with 
them. Just by watching if their chest is moving.'').
    As for his findings that RL was ``[a]ble to do partial squat and 
bend at waist,'' Respondent testified that this was essentially the 
chair test and that when ``ladies put down their purse[,] [t]hey reach 
over for that[,] [t]hey reach for things[,] [a]ll that is information 
about their movement.'' Id. at 928. On cross-

[[Page 38378]]

examination, Respondent testified that he ``may not have'' asked RL to 
do a partial squat and ``probably would not have'' asked her to bend at 
her waist. Id. at 990. Respondent then testified that ``[a]nd if it's 
not here, I must have not asked it. But I gained the information 
through observation.'' Id.
    And as for his finding that RL's hip flexor was ``R \1/4\, L \3/
4\,'' Respondent testified that ``[f]our is a norm'' and that ``[i]t's 
more of an average of what was going on.'' Id. at 928. Continuing, 
Respondent explained: ``You know, I might of [sic] observed as she sat 
down she favored--she flexed one side more than--sat one way rath[er]--
and guarded on [one] side. So that would be an estimation of that.'' 
Id. at 928-29. And regarding his finding RL's ``R hip tender with ROM 
[f]air,'' Respondent testified:

    Range of motion is how the hip moves. How the leg moves. You can 
watch that from the gait. You watch that from the movement. Tender 
would mean that I put my hand on her hip and may have pushed. May 
have said, ``is your pain here or is it[?]''

Id. at 929. Later, when asked on cross-examination whether he had 
actually asked RL to move her left leg so that he could observe her 
range of motion, Respondent, explained that:

[o]ne of the tests I conduct is to have them walk in front of me . . 
. that shows me range of motion in their body. They move through the 
exam room. They sit. They stand. I shake their hands. I do all sorts 
of things that are range of motion tests.

Id. at 991.

    On cross-examination, Respondent further testified that he did not 
do ``a more formal physical exam'' on RL, because he ``felt [he] 
gathered sufficient information to meet the needs for her first visit 
to begin to treat her and make a diagnosis and to make a basis for 
prescribing the limited amounts of medication that she was receiving.'' 
Id. at 982-83. Respondent then stated that he ``didn't perform more 
than what I did. But I told you--that's true.'' Id. at 983.
    Likewise, with respect to M.L., the Government established that 
Respondent made findings in her patient record that she had a pulse of 
80 beats per minute, a respiration rate of 18 breaths a minute, that 
she ``[h]a[s] decreased flexion and extension'' in her head, that her 
cranial nerves were intact, that her grip for both hands was a \2/4\, 
and that she moved ``both arms in abduction and adduction.'' Tr. 650-
52; RX 2, at 2. The Government then asked Dr. Schneider where in the 
transcript there was evidence that Respondent had performed these 
various tests. Tr. 653-56.
    Dr. Schneider admitted that she did not see in the transcript where 
Respondent had taken M.L.'s pulse or measured her respiration. Id. at 
653, 655. As for where Respondent had measured the extension and 
flexion of M.L.'s head, Dr. Schneider acknowledged that ``[i]t's not in 
there.'' Id. at 653. However, Dr. Schneider then testified ``that [it] 
is possible to tell from--sometimes from looking at a person.'' Id. Dr. 
Schneider also acknowledged that the transcript contained no indication 
that Respondent had done ``a formal'' cranial nerve examination, nor 
measured M.L.'s grip. Id. at 653-54. As for where in the transcript 
there was evidence that Respondent had ML move her arms, Dr. Schneider 
answered: ``[T]hat again, he may have seen just watching her.'' Id. at 
654.

    Next, the Government asked Dr. Schneider whether Respondent could 
rely on Dr. Skinner's examination of ML. More specifically, the 
Government asked:

    Q. Okay. And in your experience, is it acceptable to replace 
your own physical examination of the patient with the examination of 
someone else in your office?
    A. That's a good question and I don't have an exact answer 
because that doesn't often come up. I suppose if it's someone else 
who's skilled who is doing the physical exam that might be 
appropriate. I don't know.

Id. at 654-55.\30\
---------------------------------------------------------------------------

    \30\ In discussing the various instances in which Dr. Schneider 
acknowledged that the transcripts of the undercover visits contained 
no indication that Respondent had performed various tests or 
discussed various matters with the patients which he documented in 
the medical records, the ALJ noted Dr. Schneider's testimony that 
``parts of the written transcript were unintelligible.'' R.D. 57 
(citing Tr. 693-97). Dr. Schneider conceded, however, that she did 
not listen to the recordings. Tr. 711. Nor, apparently, did the ALJ 
listen to any of the recordings, as notwithstanding that they were 
part of the record, the R.D. contains no indication that he did so. 
However, my Office has listened to them and has concluded that none 
of the unintelligible parts are of sufficient duration to support 
the possibility that Respondent actually performed various tests or 
had various discussions which he documented in the patient records 
as having done but which did not appear in the transcripts.

    Next, the Government noted that in her letter, Dr. Schneider had 
stated that Respondent ``did a focused physical exam on the first visit 
of'' ML and asked Dr. Schneider ``where in the transcript does 
[Respondent] conduct a focused physical of [ML] on this occasion?'' 
\31\ Id. at 655-56. Dr. Schneider answered: ``I don't see it.'' Id. at 
656. And with regard to Dr. Schneider's statement in her letter that 
Respondent ``had excellent documentation of his treatment of'' ML, Dr. 
Schneider acknowledged that her definition of excellent documentation 
does not include documenting findings ``that were not actually 
discerned during the course of a visit.'' \32\ Id.
---------------------------------------------------------------------------

    \31\ Regarding what constitutes ``a focused physical exam,'' Dr. 
Schneider testified:
     It's when you concentrate on one particular part of the body. 
So for example, if someone has back pain, you watch how they get up, 
you watch how they sit down, you watch how they move, you watch how 
they pick up something and you can get some conclusions without 
doing a formal one. Ideally, you'd want to do a formal one, but it 
is possible to gather information from observing the patient.
    Tr. 664.
    \32\ In its Exceptions, the Government also cites to its cross-
examination of Dr. Schneider regarding the statements in her letter 
that, at ML's second visit, Respondent performed ``a focused 
physical exam'' and that ML had ``said her pain had decreased to 3/
10 on [the] current dose.'' Exceptions at 3-4 (citing Tr. 662-64); 
see also RX 23, at 2. When questioned about these statements in her 
letter, Dr. Schneider conceded that the transcript did not reflect 
that Respondent had done a focused physical exam, but added that 
``he could have been observing her as he talked with her.'' Tr. 664. 
Dr. Schneider also acknowledged that the transcript contained no 
indication that ML had said her pain had decreased to three out of 
ten. Id. at 663. While in her letter, Dr. Schneider made no mention 
as to whether Respondent had tested ML's grip at the second visit, 
Dr. Schneider acknowledged that the transcript contained no 
indication that he had tested ML's grip even though he documented in 
the progress note having done so. Id. at 663; see also RX 2, at 1.
---------------------------------------------------------------------------

    Regarding ML, Respondent testified that he observed her gait and 
walking during his evaluation of her and that he did not do any formal 
test of her reflexes. Id. at 957. He further testified that he ``could 
see that there was some difficulty she had with movement of her head, 
range of motion,'' but that ``she did not have any neurological 
findings that I could--from a review of [her] cranial nerves.'' Id. at 
958. Moreover, he acknowledged that he did not use any ``instruments to 
measure her flexion of her head,'' and that he had measured her grip by 
shaking her hands. Id. at 998-99. However, Respondent then stated that 
``there may have been some other way'' he used to ``sense[] her grip 
strength,'' and that he ``probably . . . t[ook] her hands in [his] 
hands.'' Id. at 999.
    And as for whether he had asked ML to move her arms in abduction or 
adduction, Respondent testified that ``I may have handed her something 
or in that sense made a prompt to move them or I may have just observed 
her in her natural moving around the room, sitting down, getting up, 
picking things up to do. It's possible that I handed her something 
purposefully to see if she could reach. Sometimes I do that.'' Id. at 
1000. Respondent then testified that he did not know how he tested 
this,

[[Page 38379]]

because he did not ``remember specifically.'' Id.
    Regarding the scope of the examination he performed on M.L., 
Respondent explained that:

    The focus on this patient was not a hip. It was neck and back. 
So the focused examination in my focus would have been on her 
mobility and her movements and her functions in that area. So that 
would be--I'd be looking at upper extremities. That there was no 
wasting of her arms. I could see her, I believe from this 
examination, I could see her arms and movement of her arms and 
movement of her head and again, we talked about how we can do pulse 
and we can do respirations. We talked about gait. That didn't seem 
to be the main issue.
Id. at 959.

    Respondent further explained that Dr. Skinner is a naturopath ``who 
is very adept at diagnosing neck and shoulder injuries.'' Id. at 963. 
He testified that he ``brought her in to look at [ML] and give me a 
second opinion.'' Id. Respondent then explained that:

She put her hands on the patient. I put my hands on the patient. We 
were looking for muscle spasm. We were looking for range of motion 
and Dr. Skinner then probably did do some kind of stretching or some 
kind of manipulation to see if that would relieve some of the spasm 
which was probably in this patient's neck.
Id.\33\
---------------------------------------------------------------------------

    \33\ The Government also introduced an affidavit from BO, a 
person who, in March 2009, saw Respondent for her depression. GX 19. 
In her affidavit, BO related that ``[w]hile in the waiting room, I 
heard other patients speaking about oxycodone'' and that ``these 
other patients were exchanging information regarding which 
pharmacies had stock of certain dosages and in what quantities.'' 
Id. at 1. Even assuming that BO's affidavit bears substantial 
indicia of reliability (such that it could constitute substantial 
evidence), there is no evidence that Respondent was aware of this 
discussion. Moreover, while BO also related that she overheard a 
conversation between Respondent and an employee in which the former 
stated that ``a pharmaceutical representative had just informed him 
that he could make a lot of money if he were to dispense medications 
directly from his office, because [he] would get a percentage of 
money from each prescription filled in-house,'' even assuming that 
this constitutes an admission, it does not establish any wrongdoing. 
Id. at 2. Finally, while BO stated that Respondent gave her 
prescriptions for Ambien (zolpidem), a schedule IV controlled 
substance, as well as Cymbalta and Depakote, two non-controlled 
medications, the record does not establish that Respondent acted 
outside of the usual course of professional practice and lacked a 
legitimate medical purpose in prescribing the Ambien. Id. at 2-3.
---------------------------------------------------------------------------

Discussion

    Section 304(a) of the Controlled Substances Act (CSA) provides that 
a registration to ``dispense a controlled substance . . . may be 
suspended or revoked by the Attorney General upon a finding that the 
registrant . . . has committed such acts as would render his 
registration under section 823 of this title inconsistent with the 
public interest as determined under such section.'' 21 U.S.C. 824(a)(4) 
(emphasis added). With respect to a practitioner, the Act requires the 
consideration of the following factors in making the public interest 
determination:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing * * * controlled 
substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

Id. Sec.  823(f).

    ``[T]hese factors are . . . considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I 
``may rely on any one or a combination of factors, and may give each 
factor the weight [I] deem[] appropriate in determining whether a 
registration should be revoked.'' Id.; see also MacKay v. DEA, 664 F.3d 
808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 
2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while 
I am required to consider each of the factors, I ``need not make 
explicit findings as to each one.'' MacKay, 664 F.3d at 816 (quoting 
Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482)).\34\
---------------------------------------------------------------------------

    \34\ In short, this is not a contest in which score is kept; the 
Agency is not required to mechanically count up the factors and 
determine how many favor the Government and how many favor the 
registrant. Rather, it is an inquiry which focuses on protecting the 
public interest; what matters is the seriousness of the registrant's 
misconduct. Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, 
as the Tenth Circuit has recognized, findings under a single factor 
can support the revocation of a registration. MacKay, 664 F.3d at 
821.
---------------------------------------------------------------------------

    The Government has the burden of proving, by a preponderance of the 
evidence, that the requirements for revocation or suspension pursuant 
to 21 U.S.C. Sec.  824(a) are met. 21 CFR 1301.44(e). However, ``once 
the [G]overnment establishes a prima facie case showing a practitioner 
has committed acts which render his registration inconsistent with the 
public interest, the burden shifts to the practitioner to show why his 
continued registration would be consistent with the public interest.'' 
MacKay, 664 F.3d at 817 (citing Medicine Shoppe-Jonesborough, 73 FR 
364, 387 (2008) (citing cases)).
    Having considered all of the factors, I agree with the ALJ's 
conclusion that the Government's evidence with respect to factors two 
(Respondent's experience in dispensing controlled substances) and four 
(Respondent's compliance with applicable controlled substance laws), 
establishes that Respondent has committed acts which render his 
registration inconsistent with the public interest.\35\ 21 U.S.C. 
824(a)(4). While I also agree with the ALJ's conclusion that Respondent 
has accepted responsibility for his misconduct and put forward evidence 
as to his remedial measures, I reject the ALJ's recommended sanction 
because the ALJ failed to consider the egregiousness of Respondent's 
misconduct and the Agency's interest in deterring others from engaging 
in similar acts. Accordingly, I will order that Respondent's 
registration be suspended for a period of one year.
---------------------------------------------------------------------------

    \35\ As for factor one, the recommendation of the state 
licensing authority, the ALJ found that the AMB's restoration of 
Respondent's authority to prescribe opioids in August 2011, 
``[w]hile not dispositive . . . does weigh against a finding that 
Respondent's continued registration would be inconsistent with the 
public interest.'' R.D. at 48. Even assuming that the Board's 
restoration constitutes a recommendation to the Agency that 
Respondent's registration be continued, DEA has repeatedly held that 
while a practitioner's possession of state authority constitutes an 
essential condition for maintaining a registration, see 21 U.S.C. 
Sec. Sec.  802(21) & 823(f), it `` `is not dispositive of the public 
interest inquiry.' '' George Mathew, 75 FR 66138, 66145 (2010), pet. 
for rev. denied Mathew v. DEA, No. 10-73480, slip op. at 5 (9th 
Cir., Mar. 16, 2012); see also Patrick W. Stodola, 74 FR 20727, 
20730 n.16 (2009); Robert A. Leslie, 68 FR 15227, 15230 (2003). As 
the Agency has long held, ``the Controlled Substances Act requires 
that the Administrator . . . make an independent determination [from 
that made by state officials] as to whether the granting of 
controlled substance privileges would be in the public interest.'' 
Mortimer Levin, 57 FR 8680, 8681 (1992). Thus, this factor is not 
dispositive either for, or against, the continuation of Respondent's 
registration. Paul Weir Battershell, 76 FR 44359, 44366 (2009) 
(citing Edmund Chein, 74 FR 6580, 6590 (2007), pet. for rev. denied 
Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008)).
    Regarding factor three, there is no evidence that Respondent has 
been convicted of an offense related to the manufacture, 
distribution or dispensing of controlled substances. However, as 
there are a number of reasons why a person may never be convicted of 
an offense falling under this factor, let alone be prosecuted for 
one, ``the absence of such a conviction is of considerably less 
consequence in the public interest inquiry'' and is thus not 
dispositive. Dewey C. MacKay, 75 FR 49956, 49973 (2010), pet. for 
rev. denied MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011).
---------------------------------------------------------------------------

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

    Under a longstanding DEA regulation, a prescription for a 
controlled substance is not ``effective'' unless it is ``issued for a 
legitimate medical purpose by an

[[Page 38380]]

individual practitioner acting in the usual course of his professional 
practice.'' 21 CFR 1306.04(a). Under the CSA, it is fundamental that a 
practitioner must establish a bonafide doctor-patient relationship in 
order to act ``in the usual course of . . . professional practice'' and 
to issue a prescription for a ``legitimate medical purpose.'' See 
United States v. Moore, 423 U.S. 122, 142-43 (1975); United States v. 
Lovern, 590 F.3d 1095, 1100-01 (10th Cir. 2009); United States v. 
Smith, 573 F.3d 639, 657 (8th Cir. 2009); see also 21 CFR 1306.04(a) 
(``an order purporting to be a prescription issued not in the usual 
course of professional treatment . . . is not a prescription within the 
meaning and intent of [21 U.S.C. 829] and . . . the person issuing it, 
shall be subject to the penalties provided for violations of the 
provisions of law related to controlled substances'').
    As the Supreme Court has explained, ``the prescription requirement 
. . . ensures patients use controlled substances under the supervision 
of a doctor so as to prevent addiction and recreational abuse. As a 
corollary, [it] also bars doctors from peddling to patients who crave 
the drugs for those prohibited uses.'' Gonzales v. Oregon, 546 U.S. 
243, 274 (2006) (citing Moore, 423 U.S. 122, 135, 143 (1975)).
    Both this Agency and the federal courts have held that 
``establishing a violation of the prescription requirement `requires 
proof that the practitioner's conduct went ``beyond the bounds of any 
legitimate medical practice, including that which would constitute 
civil negligence.'' ' '' Laurence T. McKinney, 73 FR 43260, 43266 
(2008) (quoting United States v. McIver, 470 F.3d 550, 559 (4th Cir. 
2006). See also United States v. Feingold, 454 F.3d 1001, 1010 (9th 
Cir. 2006) (``[T]he Moore Court based its decision not merely on the 
fact that the doctor had committed malpractice, or even intentional 
malpractice, but rather on the fact that his actions completely 
betrayed any semblance of legitimate medical treatment.''); Jack A. 
Danton, 76 FR 60900, 60904 (2011) (finding violations of 21 CFR 
1306.04(a), in the absence of expert testimony, ``where a physician has 
utterly failed to comply with multiple requirements of state law for 
evaluating her patients and determining whether controlled substances 
are medically indicated and thus has ```completely betrayed any 
semblance of legitimate medical treatment''''') (quoting McKinney, 73 
FR at 43266 (quoting Feingold, 454 F.3d at 1010)).
    However, as the Agency has held in multiple cases, ``the Agency's 
authority to deny an application [and] to revoke an existing 
registration . . . is not limited to those instances in which a 
practitioner intentionally diverts a controlled substance.'' Bienvenido 
Tan, 76 FR 17673, 17689 (2011) (citing Paul J. Caragine, Jr., 63 FR 
51592, 51601 (1998)); see also Dewey C. MacKay, 75 FR at 49974. As 
Caragine explained: ``[j]ust because misconduct is unintentional, 
innocent, or devoid of improper motive, [it] does not preclude 
revocation or denial. Careless or negligent handling of controlled 
substances creates the opportunity for diversion and [can] justify'' 
the revocation of an existing registration or the denial of an 
application for a registration. 63 FR at 51601.
    ``Accordingly, under the public interest standard, DEA has 
authority to consider those prescribing practices of a physician, 
which, while not rising to the level of intentional or knowing 
misconduct, nonetheless create a substantial risk of diversion.'' 
MacKay, 75 FR at 49974; see also Patrick K. Chau, 77 FR 36003, 36007 
(2012). Likewise, ``[a] practitioner who ignores the warning signs that 
[his] patients are either personally abusing or diverting controlled 
substances commits `acts inconsistent with the public interest,' 21 
U.S.C. Sec.  824(a)(4), even if [he] is merely gullible or 
na[iuml]ve.'' Jayam Krishna-Iyer, 74 FR 459, 460 n.3 (2009); see also 
Chau, 77 FR at 36007 (holding that even if physician ``did not 
intentionally divert controlled substances,'' State Board Order 
``identified numerous instances in which [physician] recklessly 
prescribed controlled substances to persons who were likely engaged in 
either self-abuse or diversion'' and that physician's ``repeated 
failure to obtain medical records for his patients, as well as to 
otherwise verify their treatment histories and other claims, created a 
substantial risk of diversion and abuse'') (citing MacKay, 75 FR at 
49974).
    In this matter, the Government alleged that Respondent violated the 
prescription requirement with respect to both the patients who were the 
subject of the AMB Orders and the undercover visitors. Notably, in his 
post-hearing brief, Respondent acknowledges that ``the First and Second 
Consent Order establish violations of Arizona State law, as explained 
more fully in the Orders.'' Resp's. Proposed Findings of Fact, 
Conclusions of Law and Argument 33. Moreover, in his post-hearing 
brief, Respondent states that he ``is prepared to concede that the 
Government established a prima facie case for revocation . . . on the 
basis of the portions of the Second Consent Order . . . that he did not 
challenge for factual insufficiency.'' Id. at 34. However, with respect 
to the first AMB Order, which involved his treatment of DK, while 
Respondent acknowledged that he ``should have obtained past medical 
records sooner'' and should have more carefully monitored her use of 
medication, he rejects other findings of the AMB. Id. at 38.
    The ALJ found that ``Respondent issued controlled substance 
prescriptions to multiple patients referenced in the 2009 Agreement and 
2010 Order for other than a legitimate medical purpose and outside the 
usual course of professional practice in violation of applicable state 
and federal law.'' ALJ at 54-55 (citing 21 CFR 1306.04(a); Ariz. Rev. 
Stat. Sec.  32-1401(27)(a), (e) & (q)). Indeed, notwithstanding that 
the ALJ improperly allowed Respondent to challenge the Board's findings 
both as to historical facts regarding his treatment of the various 
patients and the standard of care, Respondent's evidence only addressed 
four of the patients. Thus, even were I to give weight to this evidence 
(which--like the ALJ--I do not), the Government's evidence still 
establishes that Respondent committed violations of the prescription 
requirement with respect to numerous patients, as Respondent himself 
concedes.
    To be clear, the Board's findings with respect to many of the 
patients establish not simply that Respondent ``committed malpractice, 
or even intentional malpractice, but rather . . . that his actions 
completely betrayed any semblance of legitimate medical treatment,'' 
Feingold, 454 F.3d at 1010, and thus, that he intentionally or 
knowingly diverted controlled substances. More specifically, the AMB 
found that the standard of care requires that when treating a patient 
for chronic pain, a physician must obtain prior records for the past 
treatment of the pain, as well as obtain any objective measures for the 
cause of pain, and that Respondent failed to do so. Also, the AMB found 
that Respondent failed to adequately document his reasoning for 
prescribing high dose opioids as well as other drugs he added, as well 
as his treatment plan.
    Moreover, even Respondent's Expert acknowledged that in various 
instances, Respondent failed to perform a physical examination on the 
first visit, notwithstanding that Arizona law clearly required that he 
do so. Tr. 597-98; see also Ariz. Rev. Stat. Sec.  32-1401(27)(ss) 
(deeming it ``[u]nprofessional conduct'' to ``[p]rescrib[e], 
dispens[e], or furnish[] a

[[Page 38381]]

prescription medication . . . to a person unless the licensee first 
conducts a physical examination of that person or has previously 
established a doctor-patient relationship'').
    The AMB also found that Respondent violated the standard of care 
because he prescribed high dose opioids without performing adequate 
physical exams. For example, with respect to ML, the AMB found that 
Respondent diagnosed him with spondylolisthesis based on ML's report 
and prescribed oxycodone to him, but did not perform a facet, 
sacroiliac joint, myofascialpain or neural flexes examination, nor test 
him for weakness or numbness. The Board also found that Respondent did 
not order various tests such as flexion extension films or an MRI scan, 
and that he also failed to obtain ML's past medical records and 
diagnostic studies. Most significantly, the Board found in ML's chart 
an x-ray, dated eighteen months after Respondent diagnosed ML as having 
spondylolisthesis, which stated: ``no evidence of spondylolisthesis.''
    Yet, notwithstanding that the x-ray contradicted his diagnosis and 
his failure to conduct necessary tests, the Board found that Respondent 
provided ML with multiple early refills of oxycodone from February 
through December 2008.\36\ Moreover, the Board found that while in June 
2008, Respondent was notified that ML was undergoing methadone 
treatment at a facility, he did not obtain ML's records from the 
facility. And while in January 2009, Respondent discharged ML from 
opioid therapy, two months later he resumed prescribing high does 
opioids without documenting an explanation. The Board also found that 
even after the 2009 Order placed Respondent on probation by the 2009 
Order, he continued to prescribe high dose opioids to ML ``for pain 
secondary to spondylolisthesis until September 2009.''
---------------------------------------------------------------------------

    \36\ The Board also found that Respondent provided multiple 
early refills of oxycodone to ML during the period from January 
through December 2007. It further found that while in November 2007, 
Respondent had determined that ML had self-escalated his oxycodone 
dosing, Respondent did not document having cautioned ML to adhere to 
the dosing instructions.
---------------------------------------------------------------------------

    In addition, Respondent's Expert acknowledged that Respondent had 
continued to prescribe oxycodone to ML, notwithstanding several 
aberrant urine drug tests. See Tr. 675-77. For example, ML tested 
positive for cocaine, as well as benzodiazepines (twice) which 
Respondent had not prescribed to him on previous visits. Still another 
time, ML tested negative for oxycodone, notwithstanding that Respondent 
continually prescribed the drug to ML and even provided him with 
numerous early refills.
    As the AMB found, prior to initiating high dose opiate therapy, the 
standard of care requires a physician to perform an adequate exam for 
pain generators. Moreover, the AMB found that the standard of care 
requires that a physician obtain the patient's past medical records and 
diagnostic studies, offer the patient adjunct treatments that include 
non-opioid medications and physical therapy, address aberrant drug 
seeking behaviors and refrain from prescribing more than one month of 
schedule II prescriptions at a time. The Board found that Respondent 
deviated from the standard of care because he did not perform an 
adequate exam prior to initiating high dose opiate therapy, he did not 
obtain ML's past medical records and diagnostic studies, he did not 
offer adjunct treatments, he did not address ML's aberrant drug-seeking 
behaviors, nor did he refrain from prescribing more than one month of 
schedule II prescriptions at a time.\37\
---------------------------------------------------------------------------

    \37\ The Board found that the standard of care when treating a 
patient for chronic pain is to obtain objective measures as to the 
cause of pain. 2010 Order, at 16. It found that Respondent violated 
the standard of care by continuing to treat ML's reported pain with 
high-dose opioids without obtaining objective measures for the cause 
of his pain, and that his conduct could result in the perpetuation 
of ML's drug-seeking behavior/addiction or an overdose. Id. In 
addition, the Board found that there was potential for diversion or 
abuse of the oxycodone. Id. at 10.
---------------------------------------------------------------------------

    While the Board also found that Respondent violated Arizona law and 
committed unprofessional conduct by failing to maintain adequate 
records, the Board's findings establish that Respondent did far more 
than fail to comply with recordkeeping requirements. Rather, the 
Board's findings establish that Respondent's prescribing of oxycodone 
to ML ```completely betrayed any semblance of legitimate medical 
treatment''' and thus violated 21 CFR 1306.04(a). Danton, 76 FR 60900, 
60904 (2011) (quoting McKinney, 73 FR at 43266 (quoting Feingold, 454 
F.3d at 1010)).
    As the Supreme Court explained in Moore in upholding the criminal 
conviction of a physician for unlawfully distributing controlled 
substances under circumstance similar to those found by the Board:

    The evidence presented at trial was sufficient for the jury to 
find that respondent's conduct exceeded the bounds of `professional 
practice.' As detailed above, he gave inadequate physical 
examinations or none at all. He ignored the results of the tests he 
did make. He . . . took no precautions against . . . misuse and 
diversion. He did not regulate the dosage at all, prescribing as 
much and as frequently as the patient demanded.

Moore, 423 U.S. at 142-43.

    Likewise, the Board found that Respondent prescribed multiple 
controlled substances including OxyContin 40 mg, oxycodone 30 mg and 
Adderall to JF for conditions including chronic pain, attention deficit 
disorder, and obsessive compulsive disorder. While JF reported at her 
first visit (August 31, 2007) that her current prescriptions were 
OxyContin 40 mg and oxycodone 30 mg, the Board found that he did not 
obtain her past medical records to confirm the diagnosis and her 
prescriptions; he also did not document having performed a physical 
examination. Yet he prescribed 90 tablets of OxyContin 40 mg and 45 
tablets of oxycodone 30 mg to her. Moreover, in October 2007, 
Respondent added Adderall, another schedule II controlled substance, to 
her ``medication regime without any rationale for the medication.'' GX 
18, at 5.
    The Board further found that on multiple occasions during the 
course of her treatment, JF reported that her prescriptions had been 
stolen or damaged, that she had run out of medication, and that a 
pharmacy had refused to fill a prescription because of different 
handwriting. Nonetheless, Respondent continued to prescribe the drugs 
and increased the doses of oxycodone and Adderall. As the Board found, 
there was no documentation that Respondent ordered any laboratory 
studies to support his continued prescribing of the three drugs. Nor 
was there any documentation that Respondent had JF undergo urine drug 
screens to determine if she ``was taking the medication as prescribed 
and/or whether she was utilizing illicit substances.'' Id. at 6.
    With respect to his prescribing of OxyContin and oxycodone to JF 
for the treatment of chronic pain, the Board found that the standard of 
care ``requires a physician to review diagnostic studies and 
interventions, assess the chronic pain complaint prior to initiating an 
opioid trial, appropriately monitor the patient's use of the 
medication, and obtain appropriate therapeutic and laboratory test 
results that support the diagnosis.'' Id. The Board further found that 
``Respondent deviated from the standard care because he did not review 
past medical records and he did not order appropriate tests or 
consultations for JF.'' Id.
    As for his treatment of JF's psychiatric conditions, the Board 
found that

[[Page 38382]]

Respondent ``did not perform an adequate psychiatric evaluation'' of 
her and thus ``deviated from the standard of care.'' Id. The Board also 
found that Respondent deviated from the standard care because he 
prescribed Adderall to JF without ``perform[ing] tests to confirm the 
diagnosis and the necessity of the medication'' and did not monitor her 
``use of the medication.'' Id. And because ``[t]here was no collateral 
information to support prescribing Adderall,'' the Board concluded that 
this ``creat[ed] a potential for misdiagnosis, addiction, abuse, 
misuse, overdose, and diversion.'' Id.
    Finally, the Board found that Respondent's records for JF ``were 
inadequate because he did not obtain [her] past medical records, he did 
not document a physical examination prior to prescribing medications 
and he did not document any rationale for the prescriptions, dosage 
escalations, and additions of medication.'' Id. at 7. Here again, the 
Board's findings establish that Respondent's prescribing of controlled 
substances to JF ```completely betrayed any semblance of legitimate 
medical treatment''' and support the conclusion that he acted outside 
of the usual course of professional practice and lacked a legitimate 
medical purpose when he prescribed schedule II opioids (OxyContin and 
oxycodone) and Adderall (a schedule II stimulant) to her. See 21 CFR 
1306.04(a). Accordingly, I hold that Respondent knowingly diverted 
controlled substances to JF.
    Of similar consequence, the Board found that Respondent prescribed 
both OxyContin and oxycodone to patients DD, SS, AM, and MF ``based on 
[their] reported history and complaints of chronic pain.'' Id. at 7. 
Here again, the Board found that ``[t]here was no documentation that 
Respondent obtained the patients' past medical record to confirm the 
diagnoses,'' that ``he did not perform adequate physical 
examinations,'' and that he did not ``order diagnostic and laboratory 
studies.'' Id.
    The Board further found that while ``Respondent provided early 
refills and escalated the patients' doses of [o]xycodone and 
OxyContin,'' he neither ``document[ed] a rationale to support his 
diagnosis or [his] prescribing.'' Id. Nor did he ``perform[] any urine 
drug screens to determine whether the[se] patients were taking the 
medications as prescribed and/or illicit substances.'' Id.
    Here again, the Board found that ``Respondent deviated from the 
standard of care because he did not review [the four patients'] past 
diagnostic studies and interventions, assess and confirm their chronic 
pain complaints prior to initiating an opioid trial, appropriately 
monitor their use of the medication, or obtain appropriate therapeutic 
and laboratory test results to support his diagnoses of chronic pain.'' 
Id. at 8. The Board further found that because ``[t]here was no 
collateral information to support prescribing opioids to [the four 
patients],'' Respondent ``creat[ed] [the] potential for misdiagnosis, 
addiction, abuse, misuse, overdose, and diversion.'' Id.
    Finally, the Board found that ``Respondent's records were 
inadequate because he did not obtain [the four patients'] past medical 
records; he did not document adequate physical examinations or 
laboratory and diagnostic studies prior to prescribing medications; he 
did not obtain any diagnostic studies to support his continued 
prescribing of medications[;] and he did not document any rationale for 
[the] prescriptions and dosage escalations.'' Id. at 8-9. Here again, 
the Board's findings with respect to these four patients establish more 
than that Respondent failed to keep adequate records. Rather, they 
establish that Respondent acted outside of the usual course of 
professional practice and lacked a legitimate medical purpose when he 
prescribed OxyContin and oxycodone to DD, SS, AM, and MF.\38\ 21 CFR 
1306.04(a).
---------------------------------------------------------------------------

    \38\ Even if I were to give weight to Dr. Schneider's testimony 
in which she maintained that the Board's consultant made findings 
with respect to patients AM, MF and SS that were contradicted by the 
respective patient's chart, I would still adopt the Board's 
findings. As explained above, the AMB's findings cited multiple ways 
in which Respondent deviated from the standard of care, and 
Respondent offers no argument as to why, even if the Board's 
consultant may have overlooked several items, these errors would 
have materially affected the Board's conclusions. And here again, 
Respondent could have, and should have, presented Dr. Schneider's 
evaluation to the Board.
---------------------------------------------------------------------------

    The Board also made findings regarding Respondent's prescribing of 
Adderall to two patients (AL and KF) that establish violations of the 
prescription requirement. Specifically, the Board found that Respondent 
diagnosed AL with Attention Deficit Hyperactivity Disorder and 
prescribed Adderall to her. GX 18, at 2. The Board found, however, that 
Respondent deviated from the standard of care because he did not 
perform an adequate psychiatric evaluation of AL. Id. Moreover, the 
Board found that there was no documentation that Respondent obtained 
her past medical records, her history of alcohol or substances abuse, 
her psychiatric history or that he ``perform[ed] a functional 
assessment to support the diagnosis and prescription.'' Id. Respondent 
also failed to document a treatment plan. Id.
    The Board further found that over a twenty-seven month period, 
``Respondent provided AL with frequent, early and escalated doses of 
Adderall'' but did not document a rationale for doing so. Id. And the 
Board found that ``on several occasions[,] AL attempted to refill her 
Adderall prescription early,'' yet Respondent did not document that he 
``investigated or addressed AL's rationale for doing so.'' Id. In 
addition, Respondent prescribed Lorazepam, a schedule IV benzodiazepine 
to AL, ``without documenting a rationale for'' doing so and that he did 
not ``discuss[ ] the risks and benefits of taking'' the drug. Id. 
Finally, the Board found that there ``was no documentation that 
Respondent ordered any laboratory studies to support his continued 
prescribing of Adderall or any urine drug screens to determine whether 
AL was taking the medication as prescribed and/or illicit substances.'' 
Id.
    Thus, in addition to finding that Respondent deviated from the 
standard of care because he failed to perform an adequate psychiatric 
evaluation of AL, the Board found that he committed an additional 
deviation ``because he did not confirm the diagnosis and the necessity 
of the medication and he did not monitor AL's use of the medication.'' 
Id. at 3.\39\ These findings support the conclusion that Respondent 
acted outside of the usual course of professional practice and lacked a 
legitimate medical purpose when he prescribed Adderall to AL. 21 CFR 
1306.04(a).
---------------------------------------------------------------------------

    \39\ Finally, the Board found that Respondent failed to maintain 
adequate records ``because there was no documentation of the initial 
Adderall prescription, no documented initial plan of treatment, the 
psychiatric evaluation was inadequate, there was no documented 
rationale for his prescribing of several medications, and several of 
his progress notes were illegible.'' GX 18, at 3.
---------------------------------------------------------------------------

    Likewise, with respect to KF, the Board found that Respondent 
prescribed Adderall to her, yet ``[t]here was no documentation that 
[he] obtained her past medical record or ordered any laboratory tests 
that would qualify KF for a diagnosis to support the use of Adderall.'' 
GX 18, at 4. Moreover, the Board found that ``Respondent prescribed 
frequent early refills without documenting any rationale for the 
prescriptions,'' and that he ``increased KF's dose from 20mg to 30 mg 
without any rationale'' for doing so. Id. Also, the Board found that 
``[t]here was no documentation that Respondent ordered any laboratory 
studies to support his

[[Page 38383]]

continued prescribing of Adderall or any urine drug screens to 
determine whether KF was taking the medications as prescribed and/or 
any illicit substances.'' Id.
    The Board thus found that ``Respondent deviated from the standard 
care because he did not obtain prior medical records, perform tests to 
confirm the diagnosis and the necessity of the medication,'' ``did not 
perform an adequate psychiatric evaluation for KF,'' and ``did not 
monitor [her] use of the medication.'' Id. The Board also found that 
because ``[t]here was not collateral information to support prescribing 
Adderall,'' Respondent ``created [the] potential for misdiagnosis, 
addiction, abuse, misuse, overdose and diversion.'' \40\ Id. The 
Board's findings thus also support the conclusion that Respondent acted 
outside of the usual course of professional practice and lacked a 
legitimate medical purpose in prescribing Adderall to KF. 21 CFR 
1306.04(a).
---------------------------------------------------------------------------

    \40\ Here again, the Board found that ``Respondent's records 
were inadequate because he did not obtain KF's past medical records, 
he did not document a physical examination prior to prescribing 
medications, he did not document any rationale for prescriptions, 
dosage escalations, and additions of medication.'' Id. at 5.
---------------------------------------------------------------------------

    The Board also made extensive findings regarding Respondent's 
prescribing of schedule II opioids to WO for the latter's chronic pain 
over an eighteen-month period. GX 18, at 11-13. While WO had previously 
been treated by another physician, who prescribed to him both oxycodone 
and morphine sulfate, and Respondent reviewed several imaging studies, 
the Board found that the studies ``did not support the amount of opioid 
medications [Respondent] prescribed to WO.'' Id. at 11, 13. The Board 
also found that ``[t]here was no documentation that Respondent 
performed a neurological or musculoskeletal examination or ordered any 
imaging studies of WO's lumbar spine or laboratory studies prior to 
continuing the treatment of WO's previous treating physician.'' Id. at 
11.
    Moreover, the Board found that Respondent both increased the dose 
of oxycodone and added an additional drug, MS Contin, the dose of which 
he also ``subsequently increased,'' and yet did not document having 
``performed any physical examinations or [having] obtained any 
radiological studies to support his increased opioid prescribing.'' Id. 
at 12. Nor did he document ``a rationale for the increase'' in the MS 
Contin dosing. Id. The Board further found that later in his treatment 
of WO, Respondent further increased the dose of oxycodone ``to eight 
tablets per day without documenting a rationale for the increase.'' Id.
    Next, the Board found that approximately one month after the latter 
increase in WO's oxycodone dosage, Respondent obtained a urine drug 
screen from WO. Id. However, the results were negative for oxycodone 
but positive for both methadone and codeine, even though Respondent had 
not prescribed either of the latter two drugs. Id. Moreover, WO's drug 
screen was positive for heroin. Id.
    While the Board found that ``Respondent documented that he was 
aware of the positive'' test results, it further found that ``he did 
not adequately investigate or address the abnormal results, which 
include referring WO to an addiction medicine specialist or 
discontinuing the opioid prescriptions.'' Id. The Board thus also found 
that ``Respondent allowed WO to continue a pattern of illicit substance 
use and opioid misuse.'' Id. at 13.
    Accordingly, the Board found that Respondent ``deviated from the 
standard of care'' because ``he did not perform an adequate workup of 
WO prior to continuing the treatment of his previous treating 
physician,'' prescribed opioids in amounts that were not supported by 
``the physical examination and radiological data,'' and ``did not 
adequately investigate or address WO's abnormal urine drug screens.'''' 
Id. at 12-13.\41\ Here again, the Board findings support the conclusion 
that Respondent acted outside of the usual course of professional 
practice and lacked a legitimate medical purpose in prescribing 
controlled substances to WO.\42\ 21 CFR 1306.04(a).
---------------------------------------------------------------------------

    \41\ The Board also found that Respondent failed to maintain 
adequate records ``because there was no documentation that [he] 
performed neurological or musculoskeletal examination or ordered any 
imaging or laboratory studies prior to continuing the treatment and 
there was no documented rationale for his excessive prescribing of 
opioids.'' GX 18, at 13.
    \42\ It is noted that the Board faulted Respondent because he 
did not obtain imaging studies of WO's lumbar spine. GX 18, at 11. 
My conclusion that Respondent acted outside of the usual course of 
professional practice and lacked a legitimate medical purpose is 
based on the totality of the Board's findings and the multiple 
deviations of the standard of care which it found.
---------------------------------------------------------------------------

    Finally, in the 2009 Order, the Board made extensive findings 
regarding Respondent's prescribing to DK, a self-referred patient who 
complained of lower back pain and psychiatric issues. GX 17, at 4. At 
her initial visit, DK reported that she was currently taking OxyContin 
160 mg, three times per day; oxycodone 30 mg, two tablets, one to two 
times daily; and Valium; RX 30, at 40. She also reported that imaging 
studies and x-rays had been done three years earlier. Id. However, 
while at the initial visit, DK said she would provide her medical 
records, including these imaging studies, to Respondent, and Respondent 
asked her to do so on four additional visits, she did not comply for 
more than a year. Id.; see also GX 17, at 4. Regarding DK's 
noncompliance, Respondent testified that she either ``could not 
remember or give us the name [of her previous physician] or produce 
records.'' Tr. 851-52; see also id. at 1027.
    Yet, notwithstanding her non-compliance, Respondent issued monthly 
prescriptions to DK for OxyContin 80 mg (initially for 180 tablets, but 
after several months, increasing to 210 tablets) and oxycodone 30 mg 
(typically 180 tablets). RX 30, at 40. This continued for nearly one 
year and until Respondent was notified that another physician had 
recently discharged her (in the prior month, no less) for violating her 
pain contract by using cocaine, as well as methadone which had not been 
prescribed to her. Indeed, only then did he take any action. Notably, 
Respondent failed to do any urine drug screens on DK from November 
2006, when he first began prescribing to her, until June 3, 2008.
    According to the Board, under the standard of care, a physician who 
``continu[es] high dose opioid prescriptions for a self-referred, 
chronic pain management patient . . . who reports currently being 
prescribed high dose opioid medications,'' must base the prescriptions 
``on proper indications, including previous medical records and 
verified previous prescriptions, and/or contact with the previous 
prescribing physician.'' GX 17, at 5. The Board thus found that 
``Respondent deviated from the standard of care by prescribing high 
dose opioids to DK without proper indications.'' Id. Also, the Board 
found that the standard of care requires that a physician ``treating a 
chronic pain patient [with] known or suspected substance abuse problem 
. . . to utilize objective measures to monitor compliance.'' Id. The 
Board thus also found that ``Respondent deviated from the standard of 
care by failing to timely use objective measures, such as urine drug 
tests, to assess DK's compliance with her treatment even after he was 
aware of her cocaine addiction.'' Id. The deviations of the standard of 
care found by the Board are sufficient to support the conclusion that 
Respondent acted outside of the usual course of professional practice 
and lacked a legitimate medical purpose in

[[Page 38384]]

prescribing OxyContin and oxycodone to DK.\43\ See 21 CFR 1306.04(a).
---------------------------------------------------------------------------

    \43\ While the Board faulted Respondent for his ``continu[ing] 
to prescribe opiates to DK for her back pain'' after she was 
referred to Behavioral Health, as well as his continued prescribing 
of opiates after ``he learned that she had successfully completed 
inpatient opioid detoxification,'' GX 17, at 5; the Board did not 
find that either course of conduct constituted a deviation from the 
standard of care. See id. Nor did the Government offer any expert 
testimony as to whether Respondent's prescribing of opiates 
following DK's referral to Behavioral Health or following her 
completion of inpatient opioid detoxification was within usual 
course of professional practice and lacked a legitimate medical 
purpose.
     As for Respondent's continued prescribing to DK, 
notwithstanding that she purportedly could not remember the name of 
the physician who had previously (and likely was also continuing to 
prescribe to her), as well as her repeated failure to provide her 
medical records, the federal courts have held that knowledge can be 
inferred based on the ``willful blindness'' of a physician in 
ignoring various warning signs that a patient is either abusing or 
diverting drugs. United States v. Katz, 445 F.3d 1023, 1031 (8th 
Cir. 2006). See also United States v. Jewell, 532 U.S. 697, 702-704 
(9th Cir. 1976) (discussing deliberate ignorance instructions, 
noting that ``Courts of Appeals reviewing the sufficiency of 
evidence have approved the premise that `knowingly' in criminal 
statutes is not limited to positive knowledge, but includes the 
state of mind of one who does not possess positive knowledge only 
because he consciously avoided it'').
     Even if I believed that Respondent was merely na[iuml]ve or 
gullible in his treatment of DK, which I do not, I would conclude 
that Respondent is so irresponsible as to raise grave doubts as to 
his fitness to hold a registration.
---------------------------------------------------------------------------

The Undercover Patients

    The ALJ concluded that the Government did not establish that the 
Respondent acted outside of the usual course of professional practice 
and lacked a legitimate medical purpose when he prescribed controlled 
substances to RL and ML, the two undercover visitors. R.D. at 60. The 
Government takes exception to these findings, contending that ``[t]he 
evidence . . . shows that, on four occasions, Respondent prescribed 
controlled substances to [ML and RL] without ever conducting a physical 
examination,'' and thus the prescriptions were issued in violation of 
Ariz. Rev. Stat. Sec.  32-1401(27)(ss), which provides that it is 
``unprofessional conduct'' to prescribe ``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,'' and thus also violated federal law. Exceptions at 3 
(also citing 21 CFR 1306.04(a)).
    As support for its contention, the Government cites the testimony 
of a Special Agent as to hearsay statements that were made by the two 
confidential sources to the effect that Respondent did not perform a 
physical examination on them. Id. (citations omitted). It also argues 
that ``Respondent's own expert testified that Respondent failed to 
conduct a physical examination of either CS1 or CS2 prior to issuing 
them prescriptions for controlled substances.'' Id. (citations 
omitted).
    As for the hearsay statements of the confidential sources, the 
Government offered no evidence to support a finding that each statement 
is sufficiently reliable to constitute substantial evidence. See Carlos 
Gonzalez, 76 FR 63118, 63119 (2011) (citing various appellate decisions 
regarding factors which support a finding that hearsay statements are 
sufficiently reliable). And while Respondent's Expert admitted that she 
did not see in the transcripts of the undercover visits where 
Respondent had performed a physical examination at either RL or ML's 
first visit, as found above, I cannot ignore that the transcripts and 
recordings manifest that at each of the CS's first visits, either 
Respondent (or Dr. Skinner) palpated them in the area of their body 
which was the source of their purported pain complaint. Thus, the 
testimony of Respondent's Expert does not corroborate the hearsay 
statement of either RL or ML.
    It may be that the physical exams Respondent performed on RL and ML 
were totally inadequate to validly diagnose them as having a legitimate 
pain condition and to support the prescribing of controlled substances. 
However, while Arizona law requires that a physician perform a physical 
exam before he initially prescribes a drug, it does not set forth what 
is required to constitute an adequate examination. Moreover, while 
Respondent's Expert repeatedly attempted to minimize his 
misconduct,\44\ thus suggesting a less than objective portrayal on her 
part of Respondent's prescribing practices, even were I to reject the 
ALJ's credibility finding regarding her testimony that Respondent's 
prescribing to the two CSs was ``well within the standard of care,'' I 
would still reject the Government's contention because it had the 
burden of proving by substantial evidence that these four prescriptions 
violated 21 CFR 1306.04(a).\45\ Here, because the transcripts clearly 
showed that Respondent palpated (or observed Dr. Skinner palpate \46\) 
the CSs, and the transcripts otherwise contain no statements by either 
the CSs or Respondent indicating that either CS was not a legitimate 
patient, expert testimony was required to show that Respondent acted 
outside of the usual course of professional practice and lacked a 
legitimate medical purpose when he prescribed controlled substances to 
the two CSs. Accordingly, I reject the Government's exception and adopt 
the ALJ's findings with respect to the undercover patients.
---------------------------------------------------------------------------

    \44\ For example, in her letter of May 27, 2011, Dr. Schneider, 
in an apparent reference to the Board's findings, characterized 
Respondent's problematic practices as ``past minor deficiencies.'' 
RX 23, at 3. Likewise, in her testimony, she asserted that the 
Arizona Medical Board's guidelines on using controlled substances to 
treat chronic pain were not even minimum standards but were 
aspirational and ``to educate doctors.'' Tr. 588. She further 
asserted that physicians were ``being judged by standards of care 
that are current [but] that were not the standard of care at the 
time that those visits took place,'' id. at 586, as if the standards 
had actually changed between the time Respondent prescribed to the 
patients identified in the two AMB Orders and the period during 
which the Board conducted its review.
    So too, when asked whether the standard of care requires a 
physician to obtain medical records before providing the first 
prescription, she asserted that she did not ``think that most 
doctors actually get the records before providing a first 
prescription.'' Id. at 589. While she then acknowledged that it was 
risky if patients ``come in and what they want is super high doses, 
. . . it's risky to let them walk out with a prescription in the 
absence of any documentation that they indeed were on that dose 
because that could be lethal,'' she then added that ``[t]he doses 
we're talking about with [Respondent] were often minimal doses,'' 
id., as if the amounts and dosages he prescribed to DK at her first 
visit were minimal. Finally, while Dr. Schneider noted that there 
were instances in which Respondent did not do a physical exam on the 
first visit, this, notwithstanding the requirements of Arizona law, 
see Ariz. Rev. Stat. Sec.  32-1401(27)(ss), is, in her view, just 
one of the ``things that could be improved'' because Respondent 
``really need[s] education.'' Tr. 598.
    \45\ Put another way, it was not Respondent's burden to prove 
that the prescriptions were lawful. Thus, in the absence of 
probative and reliable evidence that the prescriptions were 
unlawful, Respondent had no obligation to refute the charge.
    \46\ The Government also asked Dr. Schneider as to whether 
Respondent could rely upon Dr. Skinner's examination of ML. Dr. 
Schneider testified that she did not ``have an exact answer because 
that doesn't often come up. I suppose if it's someone else who's 
skilled who is doing the physical that might be appropriate.'' Tr. 
654-55. Dr. Schneider then added that she did not know. Id. at 655. 
However, it was the Government's obligation to establish that under 
the standard of care, a physician cannot observe another physician 
examine a patient and rely on those observations as part of 
performing a physical exam and not Respondent's obligation to show 
that it is within the standard of care.
     As for the Government's contention that Respondent also failed 
to physically examine the CSs at their second visits, the Government 
offered no evidence that the standard of care requires that a 
physician perform a physical exam at each visit at which he 
prescribes a controlled substance. Indeed, the statute relied on by 
the Government suggests the opposite, as it permits prescribing 
where a physician ``has previously established a doctor-patient 
relationship.'' Ariz. Rev. Stat. Sec.  32-1401(27)(ss).
---------------------------------------------------------------------------

Sanction

    Based on his findings that Respondent acted outside of the usual 
course of

[[Page 38385]]

professional practice and lacked a legitimate medical purpose in 
prescribing controlled substances to numerous patients, the ALJ found 
that the Government had met its prima facie burden of showing that 
``Respondent has committed acts inconsistent with the public interest 
between 2006 and 2009.'' R.D. at 65. However, based on his finding that 
Respondent had ``credibly accepted responsibility for his past 
misconduct and demonstrated that he has implemented various corrective 
measures to ensure that his medical practice is consistent with the 
public interest,'' id. at 64, the ALJ recommended that Respondent's 
registration should be continued subject to the condition that he 
comply with all terms of the AMB's 2010 Order and notify the DEA field 
office of any changes in the terms and conditions of the AMB's 2010 
Order. Id. at 65-66.
    Under Agency precedent, where, as here, ``the Government has proved 
that a registrant has committed acts inconsistent with the public 
interest, a registrant must ` ``present sufficient mitigating evidence 
to assure the Administrator that [he] can be entrusted with the 
responsibility carried by such a registration.'' ' '' Medicine Shoppe-
Jonesborough, 73 FR 364, 387 (2008) (quoting Samuel S. Jackson, 72 FR 
23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988)). 
``Moreover, because `past performance is the best predictor of future 
performance,' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.1995), 
[DEA] has repeatedly held that where a registrant has committed acts 
inconsistent with the public interest, the registrant must accept 
responsibility for [his] actions and demonstrate that [he] will not 
engage in future misconduct.'' Medicine Shoppe, 73 FR at 387; see also 
Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006); 
Prince George Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v. 
DEA, 419 F.3d at 483 (``admitting fault'' is ``properly consider[ed]'' 
by DEA to be an ``important factor[]'' in the public interest 
determination).
    However, while a registrant must accept responsibility and 
demonstrate that he will not engage in future misconduct in order to 
establish that his/her continued registration is consistent with the 
public interest, DEA has repeatedly held these are not the only factors 
that are relevant in determining the appropriate sanction. See, e.g., 
Joseph Gaudio, 74 FR 10083, 10094 (2009); Southwood Pharmaceuticals, 
Inc., 72 FR 36487, 36504 (2007). Obviously, the egregiousness and 
extent of a registrant's misconduct are significant factors in 
determining the appropriate sanction. See Jacobo Dreszer, 76 FR 19386, 
19387-88 (2011) (explaining that a respondent can ``argue that even 
though the Government has made out a prima facie case, his conduct was 
not so egregious as to warrant revocation''); Paul H. Volkman, 73 FR 
30630, 30644 (2008); see also Paul Weir Battershell, 76 FR 44359, 44369 
(2010) (imposing six-month suspension, noting that the evidence was not 
limited to security and recordkeeping violations found at first 
inspection and ``manifested a disturbing pattern of indifference on the 
part of [r]espondent to his obligations as a registrant''); Gregory D. 
Owens, 74 FR 36751, 36757 n.22 (2009).
    Moreover, as I have noted in several cases, ```[n]either Jackson, 
nor any other agency decision, holds . . . that the Agency cannot 
consider the deterrent value of a sanction in deciding whether a 
registration should be [suspended or] revoked.''' Gaudio, 74 FR at 
10094 (quoting Southwood, 72 FR at 36504 (2007)); see also Robert 
Raymond Reppy, 76 FR 61154, 61158 (2011); Michael S. Moore, 76 FR 
45867, 45868 (2011). This is so, both with respect to the respondent in 
a particular case and the community of registrants. See Gaudio, 74 FR 
at 10095 (quoting Southwood, 71 FR at 36503). Cf. McCarthy v. SEC, 406 
F.3d 179, 188-89 (2d Cir. 2005) (upholding SEC's express adoptions of 
``deterrence, both specific and general, as a component in analyzing 
the remedial efficacy of sanctions'').
    Thus, in Gaudio, ``I explained that `even when a proceeding serves 
a remedial purpose, an administrative agency can properly consider the 
need to deter others from engaging in similar acts.' '' 74 FR at 10094 
(quoting Southwood, 72 FR at 36504) (citing Butz v. Glover Livestock 
Commission Co., Inc., 411 U.S. 182, 187-88 (1973)); cf. McCarthy, 406 
F.3d at 189 (``Although general deterrence is not, by itself, 
sufficient justification for expulsion or suspension, we recognize that 
it may be considered as part of the overall remedial inquiry.''); Paz 
Securities, Inc., et al. v. SEC, 494 F.3d 1059, 1066 (D.C. Cir. 2007) 
(agreeing with McCarthy). In Gaudio, I further noted that the 
``[c]onsideration of the deterrent effect of a potential sanction is 
supported by the CSA's purpose of protecting the public interest, see 
21 U.S.C. Sec.  801, and the broad grant of authority conveyed in the 
statutory text, which authorizes the [suspension or] revocation of a 
registration when a registrant `has committed such acts as would render 
[his] registration . . . inconsistent with the public interest,' id. 
Sec.  824(a)(4), and [which] specifically directs the Attorney General 
to consider [`such other conduct which may threaten public health and 
safety,' id. Sec.  823(f)].'' 74 FR at 10094 (quoting Southwood, 72 FR 
at 36504).\47\
---------------------------------------------------------------------------

    \47\ Unlike factors two (``[t]he applicant's experience in 
dispensing'') and three (``[t]he applicant's conviction record''), 
neither factor four (``Compliance with applicable laws related to 
controlled substances'') nor factor five (``Such other conduct which 
may threaten public health and safety'') contain the limiting words 
of ``[t]he applicant.'' As the Supreme Court has held, ``[w]here 
Congress includes particular language in one section of a statute 
but omits it in another section of the same Act, it is generally 
presumed that Congress acts intentionally and purposely in the 
disparate inclusion or exclusion.'' Russello v. United States, 464 
U.S. 16, 23 (1983). Thus, the text of factors four and five suggest 
that these factors are not limited to assessing the applicant's 
compliance with applicable laws and whether he has engaged in ``such 
other conduct,'' but rather authorize the Agency to also consider 
the effect of a sanction on inducing compliance with federal law by 
other practitioners.
---------------------------------------------------------------------------

    While noting that ``[a]gency precedent has recognized the 
significance of a registrant's remedial actions in continuing a 
registration,'' R.D at 63, the ALJ entirely ignored the Southwood/
Gaudio line of authority. See id. at 63-65. However, as these cases 
make clear, even where a registrant accepts responsibility and 
demonstrates that he has undertaken remedial measures, in determining 
the appropriate sanction, the Agency can still consider the need to 
deter both the particular registrant, as well as others, from engaging 
in similar acts.
    For example, in Gaudio, a case in which a physician was found to 
have recklessly dispensed controlled substances over the internet, I 
noted that ``even were I to ignore that Respondent has not accepted 
responsibility for his misconduct, and credit his testimony that he 
does not intend to resume his internet practice, I would still conclude 
that a lengthy suspension of his registration is warranted.'' 74 FR at 
10095.\48\ I rejected the ALJ's recommendation that I continue the 
physician's registration, subject only to the condition that he not 
prescribe controlled substances over the internet, id. at 10094, and 
instead suspended the physician's registration for a period of one 
year, holding that ``the ALJ's recommendation would not only `ignore 
how irresponsibly [the physician] acted'; it would also signal to 
others that one can ignore the law . . . and yet incur no consequence 
for having done

[[Page 38386]]

so.'' Id. at 10095 (quoting Southwood, 71 FR at 36503). I also noted 
that ``this is not the message that should be sent to those who 
contemplate prescribing controlled substances in'' the same unlawful 
manner as had the physician. Id.
---------------------------------------------------------------------------

    \48\ I further required that as a condition of approving the 
physician's application to renew his registration following the 
completion of his suspension, the physician was required to provide 
a sworn statement acknowledging his wrongdoing, and that without 
such an acknowledgement, his application would be denied. See 74 FR 
at 10095.
---------------------------------------------------------------------------

    In Moore, the ALJ found that a physician had unlawfully possessed 
and manufactured four pounds of marijuana. 76 FR at 45867. While 
finding that the physician had ``demonstrate[d] an acknowledgement that 
his actions were illegal,'' id. at 45877, and had ``credibly testified 
that he was in compliance with the terms of his [court-imposed] 
probation, as well as the terms of the [o]rder of'' his state medical 
board, id. at 45876, the ALJ recommended that his registration be 
suspended, noting that ``the agency has an interest in both assuring 
that the Respondent can be entrusted with the responsibilities 
attendant upon a [DEA] registrant and (notwithstanding the non-punitive 
nature of these proceedings) . . . in deterring others from similar 
acts.'' Id. at 45877.
    On review, I ``agree[d] with the ALJ that the Agency's interest in 
deterring similar misconduct on the part of others warrant[ed] a 
substantial period of outright suspension.'' Id. at 45868. However, I 
increased the length of the suspension from the ALJ's recommendation of 
six months to one year, noting, in part, that ``a six-month suspension 
[did not] sufficiently protect[ ] the Agency's interest in deterring 
misconduct on the part of others.'' Id.
    It is acknowledged that Respondent largely expressed his acceptance 
of the AMB's concerns with various aspects of his prescribing 
practices.\49\ Moreover, Respondent put on evidence of various 
improvements he had made in his prescribing practices.\50\ The ALJ also 
noted the testimony of Dr. Schneider, to the effect that Respondent was 
``doing much more careful documentation'' and ``was ordering older 
records and he . . . definitely changed the way he did things.'' R.D. 
at 64 (citing Tr. 626); see also id. at 64-65 (citing affidavits of two 
physicians regarding improvements in charting and investigation of 
patient backgrounds).
---------------------------------------------------------------------------

    \49\ In support of its contention that Respondent does not 
accept responsibility for his misconduct, the Government contends 
that Respondent lacked candor in his testimony when he ``attempted 
to explain away the inconsistencies between [the UCs'] medical 
records and the recordings/transcripts of these visits by concocting 
a patently disingenuous story about how he conducted . . . physical 
examinations through silent observation and covert methods of 
discerning pulse, respiration, grip strength etc.'' Exceptions at 6 
(citing John Stanford Noell, 59 FR 47359, 47362 (1994)). As found 
above, when confronted with the evidence that he had documented in 
each UC's medical record having taken their pulse while the 
transcript contains no indication that he had done so (at least in 
the typical way, see Tr.696), Respondent testified that he had 
determined the UC's pulses by shaking their hands. Id. at 987.
     Notably, the Government does not contend that Respondent's 
falsification of the UCs' medical records is itself actionable 
misconduct which should be considered under factor five, and even if 
it had, falsification of a medical record (and whether there is a 
materiality requirement) is a question of state law. As for the 
Government's contention that Respondent's testimony shows that he 
does not accept responsibility for his misconduct in prescribing to 
the UCs, Respondent is not required to accept responsibility for 
misconduct which has not been proved on the record. Accordingly, 
while I conclude that Respondent's testimony as to how he took the 
UCs' pulses is ludicrous, I do not rely on it in setting the 
appropriate sanction.
    \50\ Respondent testified that he had read four or five 
textbooks, taken on-line courses, and talked with other 
practitioners to make improvements to his charting and that his 
records are now more detailed and ``transparent to outside 
individuals.'' Tr. 861. In addition, Respondent testified that he 
does not ``take patients without records if they're possible to 
obtain,'' and that ``[i]f a patient comes and there are no records, 
particularly of high dose opiates, we might give them small doses 
and establish a record with them ourselves.'' Id. at 852-53. Also, 
Respondent testified that he is now using the Arizona prescription 
monitoring program to determine whether his patients are getting 
controlled substances from another provider. Id. at 853. Finally, 
Respondent testified that his practice now has ``in-office urine 
testing'' and he does ``routine urine screenings . . . on a random 
basis,'' that he has given an even ``higher priority'' to pharmacy 
calls,'' and that ``we will often call physicians . . . that we have 
records on to verify if we have any questions about dosing from 
another physician.'' Id. at 872-73.
---------------------------------------------------------------------------

    Yet Respondent's evidence as to his reform efforts is undercut to a 
significant degree by the Board's finding that, even after he had been 
placed on probation based on his prescribing to DK, he continued to 
prescribe high doses of opioids to ML without obtaining objective 
measures of ML's pain (and indeed, did so notwithstanding that ML's x-
ray contradicted his diagnosis of spondylolisthesis).\51\ GX 18, at 16. 
Thus, I give Respondent's evidence as to his remedial efforts 
substantially less weight than the ALJ did.\52\
---------------------------------------------------------------------------

    \51\ The AMB's 2010 Order also identified several other 
patients, to whom Respondent continued to prescribe controlled 
substances in deviation of the standard of care, by failing to 
obtain prior records, obtain objective measures for the cause of 
pain, and address abnormal urine drug screens, and did so even after 
he had been placed on probation. See GX 18, at 11-13 (WO); id. at 
14-15 (JR); id. at 15-16 (LP).
    \52\ In discussing Respondent's ``improvements in his 
prescribing practices . . . since the Board's actions,'' R.D. 60, 
the ALJ also cited the testimony of two patients, WR and ML (neither 
of whom is a medical professional), explaining that they ``credibly 
testified to their positive experiences in being treated by 
Respondent.'' R.D. at 61; see also id. at 62 (discussing testimony 
of Dr. SF that Respondent's care and treatment were ``excellent''). 
The term ``positive experience'' is not in the CSA, and the ALJ's 
conclusory discussion of WR's and ML's testimony offers little 
insight into what he understood the term to mean. Notably, neither 
patient offered testimony identifying specific changes in 
Respondent's prescribing practices which occurred following either 
of the AMB's orders. Thus, the testimony of WR and ML is not 
probative of the issue of whether Respondent has improved his 
prescribing practices.
    As for Dr. SF's testimony that Respondent provided him with 
``excellent'' treatment, while this Agency (as do the Federal 
courts) necessarily look to medical practice standards in assessing 
whether a physician who has prescribed controlled substances had a 
legitimate medical purpose and acted within the usual course of 
professional practice in doing so, DEA is charged with preventing 
the diversion of controlled substances and not with evaluating the 
adequacy of a physician's medical treatment. Moreover, as I have 
previously noted, ``[b]ecause under [the CSA], registration is 
limited to those who have authority to dispense controlled 
substances in the course of professional practice, and patients with 
legitimate medical conditions routinely seek treatment from licensed 
medical professionals, every registrant can undoubtedly point to an 
extensive body of legitimate prescribing over the course of [his] 
professional career.'' See Krishna-Iyer, 74 FR at 463.
     It is acknowledged that Dr. SF testified that Respondent took a 
complete history, performed a physical examination, reviewed his 
rules for prescribing medication, as well as subsequently helped SF 
taper off of his medication. Tr. 782. Yet, Dr. SF did not see 
Respondent until six to nine months after the AMB issued the first 
order, Tr. 780, and was clearly a legitimate patient. While his 
testimony bolsters to a degree the other evidence as to Respondent's 
change in his prescribing practices, it is of minimal probative 
value in assessing Respondent management of drug seeking patients.
---------------------------------------------------------------------------

    Nor does the ALJ's recommended sanction reflect an appreciation for 
the egregiousness of the violations he found proved (and which I concur 
with). In short, proof that in issuing a prescription, a practitioner 
acted outside of the usual course of professional practice and lacked a 
legitimate medical purpose, establishes that the practitioner has 
engaged in an act of intentional or knowing diversion. Such conduct 
strikes at the CSA's core purpose of preventing the abuse and diversion 
of controlled substances. See Jack A. Danton, 76 FR 60900, 60903 
(2011); George Mathew, 75 FR 66138 (2010). Indeed, this Agency has 
revoked a practitioner's registration upon proof of as few as two acts 
of intentional diversion and has further explained that proof of a 
single act of intentional diversion is sufficient to support the 
revocation of a registration. See MacKay, 75 FR at 49977 (citing 
Krishna-Iyer, 74 FR at 463 (citing Alan H. Olefsky, 57 FR 928, 928-29 
(1992))). While Respondent's misconduct would be egregious if it had 
been confined to a single patient, it was not. Rather, the Board's 
findings establish that Respondent diverted controlled substances to at 
least ten patients, and that with respect to several of these patients, 
he did so over an extensive time period.

[[Page 38387]]

    Nor--not surprisingly given that the ALJ totally ignored the Agency 
case law--does the recommended sanction reflect an appreciation for the 
growing and serious problem of the diversion of prescription drugs by 
unscrupulous practitioners and the epidemic of prescription drug 
abuse.\53\ Indeed, adopting the ALJ's recommendation--which simply 
requires Respondent to do what the State has already required him to 
do--would create a perverse incentive. In short, it would send the 
message that a practitioner can unlawfully distribute controlled 
substances until he/she gets caught, and as long as he/she then 
acknowledges wrongdoing and puts on evidence that he/she has reformed, 
he/she will get a slap on the wrist. This is the entirely wrong message 
to send to those practitioners who contemplate using their prescribing 
authority for illicit purposes. And even those practitioners who might 
fairly be described as gullible or na[iuml]ve, should know that there 
are serious consequences if they prescribe controlled substances in a 
manner that does not comply with the accepted standards of professional 
practice.\54\
---------------------------------------------------------------------------

    \53\ See Krishna-Iyer, 74 FR at 463 (quoting National Center on 
Addiction and Substance Abuse, Under the Counter: The Diversion and 
Abuse of Controlled Prescription Drugs in the U.S. 3 (2005) 
[hereinafter, Under the Counter]). As noted in Krishna-Iyer, ``[t]he 
diversion of controlled substances has become an increasingly grave 
threat to this nation's public health and safety. According to The 
National Center on Addiction and Substance Abuse (CASA), `[t]he 
number of people who admit abusing controlled prescription drugs 
increased from 7.8 million in 1992 to 15.1 million in 2003.' '' 74 
FR at 463 (quoting Under the Counter, at 3). CASA also found that `` 
`[a]pproximately six percent of the U.S. population (15.1 million 
people) admitted abusing controlled prescription drugs in 2003, 23 
percent more than the combined number abusing cocaine (5.9 million), 
hallucinogens (4.0 million), inhalants (2.1 million) and heroin 
(328,000).' '' Id. (quoting Under the Counter, at 3). Finally, CASA 
found that ```[b]etween 1992 and 2003, there has been a . . . 140.5 
percent increase in the self-reported abuse of prescription 
opioids,'' and in the same period, the ``abuse of controlled 
prescription drugs has been growing at a rate twice that of 
marijuana abuse, five times greater than cocaine abuse and 60 times 
greater than heroin abuse.'' Id. (quoting Under the Counter, at 4).
    \54\ As support for his recommendation, the ALJ also quoted from 
a letter of Dr. Schneider, in which she wrote:
    The goal of regulatory agencies needs to be (and is usually 
claimed to be) to improve the performance of physicians when a 
deficiency is noted, rather than prevent them from continuing to 
practice, thereby wasting their training and experience. 
[Respondent], like many pain management doctors, developed his 
knowledge of pain management on the job rather than through a formal 
training program. This is a rapidly evolving field, and its 
standards are evolving. [Respondent]'s skills continue to improve. I 
believe that at this point he is clearly able to practice pain 
management with sufficient skill and safety that he should be 
allowed to continue to do this.
    RX 23, at 2-3.
    Whatever the State of Arizona has chosen, in the exercise of its 
sovereignty, as the goal of its Medical Board, Congress has directed 
this Agency to protect the public interest. See 21 U.S.C. Sec. Sec.  
823(f) and 824(a)(4). This charge necessarily contemplates not only 
deterring a diverter from continuing to do so, but also deterring 
other would be diverters from doing so. And notwithstanding Dr. 
Schneider's view of the appropriate goal of a state medical board, 
here, the AMB concluded that Respondent's prescribing of opioids was 
so deficient that it suspended his prescribing authority for one 
year.
    Indeed, while in this same paragraph, Dr. Schneider 
characterized Respondent's prescribing practices as ``minor 
deficiencies,'' RX 23, at 3, the Board's findings establish that, in 
numerous instances, Respondent violated the standard of care by: (1) 
Failing to perform physical examinations; (2) failing to perform 
adequate psychiatric evaluations; (3) not obtaining prior records; 
(4) failing to perform tests to confirm diagnoses and the need for 
controlled substances; (5) failing to conduct urine drug screens and 
monitor his patients' compliance; (6) ignoring the results of drug 
tests which either showed that his patient was not taking drugs he 
prescribed or taking drugs he did not prescribe or street drugs; (7) 
providing early refills; (8) adding drugs to a patient's medication 
regime and escalating the dosing of drugs without any rationale for 
doing so; and (9) prescribing large doses of opioids to a patient, 
who purportedly could not remember the name of her previous 
prescriber and who repeatedly failed to comply with instructions to 
bring in records from prior treating physicians. These findings were 
in addition to the Board's findings that Respondent failed to 
maintain adequate records.
    If these are ``minor deficiencies,'' I would like to know what, 
in Dr. Schneider's view, would constitute a major one. As for Dr. 
Schneider's suggestion that Respondent's misconduct should be 
excused because he ``developed his knowledge of pain management on 
the job rather than through a formal training program,'' on various 
occasions (November 1997, May 1999, and June 2003), the AMB 
published guidelines on the Use of Controlled Substances for the 
Treatment of Chronic Pain, which specifically addressed many of the 
problematic practices the Board identified in its review of 
Respondent's prescribing practices, and which ``clarif[ied] the 
principles of professional practice that are endorsed by the 
Board.'' Arizona Medical Board, Use of Controlled Substances for the 
Treatment of Chronic Pain (Substantive Policy Statement  
7).
    Likewise, well before Respondent issued the prescriptions which 
were discussed in the AMB's orders, federal courts had issued 
decisions upholding convictions for violating the prescription 
requirement based on conduct similar to Respondent's. See, e.g., 
Moore, 423 U.S. at 142-43; United States v. Williams, 445 F.3d 1302, 
1305 (11th Cir. 2006) (sustaining conviction for unlawful 
distribution noting, inter alia, expert's testimony that physician 
``wrote prescriptions for patients on whom he performed no or very 
minimal physical examination,'' ``wrote prescriptions for patients 
whose toxicology screens . . . showed that they were not taking the 
prescribed drugs and were instead taking illegal drugs,'' and ``he 
frequently refilled prescriptions early and replaced `lost' 
drugs''); United States v. Tran Trong Cuong, 18 F.3d 1132, 1139 (4th 
Cir. 1994) (sustaining conviction for unlawful distribution noting, 
inter alia, that ``[m]ost of the patients were given very 
superficial physical examinations and even after months of the same 
complaints of pain and the same prescriptions of drugs, they were 
not given more complete examinations, nor were they subjected to x-
rays or blood analysis or referred to specialists in an effort to 
identify and correct the cause of the pain'').
    Certainly, those who undertake to practice in a highly regulated 
profession cannot reasonably claim ignorance of the laws, 
regulations and standards applicable to the practice of their 
profession. Cf. United States v. Southern Union Co., 630 F.3d 17, 31 
(1st Cir. 2010). Finally, given that Respondent testified that he 
read four or five textbooks to improve his understanding of 
applicable standards, one must wonder why he did not read these 
textbooks when he decided to commence treating patients for chronic 
pain.
---------------------------------------------------------------------------

    I therefore reject the ALJ's recommended sanction that Respondent's 
registration be continued subject only to the condition that he comply 
with the AMB's order (and notify the Agency of any changes to the 
order). Instead, while I will order that Respondent's renewal 
application be granted, I will further order that his registration then 
be suspended for a period of one year.
    Moreover, as Respondent suggested in his post-hearing brief, the 
Agency ``may wish to impose requirements of continued monitoring of his 
files and perhaps keeping a separate log for all medications.'' Resp. 
Prop. Findings of Fact, Conclusions of Law and Argument, at 43. 
Accordingly, upon Respondent's completion of his suspension, the 
following conditions shall be imposed on his registration.
    1. Respondent shall keep a log of all controlled substance 
prescriptions he issues. Said log shall be maintained in chronological 
order, and shall list each patient by name, and include the name of the 
drug prescribed, the number of refills authorized, the strength of the 
dosage unit, the quantity, and the dosing instruction. Not later than 
ten days following the end of each month, Respondent shall provide the 
local DEA field office with a complete copy of the log for the 
preceding month.
    2. Respondent shall agree to continued monitoring of his patient 
files, with the costs of said monitoring to be borne by him. Said 
monitor shall be board certified in pain management and licensed by the 
Arizona Medical Board. DEA retains final authority to accept or reject 
the selection of said monitor. Said monitor shall review no less than 
twenty patient files each quarter, which shall be selected by the 
monitor; the monitor's selection of any patient file may not be 
challenged by Respondent. Respondent shall agree to fully cooperate 
with the monitor.
    3. Respondent shall further consent to unannounced inspections of 
his registered location and to waive his right to require DEA personnel 
to obtain an administrative inspection warrant prior to conducting an 
inspection.
    4. These conditions shall remain in effect for a period of two 
years following the completion of Respondent's suspension. Said 
condition shall

[[Page 38388]]

thereupon terminate upon Respondent's completion of the two year period 
without violating any of the above terms. The violation of any of the 
above terms shall, however, subject, Respondent's registration to an 
Order of Immediate Suspension.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a), as well as 28 CFR 0.100(b), I order that the application of 
David A. Ruben, M.D., to renew his Certificate of Registration as a 
practitioner, be, and it hereby is, granted subject to the conditions 
set forth above. I further order that Respondent's Certificate of 
Registration be, and it hereby is, suspended for a period of one year 
to begin thirty days from the date of publication of this Order in the 
Federal Register. This Order is effectively immediately.

    Dated: June 18, 2013.
Michele M. Leonhart,
Administrator.
[FR Doc. 2013-15266 Filed 6-25-13; 8:45 am]
BILLING CODE 4410-09-P