Wesley Pope, M.D.; Decision and Order, 14944-14985 [2017-05676]

Download as PDF 14944 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 15–8] srobinson on DSK5SPTVN1PROD with NOTICES2 Wesley Pope, M.D.; Decision and Order On October 8, 2014, the former Deputy Assistant Administrator of the then-Office of Diversion Control, issued an Order to Show Cause to Wesley Pope, M.D. (hereinafter, Respondent), of Newcastle, Oklahoma. ALJ Ex. 1, at 1. The Show Cause Order proposed the denial of Respondent’s application for a new Certificate of Registration as a practitioner in schedules II through V, on the ground that his registration would be ‘‘inconsistent with the public interest.’’ Id. (citing 21 U.S.C. 823(f)). As support for the proposed denial, the Government alleged that ‘‘[f]rom on or about August 25, 2011 through on or about May 9, 2012, [Respondent] issued controlled substance prescriptions to [patient] B.B. in violation of Federal and Oklahoma . . . law.’’ Id. The Government specifically alleged that ‘‘on each of the occasions that [Respondent] issued controlled substance prescriptions to B.B.,’’ Respondent was ‘‘aware . . . that he presented a high risk of abuse and/or diversion of controlled substances, as evidenced by the red flags documented in his patient file, such as aberrant urine drug tests, a request for early refills, and a claim of stolen drugs.’’ Id. The Government then alleged that Respondent ‘‘failed to address and, in fact, ignored these red flags, continuing to issue B.B. controlled substances [sic] prescriptions in the face of mounting evidence that he was misusing, abusing, and/or diverting the controlled substances [he was] prescribing.’’ Id. The Government further alleged that ‘‘[t]he prescriptions [Respondent] issued to B.B. on each visit were below the standard of care in Oklahoma and fell outside the usual course of professional practice.’’ Id. at 1–2 (citing 21 CFR 1306.04(a); Okla. Admin. Code § 435:10–7–4; id. § 435:70–7–11 1; Okla. Bd. of Med. Lic. & Super., Use of Controlled Substances for the Treatment of Pain (Mar. 10, 2005)). The Show Cause Order then alleged that on 11 different dates, Respondent issued to B.B. prescriptions for such drugs as hydrocodone/acetaminophen, Opana (oxymorphone), fentanyl patches, 1 This is an apparent typographical error as there is no such provision. The parties, however, spent considerable time arguing as to whether Respondent complied with Okla. Admin. Code § 435:10–7–11, which governs the ‘‘Use of Controlled Substances for the Management of Chronic Pain.’’ VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 morphine sulfate, oxycodone/ acetaminophen, and Soma (carisoprodol) which were ‘‘invalid.’’ Id. at 2–6. The Government also provided detailed factual allegations pertaining to each of the prescriptions. Id. Respondent requested a hearing on the allegations. The matter was then placed on the docket of the Office of Administrative Law Judges and assigned to Chief Administrative Law Judge John J. Mulrooney, II (hereinafter, CALJ). Following pre-hearing procedures, the CALJ conducted a hearing on April 7– 8, 2015 in Oklahoma City, Oklahoma. During the hearing, both parties submitted documentary evidence; the Government elicited the testimony of several witnesses and Respondent testified on his own behalf. On July 24, 2015, the CALJ issued his Recommended Decision (cited as R.D.). Therein, the CALJ found that the allegations were sustained only with respect to five of the dates on which Respondent prescribed (and with respect to four of these dates, only sustained in part). See R.D. 44, 46, 62, 64, 68. While the CALJ concluded that Respondent had issued these prescriptions outside of the course of professional practice and thus violated 21 CFR 1306.04(a), id. at 90, he further reasoned that Respondent’s misconduct reflected ‘‘inattention to detail [and] not intentional diversion.’’ Id. at 82. He thus concluded that while the Government had made out a prima facie case to warrant some form of sanction, Respondent’s conduct was not sufficiently egregious to warrant denial even though he found that ‘‘Respondent was irresponsible in continuing to prescribe to this patient in the face of red flags of diversion, and in failing to document or even possess the ability to persuasively convey a medically-based justification for prescribing new controlled medication.’’ Id. at 92–93. And even though Respondent had failed to accept responsibility and put forward no evidence of remedial measures he had undertaken, the CALJ recommended that he be granted a new registration subject to a one-year period of probation with various conditions. Id. The Government filed Exceptions to the Recommended Decision and Respondent filed a Response to the Government’s Exceptions. Thereafter, the record was forwarded to my Office for Final Agency Action. Having considered the record in its entirety including the Recommended Decision, the Government’s Exceptions, and Respondent’s Response to the Government’s Exceptions, I agree with the CALJ’s findings and legal conclusion with respect to the first prescribing PO 00000 Frm 00002 Fmt 4701 Sfmt 4703 event (August 25, 2011). While I agree with the CALJ’s legal conclusions that Respondent acted outside of the usual course of professional practice when he prescribed controlled substances during the third, fourth, tenth, eleventh, and twelfth prescribing events, I hold that several of the exceptions raised by the Government are well taken and that additional relevant evidence should be considered in review of the record. Based on my consideration of the record as a whole, I, as the ultimate fact-finder, conclude that a preponderance of the evidence supports the conclusions that Respondent knowingly diverted controlled substances by issuing prescriptions in violation of 21 CFR 1306.04(a) when he prescribed various schedule II controlled substances on 11 occasions, beginning on September 22, 2011 and ending on May 9, 2012. I further find that Respondent’s misconduct is egregious and establishes a prima facie case for denial. Because I also agree with the CALJ that the record reflects Respondent’s ‘‘almost dogged determination to accept no responsibility for any of his actions’’ and that he ‘‘has not presented even the most modest plan for any remedial action,’’ R.D. 92, I conclude that his application should be denied. The Government’s Exceptions In its Exceptions, the Government raises multiple contentions, several of which warrant discussion prior to making factual findings. The first of these is that the CALJ erroneously concluded that the Oklahoma Medical Board’s Standards ‘‘on which the Government relied were permissive rather than mandatory.’’ Exceptions, at 5. Indeed, in making his legal conclusions, the CALJ repeatedly declined to give weight to the Government Expert’s testimony on material issues, reasoning that the Expert’s testimony was premised on his misunderstanding that the Board’s regulations, in particular its documentation and recordkeeping rules, were mandatory rather than permissive. Second, the Government maintains that the CALJ erroneously held that the Government failed to provide adequate notice to Respondent of its intent to rely on the various aberrant drug tests as part of its proof that various prescriptions were issued in violation of 21 CFR 1306.04(a). With respect to this exception, the Government argues that not only did it provide adequate notice, the aberrant nature of the various urine drug screens (UDS) was litigated by consent. Exceptions, at 15–25. It also takes exception to the CALJ’s finding E:\FR\FM\23MRN2.SGM 23MRN2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices that several of the UDSs were not aberrant. The CALJ’s Conclusion That the Board’s Standards Are Permissive Throughout his Recommended Decision, the CALJ repeatedly declined to give weight to the Government Expert’s testimony that Respondent failed to conduct a medically adequate evaluation of B.B.’s pain complaint and establish medical necessity to justify the prescribing of controlled substances. The basis of the CALJ’s reasoning was that the deficiencies identified by the Expert ‘‘generally relate to a paucity of documented proof in the chart entries as to whether or how much various medical treatment considerations that he favors were considered by the Respondent in making his prescription decision.’’ R.D. at 35. Based on his conclusion that the provisions of the Oklahoma Board’s rules applicable to a physician’s documentation of his evaluation of a patient and recordkeeping are ‘‘permissive’’ and not mandatory, the CALJ reasoned that ‘‘Respondent’s alleged lack of documentation . . . is likely not as fatal to the Respondent’s adherence to the standard of care in Oklahoma as the Government expert claims.’’ R.D. 16. I disagree. With respect to the evaluation of the patient, the Oklahoma Rule states: srobinson on DSK5SPTVN1PROD with NOTICES2 A medical history and physical examination must be obtained, evaluated and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance. Okla. Admin. Code § 435:10–7–11(1). And with respect to medical records, the Oklahoma Rule states in relevant part that ‘‘[r]ecords should remain current’’ and that ‘‘[t]he physician should keep accurate and complete records.’’ Id. § 435:10–7–11(6). The records are ‘‘to include . . . the medical history and physical examination (including vital signs),’’ ‘‘diagnostic, therapeutic and laboratory results,’’ ‘‘evaluations, consultations and followup evaluations,’’ ‘‘treatment objectives,’’ ‘‘discussion of risks and benefits,’’ ‘‘informed consent,’’ ‘‘treatments,’’ ‘‘medications (included date, type, dosage and quantity prescribed),’’ ‘‘instructions and agreements and periodic reviews.’’ Id. In the CALJ’s view, because the provisions of the Oklahoma regulation applicable to the VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 documentation of the physician’s evaluation of his patient and his recordkeeping use the word ‘‘should’’ in expressing the State’s rules, the obligations they impose are ‘‘permissive.’’ R.D. at 16. The CALJ, however, cited no authority from either the Board or the Oklahoma courts definitively interpreting the word ‘‘should’’ as used in the context of these two provisions as ‘‘permissive.’’ See, e.g., id. at 6. Indeed, the CALJ’s conclusion appears to have been based entirely on the fact that the Board’s prior version of its intractable pain rule used such words as ‘‘requires’’ and ‘‘must’’ in setting forth a practitioner’s obligations with respect to documentation and recordkeeping. See R.D. 87 n.147 (quoting Okla. Admin. Code § 435:10–7–11(b) (2004): ‘‘[t]his rule requires that a diagnosis be documented’’ and id. § 435:10–7–11(j): ‘‘[a]ccurate and complete records to document compliance with this section must be kept’’). In the CALJ’s view, ‘‘[t]he evolution of the [regulations] demonstrate [sic] that their permissive nature represents an intentional redirection by Oklahoma.’’ Id. However, when the Board promulgated the current version of the rule in 2005, it simply noted that ‘‘[t]he rule is being updated based on recommendations from the Federation of State Medical Boards.’’ 22 Okla. Reg. 2096 (June 15, 2005); see also 22 Okla. Reg. 379 (Notice of Rulemaking Intent; Feb. 1, 2005). In short, the CALJ’s reliance on the Board’s decision to adopt the Federation of State Medical Board’s model rule simply proves too much. Furthermore, although the word ‘‘should’’ is susceptible to different meanings, when used in the context of legal requirements, it generally does not connote ‘‘permission’’ but rather obligation or duty. United States v. Anderson, 798 F.2d 919, 924 (7th Cir. 1986) (‘‘The common interpretation of the word ‘should’ is ‘shall’ and thus a straight-forward construction of [the Code of Judicial Conduct] reveals that it imposes a mandatory rule of conduct upon a judge.’’) 2; Wollschlaeger v. Farmer, 814 F.Supp.2d 1367, 1376 (S.D.Fl. 2011) (‘‘Generally, laws that provide for disciplinary action in the cases of violations or noncompliance are mandatory, not precatory or hortatory. . . .’’); see also Bureau of Prisons v. FLRA, 737 F.3d 779, 787 (D.C. Cir. 2013) (‘‘ ‘Should’ is typically used to express 2 As the Seventh Circuit also noted, ‘‘as listed in Roget’s Thesaurus, [the word ‘‘should’’] means ‘be obliged, must . . . have to.’ The common interpretation of the word ‘should’ is ‘shall.’ ’’ 798 F.2d at 924. PO 00000 Frm 00003 Fmt 4701 Sfmt 4703 14945 an obligation or duty.’’) (citing Webster’s Third International Dictionary 2104 (1976)); see also Webster’s Third International Dictionary 2104 (defining ‘‘should’’ as ‘‘used in auxiliary function to express duty, obligation, necessity, propriety or expediency’’). Moreover, reading the Board’s documentation and recordkeeping provisions as permissive cannot be squared with the Oklahoma Medical Practice Act. Cf. Wollschlaeger, 814 F.Supp.2d at 1376 (rejecting interpretation that statute which used ‘‘should’’ was hortatory when State law provided that violations of provision constituted grounds for disciplinary action). Under the Medical Practice Act, a physician’s ‘‘[f]ailure to maintain an office record for each patient which accurately reflects the evaluation, treatment, and medical necessity of treatment of the patient’’ constitutes ‘‘unprofessional conduct.’’ 50 Okla. Stat. Ann. § 509(18). Another provision of the Medical Practice Act states that ‘‘[a]dequate medical records to support diagnosis, procedures, treatment, or prescribed medications must be produced and maintained.’’ Id. § 509(20) (emphasis added). And a further provision of the Medical Practice Act makes ‘‘[p]rescribing . . . controlled substances or narcotic drugs without medical need in accordance with published standards’’ ‘‘unprofessional conduct.’’ Id. § 509(16). Thus, construing the Board’s documentation and recordkeeping rules as permissive would be fundamentally inconsistent with the Medical Practice Act’s provisions on documentation and recordkeeping, which are clearly mandatory. See Abramski v. United States, 134 S.Ct. 2259, 2267 n.6 (2014) (‘‘[A] court should not interpret each word in a statute with blinders on, refusing to look at the word’s function within the broader statutory context. As we have previously put the point, a ‘provision that may seem ambiguous in isolation is often clarified by the remainder of the statutory scheme . . . because only one of the permissible meanings produces a substantive effect that is compatible with the rest of the law.’ ’’) (quoting United Sav. Assn. of Tex. v. Timbers of Inwood Forest Associates, Ltd., 484 U.S. 365, 371 (1988)). See also Jacobs v. New York Foundling Hosp., 577 F.3d 93, 99 (2d Cir. 2009). Accordingly, the Board’s Intractable Pain Rule’s documentation and recordkeeping provisions are not E:\FR\FM\23MRN2.SGM 23MRN2 14946 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices srobinson on DSK5SPTVN1PROD with NOTICES2 reasonably read as being permissive.3 Indeed, in the Policy Statement it issued contemporaneously with the promulgation of the Rule, the Board provided further evidence that the documentation and recordkeeping requirements are not permissive. For example, the Board explained that ‘‘[a]ll such prescribing [of controlled substances for pain] must be based on clear documentation of unrelieved pain. To be within the usual course of professional practice, a physicianpatient relationship must exist and the prescribing should be based on a diagnosis and documentation of unrelieved pain.’’ Policy Statement, at 2 (emphasis added). Were the CALJ’s interpretation correct, what the Board required in the first sentence was then rendered permissive by the use of the word ‘‘should’’ in the following sentence. Indeed, if the word ‘‘should’’ rendered the rules permissive, a physician could prescribe controlled substances to his patient without even having formulated a diagnosis. This makes no sense and thus, the better view is that the words ‘‘must’’ and ‘‘should’’ have the same meaning: they impose mandatory obligations. In its Policy Statement, the Board also stated that it ‘‘will judge the validity of the physician’s treatment of the patient based on available documentation.’’ Id. And finally, the Board stated that it ‘‘will not take disciplinary action against a physician for deviating from this policy when contemporaneous medical records document reasonable cause for deviation.’’ Id. It makes no sense to advise physicians that the validity of their treatment decisions will be based on documentation and recordkeeping requirements if those provisions are not requirements at all, but rather, merely hortatory and aspirational pronouncements. Accordingly, I do not agree that the Government Expert’s testimony as to the deficiencies in Respondent’s evaluations of B.B. was based on the Expert’s mistaken understanding of the scope of the Oklahoma Board’s documentation and recordkeeping standards. Thus, while I fully agree with 3 In a series of cases involving the State of Florida’s former regulation entitled ‘‘Standards for the Use of Controlled Substances for Treatment of Pain’’ (Fla. Admin. Code r. 64B8–9.013 (2009)), which adopted nearly verbatim the FSMB’s text (including the respective uses of the words ‘‘must’’ and ‘‘should’’) in setting that State’s documentation standard with respect to the evaluation of the patient, the CALJ explained that ‘‘[c]onscientious documentation is repeatedly emphasized as not just a ministerial act, but a key treatment tool and a vital indicator to evaluate whether the physician’s prescribing practices are ‘within the usual course of professional practice.’ ’’ See, e.g., Roni Dreszer, 76 FR 19434, 19448–49 (2011). So too here. VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 the CALJ that the Expert’s ‘‘testimony predictably raised no issues regarding credibility,’’ I disagree with the CALJ’s assertion that the Expert’s ‘‘testimony was not without its own ‘red flags.’ ’’ R.D. 18. I therefore find that this exception is well taken. The CALJ’s Rulings That the Government Failed To Provide Adequate Notice of Its Intent To Rely on Various Urine Drug Screen Results as Probative Evidence of the Illegality of the Prescriptions Throughout his Recommended Decision, the CALJ repeatedly declined to consider the Government’s evidence that Respondent failed to address an aberrant urine drug screen which showed that his patient B.B. was not taking a controlled substance that had been prescribed to him. See, e.g., R.D. at 38–39 n.75. In the CALJ’s view, the Government did not provide adequate notice of its intent to rely on Respondent’s failure to address an aberrant June 1UDS in either the Show Cause Order or its Pre-hearing Statements with respect to multiple prescriptions. See id. at 38–39 (Sept. 25, 2011 Rxs), 48 (Nov. 18 and Dec. 15, 2011 Rxs); 51 (Jan. 19, 2012 Rxs); 54 (Feb. 13, 2012 Rxs), 56 (Mar. 13, 2012 Rxs), 60 (April 12, 2012 Rxs), 64 n.121 (April 25, 2012 Rx). As support for his rulings, the CALJ maintained that ‘‘the Agency has recently imposed an increased standard of notice on it administrative prosecutors.’’ Id. at 39 n.75 (citing Farmacia Yani, 80 FR 29053, 29064 n.28 (2015); Jana Marjenhoff, 80 FR 29067, 29068 (2015)). A review of these decisions shows, however, that the Agency has not ‘‘imposed an increased standard of notice’’ 4 but simply applied the 4 According to the CALJ, in Farmacia Yani, ‘‘the Government’s notice was deemed insufficient in that although the alleged misconduct was disclosed and pursued, it did not include the correct regulation subsection in its [Show Cause Order] and prehearing statement.’’ R.D. 66 (citing 80 FR at 29064 n.28). This, however, misstates the case. At issue in footnote 28 of Farmacia Yani was the Government’s allegation that the pharmacy had filled Suboxone prescriptions which were clearly issued for maintenance or detoxification purposes by two physicians but which did not contain the requisite identification number or good faith statement establishing that the physician was authorized to prescribe Suboxone for these purposes. See 80 FR 29063–64. As the legal basis for the allegation, the Government cited 21 CFR 1306.04 and 1306.06. The first regulation includes, inter alia, subsection a, which makes it illegal for a pharmacist to knowingly fill a prescription issued outside of the usual course of professional practice and which lacks a legitimate medical purpose, and subsection c, which provides, in part, that a prescription may not be issued for maintenance or detoxification treatment unless ‘‘the practitioner is in compliance with the requirements’’ applicable to practitioners who prescribe Suboxone for PO 00000 Frm 00004 Fmt 4701 Sfmt 4703 maintenance or detoxification treatment. See 21 CFR 1306.04(a) & (c); id. § 1301.28 (requirements for prescribing Suboxone for this purpose); see also id. § 1306.06 (‘‘A prescription for a controlled substance may only be filled by a pharmacist, acting in the usual course of his professional practice. . . .’’). While the Decision noted that the Government had not identified the specific subsection of 1306.04 which it alleged was violated, it did not hold that the ‘‘notice was deemed insufficient.’’ R.D. 66. Indeed, while the Decision rejected the Government’s contention that the pharmacist acted outside of the usual course of professional practice in violation of 1306.04(a) and 1306.06 for lack of evidence, 80 FR at 29064, and further noted that 1306.04(c) ‘‘impose[s] duties only on the issuer of [a] prescription which has been issued to provide maintenance or detoxification purposes,’’ id. at n.28, the Decision nonetheless found that the pharmacy had violated another provision of the Agency’s regulations. Specifically, the Decision found a violation based on 21 CFR 1306.05(f), which imposes ‘‘[a] corresponding liability . . . upon the pharmacist . . . who fills a prescription not prepared in the form prescribed by DEA regulations, ’’ 21 CFR 1306.05(f), and 21 CFR 1306.05(b), which requires that such a prescription include either the prescriber’s X number or good faith statement. See 80 FR at 29064 & n.28 (citation omitted). Indeed, notwithstanding that the Government cited the wrong provision of the regulations, the respondent’s principal did not dispute that her conduct in filling these prescriptions was a violation. See Respondent’s Proposed Findings of Fact and Conclusions of Law, at 11 (Proposed Conclusion of Law #11: ‘‘The second violation[] relates to buprenorphine prescriptions from two physicians who were not authorized to prescribe such prescriptions because they were not Datawaived practitioners. Physicians are issued a specific registration that is distinguished with an X number, and this number[] should be on the prescription. Farmacia Yani dispensed 29 prescriptions in total from these two doctors that did not have an X number.’’) (citations omitted). Thus, this case does not support the CALJ’s assertion that ‘‘recent Agency precedent has imposed significantly tighter notice requirements on the Government.’’ R.D. at 66. The CALJ further asserted that ‘‘[i]n Marjenhoff, . . . the Agency refused to allow the Government to rely on noticed conduct alleged as a violation of the public interest factors because it failed to specify that the conduct would be specifically considered under factor 5.’’ R.D. 66 (citing 80 FR at 29068). Here again, this is a misstatement of the case. Apparently, the CALJ’s assertion refers to the Agency’s declination to find that the respondent’s conduct in intercepting a pharmacist’s phone calls (who questioned the validity of a prescription the respondent had created for herself by forging the signature of the purported prescriber) constituted actionable misconduct under factor five. 21 U.S.C. 823(f)(5). This factor provides for liability based on ‘‘such other conduct which may threaten public health and safety.’’ Id. Significantly, the Show Cause Order made no such allegation, and while the Government disclosed in its pre-hearing statement that it intended to elicit testimony from the pharmacist regarding his attempt to verify the prescription after it was rejected for payment by respondent’s insurer, at no point in the proceedings did the Government rely on the evidence other than as proof that the ‘‘[r]espondent illegally obtained hydrocodone on eleven occasions.’’ See Govt.’s Proposed Findings of Fact and Conclusion of Law, at 14 (discussing the pharmacist’s testimony as evidence that respondent ‘‘forged and filled hydrocodone prescriptions to herself using [a PA’s] DEA number. These actions constitute violations of 21 U.S.C. 843(a)(3) [and] 21 E:\FR\FM\23MRN2.SGM 23MRN2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices srobinson on DSK5SPTVN1PROD with NOTICES2 extensive body of judicial precedent that addresses the adequacy of notice in administrative adjudication, which, as the Second Circuit has explained, ‘‘is so peculiarly fact-bound as to make every case unique.’’ Pergament United Sales, Inc. v. NLRB, 920 F.2d 130, 135 (2d Cir. 1990) (quoted in Marjenhoff, 80 FR at 29068); see also Marjenhoff, 80 FR at 29067–68 (discussing court decisions on notice in administrative adjudication); Farmacia Yani, 80 FR at 29059 (same). The CALJ also held that the Government could not rely on this evidence under the doctrine of litigation by consent—even though Respondent never objected to the Expert’s testimony that the June 1 (and other tests) were aberrant and that Respondent failed to properly address the aberrant results— asserting that the Government had the duty to ‘‘timely and affirmatively raise[] . . . this theory’’ and failed to do so. Id. at 39 (citing Odette Campbell, 80 FR 41062, 41062 n.2 (2015)). This reasoning, however, is also based on a misreading of that case.5 CFR 1306.04. . . .’’). Moreover, in its discussion of Factor Five, the Government’s arguments were confined to arguing that the ‘‘[r]espondent has failed to accept responsibility for her actions,’’ that she had not ‘‘present[ed] any mitigating evidence,’’ and that she ‘‘has demonstrated a pattern of actions that are against the public interest by inappropriately prescribing controlled substances . . . in 2005 and forging and filling prescriptions in 2011.’’ Id. at 15–16. Thus, contrary to the CALJ’s statement, the Government never relied on this conduct as a separate ‘‘violation of the public interest factors.’’ R.D. at 66. Nor could it have, as the public interest factors do not impose substantive rules of conduct but are simply ‘‘components of the public interest’’ that ‘‘shall be considered’’ in determining whether to grant an application for a registration. Penick Corp., Inc. v. DEA, 491 F.3d 483, 490 (D.C. Cir. 2007) (citation omitted). Most importantly, at no point did the Government assert that this conduct should also be considered as a separate act of misconduct under Factor Five. 5 In Campbell, the ALJ noted that ‘‘ ‘the evidence indicate[d] that [the] [r]espondent did not follow adequate security procedures,’ ’’ but then ‘‘declined to consider the evidence on the ground that the Government did not provide adequate notice in either the Show Cause Order or its Prehearing Statements, notwithstanding that [the] [r]espondent did not object to the testimony.’’ 80 FR at 41062 n.2 (other citation omitted). While the former Administrator observed that ‘‘the record arguably support[s] a finding that the issue was litigated by consent,’’ she did not consider the evidence because ‘‘the Government did not take exception to the ALJ’s ruling.’’ Id. Here, by contrast, the Government has taken exception to the CALJ’s rulings that the issue has not been litigated by consent. See Gov. Exceptions, at 24–25. As for the CALJ’s assertion that the issue was ‘‘not timely’’ raised by the Government, given that: (1) Respondent never objected to the testimony nor argued in its post-hearing brief that it did not have fair notice that the June 1 drug screen would be at issue throughout the proceeding, and (2) the CALJ did not rule that the Government could not rely on this theory until he issued his Recommended Decision, it is unclear how the Government could have timely raised the issue VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 ‘‘The primary function of notice is to afford [a] respondent an opportunity to prepare a defense by investigating the basis of the complaint and fashioning an explanation that refutes the charge of unlawful behavior.’’ Pergament United Sales, Inc. v. NLRB, 920 F.2d 130, 135 (2d Cir. 1990) (citation omitted). Thus, as the courts have long noted, ‘‘ ‘[p]leadings in administrative proceedings are not judged by the standards applied to an indictment at common law.’ ’’ Aloha Airlines v. Civil Aeronautics Bd., 598 F.2d 250, 262 (D.C. Cir. 1979) (quoted in CBS Wholesale Distributors, 74 FR 36746, 36749 (2009)); accord Citizens State Bank of Marshfield v. FDIC, 751 F.2d 209, 213 (8th Cir. 1984). Moreover, an agency ‘‘is not burdened with the obligation to give every [Respondent] a complete bill of particulars as to every allegation that [he] will confront.’’ Boston Carrier, Inc. v. ICC, 746 F.2d 1555, 1560 (D.C. Cir. 1984). Accordingly, even where the Government fails to disclose an allegation in the Order to Show Cause, ‘‘an issue can be litigated if the Government otherwise timely notifies a [r]espondent of its intent to litigate the issue.’’ CBS Wholesale, 74 FR at 36570. Moreover, while the Agency has held that ‘‘the parameters of the hearing are determined by the prehearing statements,’’ consistent with numerous court decisions, it has also recognized that even where an allegation was not raised in either the Show Cause Order or the pre-hearing statements, the parties may nonetheless litigate an issue by consent. Pergament United Sales, 920 F.2d at 135–37; see also Duane v. Department of Defense, 275 F.3d 988, 995 (10th Cir. 2002) (discussing Facet Enterprises, Inc., v. NLRB, 907 F.2d 963, 974 (10th Cir. 1990); ‘‘we held that the defendant had constructive notice of an alternate theory of liability not described in the formal charge when the agency detailed that theory during its opening argument and at other points during the hearing and when the defendant’s conduct revealed that it understood and attempted to defend against that theory’’).6 until it received the Recommended Decision and filed its Exceptions. 6 See also Grider Drug #1 & Grider Drug #2, 77 FR 44070, 44077 n.23 (2012) (holding that while the Government did not provide adequate notice of its intent to litigate an allegation in either the Show Cause Order or its pre-hearing statements, where respondents ‘‘did not object that the allegation was beyond the scope of the proceeding and that they were denied adequate notice of it’’ and ‘‘fully litigated the issue,’’ the allegation was litigated by consent) (citing Citizens State Bank, 751 F.2d at 213; Kuhn v. Civil Aeronautics Bd., 183 F.2d 839, PO 00000 Frm 00005 Fmt 4701 Sfmt 4703 14947 To be sure, ‘‘[a]n agency may not base its decision upon an issue the parties tried inadvertently. Implied consent is not established merely because one party introduced evidence relevant to an unpleaded issue and the opposing party failed to object to its introduction. It must appear that the parties understood the evidence to be aimed at the unpleaded issue.’’ Yellow Freight System, Inc., v. Martin, 954 F.2d 353, 358 (6th Cir.1992) (citation omitted). Accordingly, where the Government’s case ‘‘focus[es] on another issue and [the] evidence of [an] uncharged violation [is] ‘at most incidental,’ ’’ the Government has not satisfied its constitutional obligation to provide a full and fair opportunity to litigate the issue and it cannot rely on the incidental issue as the basis for imposing a sanction. Pergament, 920 F.2d at 136 (quoting NLRB v. Majestic Weaving Co., 355 F.2d 854, 861–62 (2d Cir. 1966)). However, the issue of whether an allegation ‘‘has been fully and fairly litigated [by consent] is so peculiarly fact-bound as to make every case unique.’’ Id. at 136. Having reviewed the record, I find the Government’s exception well taken and hold that the Government provided Respondent with adequate notice that both the aberrant nature of the June 1 drug test and his failure to address it would be at issue throughout the proceeding. Moreover, even if the Government failed to specifically reference the June 1 test by date in the Show Cause Order (and Pre-hearing Statements) with respect to several of the prescriptions, Respondent had adequate notice that it was at issue throughout the proceeding and indeed, had a full and fair opportunity to litigate the issue. The Show Cause Order repeatedly provided notice that the aberrant nature of B.B.’s June 1 UDS and Respondent’s failure to address it would be at issue in the proceeding. For example, paragraph 3 of the Show Cause order alleged that ‘‘[f]rom on or about August 25, 2011 through on or about May 9, 2012, [Respondent] issued controlled substance[] prescriptions to B.B. in violation of Federal . . . law.’’ ALJ Ex. 1, at 1 (emphasis added). The Show Cause Order then alleged that Respondent was ‘‘aware on each of the occasions that [he] issued controlled substance[] prescriptions to B.B. that he presented a high risk of abuse and/or diversion of controlled substances, as evidenced by the red flags documented in his patient file, such as aberrant 841–42 (D.C. Cir. 1950); and Yellow Freight System, Inc., v. Martin, 954 F.2d 353, 358 (6th Cir. 1992)). E:\FR\FM\23MRN2.SGM 23MRN2 srobinson on DSK5SPTVN1PROD with NOTICES2 14948 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices urine drug tests.’’ Id. (emphasis added). And the Order then alleged that Respondent ‘‘failed to address and, in fact, ignored these red flags, continuing to issue B.B controlled substance prescriptions in the face of mounting evidence that he was misusing, abusing, and/or diverting the controlled substances you were prescribing.’’ Id. In the allegations regarding the August 25, 2011 prescriptions, the Show Cause Order provided a detailed recitation of the factual basis for the allegation that the June 1, 2011 UDS was aberrant and that this ‘‘should have indicated . . . that B.B. may have been misusing/abusing the alprazolam by consuming more than he had been prescribed, or diverting it.’’ Id. at 2. As for the September 22, 2011 prescriptions, the Show Cause Order, after setting forth the factual basis for why the August 25 UDS was aberrant, proceeded to allege that Respondent ‘‘did not address with B.B. the now second aberrant drug screen in an approximately three month period, despite noting in the record that you had ‘extensively reviewed’ B.B.’s ‘[p]ast medical history.’ ’’ Id. at 3 (emphasis added). The Show Cause order then alleged that ‘‘[y]ou took no other steps to monitor B.B.’s controlled substance use, such as requiring him [to] take another drug screen due to the two failed ones, conducting a new [prescription monitoring report] check, or requiring him to submit to a pill count.’’ Id. (emphasis added). In setting forth the allegations with respect to the October 6 and 20 prescriptions, the Show Cause Order alleged that ‘‘[y]ou still did not address with B.B. the two aberrant drug screens’’ and ‘‘[y]ou still had not confronted B.B. about the two aberrant drug screens’’ respectively. Id. at 4 (emphasis added). And with respect to the subsequent prescriptions, the Show Cause Order made multiple allegations such as that: (1) Respondent ‘‘did not take any steps to monitor [B.B.’s] controlled substance[ ] use despite his history of misusing, abusing, or diverting controlled substances’’ (Nov. 18, 2011 prescriptions); (2) ‘‘despite [B.B.’s] history of substance misuse, abuse, and/ or diversion, you did not take appropriate steps to monitor his controlled substance use before issuing him these new prescriptions’’ (Jan. 19, 2012 prescriptions); and (3) Respondent again prescribed controlled substances ‘‘without taking appropriate steps to monitor [B.B.’s] controlled substance use despite the persistent red flags of abuse and diversion he previously presented’’ (Mar. 13, 2012 prescriptions). VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 Likewise, in its Pre-hearing Statement, the Government provided notice that ‘‘Dr. Owen [its Expert] will testify that [Respondent] should have been aware from documentation in B.B.’s file of red flags that B.B. may have been abusing or diverting controlled substances prior to transferring his treatment to’’ Respondent (the period in which the June 1 UDS was obtained), as well as notice setting forth the factual basis as for why the June 1 UDS was aberrant. ALJ Ex. 5, at 10, 12–13. With respect to the September 22, 2011 prescriptions, the Pre-hearing Statement provided notice that the medical file shows that Respondent ‘‘never addressed with B.B. this now second aberrant UDS in an approximately three month period, despite noting in the record that [he] had ‘extensively reviewed’ B.B.’s past medical history’’ and that Respondent ‘‘took no other steps to monitor B.B.’s controlled substance use, such as requiring him to take another UDS due to the two failed ones.’’ Id. at 14 (emphasis added). Moreover, with respect to the October 6 prescriptions, the Pre-hearing Statement provided notice that ‘‘Dr. Owen will testify that on this visit [Respondent] again failed to address with B.B. the two aberrant UDSs,’’ and with respect to the October 20, 2011 prescriptions, ‘‘the record lacks documentation that . . . he confronted B.B. about the two aberrant UDSs.’’ Id. at 15–16 (emphasis added). And with respect to the later prescriptions, the Pre-hearing Statement provided notice that Dr. Owen ‘‘will testify’’ that Respondent ‘‘also failed to take any steps to monitor B.B.’s controlled substances use despite B.B.’s history of misusing, abusing, or diverting controlled substances.’’ Id. at 16. See also id. at 17 (Jan. 19 prescriptions; ‘‘Dr. Owen will testify that despite the fact that this was B.B.’s first visit . . . in three months, and despite his history of substances misuse, abuse, and/or diversion, [Respondent] failed to take adequate steps to monitor B.B.’s controlled substance use before issuing him these new prescriptions’’); id. at 19 (Mar. 13 prescriptions; providing notice that ‘‘Dr. Owen will testify’’ that Respondent again issued controlled substance prescriptions ‘‘without taking appropriate steps to monitor B.B.’s controlled substance use despite the persistent red flags of abuse and diversion he previously presented’’). Thus, the Show Cause Order’s allegations and the Pre-Hearing Statement’s disclosure of the expected testimony provided Respondent with more than adequate notice that the results of the June 1, 2011 UDS and his PO 00000 Frm 00006 Fmt 4701 Sfmt 4703 failure to address it would be at issue throughout the proceeding. And even if I concluded otherwise, the record is clear that the issue was litigated by consent. Notably, during its direct examination of Dr. Owen regarding the September 22, 2011 prescriptions, the Government asked Dr. Owen the following questions: Q. Would the aberrant urine drug test from June 1 have shown up in a review of the history? A. Yes. Q. Would the aberrant drug test from August 25, 2011, have shown up in the history? A. Yes. Q. And were those aberrant drug tests part of this medical file as you received it? A. Yes, it [sic] was. Q. What—how does [Respondent] address the aberrant drug tests in this 9/22 patient file note[]? A. It’s [sic] completely ignored. Q. What steps should [Respondent] have taken regarding the aberrant drug screens? A. He should have acknowledged their existence and then taken some corrective action. . . . . Q. Does it appear that [Respondent] took any safeguard regarding the potential for diversion or abuse with the aberrant drug screens? A. No. Tr. 132–33. Notably, Respondent did not object to any of this testimony. See id. Moreover, the Government asked similar questions of Dr. Owen regarding the later prescriptions, with no objection by Respondent. See id. at 136 (Oct. 6, 2011 visit; Q. ‘‘Having reviewed the patient file, can you tell me what steps [Respondent] took on this date to address the two previous aberrant urine drug tests?’’ A. ‘‘The previous aberrant urine drug tests are ignored and not addressed.’’); id. at 139 (Oct. 20, 2011visit: Q. ‘‘What steps should [Respondent] have taken on this date?’’ A. Respondent ‘‘[s]hould have, particularly in light of the previous aberrant drug tests . . . sought psychological counseling for this patient.’’).7 7 See also Tr. 143 (Nov. 18 and Dec. 15, 2011 Rxs: Q. ‘‘Is there any mention anywhere about the aberrant drug tests and the results being discussed with BB?’’ A. ‘‘No, there’s not.’’); id. at 147 (Jan. 19, 2102 visit and Rxs: Q. ‘‘Is there any mention of the aberrant urine drug tests from June or August in this [patient file] during this visit?’’ A. ‘‘There is not.’’); id. at 154 (Feb. 13 Rxs: testimony of Dr. Owen’s that Respondent’s counseling B.B. ‘‘to take only as prescribed’’ after Jan. 19 drug test was not an adequate safeguard against abuse and diversion, ‘‘especially since this is the third aberrant drug test’’); id. at 154–55 (Feb. 13 Rxs: Q. ‘‘In the face of so many aberrant drug tests, what steps—what should [Respondent] have done?’’); id. at 158 (Mar. 13, 2012 Rxs: Q. ‘‘Are there any aberrant drugtaking behaviors here?’’ A. ‘‘There has [sic] been E:\FR\FM\23MRN2.SGM 23MRN2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices srobinson on DSK5SPTVN1PROD with NOTICES2 Indeed, Respondent’s counsel raised the issue when, in Respondent’s case-inchief, she asked him: ‘Do you recall if you looked back at the previous drug tests?’’ Id. at 283. Respondent answered: ‘‘I don’t recall, but I doubt I did’’ and ‘‘I wouldn’t expect myself to.’’ Id. Respondent’s counsel then asked him if Dr. Schoelen had seen B.B.in June and July after the June 1 drug test, with Respondent answering ‘‘[t]hat’s correct.’’ Id. Respondent then testified that the test was reported back to his former partner, who saw B.B. on June 29 and July 26, before testifying that he would have ‘‘routinely looked at two, three different notes.’’ Id. at 284. Subsequently, on its crossexamination of Respondent with respect to what he looked at in the chart when he took over B.B.’s care, the Government asked: ‘‘Did you see the June 1, 2011, UD[S], urine drug test?’’ Id. at 390. Respondent’s counsel raised no objection to the question and Respondent answered: ‘‘I don’t believe I did.’’ Id. While Respondent then asserted that he ‘‘assume[d]’’ that Dr. Schoelen ‘‘addressed every UDS,’’ when pressed as to whether, based on his review of the file, Dr. Schoelen had ever addressed the June 1 UDS, Respondent answered: ‘‘I didn’t review his part of the chart.’’ Id. at 390–91. Thus, Respondent was clearly aware that his failure to address the June 1, 2011 drug test was at issue with respect to the entirety of his controlled substance prescribing to B.B. and in no sense was this ‘‘an incidental issue’’ in the case. Pergament United Sales, 920 F.2d at 136 (citation omitted). He also had a full and fair opportunity to litigate the issues of whether the June 1 (as well other tests) were aberrant and whether he properly addressed them during the course of his prescribing to B.B. Accordingly, I find the Government’s exception well taken and will consider this evidence.8 Based on the preponderance of the evidence, I make the following findings. Findings of Fact Respondent is a family practice physician licensed by the Oklahoma State Board of Medical Licensure and Supervision. RX 1. Respondent graduated from the University of Oklahoma (OU) College of Medicine in 1989. Tr. 231. Thereafter, he did an internship through the OU ‘‘Tulsa/ three previous.’’); id. at 165–66 (Apr. 12, 2012 Rxs Q. ‘‘Did he address any of the previous aberrant drug screens?’’ A. ‘‘He did not.’’). Significantly, at no point did Respondent object to the questioning or testimony. 8 The Government’s remaining exceptions are discussed throughout this decision. VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 Bartlesville program’’ and ‘‘the last two years of his residency’’ in family medicine at OU in Oklahoma City. Id. Respondent testified that upon completing his residency, he practiced family medicine and obstetrics for several years at several rural clinics. Id. at 234–35. He further explained that while working at one of the clinics, he was asked to become the medical director of a nursing home for terminal AIDS patients, which he did for approximately five years, after which he and Dr. Steve Schoelen bought a practice in Newcastle, Oklahoma which they named ‘‘Tri-City Family Medicine.’’ Id. at 235–36.9 Respondent practiced family medicine at Tri-City from approximately 2000 through 2012. Id. at 245. Respondent further testified that he was board certified in family medicine until 2015. Id. at 247. Respondent testified that he could not reapply for board certification because he had not practiced family medicine for several years and does not ‘‘qualify to show them my charts . . . to qualify to take the test.’’ Id. at 248. Respondent testified that due to the expense of malpractice insurance for his OB/GYN activities, he stopped delivering babies and focused on family medicine. Id. at 249. Respondent testified that he started seeing chronic pain patients around this time, but that Dr. Schoelen mostly saw these patients as he ‘‘took much more of an interest in the pain patients and pain management.’’ Id. He further testified that within days of Dr. Schoelen ‘‘telling Medicaid that he would accept chronic pain patients on Medicaid, we were overwhelmed with referrals from the emergency rooms . . . in Oklahoma City.’’ Id. at 253. According to Respondent, in response, Dr. Schoelen took continuing medical education (CME) classes and joined the American Academy of Pain Management. Id. The clinic also started using a pain management contract and contracted with a company for urine drug testing. Id. at 254. Respondent testified that he did drug screens ‘‘every three months’’ and that 9 Respondent also testified that for approximately three years (which are not specified in the record) and during which he was still practicing at his clinic, he was also the medical director of Unicare of Oklahoma, a subsidiary of WellPoint, and that his duties involved oversight of the clinics, reviewing chart audits, and that ‘‘[w]e also were in charge of prior authorization.’’ Tr. 237, 240. He also testified that he sat on WellPoint’s national credentialing committee, which sat once a month for three hours and reviewed the credentials of practitioners applying to the company. Id. at 240. Respondent testified that he resumed working full time at Tri-City after the State cancelled its contract with Wellpoint to provide medical care to patients covered by the State’s Medicaid program. Id. at 242. PO 00000 Frm 00007 Fmt 4701 Sfmt 4703 14949 any patient who received more than two Lortabs (hydrocodone with acetaminophen) a day would be subject to ‘‘the guidelines of our pain management contract and rules.’’ Id. at 256. Respondent further asserted that ‘‘[s]ometimes we [would] send [patients] for a second opinion’’ or for a ‘‘modality that we didn’t do’’ such as ‘‘an epidural or [a] further evaluation if something changed in their pain something changed neurologically.’’ Id. He testified that he would obtain a Prescription Monitoring Program report for ‘‘[e]very phone call for every prescription and every office visit.’’ Id. at 263. He also testified that the practice did not replace lost or stolen medications and that he had terminated a substantial number of patients over the years. Id. at 279–80. The Investigation Respondent came to the attention of the authorities on or about May 10, 2012, when police in Norman, Oklahoma found Respondent’s patient B.B., a 27-year old male (RX 3, at 2), who was ‘‘semiconscious’’ and ‘‘appeared to be intoxicated’’ in a vehicle parked ‘‘in the center median of’’ Interstate-35. Tr. 18; RX 3, at 2. The police also found ‘‘several prescription bottles of opiate pain killers’’ which had been prescribed to B.B. by Respondent. RX 3, at 2–3; Tr. 18. With B.B.’s consent, the police searched his cell phone and found text messages that ‘‘indicated that [B.B.] was illegally buying and selling prescriptions drugs,’’ as well as messages between B.B. and Respondent related to B.B.’s ‘‘medical care, prescription dosages and prescriptions to be picked up by’’ B.B. RX 3, at 3. In addition, the police found ‘‘numerous sexually explicit messages’’ that had been exchanged between Respondent’s phone and B.B. Id.; Tr. 18. A Detective with the Norman police then contacted the Chief Investigator for the Oklahoma State Board of Medical Licensure and Supervision. Tr. 18. The Detective also notified a DEA Diversion Investigator (DI) that the police had found drugs in B.B.’s car and that the latter was a patient of Respondent; the Detective also asked the DI to attend an interview of B.B., who could not be interviewed until ‘‘the next day’’ because ‘‘he was too intoxicated.’’ Id. at 46. In the meantime, the Chief Investigator, who was familiar with Respondent’s background because the latter ‘‘was on probation at that time for an incident that involved sexual misconduct,’’ obtained a report from the Oklahoma Bureau of Narcotics Prescription Monitoring Program to ‘‘see any prescriptions that were prescribed by [Respondent] to’’ B.B. Id. at 18–19. E:\FR\FM\23MRN2.SGM 23MRN2 14950 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices srobinson on DSK5SPTVN1PROD with NOTICES2 The report showed that Respondent had written ‘‘numerous controlled drug prescriptions’’ for B.B. Id. at 19. After reviewing the PMP report, the Chief Investigator notified the Board’s Executive Director of his findings, id. at 21, who, on May 11, 2012, ordered the summary suspension of Respondent’s medical license. Id.; see also RX 3, at 3. The same day, the Chief Investigator went to Respondent’s clinic to obtain B.B.’s record, interview Respondent, and serve the suspension order on him. Id. at 21. While Respondent was not at the clinic, the Chief Investigator spoke with him by phone and made arrangements to return on May 14 (a Monday); the Chief Investigator also took B.B.’s chart. Id. On May 11, 2012, the DI and two Detectives interviewed B.B., who ‘‘confirmed that he was’’ Respondent’s patient. Id. at 48. B.B. admitted that ‘‘he used the Opanas [oxymorphone] 10 himself’’ but ‘‘denied that he snorted them.’’ Id. B.B. explained that ‘‘[h]e crushed them up and put them in an energy drink, which he had in his vehicle . . . when he was found’’ by the police. Id. B.B. also told the Investigators that ‘‘[n]ot only was he a user of it, he also sold the medications.’’ Id. After the interview, the DI was informed by the lead Detective that he had spoken to the Board’s Chief Investigator and that the Board’s Investigators were going to meet on Monday May 14 and go to Respondent’s office. Id. On that day, the Chief Investigator (accompanied by another Board Investigator), the DI and the lead Detective went to Respondent’s clinic to interview him. Id. 25. During the interview, the Board’s Chief Investigator confronted Respondent ‘‘with some of the sexually graphic text messages sent from his phone to the patient.’’ RX 3, at 3. While Respondent ‘‘admitted that he may have made social comments to [B.B.],’’ he ‘‘would not answer any more questions without contacting his attorney.’’ 11 Id. ‘‘At that point,’’ the Chief Investigator asked Respondent ‘‘to allow him to examine’’ his phone ‘‘for text messages to’’ B.B. Id. Respondent stated that ‘‘his phone was not available because it had been run over with his tractor over the weekend.’’ Id. The Chief Investigator then served the Board’s 10 As discussed more fully below, Respondent issued B.B. prescriptions for Opana 10 mg. on multiple occasions, including on May 9, 2012 which B.B. filled the next day. GX 5, at 27. 11 Subsequently, Respondent denied that he had exchanged these messages and attributed this conduct to his partner at the time, stating that he had allowed his partner to have ‘‘access to his cell phone.’’ RX 3, at 3; see also Tr. 415. VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 suspension order on Respondent. RX 3, at 3. The DI then informed Respondent that because he did not have state authority, he could not maintain his DEA registration and asked Respondent to voluntarily surrender his registration; Respondent agreed to do so. Tr. 49; see also GX 1, at 1. On September 13, 2012, the Board lifted Respondent’s suspension.12 RX 3, at 4. On October 4, 2012, Respondent applied for a new registration. GX 1, at 2. Because Respondent’s application included a ‘‘yes’’ answer to the liability question which asked whether his state professional license had ever been sanctioned, the application was forwarded to the Oklahoma City field office and an investigation was opened. GX 2, at 1; Tr. 62, 65, 81. Thereafter, a Diversion Investigator obtained a copy of B.B.’s patient file from the Board and provided it to Graves Owen, M.D., an expert in pain management, to review and determine whether Respondent lawfully issued the controlled substance prescriptions. Tr. 50–52, 55. The DI testified that he did not ask Dr. Owen to come to any specific conclusion and that Dr. Owen’s compensation was not contingent on the conclusions he drew. Id. at 56. At the hearing, Dr. Owen testified that he has previously testified as to the ‘‘standard of care in pain management’’ and that he has testified for a defendant. Id. at 92. The Government’s Expert’s Testimony as to the Standards of Medical Practice Applicable to the Prescribing of Controlled Substances To Treat Pain Dr. Owen obtained a Bachelor of Science in chemistry and biology from Texas State University in 1985 and a Doctor of Medicine from the University of Texas Health Science Center 12 On March 7, 2013, Respondent voluntarily submitted to the jurisdiction of the Board and agreed to the entry of an Order which found him guilty of unprofessional conduct in that he: (1)‘‘ [v]iolated any provision of the medical practice act or the rule and regulations of the Board or of an action, stipulation, or agreement of the Board in violation of 59 O.S. § 509(13) and OAC 435:10–7– 4(39)’’; (2) ‘‘[e]ngaged in the improper management of medical records in violation of OAC 435:10–7– 4(36)’’; and (3)‘‘ [w]illfully betrayed a professional secret to the detriment of the patient[,] 12 O.S. § 509(3).’’ RX 3, at 5. The Board did not, however, make any findings as to the legitimacy of the controlled substance prescriptions Respondent issued to B.B. The Board then extended Respondent’s pre-existing probation, which was the result of a 2008 Order based on findings that he had prescribed controlled substances to a patient with whom he had a sexual relationship, ‘‘[b]eginning in or around 2001 . . . through approximately 2004.’’ RX 3, at 2. The Board further found that when questioned about his relationship with this patient, Respondent ‘‘lied and denied that it existed’’ until he was confronted ‘‘with corroborating evidence.’’ Id. PO 00000 Frm 00008 Fmt 4701 Sfmt 4703 (Houston) in 1990. Id. at 89–90; GX 4, at 1–2. After obtaining his M.D., Dr. Owen did a one year internship in internal medicine followed by a threeyear residency in Anesthesiology at the UT Health Science Center; he then did a one-year fellowship in Pain Management at the University of Pittsburg’s Pain Evaluation and Treatment Center. GX 4, at 1. Dr. Owen holds a Texas medical license and is board certified by the American Board of Pain Management and American Board of Anesthesiology. Id. at 2. He is a member of the American Pain Society, the American Academy of Pain Medicine, the American Academy of Pain Management and the Texas Pain Society. Id. at 7. With respect to the latter organization, Dr. Owen served on its Board of Directors from 2009 through 2012 and served as its President from 2012 through 2014. Id. at 8. He has also served on the Society’s Legislative Committee and on its Educational Committee for multiple years. Id. Dr. Owen’s work experience includes more than 16 years at the Texas Pain Rehabilitation Institute (Sept. 1995 through Nov. 2011), which is an interdisciplinary pain management clinic. Id. at 2. Since February 2011, he has been a Peer Reviewer on Pain Medicine for the Journal of the American Academy of Pain Medicine. Id. He has also served as a member of the Medical Quality Review Panel and as an Arbiter on the Quality Assurance Panel of the Texas Department of Insurance, Division of Workers Compensation, Office of Medical Advisor. Id. He has written several articles and made more than 40 presentations on subjects related to pain management before both professional and governmental bodies, including on the use of urine drug testing in pain management. Id. at 4–9. The CALJ accepted Dr. Owen ‘‘as an expert in pain management in Oklahoma and Texas.’’ Tr. 91. While Dr. Owen is licensed to practice medicine in Texas, he testified that he had reviewed Oklahoma’s guidelines and policies. Id. at 93. Asked what the requirements are in Oklahoma for prescribing opioid controlled substances, Dr. Owen testified: ‘‘Well, first you have to do an appropriate history and physical exam for whatever the chief complaint is. You need to get all pertinent previous medical records pertaining to this chief complaint.’’ Id. at 94. As to why a physician needs to obtain the patient’s medical records, Dr. Owen explained that: ‘‘You want to know what has previously been performed as far as treatment elements and what resulted from those E:\FR\FM\23MRN2.SGM 23MRN2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices srobinson on DSK5SPTVN1PROD with NOTICES2 treatments, and you also want to look for any previous aberrant behaviors.’’ Id. (emphasis added). The Government then asked Dr. Owen ‘‘what else is required?’’ Id. Dr. Owen explained: ‘‘So after you do an appropriate history and physical exam, you review the pertinent medical records. You may need to do consultations. You may need to do diagnostics, whether laboratory or imaging studies, and then you formulate a treatment plan based on the analysis of this information.’’ Id. at 94–95. Asked to explain ‘‘[w]hat’s a treatment plan,’’ Dr. Owen testified: ‘‘A treatment plan is what we’re going to do to move this person from wherever they are to the next place, and part of the treatment plan will be dictated by your treatment goals that you need to set up to try to get that person to the next place.’’ Id. at 95. Subsequently, Dr. Owen explained that ‘‘there [are] three broad treatments in pain management: Interventional, rehabilitative, and pharmaceutical. So your treatment plan would list each of these categories if you’re going to use elements of those categories in your treatment plan, and it would specifically define what your treatment plan is and how you tie it to your treatment goal.’’ Id. at 97. Dr. Owen further testified that while treatment goals are ‘‘tailor[ed] . . . to the individual’’ and would be different depending upon a patient’s age, ‘‘you would primarily focus on functional improvements.’’ Id. at 99–100. With respect to someone of working age, Dr. Owen explained that ‘‘return[ing] to work’’ is ‘‘the gold standard for functionality in pain management.’’ Id. at 100. Subsequently, Dr. Owen testified that a treatment plan can involve more than one of these approaches and that it evolves over the course of treating the patient if the treatment goals are not being achieved. Id. at 98–99. However, a physician ‘‘certainly would have [a treatment plan] on the initial visit.’’ Id. at 99. While Dr. Owen acknowledged that a treatment plan can be ‘‘tease[d] . . . out’’ of the patient’s record ‘‘without necessarily a formal title’’ if ‘‘enough information’’ is documented in the record, he then explained what content the plan should contain: Well, if it’s interventional, you would talk about what intervention you’re going to do. If it’s rehabilitative, you’d talk about physical therapy, occupational therapy or psychotherapy. If it’s pharmaceutical, you’re going to talk about the specific pharmaceutical, its dose and the frequency that you’re going to prescribe it and hopefully the indication it’s being used for. VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 Id. at 98–99. Asked whether the file for a patient being prescribed opioid controlled substances would contain anything else, Dr. Owen testified that you would ‘‘have an informed consent and a pain management agreement.’’ Id. at 99. Dr. Owen then explained that ‘‘[a]n informed consent is telling the patient what the risks and benefits are of this proposed treatment and what alternative treatments exist.’’ Id. As to why a physician treating a patient for pain would seek consultation with other specialists, Dr. Owen testified that ‘‘[t]hese are complex cases, and you can’t be an expert of everything, and you may need help in narrowing your diagnosis or help in stabilizing comorbidities that are outside of your scope of practice.’’ Id. at 100. Dr. Owen further explained that the need to consult with particular specialists ‘‘depends on the [patient’s] chief complaint and your differential diagnosis and what you’re trying to achieve.’’ Id. Asked by the Government if ‘‘these requirements . . . are . . . best practices,’’ Dr. Owen testified that ‘‘some of them can be best practices, but most of them are standard of care items.’’ Id. at 100–01. Then asked if ‘‘when you say standard of care, are they required,’’ Dr. Owen explained that ‘‘they’re required based on the context of the chief complaint and . . . the facts of the situation.’’ Id. at 101. When then asked ‘‘are they required by law,’’ Dr. Owen initially answered ‘‘no’’ before explaining that: Well, I’m not a lawyer. I would say that the policies and guidelines that I was sent for Oklahoma say certain things about consultations, and the one that stood out is if somebody’s a complex pain patient with psychological or psychiatric comorbidities, they should get consultations with a pain management physician with expertise in these complex cases. Id. Dr. Owen testified that ‘‘comorbid psychiatric conditions’’ include ‘‘depression, anxiety, maladaptive coping mechanisms, such as catastrophization, fear avoidance, disability conviction, and a sense of injustice,’’ which are ‘‘all built on a foundation of cognitive distortions.’’ Id. at 101–02. He also testified that there are ‘‘personality disorders and a whole host of psychiatric conditions like PTSD, OCD, bipolar, schizophrenia, [and] other scenarios like that, that make it more difficult to treat’’ a pain patient. Id. at 102. Dr. Owen then explained that these conditions ‘‘might magnify [a patient’s] perception of pain PO 00000 Frm 00009 Fmt 4701 Sfmt 4703 14951 and disability and, in doing so, [a patient’s] experience of suffering is aggravated or increased.’’ Id. The CALJ then asked Dr. Owen if the reason it is important to refer a pain patient to a mental health expert is so that the patient’s ‘‘subjective complaint[] of pain’’ can be ‘‘properly gauged?’’ Id. at 103. Dr. Owen answered: ‘‘So that you can help understand the context of their pain and what might be distorting and magnifying their pain and suffering experience, because suffering is defined as your ability to cope with adversity, and everybody comes with different skill sets of how they cope with adversity.’’ Id. at 103–04. While Dr. Owen then acknowledged that ‘‘[p]ain is subjective,’’ he further explained that ‘‘function is objective, so that’s why [a physician would] use functions as [the] primary baseline for measuring therapeutic influence.’’ Id. at 104. The CALJ then asked Dr. Owen if ‘‘ask[ing] the patient about activities of daily living’’ is ‘‘one of the tools that you use?’’ Id. Dr. Owen answered ‘‘yes’’ and added ‘‘[t]hat’s one of the things. Return to work, and you can do more global things like sitting tolerance, walking tolerance, standing tolerance, and then site-specific areas of functionality like range of motion and other physical exam measurements.’’ Id. at 104. Dr. Owen was then asked to describe ‘‘the steps that a practitioner would take to determine whether a patient is truly experiencing chronic pain?’’ Id. at 106. He replied: Well, there’s no objective way to know if somebody [is] experiencing pain, so you take them for their word at it. But what you need to do is to make sure that you go through a process to ensure that they have exhausted all the medically reasonable treatments before you go to a high-risk, non-evidencebased treatment. Id. at 107. Dr. Owen further explained that ‘‘[h]igh-risk treatments are treatments that have a potential for bad outcomes, and there’s evidence-based and nonevidence-based treatments. There’s lowrisk, medium-risk, and high-risk treatments, and you have to have some context for how you approach the problem.’’ Id. Dr. Owen then opined that ‘‘chronic opioid therapy and chronic benzodiazepine therapy’’ are high-risk treatments. Id. He also opined that chronic opioid therapy is not an evidence-based 13 treatment, noting that 13 Dr. Owen explained that ‘‘evidence-based studies are studies published in peer review articles that actually show positive outcomes for the treatment, and ideally these treatments are E:\FR\FM\23MRN2.SGM Continued 23MRN2 srobinson on DSK5SPTVN1PROD with NOTICES2 14952 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices there are ‘‘no publications’’ supporting the use of ‘‘chronic opioid therapy’’ and that ‘‘[m]ost of the opioid articles have poor outcome[ ] metrics.’’ Id. at 108. Asked whether it is ‘‘permissible to taken on a patient who’s already on high-risk treatment and to continue them on high-risk treatment,’’ Dr. Owen testified that while a physician ‘‘can do that,’’ the physician must ‘‘adequately document the justification for skipping steps,’’ i.e., low-risk 14 and medium risk treatments, and must ‘‘make sure that [the patient is] obtaining a clinically meaningful and objective therapeutic outcome.’’ Id. at 109. He then explained that this means that the patient is ‘‘having functional improvement that is truly measurable’’ and that a patient’s ‘‘subjective report is problematic.’’ Id. And later, Dr. Owen testified that even when the care of a patient is transferred from one doctor to another in the same practice, the new doctor ‘‘need[s] to make sure that any previous documentation deficiencies or standard of care violations are rectified by doing a proper evaluation.’’ Id. at 206. Next, the CALJ asked Dr. Owen what, as a chronic pain specialist, he would look at to determine if a patient who was referred to him was being successfully treated with long-term opioid therapy. Id. at 109. Dr. Owen answered that he would ‘‘first go to the previous medical records to see what functionality was documented before [the patient was] started on that treatment and compare it to’’ the patient’s current ‘‘functionality.’’ Id. Asked by the CALJ if ‘‘those would be subjective notes,’’ Dr. Owen explained that ‘‘if someone is not working and now they are working, although they’re subjective notes, there is an objective measure to it’’ and that ‘‘[w]henever possible, I like information from friends or family that’s with the patient about [the patient’s] functionality and what it was like, so there’s an independent assessment.’’ Id. at 109–10. Continuing, Dr. Owen explained that there are also ‘‘various psychometric tests on functionality, [including the] Oswestry Disability Inventory and other things like that, that measure your function in somewhat objective terms.’’ Id. at 110. However, Dr. Owen acknowledged that ‘‘it all comes down to [the patient’s] self-report.’’ Id. The CALJ then asked Dr. Owen if there are ‘‘tests that are traditionally done in the office, such as . . . range of compared to some kind of either non[-] treatment or a sham treatment.’’ Tr. 108. 14 Dr. Owen testified that low-risk, evidencebased treatments include physical therapy, occupational therapy and cognitive behavioral therapy. VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 motion and other things . . . that have an objective sense to them?’’ Id. Dr. Owen answered that while ‘‘you can measure range of motion of the various joints and spine, and you can look at muscle strength and those kinds of issues . . . they don’t always correlate to your ability to work and other more global functionality.’’ Id. Dr. Owen also explained that in evaluating the patient’s functionality, ‘‘[y]ou want to look at [the] neurological assessment. You want to look at [the] straight leg raise. You want to look at spine range of motion, and you want to ask [the patient] how far can you walk; how long can you sit, and those kinds of functional assessments as well.’’ Id. at 111. Next, the CALJ asked Dr. Owen if on taking over a long-term opioid therapy patient, it is ‘‘generally true that [the patient will be] continue[d] on the . . . regimen?’’ Id. In response, Dr. Owen testified that he would not continue the regimen if the patient is ‘‘not clinically improved from the results of this treatment.’’ Id. Continuing, he explained that ‘‘[a] lot of people deteriorate on chronic opioid therapy and they actually do better when they’re taken off of opioids’’ because they have ‘‘opioidinduced hyperalgesia.’’ Id. Dr. Owen then explained that this ‘‘is a paradoxical response in which [a patient’s] pain gets worse while [he/she is] on opioids, and when [the patient is] take[n] off of the opioids, [his/her] pain improves.’’ Id. Dr. Owen further testified that there is a difference between addiction and dependence. Id. at 112. After noting that ‘‘dependency will happen to anybody over time in which an abrupt cessation of the drug will cause withdrawal symptoms,’’ he explained that ‘‘addiction has three [additional] elements: Craving the drug, continued use despite its harms, and inability to self regulate’’ the use of the drug. Id. at 112–13. Asked how he would tell whether a patient he had ‘‘just assumed the care of’’ was dependent or addicted, Dr. Owen explained that an addicted patient ‘‘may have self-escalation of [his/her] drugs, and . . . run out early.’’ Id. at 113. Dr. Owen then explained that a physician ‘‘would use urine drug testing to see if [the patient] ha[s] all the drugs that were prescribed in [his] urine.’’ Id. The physician would also look for ‘‘other aberrant drug-taking behaviors’’ such as ‘‘lost medicines’’ and use the prescription monitoring program to look for ‘‘doctor-shopping . . . or other concerning activities.’’ Id. Dr. Owen further explained that ‘‘[y]ou would, when possible, talk to the family and PO 00000 Frm 00010 Fmt 4701 Sfmt 4703 see how [the patient’s] behavior is’’ as well as ‘‘look for volatile behavior . . . with your staff.’’ Id.; see also id. at 117– 18 (testifying that ‘‘problematic behaviors’’ or ‘‘red flags’’ include ‘‘[l]ost or stolen medications, self-escalation of . . . medications without permission, aberrant urine drugs tests, [PMP] behaviors that look problematic,’’ and receiving reports that a patient is selling drugs). While Dr. Owen acknowledged that the presence of suspicious behavior by a patient does not necessarily mean the patient is abusing or diverting controlled substances, it does require that the physician take ‘‘some type of corrective action.’’ Id. at 118. As for what type of action should be taken, Dr. Owen explained that ‘‘[i]t depends on the context’’ and that ‘‘there’s a spectrum of corrective actions . . . you might take . . . from shortening the leash and seeing the patient more frequently, with less drugs per prescription,’’ to not treating with controlled substances, ‘‘to firing the patient.’’ Id. at 118–19. Dr. Owen disputed the CALJ’s suggestion that the use of urine drug screens is ‘‘pretty controversial in the pain management field,’’ stating that ‘‘[i]t’s a standard of care.’’ Id. at 113. After explaining that he would set the frequency of drug testing based on a risk assessment of the patient, Dr. Owen acknowledged that the ‘‘point of care’’ enzyme-amino assay test is a ‘‘preliminary test’’ and that ‘‘[y]ou can’t use the results with any confidence.’’ Id. at 114–15. Dr. Owen explained, however, that ‘‘the mass spectrometry test . . . is very reliable.’’ Id. at 115. Dr. Owen further testified that a physician would ‘‘want to test for common illicit substances, because you don’t just want to know what you’re prescribing’’ and would want to know if the patient is using ‘‘non-prescribed drugs or any street drugs.’’ Id. Asked how a practitioner should respond to an aberrant drug test, Dr. Owen testified that ‘‘first you need to document the presence of the aberrant . . . test. You need to document your rationale for your corrective actions. And then you explain what the corrective action is going to be.’’ Id. at 119. Dr. Owen then reiterated his earlier testimony that ‘‘the corrective action’’ could be ‘‘seeing the patient more frequently with less drugs’’; referring the patient to see an addictionologist or a psychiatrist or psychologist ‘‘with experience in addiction medicine’’ for a consultation; having the patient see a physical medicine specialist ‘‘to look at more functional goals’’; and in severe cases, terminating treatment with E:\FR\FM\23MRN2.SGM 23MRN2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices controlled substances. Id. Dr. Owen also testified that ‘‘[t]here’s no reason ever to ignore a red flag’’ and that a physician has a duty to resolve the red flag before prescribing. Id. Returning to the issue of what constitutes an adequate medical history, Dr. Owen testified that: . . . it’s a history that’s appropriate for whatever the chief complaint is, for example, low back pain. It includes a who, what, when, why, where, and type of elements that you would do in most any kind of a journalism course. So you’d say, how did you hurt yourself; where does it hurt; does the pain radiate down an extremity; if so, how far down; does it go past the knee; where does it end up; is there any numbness or weakness associated with it. And then you would talk about what treatments have you had or what diagnostics have you had. And you’d gather as much of that information, and you’d ask . . . how’s the pain affecting you physically and psychosocially. And that’s part of the Oklahoma guidelines is that you assess the person functionally, physically and psychosocially. Id. at 115–16. Dr. Owen then testified that this information is required to be documented in the patient file, and if it is ‘‘not in the file,’’ the assumption is that ‘‘it wasn’t done.’’ Id. at 116. Continuing, Dr. Owen explained that: srobinson on DSK5SPTVN1PROD with NOTICES2 . . . if you don’t do a proper history and a proper physical exam, if you don’t look at all the pertinent previous medical records, you can’t get an accurate diagnosis. And . . . you can’t draw any accurate conclusions about what is the right treatment plan. And if you don’t do accurate assessments, it results in potentially dangerous treatments that aren’t reasonable or medically necessary. Id. at 117. Asked by the CALJ to explain what a pain management contract is, Dr. Owen testified that it’s ‘‘a document informing the patient what the rules of the road are.’’ Id. at 120. Dr. Owen testified that the contract contains provisions that the patient ‘‘won’t get drugs from anybody else . . . for th[e] condition,’’ the patient ‘‘will only go to one pharmacy,’’ that the patient ‘‘will use the drugs only as directed,’’ and the patient will ‘‘submit[ ] to urine or blood drug testing.’’ Id. Then asked by the CALJ if, in Oklahoma, the use of a pain management contract is a ‘‘best practice’’ or part of the ‘‘standard of care,’’ Dr. Owen testified that it ‘‘is part of the [Oklahoma] guidelines of [the] standard of care.’’ Id. Dr. Owen also testified that ‘‘when taking on a new patient,’’ a physician ‘‘needs to have a pain management contract and informed consent.’’ Id. at 121. Finally, when asked by the CALJ where ‘‘there is a difference’’ between the standard of care VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 for ‘‘a pain management specialist and someone who is treating a patient . . . for pain symptoms,’’ Dr. Owen explained that ‘‘[t]here’s only one standard of care.’’ Id. at 120–21. On cross-examination, Dr. Owen was asked whether a prescriptive practice can ‘‘be within . . . legitimate medical practice and still be below the standard of care?’’ Id. at 181. In response, Dr. Owen testified that a physician ‘‘can violate the standard of care and still have a legitimate medical practice, but [cannot] be in the standard of care and have an illegitimate medical practice.’’ Id. When later asked ‘‘[w]hat goes into determining if the standard of care has been met,’’ Dr. Owen testified that ‘‘the standard of care is what a reasonable and prudent physician would do in the same or similar circumstances, and a reasonable, prudent physician would go to the evidence-based literature as a foundation for how to make decisions using critical thinking skills.’’ Id. at 183. When then asked ‘‘if there’s a community standard of care in Oklahoma,’’ Dr. Owen answered that ‘‘[t]here’s no such thing as a community standard of care anymore. It’s a national standard of care, and it’s based on our evolving body of knowledge, and as we learn new things, the standard changes.’’ Id. Dr. Owen then acknowledged that he did not know the Oklahoma Medicaid rules for when a patient can be referred. Id. On further cross-examination, Dr. Owen was asked whether the Oklahoma Guideline which addresses the need for consultation with an expert in the management of patients who have a history of substance abuse or a comorbid psychiatric disorder is mandatory as he had previously testified. Id. at 185–86. Dr. Owen acknowledged that the provision states that these two conditions ‘‘may require’’ consultation. Id. at 186. He then added, however, that a physician ‘‘should document why [he] deviate[d] from that recommendation.’’ Id. The Prescribing Events The August 25, 2011 Prescriptions B.B.’s patient file reflects that from the date of his first visit on or about April 24, 2009 up until August 25, 2011, B.B. obtained narcotic prescriptions from Dr. Schoelen, Respondent’s partner. See generally GX 3; Tr. 236. While on August 25, 2011, Dr. Schoelen issued B.B. a prescription for 120 tablets of oxymorphone 10 mg, the same day, Respondent wrote B.B. prescriptions for 150 hydrocodone/acetaminophen 10/ PO 00000 Frm 00011 Fmt 4701 Sfmt 4703 14953 500 as well as 60 carisoprodol 350.15 GX 3, at 24. B.B. was not seen by either Dr. Schoelen or Respondent on this day. GX 3, at 49. However, he was required to provide a urine sample, the results of which were reported by the lab on August 29, 2011.16 Id. at 99. While the lab results were expected with respect to the narcotics B.B. had previously been prescribed, the lab also detected the presence of nordiazepam, a metabolite of diazepam; oxazepam; and temazepam; none of these drugs had been prescribed to B.B.17 Id. While the Government alleged in the Order to Show Cause that the prescriptions Respondent issued on this day were ‘‘invalid’’ and violated 21 CFR 1306.04(a) and made extensive factual allegations to support this conclusion, it did not elicit any testimony from its Expert as to why. Moreover, Respondent testified that this was ‘‘a nurse-only visit’’ and that he issued the prescriptions because ‘‘Dr. Schoelen works half [a] day’’ and while Schoelen had issued one of the prescriptions, ‘‘he had missed the fact that—or the nurses had missed and not written the other two medications for him.’’ Tr. 389. The CALJ found this testimony credible. R.D. at 31. As the Government put forward no evidence to support the conclusion that it was outside of the usual course of professional practice for Respondent to cover for his partner, nor cites to any state rule prohibiting prescribing under this circumstance, I find that the allegation is unsupported by substantial evidence.18 15 At the time carisoprodol was not controlled under the CSA. However, a proceeding to control the drug was then ongoing and the drug became federally controlled effective on January 11, 2012. See Schedules of Controlled Substances, Placement of Carisoprodol Into Schedule IV, 76 FR 77330 (final rule). However, during 2011, the drug was a controlled substance under Oklahoma law. See Okla. Stat. tit. 63, § 2–210 (2011) 16 On June 1, 2011, B.B. had also provided a urine sample. GX 3, at 103. This test, which was reported by the lab on June 6, 2011, yielded a negative result for alprazolam, even though B.B. was then being prescribed alprazolam by another physician. Id. According to a PMP report, B.B. had filled alprazolam prescriptions for a 30-day supply on both May 9 and June 6, 2011. See id. at 25. 17 While the lab results also noted that B.B. had tested positive for alpha-hydroxyalprazolam, a metabolite of alprazolam, and reported this result as ‘‘not expected based on prescribed medications,’’ B.B. had obtained a prescription for a 30-day supply of alprazolam on July 29, 2011 and filled the prescription the same day. GX 3, at 36. 18 In its Exceptions, the Government argues that the CALJ erred in finding the allegation with respect to the August 25, 2011 prescriptions not proved. See Exceptions, at 44–47. It argues that because Respondent issued the prescriptions without seeing B.B. on that date, without having E:\FR\FM\23MRN2.SGM Continued 23MRN2 14954 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices srobinson on DSK5SPTVN1PROD with NOTICES2 The September 22, 2011 Visit and Prescriptions On some date after August 25, 2011, the State Board suspended Dr. Schoelen’s medical license and Respondent took over the treatment of B.B., who came for an office visit on September 22, 2011. Tr. 290; GX 3, at 48.19 See GX 3, at 103; id. at 25. According to the progress note for the visit, B.B. had come in ‘‘for a recheck on lumbar disc disease’’ and also had a ‘‘left abdominal hernia as well.’’ Id. at 48. Respondent also indicated in the progress note that B.B.’s ‘‘[p]ast medical history [was] extensively reviewed and placed in [the] chart.’’ Id. Respondent documented that he did a physical exam, noting, inter alia, ‘‘[l]umbar very painful spinal and paraspinal tenderness,’’ a ‘‘[n]egative straight leg raise,’’ and ‘‘[n]euro intact.’’ Id. Respondent diagnosed B.B. as having ‘‘lumbar disc disease’’ and a hernia; his plan included having B.B. obtain an MRI, changing him from Lortab to Duragesic patches, and continuing Respondent on Opana and Soma (carisoprodol). Id. Respondent also documented that he had discussed the seen him previously, and without reviewing the PMP, and because he testified that he reviewed only B.B.’s ‘‘medical history and the last two office visit notes’’ made by Dr. Schoelen, the ‘‘issuance of the two prescriptions fell far below the standard of care and outside the usual course of practice.’’ Id. at 46. As noted above, the Government elicited no testimony from Dr. Owen as to whether Respondent’s issuance of the prescriptions was below the standard of care or outside of the usual course of professional practice. Apparently, the Government relies on subsection 1 of the Board’s chronic pain rule, see Okla. Admin. Code § 435:10– 7–11(1), which requires that ‘‘[a] medical history and physical examination . . . be obtained, evaluated and documented in the medical record’’ in order to prescribe a controlled substance. See Exceptions, at 45 (arguing that ‘‘the OK Pain Rule sets forth the standard of care for Oklahoma prescribing controlled substances . . . for the treatment of pain’’). However, in 2014, the Board promulgated an exception to the requirement that ‘‘[t]he physician/ patient relationship shall include a medically appropriate, timely-scheduled, face-to-face encounter with the patient,’’ which allows ‘‘providers covering the practice of another provider [to] approve refills of previously ordered medications if they have access to the medical file of the patient.’’ Okla. Admin. Code § 435:10–7– 12(1). While this rule was not in effect when Respondent issued the prescriptions, it strains credulity to suggest that providing prescriptions under the circumstances of covering for a partner violated the standard of care two years earlier when Respondent issued the prescriptions. While the Government speculates that Dr. Schoelen ‘‘may not have issued B.B. these two prescriptions purposefully pending the results of the new UDS,’’ Exceptions at 46, and argues that Respondent was required to call Dr. Schoelen as a witness to corroborate his testimony, the Government ignores that it had the burden of proof on this issue. 19 According to a PMP report in B.B.’s patient file, he had filled a prescription for a 30-day supply of alprazolam on May 9, 2011. GX 3, at 25. VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 ‘‘[a]ddictive, dependence, and tolerance nature of the medicines,’’ the ‘‘use of Duragesic,’’ and suggested ‘‘[n]onmedicinal pain-relieving modalities.’’ Id. B.B.’s file also contains a Pain Management Treatment Plan, which includes a section bearing the caption: ‘‘Treatment Objective Evaluation.’’ GX 3, at 28. This form lists several questions, with boxes for documenting by date, various findings which included: ‘‘Has patient achieved treatment objective?’’; ‘‘Patient completed . . . updated pain scale’’; ‘‘Re-review benefits and risks of using medications’’; ‘‘Consider referral to another physician for second opinion or further treatment options’’; ‘‘Changes to Treatment Plan’’; and the ‘‘[p]hysician’s initials.’’ Id. For this visit, Respondent wrote ‘‘yes’’ as to whether B.B. had achieved the treatment objective (which was documented as ‘‘to be able to work without pain,’’ id. at 29), wrote the number ‘‘3–5’’ in the pain scale block, and noted ‘‘yes’’ with respect to both whether he had re-reviewed the risks and benefits of controlled substances and considered a referral to another physician.20 Id. at 28. Dr. Owen testified that because this was B.B.’s first visit with Respondent, Respondent should have ‘‘do[ne] a 20 In contrast to this document which contains a single box in which Respondent and Dr. Schoelen would write a number for B.B’s pain (the ‘‘Patient Completed . . . updated pain scale’’), B.B.’s file contains a ‘‘Patient Comfort Assessment Guide’’ form which B.B. completed on September 2, 2009. GX 3, at 32–33. On this form, B.B. circled various words such as ‘‘aching,’’ ‘‘throbbing,’’ ‘‘shooting’’ and ‘‘stabbing’’ to describe his pain which he maintained was ‘‘continuous’’ and at its worst in the ‘‘afternoon’’ and ‘‘evening.’’ Id. The form also contains four instructions which directed B.B. to rate his pain on a numeric scale of 0 to 10 (with 0 being ‘‘no pain’’ and 10 being ‘‘[p]ain as bad as you can imagine’’), at its worst,’’ ‘‘its least,’’ and ‘‘on average in the last month,’’ as well as ‘‘right now.’’ Id. at 32. In addition, the form asked ‘‘[w]hat makes your pain better,’’ ‘‘what makes your pain worse,’’ as well as ‘‘what treatments or medicines are you receiving for your pain,’’ and it further instructed the patient to numerically rate the relief he obtained (again on a 0 for ‘‘no relief’, to 10 for ‘‘complete relief’’ scale) from the treatment or medicine. Id. On the form’s second page, it asked ‘‘[w]hat side effects or symptoms are you having,’’ and directed B.B. to ‘‘[c]ircle the number that best describes your experience during the past week,’’ again using a 0 (‘‘Barely Noticeable’’) to 10 (‘‘Severe Enough to Stop Medicine’’) scale for 10 side effects and symptoms such as nausea, vomiting, constipation, lack of appetite, difficulty thinking and insomnia. And finally, the form directed B.B. to ‘‘[c]ircle the one number’’—on a scale of 0 for ‘‘not [i]nterfer[ing]’’ to 10 for ‘‘[c]ompletely [i]nterfering’’—which ‘‘describes how during the past week pain has interfered with’’ his ‘‘[g]eneral [a]ctivity,’’ ‘‘[m]ood,’’ ‘‘[n]ormal work,’’ ‘‘[s]leep,’’ ‘‘[e]njoyment of [l]ife,’’ ‘‘[a]bility to [c]oncentrate,’’ and ‘‘[r]elations with [o]ther [p]eople.’’ Id. Of note, there is no evidence that B.B. was required to complete this form at any subsequent visit. PO 00000 Frm 00012 Fmt 4701 Sfmt 4703 proper history and physical exam and review[ed] previous treatments and everything that typically is expected for a new patient evaluation.’’ Tr. 131. According to Dr. Owen, this included reviewing B.B.’s patient file which included the aberrant June 1 and August 25, 2011 drug tests. Id. at 132. With respect to the August 25 drug test, Dr. Owen testified that B.B. had previously received prescriptions for alprazolam, hydrocodone, Soma (carisoprodol) and oxymorphone. Id. at 130. As found above, each of these drugs (or its metabolites) was detected by this test. Id. Dr. Owen then noted, however, that there were ‘‘no prescriptions for the metabolites of diazepam, which is nordiazepam, or oxazepam or temazepam.’’ Id. And he further noted that in the comment section with respect to these three drugs, the lab report stated that ‘‘[t]hese test results were not expected based on the [prescribed] medications.’’ Id. Dr. Owen testified that Respondent ‘‘completely ignored’’ the aberrant drug screens and ‘‘should have acknowledged their existence and then taken some type of corrective action.’’ Id. at 132. Dr. Owen also testified that the patient file did not reflect that Respondent had consulted or discussed B.B. with past or current prescribers and that it did not appear that Respondent had taken any ‘‘safeguards regarding the potential’’ for diversion or abuse presented by the aberrant drug screens. Id. at 132–33. Dr. Owen then testified that the patient record did not justify the prescribing of controlled substances as it did not ‘‘establish medical necessity for this type of treatment.’’ Id. at 133. As the basis for his conclusion, Dr. Owen explained that: For one, it’s a superficial evaluation that doesn’t adequately explain the chief complaint or what previous treatments have or have not been done. And there’s no evaluation of pain or function, physical or psychosocial in the documentation. There’s no evidence of a previous therapeutic benefit. There’s no medical rationale for continuing with an ineffective treatment, so there’s no justification to continue treatment with controlled substances. Id. Dr. Owen also explained that ‘‘[t]here’s no proof that he’s exhausted conservative care before going into these high-risk treatments’’ and reiterated that ‘‘[t]here’s no evidence of a therapeutic benefit.’’ Id. at 134. And with respect to the aberrant drug screens, Dr. Owen testified that Respondent ‘‘could have sent this gentleman for evaluations by an addictionologist, by a psychiatrist [or psychologist] with experience in addiction medicine, and certainly E:\FR\FM\23MRN2.SGM 23MRN2 srobinson on DSK5SPTVN1PROD with NOTICES2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices looked at being much more careful and objective about how [he] measure[d] a therapeutic benefit with the controlled substances.’’ Id. Dr. Owen thus opined that the prescriptions Respondent provided at this visit were not issued in the usual course of professional practice and lacked a legitimate medical purpose. Id. at 133. On cross-examination, Dr. Owen was asked if he considered Respondent’s ordering of an MRI at this visit to be ‘‘a safeguard.’’ Id. at 188. Dr. Owen initially answered ‘‘no,’’ before explaining that ‘‘[i]t depends [on] if you clinically need the MRI, and you only need the MRI if you’re looking for something that has potentially a surgically correctable lesion,’’ and that absent ‘‘a clinical finding’’ that suggests ‘‘an MRI is needed to confirm a lesion that’s surgically reversible . . . you don’t have medical necessity to get an MRI.’’ Id. Dr. Owen further explained that ‘‘MRIs have high false positive rates’’ and that ‘‘[a]bnormalities are commonly found in asymptomatic people.’’ Id. On questioning by the CALJ as to whether when a patient complains of ‘‘a high subjective level of pain,’’ an MRI could ‘‘at least confirm [if] there was some objective basis for it,’’ Dr. Owen explained that ‘‘without a neurological finding,’’ it is ‘‘rarely . . . valuable to get an MRI.’’ Id. at 189. He further explained that MRIs show ‘‘abnormalities that are nonspecific’’ leading to ‘‘overtreatment,’’ and thus a physician ‘‘need[s] something more objective from a physical exam finding to get an MRI.’’ Id. In response to a further question by the CALJ which posited whether an MRI would provide an objective basis such as ‘‘foraminal narrowing’’ or ‘‘spondylosis’’ for concluding that a patient ‘‘may be having a spine issue’’ and is not ‘‘making it up,’’ Dr. Owen explained that ‘‘foraminal stenosis or foraminal narrowing are common in asymptomatic people.’’ Id. at 190. Dr. Owen then explained that ‘‘[t]he only reason it would be important is if you have a radiculopathy you’ve identified on clinical exam . . . and that would be pain going down the leg in a dermatome distribution, typically below the knee.’’ Id. Continuing, Dr. Owen explained that there may be ‘‘numbness’’ and there may be ‘‘weakness associated with the isolated nerve that’s being entrapped, and you would have a positive straight leg raise.’’ Id. Dr. Owen further noted that ‘‘almost all the exams’’ on B.B. ‘‘said it was negative straight leg raise’’ and that this is ‘‘the most sensitive physical finding for low back pain.’’ Id. Dr. Owen then explained that ‘‘a sensitive test means VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 14955 that if you don’t have a positive finding you don’t have that diagnosis.’’ Id. Moreover, Dr. Owen testified that even if a patient reported symptoms consistent with radiculopathy, ‘‘you’d want physical exam findings, with the most important being the straight leg raise, according to the North American Spine Society.’’ Id. at 191. Dr. Owen further explained that ‘‘if you had a negative straight leg raise, then you don’t have radiculopathy, and if you don’t have radiculopathy . . . you really don’t need to get an MRI, because it’s just going to lead to finding things that send you on a garden path of overinterpreting the diagnosis.’’ Id. Regarding B.B.’s September 22, 2011 visit and the prescriptions he issued, Respondent testified that the first thing he would do when entered the exam room is look at the Pain Management Treatment Plan (GX 3, at 28) after which he would ‘‘look[ ] at his previous notes.’’ 21 Tr. 286. According to Respondent, he would ask the patient if he had ‘‘achieved [his] objective in the pain medicine contract’’ and ‘‘what [the patient’s] pain level is on medicine’’ and use ‘‘a scale of 1 to 10.’’ Id. Continuing, Respondent testified that ‘‘then we [would] talk about what their medicines are and what utilization that we would use, what the risks are using the medicines . . . what our plans are, what treatment, what goal we’re going to go for, and what we might need to change or initiate in the treatment, and then decide whether [to do] a urine drug screen.’’ Id. at 286–87. Respondent then testified that B.B. ‘‘basically said that he had achieved his pain goal and that he was only a 3 to 5 out of 10, that he preferred that we not make any changes or any type of referral at that time, and I did a urine drug screen.’’ Id. at 287. There is, however, no evidence that Respondent did a urine drug screen at this visit. See GX 3. Respondent was then asked by his counsel if he looked back at the August 25 drug screen. Tr. 287. Respondent testified that he ‘‘would not’’ have discussed the results with B.B. because ‘‘[b]asically he was on all the medicines he was prescribed, and according to [the lab], if you’re on one benzodiazepine, all the other benzodiazepines can appear positive within the drug screen.’’ Id. Respondent then testified that B.B. was ‘‘on Xanax [alprazolam] by another provider, and he was also on Ambien.’’ Id. Asked how he knew that B.B. was on both drugs, Respondent testified that B.B. had listed the alprazolam on the intake form he completed at his first visit and while the Ambien was not listed ‘‘on his past medical sheet, [it] was on the PMP.’’ Id. Respondent then added that the Ambien was prescribed by B.B.’s psychiatrist. Id. at 289. He further maintained that when the practice ‘‘started doing pain management, we were getting multiple episodes where patients were denying that they had taken other benzodiazepines,’’ and when they contacted the lab, the lab told them that Xanax can cross-react and cause a positive result on the mass spectrometry for other benzodiazepines. Id. Thus, Respondent maintained that he did not believe this to be an aberrant drug screen. Id. Respondent further testified that although he took over the care of B.B., he did not simply continue the same treatment that Dr. Schoelen provided. Id. at 290. Rather, he testified that based on his ‘‘education and . . . experience, especially with Lortab . . . I found it too addicting to keep people on shortacting pain medicines.’’ Id. at 291. Respondent told B.B. ‘‘that there would have to be . . . a change in his treatment, and that I would have to use a long-acting pain medicine and a shortacting only for breakthrough’’ pain. Id. While Respondent continued B.B. on carisoprodol and Opana, he took B.B. off of Lortab ‘‘and gave him a two-week trial of the Duragesic patch.’’ Id. Respondent also maintained that B.B.’s ‘‘reported pain and his objective’’ were consistent with the findings on physical examination. Id. at 292. He also testified that he had discussed the use of Duragesic and that it, as well as morphine and Opana ER, were the ‘‘only long-acting pain medications that’’ the Oklahoma Medicaid program ‘‘would cover’’ and that Medicaid would only pay for three prescriptions a month.22 Id. Respondent further 21 However, in discussing the August 25 prescriptions, Respondent testified that ‘‘[a]nytime I had to do anything with the chart of Dr. Schoelen’s or pain management or anyone that I hadn’t seen before, I would look at their last two office notes, and I’d look at their past medical history sheet on the front that’s filled out by the physician . . . and then I would look at the PMP.’’ Tr. 281. Asked with respect to the August 25 prescriptions if he ‘‘looked back at the previous drug tests,’’ Respondent answered: ‘‘I don’t recall, but I doubt I did. . . . I wouldn’t expect myself to.’’ Id. at 283. 22 It is unclear, however, whether B.B. was on Medicaid or Medicare or both at the time of the prescription. See, GX 3, at 7 (copy of B.B.’s Medicare card and Sooner Care Medical ID card); id. at 8–9 (Medical Home Agreement for SoonerCare); id. at 10–13 (Advance Beneficiary Notices dated during 2011 through 2012 advising B.B. that ‘‘Medicare probably will not pay for’’ various items or services and explaining appeal rights if Medicare did not pay); id. at 14 (referral form for SoonerCare dated 10–14–09). See also Tr. at 192–93. Moreover, Respondent offered no PO 00000 Frm 00013 Fmt 4701 Sfmt 4703 E:\FR\FM\23MRN2.SGM Continued 23MRN2 14956 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices maintained that he and B.B. had discussed non-medicinal pain-relieving modalities so that B.B. knew that he believed in them and that he then ordered the MRI. Id. at 293. As for why he ordered the MRI, Respondent testified that it was the ‘‘[s]tandard of care in Oklahoma,’’ and that while ‘‘[h]e had an X-ray done in 2009 that was consistent with his finding . . . [i]f you treat chronic pain . . . patients and [are] audited by the Board or your insurance company [and] you don’t have an objective finding in the chart, such as X-rays and MRIs, you’re quite . . . the outlier.’’ 23 Id. Respondent added that he ‘‘wanted to make sure that [B.B.] was consistent with . . . [w]hat he was being treated for and what his exam [sic] and the fact that he was on a Schedule II narcotic.’’ Id. at 293. Respondent then explained that while an MRI might give a false positive, ‘‘[if] the pain is consistent with it, it’s just one more piece of evidence that gives you a reason to believe that the patient’s legitimate and that you’re legitimately treating his condition.’’ Id. at 294. Respondent also testified that an MRI provides a baseline should his exam change at a late date. Id. The October 6, 2011 Visit srobinson on DSK5SPTVN1PROD with NOTICES2 On October 6, 2011, B.B. again saw Respondent. In the visit note, Respondent wrote: ‘‘Patient has been on the DURAGESIC 50 mcg and the OPANA. Now, he would like to try the Morphine. He is slowly trying to figure out the right regimen for him.’’ GX 3, at 47. Respondent again noted in the chart that ‘‘[p]ast medical history extensively reviewed and placed in chart.’’ Id. With respect to the physical exam, Respondent noted: ‘‘[l]ow back paraspinal tenderness,’’ ‘‘[n]egative straight leg raise,’’ and ‘‘[n]euro intact.’’ Id. Respondent also found that B.B. ‘‘has a left abdominal wall hernia.’’ Id. Respondent listed his diagnoses as ‘‘[l]umbar disc disease’’ and ‘‘anxiety.’’ 24 Id. At the visit, Respondent prescribed 30 tablets of Morphine Sulfate ER15 mg B.I.D. (one tablet twice per day), for a 15-day supply. GX 5, at 25. Respondent also recommended that B.B. ‘‘[w]ear a testimony as to whether Medicare used the same formulary as the Oklahoma Medicaid program. 23 A progress note for B.B.’s September 2, 2009 visit stated that an x-ray was obtained and confirmed the existence of lumbar thoracic scoliosis but that the disc spaces appear to be within normal limits. GX3, at 59. The Government did not, however, ask its Expert to address the significance of these findings. 24 Respondent found, however, that B.B. was ‘‘[a]lert and oriented and in no apparent distress.’’ GX 3, at 47. VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 corset if at all possible’’ for his hernia. GX 3, at 47. Regarding the prescription, Dr. Owen testified (in the words of Government counsel) that it is not ‘‘normal practice . . . for patients to dictate the controlled substances they’re prescribed.’’ Tr. 135. Asked ‘‘why not,’’ he explained that a physician must ‘‘safeguard the patient against addiction, and you need to do things that are medically necessary, not what patients want.’’ Id. at 135–36. Dr. Owen further testified that ‘‘it’s a yellow flag for a patient to ask for a drug specifically,’’ but not necessarily ‘‘a red flag’’ as ‘‘it could mean [the patient] had a previous experience with the drug and either found it helpful, or they’ve had previous experience from the drug from an illicit means.’’ Id. However, because Respondent did not document that he addressed ‘‘B.B.’s previous history with morphine’’ B.B.’s request was ‘‘elevate[d] to a red flag.’’ Id. at 136. Asked what steps Respondent should have taken, Dr. Owen testified that ‘‘just the fact that the aberrant urine drug tests were there means that you should get some consultations, because . . . this is a complex issue, and there’s behaviors going on that you can’t quite understand without a more thorough assessment by mental health providers or addictionologists.’’ Id. at 136–37. According to Dr. Owen, this was so even if B.B. had not asked for morphine. Id. at 137. Here again, Dr. Owen testified that the medical record did not justify the prescribing of controlled substances. Id. He explained that: This is a superficial evaluation that does not properly address the chief complaint of low back pain or establish medical necessity for treating with controlled substances. There’s no assessment of pain, physical or psychosocial function, and therefore, there’s no medical necessity to continue treatment with controlled substances, and if you don’t have medical necessity, you don’t have a legitimate purpose to treat. Id. And again, Dr. Owen opined that the prescriptions ‘‘were not’’ issued in the usual course of professional practice and ‘‘were not’’ for a legitimate medical purpose. Id. at 137–38. Regarding this visit, Respondent testified that B.B. had ‘‘report[ed] that his objectives were only fair’’ and that ‘‘[h]is pain level had gone up to a 6 out of 10 on the Duragesic.’’ Id. at 295. Respondent further testified that ‘‘[w]e again went over what the rules were and what the Medicaid and the Duragesic and what the risk benefits were. We talked about whether we needed to make a referral at that point or make any other changes.’’ Id. Respondent also PO 00000 Frm 00014 Fmt 4701 Sfmt 4703 testified that B.B. ‘‘had a full exam’’ but that ‘‘[t]he MRI was not back yet.’’ Id. As for the statement in the progress note that B.B. ‘‘would like to try the Morphine,’’ GX 3, at 47, Respondent testified that B.B. ‘‘did not believe the Duragesic was sufficient and that he wanted to try one of the other medicines that was on the formulary.’’ Tr. 296. Respondent testified that he did not believe this to be a ‘‘red flag’’ in B.B.’s case because he ‘‘had made it very clear to [B.B.] what our choices were’’ under the Medicaid formulary and ‘‘the majority of patients are very concerned [because] Duragesic and morphine are used for dying cancer patients, and why are we putting them on medications for dying.’’ Id. Respondent then testified that he was ‘‘sure I told [B.B. that] Duragesic, morphine and Opana ER’’ were his options. Id. The CALJ, observing that ‘‘saying the patient requested morphine . . . is kind of a remarkable note,’’ asked Respondent how his conversation with B.B. went. Id. at 298. Respondent answered: ‘‘Probably that I didn’t like the Duragesic and you suggested that morphine was an option. Can we try the morphine this time. Probably something like that.’’ Id. at 299. Respondent added that B.B. ‘‘was not pleased . . . that we changed the Lortab and the Opana, so the fact that I made him do the Duragesic, he was not happy.’’ Id. at 300. Respondent further noted that he ‘‘did his exam’’ and ‘‘[i]t was still consistent that he did have left abdominal wall weakness.’’ Id. Respondent explained that ‘‘[h]is diagnosis was lumbar disc disease, anxiety, and a questionable upper respiratory infection’’ and that he ‘‘placed [B.B.] on antibiotics.’’ Id. As for his abdominal wall pain, Respondent discussed with B.B. ‘‘wearing a corset if at all possible’’ because he did not ‘‘want to confuse his . . . abdominal pain[] with his level of pain because of my change in his pain regimen.’’ Id. Respondent further explained that B.B. ‘‘would follow up . . . in two weeks’’ and was given only ‘‘a two week supply of his new Schedule II medicine.’’ Id. According to Respondent, ‘‘anytime [he] made a large change in [a patient’s] medications, [he] would only give a two-week’’ supply in the event the patient was ‘‘allergic to it,’’ was ‘‘going to abuse it,’’ or ‘‘got no pain relief whatsoever.’’ Id. at 302. Respondent also testified that he had given B.B. a shot of Decadron, a steroid, which ‘‘sometimes’’ provides patients in ‘‘severe pain’’ with ‘‘significant relief’’ and is ‘‘a great indicator that [the patient’s] pain was more inflammatory than other nature.’’ Id. at 301. E:\FR\FM\23MRN2.SGM 23MRN2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices The October 20, 2011 Visit srobinson on DSK5SPTVN1PROD with NOTICES2 B.B. again saw Respondent on October 20, 2011. GX 3, at 46. According to the progress note, B.B. reported that ‘‘his stress [was] up,’’ that he had ‘‘los[t] his father, and ‘‘he [was] having a lot of grief.’’ 25 Id. Respondent again noted that B.B.’s ‘‘[p]ast medical history [was] extensively reviewed and placed in chart.’’ Id. As for the physical exam, Respondent noted that B.B. had ‘‘[l]ow back paraspinal and spinal tenderness’’ and a ‘‘[n]egative straight leg raise, but [that] lying down and sitting up cause him a lot of pain.’’ Id. He also noted ‘‘[n]euro intact.’’ Id. Respondent again diagnosed B.B. with ‘‘[l]umbar disc disease’’ and added a further diagnosis of ‘‘[a]cute grief.’’ Id. Respondent documented that he discussed the ‘‘[a]ddictive, dependence, and tolerance nature of the medicines as well as alternatives,’’ that he suggested ‘‘[n]on-medicinal painrelieving modalities,’’ and that the follow-up would be either ‘‘p.r.n.’’ (as needed) or ‘‘three months per his pain contract.’’ Id. Respondent also issued B.B. new prescriptions for 120 Opana 10 (one tablet every 6 hours P.R.N. for breakthrough pain) and 90 Morphine Sulfate ER 15, increasing the dosing of the latter drug to one tablet in the morning and two tablets in the evening. Id.; see also GX 5, at 19, 22. With respect to the statement in the progress note that B.B. was having a lot of stress and grief, Dr. Owen testified that this ‘‘magnifies the perception of pain and disability’’ and that because there were previous ‘‘aberrant behaviors going on and now . . . another stressor in [B.B.’s] life,’’ this ‘‘increase[d] the risk’’ that B.B. would ‘‘use [the] drugs to chemically cope.’’ Tr. 139. Dr. Owen then explained that Respondent should have ‘‘sought psychological counseling for’’ B.B. Id. Based on there being ‘‘no documentation of [Respondent] taking additional steps,’’ Dr. Owen concluded that he ‘‘did not’’ do that. Id. at 140. Dr. Owen also testified that Respondent’s notation that ‘‘[n]onmedicinal pain-relieving modalities suggested’’ lacked sufficient detail before rhetorically asking: ‘‘What does that mean, nonmedicinal modalities suggested?’’ Id. at 209–10. Continuing, Dr. Owen explained: First, you don’t suggest treatment. Your job as a physician is to advise the patient of what good medicine is, and good medicine would be if you haven’t done nonmedicinal painrelieving modalities, we need a back-up, 25 Yet Respondent also noted that B.B. was ‘‘[a]lert and oriented and in no apparent distress.’’ GX 3, at 46. VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 wean you off these controlled substances and try these other treatments first. Id. at 210. Then asked what the purpose is ‘‘of providing that level of detail in a patient file,’’ Dr. Owen answered: Well, the purpose of documentation is for continuity of care. Not only continuity of care for this same provider from visit to visit but continuity of care should somebody else assume the care later on down the road or should you need to get a consultation, that the consultant can read your notes and understand what was happening with this patient at this point in time. Id. Regarding this visit, the CALJ asked Dr. Owen if Respondent’s notation that ‘‘[n]egative straight leg raise, but lying down and sitting up causes him a lot of pain’’ had ‘‘any significance?’’ Id. Dr. Owen replied: ‘‘[I]t doesn’t—it’s not objective [in a] neurological kind of sense, but it definitely contributes to the idea that it’s not therapeutic on his controlled substances, because he’s having a lot of pain, lying down and sitting.’’ Id. When then asked by the CALJ, ‘‘[h]ow about the negative straight leg raise part of it?’’ Dr. Owen answered: ‘‘[t]hat means he cannot have a radiculopathy. There’s not likely anything surgically going on.’’ Id. at 211. Dr. Owen again testified that the medical record did not support the prescribing of controlled substances. Id. at 140. He testified that: ‘‘[a]s previously discussed, there’s an inadequate evaluation going on. There’s a lack of medical necessity to continue treatment with controlled substances since there’s no therapeutic benefit. And if you don’t have medical necessity, you can’t have a legitimate medical purpose for using controlled substances.’’ Id. Respondent testified that the ‘‘most remarkable’’ thing in the October 20 progress note was that B.B.’s blood pressure had gone up and that B.B. was also ‘‘wanting to know about his MRI report.’’ 26 Tr. 305. Respondent then testified as to the various entries in the October 20 note including B.B.’s report of having ‘‘lost his father’’ and ‘‘having a lot of grief.’’ Id. According to Respondent, B.B.’s ‘‘exam was still exactly like before, with low back paraspinal and spinal tenderness, but he still had the negative straight leg raises. But laying down and sitting up still caused him a lot of pain.’’ Id. Continuing, Respondent testified that he diagnosed B.B. with acute grief and lumbar disc disease and that he 26 However, while the visit includes the handwritten notation ‘‘Question about MRI,’’ GX 3, at 46, B.B. did not undergo the MRI until the next day. See id. at 19. PO 00000 Frm 00015 Fmt 4701 Sfmt 4703 14957 increased his Morphine to two pills or 30 milligrams in the evening while keeping his Opana for breakthrough pain. Id. He also testified that he warned B.B. about ‘‘the addictive, dependence and tolerance natures’’ of the medications and ‘‘suggested that he continue using his non-pain [sic] relieving modalities.’’ Id. Respondent did not, however, offer any further explanation as to what those modalities involved. Respondent then testified that he determined the follow-up would be in ‘‘three months’’ as he ‘‘felt like [B.B.] could really go into the three-month’’ schedule for being seen by him. Id. at 305–06. However, at this visit, Respondent did not document whether B.B. was achieving his treatment objective or that he had obtained a numeric rating from B.B. as to his pain. See GX 3, at 28. On October 21, 2011, the day after this visit, B.B. had an MRI done of his lumbar spine. Id. at 19. The Radiologist reported his impression as follows: ‘‘Degenerative changes of the lower lumbar spine as above. Most affected level is at L5–S1 where a left paracentral disc protrusion contacts the descending S1 nerve root in the lateral recess.’’ 27 Id. at 20. Regarding the MRI, Dr. Owen tested that it ‘‘did not show any specific problems that would be attributable for this kind of pain complaint[], nor was it significant to cause the perceived disability that this 26-year-old gentleman considers himself’’ to have. Tr. 207. And as he earlier testified in response to the CALJ’s question as to whether an MRI would provide an objective basis such as ‘‘foraminal narrowing’’ or ‘‘spondylosis’’ for concluding that a patient ‘‘may be having a spine issue’’ and not ‘‘making it up,’’ Dr. Owen explained that ‘‘foraminal stenosis or foraminal narrowing are common in asymptomatic people.’’ Id. at 190. Dr. Owen then explained that ‘‘[t]he only reason it would be important is if you have a radiculopathy you’ve identified on clinical exam . . . and that would be pain going down the leg in a dermatome distribution, typically below the knee.’’ Id. Continuing, Dr. Owen explained that 27 Other findings included that L1–L2, L2–L3, and L3–L4 were all normal, as well as that the alignment of his vertebrae was normal. GX 3, at 19. At L4–L5, the MRI found a ‘‘[s]mall left paracentral disc protrusion with no significant spinal canal with mild left neural foraminal and no significant right neural foraminal stenosis.’’ Id. At L5–S1, the MRI found a ‘‘[s]mall left paracentral disc protrusion measuring 8 mm in [the] AP dimension results in moderate subarticular recess narrowing, with contact of the descending S1 nerve root. There is mild left neural foraminal stenosis with no significant right neural foraminal stenosis.’’ Id. E:\FR\FM\23MRN2.SGM 23MRN2 14958 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices srobinson on DSK5SPTVN1PROD with NOTICES2 there may be ‘‘numbness’’ and there may be ‘‘weakness associated with the isolated nerve that’s being entrapped, and you would have a positive straight leg raise.’’ Id. The November 18, 2011 and December 15, 2011 Prescriptions On November 18, 2011, Respondent wrote new prescriptions with the same dosing instructions for 90 Morphine Sulfate ER 15 mg and 120 Opana 10 mg; each of these was for a 30-day supply. GX 5, at 17, 21; GX 3, at 23. B.B. filled the prescriptions the same day. While B.B.’s file contains photocopies of the prescriptions, it contains no documentation of a visit with either Respondent or a nurse on this date. See generally GX 3; Tr. 142. Likewise, on December 15, 2011, Respondent wrote new prescriptions with the same dosing instructions for 90 Morphine Sulfate ER 15 mg and 120 Opana 10 mg, each of these being for a 30-day supply. GX 3, at 67, 90. Respondent filled these prescriptions the same day. Id. at 23. Here again, there is no documentation of a visit with either Respondent or a nurse on this date. See generally GX 3; Tr. 142. Dr. Owen testified that ‘‘[e]specially in the context of the previous aberrant urine drug testing and the lack of any clear medical necessity or therapeutic benefit,’’ Respondent ‘‘should have’’ seen B.B. in his office prior to prescribing the drugs on both dates. Tr. 142. Dr. Owen further testified that notwithstanding that at the October 20 visit, B.B. had reported that ‘‘his stress is up’’ and that ‘‘he [was] having a lot of grief,’’ there is no notation in B.B.’s file as to how B.B. was dealing with these issues. Id. Dr. Owen also noted that there was no notation in the file that Respondent had discussed the results of the aberrant drugs tests with B.B. Id. at 143. Dr. Owen then testified that Respondent had ‘‘never’’ established ‘‘a medical necessity . . . to continue these treatments’’ and that this would require an in-office visit. Id. After explaining that the aberrant drugs tests and mention of B.B.’s life stressors supported the need for psychological counselling and consultations with a psychologist or addictionologist, Dr. Owen was asked what risk was created by prescribing these drugs to B.B. without requiring an office visit. Id. Dr. Owen testified that ‘‘[t]he risk is that he continues to selfescalate these medications, and [is] either chemically coping or becomes— or is addicted to it.’’ Id. Dr. Owen then opined that Respondent had never established the ‘‘medical necessity’’ of the prescriptions he issued to B.B. on VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 these two dates, that the prescriptions lacked a legitimate medical purpose, and that Respondent acted outside of the usual course of professional practice in issuing them. Id. at 144. On cross-examination, Dr. Owen was asked whether he was aware that under DEA’s regulation which allows a physician to ‘‘issue multiple prescriptions authorizing the patient to receive . . . up to a 90-day supply of a schedule II controlled substance, provided [various] conditions are met,’’ ‘‘it was okay . . . to only see a patient once . . . every 90 days?’’ Id. at 195–96; see also 21 CFR 1306.12(b). While Dr. Owen answered ‘‘yes,’’ he added that a physician must have ‘‘established medical necessity and legitimate therapeutic benefit from previous documentation and [that] a patient doesn’t have a high risk of abuse.’’ Tr. 196. Dr. Owen then re-iterated that B.B. ‘‘already had multiple aberrant urine drug tests before those prescriptions were issued.’’ Id. Regarding these prescriptions, Respondent testified that he did not understand that he had to see B.B. ‘‘every 30 days’’ and that ‘‘[w]e saw him every 90 days.’’ Id. at 307. Respondent further testified that ‘‘[a]t the time there was debate within the state as to whether’’ patients ‘‘could be seen’’ even ‘‘every four months’’ and ‘‘we had chosen every three months, so we never gave more than two refills on a II or above.’’ Id. Respondent then explained that the patients ‘‘would call one to two days ahead, a lot of times to the pharmacy, and the pharmacist faxes the request.’’ Id. at 307–08. Continuing, Respondent testified that ‘‘[a] PMP would be pulled, and then the chart would be pulled. And then we would write a prescription for the person and leave it up front for them to pick up and sign for.’’ Id. at 308. Respondent further testified that the November 18 prescriptions were issued 29 days after the previous prescriptions. Id. at 311. Respondent did not, however, address Dr. Owen’s criticism that B.B. presented a high risk of escalating the use of the controlled substances and should have been seen prior to prescribing on each of these dates. See id. at 306–13. The January 19, 2012 Visit and Prescriptions On January 19, 2012, B.B. again saw Respondent, who reported that he had gone to the emergency room ‘‘two weeks ago with right leg swelling’’ but that ‘‘[h]is ultrasound was negative.’’ GX 3, at 45. B.B. complained of ‘‘some calf pain’’ and that ‘‘[h]e still feels very tight.’’ Id. Respondent also noted that B.B. ‘‘goes to a psychiatrist’’ and PO 00000 Frm 00016 Fmt 4701 Sfmt 4703 ‘‘reports severe lumbar disc disease’’; he also noted that B.B. reported that ‘‘he ha[d] been exposed to someone with HPV’’ and ‘‘would like an exam.’’ Id. Respondent further noted that B.B.’s ‘‘[p]ast medical history [was] extensively reviewed’’ and ‘‘placed in chart.’’ Id. According to Respondent’s exam notes, B.B. was ‘‘[a]lert and oriented and in no apparent distress.’’ Id. While other portions of the exam were normal, Respondent again documented that B.B. had ‘‘[l]ow back paraspinal tenderness,’’ a ‘‘[n]egative straight leg raise,’’ and ‘‘[n]euro intact.’’ Id. He also documented that B.B. ‘‘has very tight right calf.’’ Id. However, no mention was made of B.B.’s hernia which had been noted at previous visits. Id. Respondent diagnosed B.B. with ‘‘lumbar disc disease,’’ ‘‘exposure to infectious disease,’’ and ‘‘[r]ight calf pain.’’ Id. He further documented that he discussed the ‘‘[a]ddictive dependence, and tolerance nature of the medicines as well as alternatives,’’ that he suggested ‘‘[n]on-medicinal painrelieving modalities,’’ and that the ‘‘[f]ollowup will be [in] three months.’’ Id. Respondent then issued B.B. new prescriptions for Morphine Sulfate ER 15 mg and Opana 10 mg with the same dosing instructions, thus providing a 30day supply for each drug if taken as directed. Id. At this visit, B.B. was required to provide a urine drug screen. While the results were not reported until January 31, 2012, the lab reported that morphine was ‘‘not detected’’ and that this result was ‘‘not expected with prescribed medications.’’ GX 3, at 97. Moreover, while the lab detected the presence of alpha-hydroxyalprazolam, a metabolite of alprazolam, the lab also detected the presence of nordiazepam, the metabolite of diazepam, as well as the presence of oxazepam, and temazepam. Id. With respect to the presence of the latter three drugs, the lab reported that these three results were ‘‘not expected with prescribed medications.’’ Id. Of further note, the lab report bears the handwritten but undated notation: ‘‘Pt counseled to only take what is prescribed[.]’’ Id. Dr. Owen testified that while ‘‘oxazepam can be a metabolite of several other benzodiazepines,’’ this was an aberrant drug test because nonprescribed drugs were detected and prescribed drugs were not detected. Tr. 150–51. As for the drugs that were detected but were not prescribed, Dr. Owen testified that B.B. was either ‘‘getting [them] from the illicit . . . market or from a friend.’’ Id. at 151. As for the morphine, which was prescribed E:\FR\FM\23MRN2.SGM 23MRN2 srobinson on DSK5SPTVN1PROD with NOTICES2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices but not detected, Dr. Owen explained that ‘‘[e]ither [B.B. was] selling it on the street or he self-escalated and ran out of his supply.’’ Id. Regarding this visit, Dr. Owen testified that when a patient reports having gone to the emergency room, he would get the record to find out both ‘‘what the problem was,’’ as well as if ‘‘any additional medication [was] prescribed.’’ Tr. 147. However, the patient file does not contain a note from the emergency room. Id.; see also GX 3. Moreover, after observing that the visit note contains no mention that Respondent addressed either of the two prior urine screens during this visit, Dr. Owen again testified that Respondent had failed to establish medical necessity for the prescriptions ‘‘by doing a proper history and physical exam, by defining a therapeutic benefit, by explaining what previous treatments have or have not worked . . . and . . . addressing the previous aberrant urine drug tests.’’ Id. at 148. Thus, Dr. Owen opined that Respondent acted outside of the usual course of professional practice in issuing the prescriptions and that the prescriptions lacked a legitimate medical purpose. Id. Regarding the prescriptions, Respondent testified that B.B. wanted refills and then testified as to what he had documented in the note. Id. at 313. Asked by his counsel if B.B. had ‘‘ask[ed] for anything different or call[ed] for additional drugs when he went to the ER,’’ Respondent testified that ‘‘[t]here was nothing on his PMP that revealed they prescribed anything,’’ a fact confirmed by the PMP. Id. at 314; GX 3, at 23. Observing that the visit note ‘‘almost seems as if [B.B.] would be a person that’s not in pain,’’ the CALJ asked: ‘‘doesn’t it seem like an unremarkable set of . . . notes for such a high amount of painkillers?’’ Tr. 315. Respondent answered: ‘‘He just continued to have the same pain that he had before, so I didn’t go into details on it.’’ Id. The CALJ then asked: ‘‘doesn’t it seem like kind of an unremarkable set of notes for somebody that’s on a lot of heavy medications?’’ Id. Respondent answered that he ‘‘agree[d]’’ and added that ‘‘I can only conjecture at this point as to what was going on, but I imagine I was more concerned about the fact he had went to the emergency room and making sure he didn’t get other medicine’’ and ‘‘less concentrated on his chronic pain.’’ Id. at 316. The CALJ then commented that ‘‘the notes do seem very benign’’ and asked ‘‘if that seemed normal to’’ him? Id. at 316–17. Respondent answered that ‘‘[i]t stands out that I didn’t make more.’’ Id. at 317. Respondent then VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 maintained that he ‘‘was seeing 40 to 45 patients a day and dictating that night and the next morning, and so I definitely could have done a better job.’’ Id. Continuing, Respondent testified that he thought that at this visit, B.B. ‘‘wasn’t requesting any more or any change in his pain medicines’’ and ‘‘wasn’t reporting anything except his calf pain and his new conditions.’’ Id. At this point, Respondent’s attorney suggested that he had noted ‘‘his lumbar disc disease and ‘‘low back paraspinal tenderness’’ in the visit note, prompting Respondent to state: ‘‘[t]hat’s correct. And he still had the negative straight leg raise.’’ Id. at 317–18. Respondent then conceded that his finding of a negative straight leg raise was an indicator that B.B.’s back issues were not causing radiculopathy in his legs. Id. at 318. However, Respondent maintained that ‘‘a negative straight leg raise doesn’t mean they [sic] don’t have significant pain when you raise their [sic] leg,’’ and that ‘‘if you raise their [sic] foot when they’re [sic] laying in a supine, they [sic] flinch back.’’ Id. Respondent did not, however, document this in the progress note for this visit, nor did he document as he had at the last visit that ‘‘lying down and sitting up cause [a] lot of pain.’’ Compare GX 3, at 46, with id. at 45. Moreover, when the CALJ asked if ‘‘[t]his note was more saying . . . that he’s still maintaining an absence of at least an objective sign of radiculopathy,’’ Respondent answered: ‘‘[o]f radiculopathy, but not necessarily paraspinal or muscular-skeletal pain.’’ Tr. at 318–19. Upon further questioning by the CALJ as to his reason for noting the negative straight leg raise, Respondent agreed with the CALJ’s suggestion that the reason for the note was to ‘‘more or less show that things [weren’t] getting worse’’ and then added that ‘‘there was no change.’’ Id. at 319. Yet, at this visit, Respondent neither documented that B.B. had achieved his treatment objective nor indicated if he had completed an update pain scale on the Treatment Plan form. See GX 3, at 28. Respondent did not document if B.B. was achieving his treatment objective and had completed an updated pain scale until his January 27, 2015 visit, when Respondent wrote ‘‘fair’’ in the block for ‘‘Has patient achieved treatment objective?’’ and either the number 3 or 7 in the block for ‘‘Patient Completed Updated Pain Scale’’ on the Treatment Plan form.28 Id. On the same 28 Indeed, the writing bears a strong semblance to the number 3 as written by Respondent in listing his registration number (BP2423440) on various prescriptions. Compare GX 3, at 28, with GX 5, at 23; see also GX 1, at 1. PO 00000 Frm 00017 Fmt 4701 Sfmt 4703 14959 date, Respondent also wrote ‘‘no’’ in the block for whether he considered referring B.B. for a second opinion or further treatment options. Id. According to the progress note for the January 27 visit, B.B. reported that he was ‘‘very anxious’’ about the price of the vaccine for HPV. GX 3, at 44. Respondent also documented that B.B.’s ‘‘[p]ast medical history [was] extensively reviewed and placed in chart and includes severe thoracic and lumbar pain.’’ Id. And in the physical exam section of the note, Respondent noted ‘‘low back paraspinal and spinal tenderness’’ and ‘‘[q]uestionable straight leg raise.’’ Id. He also noted ‘‘[n]euro intact.’’ Id. Respondent did not, however, prescribe any controlled substances on this date. See id.; see also id. at 22–23 (PMP Report). The CALJ also asked Respondent whether he thought the Jan. 27 visit note looked ‘‘very benign’’ if he was ‘‘really evaluating’’ the ‘‘efficacy of the pain [medication] regimen’’ as it only referred to B.B.’s ‘‘past history’’ of thoracic and lumbar pain. Id. at 323. Respondent answered that even if he ‘‘was seeing someone for something other than their [sic] pain management and not writing prescriptions that day,’’ he would ‘‘acknowledge the fact that that was still underlying’’ and ‘‘reflect[] [that] in the note,’’ so that it did not ‘‘appear[] that he has no pain in between’’ the visits. Id. at 324. The CALJ, explaining that the progress note did not ‘‘seem to discuss at all the underlying basis for the pain [medication] regimen’’ or the ‘‘activities of daily living or . . . function,’’ asked Respondent if ‘‘those [are] things that you would ordinarily include in there?’’ Id. at 324. Respondent answered that ‘‘[i]n the individual’s subjective—or the SOAP notes, a lot of times those would be neglected. With time constraints, I’m not necessarily efficient. That’s not ideal I guess is what I’d say.’’ Id. Continuing, Respondent testified: ‘‘But this patient had been disabled on Social Security and determined previously to have chronic pain and . . . objective data confirmed that. He was not doing anything to set off alarms with his PMP, doctor-shopping or changing his medications. He was stable on his medicines at that point.’’ Id. Respondent then maintained that B.B. ‘‘was one of our low-flyers’’ compared to other patients and because ‘‘[h]e wasn’t increasing his pain med [and] not asking for increased pain medicines . . . I guess [he] got less individualized SOAP notes.’’ Id. at 325. Observing that the visit notes ‘‘don’t tend to deal with activities of daily living or anything where you were E:\FR\FM\23MRN2.SGM 23MRN2 14960 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices measuring how well the treatment objectives are being attained,’’ the CALJ asked Respondent how he evaluated ‘‘how well you’re doing in treating the patient with . . . pain medications?’’ Id. at 325–26. Respondent testified that: [t]he notes could be much more well written. Much more went on in the office than what’s written. And it’s been pointed out here that if it’s not written it didn’t occur. That doesn’t mean it didn’t occur. It means I can’t prove it. But I definitely knew what was going on in his life from each visit, and I just failed to dictate that. Id. at 326. Subsequently, the CALJ asked Respondent how he knew ‘‘how the meds were doing?’’ Id. at 327. Respondent answered: ‘‘Pure subjective, and if they were needing more or less pain meds. That’s all I —.’’ Id. The CALJ then asked Respondent if he was not asking B.B. ‘‘questions about what activities he’s doing or what’s better or worse or what’s causing him pain, then aren’t you just depending on his subjective desire for more or less pain medicine?’’ Id. Respondent replied: Well, I was talking to him about those things and what all he did in a day, and he was not able to work. He . . . didn’t have a vehicle, I don’t believe. I think that was a major issue for how he got his prescriptions or not. And so he basically was stuck in the house all day, trying to figure out how to stretch or how to do his exercises at home— he was pretty much homebound, taking care of his son. srobinson on DSK5SPTVN1PROD with NOTICES2 Id. The February 13, 2012 Prescriptions On February 13, 2012, Respondent issued B.B. new prescriptions for both 120 Opana 10 and 90 Morphine Sulfate ER 15, with the same dosing instructions as the previous prescriptions. GX 5, at 3 & 23. As noted previously, the lab reported the results of the January 19, 2016 urine drug test on January 31, 2012, GX 3, at 97; and thus Respondent should have had the results by this date. Tr. 153. As explained previously, other than the undated notation on the Lab Report that B.B. was ‘‘counseled to only take what is prescribed,’’ the only documentation in the progress notes for this date (which is written at the bottom of the January 27, 2012 progress note) is the following: ‘‘Zpack, Prednisone 10 mg # 28, Phenergan.’’ GX 3, at 44. Dr. Owen testified that there should have been an office visit ‘‘in light of the previous aberrant drug-taking behaviors and the lack of medical necessity [having been] established to treat with controlled substances.’’ Tr. 154. He further explained that Respondent ‘‘need[ed] to establish medical necessity VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 and establish a therapeutic benefit, and now we have another aberrant drug test in late January.’’ Id. While he acknowledged that Respondent documented that he counseled B.B. to take only what is prescribed, Dr. Owen testified that this was not an adequate safeguard to prevent abuse or diversion, ‘‘especially since this [was] the third aberrant urine drug test.’’ Id. Asked what Respondent should have done, Dr. Owen testified that ‘‘you need to have a long discussion with the patient about the risk of addiction 29 and get some consultations by experts in [the] field of addiction.’’ Id. at 155. Based on the absence of any such documentation in the file, see generally GX 3, and that Respondent never claimed to have obtained any consultations, I find Respondent did not obtain a consultation with an expert in addiction. Moreover, Dr. Owen again found that the patient record did not justify the prescribing of controlled substances and further noted that the ‘‘medical necessity for the prescriptions ha[d] not been established in any of the previous evaluations.’’ Tr. 155. He further opined that the Opana and morphine prescriptions issued on this date lacked a legitimate medical purpose and were issued outside of the usual course of professional practice. Id. at 155–56. Respondent testified that he had reviewed the drug test results and had directed his staff to pull a PMP report. Id. at 335. He also acknowledged having written the notation that ‘‘patient was counseled to only take what is prescribed.’’ Id. Asked by his counsel if ‘‘red flags [were] raised by these test results,’’ Respondent answered: [t]he red flag that I saw—the morphine said not detected, but the oxymorphone was positive, so that was explainable. The nordiazepam, the oxazepam, and then the Xanax, the lab always said that if . . . Xanax was positive, that they could all three be positive. The temazepam, in our practice, usually didn’t show up, and temazepam is a sleeping pill called Restoril. And so I wanted to pull the chart, and so Dr. Schoelen didn’t mind his pain patients being on Restoril. I did, and so I wanted to make sure, has he been prescribed Restoril. I couldn’t find it on the PMP, so I’m sure what was told was, if you have an old Restoril or some other doctor, I do consider that breaking our rules, and so you can’t take it. Id. at 335–36. Notably, while the PMP report shows that B.B. had received a number of prescriptions for Ambien (zolpidem), it 29 Dr. Owen was not asked to provide details as to what specific areas would be discussed in such a conversation. PO 00000 Frm 00018 Fmt 4701 Sfmt 4703 does not list any prescriptions for temazepam. GX 3, at 22–26. Nor do the progress notes during the period in which B.B. was being treated by Dr. Schoelen contain any indication that Schoelen had prescribed temazepam to B.B. Id. at 50–62. And Respondent offered no testimony that he ever asked B.B. from whom he obtained the Restoril, and the chart contains no documentation that he did. In any event, even if the lab had told Respondent that using alprazolam could also trigger false positives for diazepam and oxazepam, this was still an aberrational result and was, in fact, the third aberrational UDS that B.B. had provided in less than eight months. Asked by the CALJ why he did not find the non-detection of morphine to be ‘‘an anomaly,’’ Respondent asserted that this was because oxymorphone is a metabolite of the former. Id. at 336. When then asked ‘‘[w]hy wouldn’t it show morphine positive then if the person’s on morphine,’’ Respondent testified ‘‘[t]hat would occur occasionally.’’ Id. Respondent then speculated that B.B. ‘‘probably did not take two medications on that day. Most likely it was over the 30 days since his last prescription, but it was still in his system, that it had been taken recently.’’ Id. Respondent then asserted that ‘‘[t]he same is true, the exact same thing for the carisoprodol, which is Soma. It’s on the next page, page 98 [of the Exhibit], shows that meprobamate was positive’’ and ‘‘the comments section says, ‘Test result is expected based on prescribed medications.’’’ Id. at 337. It is true that meprobamate is a metabolite of carisoprodol—as noted by the lab itself on the reports. See GX 3, at 96–98, 100, 104; see also 76 FR at 77340 (carisoprodol scheduling order). Moreover, when B.B. was under Dr. Schoelen’s care and being prescribed hydrocodone, the lab reports noted that B.B. had tested positive for hydromorphone and that this drug ‘‘is a metabolite of hydrocodone,’’ thus rendering the test result ‘‘expected with [the] prescribed medications.’’ See id. at 99, 103, 104, 105, 106. Unexplained by Respondent is why, if oxymorphone is a metabolite of morphine, the lab did not indicate that on the reports as it did when it noted that meprobamate and hydromorphone were metabolites of carisoprodol and hydrocodone respectively. Of further note, Respondent did not testify as to his basis of knowledge for this assertion. However, as found above, B.B. had last obtained a morphine prescription on December 15, 2011, 35 days before the January 19 visit, and if taken as directed, B.B. would have run out of his E:\FR\FM\23MRN2.SGM 23MRN2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices morphine five days earlier. GX 3, at 23. The Government produced no evidence as to how long morphine at this dosing would still be detectable in urine after it was last taken. Nonetheless, based on the presence of temazepam which was not prescribed, the January 19 drug test was still aberrational. The March 13, 2012 Prescriptions On March 13, 2012, Respondent issued B.B. new prescriptions for both 120 Opana 10 and 90 Morphine Sulfate ER 15, with the same dosing instructions as the previous prescriptions. See GX 5, at 10, 24. Respondent issued the prescriptions without requiring an office visit by B.B. Tr. 156, see generally GX 3, at 42–62 (visit notes for B.B.). Nor is there any notation on any of the visit notes regarding Respondent’s issuance of these prescriptions.30 Dr. Owen testified that Respondent should have required an office before issuing these prescriptions, reiterating that the ‘‘medical necessity for’’ the prescriptions still had not been established. Tr. 156. Asked to again identify the deficiencies which led him to conclude that Respondent had not established medical necessity, Dr. Owen explained: srobinson on DSK5SPTVN1PROD with NOTICES2 Reviewing all the pertinent previous medical records, including what previous treatments have been performed, an adequate history and physical exam, consultations as medically appropriate, establishing a clinically meaningful and objective therapeutic benefit, and addressing any aberrant drug-taking behaviors. Id. at 157. Dr. Owen then noted that there were three previous incidents of aberrant drug-taking behaviors, and that ‘‘[t]he only treatment plan has been continuing the controlled substances without medical necessity.’’ Id. at 158. And once again, Dr. Owen testified that the prescriptions lacked a legitimate medical purpose and ‘‘were not’’ issued in the usual course of professional practice. Id. In his direct testimony, Respondent did not address his reasons for issuing the March 13 Opana and morphine prescriptions. See Tr. at 338–39. Instead, the questioning centered on why he wrote a prescription on March 14 for Nexium, ‘‘a stomach medicine’’ and a non-controlled drug (‘‘I have no idea’’) after which the questioning 30 As found above, on the January 27, 2012 visit note, Respondent had written that on ‘‘2/13/12’’ he prescribed ‘‘Zpack, Prednisone 10 mg # 28, Phenergan.’’ GX 3, at 44. The same visit note contains a further entry for ‘‘2–22–12’’ documenting the issuance of a prescription for 60 tablets of Soma (carisoprodol) 350 mg. Id. VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 moved on to the next set of prescriptions. Id. The April 12, 2012 Visit and Prescriptions On April 12, 2012, B.B. saw Respondent for an office visit. GX 3, at 42. According to the visit note, B.B. ‘‘report[ed] his pain has been worse,’’ that ‘‘[h]e has run out of his medicines; he had them stolen,’’ and that ‘‘[h]e has done fairly well.’’ Id. Moreover, on the Treatment Objective Evaluation section of the Treatment Plan, Respondent wrote ‘‘fair → yes’’ in the block for ‘‘Has patient achieved treatment objective?’’ and ‘‘6’’ in the block for ‘‘Patient Completed . . . updated pain scale.’’ Id. at 28. In the visit note, Respondent wrote that B.B. ‘‘still has severe anxiety and depression’’ and has been ‘‘exposed to someone with HPV’’; Respondent then wrote: ‘‘[h]e is also wanting to switch his medicines because he is having trouble finding the OPANA.’’ GX 3, at 42. Respondent also noted: ‘‘[p]ast medical history extensively reviewed and placed in chart.’’ Id. In his exam findings, Respondent noted ‘‘[l]ow back paraspinal and spinal tenderness,’’ ‘‘[n]egative straight leg raise,’’ and ‘‘[n]euro intact.’’ Id. Respondent listed his diagnoses as ‘‘[l]umber disc disease,’’ ‘‘[a]nxiety and depression’’ and ‘‘[e]xposure to infectious disease,’’ although he ‘‘doubt[ed] that it was HPV.’’ Id. Respondent then changed B.B.’s medications to Opana ER (extended release) 20 mg b.i.d. (twice per day) and Percocet 10 mg (q. 12h) p.r.n. (as needed) for acute pain. Id.; see also Tr. 340. He also prescribed Soma (carisoprodol) one tablet b.i.d. GX 3, at 42. Respondent further documented that he discussed the ‘‘[a]ddictive, dependence, and tolerance nature of the medicines, as well as alternatives.’’ Id. He noted that he ‘‘suggested’’ ‘‘[n]onmedicinal pain and anxiety-relieving modalities.’’ Id. Respondent also required B.B. to undergo a urine drug screen. While the preliminary screen shows that B.B. tested positive for oxycodone (which had not been prescribed to him) and negative for opiates/morphine (which he had been prescribed), the line on the form for noting the oxycodone result includes the parenthetical ‘‘synthetic & semi-synthetic opiates’’ and the form contains no separate entry for oxymorphone, which is a semi-synthetic narcotic. GX 3, at 63. Notably, the Government produced no evidence as to whether a positive result for oxymorphone would show up as PO 00000 Frm 00019 Fmt 4701 Sfmt 4703 14961 positive for oxycodone or as positive for ‘‘opiates/morphine.’’ Moreover, Dr. Owen acknowledged that there are reliability issues with this type of test and thus, ‘‘you would send it off for a confirmatory mass spectroscopy test.’’ Tr. 164. However, according to Dr. Owen, the results are still valid until the confirmation shows otherwise. Id. Respondent did send B.B.’s. urine sample to the lab for further testing. GX 3, at 96. According to the lab report, which was reported back to Respondent on April 17, 2012, B.B. tested positive for oxymorphone, which was expected based on Respondent’s having prescribed Opana to him. Id. He also tested positive for meprobamate, which was expected based on Respondent’s having prescribed carisoprodol to B.B. Id. However, the lab further found that morphine was ‘‘not detected,’’ a result which was ‘‘not expected’’ because Respondent had prescribed morphine sulfate ER to B.B. on March 13, 2012. Id. Dr. Owen also noted that while ‘‘the confirmed . . . drug test [was] positive for some of these drugs,’’ Respondent had reported that he had run out of his medicines and that there was a ‘‘lack of documentation of what he ran out of and what he should still be on, so . . . there’s problems in interpreting this urine drug test.’’ Tr. 167. Dr. Owen testified that Respondent did not address the aberrant preliminary drug screen conducted on April 12 nor any of the previous aberrant drugs tests at this visit. Id. at 165–66. However, as found above, on the January drug test report, Respondent did note—but without specifying the date that he did so—that he had counseled B.B. to take only what was prescribed. The Government also asked Dr. Owen if it was noteworthy that B.B. had told Respondent that his pain was worse, that he had run out of his medicines and had them stolen. Id. at 159. Dr. Owen answered: Well, one, his pain is worse, so why is it worse? Two is he’s run out of his medications, and then he had them stolen. What is it? Did you run out of them because you self-escalated, or were they stolen and you ran out of them? It needs clarification. But either event, self-escalation or having them stolen, is a red flag. Id. Dr. Owen then noted that B.B.’s pain contract stated that ‘‘lost and stolen medications will not be replaced,’’ id. at 160, but acknowledged on crossexamination that Respondent had not provided an early refill of the prescriptions. Id. at 200. However, regarding B.B.’s report that his medications were stolen, Dr. Owen further testified that because there had E:\FR\FM\23MRN2.SGM 23MRN2 srobinson on DSK5SPTVN1PROD with NOTICES2 14962 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices ‘‘been the aberrant urine drug tests before . . . this, there is [sic] enough aberrant behaviors that’’ Respondent needed ‘‘to get the person to an addictionologist or a psychologist, or just stop prescribing these controlled substances since there’s no evidence they’re helping this gentleman.’’ Id. at 212–13. Dr. Owen also found problematic the notations in the visit note that B.B. reported that ‘‘his pain has been worse’’ and that ‘‘[h]e has done fairly well.’’ Id. at 160. As Dr. Owen testified, the statement that ‘‘[h]e has done fairly well . . . kind of conflicts with his pain is worse and the aberrant drug-taking behavior, so that’s an unreliable statement.’’ Id. Dr. Owen also explained that B.B.’s having ‘‘severe anxiety and depression . . . are relative contraindications to prescribing controlled substances . . . [b]ecause it magnifies [the] perception of pain and disability.’’ Id. Dr. Owen then testified that because of these conditions, Respondent should have requested a ‘‘consultation by a psychologist’’ but did not. Id. at 160–61. Dr. Owen further testified that Respondent ‘‘did not’’ address B.B.’s ‘‘ongoing stress and anxiety issues,’’ and that ‘‘[h]e did not’’ conduct a thorough patient history. Id. at 166. He then testified that Respondent had changed B.B.’s treatment plan by adding Percocet, but that Respondent ‘‘change[d] the medications without ever . . . documenting [a] medical rationale to add any new medication.’’ Id. Asked by the CALJ ‘‘why would someone add Percocet,’’ Dr. Owen testified that it is a short-acting opioid that could be added ‘‘for break-through pain, if that’s not being controlled well.’’ Id. at 167. With respect to Respondent’s notation that he had discussed ‘‘[a]ddictive dependency and tolerance nature of these medications as well as alternatives,’’ id. at 167, Dr. Owen noted that ‘‘there’s no real substance to that statement’’ as a statement of informed consent. Id. at 168. He then explained that the statement ‘‘[l]acks any details about what alternative treatments were discussed, and . . . B.B.’s already demonstrated several aberrant drugtaking behaviors.’’ Id. Continuing, Dr. Owen explained that ‘‘[t]he potential of addiction is very high in this individual, and I think you just can’t say something as generic as this statement and [not] have any meaningful documentation behind it.’’ Id. Dr. Owen was also asked about entries in a PMP report in B.B.’s file which showed the controlled substance prescriptions he obtained and filled VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 from April 12, 2011 through April 11, 2012. Tr. 170–72. The report showed that on March 14, 2012, B.B. had obtained and filled a prescription from another provider (R.H.) for 60 alprazolam 1 mg, which was a 30-day supply and that on April 6, 2012, he had obtained and filled another prescription from R.H. for 30 alprazolam 1 mg. Id. at 170–71. Dr. Owen testified that this was an early refill, as the March 14 prescriptions should have lasted until approximately the middle of April. Id. at 171. According to Dr. Owen, this ‘‘could represent [that] the person is self-escalating their medications.’’ 31 Id. Dr. Owen testified that Respondent should have addressed the early refills because although he did ‘‘not prescrib[e] this drug, it is a reflection of B.B.’s ability to self-regulate his controlled substance use.’’ Id. at 172. However, Dr. Owen then testified that an early refill does not necessarily mean that B.B. was abusing his medication if it was ‘‘a onetime situation.’’ Id. While Dr. Owen testified that ‘‘if you’re prescribing, you might call the treating doctor that is prescribing and get clarification. But when you have a pattern of early refills, it’s hard to explain that the office is closed for a holiday or a weekend and that justifying the medical necessity to prescribe early.’’ Id. at 172–73. However, given that the alprazolam prescription issued on February 15 was at most three days early and the March 14 prescription was at most two days early, the evidence does not establish a pattern of early refills but only a single early refill. Thus, I place no weight on Respondent’s failure to contact Dr. R.H. regarding the alprazolam refills. Continuing, Dr. Owen reiterated his earlier testimony that the patient record was ‘‘not adequate’’ to establish ‘‘medical necessity’’ for prescribing the controlled substances on this date and that between September 22, 2011 (when he assumed the care of B.B.) and April 12, 2012, Respondent had not established medical necessity for the drugs. Id. at 173–74. He then opined that the prescriptions Respondent 31 The Government attempted to make the same point with respect to the alprazolam prescriptions issued by R.H. on February 15 and March 14, 2012 and filled by B.B. the same day. Tr. 171; see also GX 3, at 22. However, 2012 was a leap year, and thus, the March 14 prescription was filled 28 days after the February 15 prescription, rendering it only two days early. The Government also attempted to establish that the February 15 prescription was an early refill, because B.B. had obtained a refill of alprazolam on January 20, 2012, thus rendering the February 15 prescription four days early. Tr. 171– 72; see also GX 3, at 22–23. As for the latter prescription, according to the calendar for February 2012, February 19 was a Sunday and there is no evidence as to whether the practice was open on February 18. PO 00000 Frm 00020 Fmt 4701 Sfmt 4703 issued at this visit were issued outside of the usual course of professional practice and lacked a legitimate medical purpose. Id. at 174. Regarding the April 12 visit, Respondent testified that B.B. ‘‘said he perceived [his] treatment objective was fair’’ and that ‘‘[t]here’s a ‘yes’ this time instead of just fair.’’ Id. at 339. Asked by his counsel if B.B. was able to work at that point, Respondent answered ‘‘[n]o’’ and that ‘‘[h]e ha[d] not worked any at that point.’’ Id. at 353. When then asked why he wrote ‘‘yes’’ there, Respondent testified that he did not recall. Id. Respondent also testified that ‘‘[h]is pain had gone from a 7 in January to a 6.’’ Id. at 339. Later, he testified that ‘‘[m]y subjective said his pain was worse, but it was a 6, and my last note said it was a 7.’’ Id. at 353. Respondent then asserted that B.B.’s pain rating ‘‘was still above the 4 to 5 [that] the Joint Commission says . . . needs to be addressed.’’ 32 Id. Respondent further testified that he had not replaced the stolen medication. Id. at 341. As for how B.B. had managed after his medications were stolen, Respondent testified that while ‘‘the notes don’t necessarily reflect it . . . he had a family member, and I don’t remember who it was, but someone had held some pain medicines for him, and he was trying to stretch them out to make sure that he didn’t run out.’’ Id. Continuing, Respondent asserted that B.B. did this ‘‘[b]ecause he knew how important his drug screen would be positive, and so he always kept some medicine back’’ by placing it in ‘‘an old bottle.’’ Id. At this point, the CALJ interjected that he did not ‘‘understand this, because if a person says that my medicines were stolen, the medicines are going to be gone’’ and ‘‘they won’t have medicines to keep taking them.’’ Id. at 342. After Respondent acknowledged that he ‘‘tell[s] stories,’’ he explained that the more he ‘‘did pain medicine, the more [he] found out there is such a culture, everyone wanting their pain medicines . . . that many of them keep them in a separate bottle . . . for safety’’ and ‘‘keep a stash in a different place’’ from their other prescriptions. Id. Then asked by the CALJ if it made sense that B.B. reported that his drugs were stolen but stretched them out, Respondent answered that it 32 Respondent also testified as to the contents of the visit note, largely reading into the record what the notes contained. However, he noted, inter alia, that B.B. had ‘‘reported subjectively . . . that his pain had been a little worse,’’ as well as that his straight leg raise was now negative and not ‘‘questionable’’ as he noted at the previous visit. Id. at 340. E:\FR\FM\23MRN2.SGM 23MRN2 srobinson on DSK5SPTVN1PROD with NOTICES2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices did because he knew that ‘‘most of my patients keep extra pills or keep them in a different place’’ in their house. Id. at 343. In his testimony, Respondent agreed with the CALJ that he preferred prescribing extended release drugs, and that these formulations require a patient ‘‘to keep a certain amount in [his] system so that [he] would have relief from [his] pain’’ and be able ‘‘to engage in the [ ] activities of daily living.’’ Id. at 344–45. The CALJ then asked: ‘‘doesn’t it seem to you unusual that a person would be keeping some of those back?’’ Id. at 345. Respondent testified that ‘‘[i]t would have before I started doing pain management.’’ Id. Continuing, he maintained that ‘‘[i]t’s very common that [patients] keep a stash of their medicines in an old bottle or take some with them, because they are absolutely paranoid of having their medicine stolen, and it is such a common thing for drug seekers, and basically the medicines are highly sought after, even amongst their family members.’’ Id. Respondent then maintained that ‘‘[m]any of them have lockboxes in their house, where they actually have their pills. . . . And so it’s not unusual in my practice at all for patients to keep a separate container of their medicine.’’ Id. Respondent offered no explanation as to how a patient could forgo taking extended release medication to create ‘‘a stash’’ while still managing his pain. In any event, Respondent offered no evidence that he even asked B.B. when the purported theft had occurred, which drugs had been stolen, and when B.B. had last taken the drugs he prescribed. As for why he changed B.B.’s medication, Respondent testified that ‘‘Opana was very difficult to get in some of the pharmacies’’ as some of the pharmacies ‘‘couldn’t get it from their suppliers’’ and he had a policy of requiring patients to obtain their medications at a single pharmacy. Id. at 346–47. Respondent was then asked by his counsel: ‘‘so the Percocet took the place of what?’’ Id. at 347. Respondent answered: ‘‘I used the Opana ER, because he had had good luck with the Opana short-acting, so I swapped him and used the Opana ER’’ as it was on Medicaid formulary and easier to obtain because ‘‘it was very, very expensive’’ and ‘‘didn’t have a supply problem, because people on the street or privatepay people couldn’t pay for it.’’ Id. Respondent then explained that he ‘‘changed [B.B.] off the long morphine to Percocet . . . [b]ecause I wanted another . . . short-acting . . . for his break-through’’ pain. Id. Respondent testified that he wrote only for a two- VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 week supply of the medications. Id. at 348–49. While Respondent acknowledged that ‘‘having chronic pain [can] lead to worse anxiety and depression’’ as well as that ‘‘uncontrolled anxiety or depression [can] lead [ ] to more pain,’’ id. at 409, he admitted that he never consulted with the mental health providers that B.B. was seeing. Id. at 408. Asked by the CALJ whether it was ‘‘within the standard of care’’ for him and B.B.’s mental health provider to have ‘‘ke[pt] treating [B.B.] without talking to each other,’’ Respondent answered that ‘‘[t]he mental health providers are very good about speaking to us about patients.’’ Id. at 409. Then asked by the CALJ ‘‘[h]ow about the other way around,’’ Respondent answered: ‘‘[i]f you felt it was necessary, you could report on information, I’m sure.’’ Id. Continuing, the CALJ asked Respondent if ‘‘a mental health provider [is] prescribing controlled substances simultaneously with you, ordinarily will you consult with the mental health provider?’’ Id. Respondent answered: We’ve become quite reliant on the PMPs now. Before the PMP, there was quite a bit of cross-talk, because you would get pharmacists [who] would call you and say, did you know that they’re [sic] seeing so and so, or they’re [sic] taking this, that or the other. And so there was much more of a need to try and get ahold [sic] of them. But we’ve become very reliant on the PMPs now to track that. Id. at 409–10. The CALJ then asked Respondent ‘‘if two practitioners are simultaneously providing controlled substances [to] the same patient, wouldn’t the two practitioners talk to each other about [that] approach?’’ Id. at 410. Respondent answered: ‘‘Absolutely. In every other field but mental health we do do that, and actually we don’t treat the same— we don’t treat with pain medication any patient that’s seeing another doctor for pain. We don’t go and side talk at all.’’ Id. This answer prompted the CALJ to ask: ‘‘but with a mental health practitioner, if that practitioner is also prescribing controlled substances, you wouldn’t consult with them and—or ask anything about that patient?’’ Id. Respondent testified: ‘‘[t]hat doesn’t happen very often.’’ Id. Indeed, notwithstanding that on the date of B.B.’s first visit to Respondent’s clinic, he identified Wellbutrin and alprazolam as drugs which he was either then taking or had recently used, see GX 3, at 5; there is no evidence that Respondent (or Dr. Schoelen) ever discussed B.B.’s psychiatric issues with PO 00000 Frm 00021 Fmt 4701 Sfmt 4703 14963 his mental health providers. See generally GX 3. The April 25 Prescriptions On April 25, 2012, Respondent provided B.B. with a prescription for 30 Roxicodone (oxycodone) 15 mg. GX 5, at 4. B.B.’s file contains no documentation that there was an office visit, and notwithstanding that this was a change in medication from what Respondent had prescribed at the previous visit, there is no notation in the progress notes as to why he changed the prescription. See generally GX 3; see also Tr. 174–75. Moreover, while Respondent testified that he would ‘‘routinely’’ make an entry in the Treatment Objective Evaluation section of the Pain Management Treatment Plan ‘‘if we were making a change in a medication,’’ Tr. 357, no such entry was made on this date. See GX 3, at 28. Nor is there any documentation in the patient file that Respondent addressed with B.B. the aberrant drug test result (the non-detection of morphine) which had been reported to him on April 17. See generally GX 3. According to Dr. Owen, when adding a new drug to a patient’s regimen of pain medications, a physician ‘‘would have to establish medical necessity with some type of note, using sound medical rationale.’’ Tr. 175. Dr. Owen further testified that making such a notation is ‘‘a standard of care, and it’s part of the documentation guidelines that are issued across every state for the most part.’’ Id. Asked if he could think of a reason why a physician ‘‘would add a drug for the first time without seeing a patient,’’ Dr. Owen answered: ‘‘No. Or at least documenting the medical rationale and establishing medical necessity.’’ Id. at 176. Dr. Owen then testified that Respondent did not take appropriate steps to establish medical necessity for the prescription, reiterating his earlier testimony that Respondent had not demonstrated that conservative care had been tried and been unsuccessful, as well as that there was a ‘‘clinically meaningful and objective therapeutic benefit from the previous use of controlled substances.’’ Id. He again opined that the prescription was not issued in the usual course of professional practice and lacked a legitimate medical purpose. Id. Regarding the Roxicodone prescription, Respondent asserted that he ‘‘was just doing a two-week trial, trying to figure out his dose, and at the time, most likely the patient didn’t have any punches on his card left, and Roxicodone is much cheaper than Percocet, and it’s the same medication.’’ Id. at 355. However, Respondent E:\FR\FM\23MRN2.SGM 23MRN2 14964 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices srobinson on DSK5SPTVN1PROD with NOTICES2 documented none of this in B.B.’s record. Nor did he explain why he failed to follow his routine of making an entry in the Treatment Objective Evaluation section of the Pain Management Treatment Plan given that he had changed B.B.’s medication. As for why he did not take any action with regard to the lab’s finding that the April 12 drug test result was negative for morphine sulfate, Respondent asserted that the result was not aberrant. Id. at 366. In addressing this prescription, Respondent offered no further explanation as to why he deemed the result not aberrant. However, with respect to the January 19 UDS lab report, which was also negative for morphine, Respondent asserted that oxymorphone is a metabolite of morphine and thus he did not consider the negative result to be aberrant. Id. at 336. He asserted this notwithstanding that with respect to other drugs such as hydrocodone and carisoprodol, the lab specifically reported when it detected the presence of metabolites of these drugs, such as hydromorphone for hydrocodone and meprobamate for carisoprodol. Yet, the lab report contains no notation that oxymorphone is a metabolite of morphine. Nor did he testify as to his basis of knowledge for this claim. Pursuant to 5 U.S.C. 556(e), I take official notice that morphine does not metabolize into oxymorphone. See Edward J. Cone, et al., Evidence that Morphine is Metabolized to Hydromorphone But Not to Oxymorphone, 32 J. Analytic Toxicology 319, 323 (2008) (finding, based on study of urine drug screens using liquid chromatography-tandem mass spectrometry conducted on 34 patients taking morphine exclusively for chronic pain, that while ‘‘hydromorphone was demonstrated to be a minor metabolite . . . no evidence was found that oxymorphone is a metabolite of morphine’’ and ‘‘that a positive urine test for oxymorphone can arise only from oxymorphone or oxycodone administration, and not from morphine or hydromorphone administration’’); id. at 319 (characterizing as ‘‘unsubstantiated’’ the ‘‘claim of a new metabolic pathway leading from morphine to hydromorphone to oxymorphone’’).33 33 Under the Administrative Procedure Act (APA), an agency ‘‘may take official notice of facts at any stage in a proceeding—even in the final decision.’’ U.S. Dept. of Justice, Attorney General’s Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an agency decision rests on official notice of a material fact not appearing in the evidence in the record, a party VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 The May 9, 2012 Prescriptions On May 9, 2012, Respondent wrote B.B. a prescription for 60 Opana ER 20 mg. GX 3, at 93; GX 5, at 27. Respondent did not require an office visit, and he made no notations in the progress notes regarding the prescription. See generally GX 3; see also Tr. 177–78. Regarding the prescription, Dr. Owen again testified that Respondent ‘‘needed to establish medical necessity for continuation of controlled substances’’ and ‘‘did not.’’ Id. at 178. Asked why he refilled the prescriptions,34 Respondent testified that ‘‘I got a phone call that he was wanting his medicines refilled and that the [R]oxicodone had worked for him and et cetera, so we were converting him back into the one-month prescriptions in the Schedules IIs and going back to this three-month office visit.’’ Tr. 356. Respondent offered no testimony addressing Dr. Owen’s criticism that he still had not established that there was a medical necessity for prescribing controlled substances, which included the Opana. See generally id. at 356–57. Asked to provide his opinion as to Respondent’s prescribing of controlled substances from September 2011 through May 9, 2012, Dr. Owen opined that Respondent did not adequately review B.B.’s medical history. Id. at 178. He further opined that a treatment plan that established medical necessity ‘‘would have logic behind the treatment’’ and would have ‘‘establish[ed] that conservative care has not been helpful and that [an] objective and clinically meaningful therapeutic benefit from the use of controlled substances has been established, if [they] ha[d] previously been used.’’ Id. Dr. Owen then testified that none of the is entitled, on timely request, to show the contrary.’’ Accordingly, Respondent may dispute my finding by filing a properly supported motion for reconsideration within 20 calendar days of the date of this Order. Any such motion shall be filed with the Office of the Administrator and a copy shall be served on the Government; in the event Respondent files a motion, the Government shall have 20 calendar days to file a response. 34 In her questioning of Respondent, his counsel referred to a Roxicodone prescription as having been issued on May 9, 2012 and in his testimony regarding the prescriptions he wrote on that date, Respondent referred to both a Roxicodone prescription and an Opana ER 20 mg prescription. Tr. 356. While GX 5 contains a legible copy of the May 9, 2012 Opana ER prescription, see GX 5, at 27, it does not contain a copy of a Roxicodone prescription, and as for GX 3, the copy of the purported Roxicodone prescription is illegible. GX 3, at 93. Because the Government failed to produce any reliable evidence to show that Respondent issued a Roxicodone prescription on May 9, 2012, I do not consider whether any such prescription was issued, nor whether Respondent complied with 21 CFR 1306.04(a) when he issued it. PO 00000 Frm 00022 Fmt 4701 Sfmt 4703 controlled substance prescriptions Respondent issued to B.B. were issued in the usual course of professional practice and for a legitimate medical purpose. Id. at 178–79. Respondent’s Evidence in Remediation Respondent offered only vague testimony that he has taken ‘‘extreme CME [continuing medical education] . . . in hospice care and pain medicine’’ in 1995 and had done some ‘‘reading’’ on pain management. Tr. 235, 381. Respondent offered no further detail as to the subject matter of the CME course[s] he took. See id. As for his assertions that he had read articles on pain management and that he kept current with those articles, he admitted that he had not ‘‘read anything in a couple of years’’ and could not recall any articles he had read on pain management. Id. at 385–86. Discussion Section 303(f) of the Controlled Substances Act (CSA) provides that ‘‘[t]he Attorney General may deny an application for [a practitioner’s] registration . . . if the Attorney General determines that the issuance of such registration . . . would be inconsistent with the public interest.’’ 21 U.S.C. 823(f). With respect to a practitioner, the Act requires the consideration of the following factors in making the public interest determination: (1) The recommendation of the appropriate State licensing board or professional disciplinary authority. (2) The applicant’s experience in dispensing . . . controlled substances. (3) The applicant’s conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances. (4) Compliance with applicable State, Federal, or local laws relating to controlled substances. (5) Such other conduct which may threaten the public health and safety. Id. ‘‘[T]hese factors are . . . considered in the disjunctive.’’ Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I ‘‘may rely on any one or a combination of factors, and may give each factor the weight [I] deem[ ] appropriate in determining whether 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 E:\FR\FM\23MRN2.SGM 23MRN2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices srobinson on DSK5SPTVN1PROD with NOTICES2 Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482)).35 The Government has the burden of proving, by a preponderance of the evidence, that the requirements for denial of an application pursuant to 21 U.S.C. 823(f) are met. 21 CFR 1301.44(d). However, once the Government has made a prima facie showing that issuing a new registration to the applicant would be inconsistent with the public interest, an applicant must then present sufficient mitigating evidence to show why he can be entrusted with a new registration. Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008) (citing cases)); see also MacKay, 664 F.3d at 817. Having considered all of the factors, I find that the Government’s evidence with respect to Factors Two and Four satisfies its prima facie burden of showing that granting Respondent’s application would be inconsistent with the public interest.36 I further find that 35 In short, this is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest; what matters is the seriousness of the registrant’s misconduct. Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has recognized, findings under a single factor can support the revocation of a registration or the denial of an application. MacKay, 664 F.3d at 821. 36 As to factor one, while the Oklahoma Board has taken disciplinary action against Respondent for conduct related to his prescribing to B.B., the Board has not made a recommendation to the Agency with respect to whether his application should be granted. To be sure, as a result of the Board’s restoration of his medical license without restriction of his controlled substance prescribing authority under Oklahoma law, Respondent satisfies the CSA’s prerequisite for obtaining a new practitioner’s registration. See 21 U.S.C. 823(f)(1); see also id.§ 802(21). (defining ‘‘the term ‘practitioner’ [to] mean[ ] a . . . physician . . . or other person licensed, registered or otherwise permitted, by . . . the jurisdiction in which he practices . . . to distribute, dispense, [or] administer . . . a controlled substance in the course of professional practice’’). However, the restoration of Respondent’s state authority is not dispositive of the public interest inquiry. See Mortimer Levin, 57 FR 8680, 8681 (1992) (‘‘[T]he Controlled Substances Act requires that the Administrator . . . make an independent determination [from that made by state officials] as to whether the granting of controlled substance privileges would be in the public interest.’’). To be sure, the Agency’s case law contains some older decisions which can be read as giving more than nominal weight in the public interest determination to a State Board’s decision (not involving a recommendation to DEA) either restoring or maintaining a practitioner’s state authority to dispense controlled substances. See, e.g., Gregory D. Owens, 67 FR 50461, 50463 (2002) (expressing agreement with ALJ’s conclusion that the board’s placing dentist on probation instead of suspending or limiting his controlled substance authority ‘‘reflects favorably upon [his] retaining his . . . [r]egistration, and upon DEA’s granting of [his] pending renewal application’’); Vincent J. Scolaro, 67 FR 42060, 42065 (2002) (concurring with ALJ’s VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 Respondent has failed to produce sufficient evidence to rebut the Government’s prima facie case. Factors Two and Four—Respondent’s Experience in Dispensing Controlled Substances and Record of Compliance With Applicable Controlled Substance Laws Under a longstanding DEA regulation, a prescription for a controlled substance is not ‘‘effective’’ unless it is ‘‘issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.’’ 21 CFR 1306.04(a). 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 ‘‘conclusion that’’ state board’s reinstatement of medical license ‘‘with restrictions’’ established that ‘‘[b]oard implicitly agrees that the [r]espondent is ready to maintain a DEA registration upon the terms set forth in’’ its order). Of note, these cases cannot be squared with the Agency’s longstanding holding that ‘‘[t]he Controlled Substances Act requires that the Administrator . . . make an independent determination [from that made by state officials] as to whether the granting of controlled substance privileges would be in the public interest.’’ Levin, 57 FR at 8681. Indeed, neither of these cases even acknowledged the existence of Levin, let alone attempted to reconcile the weight it gave the state board’s action with Levin. While in other cases, the Agency has given some weight to a Board’s action in allowing a practitioner to retain his state authority even in the absence of an express recommendation, see Tyson Quy, 78 FR 47412, 47417 (2013), the Agency has repeatedly held that a practitioner’s retention of his/her state authority is not dispositive of the public interest inquiry. See, e.g., Paul Weir Battershell, 76 FR 44359, 44366 (2011) (citing Edmund Chein, 72 FR 6580, 6590 (2007), pet. for rev. denied, Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008)). As to factor three, I acknowledge that there is no evidence that Respondent has been convicted of an offense under either federal or Oklahoma law ‘‘relating to the manufacture, distribution or dispensing of controlled substances.’’ 21 U.S.C. 823(f)(3). However, there are a number of reasons why even a person who has engaged in criminal misconduct may never have been convicted of an offense under this factor, let alone prosecuted for one. Dewey C. MacKay, 75 FR 49956, 49973 (2010), pet. for rev. denied, MacKay v. DEA, 664 F.3d at 822. The Agency has therefore held that ‘‘the absence of such a conviction is of considerably less consequence in the public interest inquiry’’ and is therefore not dispositive. Id. While I have considered factor five, I deem it unnecessary to make any findings. PO 00000 Frm 00023 Fmt 4701 Sfmt 4703 14965 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. E:\FR\FM\23MRN2.SGM 23MRN2 14966 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices srobinson on DSK5SPTVN1PROD with NOTICES2 ‘‘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 March 2005, the Oklahoma Board of Medical Licensure and Supervision issued its Policy Statement on the ‘‘Use of Controlled Substances for the Treatment of Pain.’’ Okla. Bd. of Med. Lic. & Super., Use of Controlled Substances for the Treatment of Pain (Mar. 10, 2005) (hereinafter, Policy Statement). Therein, the Board explained that it: will refer to current clinical practice guidelines and expert review in approaching cases involving management of pain. The medical management of pain should consider current clinical knowledge and scientific research and the use of pharmacological and non-pharmacological modalities according to the judgment of the physician. Pain should be assessed and treated promptly and the quantity and frequency of doses should be adjusted according to the intensity, duration of the pain and treatment outcomes. . . . . . . . The Board will consider prescribing, ordering, dispensing or administering controlled substances for pain to be for a legitimate medical purpose if based on sound clinical judgment. All such prescribing must be based on clear documentation of unrelieved pain. To be within the usual course of professional practice, a physicianpatient relationship must exist and the prescribing should be based on a diagnosis and documentation of unrelieved pain. Compliance with applicable state and/or federal law is required. The Board will judge the validity of the physician’s treatment of the patient based on available documentation, rather than solely VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 on the quantity and duration of medication administration. The goal is to control the patient’s pain while effectively addressing other aspect of the patient’s functioning, including physical, psychological, social and work-related factors.37 Id. at 1–2. Simultaneously with the issuance of its Policy Statement, the Board promulgated its regulation on the ‘‘[u]se of controlled substances for the management of chronic pain.’’ Okla. Admin. Code § 435:10–7–11. As the Board explained, its purpose was to adopt ‘‘criteria’’ to be used ‘‘when evaluating [a] physician’s treatment of pain, including the use of controlled substances.’’ Id. The regulation thus sets forth criteria for the ‘‘[e]valuation of the patient,’’ the ‘‘[t]reatment plan,’’ ‘‘[i]nformed consent and agreement for treatment,’’ ‘‘[p]eriodic review,’’ ‘‘[c]onsultation,’’ and ‘‘[m]edical records.’’ Id. With respect to the evaluation of the patient, the Rule states: A medical history and physical examination must be obtained, evaluated and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance. Id. § 435:10–7–11(1). As for the treatment plan, the Rule provides: The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment. Id. § 435:10–7–11(2). After providing the criteria for informed consent and agreement for treatment, which states, inter alia, that 37 See also Policy Statement, at 2 (‘‘Allegations of inappropriate pain management will be evaluated on an individual basis. The Board will not take disciplinary action against a physician for deviating from this policy when contemporaneous medical records document reasonable cause for deviation. The physician’s conduct will be evaluated to a great extent by the outcome of pain treatment, recognizing that some types of pain cannot be completely relieved, and by taking into account whether the drug used is appropriate for the diagnosis, as well as improvement in patient functioning and/or quality of life.’’). PO 00000 Frm 00024 Fmt 4701 Sfmt 4703 ‘‘[t]he physician should discuss the risks and benefits of the use of controlled substances with the patient,’’ id. § 435:10–7–11(3), the Rule sets forth the criteria for the periodic review. The Rule states: The physician should periodically review the course of pain treatment and any new information about the etiology of the pain or the patient’s state of health. Continuation or modification of controlled substances for pain management therapy depends on the physician’s evaluation of progress toward treatment objectives. Satisfactory response to treatment may be indicated by the patient’s decreased pain, increased level of function or improved quality of life. Objective evidence of improved or diminished function should be monitored and information from family members or other caregivers should be considered in determining the patient’s response to treatment. If the patient’s progress is unsatisfactory, the physician should assess the appropriateness of continued uses of the current treatment plan and consider the use of other therapeutic modalities. Id. § 435:10–7–11(4). With respect to consultation, the Rule provides: The physician should be willing to refer the patient, as necessary, for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those patients with pain who are at risk for medication misuse, abuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation and consultations with or referral to an expert in the management of such patients. Id. § 435:10–7–11(5). And finally, with respect to medical records, the Rule states in relevant part that ‘‘[r]ecords should remain current’’ and that ‘‘[t]he physician should keep accurate and complete records.’’ Id. § 435:10–7–11(6). The records are ‘‘to include . . . the medical history and physical examination,’’ ‘‘diagnostic, therapeutic and laboratory results,’’ ‘‘evaluations, consultations and followup evaluations,’’ ‘‘treatment objectives,’’ ‘‘discussion of risks and benefits,’’ ‘‘informed consent,’’ ‘‘treatments,’’ ‘‘medications (included date, type, dosage and quantity prescribed),’’ ‘‘instructions and agreements and periodic reviews.’’ Id. The CALJ rejected the bulk of the Government’s case, finding the allegations proven only ‘‘in part’’ and only with respect to the prescriptions Respondent issued on October 6 and 20, 2011 (prescribing events 3 and 4), April 12 and 25, and May 9, 2012 (prescribing events 10, 11, and 12). Even then, however, the CALJ reasoned that ‘‘[t]he E:\FR\FM\23MRN2.SGM 23MRN2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices srobinson on DSK5SPTVN1PROD with NOTICES2 errant prescribing events established by the record reveal inattention to detail, not intentional diversion,’’ R.D. at 82, only to subsequently conclude that ‘‘Respondent violated his responsibility . . . to ensure that he only prescribed controlled substances for a legitimate medical purpose in the course of professional practice.’’ Id. at 90 (citing 21 CFR 1306.04(a)); see also id. (‘‘[T]hese prescribing events violated Oklahoma medical regulations, fell below the prevailing medical practice standard in Oklahoma, and did not fall within the state and federal definitions of the usual course of a professional practice.’’ (citing Policy Statement, at 2; 21 CFR 1306.04(a))). I conclude, however, that the Government has proved additional violations of 21 CFR 1306.04(a) beyond those found by the CALJ, and I further conclude that the evidence does not simply reflect ‘‘inattention to detail’’ on Respondent’s part—a finding which is legally insufficient to support the conclusion that he violated 21 CFR 1306.04(a)—but rather, that he knowingly diverted drugs to B.B. I am mindful of the various credibility findings made by the CALJ, particularly with respect to the testimony of Respondent, as well as his finding that ‘‘Dr. Owen’s expert testimony predictably raised no issues regarding credibility’’ but that his ‘‘testimony was not without its own ‘red flags.’ ’’ R.D. 18. For reasons explained earlier, I respectfully disagree with the CALJ’s reasons for declining to give weight to much of Dr. Owen’s testimony, including his conclusion that Dr. Owen’s testimony was based upon a misunderstanding of the nature of the Oklahoma Board’s Pain Management Regulations. And to the extent the CALJ declined to consider the evidence of various UDS results with respect to the specific prescribing events on the ground that the Government did not provide adequate notice, as explained above, I conclude that Respondent had constitutionally sufficient notice and understood that the UDS results were at issue throughout the proceeding. The September 22, 2011 Prescriptions The CALJ rejected the Government’s allegation that the Duragesic and Opana prescriptions issued by Respondent on this date violated 21 CFR 1306.04(a) because they were issued outside of the usual course of professional practice and lacked a legitimate medical purpose.38 As found above, Dr. Owen 38 The CALJ asserted that in the Show Cause Order and its Prehearing Statement, ‘‘the Government noticed a theory based in the issuance VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 testified that because this was B.B.’s first visit with Respondent and Respondent was taking over his care, Respondent should have ‘‘do[ne] a proper history and physical exam,’’ reviewed the ‘‘previous treatments’’ and done ‘‘everything that typically is expected for a new patient evaluation.’’ Tr. 131. Dr. Owen testified that Respondent performed ‘‘a superficial of prescriptions outside the course of a professional practice under 21 CFR 1306.04(a), not that any prescriptions were not issued for a legitimate medical purpose.’’ R.D. 87–88. While then noting that ‘‘the Government did sporadically elicit testimony from its expert in this regard ([citing] Tr. 93, 123, 133–34, 137–38, 140, 144, 148, 155–56, 158, 174, 176, 179) and did espouse this theory in its closing brief,’’ the CALJ again asserted that this theory was unavailable to the Government because it raised the issue for the first time in its posthearing brief. Id. at 88 n.150 (citing Fred Samimi, 79 FR 18698, 18713 (2014)). I decline to adopt this ruling for multiple reasons. First, as several federal appeals courts have recognized, there is no material difference between the phrases ‘‘usual course of professional practice’’ and ‘‘legitimate medical purpose,’’ and thus the courts have sustained convictions for violating the regulation and 21 U.S.C. 841(a)(1), notwithstanding that an indictment charged the defendant ‘‘with dispensing of a controlled substance not in the usual course of professional practice’’ but did not allege that the dispensing lacked a legitimate medical purpose, as well as where the jury instructions only referenced the ‘‘usual course of professional practice’’ and did not require the jury to find that the defendant ‘‘dispensed without a legitimate medical purpose.’’ See United States v. Fuchs, 467 F.3d 889, 898–901 (5th Cir. 2006) (noting earlier decision that ‘‘appears to use the phrases . . . interchangeably’’). Likewise, in United States v. Nelson, 383 F.3d 1227, 1230–31 (10th Cir. 2004), the Tenth Circuit found no error in a jury instruction which provided that a physician could be convicted of conspiracy under 21 U.S.C. 846, ‘‘if it found the prescriptions were either without a legitimate purpose or outside the course of professional practice.’’ As the Tenth Circuit explained, ‘‘[i]t is difficult to imagine circumstances in which a practitioner could have prescribed controlled substances within the usual course of medical practice but without a legitimate medical purpose. Similarly, it is difficult to imagine circumstances in which a practitioner could have prescribed controlled substances with a legitimate medical purpose and yet be outside the usual course of medical practice.’’ Id. at 1231. See also United States v. Kirk, 584 F.2d, 773, 784 (6th Cir. 1978) (‘‘[T]here is no difference in the meanings of the . . . phrase, ‘[i]n the usual course of professional practice’ and the . . . phrase, ‘legitimate medical purpose.’ ’’) (citing United States v. Plesons, 560 F.2d 890, 897 (8th Cir. 1977) and United States v. Rosenberg, 515 F.2d 190, 197 (9th Cir. 1975)). Furthermore, even if these were two distinct theories for proving a violation of 21 CFR 1306.04(a), the record supports a finding of litigation by consent. The Government did not ‘‘sporadically elicit testimony from its expert’’ on this issue, but rather, asked Dr. Owen whether each of the prescriptions lacked a legitimate medical purpose. Respondent did not object to any of these questions, and thus, it is clear that unlike the issue in Samimi, which was raised for the first time by the Government in its post-hearing brief, Dr. Owen’s testimony that each of the prescriptions lacked a legitimate medical purpose was not directed at an incidental issue, but rather went to the heart of the Government’s case. PO 00000 Frm 00025 Fmt 4701 Sfmt 4703 14967 evaluation that’’ did not ‘‘adequately explain the chief complaint or what previous treatments have or have not been done.’’ Id. at 133. Dr. Owen further noted that Respondent documented that B.B. had a negative straight leg raise and that this is ‘‘the most sensitive physical finding for low back pain.’’ Id. at 190. He then explained that ‘‘a sensitive test means that if you don’t have a positive finding you don’t have that diagnosis.’’ Id. Dr. Owen also testified that there was ‘‘no evaluation of pain or function, physical or psychosocial in the documentation’’ and ‘‘no evidence of a previous therapeutic benefit’’ from the use of controlled substances,’’ nor ‘‘proof that [B.B. had] exhausted conservative care before going [to the] high-risk treatment[ ]’’ of ‘‘prescribing controlled substances.’’ Id. at 134. Dr. Owen thus concluded that because ‘‘[t]here’s no medical rationale for continuing with an ineffective treatment . . . there’s no justification to continue’’ to prescribe controlled substances. Id. at 133. Dr. Owen further testified that Respondent’s patient file contained two aberrant drug tests, the June 1, 2011 test, which did not detect alprazolam even though B.B. was obtaining the drug every 30 days, and the August 25, 2011 test, which detected the presence of nordiazepam, oxazepam, and temazepam, which the lab reported as not expected based on the prescribed medications. Dr. Owen testified that Respondent ‘‘completely ignored’’ the aberrant drug screens and that he ‘‘should have acknowledged their existence and . . . taken some type of corrective action.’’ Id. at 132. Dr. Owen then suggested that Respondent could have sent B.B. for an evaluation by an addictionologist or mental health professional (either a psychiatrist or psychologist) with experience in addiction medicine. Id. at 134. And he further testified that the patient file did not reflect that Respondent had discussed B.B. with either his current (such as the providers who were writing alprazolam prescriptions) or past prescribers (such as Dr. Schoelen). Id. at 132. Dr. Owen also noted that Respondent did not appear to have taken any safeguards against the potential for abuse or diversion. Id. The CALJ found uncontroverted Dr. Owen’s testimony that B.B. was a new patient and thus, Respondent was required to have done everything typically expected of a physician in the evaluation of a new patient, including a proper history and physical, reviewing previous treatments, and reviewing his patient file. R.D. at 33–34. The CALJ further found uncontroverted Dr. E:\FR\FM\23MRN2.SGM 23MRN2 srobinson on DSK5SPTVN1PROD with NOTICES2 14968 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices Owen’s testimony that Respondent ignored the June 1 aberrant drug screen, that there was no evidence Respondent discussed B.B. with either his current or past prescribers, and that Respondent took no precautions against the potential for abuse or diversion. Id. at 34. As for the aberrant drug tests, the CALJ asserted that ‘‘there is little doubt that the June 1 UDS is aberrant to the extent it shows that B.B. was not taking his alprazolam,’’ and that Dr. Owen’s testimony that ‘‘failing to act on this aberrant UDS fell below the prevailing standard . . . stands unrebutted [on] the record.’’ Id. at 38. The CALJ, however, declined to consider this evidence, reasoning that it was not properly noticed by the Government in its pleadings with respect to this prescribing event. Id. at 38–39. For reasons explained previously, I disagree and find that Respondent had fair notice that the June 1 aberrant UDS was at issue throughout the proceeding. Accordingly, I find that the June 1 drug test was aberrant and that Respondent breached the standard of care when he failed to address the test with B.B. prior to issuing the September 22, 2011 prescriptions. The CALJ, however, also rejected the Government’s contention that the drug test of August 25, 2011, which showed the presence of nordiazepam, oxazepam and temazepam when these drugs had not been prescribed to B.B. by either Dr. Schoelen or his mental health professional, was also aberrant and not properly considered and addressed by Respondent prior to prescribing to B.B. R.D. at 38. While Respondent testified that he did not remember if he reviewed this UDS prior to the September 22 visit or at any point, Tr. 397, in the visit note, Respondent stated that B.B.’s ‘‘[p]ast medical history was extensively reviewed.’’ GX 3, at 48. Moreover, Dr. Owen credibly testified as to the need to obtain ‘‘all . . . previous medical records pertaining to [the] chief complaint’’ and review them to determine what previous treatments had been tried and their results, as well as ‘‘to look for any previous aberrant behaviors.’’ Tr. 94. And Dr. Owen further explained that ‘‘if you don’t look at all the pertinent previous medical records, you can’t get an accurate diagnosis.’’ Id. at 117. This testimony is unrefuted. In rejecting the Government’s contention that the August 25 test was aberrant, the CALJ did not make a credibility finding as to Respondent’s testimony that he did not remember whether he reviewed the UDS at the time he was treating B.B. Nor did he VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 make an explicit finding as to whether Respondent reviewed the UDS. Instead, the CALJ reasoned that ‘‘Respondent credibly testified that, based on his professional opinion and his conversations with personnel at the testing lab, a patient taking any benzodiazepine may test positive for any other benzodiazepine[,] [and] [t]hus, the Respondent did not, and does not view the August 25 UDS as anomalous.’’ R.D. at 38 (emphasis added). After faulting the Government because it did not recall Dr. Owen ‘‘to rebut Respondent’s understanding about the limitations of the GC/MS,’’ the ALJ explained that ‘‘[t]here was nothing patently incredible about the Respondent’s recollection of his conversations with the UDS lab about the limits of its testing.’’ Id. However, if, in fact, Respondent did not review the UDSs prior to prescribing (notwithstanding the notation that he ‘‘extensively reviewed’’ B.B.’s medical history), Dr. Owen’s unrefuted testimony establishes that Respondent committed a gross breach of the standard of care in failing to do so. Of note, Respondent testified that Dr. Schoelen had instituted urine drug testing as a ‘‘safeguard’’ after Dr. Schoelen joined the American Academy of Pain Management and attended training, and that a drug test was done ‘‘every three months’’ on the clinic’s ‘‘chronic pain patients.’’ Tr. 253–55. Thus, Respondent clearly knew that B.B. had been subjected to drug testing. Moreover, if it is the case that Respondent did not review the August 25 drug test, then it is clear that Respondent’s testimony as to what he was told by the lab was not offered to show his state of mind in failing to address the aberrant test result. Rather, it was offered to prove the truth of the matter asserted—that because of crossreactions, ‘‘a patient taking any benzodiazepine may test positive for any other benzodiazepine.’’ Thus, Respondent’s testimony was hearsay which was uncorroborated by either the testimony of a lab employee, an expert in drug testing, or articles from scientific or medical journals. The CALJ did not, however, analyze the reliability of the hearsay statements recounted by Respondent.39 See R.D. at 37–40. 39 In multiple decisions, the Agency has made clear that the reliability of a hearsay statement should be evaluated by reference to the decisional law of the courts of appeals that would have jurisdiction over a subsequent petition for review; this includes the D.C. Circuit and the Tenth Circuit. As the D.C. Circuit has explained, ‘‘hearsay may constitute substantial evidence depending upon its probative value and reliability, considering inter PO 00000 Frm 00026 Fmt 4701 Sfmt 4703 Notably, in his Response to the Government’s Exceptions, Respondent does not maintain that this testimony was offered for the non-hearsay purpose of showing Respondent’s state of mind when he failed to address the August 25 drug test with B.B. Response to Exceptions, at 4–6. Indeed, in his brief, Respondent argues only that ‘‘there is no evidence that the written test results provided by . . . the drug testing company . . . are unreliable and inadmissible or that the results themselves are unreliable.’’ Id. at 5. However, neither the August 25 nor the January 19, 2012 lab reports—each of which detected the presence of nordiazepam, oxazepam, and temazepam in addition to the metabolite of alprazolam—contain any statements to the effect that because of crossreactions, taking alprazolam could result in a positive finding for the other three drugs. And as for Respondent’s contention that there is no evidence that the test results are unreliable, that is the very point made by the Government. Id. Moreover, even were I to consider Respondent’s testimony on the issue of his state of mind—which would seem to require a finding that he did see the lab alia, possible bias of the declarant, whether [the] statements are signed and sworn to, whether they are contradicted by direct testimony, whether the declarant is available, and whether the hearsay is corroborated.’’ Hoska v. Department of the Army, 677 F.2d 131, 138 (D.C. Cir. 1982) (quoted in Mireille Lalanne, 78 FR 47750, 47752 (2013)). By contrast, the Tenth Circuit does not appear to have set forth a set of factors for evaluating the reliability of hearsay in administrative proceedings. See Roach v. NTSB, 804 F.2d 1147, 1160 (10th Cir. 1986); Cf. Bennett v. NTSB, 66 F.3d 1130, 1137 (10th Cir. 1995) (declining to decide if uncorroborated hearsay can constitute substantial evidence in administrative proceeding ‘‘given the existence of ample corroborative evidence-both nonhearsay and hearsay exceptions’’); Sorenson v. NTSB, 684 F.2d 683, 686 (10th Cir. 1982) (declining to decide ‘‘whether uncorroborated hearsay can constitute substantial evidence in administrative proceedings’’). Applying the Hoska factors, I conclude that the statement is not entitled to weight. Even assuming that the lab employee who made the statement was not biased, the statement was neither signed nor sworn to, Respondent did not identify the employee by name, and Respondent did not disclose that he intended to testify to the lab’s statement in advance of the hearing notwithstanding that the CALJ’s Order for Prehearing Statements directed that Respondent was ‘‘to indicate clearly each and every matter as to which he intends to introduce evidence in opposition’’ and the summary of each witness’ testimony was ‘‘to state what the testimony will be.’’ ALJ Ex. 4, at 2. Moreover, that Order then stated ‘‘that testimony not disclosed in the prehearing statement or pursuant to subsequent rulings is likely to be excluded at the hearing.’’ Id. Given that Respondent did not disclose this testimony in advance of the hearing, I find that the declarant was not available. Moreover, as explained above, Respondent offered no other evidence to corroborate the lab’s statement and the statement was contradicted in part by Respondent’s testimony regarding the temazepam positive on the January 19 drug test. E:\FR\FM\23MRN2.SGM 23MRN2 srobinson on DSK5SPTVN1PROD with NOTICES2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices report—as ultimate factfinder, I would not give it weight. While the Agency must accord some deference to an ALJ’s findings on credibility issues where an ALJ observes the demeanor of the witness, ‘‘[t]he findings of the [ALJ] are to be considered along with the consistency and inherent probability of [the] testimony.’’ Universal Camera Corp. v. NLRB, 340 U.S. 474, 496 (1951). Of consequence, B.B.’s January 19, 2012 drug test also detected the presence (in addition to that of alphahydroxyalprazolam, the metabolite of alprazolam) of nordiazepam, oxazepam, and temazepam. GX 3, at 97. Yet on this occasion, Respondent noted on the Lab Report that he had ‘‘counseled [B.B.] to only take what is prescribed.’’ GX 3, at 97. And in his testimony regarding the January 19 drug test results, Respondent stated that he made the notation because ‘‘[t]he nordiazepam, the oxazepam, and then the Xanax, the lab always said that if . . . Xanax [alprazolam] was positive, that they could all three be positive. The temazepam, in our practice usually didn’t show up, and temazepam is [a] sleeping pill called Restoril.’’ Tr. 335; see also GX 3, at 105 (lab report of Dec. 7, 2010 in B.B.’s file reporting presence of alpha-hydroxyalprazolam but no other benzodiazepines even though the drugs screened for included diazepam, oxazepam, and temazepam). Respondent offered no explanation for the inconsistency between his testimony regarding why he ‘‘would not consider’’ the August 25 drug test to be aberrant and his testimony as to why he deemed the January 19 drug test as aberrant, even though both tests reported the presence of the same four benzodiazepines, and in particular, temazepam. Most significantly, the CALJ did not address the inconsistency between Respondent’s testimony regarding the August 25 and January 19 drug tests in making his credibility finding. See R.D. at 38. I conclude, however, that for the same reason that Respondent deemed the January 19 test to be aberrant, I reject his testimony that he does not believe the August 25 test was aberrant and find that it was. I further find that this was now the second aberrant drug test that B.B. had provided in the previous four months. I am also unpersuaded by the CALJ’s reasoning for rejecting Dr. Owen’s testimony as to the adequacy of Respondent’s evaluation of B.B. The CALJ reasoned that the deficiencies identified by Dr. Owen ‘‘generally relate to a paucity of documented proof in the chart entries’’ as to whether Respondent had adequately evaluated B.B.’s chief complaint, the treatments he had VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 previously undergone, his physical and psychosocial function, and whether the prescribing of controlled substances provided a therapeutic benefit. R.D. at 35–36. As explained above, the CALJ declined to give weight to Dr. Owen’s testimony based on the erroneous legal conclusion that the Board’s documentation and recordkeeping standards are permissive and not mandatory. The CALJ apparently credited Respondent’s testimony in finding that ‘‘B.B. reported pain, which was consistent with the findings of the exam the Respondent conducted on that date.’’ Id. at 37. The CALJ also gave weight to Respondent’s decision to change B.B’s medications from Lortab, a short-acting medication which Dr. Schoelen had prescribed, to Duragesic (fentanyl) patches, which are longacting, because in his view, short-acting medications are too addicting. Id. And the CALJ also reasoned that Respondent ‘‘explained that he did not have B.B. undergo physical therapy because that approach had been tried without success . . . in the past.’’ Id. at 38 (citing Tr. 392). As to Respondent’s claim that B.B. had undergone physical therapy for some time, Respondent admitted that this was not documented in the patient file. Tr. 392. Indeed, a review of the progress notes prepared by Dr. Schoelen finds no mention of B.B.’s having been referred to physical therapy, but rather, mentions only Dr. Schoelen’s recommendations of such modalities as gentle stretching, low back strengthening exercises, heat, and low back range of motion exercises. See GX 3, at 51–54, 56, 59. Likewise, B.B.’s file does not contain either a copy of any referral or prescription for physical therapy, or a copy of any physical therapist’s notes. Indeed, while Respondent cited to the Patient History Form in B.B’s file (GX 3, at 34) and testified that ‘‘[i]t says that under pain management, that he was in therapy every month on his past medical history,’’ Tr. 392, that form does not even use the words ‘‘pain management.’’ See GX 3, at 34. Instead, the form contains a column with the heading of ‘‘Chronic Problems,’’ under which the entries state: ‘‘Depression,’’ ‘‘Anxiety’’ and then ‘‘Therapy every month.’’ Id. Patients in physical therapy, however, typically receive treatment several times a week and not ‘‘every month.’’ Cf. United States v. Armstrong, 550 F.3d 382, 389 (5th Cir. 2008) (explaining that ‘‘[j]urors have had a wide variety of their own experiences in doctors’ care over their lives,’’ and can rely on those experiences when assessing evidence as PO 00000 Frm 00027 Fmt 4701 Sfmt 4703 14969 to whether a physician lawfully prescribed controlled substances). And as noted previously, other evidence of record establishes that B.B. was seeing a psychiatrist and receiving alprazolam prescriptions on a monthly basis. Accordingly, I do not find credible Respondent’s testimony that he did not have B.B. go to physical therapy because B.B. ‘‘had been on physical therapy monthly for quite some time and didn’t feel that it was of any benefit at all.’’ Tr. 392. Here too, because Respondent’s testimony is inconsistent with the evidence (and lack thereof), I decline to adopt the CALJ’s apparent credibility finding as to this testimony. I further agree with Dr. Owen’s assessment that Respondent failed to properly assess whether B.B. had undergone conservative treatments. As explained above, Dr. Owen also provided extensive testimony as to the standard of care for evaluating the history of a patient’s pain complaint and the effect of the pain on a patient’s physical and psychosocial functioning. Tr. 116. In his testimony, Dr. Owen identified various questions that Respondent should have asked B.B. and for which Respondent’s September 22 visit note contains no evidence that he did so. See id. (‘‘[H]ow did you hurt yourself; where does it hurt; does the pain radiate down an extremity; if so, how far down; does it go past the knee; where does it end up; is any numbness or weaknesses associated with it?’’); see also id. (‘‘And then you talk about what treatments have you had or what diagnostics have you had’’). And with respect to the assessment of the effect of pain on a patient’s functioning, Dr. Owen, after explaining that function is the ‘‘primary baseline for measuring therapeutic influence,’’ id. at 104, testified that a physician should ask a patient about his activities of daily living such as his ability to work and his ability to tolerate sitting, walking and standing. Id. at 106, 111. See also GX 3, at 33 (Patient Comfort Assessment Guide completed by B.B. on Sept. 2, 2009 which asked questions as to how pain interfered with his general activity, mood, sleep, enjoyment of life, ability to concentrate, and relations with other people). He also noted that in evaluating functionality, a physician would perform a neurological assessment, do a straight leg raise test, and look at the range of motion of the patient’s spine. Id. at 111. Respondent’s note for this visit is totally devoid of any documentation that he asked B.B. how he hurt himself; whether his pain radiated down his extremities and if so, how far down; if the pain went past his knee; if he had E:\FR\FM\23MRN2.SGM 23MRN2 srobinson on DSK5SPTVN1PROD with NOTICES2 14970 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices any weakness or numbness; how the pain effected various activities of daily living such as his ability to work, as well as his ability to tolerate sitting, walking and standing.40 GX 3, at 48. Indeed, the only documentation Respondent made pertinent to B.B.’s ability to function was to note ‘‘yes’’ for whether he had achieved his treatment objective and the numbers ‘‘3–5’’ in the pain scale column. Id. at 28. See Okla. Admin. Code § 435:10–7–11(1) (‘‘The medical record should document the nature and intensity of the pain, current and past treatment for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function and history of substance abuse.’’). Against this evidence, Respondent testified that B.B. reported pain which was consistent with the exam he conducted at this visit. Tr. 292. He also explained that he ordered an MRI because he ‘‘wanted to make sure that’’ the results were ‘‘consistent with his pain,’’ his physical exam, and ‘‘the fact that he was on a schedule II narcotic.’’ Id. at 293. Respondent also testified that he did not continue B.B. on Lortab (hydrocodone/acetaminophen) and prescribed fentanyl patches (a longacting) narcotic medication because of the risk of abuse and addiction present with short-acting medications. Id. at 291. While Respondent may have palpated B.B.’s lumbar region, he offered no testimony or other evidence refuting Dr. Owen’s testimony that the straight leg raise test is ‘‘the most sensitive physical finding for low back pain,’’ and that ‘‘if you don’t have a positive finding you don’t have that diagnosis.’’ Id. at 190. While the CALJ acknowledged this testimony, see R.D. at 35 nn.68–69, he did not explain why the testimony was not entitled to weight in determining whether Respondent established medical necessity to prescribe controlled substances. As this testimony stands unrefuted, I conclude that Respondent did not establish a diagnosis. As for Respondent’s having changed B.B.’s medication from Lortab to Fentanyl patches, even long-acting schedule II medications are susceptible to abuse. Moreover, because Respondent performed only a superficial evaluation and did not establish a diagnosis and medical necessity to prescribe controlled substances, let alone two 40 There is likewise no evidence that Respondent had B.B. complete a new Patient Comfort Assessment Guide or that he asked him as to how the pain interfered with his general activity, mood, sleep, enjoyment of life, ability to concentrate and relations with other people. VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 schedule II controlled substances, this evidence is entitled to no weight.41 I further hold that Respondent’s issuance of the prescriptions for the fentanyl patches and Opana (oxymorphone) prescriptions was not merely malpractice. Rather, I conclude that the evidence supports the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed these drugs to B.B. Here, not only did Respondent do a superficial evaluation as to B.B.’s purported pain complaint, his medical history, and the effect of the pain on his ability to function, he also performed a cursory examination which did not support his diagnosis, id. at 190, and ignored the results of the two aberrant drugs tests. As for the June 1 UDS, as the CALJ noted, ‘‘Respondent never addressed the absence of [the alprazolam and] presented no explanation for his failure to react to the June 1 UDS.’’ R.D. 36. Moreover, even were I to credit Respondent’s testimony that he ‘‘doubt[ed]’’ that he reviewed the drug tests performed by Dr. Schoelen and ‘‘wouldn’t expect [him]self to,’’ Tr. 283, the evidence shows that Respondent 41 In his discussion as to why the Government had not proved that Respondent violated 21 CFR 1306.04(a) in issuing the September 22, 2011 prescriptions, the CALJ also explained that ‘‘Dr. Owen’s views about the relative merits of an MRI versus an X-ray or some other treatment is a medical treatment dispute that falls squarely outside the bounds of DEA’s expertise and jurisdiction.’’ R.D. 39 (citing Gonzales v. Oregon, 546 U.S. 243, 274 (2006)). However, while Dr. Owen criticized Respondent’s decision to order an MRI in response to questioning on crossexamination and by the CALJ because there was no clinical justification for doing so and MRIs lead to over-diagnosis, his opinion that Respondent did not establish medical necessity for the September 22 prescriptions was not based on Respondent’s decision to order an MRI, but rather, the inadequacy of the evaluation of B.B.’s pain complaint, the failure to address the two aberrant drug screens, the lack of a positive finding on the straight leg raise test and the failure to exhaust conservative treatments. So too, the CALJ took issue with Dr. Owen’s testimony regarding ‘‘Respondent’s failure to make referral to other specialists.’’ R.D. 39. However, Dr. Owen’s opinion that Respondent did not establish medical necessity for the September 22 prescriptions was based on Respondent’s superficial evaluation of B.B.’s pain and function, Respondent’s failure to exhaust conservative treatments, and the lack of evidence of a therapeutic benefit. Tr. 133–34. While Dr. Owen did suggest that based on the two aberrant drug tests, Respondent ‘‘could have sent’’ B.B. to an evaluation by an addictionologist or a psychiatrist/ psychologist with experience in addiction medicine, he also testified that there was a further alternative step that Respondent could have taken: he could have been ‘‘much more careful and objective [as to] how [he] measure[d] a therapeutic benefit.’’ Id. at 134. Thus, Dr. Owen’s testimony is not fairly read as saying that such a referral was mandated at this visit. PO 00000 Frm 00028 Fmt 4701 Sfmt 4703 clearly knew that B.B. was a chronic pain patient who was on multiple narcotics and was subject to drug testing. Dr. Owen credibly testified as to the importance of reviewing a patient’s medical records to determine if the patient has a history of aberrant behaviors, id. at 94, yet Respondent maintained that he did not do so. Accordingly, I conclude that Respondent did not establish medical necessity to prescribe controlled substances and that he lacked a legitimate medical purpose and acted outside of the usual course of professional practice when he issued the Opana and Duragesic prescriptions. See 21 CFR 1306.04(a). The October 6 Prescriptions Here again, Dr. Owen testified that the medical record did not justify the prescribing of controlled substances. Tr. 137. Dr. Owen then explained that Respondent’s evaluation of B.B. was superficial in that there was no assessment of B.B.’s pain and his physical and psychosocial functioning. Dr. Owen thus concluded that once again, Respondent had not established medical necessity to prescribe controlled substances and thus, he opined that the prescriptions ‘‘were not’’ issued in the usual course of professional practice and ‘‘were not’’ for a legitimate medical purpose. Id. at 137– 38. Dr. Owen further explained that based on the aberrant drug tests, Respondent should have obtained consultations with mental health providers or addictionologists. Id. at 137. And based on the notation in the visit note that ‘‘[n]ow, B.B. would like to try the morphine,’’ Dr. Owen further faulted Respondent for not properly addressing B.B.’s request to try morphine. Id. at 135. Explaining that ‘‘[t]he principal issue raised by Dr. Owen and noticed by the Government’’ with respect to these prescriptions ‘‘centers on’’ this notation, the CALJ found credible Respondent’s testimony regarding B.B.’s request to try morphine, characterizing the notation as ‘‘a poorly-worded memorialization of a longer conversation wherein he got medication efficacy input from B.B. and outlined several medication options based on the existing Oklahoma Medicaid formulary.’’ R.D. 43. The CALJ then explained that ‘‘[t]he progress notes related to issues regarding the Respondent’s evaluation and treatment of a suspected upper respiratory ailment are likewise more consistent with a conscientious practitioner than a pill mill operator.’’ Id. Next, while the CALJ rejected the Government’s contention that the E:\FR\FM\23MRN2.SGM 23MRN2 srobinson on DSK5SPTVN1PROD with NOTICES2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices August 25 UDS was anomalous based on ‘‘Respondent’s plausible and credible explanation,’’ he then found that ‘‘[t]he aberrant nature of the June 1 UDS is uncontroverted by the evidence.’’ Id. The CALJ further found that the Government had proved that ‘‘Respondent’s actions in continuing to prescribe controlled medications without acting to investigate or institute safeguards upon encountering an anomalous UDS . . . fell below the standard expected of a prudent controlled substances prescriber.’’ Id. As explained previously, with respect to those instances in which he found violations, the CALJ simply concluded that Respondent’s actions were neglectful. However, even accepting the CALJ’s credibility finding with respect to Respondent’s testimony regarding B.B.’s request to try morphine, I find that the evidence still supports the conclusion that Respondent violated 21 CFR 1306.04(a) in issuing the prescriptions for both morphine ER and Opana (oxymorphone). As explained in my discussion of the September 22nd prescriptions, I conclude that the August 25, 2011 UDS was anomalous. And as also discussed previously, I find that the Board’s documentation and recordkeeping provisions are mandatory and thus, Dr. Owen’s testimony should be given weight. In refutation of Dr. Owen’s testimony that Respondent’s evaluation was inadequate, Respondent testified that B.B. reported that ‘‘his objectives were only fair’’ and that his pain level had increased to a six out of ten. Respondent further noted that he did ‘‘a full exam’’ but that ‘‘[t]he MRI was not back yet.’’ Tr. 295. As the CALJ noted, Respondent ‘‘admitted that this part of the patient visit went very quickly, and that a patient may not remember the treatment goal when asked this.’’ R.D. 41 n.80. Indeed, after admitting that ‘‘that part would be very quick in my office,’’ Respondent added that ‘‘I wouldn’t ask him what he was actually doing to achieve that.’’ Tr. 393. He also testified that he was not sure as to why, when the question was ‘‘has patient achieved treatment objective’’ and was, in essence, a yes or no question, and the patient may not even remember what his treatment objective was, B.B. would have answered ‘‘fair.’’ Id. at 395. Given that Respondent offered no further testimony as to other questions he asked B.B. to ascertain how the pain was effecting his ability to function in various aspects of his life activities, nor maintained that he asked any other questions about B.B.’s pain level, I give VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 weight to Dr. Owen’s testimony that Respondent’s evaluation of B.B.’s pain and ability to function was superficial. Although Respondent maintained that he did a full physical exam, once again he found that B.B.’s straight leg raise was negative. As Dr. Owen testified, without a positive finding on this test, Respondent did not have a diagnosis for lumbar disc disease. And as for the Respondent’s testimony that ‘‘the MRI results were not back yet,’’ B.B. had not even gone for the MRI as of this date. Nor do I find persuasive the reasoning that Respondent’s treatment of B.B.’s upper respiratory ailment was ‘‘more consistent’’ with the treatment provided by ‘‘a conscientious practitioner than a pill mill operator.’’ R.D. 43. Putting aside that there is no evidence as to how a conscientious practitioner would treat a patient who complains of a potential upper respiratory ailment, even patients who engage in the abuse or diversion of controlled substances may seek treatment for legitimate health conditions. So too, a physician may nonetheless divert controlled substances to some patients without being a pill mill operator. Thus, even assuming that Respondent properly evaluated and treated B.B. for this condition, this has no bearing on whether he properly evaluated B.B. to determine whether he had a legitimate pain condition which warranted the prescription of controlled substances.42 In sum, because I agree with Dr. Owen that Respondent still had not established medical necessity for the prescriptions and had still failed to address the two aberrant drug tests, I conclude that the prescriptions lacked a legitimate medical purpose and that Respondent acted outside of the usual course of professional practice in issuing them. 21 CFR 1306.04(a). The October 20 Prescriptions At this visit, Respondent noted that B.B. reported that ‘‘his stress [was] up’’ and that he had ‘‘lo[st] his father’’ and 42 To be sure, the visit note also stated that B.B. had ‘‘a left abdominal wall hernia’’ and Respondent recommended that he ‘‘wear a corset if at all possible.’’ GX 3, at 47. While Respondent testified that he suggested the use of a corset because he didn’t want B.B. to confuse his abdominal pain with his level of pain because of his having changed B.B.’s pain regimen, here again, there is no evidence that he evaluated the cause of the hernia, how much pain it was generating, and how it was effecting B.B.’s ability to function. Tr. 300. Notably, B.B. returned for another office visit only two weeks later. GX 3, at 46. Yet the note for the visit contains no mention of the hernia. Id. Nor is the hernia mentioned in the visit notes for B.B.’s later visits. See id. at 42, 44–45. And in his testimony, Respondent offered no explanation as to what happened to B.B’s hernia such that it was no longer mentioned in subsequent visit notes. PO 00000 Frm 00029 Fmt 4701 Sfmt 4703 14971 was ‘‘having a lot of grief.’’ GX 3, at 46. He made similar physical exam findings as at the previous visit, again noting that B.B.’s straight leg raise was negative but that ‘‘lying down and sitting up cause him a lot of pain.’’ Id.; see also Tr. 305 (Respondent’s testimony that B.B.’s ‘‘exam was still exactly like before, with low back paraspinal and spinal tenderness, but he still had the negative straight leg raises. But lying down and sitting up still caused him a lot of pain.’’). Respondent did not even obtain a numerical pain rating at this visit nor note whether B.B. was achieving his treatment objective. Respondent diagnosed B.B. as having both acute grief and lumbar disc disease. Dr. Owen testified that B.B.’s having a lot of stress and grief would magnify B.B.’s ‘‘perception of pain and disability.’’ Tr. 139. He further explained that because of B.B.’s previous aberrant behaviors and the new stressors in B.B.’s life, he was at increased risk to ‘‘use [the] drugs to chemically cope’’ and that Respondent should have ‘‘sought psychological counselling for’’ him but did not do so. Id. Dr. Owen also took issue with Respondent’s notation in the visit note that he suggested nonmedicinal modalities for two reasons. Id. at 209– 10. First, he explained that ‘‘good medicine would be [that] if you haven’t done nonmedicinal pain-relieving modalities,’’ Respondent should have ‘‘wean[ed] [B.B.] off these controlled substances and tr[ied] these other treatments first.’’ Id. at 210. Second, he explained that the note did not provide an adequate level of detail such that any person who took over B.B.’s care or was asked to provide a consultation would be able to ‘‘understand what was happening with this patient at that point.’’ Id. As for Respondent’s notations that the straight leg raise test was negative but that lying down and sitting up caused B.B. a lot of pain, Dr. Owen testified that these were not objective findings in a neurological sense in that B.B. could not ‘‘have a radiculopathy’’ absent a positive straight leg raise test. Id. at 210–11. As for the pain that B.B. had lying down and sitting up, Dr. Owen testified that this contributed to the idea that the controlled substances did not provide a therapeutic benefit and thus did not warrant the continued prescribing of controlled substances. Id. at 210. The CALJ declined to give weight to much of Dr. Owen’s testimony, reasoning that his ‘‘view of the level of documentation detail required in Oklahoma, as well as his description of E:\FR\FM\23MRN2.SGM 23MRN2 srobinson on DSK5SPTVN1PROD with NOTICES2 14972 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices a mandatory mental health referral requirement, is [sic] not consonant with the requirement of the Oklahoma Pain Management Regulations.’’ R.D. 46. With respect to Respondent’s recordkeeping, the CALJ explained that ‘‘[t]here was sufficient detail to support the proposition that the office visit that was conducted in conjunction with this prescribing event presented efforts on the part of the Respondent to treat B.B.’’ Id. (emphasis added). However, as he did with the October 6 prescriptions, the CALJ found that the August 25 UDS was not anomalous (based on Respondent’s uncorroborated hearsay testimony) but nonetheless found that the June 1 UDS was aberrant and that ‘‘Respondent’s continued controlled substance prescribing under these circumstances . . . fell outside the course of a professional medical practice, and fell short of his obligations as a DEA registrant to safeguard against diversion.’’ Id. I do not read Dr. Owen’s testimony as categorically stating that the Oklahoma regulation imposes a mandatory requirement of obtaining a consultation when a patient presents with a comorbid psychiatric disorder. While Dr. Owen testified that one of the provisions in Oklahoma’s ‘‘policies and guidelines . . . that stood out is if somebody’s a complex pain patient with psychological or psychiatric comorbidities, they should get consultations with a pain management physician with expertise in these complex cases,’’ Tr. 101, he acknowledged that the Board’s rule used the words ‘‘may require’’ but that a physician ‘‘should document why [he] deviate[s] from that recommendation.’’ Id. at 186. Thus, Dr. Owen’s testimony is not fairly read as asserting that Oklahoma imposes a mandatory requirement of obtaining a consultation in all instances in which a patient presents with a comorbid psychiatric disorder. Moreover, even if I agreed with the CALJ’s characterization of Dr. Owen’s testimony on this issue, the Board’s standard is nonetheless evidence that the standard of care may require referral or consultation depending on the circumstances presented by the patient, and there is ample evidence to support Dr. Owen’s conclusion that Respondent breached the standard of care when he failed to even consult with B.B.’s mental health providers. Dr. Owen testified that patients who present with comorbid psychiatric conditions present a heightened risk of abusing controlled substances because these conditions may magnify a patient’s perception of pain and VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 disability and aggravate a patient’s experience of suffering, id. 102–04, and Respondent agreed with Dr. Owen. Id. at 409 (Respondent’s testimony that ‘‘having chronic pain [can] lead to worse anxiety and depression’’ and that ‘‘uncontrolled anxiety or depression [can] lead[] to more pain.’’). And throughout his testimony, Dr. Owen repeatedly noted that based on B.B.’s aberrant behavior alone, Respondent should have obtained consultations with mental health providers or addictionologists to obtain a more thorough assessment of B.B.’s behavior. Thus, Dr. Owen opined that Respondent should have sought psychological counselling for B.B. based on his presentation of suffering from greater stress and acute grief at this visit. Id. at 139. To be sure, the evidence shows that B.B. was already seeing a mental health professional during this period. However, Respondent admitted that he never even consulted with the mental health professionals who were simultaneously prescribing controlled substances to B.B., whether in response to B.B.’s report of increased stress and grief at this visit, or at any point during the course of his prescribing to B.B. Id. at 408. Notably, when Respondent was asked if it was within the standard of care for him and B.B.’s mental health provider to keep treating B.B. ‘‘without talking to each other,’’ Respondent explained that ‘‘the mental health providers are very good about speaking to us about patients.’’ Id. at 409. When then asked if he would ordinarily consult with a patient’s mental health provider if the latter is simultaneously prescribing controlled substances, Respondent offered the unresponsive answer that ‘‘[w]e’ve become quite reliant on the PMP [reports] now’’ and that ‘‘[b]efore the PMP, there was quite a bit of cross-talk, because . . . pharmacists would call’’ and tell him that a patient was seeing another physician. Id. at 409–10. However, the PMP reports in the record show that they did not contain any medical information for B.B. other than the controlled substance prescriptions he obtained and filled and the names of the prescribers. When then asked if two practitioners who are simultaneously prescribing controlled substances to the same patient wouldn’t ‘‘talk to each other about’’ their joint prescribing, Respondent initially answered ‘‘absolutely.’’ Id. at 410. However, notwithstanding his earlier testimony that ‘‘[t]he mental health providers are very good about speaking to us about patients,’’ he then asserted that ‘‘[i]n PO 00000 Frm 00030 Fmt 4701 Sfmt 4703 every other field but mental health we do do that,’’ and added that consulting with his patient’s mental health professionals ‘‘doesn’t happen very often.’’ Id. In short, none of this testimony refutes Dr. Owen’s testimony that a patient with a comorbid psychiatric disorder is at a higher risk of abusing controlled substances to cope, that consultations are important to obtain a better understanding of such a patient’s behavior, and that based on the aberrant drug screens and his report of acute grief, Respondent should have consulted with either B.B.’s mental health providers or an addictionologist. While, when considered in isolation, Respondent’s failure to consult with B.B.’s mental health providers would not establish a violation of 21 CFR 1306.04(a), Dr. Owen again explained that Respondent’s evaluation was ‘‘inadequate’’ and did not support a finding of medical necessity to continue prescribing controlled substances. Id. at 140. Moreover, while Respondent testified that lying down and sitting up caused B.B. a lot of pain, B.B. had been on controlled substances for more than two and a half years at this point and was receiving prescriptions for even more potent narcotics and in larger doses (morphine and oxymorphone, both schedule II drugs) and yet he had never been referred for physical therapy. Thus, as Dr. Owen explained, Respondent’s findings that B.B. was having a lot of pain lying down and sitting up supported the finding that prescribing controlled substances was not providing a therapeutic benefit. Id. at 211. As before, Respondent’s failure to address the aberrant drug screens as well as Dr. Owen’s testimony that the evaluation was inadequate, that prescribing controlled substances did not provide a therapeutic benefit, and that Respondent did not establish medical necessity to continue prescribing controlled substances, are sufficient to support a finding that Respondent violated 21 CFR 1306.04(a). Respondent’s failure to consult with B.B.’s mental health providers given B.B.’s report of increased stress and grief provides additional support for this conclusion. The November 18 and December 15, 2011 Prescriptions On both dates, Respondent issued B.B. prescriptions for 90 Morphine Sulfate ER 15 mg and 120 Opana 10 mg without requiring that B.B. appear for an office visit with him. Dr. Owen again found that Respondent should have seen B.B. prior to issuing the prescriptions and that Respondent still E:\FR\FM\23MRN2.SGM 23MRN2 srobinson on DSK5SPTVN1PROD with NOTICES2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices had not established medical necessity to continue to prescribe controlled substances. Tr. 142. Dr. Owen also noted that Respondent still had not addressed the aberrant drug screens. Id. at 143. He further observed that notwithstanding B.B.’s report of increased stress and grief at the previous visit and that B.B. presented a high risk of escalating his medications and abusing them, Respondent obviously did not discuss these issues with B.B. Id. Dr. Owen acknowledged that under a DEA regulation (21 CFR 1306.12(b)), a practitioner may issue multiple prescriptions for a schedule II drug to provide up to a 90-day supply of the drug based on only seeing the patient once every 90 days. However, Dr. Owen explained that a physician who does so must have ‘‘established medical necessity and legitimate therapeutic benefit . . . and [that] a patient doesn’t have a high risk of abuse,’’ but that B.B. already had provided two aberrant drug screens before Respondent issued the prescriptions. Id. at 196. In refutation, Respondent offered only that after the October 20 visit, he ‘‘felt like [B.B.] could really go into the threemonth’’ and that he did not understand that he had to see B.B. ‘‘every 30 days.’’ Id. at 307. Respondent further asserted that when a patient requested a new schedule II prescription, a PMP report would be obtained, the patient’s file would be pulled, and that he would write the prescription and leave it ‘‘up front.’’ Id. at 308. Respondent did not offer any testimony refuting Dr. Owen’s testimony that B.B. presented a high risk of escalating the use of controlled substances and should have been seen prior to the issuance of the prescriptions on both dates. The CALJ found the allegations ‘‘not sustained’’ with respect to both the November 18 and December 15 prescriptions. R.D. at 51. In the CALJ’s view, although the June 1 UDS was aberrant, it was not adequately noticed with respect to these two prescribing events, and as for the August 25 UDS, ‘‘the record evidence [did] not support a finding that the . . . results [were] aberrant.’’ Id. The CALJ again rejected Dr. Owen’s testimony as to the lack of therapeutic benefit and medical necessity, on the ground that Dr. Owen’s view as to the required level of documentation ‘‘is at odds with the requirements of the Oklahoma Pain Management Regulations.’’ Id. at 48. And finally, the CALJ rejected Dr. Owen’s testimony regarding Respondent’s failure to require an office visit, reasoning that DEA’s regulation allows for the issuance of multiple VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 prescriptions for up to a 90-day supply of a schedule II drug and that Dr. Owen’s opinion was ‘‘based on his assumptions that the chart contains insufficient documentation detail and two aberrant UDS lab results.’’ Id. I find, however that on both dates, Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing the morphine and Opana prescriptions without requiring an office visit. As previously explained, the Show Cause Order provided Respondent with fair notice that the aberrant June 1 drug test would be at issue throughout this proceeding, including with respect to the prescriptions he issued on November 18 and December 15, 2011. See supra discussion at 72–77. With respect to the August 25 drug test, the CALJ’s reasoning makes clear that he considered Respondent’s testimony as to what he was told by the lab to prove the truth of the matter asserted. As explained previously, his testimony is uncorroborated hearsay and thus unreliable. Moreover, Respondent’s testimony that he did not consider the positive test results for the other benzodiazepines including the temazepam positive to be aberrant is amply refuted by his testimony regarding the January 19, 2012, which he deemed aberrant. So too, for reasons explained previously, I reject the CALJ’s interpretation of the documentation requirements imposed by the Oklahoma regulations. In any event, in his testimony regarding his evaluation of B.B., Respondent simply read aloud what he had documented in the visit notes and in the Treatment Objective Evaluation section of the Treatment Plan (GX 3, at 28) and never identified additional measures he took to evaluate B.B.’s pain and how it affected his ability to function.43 Thus, I give weight to Dr. Owen’s testimony that Respondent did not establish medical necessity to continue to prescribe controlled substances. As for the CALJ’s reliance on the regulation which allows a practitioner to issue to a patient multiple schedule II prescriptions for up to a 90-day supply at one time, provided the practitioner meets certain conditions, the rationale underlying this provision 43 While Respondent had received the MRI results before he issued the November prescriptions, GX 3, at 20; Dr. Owen testified that the MRI ‘‘did not show any specific problems that would be attributable for this kind of pain complaint[], nor was it significant to cause the perceived disability that this 26-year-old gentleman considers himself’’ to have. Tr. 207. At no point in his testimony did Respondent refute Dr. Owen’s review of the MRI results. PO 00000 Frm 00031 Fmt 4701 Sfmt 4703 14973 does not provide a safe harbor to Respondent.44 Of relevance here, these conditions include, inter alia, that: ‘‘[e]ach separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice’’; and ‘‘[t]he individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse.’’ 21 CFR 1306.12(b)(i) and (iii). As found above, based on my conclusions that the prescriptions Respondent issued at the three previous office visits were issued outside of the usual course of professional practice and lacked a legitimate medical purpose, Respondent did not meet the first condition. Moreover, based on Respondent’s testimony that he did not remember whether he reviewed either the June 1 or August 25 drug test results, that he doubted that he did and ‘‘wouldn’t expect [him]self to’’ have done so even though he knew his partner had instituted drug testing of the clinic’s chronic pain patients (Tr. 283, 397), Respondent failed to determine whether issuing the prescriptions created an undue risk of diversion. Thus, the rationale underlying this regulation provides no basis to reject Dr. Owen’s testimony that these prescriptions were issued outside of the usual course of professional practice and lacked a legitimate medical purpose. 21 CFR 1306.04(a). The January 19, 2012 Prescriptions On January 19, 2012, B.B. again saw Respondent. B.B. reported that he had gone to the emergency room ‘‘two weeks ago with right leg swelling’’ but that ‘‘[h]is ultrasound was negative’’; he complained of ‘‘some calf pain’’ and that ‘‘[h]e still feels very tight.’’ GX 3, at 45. Respondent also noted that B.B. ‘‘goes to a psychiatrist’’ and ‘‘reports severe lumbar disc disease.’’ Id. In addition, Respondent documented that B.B. reported that ‘‘he ha[d] been exposed to someone with HPV’’ and ‘‘would like an exam.’’ Id. Respondent further noted that B.B.’s ‘‘[p]ast medical history [was] extensively reviewed’’ and ‘‘placed in chart.’’ Id. 44 As this provision contemplates the issuance of multiple prescriptions at one time provided the prescriptions ‘‘indicat[e] the earliest date on which a pharmacy may fill each prescription,’’ it is not directly applicable here. However, as to the frequency of office visits, the regulation states that a physician ‘‘must determine . . . based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so.’’ 21 CFR 1306.12(b)(2). E:\FR\FM\23MRN2.SGM 23MRN2 srobinson on DSK5SPTVN1PROD with NOTICES2 14974 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices According to Respondent’s exam notes, B.B. was ‘‘[a]lert and oriented and in no apparent distress.’’ Id. While other portions of the exam were normal, Respondent again documented that B.B. had ‘‘[l]ow back paraspinal tenderness,’’ a ‘‘[n]egative straight leg raise,’’ and ‘‘[n]euro intact.’’ Id. He also documented that B.B. ‘‘has very tight right calf.’’ Id. However, no mention was made of B.B.’s hernia which had been noted at previous visits. Id. Respondent diagnosed B.B. with ‘‘lumbar disc disease,’’ ‘‘exposure to infectious disease,’’ and ‘‘[r]ight calf pain.’’ Id. He further documented that he discussed the ‘‘[a]ddictive dependence, and tolerance nature of the medicines as well as alternatives,’’ that he suggested ‘‘[n]on-medicinal painrelieving modalities,’’ and that the ‘‘[f]ollowup will be [in] three months.’’ Id. Respondent then issued B.B. new prescriptions for Morphine Sulfate ER 15 mg and Opana 10 mg with the same dosing instructions, thus providing a 30day supply for each drug if taken as directed. Id. Dr. Owen testified that when a patient reports having gone to the emergency room, he would get the record to find out both ‘‘what the problem was’’ as well as if ‘‘any additional medication [was] prescribed.’’ Tr. 147. B.B.’s file does not, however, contain a note from the emergency room. Id.; see also GX 3. Moreover, after observing that the visit note contains no mention that Respondent addressed either of the two prior urine screens during this visit, Dr. Owen again testified that Respondent had failed to establish medical necessity for the prescriptions ‘‘by doing a proper history and physical exam, by defining a therapeutic benefit, by explaining what previous treatments have or have not worked . . . and . . . addressing the previous aberrant urine drug tests.’’ Id. at 148. Thus, Dr. Owen opined that the Respondent acted outside of the usual course of professional practice in issuing the prescriptions and that the prescriptions lacked a legitimate medical purpose. Id. In refutation of Dr. Owen’s testimony, Respondent asserted that B.B. did not report anything other than his calf pain and his new conditions (apparently a reference to his exposure to someone with HPV). Id. at 314, 317. He further testified that there was nothing in the PMP report that showed that B.B. had been prescribed anything during his emergency room visit. Id. at 314. He also acknowledged that during the physical exam, he again found that B.B. had a negative straight leg raise test and thus did not have radiculopathy but that this did not mean that B.B. did not have VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 paraspinal or muscular skeletal pain. Id. at 318–19. However, in contrast to the last visit where Respondent documented that lying down and sitting up was causing B.B. a lot of pain, Respondent made no such note in the visit note. GX 3, at 45. While Respondent agreed that his visit notes were unremarkable given the high amount of narcotics he was prescribing and asserted he could have done a better job dictating his notes (which he attributed to seeing 40 to 45 patients a day and dictating the notes), he maintained that because B.B. ‘‘just continued to have the same pain that he had before . . . I didn’t go into details on it.’’ Tr. 315. However, notwithstanding that he had not seen B.B. in three months, he did not document whether B.B. had achieved his treatment objective nor document a numeric pain rating. GX 3, at 28. The CALJ rejected the Government’s contention that the controlled substance prescriptions Respondent issued at this visit violated 21 CFR 1306.04(a). Again, the CALJ concluded that the Government did not provide adequate notice regarding its reliance on the June 1 UDS and that the record does not support a finding that the August 25 UDS result was aberrant. R.D. at 51. And again, the CALJ reasoned that Dr. Owen’s view of the level of documentation required findings of therapeutic benefit and medical necessity, as well as his conclusion that Respondent did not adequately document B.B.’s visit to the emergency room and should have obtained the record of that visit, were ‘‘at odds with the requirements of the’’ Board’s rules. Id. Finally, the CALJ asserted that ‘‘Respondent’s testimony provide[s] convincing evidence that the Respondent was engaged in bona fide attempts to treat B.B., not act as a drug supplier. The same can be said of the evidence that the Respondent was seeing B.B. for maladies beyond his pain complaints.’’ Id. For reasons explained previously, I find that Respondent was provided adequate notice regarding the Government’s reliance on the June 1 UDS and that the record supports a finding that the August 25 UDS was aberrant. As also explained previously, because I do not agree with the conclusion that Dr. Owen’s understanding of the Oklahoma documentation requirement is ‘‘at odds’’ with the permissive nature of the State’s regulations, R.D. 51, and agree with the CALJ’s conclusion that Dr. Owen’s testimony ‘‘predictably raised no issues regarding credibility,’’ I give weight to Dr. Owen’s testimony that Respondent PO 00000 Frm 00032 Fmt 4701 Sfmt 4703 did not establish medical necessity to issue the prescriptions. As for Dr. Owen’s criticism of Respondent for failing to obtain the emergency room record, Respondent testified that he checked the PMP and found no evidence that B.B. had been prescribed controlled substances. Moreover, even if the standard of care does require a pain management physician to obtain an ER record for his patient, it not clear how quickly that record could have been obtained on the date of this visit. Nor is it clear why, if a physician has otherwise properly evaluated his patient, his failure to obtain an ER record on that date would preclude his issuance of controlled substance prescriptions. However, Dr. Owen provided credible testimony that when Respondent issued the January 19 prescriptions, he still did not perform an adequate evaluation of B.B.’s pain complaint by doing a proper history and physical exam, nor determined whether there was a therapeutic benefit to justify the continued prescribing of controlled substances, nor addressed the previous aberrant drugs tests. Dr. Owen’s testimony provides substantial evidence to conclude that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he issued the prescriptions. In discussing Respondent’s testimony regarding the notes he made after B.B.’s January 27 office visit (on which occasion he did not prescribe controlled substances), the CALJ stated that ‘‘Respondent noted that B.B. was on Social Security disability, and objective data had confirmed that he had chronic pain.’’ R.D. at 50 (citing Tr. 324). However, Respondent did not identify what the ‘‘objective data’’ were. See Tr. 324–25. The CALJ also found that in the Respondent’s view, B.B. had not behaved in a way that set off alarms, and was stable on his medications.’’ R.D. at 50. However, as found previously, Respondent testified that he probably never even looked at the UDS results that were in B.B.’s chart and didn’t expect that he would have done so. Yet Respondent also testified that Dr. Schoelen had instituted urine drug testing for the clinic’s chronic pain patients and thus Respondent obviously knew that B.B.’s file likely contained UDS results. And the evidence also shows that Respondent did not conduct a drug test of B.B. at any of his first three visits and yet concluded that he only needed to see B.B. once every three months. Thus, to the extent Respondent claims that B.B’s behavior did not set off E:\FR\FM\23MRN2.SGM 23MRN2 srobinson on DSK5SPTVN1PROD with NOTICES2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices alarm bells, it is because Respondent deliberately ignored relevant evidence and failed to monitor his patient. The CALJ apparently also credited Respondent’s testimony to the effect that ‘‘[m]uch more went on in the office than what’s written’’ in the visit notes and that he ‘‘definitely knew what was going on in [B.B’s] life from each visit, and I just failed to dictate that.’’ Tr. 326. And the CALJ further asserted that ‘‘Respondent provided details to demonstrate that he knew his patient,’’ R.D. 50, and apparently credited Respondent’s testimony that he ‘‘was talking to [B.B] about those things and what all he did in a day, and he was not able to work.’’ Tr. 327 (cited at R.D. 51). Yet, on the occasion of the January 19 visit, during which he issued B.B. new prescriptions for morphine and oxymorphone, Respondent did not even document in the Treatment Objective Evaluation section on the Treatment Plan if B.B. was meeting his treatment objectives and did not obtain a pain rating. Of note, the former was typically documented with a handwritten oneword answer of either ‘‘yes’’ or ‘‘fair,’’ and the latter was documented with a handwritten notation of a number; thus neither of these inquiries required dictation at all.45 Moreover, when asked by the CALJ how he knew how the meds he prescribed ‘‘were doing,’’ Respondent replied that his evaluation was ‘‘purely subjective, and if they were needing more or less pain meds.’’ Only after a further question as to whether he asked objective questions in assessing how B.B. was responding to the medications did Respondent maintain that he was aware of what B.B. did all day and that he had not returned to work. Dr. Owen provided unrefuted testimony that ‘‘return[ing] to work’’ is ‘‘the gold standard for functionality in pain management.’’ Tr. 100. Given this, it is telling that Respondent never documented whether B.B. had returned to work in the progress notes he prepared for the various visits. Moreover, given that B.B.’s treatment objective was to return to work without pain and yet B.B. never returned to work during the course of Respondent’s prescribing to him, id. at 353, it is hard to understand why Respondent wrote ‘‘fair’’ for whether B.B. was meeting his treatment objective. As for why he did so, Respondent testified that he would ask his patients if they were meeting their treatment objective and he would write down 45 Indeed, on each of the dates on which Respondent made notations in this section of the chart, each of the entries was handwritten. VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 what the patient told him. Tr. 392. However, Respondent further testified that ‘‘[a]ctually that part [of the visit] would be very quick in my office. I wouldn’t ask him what he was actually doing to achieve that.’’ Id. at 393. Respondent ‘‘absolutely’’ agreed with the CALJ that he would ask his patients ‘‘[h]ave you achieved your treatment objective?’’ only to then acknowledge that his patients ‘‘may not’’ remember what their treatment objective was. Tr. 394. And while this question appears to have been directed at assessing a patient’s function, Respondent testified that the question was intended to elicit ‘‘[b]asically if they were satisfied with the care or the standard that they meet.’’ Id. When then asked why B.B. would answer ‘‘fair’’ to what seemed to be ‘‘a yes or no question,’’ Respondent testified that he was ‘‘not sure’’ why the answer would come out as ‘‘fair.’’ Id. at 395. Tellingly, at another point during his testimony on this issue, Respondent explained: They [the patients] were very well trained by the time this was here. Whenever we walked in, they knew the questions before we asked them. You know, are you meeting your objective? What’s your pain level? And do you wish to change? Do you think we should make a referral? We asked it every time, just like clockwork. Tr. 394–95. I disagree with the CALJ that ‘‘Respondent’s testimony provides convincing evidence that he was engaged in bona fide attempts to treat B.B., not act as a drug supplier.’’ On the issue of how he evaluated B.B.’s function, Respondent offered only the vague testimony that he ‘‘was talking to B.B about those things and what all he did in a day.’’ Yet Respondent never documented any such findings other than to make the nonsensical notation of ‘‘fair’’ for whether B.B. was achieving his treatment objective, and even at the hearing, Respondent still could not explain why he did so even though he did so on multiple occasions. As for his assessment of B.B.’s pain level, Respondent testified to only asking ‘‘what’s your pain level’’—as if over the course of the preceding 90-day period, a patient’s pain level would not fluctuate depending upon the activities engaged in by the patient. While I am mindful that the CALJ’s finding was based on his credibility determination, it is noteworthy that in his decision, the CALJ did not discuss this portion of Respondent’s testimony (Tr. 392–95), which is clearly relevant and probative PO 00000 Frm 00033 Fmt 4701 Sfmt 4703 14975 on the issue of the scope of his evaluation of B.B.46 As noted previously, in its Policy Statement, the Board stated that it ‘‘will judge the validity of the physician’s treatment of the patient based on available documentation’’ and that ‘‘[t]he goal is to control the patient’s pain while effectively addressing other aspects of the patient’s functioning, including physical, psychological, social and work-related factors.’’ Policy Statement, at 2 (emphasis added). Given that Respondent’s documentation was confined to the two superficial notations in the Treatment Objective Evaluation section of the Treatment Plan and given the emphasis which the Board’s Policy Statement places on the available documentation in judging the validity of treatment, as well as Respondent’s testimony as to the scope of the questions he would ask, I conclude that Respondent has not refuted Dr. Owen’s testimony that he failed to adequately evaluate whether there was a medical necessity to prescribe controlled substances to B.B. In concluding so, I am mindful that while the Board initially charged Respondent with ‘‘fail[ing] to maintain adequate medical records to support diagnosis . . . treatment or prescribed medications, in violation of 59 O.S. § 509(20),’’ RX 1, at 4, the Board ultimately entered into a settlement with him prior to hearing which did not include a finding that he violated this provision. There is, however, nothing unusual about prosecutors agreeing to enter settlement agreements in which they waive meritorious allegations and, as the voluntary settlement agreement offers no explanation as to why the Board did not rely on this specific allegation, I place no weight on the failure of the Board to find that Respondent violated the provision. I am also mindful of the CALJ’s criticism that Dr. Owen is not licensed to practice in Oklahoma and has never practiced there, as well as that Dr. Owen’s ‘‘representation that the controlled substance prescribing standards in his home state of Texas are similar to, but less restrictive than Oklahoma, is flat out wrong,’’ and that this diminishes the weight to be given to his testimony. R.D. 89 (citing Tr. 87, 94, 105–06). 46 While Respondent also asserted that B.B. ‘‘basically was stuck in the house all day,’’ that obviously was not the case when B.B. was found semiconscious and in an apparent state of intoxication in a vehicle parked on the median strip of I–35. As far as B.B.’s inability to work, the evidence shows that he was working by ‘‘illegally buying and selling prescriptions drugs.’’ RX 3, at 3 (stipulated findings of fact of the March 8, 2013 Board Order). E:\FR\FM\23MRN2.SGM 23MRN2 14976 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices It is true that in several respects the Texas Board’s standards are more restrictive than Oklahoma’s, and thus, Dr. Owen’s testimony that Texas’s standards are less restrictive was erroneous. However, on the critical issues of the scope of the evaluation of the patient and the documentation required, as explained previously, I conclude that the Oklahoma Board’s standards on these issues are mandatory. While the Texas Board uses even more emphatic language to express the mandatory nature of these requirements, I conclude that there is no material difference between the standards of Oklahoma and Texas. Moreover, Dr. Owen provided additional evidence to support the view that the standards of medical practice require the documentation of considerably more information than found in B.B.’s progress notes. As he explained: srobinson on DSK5SPTVN1PROD with NOTICES2 the purpose of documentation is for continuity of care. Not only continuity of care for this same provider from visit to visit but continuity of care should somebody else assume the care later on down the road or should you need to get a consultation, that the consultant can read your notes and understand what was happening with this patient at this point in time. Tr. 210. Notably, Respondent put on no evidence showing that Oklahoma’s standard was materially different than what Dr. Owen testified to on the issue of the adequacy of the evaluation and required level of documentation. See United States v. Joseph, 709 F.3d 1082, 1096 (11th Cir. 2013) (upholding criminal conviction for violation 21 CFR 1306.04(a); ‘‘[e]ven if the district court should have instructed the jury to evaluate the conduct of the defendants against only a Georgia standard of medical practice, the defendants failed to offer any proof that the Georgia standard differs at all from any national standard that the jury purportedly considered’’). Moreover, while States have the primary responsibility for the regulation of the medical profession, many of the profession’s norms were created by the profession itself. Thus, on such issues as the adequacy of a clinical evaluation for a particular pain complaint and the necessary documentation to support the prescribing of controlled substances, the standard of medical practice would not seem to vary to any material degree between States, especially between States that border each other. Finally, unlike Respondent, Dr. Owen is board certified in pain management, is a member of multiple pain management professional organizations, VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 including the American Academy of Pain Medicine and the American Academy of Pain Management, has practiced pain management for more than sixteen years, serves as a peer reviewer on pain medicine for the Journal of the American Academy of Pain Medicine, and has made numerous presentations on pain-management. In light of his extensive professional credentials, I conclude that even though he has not practiced in Oklahoma, I find persuasive his testimony as to the inadequacy of Respondent’s evaluations of B.B. and Respondent’s failure to establish a medical necessity for the prescriptions. I thus conclude that the January 19, 2012 Morphine and Opana prescriptions lacked a legitimate medical purpose and that Respondent acted outside of the usual course of professional practice in issuing them. 21 CFR 1306.04(a). The February 13, 2013 Prescriptions On this date, Respondent issued B.B. new prescriptions for 120 Opana 10 and 90 Morphine Sulfate ER 15. Moreover, by this date, Respondent likely had the results of the January 19 UDS, which showed that Morphine Sulfate was not detected and that B.B. had tested positive for nordiazepam, oxazepam and temazepam (as well as alprazolam). On the lab report, Respondent wrote that B.B. was ‘‘counsel[led] to only take what is prescribed.’’ Respondent did not require that B.B. appear for an office visit. Dr. Owen testified that Respondent should have required an office visit because of B.B.’s previous aberrant drug-taking behaviors and because Respondent still needed to establish that there was a medical necessity to prescribe controlled substances and a therapeutic benefit. Tr. 154. While Dr. Owen acknowledged Respondent’s notation that he had counseled B.B., Dr. Owen testified that this was not an adequate safeguard to prevent abuse or diversion because this was B.B.’s third aberrant drug test. Id. Dr. Owen further testified that Respondent ‘‘need[ed] to have a long discussion with [B.B.] about the risk of addiction’’ and obtain a consultation by a specialist in addiction. In refutation, Respondent maintained that ‘‘the morphine said not detected, but the oxymorphone was positive, so that was explainable.’’ Id. at 335. And he again maintained that ‘‘the lab always said that if ‘‘the Xanax was positive,’’ then nordiazepam, oxazepam and Xanax ‘‘could all three be positive.’’ Id. Continuing, Respondent testified that ‘‘temazepam, in our practice, usually didn’t show up,’’ so he checked B.B.’s PMP report to see if he had been PO 00000 Frm 00034 Fmt 4701 Sfmt 4703 prescribed Restoril (the name of the legend drug) but ‘‘couldn’t find it on the PMP.’’ Id. Respondent then maintained that ‘‘Dr. Schoelen didn’t mind his pain patient being on Restoril,’’ but ‘‘I did, and so I wanted to make sure, has he been prescribed Restoril.’’ Id. at 335–36. Respondent then testified that he was ‘‘sure’’ that he told B.B. that if he had ‘‘an old Restoril or some other doctor, I do consider that breaking our rules, and so you can’t take it.’’ Id. at 336. The CALJ again rejected the Government’s contention that Respondent violated 21 CFR 1306.04(a) when he issued the prescriptions, reasoning that ‘‘the record evidence does not support a finding that the August 25 or January 19 UDS results are aberrant.’’ R.D. at 54. While the CALJ again explained that ‘‘it is beyond argument that the June 1 UDS does present an anomaly, reliance on that event [was] not adequately notice by the Government in support’’ of its contentions regarding these prescriptions. Id. In addition, the CALJ found that Respondent ‘‘provided a thoughtful and reasoned explanation (based on his professional experience and knowledge of operating Tri-City) of why B.B. may have tested positive for temazepam despite not having been prescribed it.’’ Id. at 54–55. Taking the January 19 UDS in isolation, the CALJ explained that the Government did not ‘‘establish that the Respondent’s counseling B.B. to ‘only take what is prescribed’ fell below the standard of care in Oklahoma.’’ Id. at 55. The CALJ then rejected Dr. Owen’s testimony that Respondent should have referred B.B. to an addictionologist, explaining that ‘‘the existence of the UDS reports that are unavailable to the Government and/or unsupported by the evidence were integral to that recommendation, and their absence from a useful role in the record likewise undermines his testimony in this regards [sic].’’ Id. However, as explained above, even though the June 1 UDS was not specifically referenced in the Show Cause Order with respect to the February 13 prescriptions, the issues of the aberrant nature of the June 1 test (as well as the August 25 test) were litigated by consent. As for the CALJ’s assertion that the record does not support a finding that the August 25 and January 19 UDS results were aberrant, Respondent’s testimony and the notation he placed on the report of the January 19 test establish that both tests were aberrant in that B.B. was taking a medication which Respondent had not prescribed to him and which was not listed on the PMP reports, including one E:\FR\FM\23MRN2.SGM 23MRN2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices srobinson on DSK5SPTVN1PROD with NOTICES2 that went back as far as August 27, 2010. Moreover, none of Dr. Schoelen’s progress notes ever mentioned that B.B. was taking Restoril or temazepam, whether prescribed by Dr. Schoelen or another authorized prescriber. And while the CALJ noted that Respondent provided a thoughtful and reasoned explanation as to ‘‘why B.B. may have tested positive for temazepam,’’ the fact of the matter is that in his testimony, Respondent never maintained that he even asked B.B. if he had an old prescription for the drug and who prescribed it to him. Thus, B.B. may have tested positive for the drug because he was obtaining it without a prescription. As for the CALJ’s assertion that the Government provided no evidence that Respondent’s action in counseling B.B. to take only what he was prescribed fell below the standard of care, the CALJ’s reasoning rests on the erroneous premise that this was B.B.’s first aberrant drug test. However, for reasons explained previously, it was his third aberrant test in less than eight months, and each of his last three tests produced an aberrational result.47 In rejecting Dr. Owen’s testimony that Respondent needed to obtain a consultation, the CALJ further asserted that Oklahoma’s referral standard (which uses the language ‘‘may require’’) is ‘‘permissive’’ and not ‘‘directive.’’ R.D. at 55. The provision is, however, more appropriately read as conferring a degree of discretion which must be exercised within the bounds of ‘‘sound clinical judgment,’’ Policy Statement, at 2; and which is necessarily dependent on the facts and circumstances presented by the patient. Thus, in contrast to the CALJ, I give weight to Dr. Owen’s testimony that based on B.B.’s multiple aberrational tests, Respondent needed to obtain a consultation with a specialist in addiction. Moreover, as Respondent did not require an office visit, I also give weight to Dr. Owen’s testimony that Respondent had still not established medical necessity to justify the continued prescribing of controlled substances. Accordingly, I conclude that the Opana and Morphine prescriptions lacked a legitimate medical purpose and 47 However, I do not rely on the January 19 UDS result that morphine was not detected. In contrast to the results which showed the presence of drugs which B.B. had not been prescribed, B.B. was five days past 30 days (the number of days the morphine prescription would have lasted if taken as directed), and the Government put forward no evidence that morphine would still be detectable five days later. While B.B.’s having been five days late raises other issues (such as whether he should have been going through withdrawal by January 19), the Government elicited no such testimony from Dr. Owen. VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 that Respondent acted outside of the usual course of professional practice in issuing them. 21 CFR 1306.04(a). The March 13, 2012 Prescriptions On March 13, 2012, Respondent issued B.B. new prescriptions for both 120 Opana 10 and 90 Morphine Sulfate ER 15. See GX 5, at 10, 24. Respondent issued the prescriptions without requiring an office visit by B.B. Tr. 156; see generally GX 3, at 42–62 (visit notes for B.B.). Nor is there any notation on any of the visit notes regarding Respondent’s issuance of these prescriptions.48 Dr. Owen testified that Respondent should have required an office visit before issuing these prescriptions, reiterating that Respondent still had not established ‘‘medical necessity for’’ prescribing controlled substances to B.B. Tr. 155. Asked to again identify the deficiencies which led him to conclude that Respondent had not established medical necessity, Dr. Owen explained: Reviewing all the pertinent previous medical records, including what previous treatments have been performed, an adequate history and physical exam, consultations as medically appropriate, establishing a clinically meaningful and objective therapeutic benefit, and addressing any aberrant drug-taking behaviors. Id. at 157. Dr. Owen again noted that there were three previous incidents of aberrant drug-taking behaviors, and that ‘‘[t]he only treatment plan has been continuing the controlled substances without medical necessity.’’ Id. at 158. And once again, Dr. Owen testified that the prescriptions lacked a legitimate medical purpose and ‘‘were not’’ issued in the usual course of professional practice. Id. In his direct testimony, Respondent did not address his reasons for issuing the March 13 Opana and morphine prescriptions. See Tr. at 338–39. Instead, the questioning centered on the issue of why he wrote a prescription on March 14 for Nexium, ‘‘a stomach medicine’’ and a non-controlled drug (‘‘I have no idea’’) after which the questioning moved on to the next set of prescriptions. Id. Here again, the CALJ concluded that the Government’s evidence was not sufficient to sustain the allegations that Respondent violated 21 CFR 1306.04(a) in issuing the prescriptions. According to the CALJ, ‘‘there [was] no persuasive 48 As found above, on the January 27, 2012 visit note, Respondent had written that on ‘‘2/13/12’’ he prescribed ‘‘Zpack, Prednisone 10 mg # 28, Phenergan.’’ GX 3, at 44. The same visit note contains a further entry for ‘‘2–22–12’’ documenting the issuance of a prescription for 60 tablets of Soma (carisoprodol) 350 mg. Id. PO 00000 Frm 00035 Fmt 4701 Sfmt 4703 14977 evidence to support the conclusion that the absence of an office visit by B.B., standing alone, render[ed] this prescribing event below the prevailing medical standard in Oklahoma.’’ R.D. at 56. Again noting that under 21 CFR 1306.12(b), which allows for the issuance of multiple schedule II prescriptions to provide up to a 90-day supply provided certain conditions are met, the CALJ concluded that ‘‘without persuasive expert or state regulatory guidance, evidence [of] the failure to conduct an in-person office visit does not establish that this prescribing event fell below the standard of care required in Oklahoma.’’ Id. And in rejecting the allegations, the CALJ further cited the purported permissive nature of the State’s documentation standard and asserted that ‘‘none of the UDS results raised by Dr. Owen in his testimony were adequately noticed by the Government regarding this prescribing event.’’ Id. As for the CALJ’s assertion that the UDS results were not adequately noticed, in the Show Cause Order, the Government alleged with respect to these prescriptions that Respondent ‘‘once again issued [B.B.] controlled substance prescriptions . . . without taking appropriate steps to monitor his controlled substances use despite the persistent red flags of abuse and diversion he previously presented.’’ ALJ Ex. 1, at 5 (¶ 3h). Even if this was not enough to provide Respondent with notice that the three UDSs would be at issue with respect to these prescriptions, Respondent did not object when the Government asked Dr. Owen: ‘‘[a]re there any aberrant drug-taking behaviors here?’’ and he answered: ‘‘[t]here has [sic] been three previous.’’ Tr. 158. I thus conclude that Respondent consented to the litigation of the issue. As for the CALJ’s assertion that there is no persuasive evidence that standing alone, the absence of an office visit rendered these prescriptions below the prevailing medical standard, the Respondent’s prescribing without requiring an office visit does not stand alone. Rather, Dr. Owen credibly identified multiple deficiencies in Respondent’s evaluation of B.B.’s pain complaint, including his failure to perform an adequate history and physical, his failure to properly evaluate how B.B.’s pain was effecting his ability to function, his failure to determine if the controlled substances were providing a therapeutic benefit and to try conservative treatments, and his failure to address the multiple instances of aberrant behavior. Of further note, Respondent offered no evidence refuting E:\FR\FM\23MRN2.SGM 23MRN2 14978 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices srobinson on DSK5SPTVN1PROD with NOTICES2 Dr. Owen’s testimony regarding these prescriptions. I thus conclude that these prescriptions lacked a legitimate medical purpose and that Respondent acted outside of the usual course of professional practice in issuing them. 21 CFR 1306.04(a). The April 12 Prescriptions On April 12, 2012, B.B. saw Respondent for an office visit. GX 3, at 42. According to the visit note, B.B. ‘‘report[ed] his pain has been worse,’’ that ‘‘[h]e has run out of his medicines; he had them stolen,’’ and that ‘‘[h]e has done fairly well.’’ Id. Moreover, on the Treatment Objective Evaluation section of the Treatment Plan, Respondent wrote ‘‘fair → yes’’ and made an arrow pointing to ‘‘yes’’ in the block for ‘‘Has patient achieved treatment objective?’’ and ‘‘6’’ in the block for ‘‘Patient Completed . . . update [sic] pain scale.’’ Id. at 28. In the visit note, Respondent wrote that B.B. ‘‘still has severe anxiety and depression’’ and has been ‘‘exposed to someone with HPV’’; Respondent then wrote: ‘‘[h]e is also wanting to switch his medicines because he is having trouble finding the OPANA.’’ Id. Respondent also noted: ‘‘[p]ast medical history extensively reviewed and placed in chart.’’ Id. In his exam findings, Respondent noted ‘‘[l]ow back paraspinal and spinal tenderness,’’ ‘‘[n]egative straight leg raise,’’ and ‘‘[n]euro intact.’’ Id. Respondent listed his diagnoses as ‘‘[l]umber disc disease,’’ ‘‘[a]nxiety and depression’’ and ‘‘[e]xposure to infectious disease’’ although he ‘‘doubt[ed] that it was HPV.’’ Id. Respondent then changed B.B.’s medications to Opana ER (extended release) 20 mg, b.i.d. (twice per day) and Percocet 10 mg (q. 12h) p.r.n. (as needed) for acute pain. Id.; see also Tr. 340. He also prescribed Soma (carisoprodol) one tablet b.i.d. GX 3, at 42. Respondent further documented that he discussed the ‘‘[a]ddictive, dependence, and tolerance nature of the medicines, as well as alternatives.’’ Id. He noted that he ‘‘suggested’’ ‘‘[n]onmedicinal pain and anxiety-relieving modalities.’’ Id. During this visit, Respondent also required B.B. to provide a UDS. The preliminary screening found that B.B. was negative for opiates and morphine. And according to the confirmatory testing done by the lab, which was reported back to Respondent on April 17, 2012, B.B. tested positive for oxymorphone, which was expected based on Respondent’s having prescribed Opana to him. Id. He also VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 tested positive for meprobamate, which was expected based on Respondent’s having prescribed carisoprodol to B.B. Id. However, the lab further found that morphine was ‘‘not detected,’’ a result which was ‘‘not expected’’ because Respondent had prescribed morphine sulfate ER to B.B. on March 13, 2012. Id. Dr. Owen also noted that while ‘‘the confirmed . . . drug test [was] positive for some of these drugs,’’ Respondent had reported that he had run out of his medicines and that there was a ‘‘lack of documentation of what he ran out of and what he should still be on.’’ Tr. 167. Dr. Owen found it problematic that B.B. had told Respondent that his pain was worse, that he had run out of his medicines and had them stolen. Id. at 159. As he explained: Well, one, his pain is worse, so why is it worse? Two is he’s run out of his medications, and then he had them stolen. What is it? Did you run out of them because you self-escalated, or were they stolen and you ran out of them? It needs clarification. But either event, self-escalation or having them stolen, is a red flag. Id. Regarding B.B.’s report that his medications were stolen, Dr. Owen testified that because there had ‘‘been the aberrant urine drug tests before . . . this, there is [sic] enough aberrant behaviors that’’ Respondent needed ‘‘to get the person to an addictionologist or a psychologist, or just stop prescribing these controlled substances since there’s no evidence they’re helping this gentleman.’’ Id. at 212–13. Dr. Owen also found problematic the notations in the visit note that B.B. reported that ‘‘his pain has been was worse’’ and that ‘‘[h]e has done fairly well.’’ Id. at 160. As Dr. Owen testified, the statement that ‘‘[h]e has done fairly well . . . kind of conflicts with his pain is worse and the aberrant drug-taking behavior, so that’s an unreliable statement.’’ Id. Dr. Owen also explained that B.B.’s having ‘‘severe anxiety and depression . . . are relative contraindications to prescribing controlled substances . . . [b]ecause it magnifies [the] perception of pain and disability.’’ Id. Dr. Owen then testified that because of these conditions, Respondent should have requested a ‘‘consultation by a psychologist’’ but did not. Id. at 160–61. Dr. Owen further testified that Respondent ‘‘did not’’ address B.B.’s ‘‘ongoing stress and anxiety issues’’ and that ‘‘[h]e did not’’ conduct a thorough patient history. Id. at 166. He then testified that Respondent had changed B.B.’s treatment plan by adding Percocet, but that Respondent ‘‘change[d] the medications without PO 00000 Frm 00036 Fmt 4701 Sfmt 4703 ever . . . documenting [a] medical rationale to add any new medication.’’ Id. Asked by the CALJ ‘‘why would someone add Percocet,’’ Dr. Owen testified that it is a short-acting opioid that could be added ‘‘for break-through pain, if that’s not being controlled well.’’ Id. at 167. Dr. Owen reiterated his earlier testimony that the patient record was ‘‘not adequate’’ to establish ‘‘medical necessity’’ for prescribing the controlled substances on this date and that between September 22, 2011 (when he assumed the care of B.B.) and April 12, 2012, Respondent had never established medical necessity for prescribing controlled substances to B.B. Id. at 173– 74. He then opined that the prescriptions Respondent issued at this visit were issued outside of the usual course of professional practice and lacked a legitimate medical purpose. Id. at 174. The CALJ sustained the Government’s allegations only with respect to its contention that Respondent ignored the PMP data showing that B.B. was obtaining early refills of alprazolam and failed to take any action in response to this information, such as contacting the other prescribers or cautioning B.B. in response to this information. R.D. at 61– 62. For reasons explained previously, the evidence does not support the contention that B.B. exhibited a pattern of obtaining early refills as of this visit. I also agree with the CALJ that the evidence does not support a finding that Respondent provided B.B. with an early refill of his pain medications. However, for many of the same reasons previously discussed, the CALJ rejected the other evidence offered by the Government to prove that the prescriptions violated 21 CFR 1306.04(a). For example, the CALJ again reasoned that ‘‘the UDS results prior to the April 12 amino assay UDS’’ were not ‘‘adequately noticed by the Government . . . regarding this prescribing event [and] are unavailable to support its expert’s opinion here.’’ R.D. at 60. And the CALJ further asserted that the Government could not rely on litigation by consent because it did ‘‘not timely and affirmatively raise[]’’ this theory. Id. However, as discussed previously, paragraph 3 of the Show Cause Order provided adequate notice that various aberrant drug tests would be at issue throughout the proceeding.49 And even 49 As the Show Cause Order alleged: From on or about August 25, 2011 through on or about May 9, 2012, you issued controlled substance[] prescriptions to B.B. in violation of Federal and Oklahoma state law. You were aware on each of the occasions that you issued controlled substance[] prescriptions to B.B. that he presented E:\FR\FM\23MRN2.SGM 23MRN2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices srobinson on DSK5SPTVN1PROD with NOTICES2 if it did not, the record fully supports the conclusion that the issue was litigated by consent as, given the absence of an objection, the Government had no obligation to affirmatively raise the argument (which it did in its Exceptions) until the CALJ issued his Recommended Decision. The CALJ also failed to give weight to Dr. Owen’s testimony that Respondent should have either referred B.B. to a specialist in addiction or spoken with his mental health professional, asserting that the Government did ‘‘not establish[ ] that good medical practice in Oklahoma require[d] that.’’ R.D. at 60. However, Dr. Owen is board-certified in pain management, a member of multiple national professional societies which focus on pain medicine and is a peer reviewer on pain medicine for the Journal of Pain Management. As previously explained, while the Oklahoma referral provision does not categorically require that a physician refer a patient to a specialist in addiction or consult with other providers, it clearly contemplates that a physician will use sound clinical judgment in determining whether a referral or consultation is necessary. And as to whether Respondent exercised sound clinical judgment when he neither referred B.B. to an addictionologist nor consulted with his mental health providers, Respondent produced no evidence showing that the standard of care in Oklahoma is materially different from the standard in Texas or the standard that is generally recognized by pain management practitioners. See United States v. Joseph, 709 F.3d at 1096. In rejecting the Government’s evidence, the CALJ also explained that the Government did not establish that ‘‘good medical practice in Oklahoma require[d]’’ that Respondent ‘‘document[] in any specific level of detail the Respondent’s discussion with B.B. about . . . [his] success on the treatment plan.’’ R.D. at 60. Yet the Board’s Regulation directs that ‘‘[t]he physician should periodically review the course of pain treatment’’ and ‘‘[c]ontinuation or modification of controlled substances for pain management therapy depends on the physician’s evaluation of progress a high risk of abuse and/or diversion of controlled substances, as evidenced by the red flags documented in his patient file, such as aberrant urine drug tests, a request for early refills, and a claim of stolen drugs. You failed to address and, in fact, ignored these red flags, continuing to issue B.B. controlled substance prescriptions in the face of mounting evidence that he was misusing, abusing, and/or diverting the controlled substances you were prescribing. ALJ Ex. 1, at 1 ¶ 3. VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 toward treatment objectives. Satisfactory response to treatment may be indicated by the patient’s decreased pain, increased level of function or improved quality of life. Objective evidence of improved or diminished function should be monitored . . . ’’ Okla. Admin. Code § 435:10–7–11(4). Moreover, another provision of the regulation requires physicians to ‘‘keep accurate and complete records to include . . . follow-up evaluations . . . . [and] periodic reviews.’’ Id. § 435:10–7–11(6). And the Board’s Policy Statement explains that ‘‘[a]ll such prescribing must be based on clear documentation of unrelieved pain’’ and that ‘‘the validity of the physician’s treatment of the patient’’ will be judged ‘‘based on available documentation.’’ Policy Statement, at 2. Moreover, even if the Board’s rule does not mandate ‘‘any specific level of detail,’’ Dr. Owen offered credible testimony as to why the standard of care clearly requires more documentation than that made by Respondent. As he explained, ‘‘the purpose of documentation is for continuity of care. Not only continuity of care for this same provider from visit to visit but continuity of care should somebody else assume the care later on down the road or should you need to get a consultation, that the consultant can read your notes and understand what was happening with this patient at this point in time.’’ Tr. 210. Notably, while B.B.’s treatment objective was to return to work without pain, B.B. had not returned to work as of the April 12 visit (and never did during the course of Respondent’s prescribing) and yet in the box for documenting whether he was meeting his treatment objective, Respondent wrote the words ‘‘fair’’ and ‘‘yes.’’ Yet at the hearing, Respondent did not recall why he wrote ‘‘yes,’’ just as he was ‘‘unsure’’ as to why he had written ‘‘fair’’ in the box at previous visits. As Respondent could not even explain why he made these entries, it is clear that no other physician who subsequently took over B.B.’s care could ‘‘understand what was happening with’’ B.B. at various points. So too, as Respondent could not explain the inconsistency between his having noted in B.B.’s progress note that ‘‘his pain was worse’’ while B.B. reported a decrease in his numeric pain rating and that ‘‘he has done fairly well,’’ I give weight to Dr. Owen’s testimony that Respondent’s notes fell below the standard of care. Finally, the CALJ declined to give weight to Dr. Owen’s testimony regarding Respondent’s failure to address the aberrant immunoassay drug PO 00000 Frm 00037 Fmt 4701 Sfmt 4703 14979 test result once again asserting that the Board’s regulations ‘‘contain no specific directive to mandate such a notation.’’ R.D. at 61. However, as the CALJ noted, ‘‘Respondent did not address this issue in his testimony’’ and thus, there is no dispute that he took no action other than to send the specimen in for confirmatory testing. While it is true that Dr. Owen testified that the immunoassay test has reliability problems and thus, by sending the specimen to the lab for further testing ‘‘it could not be said that [Respondent] took no action,’’ what is notable is that Respondent offered no testimony that he ever asked B.B. which drugs had been purportedly stolen and when they had been stolen. Obviously, without determining and documenting what drugs had been stolen, Respondent could not evaluate whether the lab’s finding (using GC–MS testing) that B.B. had tested negative for morphine was aberrational.50 Moreover, even crediting Respondent’s testimony regarding the notation that B.B. wanted to switch medications because he was having troubling finding immediate release Opana, his testimony regarding the limitations imposed by the Medicaid formulary, and his explanation for why he provided B.B. with Percocet, I still conclude that the Government has proved that Respondent violated 21 CFR 1306.04(a) when he issued the Opana 20 ER and Percocet 10 prescriptions at this visit. As Dr. Owen testified, Respondent still had not done a thorough patient history and evaluation of B.B.’s pain complaint; failed to properly address multiple instances of aberrant behavior including the three previous UDSs and the other red flags he presented (i.e., the claims of stolen medications and having run out of them); never consulted with B.B.’s mental health providers notwithstanding Respondent’s finding that B.B. had severe anxiety and depression and that these are relative contraindications to prescribing controlled substances; never determined which drugs were stolen from B.B. or which drugs he ran out of thus rendering the UDS he obtained at this visit useless; never resolved inconsistencies in B.B.’s report of pain; and never established that the controlled substances provided a therapeutic benefit and that there was a 50 While Respondent offered testimony to the effect that pain patients will maintain ‘‘a stash’’ of controlled substances in the event their medications are stolen, and asserted that B.B. did this as well, he offered no explanation as to how B.B. could have accumulated a stash of extended release medications (such as Morphine Sulfate ER, the drug which was not detected) while still managing pain. E:\FR\FM\23MRN2.SGM 23MRN2 14980 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices srobinson on DSK5SPTVN1PROD with NOTICES2 medical necessity for the prescriptions. Also, while Dr. Owen did not specifically cite Respondent’s failure to try conservative treatments such as physical therapy when he testified regarding these two prescriptions, the evidence shows that Respondent never referred B.B. for physical therapy. Of further note, Respondent could not explain why he made the entries of ‘‘fair’’ and ‘‘yes’’ for whether B.B. was meeting his treatment objective, when he acknowledged that B.B.’s treatment objective was to return to work but never did so. And while he essentially agreed with Dr. Owen’s testimony that a patient with depression and anxiety has a higher perception of pain and is at greater risk of self-escalating his use of controlled substances, he nonetheless maintained that while ‘‘[i]n every other field but mental health we do’’ consult with the patient’s other practitioners, consulting with mental health practitioners who are ‘‘also prescribing controlled substances . . . [t]hat doesn’t happen very often.’’ Tr. 410. I thus conclude that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when, on this date, he issued the Opana and Percocet prescriptions to B.B. 21 CFR 1306.04(a). The April 25 Prescriptions On April 25, 2012, Respondent provided B.B. with a prescription for 30 Roxicodone (oxycodone) 15 mg. GX 5, at 4. B.B.’s file contains no documentation that there was an office visit, and notwithstanding that this was a change in medication from what Respondent had prescribed at the previous visit, there is no notation in the progress notes as to why he changed the prescription. See generally GX 3; see also Tr. 174–75. Moreover, while Respondent testified that he would ‘‘routinely’’ make an entry in the Treatment Objective Evaluation section of the Pain Management Treatment Plan ‘‘if we were making a change in a medication,’’ Tr. 357, no such entry was made on this date. See GX 3, at 28. Nor is there any documentation in the patient file that Respondent addressed with B.B. the aberrant drug test result (the non-detection of morphine) which had been reported to him on April 17. See generally GX 3. According to Dr. Owen, when adding a new drug to a patient’s regimen of pain medications, a physician ‘‘would have to establish medical necessity with some type of note, using sound medical rationale.’’ Tr. 175. Dr. Owen further testified that making such a notation is ‘‘a standard of care, and it’s part of the documentation guidelines that are VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 issued across every state for the most part.’’ Id. Asked if he could think of a reason why a physician ‘‘would add a drug for the first time without seeing a patient,’’ Dr. Owen answered: ‘‘No. Or at least documenting the medical rationale and establishing medical necessity.’’ Id. at 176. Dr. Owen then testified that Respondent did not take appropriate steps to establish medical necessity for the prescription, reiterating his earlier testimony that Respondent had not demonstrated that conservative care had been tried and been unsuccessful, as well as that there was a ‘‘clinically meaningful and objective therapeutic benefit from the previous use of controlled substances.’’ Id. He again opined that the prescription was not issued in the usual course of professional practice and lacked a legitimate medical purpose. Id. Regarding the Roxicodone prescription, Respondent asserted that he ‘‘was just doing a two-week trial, trying to figure out his dose, and at the time, most likely the patient didn’t have any punches on his card left, and Roxicodone is much cheaper than Percocet, and it’s the same medication.’’ Id. at 355. However, Respondent did not document any of this in B.B.’s record. Nor did he explain why he failed to follow his routine of making an entry in the Treatment Objective Evaluation section of the Pain Management Treatment Plan given that he had changed B.B.’s medication. As for the April 12 UDS lab report, which he had obtained prior to issuing the prescription and which found that morphine was not detected and that this result was not expected based on the prescribed medications, Respondent testified that in his opinion the result was not aberrant. Respondent did not explain whether this was based on his previous claim that the oxymorphone is a metabolite of morphine or because B.B. had reported that his medications were stolen. Tr. 364–66. As Respondent offered no testimony that he asked B.B which of his drugs were stolen and was told that it was the morphine, B.B.’s claim of stolen drugs does not render the test non-aberrant. Moreover, the lab reports noted various instances in which the presence of various metabolites was consistent with prescribed medications and that the particular substances were metabolites of prescribed drugs but included no such notation with respect to oxymorphone and morphine. Finally, Respondent’s testimony is contradicted by science and he offered no evidence which would support a finding that he had a good faith but mistaken belief that oxymorphone is a metabolite of PO 00000 Frm 00038 Fmt 4701 Sfmt 4703 morphine. Based on these reasons, I find that the April 12 UDS was aberrant and that Respondent knew it to be. While the CALJ concluded that the Government could not rely on the four UDS reports, he nonetheless found that the evidence supported the Government’s contention that Respondent acted outside of the usual course of professional practice in issuing the prescriptions. R.D. at 64. While the CALJ accepted Respondent’s assertion that Percocet and Roxicodone are similar drugs in that they both contain oxycodone (although he noted that Roxicodone does not contain acetaminophen and contains only oxycodone), id. at n.119, he explained that Respondent did not merely provide a refill but was changing B.B.’s medications. Id. at 63–64. While the CALJ then noted Dr. Owen’s opinion that the standard of care required the ‘‘establish[ment] of medical necessity with some type of note, using sound medical rationale,’’ the CALJ then explained that ‘‘it is not the documentation of the medical determination that carries the day here. Rather, it is whether the evidence or record supports the Respondent’s proposition that he made such a determination; and it does not.’’ Id. at 64. And while again asserting erroneously that the Oklahoma regulation stating that ‘‘[t]he medical record . . . should document the presence of one or more recognized medical indications for the use of a controlled substance’’ is permissive, id. (emphasis added by CALJ), he concluded that Respondent acted outside of the usual course of professional practice because he neither documented an indication for a medication change nor could ‘‘remember it in a way that is persuasive.’’ 51 Id. While I agree with the CALJ that Respondent’s testimony was unpersuasive, I also give weight to Dr. Owen’s testimony that Respondent had not established medical necessity for prescribing controlled substances by demonstrating that conservative treatments had been tried and been unsuccessful and by establishing an ‘‘objective therapeutic benefit from the previous use of controlled substances.’’ Tr. 176. Moreover, Dr. Owen’s testimony as to the other reasons why 51 Unexplained by the CALJ is why he did not apply the same reasoning to Respondent’s testimony that he was ‘‘unsure’’ as to why, on various occasions, he wrote ‘‘fair’’ in the block for noting whether B.B. had achieved his treatment objective as well as to why he wrote ‘‘yes’’ when B.B never returned to work during the course of Respondent’s prescribing to him. E:\FR\FM\23MRN2.SGM 23MRN2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices the Respondent did not establish a medical necessity for the previous prescriptions likewise applies to the Roxicodone prescription issued on this date. Finally, once again B.B. provided an aberrant drug test which Respondent ignored (and could not properly evaluate). I therefore conclude that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed Roxicodone to B.B. on this date. srobinson on DSK5SPTVN1PROD with NOTICES2 The May 9, 2012 Prescriptions On May 9, 2012, Respondent wrote B.B. a prescription for 60 Opana ER 20 mg. GX 3, at 93; GX 5, at 27. Respondent did not require an office visit, and he made no notations in the progress notes regarding the prescription. See generally GX 3; see also Tr. 177–78. Regarding the prescription, Dr. Owen again testified that Respondent ‘‘needed to establish medical necessity for continuation of controlled substances’’ and ‘‘did not.’’ Id. at 178. Asked to provide his opinion as to Respondent’s prescribing of controlled substances from September 2011 through May 9, 2012, Dr. Owen opined that Respondent did not adequately review B.B.’s medical history. Id. He further opined that the treatment plan ‘‘would have the logic behind the treatment’’ and would have ‘‘establish[ed] that conservative care has not been helpful and that [an] objective and clinically meaningful therapeutic benefit from the use of controlled substances has been established, if [they] ha[d] previously been used.’’ Id. Dr. Owen then testified that none of the controlled substance prescriptions Respondent issued to B.B. were issued in the usual course of professional practice and for a legitimate medical purpose. Id. at 178–79. Asked why he refilled the prescriptions,52 Respondent testified 52 In her questioning of Respondent, Respondent’s counsel referred to a Roxicodone prescription as having been issued on May 9, 2012, and in his testimony regarding the prescriptions he wrote on that date, Respondent referred to both a Roxicodone prescription and an Opana ER 20 mg prescription. Tr. 356. While GX 5 contains a legible copy of the May 9, 2012 Opana ER prescription, see GX 5, at 27, it does not contain a copy of a Roxicodone prescription, and as for GX 3, the copy of the purported Roxicodone prescription is illegible. GX 3, at 93. Moreover, at no point did the Government put in issue whether Respondent violated 21 CFR 1306.04(a) when he issued the Roxicodone prescription. The Government did not mention this prescription in the specific allegation it made in the Show Cause Order regarding the events of May 9, 2012, see ALJ Ex. 1, at 6 ¶ 3(j); it did not mention the prescription in its Pre-hearing Statement, see ALJ Ex. 5, at 21; it did not question Dr. Owen about this prescription, see Tr. 177–78; and even after VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 that ‘‘I got a phone call that he was wanting his medicines refilled and that the [R]oxicodone had worked for him and et cetera, so we were converting him back into the one-month prescriptions in the Schedule IIs and going back to this three-month office visit.’’ Tr. 356. Respondent offered no testimony addressing Dr. Owen’s criticism that he still had not established that there was a medical necessity for prescribing controlled substances, which included the Opana. See generally id. at 356–57. The CALJ found that because he ‘‘had PMP data indicating that B.B. had previously engaged in a pattern of procuring early refills from multiple prescribers,’’ Respondent’s issuance of the prescription was ‘‘a breach of [his] obligation as a registrant to guard against the diversion of controlled substances.’’ R.D. at 67–68. The CALJ thus concluded that Respondent acted outside of the course of professional practice in issuing the Opana prescription.53 Id. at 68. Respondent testified about it, the Government did not argue in its post-hearing brief that Respondent issued this Roxicodone prescription in violation of 21 CFR 1306.04(a). Thus, I do not consider the prescription. 53 In his decision, the CALJ explained that ‘‘[a]lthough the Government’s pleadings do not specifically refer to the early refills in support of this prescribing event, the [Show Cause Order] alleges that the prescribing was effected ‘despite previous indications that B.B. was at risk for abuse or diversion of controlled substance[s].’’’ R.D. 67– 68 n.124 (quoting ALJ Ex. 1, at 6). The CALJ also noted that ‘‘[t]he Government Prehearing Statement alleges that the prescription for Opana was issued ‘despite previous indications that B.B. was at risk for abuse or diversion of controlled substances[s] . . . .’’’ Id. (quoting ALJ Ex. 5, at 21). The CALJ then explained that ‘‘[t]hese broadly-worded phrases supply sufficient notice . . . to constitute sufficient notice to use the PMP early refill evidence in support of this prescribing event.’’ Id. I am, however, left to wonder why the same reasoning did not apply to the multiple instances in which the CALJ asserted that the Government did not provide sufficient notice that it intended to rely on the various UDSs. Notably, paragraph 3 of the Show Cause Order alleged that: [f]rom on or about August 25, 2011 through on or about May 9, 2012, you issued controlled substance[] prescriptions to B.B. in violation of Federal and Oklahoma state law. You were aware on each of the occasions that you issued controlled substance[] prescriptions to B.B. that he presented a high risk of abuse and/or diversion of controlled substances, as evidenced by the red flags documented in his patient file, such as aberrant urine drug tests. . . . You failed to address and, in fact, ignored these red flags, continuing to issue B.B. controlled substance prescriptions in the face of mounting evidence that he was misusing, abusing, and/or diverting the controlled substances you were prescribing. ALJ Ex. 1, at 1. See also, e.g., id. at 3 (Sept. 22, 2011 Rxs: ‘‘You did not address with B.B. the now second aberrant drug screen in an approximately three month period’’ and ‘‘[y]ou took no other steps to monitor B.B’s controlled substance use, such as requiring him [to] take another drug screen due to the two failed ones’’); id. at 4 (Nov. 18 and Dec. 15 PO 00000 Frm 00039 Fmt 4701 Sfmt 4703 14981 While I agree with the CALJ that Respondent violated 21 CFR 1306.04(a) in issuing the prescription, I do so for reasons other than that B.B. had ‘‘engaged in a pattern of early refills.’’ As Respondent did not see B.B. on this date, I give weight to Dr. Owen’s testimony that Respondent did not establish medical necessity for the prescription (or any of the prescriptions for that matter) for the reasons he explained throughout his testimony as well as for the other reasons discussed in this Decision. * * * In his Recommended Decision, the CALJ alleges that the Agency ‘‘has been engaged in a deliberate winnowing of the scope of Factor 2, to the extent that . . . it now largely mirrors the considerations found in Factor 4.’’ R.D. 77. He further asserts that the Agency’s rejection of dicta which has appeared in various recommended decisions to the effect that Factor 2 ‘‘manifests Congress’s acknowledgement that . . . the quantitative volume in which an applicant has engaged in the dispensing of controlled substances may be [a] significant factor’’ in the public interest determination, see JM Pharmacy Group, Inc., 80 FR 28667, 28684 (2015), is inconsistent with the plain meaning of Factor 2. R.D. 77–81. Congress did not, however, define the term ‘‘experience’’ in the CSA, and as the Administrator has explained at length, the word has multiple meanings, none of which ‘‘compels the conclusion that Congress acknowledged that the quantitative volume of an applicant’s dispensing may be a significant consideration under this factor, and certainly none [of these definitions] suggests that the Agency is required to count up the number of times an applicant or registrant has dispensed controlled substances,’’ JM Pharmacy Group, 80 FR at 28667 n.1, let alone compare the number of lawful dispensings against those shown to be unlawful, as some registrants have argued. See, e.g., Syed-Jawed AkhtarZaidi, 80 FR 42961, 42967 (2015) (arguing that physician was denied a ‘‘fair adjudication’’ where the Government based its case only on undercover visits but had seized 400 patient files from physician’s office and yet ‘‘failed to present any evidence . . . Rxs: alleging that ‘‘you did not take any steps to monitor [B.B.’s] controlled substances use despite his history of misusing, abusing, or diverting controlled substances’’); id. at 5 (Mar. 13, 2012 Rxs: ‘‘you once again issued him controlled substance[] prescriptions . . . without taking appropriate steps to monitor his controlled substance use despite the persistent red flags of abuse and diversion he previously presented’’). E:\FR\FM\23MRN2.SGM 23MRN2 14982 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices srobinson on DSK5SPTVN1PROD with NOTICES2 that the treatment of those patients failed to meet the standard of care,’’ as well as any evidence regarding the treatment of ‘‘over 400 additional patients’’’ whose charts were not seized), pet. for rev. denied, 841 F.3d 707, 713 (6th Cir. 2016). Notably, the CALJ does not cite to any of the sources typically invoked by the courts in cases which have held that a statute has a plain meaning.54 See, e.g.,Williams v. Taylor, 529 U.S. 420, 431–32 (2000) (giving statutory text its ‘‘ordinary, contemporary, common meaning’’ based on definitions from Webster’s New International Dictionary and Black’s Law Dictionary); United States v. Labonte, 520 U.S. 751, 757–58 (1997) (giving statutory text ordinary meaning by reference to same dictionaries); Levorsen v. Octapharma Plasma, Inc., 828 F.3d 1227, 1231 (10th Cir. 2016) (relying on Webster’s Third New International Dictionary for meaning of statutory terms). And while ‘‘[t]he plainness or ambiguity of statutory language is [also] determined by reference to the . . . specific context in which that language is used, and the broader context of the statute as a whole,’’ Yates v. United States, 135 S.Ct. 1074, 1082 (2015), nothing in the context of providing factors for determining the public interest supports the notion that the term ‘‘experience’’ requires a consideration of the quantitative volume of an applicant’s dispensing. As previously explained, Congress enacted the public interest standard to provide DEA with additional authority to address the diversion of controlled substances because prior to the 1984 amendment of section 823(f), the Agency’s authority to deny an application or revoke a registration was limited to cases in which a practitioner: (1) Had materially falsified an application, (2) had been convicted of a State or Federal felony offense related to controlled substances, or (3) had his 54 As the Administrator noted in JM Pharmacy, the word ‘‘experience’’ has multiple meanings. Among those most relevant in assessing its meaning as used in the context of Factor Two are: (1) The ‘‘direct observation of or participation in events as a basis for knowledge,’’ (2) ‘‘the fact or state of having been affected by or gained knowledge through direct observation or participation,’’ (3) ‘‘practical knowledge, skill, or practice derived from direct observation of or participation in events or in a particular activity,’’ and (4) ‘‘the length of such participation.’’ See Merriam-Webster’s Collegiate Dictionary 409 (10th ed. 1998); see also The Random House Dictionary of the English Language 681 (2d ed. 1987) (defining experience to include ‘‘the process or fact of personally observing encountering, or undergoing something,’’ ‘‘the observing, encountering, or undergoing of things generally as they occur in the course of time,’’ ‘‘knowledge or practical wisdom gained from what one has observed, encountered, or undergone’’). VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 State license or registration suspended, revoked, or denied. See S. Rep. No. 98– 225, at 266 (1983), as reprinted in 1984 U.S.C.C.A.N. 3182, 3448. Finding that the ‘‘[i]mproper diversion of controlled substances’’ was ‘‘one of the most serious aspects of the drug abuse problem,’’ and yet ‘‘effective Federal action against practitioners ha[d] been severely inhibited by the [then] limited authority to deny or revoke practitioner registrations,’’ id., Congress concluded that ‘‘the overly limited bases in current law for denial or revocation of a practitioner’s registration do not operate in the public interest.’’ Id. The Senate Report thus explained that ‘‘the bill would amend 21 U.S.C. 824(f) [sic] to expand the authority of the Attorney General to deny a practitioner’s registration application.’’ Id. The Report further explained that ‘‘in those cases in which registration is clearly contrary to the public interest, the amendment would allow a swift and sure response to the danger posed to the public health and safety by the registration of the practitioner in question.’’ Id. at 267, as reprinted in 1984 U.S.C.C.A.N. at 3449. Accordingly, section 823(f) was amended to provide the Agency with authority to deny an application based upon a finding that the issuance of a registration ‘‘would be inconsistent with the public interest,’’ upon consideration of the five public interest factors, including the experience factor. Id. See also 21 U.S.C. 824(a)(4). Nowhere in the Report’s discussion of the amendments to sections 823 and 824 is there any support for the notion that Congress deemed the quantitative volume of a practitioner’s dispensings to be a significant consideration in making findings under the experience factor.55 Indeed, as Krishna-Iyer explained, because the CSA limits registration to those practitioners who possess authority under state law to dispense controlled substances in the course of professional practice, and patients with legitimate medical conditions routinely seek treatment from licensed medical 55 As the CALJ noted, one of the House Reports explained that ‘‘[t]he second factor shall not, of course, be construed in anyway to hinder registration of recent graduates of professional schools who may have no professional experience dispensing or conducting research with controlled substances.’’ H.R. Rep. No. 98–835, Pt. 1, at 14. Obviously, if Factor Two’s meaning was so plain, the Judiciary Committee had no need to express that it should not be construed to deny registrations to newly-licensed practitioners, most of whom can point to no volume of dispensings other than by observing a physician during clinical rotations. Thus, the Committee’s direction refutes the notion that the quantitative volume of an applicant’s dispensings may be a significant consideration under the factor. PO 00000 Frm 00040 Fmt 4701 Sfmt 4703 professionals, every registrant can undoubtedly point to an extensive body of legitimate prescribing over the course of his professional career. See KrishnaIyer, 459 FR at 463. Thus, in past cases, this Agency has given no more than nominal weight to a practitioner’s evidence that he has dispensed controlled substances to thousands of patients in circumstances which did not involve diversion. See, e.g., Caragine, 63 FR at 51599 (‘‘[T]he Government does not dispute that during Respondent’s 20 years in practice he has seen over 15,000 patients. At issue in this proceeding is Respondent’s controlled substance prescribing to 18 patients.’’); id. at 51600 (‘‘[E]ven though the patients at issue are only a small portion of Respondent’s patient population, his prescribing of controlled substances to these individuals raises serious concerns regarding [his] ability to responsibly handle controlled substances in the future.’’); see also Medicine Shoppe—Jonesborough, 73 FR 364, 386 & n.56 (2008) (noting that pharmacy ‘‘had 17,000 patients,’’ but that ‘‘[n]o amount of legitimate dispensings can render . . . flagrant violations [acts which are] ‘consistent with the public interest.’’’), pet. for review denied, Medicine ShoppeJonesborough v. DEA, slip. op. at 11 (6th Cir. Nov. 13, 2008). As in past cases, the parties may continue to introduce evidence as to the extent of both a practitioner’s lawful or unlawful dispensing activities. However, under Agency precedent, proof of a single act of intentional or knowing diversion remains sufficient to satisfy the Government’s prima facie burden and to impose on a respondent the obligation to produce evidence to show that it can be entrusted with a registration. See Krishna-Iyer, 74 FR 459, 463 (2009); see also Alan H. Olefsky, 57 FR 928, 928–29 (1992) (revoking registration based on physician’s presentation of two fraudulent prescriptions to pharmacy and noting that the respondent ‘‘refuses to accept responsibility for his actions and does not even acknowledge the criminality of his behavior’’). The CALJ further alleges that on remand in Krishna-Iyer, the Agency failed to follow the Eleventh Circuit’s unpublished decision, in which the Administrator was directed to consider 12 additional patient files as well as the ‘‘entire corpus’’ of the physician’s controlled substance dispensing for evidence of the physician’s ‘‘positive experience’’ in dispensing controlled substances. R.D. 79. However, the Administrator carefully reviewed those files, and noted that the files ‘‘included E:\FR\FM\23MRN2.SGM 23MRN2 srobinson on DSK5SPTVN1PROD with NOTICES2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices numerous instances in which [the physician] appear[ed] to have ignored warning signs that the patient was either abusing or diverting controlled substance’’; she also made findings with respect to multiple incidents. 74 FR at 460–61 n.3. And as for the ‘‘entire corpus’’ of the physician’s prescribing, notwithstanding the physician had not introduced any evidence as to the propriety of her prescribing to the ‘‘thousands of other patients’’ she had treated, the Administrator assumed that every one of those prescriptions was lawfully issued. Id. at 461. However, as the Administrator explained, even if those prescriptions were lawfully issued, they did not negate the Government’s prima facie showing that the physician had knowingly diverted drugs to others. Id. at 462–63. And while the Administrator granted the physician a new registration, she made clear that had the physician not acknowledged her misconduct, she would have again revoked the physician’s registration. Id. at 463. Not mentioned by the CALJ is that several years later, the exact same arguments were raised before the Eleventh Circuit by two different physicians and rejected without any discussion. In Lynch v. DEA, a physician whose registration was revoked by the Agency for unlawful prescribing,56 argued that the Agency’s Decision arbitrarily ‘‘limited its consideration of [his] experience to only ten prescriptions issued to out of state patients, the two undercover patients, and the use of a rubber stamp on nine prescriptions . . . and did not consider the evidence that he had been dispensing controlled substances for over twenty years,’’ and thus ‘‘fail[ed] to consider the overwhelming evidence of positive experience.’’ See Brief of Petitioner 31–32, Lynch v. DEA, No. 11– 10207–EE (11th Cir. 2011) (citing Krishna-Iyer, M.D., v. DEA, 249 Fed. Appx. 159, 161 (11th Cir. 2007) (unpublished)). Notably, the Eleventh Circuit denied the physician’s petition for review, holding that the revocation of the physician’s registration ‘‘was not arbitrary, capricious, an abuse of discretion or contrary to law.’’ Lynch v. DEA, Slip. Op. at 4 (11th Cir. May 22, 2012) (per curiam). Indeed, the Court of Appeals did not even deem the respondent’s argument to warrant discussion. See id. at 2–4. So too, in McNichol v. DEA, another physician whose registration was revoked for issuing unlawful prescriptions to four undercover officers relied on Krishna-Iyer to argue that the 56 See Ronald Lynch, 75 FR 78745 (2010). VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 Agency’s final decision was arbitrary and capricious because the investigation ‘‘failed to take into account any positive conduct on [his] part’’ and ‘‘intentionally ignored any evidence not specifically related to the undercover patients.’’ Brief of Petitioner 21–23, McNichol v. DEA, No. 12–15292 (11th Cir. 2013) (citing Krishna-Iyer, 249 Fed. Appx. at 161). Of note, the Agency’s Decision specifically rejected the ALJ’s assertion that the Government was required to review the patient charts for patients other than the undercover officers and look for evidence of the physician’s ‘‘positive prescribing practices’’ so as to ‘‘develop evidence to enlighten the administrative record.’’ T.J. McNichol, 77 FR 57133, 57146 (2012). The Administrator further explained that ‘‘[h]aving garnered evidence of what it believed to be unlawful prescriptions issued to the four undercover officers, the Government was entitled to go to hearing with that evidence.’’ Id. Again, the Eleventh Circuit denied the physician’s petition for review, holding that ‘‘the record supports that the administrator considered all aspects of the evidence in light of the applicable statutory factors and . . . [her] decision was not arbitrary and capricious. . . . [w]e also agree with the administrator’s conclusion that [the physician’s] continued registration would be inconsistent with the public interest.’’ McNichol v. DEA, Slip. Op. at 4 (11th Cir. Oct. 17, 2013) (per curiam). Here again, the Court did not deem Respondent’s argument to warrant discussion. The CALJ also dismisses the published decision of the Tenth Circuit in MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011), asserting that ‘‘the Agency’s view of Factor 2 was not a focus of the court’s decision.’’ R.D. 80 (emphasis added). Therein, after the Agency revoked the physician’s registration based on his unlawful prescribing to two patients, the physician argued on review that: The DEA must consider the totality of the experiences a physician has, including: the interaction reflected in each of the medical charts of patients that were seized by the DEA, the ‘‘thousands of other patients . . . [and] positive experience’’ with dispensing controlled substances and not merely the testimony of people trying to make a case against the physician. The DEA, in fact, flat out disregarded the substantial experience Dr. MacKay has had with dispensing controlled substances. The law requires the DEA to consider evidence that reflects that the physician is not a danger to the public and delineates how the DEA must do so. PO 00000 Frm 00041 Fmt 4701 Sfmt 4703 14983 Brief of Petitioner, 13–14, MacKay v. DEA. Moreover, after discussing the affidavits of several patients who testified that Dr. MacKay had provided medically appropriate, and in some instances, beneficial treatment for their pain, Respondent argued that ‘‘[t]he DEA decision is based only on the medical charts of a few patients out of thousands Dr. MacKay has successfully treated over the years. In fact . . . the DEA’s expert only reviewed twelve patient files and testified about even fewer.’’ Id. at 20. Notwithstanding that the Agency’s decision was based entirely on the evidence with respect to two patients (K.R. and M.R.), see Dewey C. MacKay, 75 FR 49956, 49972 (2009); the Tenth Circuit rejected Respondent’s contention that the Agency had failed to consider his ‘‘positive experience’’ evidence. As the Court of Appeals explained: Despite Dr. MacKay’s claim to the contrary, the Deputy Administrator considered the entire record, including the evidence in Dr. MacKay’s favor. She determined, however, that none of Dr. MacKay’s evidence negated the DEA’s prima facie showing that Dr. MacKay had intentionally diverted drugs to K.D. and M.R. Indeed, she found that even if Dr. MacKay had provided proper medical care to all of his other patients, that fact would not overcome the government’s evidence with regard to M.R. and K.D. None of the evidence presented by Dr. MacKay undermines the evidence relating to M.R. and K.D. Although numerous patients and colleagues of Dr. MacKay related their positive experiences with him, none had any personal knowledge regarding his treatment of M.R. and K.D. Notably, Dr. MacKay’s medical expert . . . failed to specifically discuss and justify Dr. MacKay’s treatment of M.R. and K.D. As a result, none of Dr. MacKay’s evidence contradicts the testimony and evidence presented by the DEA relating to the knowing diversion of drugs to these two patients. 664 F.3d at 819. The Court of Appeals then rejected MacKay’s contention that the Deputy Administrator had misweighed the public interest factors. As the Court explained: ‘‘[i]n light of Dr. MacKay’s misconduct relating to factors two and four, the government made a prima facie showing that [his] continued registration is inconsistent with the public interest.’’ Id. (citing 75 FR at 49977). And the Court further explained that ‘‘[a]lthough Dr. MacKay may have engaged in the legitimate practice of pain medicine for many of his patients, the conduct found by the Deputy Administrator with respect to K.D. and M.R. is sufficient to support her determination that his continued registration is inconsistent with the public interest.’’ Id. E:\FR\FM\23MRN2.SGM 23MRN2 srobinson on DSK5SPTVN1PROD with NOTICES2 14984 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices The CALJ further asserts that ‘‘to the extent that the ever-widening range of activity that the Agency considers ‘positive experience’ is banned, Factor 2 analysis, in the majority of Agency cases, will largely consist of a reprise of evidence also considered under Factor 4.’’ R.D. 81. Continuing, the CALJ contends that ‘‘[t]he Government’s ability to introduce alleged acts of malfeasance will warrant double consideration under Factor 2 and again under Factor 4, but respondents will remain unable to demonstrate that a transgression constituted an isolated occurrence when compared with even many years of compliant practice as a registrant.’’ Id. The CALJ is mistaken. As JM Pharmacy made clear, ‘‘[a]s in past cases, the parties may continue to introduce evidence as to the extent of both a practitioner’s lawful or unlawful dispensing activities.’’ 80 FR at 28668 n.2. Indeed, in these proceedings, the Agency will assume, without requiring the production of any evidence by a respondent, that the practitioner has lawfully issued every prescription other than those alleged by the Government to be unlawful. And contrary to the CALJ’s understanding, notwithstanding the Agency’s rejection of the notion that ‘‘the plain meaning’’ of Factor 2 mandates the consideration of ‘‘the quantitative volume’’ of a respondent’s dispensing, a respondent may still argue that his conduct was ‘‘an isolated occurrence when compared with even many years of compliant practice’’ or an ‘‘aberration.’’ R.D. 81–82. Equally misplaced is the CALJ’s assertion that the Government’s evidence of unlawful prescribing will hence be given double consideration in the public interest determination. Id. at 82. While evidence of a respondent’s unlawful prescribing is clearly relevant in assessing both his/her experience in dispensing controlled substances and compliance with applicable laws related to controlled substances and thus typically discussed under both factors— indeed, because of the overlap between the factors, the Agency has long discussed both factors together—this does not mean that the prescriptions have been double weighted. See, e.g., Albert Lepis, 51 FR 17555, 17555–56 (1986). As the Agency’s decision on remand in Krishna-Iyer explained, ‘‘[w]hether this conduct is evaluated under factor two . . . or factor four, or both [factors], is of no legal consequence. In establishing [the Government’s] prima facie case, the fundamental question is whether [a] [r]espondent ‘has committed such acts as would render [his] VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 registration inconsistent with the public interest.’ ’’ 57 74 FR at 462 (quoting 21 U.S.C. 824(a)(4)). Moreover, as both the Agency and federal courts have recognized, findings under a single factor can support the denial of an application or the revocation of a registration. See MacKay, 664 F.3d at 821 (quoting Krishna-Iyer, 74 FR at 462). While the Agency has explained that proof of a single act of intentional or knowing diversion remains sufficient to satisfy the Government’s prima facie burden and to impose on a respondent the obligation to produce evidence to show that he can be entrusted with a registration, this is not the result of double weighting the misconduct. See Krishna-Iyer, 74 FR at 463; see also MacKay, 664 F.3d at 819. Rather, it is based on the recognition that a violation of the prescription requirement (21 CFR 1306.04(a)) ‘‘strikes at the CSA’s core purpose of preventing the abuse and diversion of controlled substances.’’ Samuel Mintlow, 80 FR 3630, 3653 (2015); accord David A. Ruben, 78 FR 38363, 38386 (2013). Accordingly, the Agency has held that where the Government proves that a practitioner has engaged in knowing or intentional diversion, a respondent is not entitled to be registered (or maintain an existing registration) absent a credible acceptance of responsibility.58 As the Tenth Circuit has recognized: . . . the DEA may properly consider whether a physician admits fault in determining if the physician’s registration should be revoked. When faced with evidence that a doctor has a history of distributing controlled substances unlawfully, it is reasonable for the . . . Administrator to consider whether that doctor will change his or her behavior in the future. And that consideration is vital to whether continued registration is in the 57 While Krishna-Iyer involved a revocation proceeding, the public interest inquiry is essentially the same where the Agency proposes the denial of an application. 58 In Krishna-Iyer, the Agency explained that ‘‘while some isolated decisions . . . may suggest that a practitioner who committed only a few acts of diversion was entitled to regain his registration even without having to accept responsibility for his misconduct, see Anant N. Mauskar, 63 FR 13687, 13689 (1998), the great weight of the Agency’s decisions are to the contrary.’’ 74 FR at 464. Noting that ‘‘[t]he diversion of controlled substances has become an increasingly grave threat to this nation’s public health and safety,’’ the Agency clarified its policy and explained that ‘‘[t]o the extent Mauskar, or any other decision of this Agency suggests otherwise, it [wa]s overruled.’’ Id. at 464 n.9. Continuing, the Agency explained that because of the grave and increasing harm to public health and safety caused by the diversion of prescription controlled substances, even where the Agency’s proof establishes that a practitioner has committed only a few acts of knowing or intentional diversion, this Agency will not grant or continue the practitioner’s registration unless he accepts responsibility for his misconduct. Id. at 464. PO 00000 Frm 00042 Fmt 4701 Sfmt 4703 public interest. Without Dr. MacKay’s testimony, the Deputy Administrator had no evidence that Dr. MacKay recognized the extent of his misconduct and was prepared to remedy his prescribing practices. MacKay, 664 F.3d at 820 (citing Hoxie v. DEA, 419 F.3d 477, 483 (2005)). Thus, contrary to the CALJ’s understanding, a respondent can still argue (as he/she always could) that his/ her misconduct in knowingly or intentionally diverting controlled substances was ‘‘an isolated occurrence’’ or an ‘‘aberration’’ in his/ her years of otherwise compliant professional practice. However, one cannot argue that his/her conduct was ‘‘an isolated occurrence’’ or ‘‘an aberration’’ without first acknowledging that he/she has engaged in unlawful conduct.59 And in any case, Respondent has made no such argument. Summary of Factors Two and Four While Respondent put on no evidence as to the lawfulness of his controlled substance prescribing to patients other than B.B., I have assumed that every other prescription he has issued in the course of his professional career complied with 21 CFR 1306.04(a).60 Nonetheless, as found above, 59 The CALJ also asserts that in JM Pharmacy, ‘‘the Agency determined in clear terms that it will no longer consider whether established misconduct presented an isolated piece of an applicant’s record, irrespective of whether the misconduct is intentional or otherwise.’’ R.D. at 82 (emphasis added). To the contrary, in JM Pharmacy, the Administrator denied two applications for pharmacy registrations, expressly adopting the CALJ’s conclusion that the owner of the two pharmacies had ‘‘knowingly and materially falsified the applications he submitted.’’ 80 FR at 28669; see also id. at 28683 (CALJ’s Recommended Decision: ‘‘It is clear that the Respondents, through their common owner . . . knew or should have known that the answers provided to Question 2 were false, and that their . . . applications contained material falsifications. The absence of any logical basis for confusion and the past experience of [their owner] as a registrant holder and pharmacist preponderantly support a finding that the misrepresentations were intentional, not negligent. . . . [E]ven standing alone, the denial of the Respondent’s . . . applications is adequately supported on this record based on the material falsifications set forth in the filed applications.’’) (emphasis added); id. at 28689 (CALJ noting that owner’s ‘‘insistence that his false response to an application query . . . was simply not credible and defeats the Respondents’ efforts to meet the Government’s case. The false misrepresentation[s] . . . are sufficiently egregious on their face to warrant sanction’’). Thus, JM Pharmacy does not support the CALJ’s assertion that the Agency does not consider a respondent’s level of culpability in committing misconduct. 60 This assumption may actually be more favorable to Respondent than what is warranted with respect to his experience in dispensing controlled substances. In 2008, Respondent was sanctioned by the Board for ‘‘prescribing controlled dangerous substances’’ over the course of a threeyear period to a patient with whom he had sexual relations. RX 3, at 2. E:\FR\FM\23MRN2.SGM 23MRN2 Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices Respondent issued multiple prescriptions for various schedule II narcotics outside the course of professional practice and which lacked a legitimate medical purpose. 21 CFR 1306.04(a). Moreover, the evidence in no sense shows that Respondent was merely neglectful, but rather supports a finding that Respondent acted with knowledge that B.B. was abusing and/or diverting the controlled substances he prescribed. And while the evidence of record does not support a finding that Respondent unlawfully prescribed to any other patient, it is significant that his misconduct went on for eight months and involved 19 prescriptions for schedule II narcotics alone. Thus, I conclude that Respondent has engaged in egregious misconduct which supports the denial of his registration. See MacKay, 75 FR at 49997; Krishna-Iyer, 74 FR at 463; Olefsky, 57 FR at 928–29. I therefore hold that the Government has established its prima facie case that Respondent’s registration ‘‘would be inconsistent with the public interest.’’ 21 U.S.C. 823(f). Sanction Where, as here,61 the Government has met its prima facie burden of showing that issuing a new registration to the applicant would be inconsistent with the public interest, a respondent must come forward with ‘‘‘‘‘sufficient mitigating evidence’’’’’ to show why he can be entrusted with a new registration. Medicine ShoppeJonesborough, 73 FR 364, 387 (2008) (quoting Samuel S. Jackson, 72 FR srobinson on DSK5SPTVN1PROD with NOTICES2 61 So too, the egregiousness and extent of a registrant’s misconduct are significant factors in determining the appropriate sanction. See Jacobo Dreszer, 76 FR 19386, 19387–88 (2011) (explaining that a respondent can ‘‘argue that even though the Government has made out a prima facie case, his conduct was not so egregious as to warrant revocation’’); Paul H. Volkman, 73 FR 30630, 30644 (2008); see also Paul Weir Battershell, 76 FR 44359, 44369 (2011) (imposing six-month suspension, noting that the evidence was not limited to security and recordkeeping violations found at first inspection and ‘‘manifested a disturbing pattern of indifference on the part of [r]espondent to his obligations as a registrant’’); Gregory D. Owens, 74 FR 36751, 36757 n.22 (2009). As explained above, Respondent’s misconduct in knowingly issuing multiple prescriptions in violation of 21 CFR 1306.04(a) is egregious and supports the denial of his registration and not the issuance of a registration subject to conditions. Indeed, this is not a close call. VerDate Sep<11>2014 17:59 Mar 22, 2017 Jkt 241001 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 MacKay v. DEA, 664 F.3d at 820; 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). Finally, the Agency has also held that ‘‘‘[n]either Jackson, nor any other agency decision, holds . . . that the Agency cannot consider the deterrent value of a sanction in deciding whether a registration should be [suspended or] revoked.’’’ Joseph Gaudio, 74 FR 10083, 10094 (2009) (quoting Southwood Pharmaceuticals, Inc., 72 FR 36487, 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’’). Even with respect to the violations which he found proven, the CALJ found that ‘‘one clear and consistent aspect of the record is the Respondent’s almost dogged determination to accept no responsibility for his actions.’’ R.D. 92. This holds equally true with respect to each of the controlled substance prescriptions he issued in violation of 21 CFR 1306.04(a), as other than his meager acknowledgement that his documentation on certain progress notes could have been better, Respondent has not accepted responsibility for his PO 00000 Frm 00043 Fmt 4701 Sfmt 9990 14985 misconduct with respect to any of the controlled substance prescriptions he unlawfully issued to B.B. beginning on September 22, 2011 and ending on May 9, 2012. And as explained above, the evidence supports the conclusion that Respondent was not merely neglectful, but that he engaged in knowing misconduct when he issued the prescriptions. As the Tenth Circuit has recognized, Respondent’s failure to acknowledge his misconduct establishes that he is not prepared to remedy his unlawful prescribing practices. MacKay, 664 F.3d at 820. This alone supports the conclusion that he cannot be entrusted with a new registration.62 So too, while the Agency’s interest in specific deterrence is not triggered (because I deny his application), as found above, Respondent’s misconduct is egregious and the Agency has a manifest interest in deterring similar misconduct by other practitioners. This interest would be compelling even if it was not the case that the nation was confronting an epidemic of opioid abuse. I therefore conclude that granting Respondent’s application ‘‘would be inconsistent with the public interest.’’ 21 U.S.C. 823(f). Accordingly, I will deny his application. Order Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 CFR 0.100(b), I order that the application of Wesley Pope, M.D., for a DEA Certificate of Registration as a practitioner, be, and it hereby is, denied. This Order is effective immediately. Dated: March 16, 2017. Chuck Rosenberg, Acting Administrator. [FR Doc. 2017–05676 Filed 3–22–17; 8:45 am] BILLING CODE 4410–09–P 62 Even if Respondent had credibly accepted responsibility for his misconduct, he has offered no evidence of any remedial training he has undertaken in controlled substance prescribing. While the CSA does not impose a time bar on a practitioner’s ability to reapply for a registration, the rules of the Agency are clear. Thus, to obtain favorable consideration of any new application, Respondent must both credibly acknowledge his misconduct in prescribing to B.B. and provide evidence of remedial training he has undertaken in the proper prescribing of controlled substances. E:\FR\FM\23MRN2.SGM 23MRN2

Agencies

[Federal Register Volume 82, Number 55 (Thursday, March 23, 2017)]
[Notices]
[Pages 14944-14985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05676]



[[Page 14943]]

Vol. 82

Thursday,

No. 55

March 23, 2017

Part II





Department of Justice





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Drug Enforcement Administration





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Wesley Pope, M.D.; Decision and Order; Notice

Federal Register / Vol. 82 , No. 55 / Thursday, March 23, 2017 / 
Notices

[[Page 14944]]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 15-8]


Wesley Pope, M.D.; Decision and Order

    On October 8, 2014, the former Deputy Assistant Administrator of 
the then-Office of Diversion Control, issued an Order to Show Cause to 
Wesley Pope, M.D. (hereinafter, Respondent), of Newcastle, Oklahoma. 
ALJ Ex. 1, at 1. The Show Cause Order proposed the denial of 
Respondent's application for a new Certificate of Registration as a 
practitioner in schedules II through V, on the ground that his 
registration would be ``inconsistent with the public interest.'' Id. 
(citing 21 U.S.C. 823(f)).
    As support for the proposed denial, the Government alleged that 
``[f]rom on or about August 25, 2011 through on or about May 9, 2012, 
[Respondent] issued controlled substance prescriptions to [patient] 
B.B. in violation of Federal and Oklahoma . . . law.'' Id. The 
Government specifically alleged that ``on each of the occasions that 
[Respondent] issued controlled substance prescriptions to B.B.,'' 
Respondent was ``aware . . . that he presented a high risk of abuse 
and/or diversion of controlled substances, as evidenced by the red 
flags documented in his patient file, such as aberrant urine drug 
tests, a request for early refills, and a claim of stolen drugs.'' Id. 
The Government then alleged that Respondent ``failed to address and, in 
fact, ignored these red flags, continuing to issue B.B. controlled 
substances [sic] prescriptions in the face of mounting evidence that he 
was misusing, abusing, and/or diverting the controlled substances [he 
was] prescribing.'' Id. The Government further alleged that ``[t]he 
prescriptions [Respondent] issued to B.B. on each visit were below the 
standard of care in Oklahoma and fell outside the usual course of 
professional practice.'' Id. at 1-2 (citing 21 CFR 1306.04(a); Okla. 
Admin. Code Sec.  435:10-7-4; id. Sec.  435:70-7-11 \1\; Okla. Bd. of 
Med. Lic. & Super., Use of Controlled Substances for the Treatment of 
Pain (Mar. 10, 2005)). The Show Cause Order then alleged that on 11 
different dates, Respondent issued to B.B. prescriptions for such drugs 
as hydrocodone/acetaminophen, Opana (oxymorphone), fentanyl patches, 
morphine sulfate, oxycodone/acetaminophen, and Soma (carisoprodol) 
which were ``invalid.'' Id. at 2-6. The Government also provided 
detailed factual allegations pertaining to each of the prescriptions. 
Id.
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    \1\ This is an apparent typographical error as there is no such 
provision. The parties, however, spent considerable time arguing as 
to whether Respondent complied with Okla. Admin. Code Sec.  435:10-
7-11, which governs the ``Use of Controlled Substances for the 
Management of Chronic Pain.''
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    Respondent requested a hearing on the allegations. The matter was 
then placed on the docket of the Office of Administrative Law Judges 
and assigned to Chief Administrative Law Judge John J. Mulrooney, II 
(hereinafter, CALJ). Following pre-hearing procedures, the CALJ 
conducted a hearing on April 7-8, 2015 in Oklahoma City, Oklahoma. 
During the hearing, both parties submitted documentary evidence; the 
Government elicited the testimony of several witnesses and Respondent 
testified on his own behalf.
    On July 24, 2015, the CALJ issued his Recommended Decision (cited 
as R.D.). Therein, the CALJ found that the allegations were sustained 
only with respect to five of the dates on which Respondent prescribed 
(and with respect to four of these dates, only sustained in part). See 
R.D. 44, 46, 62, 64, 68. While the CALJ concluded that Respondent had 
issued these prescriptions outside of the course of professional 
practice and thus violated 21 CFR 1306.04(a), id. at 90, he further 
reasoned that Respondent's misconduct reflected ``inattention to detail 
[and] not intentional diversion.'' Id. at 82. He thus concluded that 
while the Government had made out a prima facie case to warrant some 
form of sanction, Respondent's conduct was not sufficiently egregious 
to warrant denial even though he found that ``Respondent was 
irresponsible in continuing to prescribe to this patient in the face of 
red flags of diversion, and in failing to document or even possess the 
ability to persuasively convey a medically-based justification for 
prescribing new controlled medication.'' Id. at 92-93. And even though 
Respondent had failed to accept responsibility and put forward no 
evidence of remedial measures he had undertaken, the CALJ recommended 
that he be granted a new registration subject to a one-year period of 
probation with various conditions. Id.
    The Government filed Exceptions to the Recommended Decision and 
Respondent filed a Response to the Government's Exceptions. Thereafter, 
the record was forwarded to my Office for Final Agency Action.
    Having considered the record in its entirety including the 
Recommended Decision, the Government's Exceptions, and Respondent's 
Response to the Government's Exceptions, I agree with the CALJ's 
findings and legal conclusion with respect to the first prescribing 
event (August 25, 2011). While I agree with the CALJ's legal 
conclusions that Respondent acted outside of the usual course of 
professional practice when he prescribed controlled substances during 
the third, fourth, tenth, eleventh, and twelfth prescribing events, I 
hold that several of the exceptions raised by the Government are well 
taken and that additional relevant evidence should be considered in 
review of the record. Based on my consideration of the record as a 
whole, I, as the ultimate fact-finder, conclude that a preponderance of 
the evidence supports the conclusions that Respondent knowingly 
diverted controlled substances by issuing prescriptions in violation of 
21 CFR 1306.04(a) when he prescribed various schedule II controlled 
substances on 11 occasions, beginning on September 22, 2011 and ending 
on May 9, 2012.
    I further find that Respondent's misconduct is egregious and 
establishes a prima facie case for denial. Because I also agree with 
the CALJ that the record reflects Respondent's ``almost dogged 
determination to accept no responsibility for any of his actions'' and 
that he ``has not presented even the most modest plan for any remedial 
action,'' R.D. 92, I conclude that his application should be denied.

The Government's Exceptions

    In its Exceptions, the Government raises multiple contentions, 
several of which warrant discussion prior to making factual findings. 
The first of these is that the CALJ erroneously concluded that the 
Oklahoma Medical Board's Standards ``on which the Government relied 
were permissive rather than mandatory.'' Exceptions, at 5. Indeed, in 
making his legal conclusions, the CALJ repeatedly declined to give 
weight to the Government Expert's testimony on material issues, 
reasoning that the Expert's testimony was premised on his 
misunderstanding that the Board's regulations, in particular its 
documentation and recordkeeping rules, were mandatory rather than 
permissive.
    Second, the Government maintains that the CALJ erroneously held 
that the Government failed to provide adequate notice to Respondent of 
its intent to rely on the various aberrant drug tests as part of its 
proof that various prescriptions were issued in violation of 21 CFR 
1306.04(a). With respect to this exception, the Government argues that 
not only did it provide adequate notice, the aberrant nature of the 
various urine drug screens (UDS) was litigated by consent. Exceptions, 
at 15-25. It also takes exception to the CALJ's finding

[[Page 14945]]

that several of the UDSs were not aberrant.

The CALJ's Conclusion That the Board's Standards Are Permissive

    Throughout his Recommended Decision, the CALJ repeatedly declined 
to give weight to the Government Expert's testimony that Respondent 
failed to conduct a medically adequate evaluation of B.B.'s pain 
complaint and establish medical necessity to justify the prescribing of 
controlled substances. The basis of the CALJ's reasoning was that the 
deficiencies identified by the Expert ``generally relate to a paucity 
of documented proof in the chart entries as to whether or how much 
various medical treatment considerations that he favors were considered 
by the Respondent in making his prescription decision.'' R.D. at 35. 
Based on his conclusion that the provisions of the Oklahoma Board's 
rules applicable to a physician's documentation of his evaluation of a 
patient and recordkeeping are ``permissive'' and not mandatory, the 
CALJ reasoned that ``Respondent's alleged lack of documentation . . . 
is likely not as fatal to the Respondent's adherence to the standard of 
care in Oklahoma as the Government expert claims.'' R.D. 16. I 
disagree.
    With respect to the evaluation of the patient, the Oklahoma Rule 
states:

    A medical history and physical examination must be obtained, 
evaluated and documented in the medical record. The medical record 
should document the nature and intensity of the pain, current and 
past treatments for pain, underlying or coexisting diseases or 
conditions, the effect of the pain on physical and psychological 
function and history of substance abuse. The medical record also 
should document the presence of one or more recognized medical 
indications for the use of a controlled substance.

Okla. Admin. Code Sec.  435:10-7-11(1). And with respect to medical 
records, the Oklahoma Rule states in relevant part that ``[r]ecords 
should remain current'' and that ``[t]he physician should keep accurate 
and complete records.'' Id. Sec.  435:10-7-11(6). The records are ``to 
include . . . the medical history and physical examination (including 
vital signs),'' ``diagnostic, therapeutic and laboratory results,'' 
``evaluations, consultations and follow-up evaluations,'' ``treatment 
objectives,'' ``discussion of risks and benefits,'' ``informed 
consent,'' ``treatments,'' ``medications (included date, type, dosage 
and quantity prescribed),'' ``instructions and agreements and periodic 
reviews.'' Id. In the CALJ's view, because the provisions of the 
Oklahoma regulation applicable to the documentation of the physician's 
evaluation of his patient and his recordkeeping use the word ``should'' 
in expressing the State's rules, the obligations they impose are 
``permissive.'' R.D. at 16.
    The CALJ, however, cited no authority from either the Board or the 
Oklahoma courts definitively interpreting the word ``should'' as used 
in the context of these two provisions as ``permissive.'' See, e.g., 
id. at 6. Indeed, the CALJ's conclusion appears to have been based 
entirely on the fact that the Board's prior version of its intractable 
pain rule used such words as ``requires'' and ``must'' in setting forth 
a practitioner's obligations with respect to documentation and 
recordkeeping. See R.D. 87 n.147 (quoting Okla. Admin. Code Sec.  
435:10-7-11(b) (2004): ``[t]his rule requires that a diagnosis be 
documented'' and id. Sec.  435:10-7-11(j): ``[a]ccurate and complete 
records to document compliance with this section must be kept''). In 
the CALJ's view, ``[t]he evolution of the [regulations] demonstrate 
[sic] that their permissive nature represents an intentional re-
direction by Oklahoma.'' Id.
    However, when the Board promulgated the current version of the rule 
in 2005, it simply noted that ``[t]he rule is being updated based on 
recommendations from the Federation of State Medical Boards.'' 22 Okla. 
Reg. 2096 (June 15, 2005); see also 22 Okla. Reg. 379 (Notice of 
Rulemaking Intent; Feb. 1, 2005). In short, the CALJ's reliance on the 
Board's decision to adopt the Federation of State Medical Board's model 
rule simply proves too much.
    Furthermore, although the word ``should'' is susceptible to 
different meanings, when used in the context of legal requirements, it 
generally does not connote ``permission'' but rather obligation or 
duty. United States v. Anderson, 798 F.2d 919, 924 (7th Cir. 1986) 
(``The common interpretation of the word `should' is `shall' and thus a 
straight-forward construction of [the Code of Judicial Conduct] reveals 
that it imposes a mandatory rule of conduct upon a judge.'') \2\; 
Wollschlaeger v. Farmer, 814 F.Supp.2d 1367, 1376 (S.D.Fl. 2011) 
(``Generally, laws that provide for disciplinary action in the cases of 
violations or noncompliance are mandatory, not precatory or hortatory. 
. . .''); see also Bureau of Prisons v. FLRA, 737 F.3d 779, 787 (D.C. 
Cir. 2013) (`` `Should' is typically used to express an obligation or 
duty.'') (citing Webster's Third International Dictionary 2104 (1976)); 
see also Webster's Third International Dictionary 2104 (defining 
``should'' as ``used in auxiliary function to express duty, obligation, 
necessity, propriety or expediency'').
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    \2\ As the Seventh Circuit also noted, ``as listed in Roget's 
Thesaurus, [the word ``should''] means `be obliged, must . . . have 
to.' The common interpretation of the word `should' is `shall.' '' 
798 F.2d at 924.
---------------------------------------------------------------------------

    Moreover, reading the Board's documentation and recordkeeping 
provisions as permissive cannot be squared with the Oklahoma Medical 
Practice Act. Cf. Wollschlaeger, 814 F.Supp.2d at 1376 (rejecting 
interpretation that statute which used ``should'' was hortatory when 
State law provided that violations of provision constituted grounds for 
disciplinary action). Under the Medical Practice Act, a physician's 
``[f]ailure to maintain an office record for each patient which 
accurately reflects the evaluation, treatment, and medical necessity of 
treatment of the patient'' constitutes ``unprofessional conduct.'' 50 
Okla. Stat. Ann. Sec.  509(18). Another provision of the Medical 
Practice Act states that ``[a]dequate medical records to support 
diagnosis, procedures, treatment, or prescribed medications must be 
produced and maintained.'' Id. Sec.  509(20) (emphasis added). And a 
further provision of the Medical Practice Act makes ``[p]rescribing . . 
. controlled substances or narcotic drugs without medical need in 
accordance with published standards'' ``unprofessional conduct.'' Id. 
Sec.  509(16).
    Thus, construing the Board's documentation and recordkeeping rules 
as permissive would be fundamentally inconsistent with the Medical 
Practice Act's provisions on documentation and recordkeeping, which are 
clearly mandatory. See Abramski v. United States, 134 S.Ct. 2259, 2267 
n.6 (2014) (``[A] court should not interpret each word in a statute 
with blinders on, refusing to look at the word's function within the 
broader statutory context. As we have previously put the point, a 
`provision that may seem ambiguous in isolation is often clarified by 
the remainder of the statutory scheme . . . because only one of the 
permissible meanings produces a substantive effect that is compatible 
with the rest of the law.' '') (quoting United Sav. Assn. of Tex. v. 
Timbers of Inwood Forest Associates, Ltd., 484 U.S. 365, 371 (1988)). 
See also Jacobs v. New York Foundling Hosp., 577 F.3d 93, 99 (2d Cir. 
2009).
    Accordingly, the Board's Intractable Pain Rule's documentation and 
recordkeeping provisions are not

[[Page 14946]]

reasonably read as being permissive.\3\ Indeed, in the Policy Statement 
it issued contemporaneously with the promulgation of the Rule, the 
Board provided further evidence that the documentation and 
recordkeeping requirements are not permissive. For example, the Board 
explained that ``[a]ll such prescribing [of controlled substances for 
pain] must be based on clear documentation of unrelieved pain. To be 
within the usual course of professional practice, a physician-patient 
relationship must exist and the prescribing should be based on a 
diagnosis and documentation of unrelieved pain.'' Policy Statement, at 
2 (emphasis added). Were the CALJ's interpretation correct, what the 
Board required in the first sentence was then rendered permissive by 
the use of the word ``should'' in the following sentence. Indeed, if 
the word ``should'' rendered the rules permissive, a physician could 
prescribe controlled substances to his patient without even having 
formulated a diagnosis. This makes no sense and thus, the better view 
is that the words ``must'' and ``should'' have the same meaning: they 
impose mandatory obligations.
---------------------------------------------------------------------------

    \3\ In a series of cases involving the State of Florida's former 
regulation entitled ``Standards for the Use of Controlled Substances 
for Treatment of Pain'' (Fla. Admin. Code r. 64B8-9.013 (2009)), 
which adopted nearly verbatim the FSMB's text (including the 
respective uses of the words ``must'' and ``should'') in setting 
that State's documentation standard with respect to the evaluation 
of the patient, the CALJ explained that ``[c]onscientious 
documentation is repeatedly emphasized as not just a ministerial 
act, but a key treatment tool and a vital indicator to evaluate 
whether the physician's prescribing practices are `within the usual 
course of professional practice.' '' See, e.g., Roni Dreszer, 76 FR 
19434, 19448-49 (2011). So too here.
---------------------------------------------------------------------------

    In its Policy Statement, the Board also stated that it ``will judge 
the validity of the physician's treatment of the patient based on 
available documentation.'' Id. And finally, the Board stated that it 
``will not take disciplinary action against a physician for deviating 
from this policy when contemporaneous medical records document 
reasonable cause for deviation.'' Id. It makes no sense to advise 
physicians that the validity of their treatment decisions will be based 
on documentation and recordkeeping requirements if those provisions are 
not requirements at all, but rather, merely hortatory and aspirational 
pronouncements.
    Accordingly, I do not agree that the Government Expert's testimony 
as to the deficiencies in Respondent's evaluations of B.B. was based on 
the Expert's mistaken understanding of the scope of the Oklahoma 
Board's documentation and recordkeeping standards. Thus, while I fully 
agree with the CALJ that the Expert's ``testimony predictably raised no 
issues regarding credibility,'' I disagree with the CALJ's assertion 
that the Expert's ``testimony was not without its own `red flags.' '' 
R.D. 18. I therefore find that this exception is well taken.

The CALJ's Rulings That the Government Failed To Provide Adequate 
Notice of Its Intent To Rely on Various Urine Drug Screen Results as 
Probative Evidence of the Illegality of the Prescriptions

    Throughout his Recommended Decision, the CALJ repeatedly declined 
to consider the Government's evidence that Respondent failed to address 
an aberrant urine drug screen which showed that his patient B.B. was 
not taking a controlled substance that had been prescribed to him. See, 
e.g., R.D. at 38-39 n.75. In the CALJ's view, the Government did not 
provide adequate notice of its intent to rely on Respondent's failure 
to address an aberrant June 1UDS in either the Show Cause Order or its 
Pre-hearing Statements with respect to multiple prescriptions. See id. 
at 38-39 (Sept. 25, 2011 Rxs), 48 (Nov. 18 and Dec. 15, 2011 Rxs); 51 
(Jan. 19, 2012 Rxs); 54 (Feb. 13, 2012 Rxs), 56 (Mar. 13, 2012 Rxs), 60 
(April 12, 2012 Rxs), 64 n.121 (April 25, 2012 Rx). As support for his 
rulings, the CALJ maintained that ``the Agency has recently imposed an 
increased standard of notice on it administrative prosecutors.'' Id. at 
39 n.75 (citing Farmacia Yani, 80 FR 29053, 29064 n.28 (2015); Jana 
Marjenhoff, 80 FR 29067, 29068 (2015)). A review of these decisions 
shows, however, that the Agency has not ``imposed an increased standard 
of notice'' \4\ but simply applied the

[[Page 14947]]

extensive body of judicial precedent that addresses the adequacy of 
notice in administrative adjudication, which, as the Second Circuit has 
explained, ``is so peculiarly fact-bound as to make every case 
unique.'' Pergament United Sales, Inc. v. NLRB, 920 F.2d 130, 135 (2d 
Cir. 1990) (quoted in Marjenhoff, 80 FR at 29068); see also Marjenhoff, 
80 FR at 29067-68 (discussing court decisions on notice in 
administrative adjudication); Farmacia Yani, 80 FR at 29059 (same).
---------------------------------------------------------------------------

    \4\ According to the CALJ, in Farmacia Yani, ``the Government's 
notice was deemed insufficient in that although the alleged 
misconduct was disclosed and pursued, it did not include the correct 
regulation subsection in its [Show Cause Order] and prehearing 
statement.'' R.D. 66 (citing 80 FR at 29064 n.28). This, however, 
misstates the case.
    At issue in footnote 28 of Farmacia Yani was the Government's 
allegation that the pharmacy had filled Suboxone prescriptions which 
were clearly issued for maintenance or detoxification purposes by 
two physicians but which did not contain the requisite 
identification number or good faith statement establishing that the 
physician was authorized to prescribe Suboxone for these purposes. 
See 80 FR 29063-64. As the legal basis for the allegation, the 
Government cited 21 CFR 1306.04 and 1306.06. The first regulation 
includes, inter alia, subsection a, which makes it illegal for a 
pharmacist to knowingly fill a prescription issued outside of the 
usual course of professional practice and which lacks a legitimate 
medical purpose, and subsection c, which provides, in part, that a 
prescription may not be issued for maintenance or detoxification 
treatment unless ``the practitioner is in compliance with the 
requirements'' applicable to practitioners who prescribe Suboxone 
for maintenance or detoxification treatment. See 21 CFR 1306.04(a) & 
(c); id. Sec.  1301.28 (requirements for prescribing Suboxone for 
this purpose); see also id. Sec.  1306.06 (``A prescription for a 
controlled substance may only be filled by a pharmacist, acting in 
the usual course of his professional practice. . . .'').
    While the Decision noted that the Government had not identified 
the specific subsection of 1306.04 which it alleged was violated, it 
did not hold that the ``notice was deemed insufficient.'' R.D. 66. 
Indeed, while the Decision rejected the Government's contention that 
the pharmacist acted outside of the usual course of professional 
practice in violation of 1306.04(a) and 1306.06 for lack of 
evidence, 80 FR at 29064, and further noted that 1306.04(c) 
``impose[s] duties only on the issuer of [a] prescription which has 
been issued to provide maintenance or detoxification purposes,'' id. 
at n.28, the Decision nonetheless found that the pharmacy had 
violated another provision of the Agency's regulations. 
Specifically, the Decision found a violation based on 21 CFR 
1306.05(f), which imposes ``[a] corresponding liability . . . upon 
the pharmacist . . . who fills a prescription not prepared in the 
form prescribed by DEA regulations, '' 21 CFR 1306.05(f), and 21 CFR 
1306.05(b), which requires that such a prescription include either 
the prescriber's X number or good faith statement. See 80 FR at 
29064 & n.28 (citation omitted).
    Indeed, notwithstanding that the Government cited the wrong 
provision of the regulations, the respondent's principal did not 
dispute that her conduct in filling these prescriptions was a 
violation. See Respondent's Proposed Findings of Fact and 
Conclusions of Law, at 11 (Proposed Conclusion of Law #11: ``The 
second violation[] relates to buprenorphine prescriptions from two 
physicians who were not authorized to prescribe such prescriptions 
because they were not Data-waived practitioners. Physicians are 
issued a specific registration that is distinguished with an X 
number, and this number[] should be on the prescription. Farmacia 
Yani dispensed 29 prescriptions in total from these two doctors that 
did not have an X number.'') (citations omitted). Thus, this case 
does not support the CALJ's assertion that ``recent Agency precedent 
has imposed significantly tighter notice requirements on the 
Government.'' R.D. at 66.
    The CALJ further asserted that ``[i]n Marjenhoff, . . . the 
Agency refused to allow the Government to rely on noticed conduct 
alleged as a violation of the public interest factors because it 
failed to specify that the conduct would be specifically considered 
under factor 5.'' R.D. 66 (citing 80 FR at 29068). Here again, this 
is a misstatement of the case.
    Apparently, the CALJ's assertion refers to the Agency's 
declination to find that the respondent's conduct in intercepting a 
pharmacist's phone calls (who questioned the validity of a 
prescription the respondent had created for herself by forging the 
signature of the purported prescriber) constituted actionable 
misconduct under factor five. 21 U.S.C. 823(f)(5). This factor 
provides for liability based on ``such other conduct which may 
threaten public health and safety.'' Id.
     Significantly, the Show Cause Order made no such allegation, 
and while the Government disclosed in its pre-hearing statement that 
it intended to elicit testimony from the pharmacist regarding his 
attempt to verify the prescription after it was rejected for payment 
by respondent's insurer, at no point in the proceedings did the 
Government rely on the evidence other than as proof that the 
``[r]espondent illegally obtained hydrocodone on eleven occasions.'' 
See Govt.'s Proposed Findings of Fact and Conclusion of Law, at 14 
(discussing the pharmacist's testimony as evidence that respondent 
``forged and filled hydrocodone prescriptions to herself using [a 
PA's] DEA number. These actions constitute violations of 21 U.S.C. 
843(a)(3) [and] 21 CFR 1306.04. . . .''). Moreover, in its 
discussion of Factor Five, the Government's arguments were confined 
to arguing that the ``[r]espondent has failed to accept 
responsibility for her actions,'' that she had not ``present[ed] any 
mitigating evidence,'' and that she ``has demonstrated a pattern of 
actions that are against the public interest by inappropriately 
prescribing controlled substances . . . in 2005 and forging and 
filling prescriptions in 2011.'' Id. at 15-16.
    Thus, contrary to the CALJ's statement, the Government never 
relied on this conduct as a separate ``violation of the public 
interest factors.'' R.D. at 66. Nor could it have, as the public 
interest factors do not impose substantive rules of conduct but are 
simply ``components of the public interest'' that ``shall be 
considered'' in determining whether to grant an application for a 
registration. Penick Corp., Inc. v. DEA, 491 F.3d 483, 490 (D.C. 
Cir. 2007) (citation omitted). Most importantly, at no point did the 
Government assert that this conduct should also be considered as a 
separate act of misconduct under Factor Five.
---------------------------------------------------------------------------

    The CALJ also held that the Government could not rely on this 
evidence under the doctrine of litigation by consent--even though 
Respondent never objected to the Expert's testimony that the June 1 
(and other tests) were aberrant and that Respondent failed to properly 
address the aberrant results--asserting that the Government had the 
duty to ``timely and affirmatively raise[] . . . this theory'' and 
failed to do so. Id. at 39 (citing Odette Campbell, 80 FR 41062, 41062 
n.2 (2015)). This reasoning, however, is also based on a misreading of 
that case.\5\
---------------------------------------------------------------------------

    \5\ In Campbell, the ALJ noted that `` `the evidence indicate[d] 
that [the] [r]espondent did not follow adequate security 
procedures,' '' but then ``declined to consider the evidence on the 
ground that the Government did not provide adequate notice in either 
the Show Cause Order or its Prehearing Statements, notwithstanding 
that [the] [r]espondent did not object to the testimony.'' 80 FR at 
41062 n.2 (other citation omitted). While the former Administrator 
observed that ``the record arguably support[s] a finding that the 
issue was litigated by consent,'' she did not consider the evidence 
because ``the Government did not take exception to the ALJ's 
ruling.'' Id.
    Here, by contrast, the Government has taken exception to the 
CALJ's rulings that the issue has not been litigated by consent. See 
Gov. Exceptions, at 24-25. As for the CALJ's assertion that the 
issue was ``not timely'' raised by the Government, given that: (1) 
Respondent never objected to the testimony nor argued in its post-
hearing brief that it did not have fair notice that the June 1 drug 
screen would be at issue throughout the proceeding, and (2) the CALJ 
did not rule that the Government could not rely on this theory until 
he issued his Recommended Decision, it is unclear how the Government 
could have timely raised the issue until it received the Recommended 
Decision and filed its Exceptions.
---------------------------------------------------------------------------

    ``The primary function of notice is to afford [a] respondent an 
opportunity to prepare a defense by investigating the basis of the 
complaint and fashioning an explanation that refutes the charge of 
unlawful behavior.'' Pergament United Sales, Inc. v. NLRB, 920 F.2d 
130, 135 (2d Cir. 1990) (citation omitted). Thus, as the courts have 
long noted, `` `[p]leadings in administrative proceedings are not 
judged by the standards applied to an indictment at common law.' '' 
Aloha Airlines v. Civil Aeronautics Bd., 598 F.2d 250, 262 (D.C. Cir. 
1979) (quoted in CBS Wholesale Distributors, 74 FR 36746, 36749 
(2009)); accord Citizens State Bank of Marshfield v. FDIC, 751 F.2d 
209, 213 (8th Cir. 1984). Moreover, an agency ``is not burdened with 
the obligation to give every [Respondent] a complete bill of 
particulars as to every allegation that [he] will confront.'' Boston 
Carrier, Inc. v. ICC, 746 F.2d 1555, 1560 (D.C. Cir. 1984).
    Accordingly, even where the Government fails to disclose an 
allegation in the Order to Show Cause, ``an issue can be litigated if 
the Government otherwise timely notifies a [r]espondent of its intent 
to litigate the issue.'' CBS Wholesale, 74 FR at 36570. Moreover, while 
the Agency has held that ``the parameters of the hearing are determined 
by the prehearing statements,'' consistent with numerous court 
decisions, it has also recognized that even where an allegation was not 
raised in either the Show Cause Order or the pre-hearing statements, 
the parties may nonetheless litigate an issue by consent. Pergament 
United Sales, 920 F.2d at 135-37; see also Duane v. Department of 
Defense, 275 F.3d 988, 995 (10th Cir. 2002) (discussing Facet 
Enterprises, Inc., v. NLRB, 907 F.2d 963, 974 (10th Cir. 1990); ``we 
held that the defendant had constructive notice of an alternate theory 
of liability not described in the formal charge when the agency 
detailed that theory during its opening argument and at other points 
during the hearing and when the defendant's conduct revealed that it 
understood and attempted to defend against that theory'').\6\
---------------------------------------------------------------------------

    \6\ See also Grider Drug #1 & Grider Drug #2, 77 FR 44070, 44077 
n.23 (2012) (holding that while the Government did not provide 
adequate notice of its intent to litigate an allegation in either 
the Show Cause Order or its pre-hearing statements, where 
respondents ``did not object that the allegation was beyond the 
scope of the proceeding and that they were denied adequate notice of 
it'' and ``fully litigated the issue,'' the allegation was litigated 
by consent) (citing Citizens State Bank, 751 F.2d at 213; Kuhn v. 
Civil Aeronautics Bd., 183 F.2d 839, 841-42 (D.C. Cir. 1950); and 
Yellow Freight System, Inc., v. Martin, 954 F.2d 353, 358 (6th Cir. 
1992)).
---------------------------------------------------------------------------

    To be sure, ``[a]n agency may not base its decision upon an issue 
the parties tried inadvertently. Implied consent is not established 
merely because one party introduced evidence relevant to an unpleaded 
issue and the opposing party failed to object to its introduction. It 
must appear that the parties understood the evidence to be aimed at the 
unpleaded issue.'' Yellow Freight System, Inc., v. Martin, 954 F.2d 
353, 358 (6th Cir.1992) (citation omitted). Accordingly, where the 
Government's case ``focus[es] on another issue and [the] evidence of 
[an] uncharged violation [is] `at most incidental,' '' the Government 
has not satisfied its constitutional obligation to provide a full and 
fair opportunity to litigate the issue and it cannot rely on the 
incidental issue as the basis for imposing a sanction. Pergament, 920 
F.2d at 136 (quoting NLRB v. Majestic Weaving Co., 355 F.2d 854, 861-62 
(2d Cir. 1966)). However, the issue of whether an allegation ``has been 
fully and fairly litigated [by consent] is so peculiarly fact-bound as 
to make every case unique.'' Id. at 136.
    Having reviewed the record, I find the Government's exception well 
taken and hold that the Government provided Respondent with adequate 
notice that both the aberrant nature of the June 1 drug test and his 
failure to address it would be at issue throughout the proceeding. 
Moreover, even if the Government failed to specifically reference the 
June 1 test by date in the Show Cause Order (and Pre-hearing 
Statements) with respect to several of the prescriptions, Respondent 
had adequate notice that it was at issue throughout the proceeding and 
indeed, had a full and fair opportunity to litigate the issue.
    The Show Cause Order repeatedly provided notice that the aberrant 
nature of B.B.'s June 1 UDS and Respondent's failure to address it 
would be at issue in the proceeding. For example, paragraph 3 of the 
Show Cause order alleged that ``[f]rom on or about August 25, 2011 
through on or about May 9, 2012, [Respondent] issued controlled 
substance[] prescriptions to B.B. in violation of Federal . . . law.'' 
ALJ Ex. 1, at 1 (emphasis added). The Show Cause Order then alleged 
that Respondent was ``aware on each of the occasions that [he] issued 
controlled substance[] prescriptions to B.B. that he presented a high 
risk of abuse and/or diversion of controlled substances, as evidenced 
by the red flags documented in his patient file, such as aberrant

[[Page 14948]]

urine drug tests.'' Id. (emphasis added). And the Order then alleged 
that Respondent ``failed to address and, in fact, ignored these red 
flags, continuing to issue B.B controlled substance prescriptions in 
the face of mounting evidence that he was misusing, abusing, and/or 
diverting the controlled substances you were prescribing.'' Id.
    In the allegations regarding the August 25, 2011 prescriptions, the 
Show Cause Order provided a detailed recitation of the factual basis 
for the allegation that the June 1, 2011 UDS was aberrant and that this 
``should have indicated . . . that B.B. may have been misusing/abusing 
the alprazolam by consuming more than he had been prescribed, or 
diverting it.'' Id. at 2. As for the September 22, 2011 prescriptions, 
the Show Cause Order, after setting forth the factual basis for why the 
August 25 UDS was aberrant, proceeded to allege that Respondent ``did 
not address with B.B. the now second aberrant drug screen in an 
approximately three month period, despite noting in the record that you 
had `extensively reviewed' B.B.'s `[p]ast medical history.' '' Id. at 3 
(emphasis added). The Show Cause order then alleged that ``[y]ou took 
no other steps to monitor B.B.'s controlled substance use, such as 
requiring him [to] take another drug screen due to the two failed ones, 
conducting a new [prescription monitoring report] check, or requiring 
him to submit to a pill count.'' Id. (emphasis added).
    In setting forth the allegations with respect to the October 6 and 
20 prescriptions, the Show Cause Order alleged that ``[y]ou still did 
not address with B.B. the two aberrant drug screens'' and ``[y]ou still 
had not confronted B.B. about the two aberrant drug screens'' 
respectively. Id. at 4 (emphasis added). And with respect to the 
subsequent prescriptions, the Show Cause Order made multiple 
allegations such as that: (1) Respondent ``did not take any steps to 
monitor [B.B.'s] controlled substance[ ] use despite his history of 
misusing, abusing, or diverting controlled substances'' (Nov. 18, 2011 
prescriptions); (2) ``despite [B.B.'s] history of substance misuse, 
abuse, and/or diversion, you did not take appropriate steps to monitor 
his controlled substance use before issuing him these new 
prescriptions'' (Jan. 19, 2012 prescriptions); and (3) Respondent again 
prescribed controlled substances ``without taking appropriate steps to 
monitor [B.B.'s] controlled substance use despite the persistent red 
flags of abuse and diversion he previously presented'' (Mar. 13, 2012 
prescriptions).
    Likewise, in its Pre-hearing Statement, the Government provided 
notice that ``Dr. Owen [its Expert] will testify that [Respondent] 
should have been aware from documentation in B.B.'s file of red flags 
that B.B. may have been abusing or diverting controlled substances 
prior to transferring his treatment to'' Respondent (the period in 
which the June 1 UDS was obtained), as well as notice setting forth the 
factual basis as for why the June 1 UDS was aberrant. ALJ Ex. 5, at 10, 
12-13. With respect to the September 22, 2011 prescriptions, the Pre-
hearing Statement provided notice that the medical file shows that 
Respondent ``never addressed with B.B. this now second aberrant UDS in 
an approximately three month period, despite noting in the record that 
[he] had `extensively reviewed' B.B.'s past medical history'' and that 
Respondent ``took no other steps to monitor B.B.'s controlled substance 
use, such as requiring him to take another UDS due to the two failed 
ones.'' Id. at 14 (emphasis added).
    Moreover, with respect to the October 6 prescriptions, the Pre-
hearing Statement provided notice that ``Dr. Owen will testify that on 
this visit [Respondent] again failed to address with B.B. the two 
aberrant UDSs,'' and with respect to the October 20, 2011 
prescriptions, ``the record lacks documentation that . . . he 
confronted B.B. about the two aberrant UDSs.'' Id. at 15-16 (emphasis 
added). And with respect to the later prescriptions, the Pre-hearing 
Statement provided notice that Dr. Owen ``will testify'' that 
Respondent ``also failed to take any steps to monitor B.B.'s controlled 
substances use despite B.B.'s history of misusing, abusing, or 
diverting controlled substances.'' Id. at 16. See also id. at 17 (Jan. 
19 prescriptions; ``Dr. Owen will testify that despite the fact that 
this was B.B.'s first visit . . . in three months, and despite his 
history of substances misuse, abuse, and/or diversion, [Respondent] 
failed to take adequate steps to monitor B.B.'s controlled substance 
use before issuing him these new prescriptions''); id. at 19 (Mar. 13 
prescriptions; providing notice that ``Dr. Owen will testify'' that 
Respondent again issued controlled substance prescriptions ``without 
taking appropriate steps to monitor B.B.'s controlled substance use 
despite the persistent red flags of abuse and diversion he previously 
presented'').
    Thus, the Show Cause Order's allegations and the Pre-Hearing 
Statement's disclosure of the expected testimony provided Respondent 
with more than adequate notice that the results of the June 1, 2011 UDS 
and his failure to address it would be at issue throughout the 
proceeding. And even if I concluded otherwise, the record is clear that 
the issue was litigated by consent.
    Notably, during its direct examination of Dr. Owen regarding the 
September 22, 2011 prescriptions, the Government asked Dr. Owen the 
following questions:

    Q. Would the aberrant urine drug test from June 1 have shown up 
in a review of the history?
    A. Yes.
    Q. Would the aberrant drug test from August 25, 2011, have shown 
up in the history?
    A. Yes.
    Q. And were those aberrant drug tests part of this medical file 
as you received it?
    A. Yes, it [sic] was.
    Q. What--how does [Respondent] address the aberrant drug tests 
in this 9/22 patient file note[]?
    A. It's [sic] completely ignored.
    Q. What steps should [Respondent] have taken regarding the 
aberrant drug screens?
    A. He should have acknowledged their existence and then taken 
some corrective action.
    . . . .
    Q. Does it appear that [Respondent] took any safeguard regarding 
the potential for diversion or abuse with the aberrant drug screens?
    A. No.

    Tr. 132-33.
    Notably, Respondent did not object to any of this testimony. See 
id. Moreover, the Government asked similar questions of Dr. Owen 
regarding the later prescriptions, with no objection by Respondent. See 
id. at 136 (Oct. 6, 2011 visit; Q. ``Having reviewed the patient file, 
can you tell me what steps [Respondent] took on this date to address 
the two previous aberrant urine drug tests?'' A. ``The previous 
aberrant urine drug tests are ignored and not addressed.''); id. at 139 
(Oct. 20, 2011visit: Q. ``What steps should [Respondent] have taken on 
this date?'' A. Respondent ``[s]hould have, particularly in light of 
the previous aberrant drug tests . . . sought psychological counseling 
for this patient.'').\7\
---------------------------------------------------------------------------

    \7\ See also Tr. 143 (Nov. 18 and Dec. 15, 2011 Rxs: Q. ``Is 
there any mention anywhere about the aberrant drug tests and the 
results being discussed with BB?'' A. ``No, there's not.''); id. at 
147 (Jan. 19, 2102 visit and Rxs: Q. ``Is there any mention of the 
aberrant urine drug tests from June or August in this [patient file] 
during this visit?'' A. ``There is not.''); id. at 154 (Feb. 13 Rxs: 
testimony of Dr. Owen's that Respondent's counseling B.B. ``to take 
only as prescribed'' after Jan. 19 drug test was not an adequate 
safeguard against abuse and diversion, ``especially since this is 
the third aberrant drug test''); id. at 154-55 (Feb. 13 Rxs: Q. ``In 
the face of so many aberrant drug tests, what steps--what should 
[Respondent] have done?''); id. at 158 (Mar. 13, 2012 Rxs: Q. ``Are 
there any aberrant drug-taking behaviors here?'' A. ``There has 
[sic] been three previous.''); id. at 165-66 (Apr. 12, 2012 Rxs Q. 
``Did he address any of the previous aberrant drug screens?'' A. 
``He did not.''). Significantly, at no point did Respondent object 
to the questioning or testimony.

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

[[Page 14949]]

    Indeed, Respondent's counsel raised the issue when, in Respondent's 
case-in-chief, she asked him: `Do you recall if you looked back at the 
previous drug tests?'' Id. at 283. Respondent answered: ``I don't 
recall, but I doubt I did'' and ``I wouldn't expect myself to.'' Id. 
Respondent's counsel then asked him if Dr. Schoelen had seen B.B.in 
June and July after the June 1 drug test, with Respondent answering 
``[t]hat's correct.'' Id. Respondent then testified that the test was 
reported back to his former partner, who saw B.B. on June 29 and July 
26, before testifying that he would have ``routinely looked at two, 
three different notes.'' Id. at 284.
    Subsequently, on its cross-examination of Respondent with respect 
to what he looked at in the chart when he took over B.B.'s care, the 
Government asked: ``Did you see the June 1, 2011, UD[S], urine drug 
test?'' Id. at 390. Respondent's counsel raised no objection to the 
question and Respondent answered: ``I don't believe I did.'' Id. While 
Respondent then asserted that he ``assume[d]'' that Dr. Schoelen 
``addressed every UDS,'' when pressed as to whether, based on his 
review of the file, Dr. Schoelen had ever addressed the June 1 UDS, 
Respondent answered: ``I didn't review his part of the chart.'' Id. at 
390-91.
    Thus, Respondent was clearly aware that his failure to address the 
June 1, 2011 drug test was at issue with respect to the entirety of his 
controlled substance prescribing to B.B. and in no sense was this ``an 
incidental issue'' in the case. Pergament United Sales, 920 F.2d at 136 
(citation omitted). He also had a full and fair opportunity to litigate 
the issues of whether the June 1 (as well other tests) were aberrant 
and whether he properly addressed them during the course of his 
prescribing to B.B. Accordingly, I find the Government's exception well 
taken and will consider this evidence.\8\
---------------------------------------------------------------------------

    \8\ The Government's remaining exceptions are discussed 
throughout this decision.
---------------------------------------------------------------------------

    Based on the preponderance of the evidence, I make the following 
findings.

Findings of Fact

    Respondent is a family practice physician licensed by the Oklahoma 
State Board of Medical Licensure and Supervision. RX 1. Respondent 
graduated from the University of Oklahoma (OU) College of Medicine in 
1989. Tr. 231. Thereafter, he did an internship through the OU ``Tulsa/
Bartlesville program'' and ``the last two years of his residency'' in 
family medicine at OU in Oklahoma City. Id.
    Respondent testified that upon completing his residency, he 
practiced family medicine and obstetrics for several years at several 
rural clinics. Id. at 234-35. He further explained that while working 
at one of the clinics, he was asked to become the medical director of a 
nursing home for terminal AIDS patients, which he did for approximately 
five years, after which he and Dr. Steve Schoelen bought a practice in 
Newcastle, Oklahoma which they named ``Tri-City Family Medicine.'' Id. 
at 235-36.\9\ Respondent practiced family medicine at Tri-City from 
approximately 2000 through 2012. Id. at 245. Respondent further 
testified that he was board certified in family medicine until 2015. 
Id. at 247. Respondent testified that he could not reapply for board 
certification because he had not practiced family medicine for several 
years and does not ``qualify to show them my charts . . . to qualify to 
take the test.'' Id. at 248.
---------------------------------------------------------------------------

    \9\ Respondent also testified that for approximately three years 
(which are not specified in the record) and during which he was 
still practicing at his clinic, he was also the medical director of 
Unicare of Oklahoma, a subsidiary of WellPoint, and that his duties 
involved oversight of the clinics, reviewing chart audits, and that 
``[w]e also were in charge of prior authorization.'' Tr. 237, 240. 
He also testified that he sat on WellPoint's national credentialing 
committee, which sat once a month for three hours and reviewed the 
credentials of practitioners applying to the company. Id. at 240. 
Respondent testified that he resumed working full time at Tri-City 
after the State cancelled its contract with Wellpoint to provide 
medical care to patients covered by the State's Medicaid program. 
Id. at 242.
---------------------------------------------------------------------------

    Respondent testified that due to the expense of malpractice 
insurance for his OB/GYN activities, he stopped delivering babies and 
focused on family medicine. Id. at 249. Respondent testified that he 
started seeing chronic pain patients around this time, but that Dr. 
Schoelen mostly saw these patients as he ``took much more of an 
interest in the pain patients and pain management.'' Id. He further 
testified that within days of Dr. Schoelen ``telling Medicaid that he 
would accept chronic pain patients on Medicaid, we were overwhelmed 
with referrals from the emergency rooms . . . in Oklahoma City.'' Id. 
at 253. According to Respondent, in response, Dr. Schoelen took 
continuing medical education (CME) classes and joined the American 
Academy of Pain Management. Id. The clinic also started using a pain 
management contract and contracted with a company for urine drug 
testing. Id. at 254.
    Respondent testified that he did drug screens ``every three 
months'' and that any patient who received more than two Lortabs 
(hydrocodone with acetaminophen) a day would be subject to ``the 
guidelines of our pain management contract and rules.'' Id. at 256. 
Respondent further asserted that ``[s]ometimes we [would] send 
[patients] for a second opinion'' or for a ``modality that we didn't 
do'' such as ``an epidural or [a] further evaluation if something 
changed in their pain something changed neurologically.'' Id. He 
testified that he would obtain a Prescription Monitoring Program report 
for ``[e]very phone call for every prescription and every office 
visit.'' Id. at 263. He also testified that the practice did not 
replace lost or stolen medications and that he had terminated a 
substantial number of patients over the years. Id. at 279-80.

The Investigation

    Respondent came to the attention of the authorities on or about May 
10, 2012, when police in Norman, Oklahoma found Respondent's patient 
B.B., a 27-year old male (RX 3, at 2), who was ``semiconscious'' and 
``appeared to be intoxicated'' in a vehicle parked ``in the center 
median of'' Interstate-35. Tr. 18; RX 3, at 2. The police also found 
``several prescription bottles of opiate pain killers'' which had been 
prescribed to B.B. by Respondent. RX 3, at 2-3; Tr. 18. With B.B.'s 
consent, the police searched his cell phone and found text messages 
that ``indicated that [B.B.] was illegally buying and selling 
prescriptions drugs,'' as well as messages between B.B. and Respondent 
related to B.B.'s ``medical care, prescription dosages and 
prescriptions to be picked up by'' B.B. RX 3, at 3. In addition, the 
police found ``numerous sexually explicit messages'' that had been 
exchanged between Respondent's phone and B.B. Id.; Tr. 18. A Detective 
with the Norman police then contacted the Chief Investigator for the 
Oklahoma State Board of Medical Licensure and Supervision. Tr. 18. The 
Detective also notified a DEA Diversion Investigator (DI) that the 
police had found drugs in B.B.'s car and that the latter was a patient 
of Respondent; the Detective also asked the DI to attend an interview 
of B.B., who could not be interviewed until ``the next day'' because 
``he was too intoxicated.'' Id. at 46.
    In the meantime, the Chief Investigator, who was familiar with 
Respondent's background because the latter ``was on probation at that 
time for an incident that involved sexual misconduct,'' obtained a 
report from the Oklahoma Bureau of Narcotics Prescription Monitoring 
Program to ``see any prescriptions that were prescribed by [Respondent] 
to'' B.B. Id. at 18-19.

[[Page 14950]]

The report showed that Respondent had written ``numerous controlled 
drug prescriptions'' for B.B. Id. at 19.
    After reviewing the PMP report, the Chief Investigator notified the 
Board's Executive Director of his findings, id. at 21, who, on May 11, 
2012, ordered the summary suspension of Respondent's medical license. 
Id.; see also RX 3, at 3. The same day, the Chief Investigator went to 
Respondent's clinic to obtain B.B.'s record, interview Respondent, and 
serve the suspension order on him. Id. at 21. While Respondent was not 
at the clinic, the Chief Investigator spoke with him by phone and made 
arrangements to return on May 14 (a Monday); the Chief Investigator 
also took B.B.'s chart. Id.
    On May 11, 2012, the DI and two Detectives interviewed B.B., who 
``confirmed that he was'' Respondent's patient. Id. at 48. B.B. 
admitted that ``he used the Opanas [oxymorphone] \10\ himself'' but 
``denied that he snorted them.'' Id. B.B. explained that ``[h]e crushed 
them up and put them in an energy drink, which he had in his vehicle . 
. . when he was found'' by the police. Id. B.B. also told the 
Investigators that ``[n]ot only was he a user of it, he also sold the 
medications.'' Id. After the interview, the DI was informed by the lead 
Detective that he had spoken to the Board's Chief Investigator and that 
the Board's Investigators were going to meet on Monday May 14 and go to 
Respondent's office. Id.
---------------------------------------------------------------------------

    \10\ As discussed more fully below, Respondent issued B.B. 
prescriptions for Opana 10 mg. on multiple occasions, including on 
May 9, 2012 which B.B. filled the next day. GX 5, at 27.
---------------------------------------------------------------------------

    On that day, the Chief Investigator (accompanied by another Board 
Investigator), the DI and the lead Detective went to Respondent's 
clinic to interview him. Id. 25. During the interview, the Board's 
Chief Investigator confronted Respondent ``with some of the sexually 
graphic text messages sent from his phone to the patient.'' RX 3, at 3. 
While Respondent ``admitted that he may have made social comments to 
[B.B.],'' he ``would not answer any more questions without contacting 
his attorney.'' \11\ Id. ``At that point,'' the Chief Investigator 
asked Respondent ``to allow him to examine'' his phone ``for text 
messages to'' B.B. Id. Respondent stated that ``his phone was not 
available because it had been run over with his tractor over the 
weekend.'' Id. The Chief Investigator then served the Board's 
suspension order on Respondent. RX 3, at 3. The DI then informed 
Respondent that because he did not have state authority, he could not 
maintain his DEA registration and asked Respondent to voluntarily 
surrender his registration; Respondent agreed to do so. Tr. 49; see 
also GX 1, at 1.
---------------------------------------------------------------------------

    \11\ Subsequently, Respondent denied that he had exchanged these 
messages and attributed this conduct to his partner at the time, 
stating that he had allowed his partner to have ``access to his cell 
phone.'' RX 3, at 3; see also Tr. 415.
---------------------------------------------------------------------------

    On September 13, 2012, the Board lifted Respondent's 
suspension.\12\ RX 3, at 4. On October 4, 2012, Respondent applied for 
a new registration. GX 1, at 2. Because Respondent's application 
included a ``yes'' answer to the liability question which asked whether 
his state professional license had ever been sanctioned, the 
application was forwarded to the Oklahoma City field office and an 
investigation was opened. GX 2, at 1; Tr. 62, 65, 81.
---------------------------------------------------------------------------

    \12\ On March 7, 2013, Respondent voluntarily submitted to the 
jurisdiction of the Board and agreed to the entry of an Order which 
found him guilty of unprofessional conduct in that he: (1)`` 
[v]iolated any provision of the medical practice act or the rule and 
regulations of the Board or of an action, stipulation, or agreement 
of the Board in violation of 59 O.S. Sec.  509(13) and OAC 435:10-7-
4(39)''; (2) ``[e]ngaged in the improper management of medical 
records in violation of OAC 435:10-7-4(36)''; and (3)`` [w]illfully 
betrayed a professional secret to the detriment of the patient[,] 12 
O.S. Sec.  509(3).'' RX 3, at 5. The Board did not, however, make 
any findings as to the legitimacy of the controlled substance 
prescriptions Respondent issued to B.B. The Board then extended 
Respondent's pre-existing probation, which was the result of a 2008 
Order based on findings that he had prescribed controlled substances 
to a patient with whom he had a sexual relationship, ``[b]eginning 
in or around 2001 . . . through approximately 2004.'' RX 3, at 2. 
The Board further found that when questioned about his relationship 
with this patient, Respondent ``lied and denied that it existed'' 
until he was confronted ``with corroborating evidence.'' Id.
---------------------------------------------------------------------------

    Thereafter, a Diversion Investigator obtained a copy of B.B.'s 
patient file from the Board and provided it to Graves Owen, M.D., an 
expert in pain management, to review and determine whether Respondent 
lawfully issued the controlled substance prescriptions. Tr. 50-52, 55. 
The DI testified that he did not ask Dr. Owen to come to any specific 
conclusion and that Dr. Owen's compensation was not contingent on the 
conclusions he drew. Id. at 56. At the hearing, Dr. Owen testified that 
he has previously testified as to the ``standard of care in pain 
management'' and that he has testified for a defendant. Id. at 92.

The Government's Expert's Testimony as to the Standards of Medical 
Practice Applicable to the Prescribing of Controlled Substances To 
Treat Pain

    Dr. Owen obtained a Bachelor of Science in chemistry and biology 
from Texas State University in 1985 and a Doctor of Medicine from the 
University of Texas Health Science Center (Houston) in 1990. Id. at 89-
90; GX 4, at 1-2. After obtaining his M.D., Dr. Owen did a one year 
internship in internal medicine followed by a three-year residency in 
Anesthesiology at the UT Health Science Center; he then did a one-year 
fellowship in Pain Management at the University of Pittsburg's Pain 
Evaluation and Treatment Center. GX 4, at 1. Dr. Owen holds a Texas 
medical license and is board certified by the American Board of Pain 
Management and American Board of Anesthesiology. Id. at 2. He is a 
member of the American Pain Society, the American Academy of Pain 
Medicine, the American Academy of Pain Management and the Texas Pain 
Society. Id. at 7. With respect to the latter organization, Dr. Owen 
served on its Board of Directors from 2009 through 2012 and served as 
its President from 2012 through 2014. Id. at 8. He has also served on 
the Society's Legislative Committee and on its Educational Committee 
for multiple years. Id.
    Dr. Owen's work experience includes more than 16 years at the Texas 
Pain Rehabilitation Institute (Sept. 1995 through Nov. 2011), which is 
an interdisciplinary pain management clinic. Id. at 2. Since February 
2011, he has been a Peer Reviewer on Pain Medicine for the Journal of 
the American Academy of Pain Medicine. Id. He has also served as a 
member of the Medical Quality Review Panel and as an Arbiter on the 
Quality Assurance Panel of the Texas Department of Insurance, Division 
of Workers Compensation, Office of Medical Advisor. Id. He has written 
several articles and made more than 40 presentations on subjects 
related to pain management before both professional and governmental 
bodies, including on the use of urine drug testing in pain management. 
Id. at 4-9. The CALJ accepted Dr. Owen ``as an expert in pain 
management in Oklahoma and Texas.'' Tr. 91.
    While Dr. Owen is licensed to practice medicine in Texas, he 
testified that he had reviewed Oklahoma's guidelines and policies. Id. 
at 93. Asked what the requirements are in Oklahoma for prescribing 
opioid controlled substances, Dr. Owen testified: ``Well, first you 
have to do an appropriate history and physical exam for whatever the 
chief complaint is. You need to get all pertinent previous medical 
records pertaining to this chief complaint.'' Id. at 94. As to why a 
physician needs to obtain the patient's medical records, Dr. Owen 
explained that: ``You want to know what has previously been performed 
as far as treatment elements and what resulted from those

[[Page 14951]]

treatments, and you also want to look for any previous aberrant 
behaviors.'' Id. (emphasis added).
    The Government then asked Dr. Owen ``what else is required?'' Id. 
Dr. Owen explained: ``So after you do an appropriate history and 
physical exam, you review the pertinent medical records. You may need 
to do consultations. You may need to do diagnostics, whether laboratory 
or imaging studies, and then you formulate a treatment plan based on 
the analysis of this information.'' Id. at 94-95. Asked to explain 
``[w]hat's a treatment plan,'' Dr. Owen testified: ``A treatment plan 
is what we're going to do to move this person from wherever they are to 
the next place, and part of the treatment plan will be dictated by your 
treatment goals that you need to set up to try to get that person to 
the next place.'' Id. at 95.
    Subsequently, Dr. Owen explained that ``there [are] three broad 
treatments in pain management: Interventional, rehabilitative, and 
pharmaceutical. So your treatment plan would list each of these 
categories if you're going to use elements of those categories in your 
treatment plan, and it would specifically define what your treatment 
plan is and how you tie it to your treatment goal.'' Id. at 97. Dr. 
Owen further testified that while treatment goals are ``tailor[ed] . . 
. to the individual'' and would be different depending upon a patient's 
age, ``you would primarily focus on functional improvements.'' Id. at 
99-100. With respect to someone of working age, Dr. Owen explained that 
``return[ing] to work'' is ``the gold standard for functionality in 
pain management.'' Id. at 100.
    Subsequently, Dr. Owen testified that a treatment plan can involve 
more than one of these approaches and that it evolves over the course 
of treating the patient if the treatment goals are not being achieved. 
Id. at 98-99. However, a physician ``certainly would have [a treatment 
plan] on the initial visit.'' Id. at 99. While Dr. Owen acknowledged 
that a treatment plan can be ``tease[d] . . . out'' of the patient's 
record ``without necessarily a formal title'' if ``enough information'' 
is documented in the record, he then explained what content the plan 
should contain:

    Well, if it's interventional, you would talk about what 
intervention you're going to do. If it's rehabilitative, you'd talk 
about physical therapy, occupational therapy or psychotherapy. If 
it's pharmaceutical, you're going to talk about the specific 
pharmaceutical, its dose and the frequency that you're going to 
prescribe it and hopefully the indication it's being used for.
Id. at 98-99.

    Asked whether the file for a patient being prescribed opioid 
controlled substances would contain anything else, Dr. Owen testified 
that you would ``have an informed consent and a pain management 
agreement.'' Id. at 99. Dr. Owen then explained that ``[a]n informed 
consent is telling the patient what the risks and benefits are of this 
proposed treatment and what alternative treatments exist.'' Id.
    As to why a physician treating a patient for pain would seek 
consultation with other specialists, Dr. Owen testified that ``[t]hese 
are complex cases, and you can't be an expert of everything, and you 
may need help in narrowing your diagnosis or help in stabilizing 
comorbidities that are outside of your scope of practice.'' Id. at 100. 
Dr. Owen further explained that the need to consult with particular 
specialists ``depends on the [patient's] chief complaint and your 
differential diagnosis and what you're trying to achieve.'' Id.
    Asked by the Government if ``these requirements . . . are . . . 
best practices,'' Dr. Owen testified that ``some of them can be best 
practices, but most of them are standard of care items.'' Id. at 100-
01. Then asked if ``when you say standard of care, are they required,'' 
Dr. Owen explained that ``they're required based on the context of the 
chief complaint and . . . the facts of the situation.'' Id. at 101. 
When then asked ``are they required by law,'' Dr. Owen initially 
answered ``no'' before explaining that:

    Well, I'm not a lawyer. I would say that the policies and 
guidelines that I was sent for Oklahoma say certain things about 
consultations, and the one that stood out is if somebody's a complex 
pain patient with psychological or psychiatric comorbidities, they 
should get consultations with a pain management physician with 
expertise in these complex cases.

Id.
    Dr. Owen testified that ``comorbid psychiatric conditions'' include 
``depression, anxiety, maladaptive coping mechanisms, such as 
catastrophization, fear avoidance, disability conviction, and a sense 
of injustice,'' which are ``all built on a foundation of cognitive 
distortions.'' Id. at 101-02. He also testified that there are 
``personality disorders and a whole host of psychiatric conditions like 
PTSD, OCD, bipolar, schizophrenia, [and] other scenarios like that, 
that make it more difficult to treat'' a pain patient. Id. at 102. Dr. 
Owen then explained that these conditions ``might magnify [a patient's] 
perception of pain and disability and, in doing so, [a patient's] 
experience of suffering is aggravated or increased.'' Id.
    The CALJ then asked Dr. Owen if the reason it is important to refer 
a pain patient to a mental health expert is so that the patient's 
``subjective complaint[] of pain'' can be ``properly gauged?'' Id. at 
103. Dr. Owen answered: ``So that you can help understand the context 
of their pain and what might be distorting and magnifying their pain 
and suffering experience, because suffering is defined as your ability 
to cope with adversity, and everybody comes with different skill sets 
of how they cope with adversity.'' Id. at 103-04. While Dr. Owen then 
acknowledged that ``[p]ain is subjective,'' he further explained that 
``function is objective, so that's why [a physician would] use 
functions as [the] primary baseline for measuring therapeutic 
influence.'' Id. at 104.
    The CALJ then asked Dr. Owen if ``ask[ing] the patient about 
activities of daily living'' is ``one of the tools that you use?'' Id. 
Dr. Owen answered ``yes'' and added ``[t]hat's one of the things. 
Return to work, and you can do more global things like sitting 
tolerance, walking tolerance, standing tolerance, and then site-
specific areas of functionality like range of motion and other physical 
exam measurements.'' Id. at 104.
    Dr. Owen was then asked to describe ``the steps that a practitioner 
would take to determine whether a patient is truly experiencing chronic 
pain?'' Id. at 106. He replied:

    Well, there's no objective way to know if somebody [is] 
experiencing pain, so you take them for their word at it. But what 
you need to do is to make sure that you go through a process to 
ensure that they have exhausted all the medically reasonable 
treatments before you go to a high-risk, non-evidence-based 
treatment.

Id. at 107.
    Dr. Owen further explained that ``[h]igh-risk treatments are 
treatments that have a potential for bad outcomes, and there's 
evidence-based and non-evidence-based treatments. There's low-risk, 
medium-risk, and high-risk treatments, and you have to have some 
context for how you approach the problem.'' Id. Dr. Owen then opined 
that ``chronic opioid therapy and chronic benzodiazepine therapy'' are 
high-risk treatments. Id. He also opined that chronic opioid therapy is 
not an evidence-based \13\ treatment, noting that

[[Page 14952]]

there are ``no publications'' supporting the use of ``chronic opioid 
therapy'' and that ``[m]ost of the opioid articles have poor outcome[ ] 
metrics.'' Id. at 108.
---------------------------------------------------------------------------

    \13\ Dr. Owen explained that ``evidence-based studies are 
studies published in peer review articles that actually show 
positive outcomes for the treatment, and ideally these treatments 
are compared to some kind of either non[-] treatment or a sham 
treatment.'' Tr. 108.
---------------------------------------------------------------------------

    Asked whether it is ``permissible to taken on a patient who's 
already on high-risk treatment and to continue them on high-risk 
treatment,'' Dr. Owen testified that while a physician ``can do that,'' 
the physician must ``adequately document the justification for skipping 
steps,'' i.e., low-risk \14\ and medium risk treatments, and must 
``make sure that [the patient is] obtaining a clinically meaningful and 
objective therapeutic outcome.'' Id. at 109. He then explained that 
this means that the patient is ``having functional improvement that is 
truly measurable'' and that a patient's ``subjective report is 
problematic.'' Id. And later, Dr. Owen testified that even when the 
care of a patient is transferred from one doctor to another in the same 
practice, the new doctor ``need[s] to make sure that any previous 
documentation deficiencies or standard of care violations are rectified 
by doing a proper evaluation.'' Id. at 206.
---------------------------------------------------------------------------

    \14\ Dr. Owen testified that low-risk, evidence-based treatments 
include physical therapy, occupational therapy and cognitive 
behavioral therapy.
---------------------------------------------------------------------------

    Next, the CALJ asked Dr. Owen what, as a chronic pain specialist, 
he would look at to determine if a patient who was referred to him was 
being successfully treated with long-term opioid therapy. Id. at 109. 
Dr. Owen answered that he would ``first go to the previous medical 
records to see what functionality was documented before [the patient 
was] started on that treatment and compare it to'' the patient's 
current ``functionality.'' Id. Asked by the CALJ if ``those would be 
subjective notes,'' Dr. Owen explained that ``if someone is not working 
and now they are working, although they're subjective notes, there is 
an objective measure to it'' and that ``[w]henever possible, I like 
information from friends or family that's with the patient about [the 
patient's] functionality and what it was like, so there's an 
independent assessment.'' Id. at 109-10. Continuing, Dr. Owen explained 
that there are also ``various psychometric tests on functionality, 
[including the] Oswestry Disability Inventory and other things like 
that, that measure your function in somewhat objective terms.'' Id. at 
110. However, Dr. Owen acknowledged that ``it all comes down to [the 
patient's] self-report.'' Id.
    The CALJ then asked Dr. Owen if there are ``tests that are 
traditionally done in the office, such as . . . range of motion and 
other things . . . that have an objective sense to them?'' Id. Dr. Owen 
answered that while ``you can measure range of motion of the various 
joints and spine, and you can look at muscle strength and those kinds 
of issues . . . they don't always correlate to your ability to work and 
other more global functionality.'' Id. Dr. Owen also explained that in 
evaluating the patient's functionality, ``[y]ou want to look at [the] 
neurological assessment. You want to look at [the] straight leg raise. 
You want to look at spine range of motion, and you want to ask [the 
patient] how far can you walk; how long can you sit, and those kinds of 
functional assessments as well.'' Id. at 111.
    Next, the CALJ asked Dr. Owen if on taking over a long-term opioid 
therapy patient, it is ``generally true that [the patient will be] 
continue[d] on the . . . regimen?'' Id. In response, Dr. Owen testified 
that he would not continue the regimen if the patient is ``not 
clinically improved from the results of this treatment.'' Id. 
Continuing, he explained that ``[a] lot of people deteriorate on 
chronic opioid therapy and they actually do better when they're taken 
off of opioids'' because they have ``opioid-induced hyperalgesia.'' Id. 
Dr. Owen then explained that this ``is a paradoxical response in which 
[a patient's] pain gets worse while [he/she is] on opioids, and when 
[the patient is] take[n] off of the opioids, [his/her] pain improves.'' 
Id.
    Dr. Owen further testified that there is a difference between 
addiction and dependence. Id. at 112. After noting that ``dependency 
will happen to anybody over time in which an abrupt cessation of the 
drug will cause withdrawal symptoms,'' he explained that ``addiction 
has three [additional] elements: Craving the drug, continued use 
despite its harms, and inability to self regulate'' the use of the 
drug. Id. at 112-13. Asked how he would tell whether a patient he had 
``just assumed the care of'' was dependent or addicted, Dr. Owen 
explained that an addicted patient ``may have self-escalation of [his/
her] drugs, and . . . run out early.'' Id. at 113.
    Dr. Owen then explained that a physician ``would use urine drug 
testing to see if [the patient] ha[s] all the drugs that were 
prescribed in [his] urine.'' Id. The physician would also look for 
``other aberrant drug-taking behaviors'' such as ``lost medicines'' and 
use the prescription monitoring program to look for ``doctor-shopping . 
. . or other concerning activities.'' Id. Dr. Owen further explained 
that ``[y]ou would, when possible, talk to the family and see how [the 
patient's] behavior is'' as well as ``look for volatile behavior . . . 
with your staff.'' Id.; see also id. at 117-18 (testifying that 
``problematic behaviors'' or ``red flags'' include ``[l]ost or stolen 
medications, self-escalation of . . . medications without permission, 
aberrant urine drugs tests, [PMP] behaviors that look problematic,'' 
and receiving reports that a patient is selling drugs).
    While Dr. Owen acknowledged that the presence of suspicious 
behavior by a patient does not necessarily mean the patient is abusing 
or diverting controlled substances, it does require that the physician 
take ``some type of corrective action.'' Id. at 118. As for what type 
of action should be taken, Dr. Owen explained that ``[i]t depends on 
the context'' and that ``there's a spectrum of corrective actions . . . 
you might take . . . from shortening the leash and seeing the patient 
more frequently, with less drugs per prescription,'' to not treating 
with controlled substances, ``to firing the patient.'' Id. at 118-19.
    Dr. Owen disputed the CALJ's suggestion that the use of urine drug 
screens is ``pretty controversial in the pain management field,'' 
stating that ``[i]t's a standard of care.'' Id. at 113. After 
explaining that he would set the frequency of drug testing based on a 
risk assessment of the patient, Dr. Owen acknowledged that the ``point 
of care'' enzyme-amino assay test is a ``preliminary test'' and that 
``[y]ou can't use the results with any confidence.'' Id. at 114-15. Dr. 
Owen explained, however, that ``the mass spectrometry test . . . is 
very reliable.'' Id. at 115. Dr. Owen further testified that a 
physician would ``want to test for common illicit substances, because 
you don't just want to know what you're prescribing'' and would want to 
know if the patient is using ``non-prescribed drugs or any street 
drugs.'' Id.
    Asked how a practitioner should respond to an aberrant drug test, 
Dr. Owen testified that ``first you need to document the presence of 
the aberrant . . . test. You need to document your rationale for your 
corrective actions. And then you explain what the corrective action is 
going to be.'' Id. at 119. Dr. Owen then reiterated his earlier 
testimony that ``the corrective action'' could be ``seeing the patient 
more frequently with less drugs''; referring the patient to see an 
addictionologist or a psychiatrist or psychologist ``with experience in 
addiction medicine'' for a consultation; having the patient see a 
physical medicine specialist ``to look at more functional goals''; and 
in severe cases, terminating treatment with

[[Page 14953]]

controlled substances. Id. Dr. Owen also testified that ``[t]here's no 
reason ever to ignore a red flag'' and that a physician has a duty to 
resolve the red flag before prescribing. Id.
    Returning to the issue of what constitutes an adequate medical 
history, Dr. Owen testified that:

    . . . it's a history that's appropriate for whatever the chief 
complaint is, for example, low back pain. It includes a who, what, 
when, why, where, and type of elements that you would do in most any 
kind of a journalism course.
    So you'd say, how did you hurt yourself; where does it hurt; 
does the pain radiate down an extremity; if so, how far down; does 
it go past the knee; where does it end up; is there any numbness or 
weakness associated with it. And then you would talk about what 
treatments have you had or what diagnostics have you had.
    And you'd gather as much of that information, and you'd ask . . 
. how's the pain affecting you physically and psychosocially. And 
that's part of the Oklahoma guidelines is that you assess the person 
functionally, physically and psychosocially.

Id. at 115-16. Dr. Owen then testified that this information is 
required to be documented in the patient file, and if it is ``not in 
the file,'' the assumption is that ``it wasn't done.'' Id. at 116.
    Continuing, Dr. Owen explained that:

    . . . if you don't do a proper history and a proper physical 
exam, if you don't look at all the pertinent previous medical 
records, you can't get an accurate diagnosis. And . . . you can't 
draw any accurate conclusions about what is the right treatment 
plan. And if you don't do accurate assessments, it results in 
potentially dangerous treatments that aren't reasonable or medically 
necessary.

Id. at 117.
    Asked by the CALJ to explain what a pain management contract is, 
Dr. Owen testified that it's ``a document informing the patient what 
the rules of the road are.'' Id. at 120. Dr. Owen testified that the 
contract contains provisions that the patient ``won't get drugs from 
anybody else . . . for th[e] condition,'' the patient ``will only go to 
one pharmacy,'' that the patient ``will use the drugs only as 
directed,'' and the patient will ``submit[ ] to urine or blood drug 
testing.'' Id. Then asked by the CALJ if, in Oklahoma, the use of a 
pain management contract is a ``best practice'' or part of the 
``standard of care,'' Dr. Owen testified that it ``is part of the 
[Oklahoma] guidelines of [the] standard of care.'' Id. Dr. Owen also 
testified that ``when taking on a new patient,'' a physician ``needs to 
have a pain management contract and informed consent.'' Id. at 121. 
Finally, when asked by the CALJ where ``there is a difference'' between 
the standard of care for ``a pain management specialist and someone who 
is treating a patient . . . for pain symptoms,'' Dr. Owen explained 
that ``[t]here's only one standard of care.'' Id. at 120-21.
    On cross-examination, Dr. Owen was asked whether a prescriptive 
practice can ``be within . . . legitimate medical practice and still be 
below the standard of care?'' Id. at 181. In response, Dr. Owen 
testified that a physician ``can violate the standard of care and still 
have a legitimate medical practice, but [cannot] be in the standard of 
care and have an illegitimate medical practice.'' Id. When later asked 
``[w]hat goes into determining if the standard of care has been met,'' 
Dr. Owen testified that ``the standard of care is what a reasonable and 
prudent physician would do in the same or similar circumstances, and a 
reasonable, prudent physician would go to the evidence-based literature 
as a foundation for how to make decisions using critical thinking 
skills.'' Id. at 183. When then asked ``if there's a community standard 
of care in Oklahoma,'' Dr. Owen answered that ``[t]here's no such thing 
as a community standard of care anymore. It's a national standard of 
care, and it's based on our evolving body of knowledge, and as we learn 
new things, the standard changes.'' Id. Dr. Owen then acknowledged that 
he did not know the Oklahoma Medicaid rules for when a patient can be 
referred. Id.
    On further cross-examination, Dr. Owen was asked whether the 
Oklahoma Guideline which addresses the need for consultation with an 
expert in the management of patients who have a history of substance 
abuse or a comorbid psychiatric disorder is mandatory as he had 
previously testified. Id. at 185-86. Dr. Owen acknowledged that the 
provision states that these two conditions ``may require'' 
consultation. Id. at 186. He then added, however, that a physician 
``should document why [he] deviate[d] from that recommendation.'' Id.

The Prescribing Events

The August 25, 2011 Prescriptions

    B.B.'s patient file reflects that from the date of his first visit 
on or about April 24, 2009 up until August 25, 2011, B.B. obtained 
narcotic prescriptions from Dr. Schoelen, Respondent's partner. See 
generally GX 3; Tr. 236. While on August 25, 2011, Dr. Schoelen issued 
B.B. a prescription for 120 tablets of oxymorphone 10 mg, the same day, 
Respondent wrote B.B. prescriptions for 150 hydrocodone/acetaminophen 
10/500 as well as 60 carisoprodol 350.\15\ GX 3, at 24.
---------------------------------------------------------------------------

    \15\ At the time carisoprodol was not controlled under the CSA. 
However, a proceeding to control the drug was then ongoing and the 
drug became federally controlled effective on January 11, 2012. See 
Schedules of Controlled Substances, Placement of Carisoprodol Into 
Schedule IV, 76 FR 77330 (final rule). However, during 2011, the 
drug was a controlled substance under Oklahoma law. See Okla. Stat. 
tit. 63, Sec.  2-210 (2011)
---------------------------------------------------------------------------

    B.B. was not seen by either Dr. Schoelen or Respondent on this day. 
GX 3, at 49. However, he was required to provide a urine sample, the 
results of which were reported by the lab on August 29, 2011.\16\ Id. 
at 99. While the lab results were expected with respect to the 
narcotics B.B. had previously been prescribed, the lab also detected 
the presence of nordiazepam, a metabolite of diazepam; oxazepam; and 
temazepam; none of these drugs had been prescribed to B.B.\17\ Id.
---------------------------------------------------------------------------

    \16\ On June 1, 2011, B.B. had also provided a urine sample. GX 
3, at 103. This test, which was reported by the lab on June 6, 2011, 
yielded a negative result for alprazolam, even though B.B. was then 
being prescribed alprazolam by another physician. Id. According to a 
PMP report, B.B. had filled alprazolam prescriptions for a 30-day 
supply on both May 9 and June 6, 2011. See id. at 25.
    \17\ While the lab results also noted that B.B. had tested 
positive for alpha-hydroxyalprazolam, a metabolite of alprazolam, 
and reported this result as ``not expected based on prescribed 
medications,'' B.B. had obtained a prescription for a 30-day supply 
of alprazolam on July 29, 2011 and filled the prescription the same 
day. GX 3, at 36.
---------------------------------------------------------------------------

    While the Government alleged in the Order to Show Cause that the 
prescriptions Respondent issued on this day were ``invalid'' and 
violated 21 CFR 1306.04(a) and made extensive factual allegations to 
support this conclusion, it did not elicit any testimony from its 
Expert as to why. Moreover, Respondent testified that this was ``a 
nurse-only visit'' and that he issued the prescriptions because ``Dr. 
Schoelen works half [a] day'' and while Schoelen had issued one of the 
prescriptions, ``he had missed the fact that--or the nurses had missed 
and not written the other two medications for him.'' Tr. 389. The CALJ 
found this testimony credible. R.D. at 31.
    As the Government put forward no evidence to support the conclusion 
that it was outside of the usual course of professional practice for 
Respondent to cover for his partner, nor cites to any state rule 
prohibiting prescribing under this circumstance, I find that the 
allegation is unsupported by substantial evidence.\18\
---------------------------------------------------------------------------

    \18\ In its Exceptions, the Government argues that the CALJ 
erred in finding the allegation with respect to the August 25, 2011 
prescriptions not proved. See Exceptions, at 44-47. It argues that 
because Respondent issued the prescriptions without seeing B.B. on 
that date, without having seen him previously, and without reviewing 
the PMP, and because he testified that he reviewed only B.B.'s 
``medical history and the last two office visit notes'' made by Dr. 
Schoelen, the ``issuance of the two prescriptions fell far below the 
standard of care and outside the usual course of practice.'' Id. at 
46.
    As noted above, the Government elicited no testimony from Dr. 
Owen as to whether Respondent's issuance of the prescriptions was 
below the standard of care or outside of the usual course of 
professional practice. Apparently, the Government relies on 
subsection 1 of the Board's chronic pain rule, see Okla. Admin. Code 
Sec.  435:10-7-11(1), which requires that ``[a] medical history and 
physical examination . . . be obtained, evaluated and documented in 
the medical record'' in order to prescribe a controlled substance. 
See Exceptions, at 45 (arguing that ``the OK Pain Rule sets forth 
the standard of care for Oklahoma prescribing controlled substances 
. . . for the treatment of pain'').
    However, in 2014, the Board promulgated an exception to the 
requirement that ``[t]he physician/patient relationship shall 
include a medically appropriate, timely-scheduled, face-to-face 
encounter with the patient,'' which allows ``providers covering the 
practice of another provider [to] approve refills of previously 
ordered medications if they have access to the medical file of the 
patient.'' Okla. Admin. Code Sec.  435:10-7-12(1). While this rule 
was not in effect when Respondent issued the prescriptions, it 
strains credulity to suggest that providing prescriptions under the 
circumstances of covering for a partner violated the standard of 
care two years earlier when Respondent issued the prescriptions. 
While the Government speculates that Dr. Schoelen ``may not have 
issued B.B. these two prescriptions purposefully pending the results 
of the new UDS,'' Exceptions at 46, and argues that Respondent was 
required to call Dr. Schoelen as a witness to corroborate his 
testimony, the Government ignores that it had the burden of proof on 
this issue.

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

[[Page 14954]]

The September 22, 2011 Visit and Prescriptions

    On some date after August 25, 2011, the State Board suspended Dr. 
Schoelen's medical license and Respondent took over the treatment of 
B.B., who came for an office visit on September 22, 2011. Tr. 290; GX 
3, at 48.\19\ See GX 3, at 103; id. at 25. According to the progress 
note for the visit, B.B. had come in ``for a recheck on lumbar disc 
disease'' and also had a ``left abdominal hernia as well.'' Id. at 48. 
Respondent also indicated in the progress note that B.B.'s ``[p]ast 
medical history [was] extensively reviewed and placed in [the] chart.'' 
Id. Respondent documented that he did a physical exam, noting, inter 
alia, ``[l]umbar very painful spinal and paraspinal tenderness,'' a 
``[n]egative straight leg raise,'' and ``[n]euro intact.'' Id. 
Respondent diagnosed B.B. as having ``lumbar disc disease'' and a 
hernia; his plan included having B.B. obtain an MRI, changing him from 
Lortab to Duragesic patches, and continuing Respondent on Opana and 
Soma (carisoprodol). Id. Respondent also documented that he had 
discussed the ``[a]ddictive, dependence, and tolerance nature of the 
medicines,'' the ``use of Duragesic,'' and suggested ``[n]on-medicinal 
pain-relieving modalities.'' Id.
---------------------------------------------------------------------------

    \19\ According to a PMP report in B.B.'s patient file, he had 
filled a prescription for a 30-day supply of alprazolam on May 9, 
2011. GX 3, at 25.
---------------------------------------------------------------------------

    B.B.'s file also contains a Pain Management Treatment Plan, which 
includes a section bearing the caption: ``Treatment Objective 
Evaluation.'' GX 3, at 28. This form lists several questions, with 
boxes for documenting by date, various findings which included: ``Has 
patient achieved treatment objective?''; ``Patient completed . . . 
updated pain scale''; ``Re-review benefits and risks of using 
medications''; ``Consider referral to another physician for second 
opinion or further treatment options''; ``Changes to Treatment Plan''; 
and the ``[p]hysician's initials.'' Id. For this visit, Respondent 
wrote ``yes'' as to whether B.B. had achieved the treatment objective 
(which was documented as ``to be able to work without pain,'' id. at 
29), wrote the number ``3-5'' in the pain scale block, and noted 
``yes'' with respect to both whether he had re-reviewed the risks and 
benefits of controlled substances and considered a referral to another 
physician.\20\ Id. at 28.
---------------------------------------------------------------------------

    \20\ In contrast to this document which contains a single box in 
which Respondent and Dr. Schoelen would write a number for B.B's 
pain (the ``Patient Completed . . . updated pain scale''), B.B.'s 
file contains a ``Patient Comfort Assessment Guide'' form which B.B. 
completed on September 2, 2009. GX 3, at 32-33. On this form, B.B. 
circled various words such as ``aching,'' ``throbbing,'' 
``shooting'' and ``stabbing'' to describe his pain which he 
maintained was ``continuous'' and at its worst in the ``afternoon'' 
and ``evening.'' Id. The form also contains four instructions which 
directed B.B. to rate his pain on a numeric scale of 0 to 10 (with 0 
being ``no pain'' and 10 being ``[p]ain as bad as you can 
imagine''), at its worst,'' ``its least,'' and ``on average in the 
last month,'' as well as ``right now.'' Id. at 32. In addition, the 
form asked ``[w]hat makes your pain better,'' ``what makes your pain 
worse,'' as well as ``what treatments or medicines are you receiving 
for your pain,'' and it further instructed the patient to 
numerically rate the relief he obtained (again on a 0 for ``no 
relief', to 10 for ``complete relief'' scale) from the treatment or 
medicine. Id.
    On the form's second page, it asked ``[w]hat side effects or 
symptoms are you having,'' and directed B.B. to ``[c]ircle the 
number that best describes your experience during the past week,'' 
again using a 0 (``Barely Noticeable'') to 10 (``Severe Enough to 
Stop Medicine'') scale for 10 side effects and symptoms such as 
nausea, vomiting, constipation, lack of appetite, difficulty 
thinking and insomnia. And finally, the form directed B.B. to 
``[c]ircle the one number''--on a scale of 0 for ``not 
[i]nterfer[ing]'' to 10 for ``[c]ompletely [i]nterfering''--which 
``describes how during the past week pain has interfered with'' his 
``[g]eneral [a]ctivity,'' ``[m]ood,'' ``[n]ormal work,'' 
``[s]leep,'' ``[e]njoyment of [l]ife,'' ``[a]bility to 
[c]oncentrate,'' and ``[r]elations with [o]ther [p]eople.'' Id. Of 
note, there is no evidence that B.B. was required to complete this 
form at any subsequent visit.
---------------------------------------------------------------------------

    Dr. Owen testified that because this was B.B.'s first visit with 
Respondent, Respondent should have ``do[ne] a proper history and 
physical exam and review[ed] previous treatments and everything that 
typically is expected for a new patient evaluation.'' Tr. 131. 
According to Dr. Owen, this included reviewing B.B.'s patient file 
which included the aberrant June 1 and August 25, 2011 drug tests. Id. 
at 132.
    With respect to the August 25 drug test, Dr. Owen testified that 
B.B. had previously received prescriptions for alprazolam, hydrocodone, 
Soma (carisoprodol) and oxymorphone. Id. at 130. As found above, each 
of these drugs (or its metabolites) was detected by this test. Id. Dr. 
Owen then noted, however, that there were ``no prescriptions for the 
metabolites of diazepam, which is nordiazepam, or oxazepam or 
temazepam.'' Id. And he further noted that in the comment section with 
respect to these three drugs, the lab report stated that ``[t]hese test 
results were not expected based on the [prescribed] medications.'' Id.
    Dr. Owen testified that Respondent ``completely ignored'' the 
aberrant drug screens and ``should have acknowledged their existence 
and then taken some type of corrective action.'' Id. at 132. Dr. Owen 
also testified that the patient file did not reflect that Respondent 
had consulted or discussed B.B. with past or current prescribers and 
that it did not appear that Respondent had taken any ``safeguards 
regarding the potential'' for diversion or abuse presented by the 
aberrant drug screens. Id. at 132-33.
    Dr. Owen then testified that the patient record did not justify the 
prescribing of controlled substances as it did not ``establish medical 
necessity for this type of treatment.'' Id. at 133. As the basis for 
his conclusion, Dr. Owen explained that:

    For one, it's a superficial evaluation that doesn't adequately 
explain the chief complaint or what previous treatments have or have 
not been done. And there's no evaluation of pain or function, 
physical or psychosocial in the documentation. There's no evidence 
of a previous therapeutic benefit. There's no medical rationale for 
continuing with an ineffective treatment, so there's no 
justification to continue treatment with controlled substances.

    Id. Dr. Owen also explained that ``[t]here's no proof that he's 
exhausted conservative care before going into these high-risk 
treatments'' and reiterated that ``[t]here's no evidence of a 
therapeutic benefit.'' Id. at 134. And with respect to the aberrant 
drug screens, Dr. Owen testified that Respondent ``could have sent this 
gentleman for evaluations by an addictionologist, by a psychiatrist [or 
psychologist] with experience in addiction medicine, and certainly

[[Page 14955]]

looked at being much more careful and objective about how [he] 
measure[d] a therapeutic benefit with the controlled substances.'' Id. 
Dr. Owen thus opined that the prescriptions Respondent provided at this 
visit were not issued in the usual course of professional practice and 
lacked a legitimate medical purpose. Id. at 133.
    On cross-examination, Dr. Owen was asked if he considered 
Respondent's ordering of an MRI at this visit to be ``a safeguard.'' 
Id. at 188. Dr. Owen initially answered ``no,'' before explaining that 
``[i]t depends [on] if you clinically need the MRI, and you only need 
the MRI if you're looking for something that has potentially a 
surgically correctable lesion,'' and that absent ``a clinical finding'' 
that suggests ``an MRI is needed to confirm a lesion that's surgically 
reversible . . . you don't have medical necessity to get an MRI.'' Id. 
Dr. Owen further explained that ``MRIs have high false positive rates'' 
and that ``[a]bnormalities are commonly found in asymptomatic people.'' 
Id. On questioning by the CALJ as to whether when a patient complains 
of ``a high subjective level of pain,'' an MRI could ``at least confirm 
[if] there was some objective basis for it,'' Dr. Owen explained that 
``without a neurological finding,'' it is ``rarely . . . valuable to 
get an MRI.'' Id. at 189. He further explained that MRIs show 
``abnormalities that are nonspecific'' leading to ``overtreatment,'' 
and thus a physician ``need[s] something more objective from a physical 
exam finding to get an MRI.'' Id.
    In response to a further question by the CALJ which posited whether 
an MRI would provide an objective basis such as ``foraminal narrowing'' 
or ``spondylosis'' for concluding that a patient ``may be having a 
spine issue'' and is not ``making it up,'' Dr. Owen explained that 
``foraminal stenosis or foraminal narrowing are common in asymptomatic 
people.'' Id. at 190. Dr. Owen then explained that ``[t]he only reason 
it would be important is if you have a radiculopathy you've identified 
on clinical exam . . . and that would be pain going down the leg in a 
dermatome distribution, typically below the knee.'' Id. Continuing, Dr. 
Owen explained that there may be ``numbness'' and there may be 
``weakness associated with the isolated nerve that's being entrapped, 
and you would have a positive straight leg raise.'' Id.
    Dr. Owen further noted that ``almost all the exams'' on B.B. ``said 
it was negative straight leg raise'' and that this is ``the most 
sensitive physical finding for low back pain.'' Id. Dr. Owen then 
explained that ``a sensitive test means that if you don't have a 
positive finding you don't have that diagnosis.'' Id. Moreover, Dr. 
Owen testified that even if a patient reported symptoms consistent with 
radiculopathy, ``you'd want physical exam findings, with the most 
important being the straight leg raise, according to the North American 
Spine Society.'' Id. at 191. Dr. Owen further explained that ``if you 
had a negative straight leg raise, then you don't have radiculopathy, 
and if you don't have radiculopathy . . . you really don't need to get 
an MRI, because it's just going to lead to finding things that send you 
on a garden path of overinterpreting the diagnosis.'' Id.
    Regarding B.B.'s September 22, 2011 visit and the prescriptions he 
issued, Respondent testified that the first thing he would do when 
entered the exam room is look at the Pain Management Treatment Plan (GX 
3, at 28) after which he would ``look[ ] at his previous notes.'' \21\ 
Tr. 286. According to Respondent, he would ask the patient if he had 
``achieved [his] objective in the pain medicine contract'' and ``what 
[the patient's] pain level is on medicine'' and use ``a scale of 1 to 
10.'' Id. Continuing, Respondent testified that ``then we [would] talk 
about what their medicines are and what utilization that we would use, 
what the risks are using the medicines . . . what our plans are, what 
treatment, what goal we're going to go for, and what we might need to 
change or initiate in the treatment, and then decide whether [to do] a 
urine drug screen.'' Id. at 286-87. Respondent then testified that B.B. 
``basically said that he had achieved his pain goal and that he was 
only a 3 to 5 out of 10, that he preferred that we not make any changes 
or any type of referral at that time, and I did a urine drug screen.'' 
Id. at 287. There is, however, no evidence that Respondent did a urine 
drug screen at this visit. See GX 3.
---------------------------------------------------------------------------

    \21\ However, in discussing the August 25 prescriptions, 
Respondent testified that ``[a]nytime I had to do anything with the 
chart of Dr. Schoelen's or pain management or anyone that I hadn't 
seen before, I would look at their last two office notes, and I'd 
look at their past medical history sheet on the front that's filled 
out by the physician . . . and then I would look at the PMP.'' Tr. 
281.
    Asked with respect to the August 25 prescriptions if he ``looked 
back at the previous drug tests,'' Respondent answered: ``I don't 
recall, but I doubt I did. . . . I wouldn't expect myself to.'' Id. 
at 283.
---------------------------------------------------------------------------

    Respondent was then asked by his counsel if he looked back at the 
August 25 drug screen. Tr. 287. Respondent testified that he ``would 
not'' have discussed the results with B.B. because ``[b]asically he was 
on all the medicines he was prescribed, and according to [the lab], if 
you're on one benzodiazepine, all the other benzodiazepines can appear 
positive within the drug screen.'' Id. Respondent then testified that 
B.B. was ``on Xanax [alprazolam] by another provider, and he was also 
on Ambien.'' Id. Asked how he knew that B.B. was on both drugs, 
Respondent testified that B.B. had listed the alprazolam on the intake 
form he completed at his first visit and while the Ambien was not 
listed ``on his past medical sheet, [it] was on the PMP.'' Id. 
Respondent then added that the Ambien was prescribed by B.B.'s 
psychiatrist. Id. at 289. He further maintained that when the practice 
``started doing pain management, we were getting multiple episodes 
where patients were denying that they had taken other 
benzodiazepines,'' and when they contacted the lab, the lab told them 
that Xanax can cross-react and cause a positive result on the mass 
spectrometry for other benzodiazepines. Id. Thus, Respondent maintained 
that he did not believe this to be an aberrant drug screen. Id.
    Respondent further testified that although he took over the care of 
B.B., he did not simply continue the same treatment that Dr. Schoelen 
provided. Id. at 290. Rather, he testified that based on his 
``education and . . . experience, especially with Lortab . . . I found 
it too addicting to keep people on short-acting pain medicines.'' Id. 
at 291. Respondent told B.B. ``that there would have to be . . . a 
change in his treatment, and that I would have to use a long-acting 
pain medicine and a short-acting only for breakthrough'' pain. Id. 
While Respondent continued B.B. on carisoprodol and Opana, he took B.B. 
off of Lortab ``and gave him a two-week trial of the Duragesic patch.'' 
Id.
    Respondent also maintained that B.B.'s ``reported pain and his 
objective'' were consistent with the findings on physical examination. 
Id. at 292. He also testified that he had discussed the use of 
Duragesic and that it, as well as morphine and Opana ER, were the 
``only long-acting pain medications that'' the Oklahoma Medicaid 
program ``would cover'' and that Medicaid would only pay for three 
prescriptions a month.\22\ Id. Respondent further

[[Page 14956]]

maintained that he and B.B. had discussed non-medicinal pain-relieving 
modalities so that B.B. knew that he believed in them and that he then 
ordered the MRI. Id. at 293.
---------------------------------------------------------------------------

    \22\ It is unclear, however, whether B.B. was on Medicaid or 
Medicare or both at the time of the prescription. See, GX 3, at 7 
(copy of B.B.'s Medicare card and Sooner Care Medical ID card); id. 
at 8-9 (Medical Home Agreement for SoonerCare); id. at 10-13 
(Advance Beneficiary Notices dated during 2011 through 2012 advising 
B.B. that ``Medicare probably will not pay for'' various items or 
services and explaining appeal rights if Medicare did not pay); id. 
at 14 (referral form for SoonerCare dated 10-14-09). See also Tr. at 
192-93. Moreover, Respondent offered no testimony as to whether 
Medicare used the same formulary as the Oklahoma Medicaid program.
---------------------------------------------------------------------------

    As for why he ordered the MRI, Respondent testified that it was the 
``[s]tandard of care in Oklahoma,'' and that while ``[h]e had an X-ray 
done in 2009 that was consistent with his finding . . . [i]f you treat 
chronic pain . . . patients and [are] audited by the Board or your 
insurance company [and] you don't have an objective finding in the 
chart, such as X-rays and MRIs, you're quite . . . the outlier.'' \23\ 
Id. Respondent added that he ``wanted to make sure that [B.B.] was 
consistent with . . . [w]hat he was being treated for and what his exam 
[sic] and the fact that he was on a Schedule II narcotic.'' Id. at 293. 
Respondent then explained that while an MRI might give a false 
positive, ``[if] the pain is consistent with it, it's just one more 
piece of evidence that gives you a reason to believe that the patient's 
legitimate and that you're legitimately treating his condition.'' Id. 
at 294. Respondent also testified that an MRI provides a baseline 
should his exam change at a late date. Id.
---------------------------------------------------------------------------

    \23\ A progress note for B.B.'s September 2, 2009 visit stated 
that an x-ray was obtained and confirmed the existence of lumbar 
thoracic scoliosis but that the disc spaces appear to be within 
normal limits. GX3, at 59. The Government did not, however, ask its 
Expert to address the significance of these findings.
---------------------------------------------------------------------------

The October 6, 2011 Visit

    On October 6, 2011, B.B. again saw Respondent. In the visit note, 
Respondent wrote: ``Patient has been on the DURAGESIC 50 mcg and the 
OPANA. Now, he would like to try the Morphine. He is slowly trying to 
figure out the right regimen for him.'' GX 3, at 47. Respondent again 
noted in the chart that ``[p]ast medical history extensively reviewed 
and placed in chart.'' Id. With respect to the physical exam, 
Respondent noted: ``[l]ow back paraspinal tenderness,'' ``[n]egative 
straight leg raise,'' and ``[n]euro intact.'' Id. Respondent also found 
that B.B. ``has a left abdominal wall hernia.'' Id. Respondent listed 
his diagnoses as ``[l]umbar disc disease'' and ``anxiety.'' \24\ Id.
---------------------------------------------------------------------------

    \24\ Respondent found, however, that B.B. was ``[a]lert and 
oriented and in no apparent distress.'' GX 3, at 47.
---------------------------------------------------------------------------

    At the visit, Respondent prescribed 30 tablets of Morphine Sulfate 
ER15 mg B.I.D. (one tablet twice per day), for a 15-day supply. GX 5, 
at 25. Respondent also recommended that B.B. ``[w]ear a corset if at 
all possible'' for his hernia. GX 3, at 47.
    Regarding the prescription, Dr. Owen testified (in the words of 
Government counsel) that it is not ``normal practice . . . for patients 
to dictate the controlled substances they're prescribed.'' Tr. 135. 
Asked ``why not,'' he explained that a physician must ``safeguard the 
patient against addiction, and you need to do things that are medically 
necessary, not what patients want.'' Id. at 135-36. Dr. Owen further 
testified that ``it's a yellow flag for a patient to ask for a drug 
specifically,'' but not necessarily ``a red flag'' as ``it could mean 
[the patient] had a previous experience with the drug and either found 
it helpful, or they've had previous experience from the drug from an 
illicit means.'' Id. However, because Respondent did not document that 
he addressed ``B.B.'s previous history with morphine'' B.B.'s request 
was ``elevate[d] to a red flag.'' Id. at 136.
    Asked what steps Respondent should have taken, Dr. Owen testified 
that ``just the fact that the aberrant urine drug tests were there 
means that you should get some consultations, because . . . this is a 
complex issue, and there's behaviors going on that you can't quite 
understand without a more thorough assessment by mental health 
providers or addictionologists.'' Id. at 136-37. According to Dr. Owen, 
this was so even if B.B. had not asked for morphine. Id. at 137.
    Here again, Dr. Owen testified that the medical record did not 
justify the prescribing of controlled substances. Id. He explained 
that:

This is a superficial evaluation that does not properly address the 
chief complaint of low back pain or establish medical necessity for 
treating with controlled substances. There's no assessment of pain, 
physical or psychosocial function, and therefore, there's no medical 
necessity to continue treatment with controlled substances, and if 
you don't have medical necessity, you don't have a legitimate 
purpose to treat.

Id. And again, Dr. Owen opined that the prescriptions ``were not'' 
issued in the usual course of professional practice and ``were not'' 
for a legitimate medical purpose. Id. at 137-38.
    Regarding this visit, Respondent testified that B.B. had 
``report[ed] that his objectives were only fair'' and that ``[h]is pain 
level had gone up to a 6 out of 10 on the Duragesic.'' Id. at 295. 
Respondent further testified that ``[w]e again went over what the rules 
were and what the Medicaid and the Duragesic and what the risk benefits 
were. We talked about whether we needed to make a referral at that 
point or make any other changes.'' Id. Respondent also testified that 
B.B. ``had a full exam'' but that ``[t]he MRI was not back yet.'' Id.
    As for the statement in the progress note that B.B. ``would like to 
try the Morphine,'' GX 3, at 47, Respondent testified that B.B. ``did 
not believe the Duragesic was sufficient and that he wanted to try one 
of the other medicines that was on the formulary.'' Tr. 296. Respondent 
testified that he did not believe this to be a ``red flag'' in B.B.'s 
case because he ``had made it very clear to [B.B.] what our choices 
were'' under the Medicaid formulary and ``the majority of patients are 
very concerned [because] Duragesic and morphine are used for dying 
cancer patients, and why are we putting them on medications for 
dying.'' Id. Respondent then testified that he was ``sure I told [B.B. 
that] Duragesic, morphine and Opana ER'' were his options. Id.
    The CALJ, observing that ``saying the patient requested morphine . 
. . is kind of a remarkable note,'' asked Respondent how his 
conversation with B.B. went. Id. at 298. Respondent answered: 
``Probably that I didn't like the Duragesic and you suggested that 
morphine was an option. Can we try the morphine this time. Probably 
something like that.'' Id. at 299. Respondent added that B.B. ``was not 
pleased . . . that we changed the Lortab and the Opana, so the fact 
that I made him do the Duragesic, he was not happy.'' Id. at 300. 
Respondent further noted that he ``did his exam'' and ``[i]t was still 
consistent that he did have left abdominal wall weakness.'' Id. 
Respondent explained that ``[h]is diagnosis was lumbar disc disease, 
anxiety, and a questionable upper respiratory infection'' and that he 
``placed [B.B.] on antibiotics.'' Id. As for his abdominal wall pain, 
Respondent discussed with B.B. ``wearing a corset if at all possible'' 
because he did not ``want to confuse his . . . abdominal pain[] with 
his level of pain because of my change in his pain regimen.'' Id. 
Respondent further explained that B.B. ``would follow up . . . in two 
weeks'' and was given only ``a two week supply of his new Schedule II 
medicine.'' Id. According to Respondent, ``anytime [he] made a large 
change in [a patient's] medications, [he] would only give a two-week'' 
supply in the event the patient was ``allergic to it,'' was ``going to 
abuse it,'' or ``got no pain relief whatsoever.'' Id. at 302.
    Respondent also testified that he had given B.B. a shot of 
Decadron, a steroid, which ``sometimes'' provides patients in ``severe 
pain'' with ``significant relief'' and is ``a great indicator that [the 
patient's] pain was more inflammatory than other nature.'' Id. at 301.

[[Page 14957]]

The October 20, 2011 Visit

    B.B. again saw Respondent on October 20, 2011. GX 3, at 46. 
According to the progress note, B.B. reported that ``his stress [was] 
up,'' that he had ``los[t] his father, and ``he [was] having a lot of 
grief.'' \25\ Id. Respondent again noted that B.B.'s ``[p]ast medical 
history [was] extensively reviewed and placed in chart.'' Id.
---------------------------------------------------------------------------

    \25\ Yet Respondent also noted that B.B. was ``[a]lert and 
oriented and in no apparent distress.'' GX 3, at 46.
---------------------------------------------------------------------------

    As for the physical exam, Respondent noted that B.B. had ``[l]ow 
back paraspinal and spinal tenderness'' and a ``[n]egative straight leg 
raise, but [that] lying down and sitting up cause him a lot of pain.'' 
Id. He also noted ``[n]euro intact.'' Id. Respondent again diagnosed 
B.B. with ``[l]umbar disc disease'' and added a further diagnosis of 
``[a]cute grief.'' Id. Respondent documented that he discussed the 
``[a]ddictive, dependence, and tolerance nature of the medicines as 
well as alternatives,'' that he suggested ``[n]on-medicinal pain-
relieving modalities,'' and that the follow-up would be either 
``p.r.n.'' (as needed) or ``three months per his pain contract.'' Id. 
Respondent also issued B.B. new prescriptions for 120 Opana 10 (one 
tablet every 6 hours P.R.N. for breakthrough pain) and 90 Morphine 
Sulfate ER 15, increasing the dosing of the latter drug to one tablet 
in the morning and two tablets in the evening. Id.; see also GX 5, at 
19, 22.
    With respect to the statement in the progress note that B.B. was 
having a lot of stress and grief, Dr. Owen testified that this 
``magnifies the perception of pain and disability'' and that because 
there were previous ``aberrant behaviors going on and now . . . another 
stressor in [B.B.'s] life,'' this ``increase[d] the risk'' that B.B. 
would ``use [the] drugs to chemically cope.'' Tr. 139. Dr. Owen then 
explained that Respondent should have ``sought psychological counseling 
for'' B.B. Id. Based on there being ``no documentation of [Respondent] 
taking additional steps,'' Dr. Owen concluded that he ``did not'' do 
that. Id. at 140.
    Dr. Owen also testified that Respondent's notation that 
``[n]onmedicinal pain-relieving modalities suggested'' lacked 
sufficient detail before rhetorically asking: ``What does that mean, 
nonmedicinal modalities suggested?'' Id. at 209-10. Continuing, Dr. 
Owen explained:

First, you don't suggest treatment. Your job as a physician is to 
advise the patient of what good medicine is, and good medicine would 
be if you haven't done nonmedicinal pain-relieving modalities, we 
need a back-up, wean you off these controlled substances and try 
these other treatments first.

Id. at 210. Then asked what the purpose is ``of providing that level of 
detail in a patient file,'' Dr. Owen answered:

    Well, the purpose of documentation is for continuity of care. 
Not only continuity of care for this same provider from visit to 
visit but continuity of care should somebody else assume the care 
later on down the road or should you need to get a consultation, 
that the consultant can read your notes and understand what was 
happening with this patient at this point in time.

Id.
    Regarding this visit, the CALJ asked Dr. Owen if Respondent's 
notation that ``[n]egative straight leg raise, but lying down and 
sitting up causes him a lot of pain'' had ``any significance?'' Id. Dr. 
Owen replied: ``[I]t doesn't--it's not objective [in a] neurological 
kind of sense, but it definitely contributes to the idea that it's not 
therapeutic on his controlled substances, because he's having a lot of 
pain, lying down and sitting.'' Id. When then asked by the CALJ, 
``[h]ow about the negative straight leg raise part of it?'' Dr. Owen 
answered: ``[t]hat means he cannot have a radiculopathy. There's not 
likely anything surgically going on.'' Id. at 211.
    Dr. Owen again testified that the medical record did not support 
the prescribing of controlled substances. Id. at 140. He testified 
that: ``[a]s previously discussed, there's an inadequate evaluation 
going on. There's a lack of medical necessity to continue treatment 
with controlled substances since there's no therapeutic benefit. And if 
you don't have medical necessity, you can't have a legitimate medical 
purpose for using controlled substances.'' Id.
    Respondent testified that the ``most remarkable'' thing in the 
October 20 progress note was that B.B.'s blood pressure had gone up and 
that B.B. was also ``wanting to know about his MRI report.'' \26\ Tr. 
305. Respondent then testified as to the various entries in the October 
20 note including B.B.'s report of having ``lost his father'' and 
``having a lot of grief.'' Id. According to Respondent, B.B.'s ``exam 
was still exactly like before, with low back paraspinal and spinal 
tenderness, but he still had the negative straight leg raises. But 
laying down and sitting up still caused him a lot of pain.'' Id.
---------------------------------------------------------------------------

    \26\ However, while the visit includes the handwritten notation 
``Question about MRI,'' GX 3, at 46, B.B. did not undergo the MRI 
until the next day. See id. at 19.
---------------------------------------------------------------------------

    Continuing, Respondent testified that he diagnosed B.B. with acute 
grief and lumbar disc disease and that he increased his Morphine to two 
pills or 30 milligrams in the evening while keeping his Opana for 
breakthrough pain. Id. He also testified that he warned B.B. about 
``the addictive, dependence and tolerance natures'' of the medications 
and ``suggested that he continue using his non-pain [sic] relieving 
modalities.'' Id. Respondent did not, however, offer any further 
explanation as to what those modalities involved. Respondent then 
testified that he determined the follow-up would be in ``three months'' 
as he ``felt like [B.B.] could really go into the three-month'' 
schedule for being seen by him. Id. at 305-06. However, at this visit, 
Respondent did not document whether B.B. was achieving his treatment 
objective or that he had obtained a numeric rating from B.B. as to his 
pain. See GX 3, at 28.
    On October 21, 2011, the day after this visit, B.B. had an MRI done 
of his lumbar spine. Id. at 19. The Radiologist reported his impression 
as follows: ``Degenerative changes of the lower lumbar spine as above. 
Most affected level is at L5-S1 where a left paracentral disc 
protrusion contacts the descending S1 nerve root in the lateral 
recess.'' \27\ Id. at 20.
---------------------------------------------------------------------------

    \27\ Other findings included that L1-L2, L2-L3, and L3-L4 were 
all normal, as well as that the alignment of his vertebrae was 
normal. GX 3, at 19. At L4-L5, the MRI found a ``[s]mall left 
paracentral disc protrusion with no significant spinal canal with 
mild left neural foraminal and no significant right neural foraminal 
stenosis.'' Id. At L5-S1, the MRI found a ``[s]mall left paracentral 
disc protrusion measuring 8 mm in [the] AP dimension results in 
moderate subarticular recess narrowing, with contact of the 
descending S1 nerve root. There is mild left neural foraminal 
stenosis with no significant right neural foraminal stenosis.'' Id.
---------------------------------------------------------------------------

    Regarding the MRI, Dr. Owen tested that it ``did not show any 
specific problems that would be attributable for this kind of pain 
complaint[], nor was it significant to cause the perceived disability 
that this 26-year-old gentleman considers himself'' to have. Tr. 207. 
And as he earlier testified in response to the CALJ's question as to 
whether an MRI would provide an objective basis such as ``foraminal 
narrowing'' or ``spondylosis'' for concluding that a patient ``may be 
having a spine issue'' and not ``making it up,'' Dr. Owen explained 
that ``foraminal stenosis or foraminal narrowing are common in 
asymptomatic people.'' Id. at 190. Dr. Owen then explained that ``[t]he 
only reason it would be important is if you have a radiculopathy you've 
identified on clinical exam . . . and that would be pain going down the 
leg in a dermatome distribution, typically below the knee.'' Id. 
Continuing, Dr. Owen explained that

[[Page 14958]]

there may be ``numbness'' and there may be ``weakness associated with 
the isolated nerve that's being entrapped, and you would have a 
positive straight leg raise.'' Id.

The November 18, 2011 and December 15, 2011 Prescriptions

    On November 18, 2011, Respondent wrote new prescriptions with the 
same dosing instructions for 90 Morphine Sulfate ER 15 mg and 120 Opana 
10 mg; each of these was for a 30-day supply. GX 5, at 17, 21; GX 3, at 
23. B.B. filled the prescriptions the same day. While B.B.'s file 
contains photocopies of the prescriptions, it contains no documentation 
of a visit with either Respondent or a nurse on this date. See 
generally GX 3; Tr. 142.
    Likewise, on December 15, 2011, Respondent wrote new prescriptions 
with the same dosing instructions for 90 Morphine Sulfate ER 15 mg and 
120 Opana 10 mg, each of these being for a 30-day supply. GX 3, at 67, 
90. Respondent filled these prescriptions the same day. Id. at 23. Here 
again, there is no documentation of a visit with either Respondent or a 
nurse on this date. See generally GX 3; Tr. 142.
    Dr. Owen testified that ``[e]specially in the context of the 
previous aberrant urine drug testing and the lack of any clear medical 
necessity or therapeutic benefit,'' Respondent ``should have'' seen 
B.B. in his office prior to prescribing the drugs on both dates. Tr. 
142. Dr. Owen further testified that notwithstanding that at the 
October 20 visit, B.B. had reported that ``his stress is up'' and that 
``he [was] having a lot of grief,'' there is no notation in B.B.'s file 
as to how B.B. was dealing with these issues. Id. Dr. Owen also noted 
that there was no notation in the file that Respondent had discussed 
the results of the aberrant drugs tests with B.B. Id. at 143. Dr. Owen 
then testified that Respondent had ``never'' established ``a medical 
necessity . . . to continue these treatments'' and that this would 
require an in-office visit. Id.
    After explaining that the aberrant drugs tests and mention of 
B.B.'s life stressors supported the need for psychological counselling 
and consultations with a psychologist or addictionologist, Dr. Owen was 
asked what risk was created by prescribing these drugs to B.B. without 
requiring an office visit. Id. Dr. Owen testified that ``[t]he risk is 
that he continues to self-escalate these medications, and [is] either 
chemically coping or becomes--or is addicted to it.'' Id. Dr. Owen then 
opined that Respondent had never established the ``medical necessity'' 
of the prescriptions he issued to B.B. on these two dates, that the 
prescriptions lacked a legitimate medical purpose, and that Respondent 
acted outside of the usual course of professional practice in issuing 
them. Id. at 144.
    On cross-examination, Dr. Owen was asked whether he was aware that 
under DEA's regulation which allows a physician to ``issue multiple 
prescriptions authorizing the patient to receive . . . up to a 90-day 
supply of a schedule II controlled substance, provided [various] 
conditions are met,'' ``it was okay . . . to only see a patient once . 
. . every 90 days?'' Id. at 195-96; see also 21 CFR 1306.12(b). While 
Dr. Owen answered ``yes,'' he added that a physician must have 
``established medical necessity and legitimate therapeutic benefit from 
previous documentation and [that] a patient doesn't have a high risk of 
abuse.'' Tr. 196. Dr. Owen then re-iterated that B.B. ``already had 
multiple aberrant urine drug tests before those prescriptions were 
issued.'' Id.
    Regarding these prescriptions, Respondent testified that he did not 
understand that he had to see B.B. ``every 30 days'' and that ``[w]e 
saw him every 90 days.'' Id. at 307. Respondent further testified that 
``[a]t the time there was debate within the state as to whether'' 
patients ``could be seen'' even ``every four months'' and ``we had 
chosen every three months, so we never gave more than two refills on a 
II or above.'' Id. Respondent then explained that the patients ``would 
call one to two days ahead, a lot of times to the pharmacy, and the 
pharmacist faxes the request.'' Id. at 307-08. Continuing, Respondent 
testified that ``[a] PMP would be pulled, and then the chart would be 
pulled. And then we would write a prescription for the person and leave 
it up front for them to pick up and sign for.'' Id. at 308. Respondent 
further testified that the November 18 prescriptions were issued 29 
days after the previous prescriptions. Id. at 311. Respondent did not, 
however, address Dr. Owen's criticism that B.B. presented a high risk 
of escalating the use of the controlled substances and should have been 
seen prior to prescribing on each of these dates. See id. at 306-13.

The January 19, 2012 Visit and Prescriptions

    On January 19, 2012, B.B. again saw Respondent, who reported that 
he had gone to the emergency room ``two weeks ago with right leg 
swelling'' but that ``[h]is ultrasound was negative.'' GX 3, at 45. 
B.B. complained of ``some calf pain'' and that ``[h]e still feels very 
tight.'' Id. Respondent also noted that B.B. ``goes to a psychiatrist'' 
and ``reports severe lumbar disc disease''; he also noted that B.B. 
reported that ``he ha[d] been exposed to someone with HPV'' and ``would 
like an exam.'' Id. Respondent further noted that B.B.'s ``[p]ast 
medical history [was] extensively reviewed'' and ``placed in chart.'' 
Id.
    According to Respondent's exam notes, B.B. was ``[a]lert and 
oriented and in no apparent distress.'' Id. While other portions of the 
exam were normal, Respondent again documented that B.B. had ``[l]ow 
back paraspinal tenderness,'' a ``[n]egative straight leg raise,'' and 
``[n]euro intact.'' Id. He also documented that B.B. ``has very tight 
right calf.'' Id. However, no mention was made of B.B.'s hernia which 
had been noted at previous visits. Id.
    Respondent diagnosed B.B. with ``lumbar disc disease,'' ``exposure 
to infectious disease,'' and ``[r]ight calf pain.'' Id. He further 
documented that he discussed the ``[a]ddictive dependence, and 
tolerance nature of the medicines as well as alternatives,'' that he 
suggested ``[n]on-medicinal pain-relieving modalities,'' and that the 
``[f]ollowup will be [in] three months.'' Id. Respondent then issued 
B.B. new prescriptions for Morphine Sulfate ER 15 mg and Opana 10 mg 
with the same dosing instructions, thus providing a 30-day supply for 
each drug if taken as directed. Id.
    At this visit, B.B. was required to provide a urine drug screen. 
While the results were not reported until January 31, 2012, the lab 
reported that morphine was ``not detected'' and that this result was 
``not expected with prescribed medications.'' GX 3, at 97. Moreover, 
while the lab detected the presence of alpha-hydroxyalprazolam, a 
metabolite of alprazolam, the lab also detected the presence of 
nordiazepam, the metabolite of diazepam, as well as the presence of 
oxazepam, and temazepam. Id. With respect to the presence of the latter 
three drugs, the lab reported that these three results were ``not 
expected with prescribed medications.'' Id. Of further note, the lab 
report bears the handwritten but undated notation: ``Pt counseled to 
only take what is prescribed[.]'' Id.
    Dr. Owen testified that while ``oxazepam can be a metabolite of 
several other benzodiazepines,'' this was an aberrant drug test because 
non-prescribed drugs were detected and prescribed drugs were not 
detected. Tr. 150-51. As for the drugs that were detected but were not 
prescribed, Dr. Owen testified that B.B. was either ``getting [them] 
from the illicit . . . market or from a friend.'' Id. at 151. As for 
the morphine, which was prescribed

[[Page 14959]]

but not detected, Dr. Owen explained that ``[e]ither [B.B. was] selling 
it on the street or he self-escalated and ran out of his supply.'' Id.
    Regarding this visit, Dr. Owen testified that when a patient 
reports having gone to the emergency room, he would get the record to 
find out both ``what the problem was,'' as well as if ``any additional 
medication [was] prescribed.'' Tr. 147. However, the patient file does 
not contain a note from the emergency room. Id.; see also GX 3. 
Moreover, after observing that the visit note contains no mention that 
Respondent addressed either of the two prior urine screens during this 
visit, Dr. Owen again testified that Respondent had failed to establish 
medical necessity for the prescriptions ``by doing a proper history and 
physical exam, by defining a therapeutic benefit, by explaining what 
previous treatments have or have not worked . . . and . . . addressing 
the previous aberrant urine drug tests.'' Id. at 148. Thus, Dr. Owen 
opined that Respondent acted outside of the usual course of 
professional practice in issuing the prescriptions and that the 
prescriptions lacked a legitimate medical purpose. Id.
    Regarding the prescriptions, Respondent testified that B.B. wanted 
refills and then testified as to what he had documented in the note. 
Id. at 313. Asked by his counsel if B.B. had ``ask[ed] for anything 
different or call[ed] for additional drugs when he went to the ER,'' 
Respondent testified that ``[t]here was nothing on his PMP that 
revealed they prescribed anything,'' a fact confirmed by the PMP. Id. 
at 314; GX 3, at 23.
    Observing that the visit note ``almost seems as if [B.B.] would be 
a person that's not in pain,'' the CALJ asked: ``doesn't it seem like 
an unremarkable set of . . . notes for such a high amount of 
painkillers?'' Tr. 315. Respondent answered: ``He just continued to 
have the same pain that he had before, so I didn't go into details on 
it.'' Id. The CALJ then asked: ``doesn't it seem like kind of an 
unremarkable set of notes for somebody that's on a lot of heavy 
medications?'' Id. Respondent answered that he ``agree[d]'' and added 
that ``I can only conjecture at this point as to what was going on, but 
I imagine I was more concerned about the fact he had went to the 
emergency room and making sure he didn't get other medicine'' and 
``less concentrated on his chronic pain.'' Id. at 316. The CALJ then 
commented that ``the notes do seem very benign'' and asked ``if that 
seemed normal to'' him? Id. at 316-17. Respondent answered that ``[i]t 
stands out that I didn't make more.'' Id. at 317. Respondent then 
maintained that he ``was seeing 40 to 45 patients a day and dictating 
that night and the next morning, and so I definitely could have done a 
better job.'' Id. Continuing, Respondent testified that he thought that 
at this visit, B.B. ``wasn't requesting any more or any change in his 
pain medicines'' and ``wasn't reporting anything except his calf pain 
and his new conditions.'' Id.
    At this point, Respondent's attorney suggested that he had noted 
``his lumbar disc disease and ``low back paraspinal tenderness'' in the 
visit note, prompting Respondent to state: ``[t]hat's correct. And he 
still had the negative straight leg raise.'' Id. at 317-18. Respondent 
then conceded that his finding of a negative straight leg raise was an 
indicator that B.B.'s back issues were not causing radiculopathy in his 
legs. Id. at 318. However, Respondent maintained that ``a negative 
straight leg raise doesn't mean they [sic] don't have significant pain 
when you raise their [sic] leg,'' and that ``if you raise their [sic] 
foot when they're [sic] laying in a supine, they [sic] flinch back.'' 
Id. Respondent did not, however, document this in the progress note for 
this visit, nor did he document as he had at the last visit that 
``lying down and sitting up cause [a] lot of pain.'' Compare GX 3, at 
46, with id. at 45.
    Moreover, when the CALJ asked if ``[t]his note was more saying . . 
. that he's still maintaining an absence of at least an objective sign 
of radiculopathy,'' Respondent answered: ``[o]f radiculopathy, but not 
necessarily paraspinal or muscular-skeletal pain.'' Tr. at 318-19. Upon 
further questioning by the CALJ as to his reason for noting the 
negative straight leg raise, Respondent agreed with the CALJ's 
suggestion that the reason for the note was to ``more or less show that 
things [weren't] getting worse'' and then added that ``there was no 
change.'' Id. at 319.
    Yet, at this visit, Respondent neither documented that B.B. had 
achieved his treatment objective nor indicated if he had completed an 
update pain scale on the Treatment Plan form. See GX 3, at 28. 
Respondent did not document if B.B. was achieving his treatment 
objective and had completed an updated pain scale until his January 27, 
2015 visit, when Respondent wrote ``fair'' in the block for ``Has 
patient achieved treatment objective?'' and either the number 3 or 7 in 
the block for ``Patient Completed Updated Pain Scale'' on the Treatment 
Plan form.\28\ Id. On the same date, Respondent also wrote ``no'' in 
the block for whether he considered referring B.B. for a second opinion 
or further treatment options. Id.
---------------------------------------------------------------------------

    \28\ Indeed, the writing bears a strong semblance to the number 
3 as written by Respondent in listing his registration number 
(BP2423440) on various prescriptions. Compare GX 3, at 28, with GX 
5, at 23; see also GX 1, at 1.
---------------------------------------------------------------------------

    According to the progress note for the January 27 visit, B.B. 
reported that he was ``very anxious'' about the price of the vaccine 
for HPV. GX 3, at 44. Respondent also documented that B.B.'s ``[p]ast 
medical history [was] extensively reviewed and placed in chart and 
includes severe thoracic and lumbar pain.'' Id. And in the physical 
exam section of the note, Respondent noted ``low back paraspinal and 
spinal tenderness'' and ``[q]uestionable straight leg raise.'' Id. He 
also noted ``[n]euro intact.'' Id. Respondent did not, however, 
prescribe any controlled substances on this date. See id.; see also id. 
at 22-23 (PMP Report).
    The CALJ also asked Respondent whether he thought the Jan. 27 visit 
note looked ``very benign'' if he was ``really evaluating'' the 
``efficacy of the pain [medication] regimen'' as it only referred to 
B.B.'s ``past history'' of thoracic and lumbar pain. Id. at 323. 
Respondent answered that even if he ``was seeing someone for something 
other than their [sic] pain management and not writing prescriptions 
that day,'' he would ``acknowledge the fact that that was still 
underlying'' and ``reflect[] [that] in the note,'' so that it did not 
``appear[] that he has no pain in between'' the visits. Id. at 324.
    The CALJ, explaining that the progress note did not ``seem to 
discuss at all the underlying basis for the pain [medication] regimen'' 
or the ``activities of daily living or . . . function,'' asked 
Respondent if ``those [are] things that you would ordinarily include in 
there?'' Id. at 324. Respondent answered that ``[i]n the individual's 
subjective--or the SOAP notes, a lot of times those would be neglected. 
With time constraints, I'm not necessarily efficient. That's not ideal 
I guess is what I'd say.'' Id. Continuing, Respondent testified: ``But 
this patient had been disabled on Social Security and determined 
previously to have chronic pain and . . . objective data confirmed 
that. He was not doing anything to set off alarms with his PMP, doctor-
shopping or changing his medications. He was stable on his medicines at 
that point.'' Id. Respondent then maintained that B.B. ``was one of our 
low-flyers'' compared to other patients and because ``[h]e wasn't 
increasing his pain med [and] not asking for increased pain medicines . 
. . I guess [he] got less individualized SOAP notes.'' Id. at 325.
    Observing that the visit notes ``don't tend to deal with activities 
of daily living or anything where you were

[[Page 14960]]

measuring how well the treatment objectives are being attained,'' the 
CALJ asked Respondent how he evaluated ``how well you're doing in 
treating the patient with . . . pain medications?'' Id. at 325-26. 
Respondent testified that:

[t]he notes could be much more well written. Much more went on in 
the office than what's written. And it's been pointed out here that 
if it's not written it didn't occur. That doesn't mean it didn't 
occur. It means I can't prove it. But I definitely knew what was 
going on in his life from each visit, and I just failed to dictate 
that.

Id. at 326.
    Subsequently, the CALJ asked Respondent how he knew ``how the meds 
were doing?'' Id. at 327. Respondent answered: ``Pure subjective, and 
if they were needing more or less pain meds. That's all I --.'' Id.
    The CALJ then asked Respondent if he was not asking B.B. 
``questions about what activities he's doing or what's better or worse 
or what's causing him pain, then aren't you just depending on his 
subjective desire for more or less pain medicine?'' Id. Respondent 
replied:

    Well, I was talking to him about those things and what all he 
did in a day, and he was not able to work. He . . . didn't have a 
vehicle, I don't believe. I think that was a major issue for how he 
got his prescriptions or not. And so he basically was stuck in the 
house all day, trying to figure out how to stretch or how to do his 
exercises at home--he was pretty much homebound, taking care of his 
son.

Id.

The February 13, 2012 Prescriptions

    On February 13, 2012, Respondent issued B.B. new prescriptions for 
both 120 Opana 10 and 90 Morphine Sulfate ER 15, with the same dosing 
instructions as the previous prescriptions. GX 5, at 3 & 23. As noted 
previously, the lab reported the results of the January 19, 2016 urine 
drug test on January 31, 2012, GX 3, at 97; and thus Respondent should 
have had the results by this date. Tr. 153. As explained previously, 
other than the undated notation on the Lab Report that B.B. was 
``counseled to only take what is prescribed,'' the only documentation 
in the progress notes for this date (which is written at the bottom of 
the January 27, 2012 progress note) is the following: ``Zpack, 
Prednisone 10 mg # 28, Phenergan.'' GX 3, at 44.
    Dr. Owen testified that there should have been an office visit ``in 
light of the previous aberrant drug-taking behaviors and the lack of 
medical necessity [having been] established to treat with controlled 
substances.'' Tr. 154. He further explained that Respondent ``need[ed] 
to establish medical necessity and establish a therapeutic benefit, and 
now we have another aberrant drug test in late January.'' Id. While he 
acknowledged that Respondent documented that he counseled B.B. to take 
only what is prescribed, Dr. Owen testified that this was not an 
adequate safeguard to prevent abuse or diversion, ``especially since 
this [was] the third aberrant urine drug test.'' Id. Asked what 
Respondent should have done, Dr. Owen testified that ``you need to have 
a long discussion with the patient about the risk of addiction \29\ and 
get some consultations by experts in [the] field of addiction.'' Id. at 
155. Based on the absence of any such documentation in the file, see 
generally GX 3, and that Respondent never claimed to have obtained any 
consultations, I find Respondent did not obtain a consultation with an 
expert in addiction.
---------------------------------------------------------------------------

    \29\ Dr. Owen was not asked to provide details as to what 
specific areas would be discussed in such a conversation.
---------------------------------------------------------------------------

    Moreover, Dr. Owen again found that the patient record did not 
justify the prescribing of controlled substances and further noted that 
the ``medical necessity for the prescriptions ha[d] not been 
established in any of the previous evaluations.'' Tr. 155. He further 
opined that the Opana and morphine prescriptions issued on this date 
lacked a legitimate medical purpose and were issued outside of the 
usual course of professional practice. Id. at 155-56.
    Respondent testified that he had reviewed the drug test results and 
had directed his staff to pull a PMP report. Id. at 335. He also 
acknowledged having written the notation that ``patient was counseled 
to only take what is prescribed.'' Id. Asked by his counsel if ``red 
flags [were] raised by these test results,'' Respondent answered:

    [t]he red flag that I saw--the morphine said not detected, but 
the oxymorphone was positive, so that was explainable. The 
nordiazepam, the oxazepam, and then the Xanax, the lab always said 
that if . . . Xanax was positive, that they could all three be 
positive. The temazepam, in our practice, usually didn't show up, 
and temazepam is a sleeping pill called Restoril.
    And so I wanted to pull the chart, and so Dr. Schoelen didn't 
mind his pain patients being on Restoril. I did, and so I wanted to 
make sure, has he been prescribed Restoril. I couldn't find it on 
the PMP, so I'm sure what was told was, if you have an old Restoril 
or some other doctor, I do consider that breaking our rules, and so 
you can't take it.

Id. at 335-36.
    Notably, while the PMP report shows that B.B. had received a number 
of prescriptions for Ambien (zolpidem), it does not list any 
prescriptions for temazepam. GX 3, at 22-26. Nor do the progress notes 
during the period in which B.B. was being treated by Dr. Schoelen 
contain any indication that Schoelen had prescribed temazepam to B.B. 
Id. at 50-62. And Respondent offered no testimony that he ever asked 
B.B. from whom he obtained the Restoril, and the chart contains no 
documentation that he did. In any event, even if the lab had told 
Respondent that using alprazolam could also trigger false positives for 
diazepam and oxazepam, this was still an aberrational result and was, 
in fact, the third aberrational UDS that B.B. had provided in less than 
eight months.
    Asked by the CALJ why he did not find the non-detection of morphine 
to be ``an anomaly,'' Respondent asserted that this was because 
oxymorphone is a metabolite of the former. Id. at 336. When then asked 
``[w]hy wouldn't it show morphine positive then if the person's on 
morphine,'' Respondent testified ``[t]hat would occur occasionally.'' 
Id. Respondent then speculated that B.B. ``probably did not take two 
medications on that day. Most likely it was over the 30 days since his 
last prescription, but it was still in his system, that it had been 
taken recently.'' Id. Respondent then asserted that ``[t]he same is 
true, the exact same thing for the carisoprodol, which is Soma. It's on 
the next page, page 98 [of the Exhibit], shows that meprobamate was 
positive'' and ``the comments section says, `Test result is expected 
based on prescribed medications.''' Id. at 337.
    It is true that meprobamate is a metabolite of carisoprodol--as 
noted by the lab itself on the reports. See GX 3, at 96-98, 100, 104; 
see also 76 FR at 77340 (carisoprodol scheduling order). Moreover, when 
B.B. was under Dr. Schoelen's care and being prescribed hydrocodone, 
the lab reports noted that B.B. had tested positive for hydromorphone 
and that this drug ``is a metabolite of hydrocodone,'' thus rendering 
the test result ``expected with [the] prescribed medications.'' See id. 
at 99, 103, 104, 105, 106. Unexplained by Respondent is why, if 
oxymorphone is a metabolite of morphine, the lab did not indicate that 
on the reports as it did when it noted that meprobamate and 
hydromorphone were metabolites of carisoprodol and hydrocodone 
respectively. Of further note, Respondent did not testify as to his 
basis of knowledge for this assertion.
    However, as found above, B.B. had last obtained a morphine 
prescription on December 15, 2011, 35 days before the January 19 visit, 
and if taken as directed, B.B. would have run out of his

[[Page 14961]]

morphine five days earlier. GX 3, at 23. The Government produced no 
evidence as to how long morphine at this dosing would still be 
detectable in urine after it was last taken. Nonetheless, based on the 
presence of temazepam which was not prescribed, the January 19 drug 
test was still aberrational.

The March 13, 2012 Prescriptions

    On March 13, 2012, Respondent issued B.B. new prescriptions for 
both 120 Opana 10 and 90 Morphine Sulfate ER 15, with the same dosing 
instructions as the previous prescriptions. See GX 5, at 10, 24. 
Respondent issued the prescriptions without requiring an office visit 
by B.B. Tr. 156, see generally GX 3, at 42-62 (visit notes for B.B.). 
Nor is there any notation on any of the visit notes regarding 
Respondent's issuance of these prescriptions.\30\
---------------------------------------------------------------------------

    \30\ As found above, on the January 27, 2012 visit note, 
Respondent had written that on ``2/13/12'' he prescribed ``Zpack, 
Prednisone 10 mg # 28, Phenergan.'' GX 3, at 44. The same visit note 
contains a further entry for ``2-22-12'' documenting the issuance of 
a prescription for 60 tablets of Soma (carisoprodol) 350 mg. Id.
---------------------------------------------------------------------------

    Dr. Owen testified that Respondent should have required an office 
before issuing these prescriptions, reiterating that the ``medical 
necessity for'' the prescriptions still had not been established. Tr. 
156. Asked to again identify the deficiencies which led him to conclude 
that Respondent had not established medical necessity, Dr. Owen 
explained:

    Reviewing all the pertinent previous medical records, including 
what previous treatments have been performed, an adequate history 
and physical exam, consultations as medically appropriate, 
establishing a clinically meaningful and objective therapeutic 
benefit, and addressing any aberrant drug-taking behaviors.

Id. at 157. Dr. Owen then noted that there were three previous 
incidents of aberrant drug-taking behaviors, and that ``[t]he only 
treatment plan has been continuing the controlled substances without 
medical necessity.'' Id. at 158. And once again, Dr. Owen testified 
that the prescriptions lacked a legitimate medical purpose and ``were 
not'' issued in the usual course of professional practice. Id.
    In his direct testimony, Respondent did not address his reasons for 
issuing the March 13 Opana and morphine prescriptions. See Tr. at 338-
39. Instead, the questioning centered on why he wrote a prescription on 
March 14 for Nexium, ``a stomach medicine'' and a non-controlled drug 
(``I have no idea'') after which the questioning moved on to the next 
set of prescriptions. Id.

The April 12, 2012 Visit and Prescriptions

    On April 12, 2012, B.B. saw Respondent for an office visit. GX 3, 
at 42. According to the visit note, B.B. ``report[ed] his pain has been 
worse,'' that ``[h]e has run out of his medicines; he had them 
stolen,'' and that ``[h]e has done fairly well.'' Id. Moreover, on the 
Treatment Objective Evaluation section of the Treatment Plan, 
Respondent wrote ``fair [rarr] yes'' in the block for ``Has patient 
achieved treatment objective?'' and ``6'' in the block for ``Patient 
Completed . . . updated pain scale.'' Id. at 28.
    In the visit note, Respondent wrote that B.B. ``still has severe 
anxiety and depression'' and has been ``exposed to someone with HPV''; 
Respondent then wrote: ``[h]e is also wanting to switch his medicines 
because he is having trouble finding the OPANA.'' GX 3, at 42. 
Respondent also noted: ``[p]ast medical history extensively reviewed 
and placed in chart.'' Id.
    In his exam findings, Respondent noted ``[l]ow back paraspinal and 
spinal tenderness,'' ``[n]egative straight leg raise,'' and ``[n]euro 
intact.'' Id. Respondent listed his diagnoses as ``[l]umber disc 
disease,'' ``[a]nxiety and depression'' and ``[e]xposure to infectious 
disease,'' although he ``doubt[ed] that it was HPV.'' Id. Respondent 
then changed B.B.'s medications to Opana ER (extended release) 20 mg 
b.i.d. (twice per day) and Percocet 10 mg (q. 12h) p.r.n. (as needed) 
for acute pain. Id.; see also Tr. 340. He also prescribed Soma 
(carisoprodol) one tablet b.i.d. GX 3, at 42.
    Respondent further documented that he discussed the ``[a]ddictive, 
dependence, and tolerance nature of the medicines, as well as 
alternatives.'' Id. He noted that he ``suggested'' ``[n]on-medicinal 
pain and anxiety-relieving modalities.'' Id.
    Respondent also required B.B. to undergo a urine drug screen. While 
the preliminary screen shows that B.B. tested positive for oxycodone 
(which had not been prescribed to him) and negative for opiates/
morphine (which he had been prescribed), the line on the form for 
noting the oxycodone result includes the parenthetical ``synthetic & 
semi-synthetic opiates'' and the form contains no separate entry for 
oxymorphone, which is a semi-synthetic narcotic. GX 3, at 63. Notably, 
the Government produced no evidence as to whether a positive result for 
oxymorphone would show up as positive for oxycodone or as positive for 
``opiates/morphine.'' Moreover, Dr. Owen acknowledged that there are 
reliability issues with this type of test and thus, ``you would send it 
off for a confirmatory mass spectroscopy test.'' Tr. 164. However, 
according to Dr. Owen, the results are still valid until the 
confirmation shows otherwise. Id.
    Respondent did send B.B.'s. urine sample to the lab for further 
testing. GX 3, at 96. According to the lab report, which was reported 
back to Respondent on April 17, 2012, B.B. tested positive for 
oxymorphone, which was expected based on Respondent's having prescribed 
Opana to him. Id. He also tested positive for meprobamate, which was 
expected based on Respondent's having prescribed carisoprodol to B.B. 
Id. However, the lab further found that morphine was ``not detected,'' 
a result which was ``not expected'' because Respondent had prescribed 
morphine sulfate ER to B.B. on March 13, 2012. Id. Dr. Owen also noted 
that while ``the confirmed . . . drug test [was] positive for some of 
these drugs,'' Respondent had reported that he had run out of his 
medicines and that there was a ``lack of documentation of what he ran 
out of and what he should still be on, so . . . there's problems in 
interpreting this urine drug test.'' Tr. 167.
    Dr. Owen testified that Respondent did not address the aberrant 
preliminary drug screen conducted on April 12 nor any of the previous 
aberrant drugs tests at this visit. Id. at 165-66. However, as found 
above, on the January drug test report, Respondent did note--but 
without specifying the date that he did so--that he had counseled B.B. 
to take only what was prescribed.
    The Government also asked Dr. Owen if it was noteworthy that B.B. 
had told Respondent that his pain was worse, that he had run out of his 
medicines and had them stolen. Id. at 159. Dr. Owen answered:

    Well, one, his pain is worse, so why is it worse? Two is he's 
run out of his medications, and then he had them stolen. What is it? 
Did you run out of them because you self-escalated, or were they 
stolen and you ran out of them? It needs clarification. But either 
event, self-escalation or having them stolen, is a red flag.

Id.
    Dr. Owen then noted that B.B.'s pain contract stated that ``lost 
and stolen medications will not be replaced,'' id. at 160, but 
acknowledged on cross-examination that Respondent had not provided an 
early refill of the prescriptions. Id. at 200. However, regarding 
B.B.'s report that his medications were stolen, Dr. Owen further 
testified that because there had

[[Page 14962]]

``been the aberrant urine drug tests before . . . this, there is [sic] 
enough aberrant behaviors that'' Respondent needed ``to get the person 
to an addictionologist or a psychologist, or just stop prescribing 
these controlled substances since there's no evidence they're helping 
this gentleman.'' Id. at 212-13.
    Dr. Owen also found problematic the notations in the visit note 
that B.B. reported that ``his pain has been worse'' and that ``[h]e has 
done fairly well.'' Id. at 160. As Dr. Owen testified, the statement 
that ``[h]e has done fairly well . . . kind of conflicts with his pain 
is worse and the aberrant drug-taking behavior, so that's an unreliable 
statement.'' Id. Dr. Owen also explained that B.B.'s having ``severe 
anxiety and depression . . . are relative contraindications to 
prescribing controlled substances . . . [b]ecause it magnifies [the] 
perception of pain and disability.'' Id. Dr. Owen then testified that 
because of these conditions, Respondent should have requested a 
``consultation by a psychologist'' but did not. Id. at 160-61.
    Dr. Owen further testified that Respondent ``did not'' address 
B.B.'s ``ongoing stress and anxiety issues,'' and that ``[h]e did not'' 
conduct a thorough patient history. Id. at 166. He then testified that 
Respondent had changed B.B.'s treatment plan by adding Percocet, but 
that Respondent ``change[d] the medications without ever . . . 
documenting [a] medical rationale to add any new medication.'' Id. 
Asked by the CALJ ``why would someone add Percocet,'' Dr. Owen 
testified that it is a short-acting opioid that could be added ``for 
break-through pain, if that's not being controlled well.'' Id. at 167.
    With respect to Respondent's notation that he had discussed 
``[a]ddictive dependency and tolerance nature of these medications as 
well as alternatives,'' id. at 167, Dr. Owen noted that ``there's no 
real substance to that statement'' as a statement of informed consent. 
Id. at 168. He then explained that the statement ``[l]acks any details 
about what alternative treatments were discussed, and . . . B.B.'s 
already demonstrated several aberrant drug-taking behaviors.'' Id. 
Continuing, Dr. Owen explained that ``[t]he potential of addiction is 
very high in this individual, and I think you just can't say something 
as generic as this statement and [not] have any meaningful 
documentation behind it.'' Id.
    Dr. Owen was also asked about entries in a PMP report in B.B.'s 
file which showed the controlled substance prescriptions he obtained 
and filled from April 12, 2011 through April 11, 2012. Tr. 170-72. The 
report showed that on March 14, 2012, B.B. had obtained and filled a 
prescription from another provider (R.H.) for 60 alprazolam 1 mg, which 
was a 30-day supply and that on April 6, 2012, he had obtained and 
filled another prescription from R.H. for 30 alprazolam 1 mg. Id. at 
170-71. Dr. Owen testified that this was an early refill, as the March 
14 prescriptions should have lasted until approximately the middle of 
April. Id. at 171. According to Dr. Owen, this ``could represent [that] 
the person is self-escalating their medications.'' \31\ Id.
---------------------------------------------------------------------------

    \31\ The Government attempted to make the same point with 
respect to the alprazolam prescriptions issued by R.H. on February 
15 and March 14, 2012 and filled by B.B. the same day. Tr. 171; see 
also GX 3, at 22. However, 2012 was a leap year, and thus, the March 
14 prescription was filled 28 days after the February 15 
prescription, rendering it only two days early. The Government also 
attempted to establish that the February 15 prescription was an 
early refill, because B.B. had obtained a refill of alprazolam on 
January 20, 2012, thus rendering the February 15 prescription four 
days early. Tr. 171-72; see also GX 3, at 22-23. As for the latter 
prescription, according to the calendar for February 2012, February 
19 was a Sunday and there is no evidence as to whether the practice 
was open on February 18.
---------------------------------------------------------------------------

    Dr. Owen testified that Respondent should have addressed the early 
refills because although he did ``not prescrib[e] this drug, it is a 
reflection of B.B.'s ability to self-regulate his controlled substance 
use.'' Id. at 172. However, Dr. Owen then testified that an early 
refill does not necessarily mean that B.B. was abusing his medication 
if it was ``a one-time situation.'' Id. While Dr. Owen testified that 
``if you're prescribing, you might call the treating doctor that is 
prescribing and get clarification. But when you have a pattern of early 
refills, it's hard to explain that the office is closed for a holiday 
or a weekend and that justifying the medical necessity to prescribe 
early.'' Id. at 172-73. However, given that the alprazolam prescription 
issued on February 15 was at most three days early and the March 14 
prescription was at most two days early, the evidence does not 
establish a pattern of early refills but only a single early refill. 
Thus, I place no weight on Respondent's failure to contact Dr. R.H. 
regarding the alprazolam refills.
    Continuing, Dr. Owen reiterated his earlier testimony that the 
patient record was ``not adequate'' to establish ``medical necessity'' 
for prescribing the controlled substances on this date and that between 
September 22, 2011 (when he assumed the care of B.B.) and April 12, 
2012, Respondent had not established medical necessity for the drugs. 
Id. at 173-74. He then opined that the prescriptions Respondent issued 
at this visit were issued outside of the usual course of professional 
practice and lacked a legitimate medical purpose. Id. at 174.
    Regarding the April 12 visit, Respondent testified that B.B. ``said 
he perceived [his] treatment objective was fair'' and that ``[t]here's 
a `yes' this time instead of just fair.'' Id. at 339. Asked by his 
counsel if B.B. was able to work at that point, Respondent answered 
``[n]o'' and that ``[h]e ha[d] not worked any at that point.'' Id. at 
353. When then asked why he wrote ``yes'' there, Respondent testified 
that he did not recall. Id.
    Respondent also testified that ``[h]is pain had gone from a 7 in 
January to a 6.'' Id. at 339. Later, he testified that ``[m]y 
subjective said his pain was worse, but it was a 6, and my last note 
said it was a 7.'' Id. at 353. Respondent then asserted that B.B.'s 
pain rating ``was still above the 4 to 5 [that] the Joint Commission 
says . . . needs to be addressed.'' \32\ Id.
---------------------------------------------------------------------------

    \32\ Respondent also testified as to the contents of the visit 
note, largely reading into the record what the notes contained. 
However, he noted, inter alia, that B.B. had ``reported subjectively 
. . . that his pain had been a little worse,'' as well as that his 
straight leg raise was now negative and not ``questionable'' as he 
noted at the previous visit. Id. at 340.
---------------------------------------------------------------------------

    Respondent further testified that he had not replaced the stolen 
medication. Id. at 341. As for how B.B. had managed after his 
medications were stolen, Respondent testified that while ``the notes 
don't necessarily reflect it . . . he had a family member, and I don't 
remember who it was, but someone had held some pain medicines for him, 
and he was trying to stretch them out to make sure that he didn't run 
out.'' Id. Continuing, Respondent asserted that B.B. did this 
``[b]ecause he knew how important his drug screen would be positive, 
and so he always kept some medicine back'' by placing it in ``an old 
bottle.'' Id.
    At this point, the CALJ interjected that he did not ``understand 
this, because if a person says that my medicines were stolen, the 
medicines are going to be gone'' and ``they won't have medicines to 
keep taking them.'' Id. at 342. After Respondent acknowledged that he 
``tell[s] stories,'' he explained that the more he ``did pain medicine, 
the more [he] found out there is such a culture, everyone wanting their 
pain medicines . . . that many of them keep them in a separate bottle . 
. . for safety'' and ``keep a stash in a different place'' from their 
other prescriptions. Id. Then asked by the CALJ if it made sense that 
B.B. reported that his drugs were stolen but stretched them out, 
Respondent answered that it

[[Page 14963]]

did because he knew that ``most of my patients keep extra pills or keep 
them in a different place'' in their house. Id. at 343.
    In his testimony, Respondent agreed with the CALJ that he preferred 
prescribing extended release drugs, and that these formulations require 
a patient ``to keep a certain amount in [his] system so that [he] would 
have relief from [his] pain'' and be able ``to engage in the [ ] 
activities of daily living.'' Id. at 344-45. The CALJ then asked: 
``doesn't it seem to you unusual that a person would be keeping some of 
those back?'' Id. at 345. Respondent testified that ``[i]t would have 
before I started doing pain management.'' Id. Continuing, he maintained 
that ``[i]t's very common that [patients] keep a stash of their 
medicines in an old bottle or take some with them, because they are 
absolutely paranoid of having their medicine stolen, and it is such a 
common thing for drug seekers, and basically the medicines are highly 
sought after, even amongst their family members.'' Id. Respondent then 
maintained that ``[m]any of them have lockboxes in their house, where 
they actually have their pills. . . . And so it's not unusual in my 
practice at all for patients to keep a separate container of their 
medicine.'' Id.
    Respondent offered no explanation as to how a patient could forgo 
taking extended release medication to create ``a stash'' while still 
managing his pain. In any event, Respondent offered no evidence that he 
even asked B.B. when the purported theft had occurred, which drugs had 
been stolen, and when B.B. had last taken the drugs he prescribed.
    As for why he changed B.B.'s medication, Respondent testified that 
``Opana was very difficult to get in some of the pharmacies'' as some 
of the pharmacies ``couldn't get it from their suppliers'' and he had a 
policy of requiring patients to obtain their medications at a single 
pharmacy. Id. at 346-47. Respondent was then asked by his counsel: ``so 
the Percocet took the place of what?'' Id. at 347. Respondent answered: 
``I used the Opana ER, because he had had good luck with the Opana 
short-acting, so I swapped him and used the Opana ER'' as it was on 
Medicaid formulary and easier to obtain because ``it was very, very 
expensive'' and ``didn't have a supply problem, because people on the 
street or private-pay people couldn't pay for it.'' Id. Respondent then 
explained that he ``changed [B.B.] off the long morphine to Percocet . 
. . [b]ecause I wanted another . . . short-acting . . . for his break-
through'' pain. Id. Respondent testified that he wrote only for a two-
week supply of the medications. Id. at 348-49.
    While Respondent acknowledged that ``having chronic pain [can] lead 
to worse anxiety and depression'' as well as that ``uncontrolled 
anxiety or depression [can] lead [ ] to more pain,'' id. at 409, he 
admitted that he never consulted with the mental health providers that 
B.B. was seeing. Id. at 408. Asked by the CALJ whether it was ``within 
the standard of care'' for him and B.B.'s mental health provider to 
have ``ke[pt] treating [B.B.] without talking to each other,'' 
Respondent answered that ``[t]he mental health providers are very good 
about speaking to us about patients.'' Id. at 409. Then asked by the 
CALJ ``[h]ow about the other way around,'' Respondent answered: ``[i]f 
you felt it was necessary, you could report on information, I'm sure.'' 
Id.
    Continuing, the CALJ asked Respondent if ``a mental health provider 
[is] prescribing controlled substances simultaneously with you, 
ordinarily will you consult with the mental health provider?'' Id. 
Respondent answered:

    We've become quite reliant on the PMPs now. Before the PMP, 
there was quite a bit of cross-talk, because you would get 
pharmacists [who] would call you and say, did you know that they're 
[sic] seeing so and so, or they're [sic] taking this, that or the 
other. And so there was much more of a need to try and get ahold 
[sic] of them. But we've become very reliant on the PMPs now to 
track that.

Id. at 409-10.
    The CALJ then asked Respondent ``if two practitioners are 
simultaneously providing controlled substances [to] the same patient, 
wouldn't the two practitioners talk to each other about [that] 
approach?'' Id. at 410. Respondent answered: ``Absolutely. In every 
other field but mental health we do do that, and actually we don't 
treat the same--we don't treat with pain medication any patient that's 
seeing another doctor for pain. We don't go and side talk at all.'' Id.
    This answer prompted the CALJ to ask: ``but with a mental health 
practitioner, if that practitioner is also prescribing controlled 
substances, you wouldn't consult with them and--or ask anything about 
that patient?'' Id. Respondent testified: ``[t]hat doesn't happen very 
often.'' Id. Indeed, notwithstanding that on the date of B.B.'s first 
visit to Respondent's clinic, he identified Wellbutrin and alprazolam 
as drugs which he was either then taking or had recently used, see GX 
3, at 5; there is no evidence that Respondent (or Dr. Schoelen) ever 
discussed B.B.'s psychiatric issues with his mental health providers. 
See generally GX 3.

The April 25 Prescriptions

    On April 25, 2012, Respondent provided B.B. with a prescription for 
30 Roxicodone (oxycodone) 15 mg. GX 5, at 4. B.B.'s file contains no 
documentation that there was an office visit, and notwithstanding that 
this was a change in medication from what Respondent had prescribed at 
the previous visit, there is no notation in the progress notes as to 
why he changed the prescription. See generally GX 3; see also Tr. 174-
75. Moreover, while Respondent testified that he would ``routinely'' 
make an entry in the Treatment Objective Evaluation section of the Pain 
Management Treatment Plan ``if we were making a change in a 
medication,'' Tr. 357, no such entry was made on this date. See GX 3, 
at 28. Nor is there any documentation in the patient file that 
Respondent addressed with B.B. the aberrant drug test result (the non-
detection of morphine) which had been reported to him on April 17. See 
generally GX 3.
    According to Dr. Owen, when adding a new drug to a patient's 
regimen of pain medications, a physician ``would have to establish 
medical necessity with some type of note, using sound medical 
rationale.'' Tr. 175. Dr. Owen further testified that making such a 
notation is ``a standard of care, and it's part of the documentation 
guidelines that are issued across every state for the most part.'' Id. 
Asked if he could think of a reason why a physician ``would add a drug 
for the first time without seeing a patient,'' Dr. Owen answered: ``No. 
Or at least documenting the medical rationale and establishing medical 
necessity.'' Id. at 176. Dr. Owen then testified that Respondent did 
not take appropriate steps to establish medical necessity for the 
prescription, reiterating his earlier testimony that Respondent had not 
demonstrated that conservative care had been tried and been 
unsuccessful, as well as that there was a ``clinically meaningful and 
objective therapeutic benefit from the previous use of controlled 
substances.'' Id. He again opined that the prescription was not issued 
in the usual course of professional practice and lacked a legitimate 
medical purpose. Id.
    Regarding the Roxicodone prescription, Respondent asserted that he 
``was just doing a two-week trial, trying to figure out his dose, and 
at the time, most likely the patient didn't have any punches on his 
card left, and Roxicodone is much cheaper than Percocet, and it's the 
same medication.'' Id. at 355. However, Respondent

[[Page 14964]]

documented none of this in B.B.'s record. Nor did he explain why he 
failed to follow his routine of making an entry in the Treatment 
Objective Evaluation section of the Pain Management Treatment Plan 
given that he had changed B.B.'s medication.
    As for why he did not take any action with regard to the lab's 
finding that the April 12 drug test result was negative for morphine 
sulfate, Respondent asserted that the result was not aberrant. Id. at 
366. In addressing this prescription, Respondent offered no further 
explanation as to why he deemed the result not aberrant. However, with 
respect to the January 19 UDS lab report, which was also negative for 
morphine, Respondent asserted that oxymorphone is a metabolite of 
morphine and thus he did not consider the negative result to be 
aberrant. Id. at 336. He asserted this notwithstanding that with 
respect to other drugs such as hydrocodone and carisoprodol, the lab 
specifically reported when it detected the presence of metabolites of 
these drugs, such as hydromorphone for hydrocodone and meprobamate for 
carisoprodol. Yet, the lab report contains no notation that oxymorphone 
is a metabolite of morphine. Nor did he testify as to his basis of 
knowledge for this claim.
    Pursuant to 5 U.S.C. 556(e), I take official notice that morphine 
does not metabolize into oxymorphone. See Edward J. Cone, et al., 
Evidence that Morphine is Metabolized to Hydromorphone But Not to 
Oxymorphone, 32 J. Analytic Toxicology 319, 323 (2008) (finding, based 
on study of urine drug screens using liquid chromatography-tandem mass 
spectrometry conducted on 34 patients taking morphine exclusively for 
chronic pain, that while ``hydromorphone was demonstrated to be a minor 
metabolite . . . no evidence was found that oxymorphone is a metabolite 
of morphine'' and ``that a positive urine test for oxymorphone can 
arise only from oxymorphone or oxycodone administration, and not from 
morphine or hydromorphone administration''); id. at 319 (characterizing 
as ``unsubstantiated'' the ``claim of a new metabolic pathway leading 
from morphine to hydromorphone to oxymorphone'').\33\
---------------------------------------------------------------------------

    \33\ Under the Administrative Procedure Act (APA), an agency 
``may take official notice of facts at any stage in a proceeding--
even in the final decision.'' U.S. Dept. of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), 
``[w]hen an agency decision rests on official notice of a material 
fact not appearing in the evidence in the record, a party is 
entitled, on timely request, to show the contrary.'' Accordingly, 
Respondent may dispute my finding by filing a properly supported 
motion for reconsideration within 20 calendar days of the date of 
this Order. Any such motion shall be filed with the Office of the 
Administrator and a copy shall be served on the Government; in the 
event Respondent files a motion, the Government shall have 20 
calendar days to file a response.
---------------------------------------------------------------------------

The May 9, 2012 Prescriptions

    On May 9, 2012, Respondent wrote B.B. a prescription for 60 Opana 
ER 20 mg. GX 3, at 93; GX 5, at 27. Respondent did not require an 
office visit, and he made no notations in the progress notes regarding 
the prescription. See generally GX 3; see also Tr. 177-78. Regarding 
the prescription, Dr. Owen again testified that Respondent ``needed to 
establish medical necessity for continuation of controlled substances'' 
and ``did not.'' Id. at 178.
    Asked why he refilled the prescriptions,\34\ Respondent testified 
that ``I got a phone call that he was wanting his medicines refilled 
and that the [R]oxicodone had worked for him and et cetera, so we were 
converting him back into the one-month prescriptions in the Schedules 
IIs and going back to this three-month office visit.'' Tr. 356. 
Respondent offered no testimony addressing Dr. Owen's criticism that he 
still had not established that there was a medical necessity for 
prescribing controlled substances, which included the Opana. See 
generally id. at 356-57.
---------------------------------------------------------------------------

    \34\ In her questioning of Respondent, his counsel referred to a 
Roxicodone prescription as having been issued on May 9, 2012 and in 
his testimony regarding the prescriptions he wrote on that date, 
Respondent referred to both a Roxicodone prescription and an Opana 
ER 20 mg prescription. Tr. 356. While GX 5 contains a legible copy 
of the May 9, 2012 Opana ER prescription, see GX 5, at 27, it does 
not contain a copy of a Roxicodone prescription, and as for GX 3, 
the copy of the purported Roxicodone prescription is illegible. GX 
3, at 93. Because the Government failed to produce any reliable 
evidence to show that Respondent issued a Roxicodone prescription on 
May 9, 2012, I do not consider whether any such prescription was 
issued, nor whether Respondent complied with 21 CFR 1306.04(a) when 
he issued it.
---------------------------------------------------------------------------

    Asked to provide his opinion as to Respondent's prescribing of 
controlled substances from September 2011 through May 9, 2012, Dr. Owen 
opined that Respondent did not adequately review B.B.'s medical 
history. Id. at 178. He further opined that a treatment plan that 
established medical necessity ``would have logic behind the treatment'' 
and would have ``establish[ed] that conservative care has not been 
helpful and that [an] objective and clinically meaningful therapeutic 
benefit from the use of controlled substances has been established, if 
[they] ha[d] previously been used.'' Id. Dr. Owen then testified that 
none of the controlled substance prescriptions Respondent issued to 
B.B. were issued in the usual course of professional practice and for a 
legitimate medical purpose. Id. at 178-79.

Respondent's Evidence in Remediation

    Respondent offered only vague testimony that he has taken ``extreme 
CME [continuing medical education] . . . in hospice care and pain 
medicine'' in 1995 and had done some ``reading'' on pain management. 
Tr. 235, 381. Respondent offered no further detail as to the subject 
matter of the CME course[s] he took. See id. As for his assertions that 
he had read articles on pain management and that he kept current with 
those articles, he admitted that he had not ``read anything in a couple 
of years'' and could not recall any articles he had read on pain 
management. Id. at 385-86.

Discussion

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

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

Id.
    ``[T]hese factors are . . . considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I 
``may rely on any one or a combination of factors, and may give each 
factor the weight [I] deem[ ] appropriate in determining whether 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

[[Page 14965]]

Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482)).\35\
---------------------------------------------------------------------------

    \35\ In short, this is not a contest in which score is kept; the 
Agency is not required to mechanically count up the factors and 
determine how many favor the Government and how many favor the 
registrant. Rather, it is an inquiry which focuses on protecting the 
public interest; what matters is the seriousness of the registrant's 
misconduct. Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, 
as the Tenth Circuit has recognized, findings under a single factor 
can support the revocation of a registration or the denial of an 
application. MacKay, 664 F.3d at 821.
---------------------------------------------------------------------------

    The Government has the burden of proving, by a preponderance of the 
evidence, that the requirements for denial of an application pursuant 
to 21 U.S.C. 823(f) are met. 21 CFR 1301.44(d). However, once the 
Government has made a prima facie showing that issuing a new 
registration to the applicant would be inconsistent with the public 
interest, an applicant must then present sufficient mitigating evidence 
to show why he can be entrusted with a new registration. Medicine 
Shoppe-Jonesborough, 73 FR 364, 387 (2008) (citing cases)); see also 
MacKay, 664 F.3d at 817.
    Having considered all of the factors, I find that the Government's 
evidence with respect to Factors Two and Four satisfies its prima facie 
burden of showing that granting Respondent's application would be 
inconsistent with the public interest.\36\ I further find that 
Respondent has failed to produce sufficient evidence to rebut the 
Government's prima facie case.
---------------------------------------------------------------------------

    \36\ As to factor one, while the Oklahoma Board has taken 
disciplinary action against Respondent for conduct related to his 
prescribing to B.B., the Board has not made a recommendation to the 
Agency with respect to whether his application should be granted. To 
be sure, as a result of the Board's restoration of his medical 
license without restriction of his controlled substance prescribing 
authority under Oklahoma law, Respondent satisfies the CSA's 
prerequisite for obtaining a new practitioner's registration. See 21 
U.S.C. 823(f)(1); see also id.Sec.  802(21). (defining ``the term 
`practitioner' [to] mean[ ] a . . . physician . . . or other person 
licensed, registered or otherwise permitted, by . . . the 
jurisdiction in which he practices . . . to distribute, dispense, 
[or] administer . . . a controlled substance in the course of 
professional practice''). However, the restoration of Respondent's 
state authority is not dispositive of the public interest inquiry. 
See Mortimer Levin, 57 FR 8680, 8681 (1992) (``[T]he Controlled 
Substances Act requires that the Administrator . . . make an 
independent determination [from that made by state officials] as to 
whether the granting of controlled substance privileges would be in 
the public interest.'').
    To be sure, the Agency's case law contains some older decisions 
which can be read as giving more than nominal weight in the public 
interest determination to a State Board's decision (not involving a 
recommendation to DEA) either restoring or maintaining a 
practitioner's state authority to dispense controlled substances. 
See, e.g., Gregory D. Owens, 67 FR 50461, 50463 (2002) (expressing 
agreement with ALJ's conclusion that the board's placing dentist on 
probation instead of suspending or limiting his controlled substance 
authority ``reflects favorably upon [his] retaining his . . . 
[r]egistration, and upon DEA's granting of [his] pending renewal 
application''); Vincent J. Scolaro, 67 FR 42060, 42065 (2002) 
(concurring with ALJ's ``conclusion that'' state board's 
reinstatement of medical license ``with restrictions'' established 
that ``[b]oard implicitly agrees that the [r]espondent is ready to 
maintain a DEA registration upon the terms set forth in'' its 
order).
    Of note, these cases cannot be squared with the Agency's 
longstanding holding that ``[t]he Controlled Substances Act requires 
that the Administrator . . . make an independent determination [from 
that made by state officials] as to whether the granting of 
controlled substance privileges would be in the public interest.'' 
Levin, 57 FR at 8681. Indeed, neither of these cases even 
acknowledged the existence of Levin, let alone attempted to 
reconcile the weight it gave the state board's action with Levin. 
While in other cases, the Agency has given some weight to a Board's 
action in allowing a practitioner to retain his state authority even 
in the absence of an express recommendation, see Tyson Quy, 78 FR 
47412, 47417 (2013), the Agency has repeatedly held that a 
practitioner's retention of his/her state authority is not 
dispositive of the public interest inquiry. See, e.g., Paul Weir 
Battershell, 76 FR 44359, 44366 (2011) (citing Edmund Chein, 72 FR 
6580, 6590 (2007), pet. for rev. denied, Chein v. DEA, 533 F.3d 828 
(D.C. Cir. 2008)).
    As to factor three, I acknowledge that there is no evidence that 
Respondent has been convicted of an offense under either federal or 
Oklahoma law ``relating to the manufacture, distribution or 
dispensing of controlled substances.'' 21 U.S.C. 823(f)(3). However, 
there are a number of reasons why even a person who has engaged in 
criminal misconduct may never have been convicted of an offense 
under this factor, let alone prosecuted for one. Dewey C. MacKay, 75 
FR 49956, 49973 (2010), pet. for rev. denied, MacKay v. DEA, 664 
F.3d at 822. The Agency has therefore held that ``the absence of 
such a conviction is of considerably less consequence in the public 
interest inquiry'' and is therefore not dispositive. Id.
    While I have considered factor five, I deem it unnecessary to 
make any findings.
---------------------------------------------------------------------------

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

    Under a longstanding DEA regulation, a prescription for a 
controlled substance is not ``effective'' unless it is ``issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his professional practice.'' 21 CFR 1306.04(a). 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.

[[Page 14966]]

    ``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 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 March 2005, the Oklahoma Board of Medical Licensure and 
Supervision issued its Policy Statement on the ``Use of Controlled 
Substances for the Treatment of Pain.'' Okla. Bd. of Med. Lic. & 
Super., Use of Controlled Substances for the Treatment of Pain (Mar. 
10, 2005) (hereinafter, Policy Statement). Therein, the Board explained 
that it:

will refer to current clinical practice guidelines and expert review 
in approaching cases involving management of pain. The medical 
management of pain should consider current clinical knowledge and 
scientific research and the use of pharmacological and non-
pharmacological modalities according to the judgment of the 
physician. Pain should be assessed and treated promptly and the 
quantity and frequency of doses should be adjusted according to the 
intensity, duration of the pain and treatment outcomes.
    . . . .
    . . . The Board will consider prescribing, ordering, dispensing 
or administering controlled substances for pain to be for a 
legitimate medical purpose if based on sound clinical judgment. All 
such prescribing must be based on clear documentation of unrelieved 
pain. To be within the usual course of professional practice, a 
physician-patient relationship must exist and the prescribing should 
be based on a diagnosis and documentation of unrelieved pain. 
Compliance with applicable state and/or federal law is required.
    The Board will judge the validity of the physician's treatment 
of the patient based on available documentation, rather than solely 
on the quantity and duration of medication administration. The goal 
is to control the patient's pain while effectively addressing other 
aspect of the patient's functioning, including physical, 
psychological, social and work-related factors.\37\
---------------------------------------------------------------------------

    \37\ See also Policy Statement, at 2 (``Allegations of 
inappropriate pain management will be evaluated on an individual 
basis. The Board will not take disciplinary action against a 
physician for deviating from this policy when contemporaneous 
medical records document reasonable cause for deviation. The 
physician's conduct will be evaluated to a great extent by the 
outcome of pain treatment, recognizing that some types of pain 
cannot be completely relieved, and by taking into account whether 
the drug used is appropriate for the diagnosis, as well as 
improvement in patient functioning and/or quality of life.'').

Id. at 1-2.
    Simultaneously with the issuance of its Policy Statement, the Board 
promulgated its regulation on the ``[u]se of controlled substances for 
the management of chronic pain.'' Okla. Admin. Code Sec.  435:10-7-11. 
As the Board explained, its purpose was to adopt ``criteria'' to be 
used ``when evaluating [a] physician's treatment of pain, including the 
use of controlled substances.'' Id. The regulation thus sets forth 
criteria for the ``[e]valuation of the patient,'' the ``[t]reatment 
plan,'' ``[i]nformed consent and agreement for treatment,'' 
``[p]eriodic review,'' ``[c]onsultation,'' and ``[m]edical records.'' 
Id.
    With respect to the evaluation of the patient, the Rule states:

    A medical history and physical examination must be obtained, 
evaluated and documented in the medical record. The medical record 
should document the nature and intensity of the pain, current and 
past treatments for pain, underlying or coexisting diseases or 
conditions, the effect of the pain on physical and psychological 
function and history of substance abuse. The medical record also 
should document the presence of one or more recognized medical 
indications for the use of a controlled substance.

Id. Sec.  435:10-7-11(1). As for the treatment plan, the Rule provides:

    The written treatment plan should state objectives that will be 
used to determine treatment success, such as pain relief and 
improved physical and psychosocial function, and should indicate if 
any further diagnostic evaluations or other treatments are planned. 
After treatment begins, the physician should adjust drug therapy to 
the individual medical needs of each patient. Other treatment 
modalities or a rehabilitation program may be necessary depending on 
the etiology of the pain and the extent to which the pain is 
associated with physical and psychosocial impairment.

Id. Sec.  435:10-7-11(2).
    After providing the criteria for informed consent and agreement for 
treatment, which states, inter alia, that ``[t]he physician should 
discuss the risks and benefits of the use of controlled substances with 
the patient,'' id. Sec.  435:10-7-11(3), the Rule sets forth the 
criteria for the periodic review. The Rule states:

    The physician should periodically review the course of pain 
treatment and any new information about the etiology of the pain or 
the patient's state of health. Continuation or modification of 
controlled substances for pain management therapy depends on the 
physician's evaluation of progress toward treatment objectives. 
Satisfactory response to treatment may be indicated by the patient's 
decreased pain, increased level of function or improved quality of 
life. Objective evidence of improved or diminished function should 
be monitored and information from family members or other caregivers 
should be considered in determining the patient's response to 
treatment. If the patient's progress is unsatisfactory, the 
physician should assess the appropriateness of continued uses of the 
current treatment plan and consider the use of other therapeutic 
modalities.

Id. Sec.  435:10-7-11(4).
    With respect to consultation, the Rule provides:

    The physician should be willing to refer the patient, as 
necessary, for additional evaluation and treatment in order to 
achieve treatment objectives. Special attention should be given to 
those patients with pain who are at risk for medication misuse, 
abuse or diversion. The management of pain in patients with a 
history of substance abuse or with a comorbid psychiatric disorder 
may require extra care, monitoring, documentation and consultations 
with or referral to an expert in the management of such patients.

Id. Sec.  435:10-7-11(5).
    And finally, with respect to medical records, the Rule states in 
relevant part that ``[r]ecords should remain current'' and that ``[t]he 
physician should keep accurate and complete records.'' Id. Sec.  
435:10-7-11(6). The records are ``to include . . . the medical history 
and physical examination,'' ``diagnostic, therapeutic and laboratory 
results,'' ``evaluations, consultations and follow-up evaluations,'' 
``treatment objectives,'' ``discussion of risks and benefits,'' 
``informed consent,'' ``treatments,'' ``medications (included date, 
type, dosage and quantity prescribed),'' ``instructions and agreements 
and periodic reviews.'' Id.
    The CALJ rejected the bulk of the Government's case, finding the 
allegations proven only ``in part'' and only with respect to the 
prescriptions Respondent issued on October 6 and 20, 2011 (prescribing 
events 3 and 4), April 12 and 25, and May 9, 2012 (prescribing events 
10, 11, and 12). Even then, however, the CALJ reasoned that ``[t]he

[[Page 14967]]

errant prescribing events established by the record reveal inattention 
to detail, not intentional diversion,'' R.D. at 82, only to 
subsequently conclude that ``Respondent violated his responsibility . . 
. to ensure that he only prescribed controlled substances for a 
legitimate medical purpose in the course of professional practice.'' 
Id. at 90 (citing 21 CFR 1306.04(a)); see also id. (``[T]hese 
prescribing events violated Oklahoma medical regulations, fell below 
the prevailing medical practice standard in Oklahoma, and did not fall 
within the state and federal definitions of the usual course of a 
professional practice.'' (citing Policy Statement, at 2; 21 CFR 
1306.04(a))).
    I conclude, however, that the Government has proved additional 
violations of 21 CFR 1306.04(a) beyond those found by the CALJ, and I 
further conclude that the evidence does not simply reflect 
``inattention to detail'' on Respondent's part--a finding which is 
legally insufficient to support the conclusion that he violated 21 CFR 
1306.04(a)--but rather, that he knowingly diverted drugs to B.B. I am 
mindful of the various credibility findings made by the CALJ, 
particularly with respect to the testimony of Respondent, as well as 
his finding that ``Dr. Owen's expert testimony predictably raised no 
issues regarding credibility'' but that his ``testimony was not without 
its own `red flags.' '' R.D. 18. For reasons explained earlier, I 
respectfully disagree with the CALJ's reasons for declining to give 
weight to much of Dr. Owen's testimony, including his conclusion that 
Dr. Owen's testimony was based upon a misunderstanding of the nature of 
the Oklahoma Board's Pain Management Regulations. And to the extent the 
CALJ declined to consider the evidence of various UDS results with 
respect to the specific prescribing events on the ground that the 
Government did not provide adequate notice, as explained above, I 
conclude that Respondent had constitutionally sufficient notice and 
understood that the UDS results were at issue throughout the 
proceeding.

The September 22, 2011 Prescriptions

    The CALJ rejected the Government's allegation that the Duragesic 
and Opana prescriptions issued by Respondent on this date violated 21 
CFR 1306.04(a) because they were issued outside of the usual course of 
professional practice and lacked a legitimate medical purpose.\38\ As 
found above, Dr. Owen testified that because this was B.B.'s first 
visit with Respondent and Respondent was taking over his care, 
Respondent should have ``do[ne] a proper history and physical exam,'' 
reviewed the ``previous treatments'' and done ``everything that 
typically is expected for a new patient evaluation.'' Tr. 131. Dr. Owen 
testified that Respondent performed ``a superficial evaluation that'' 
did not ``adequately explain the chief complaint or what previous 
treatments have or have not been done.'' Id. at 133.
---------------------------------------------------------------------------

    \38\ The CALJ asserted that in the Show Cause Order and its 
Prehearing Statement, ``the Government noticed a theory based in the 
issuance of prescriptions outside the course of a professional 
practice under 21 CFR 1306.04(a), not that any prescriptions were 
not issued for a legitimate medical purpose.'' R.D. 87-88. While 
then noting that ``the Government did sporadically elicit testimony 
from its expert in this regard ([citing] Tr. 93, 123, 133-34, 137-
38, 140, 144, 148, 155-56, 158, 174, 176, 179) and did espouse this 
theory in its closing brief,'' the CALJ again asserted that this 
theory was unavailable to the Government because it raised the issue 
for the first time in its post-hearing brief. Id. at 88 n.150 
(citing Fred Samimi, 79 FR 18698, 18713 (2014)).
    I decline to adopt this ruling for multiple reasons. First, as 
several federal appeals courts have recognized, there is no material 
difference between the phrases ``usual course of professional 
practice'' and ``legitimate medical purpose,'' and thus the courts 
have sustained convictions for violating the regulation and 21 
U.S.C. 841(a)(1), notwithstanding that an indictment charged the 
defendant ``with dispensing of a controlled substance not in the 
usual course of professional practice'' but did not allege that the 
dispensing lacked a legitimate medical purpose, as well as where the 
jury instructions only referenced the ``usual course of professional 
practice'' and did not require the jury to find that the defendant 
``dispensed without a legitimate medical purpose.'' See United 
States v. Fuchs, 467 F.3d 889, 898-901 (5th Cir. 2006) (noting 
earlier decision that ``appears to use the phrases . . . 
interchangeably'').
    Likewise, in United States v. Nelson, 383 F.3d 1227, 1230-31 
(10th Cir. 2004), the Tenth Circuit found no error in a jury 
instruction which provided that a physician could be convicted of 
conspiracy under 21 U.S.C. 846, ``if it found the prescriptions were 
either without a legitimate purpose or outside the course of 
professional practice.'' As the Tenth Circuit explained, ``[i]t is 
difficult to imagine circumstances in which a practitioner could 
have prescribed controlled substances within the usual course of 
medical practice but without a legitimate medical purpose. 
Similarly, it is difficult to imagine circumstances in which a 
practitioner could have prescribed controlled substances with a 
legitimate medical purpose and yet be outside the usual course of 
medical practice.'' Id. at 1231. See also United States v. Kirk, 584 
F.2d, 773, 784 (6th Cir. 1978) (``[T]here is no difference in the 
meanings of the . . . phrase, `[i]n the usual course of professional 
practice' and the . . . phrase, `legitimate medical purpose.' '') 
(citing United States v. Plesons, 560 F.2d 890, 897 (8th Cir. 1977) 
and United States v. Rosenberg, 515 F.2d 190, 197 (9th Cir. 1975)).
    Furthermore, even if these were two distinct theories for 
proving a violation of 21 CFR 1306.04(a), the record supports a 
finding of litigation by consent. The Government did not 
``sporadically elicit testimony from its expert'' on this issue, but 
rather, asked Dr. Owen whether each of the prescriptions lacked a 
legitimate medical purpose. Respondent did not object to any of 
these questions, and thus, it is clear that unlike the issue in 
Samimi, which was raised for the first time by the Government in its 
post-hearing brief, Dr. Owen's testimony that each of the 
prescriptions lacked a legitimate medical purpose was not directed 
at an incidental issue, but rather went to the heart of the 
Government's case.
---------------------------------------------------------------------------

    Dr. Owen further noted that Respondent documented that B.B. had a 
negative straight leg raise and that this is ``the most sensitive 
physical finding for low back pain.'' Id. at 190. He then explained 
that ``a sensitive test means that if you don't have a positive finding 
you don't have that diagnosis.'' Id. Dr. Owen also testified that there 
was ``no evaluation of pain or function, physical or psychosocial in 
the documentation'' and ``no evidence of a previous therapeutic 
benefit'' from the use of controlled substances,'' nor ``proof that 
[B.B. had] exhausted conservative care before going [to the] high-risk 
treatment[ ]'' of ``prescribing controlled substances.'' Id. at 134. 
Dr. Owen thus concluded that because ``[t]here's no medical rationale 
for continuing with an ineffective treatment . . . there's no 
justification to continue'' to prescribe controlled substances. Id. at 
133.
    Dr. Owen further testified that Respondent's patient file contained 
two aberrant drug tests, the June 1, 2011 test, which did not detect 
alprazolam even though B.B. was obtaining the drug every 30 days, and 
the August 25, 2011 test, which detected the presence of nordiazepam, 
oxazepam, and temazepam, which the lab reported as not expected based 
on the prescribed medications. Dr. Owen testified that Respondent 
``completely ignored'' the aberrant drug screens and that he ``should 
have acknowledged their existence and . . . taken some type of 
corrective action.'' Id. at 132. Dr. Owen then suggested that 
Respondent could have sent B.B. for an evaluation by an 
addictionologist or mental health professional (either a psychiatrist 
or psychologist) with experience in addiction medicine. Id. at 134. And 
he further testified that the patient file did not reflect that 
Respondent had discussed B.B. with either his current (such as the 
providers who were writing alprazolam prescriptions) or past 
prescribers (such as Dr. Schoelen). Id. at 132. Dr. Owen also noted 
that Respondent did not appear to have taken any safeguards against the 
potential for abuse or diversion. Id.
    The CALJ found uncontroverted Dr. Owen's testimony that B.B. was a 
new patient and thus, Respondent was required to have done everything 
typically expected of a physician in the evaluation of a new patient, 
including a proper history and physical, reviewing previous treatments, 
and reviewing his patient file. R.D. at 33-34. The CALJ further found 
uncontroverted Dr.

[[Page 14968]]

Owen's testimony that Respondent ignored the June 1 aberrant drug 
screen, that there was no evidence Respondent discussed B.B. with 
either his current or past prescribers, and that Respondent took no 
precautions against the potential for abuse or diversion. Id. at 34.
    As for the aberrant drug tests, the CALJ asserted that ``there is 
little doubt that the June 1 UDS is aberrant to the extent it shows 
that B.B. was not taking his alprazolam,'' and that Dr. Owen's 
testimony that ``failing to act on this aberrant UDS fell below the 
prevailing standard . . . stands unrebutted [on] the record.'' Id. at 
38. The CALJ, however, declined to consider this evidence, reasoning 
that it was not properly noticed by the Government in its pleadings 
with respect to this prescribing event. Id. at 38-39. For reasons 
explained previously, I disagree and find that Respondent had fair 
notice that the June 1 aberrant UDS was at issue throughout the 
proceeding.
    Accordingly, I find that the June 1 drug test was aberrant and that 
Respondent breached the standard of care when he failed to address the 
test with B.B. prior to issuing the September 22, 2011 prescriptions. 
The CALJ, however, also rejected the Government's contention that the 
drug test of August 25, 2011, which showed the presence of nordiazepam, 
oxazepam and temazepam when these drugs had not been prescribed to B.B. 
by either Dr. Schoelen or his mental health professional, was also 
aberrant and not properly considered and addressed by Respondent prior 
to prescribing to B.B. R.D. at 38. While Respondent testified that he 
did not remember if he reviewed this UDS prior to the September 22 
visit or at any point, Tr. 397, in the visit note, Respondent stated 
that B.B.'s ``[p]ast medical history was extensively reviewed.'' GX 3, 
at 48. Moreover, Dr. Owen credibly testified as to the need to obtain 
``all . . . previous medical records pertaining to [the] chief 
complaint'' and review them to determine what previous treatments had 
been tried and their results, as well as ``to look for any previous 
aberrant behaviors.'' Tr. 94. And Dr. Owen further explained that ``if 
you don't look at all the pertinent previous medical records, you can't 
get an accurate diagnosis.'' Id. at 117. This testimony is unrefuted.
    In rejecting the Government's contention that the August 25 test 
was aberrant, the CALJ did not make a credibility finding as to 
Respondent's testimony that he did not remember whether he reviewed the 
UDS at the time he was treating B.B. Nor did he make an explicit 
finding as to whether Respondent reviewed the UDS.
    Instead, the CALJ reasoned that ``Respondent credibly testified 
that, based on his professional opinion and his conversations with 
personnel at the testing lab, a patient taking any benzodiazepine may 
test positive for any other benzodiazepine[,] [and] [t]hus, the 
Respondent did not, and does not view the August 25 UDS as anomalous.'' 
R.D. at 38 (emphasis added). After faulting the Government because it 
did not recall Dr. Owen ``to rebut Respondent's understanding about the 
limitations of the GC/MS,'' the ALJ explained that ``[t]here was 
nothing patently incredible about the Respondent's recollection of his 
conversations with the UDS lab about the limits of its testing.'' Id.
    However, if, in fact, Respondent did not review the UDSs prior to 
prescribing (notwithstanding the notation that he ``extensively 
reviewed'' B.B.'s medical history), Dr. Owen's unrefuted testimony 
establishes that Respondent committed a gross breach of the standard of 
care in failing to do so. Of note, Respondent testified that Dr. 
Schoelen had instituted urine drug testing as a ``safeguard'' after Dr. 
Schoelen joined the American Academy of Pain Management and attended 
training, and that a drug test was done ``every three months'' on the 
clinic's ``chronic pain patients.'' Tr. 253-55. Thus, Respondent 
clearly knew that B.B. had been subjected to drug testing.
    Moreover, if it is the case that Respondent did not review the 
August 25 drug test, then it is clear that Respondent's testimony as to 
what he was told by the lab was not offered to show his state of mind 
in failing to address the aberrant test result. Rather, it was offered 
to prove the truth of the matter asserted--that because of cross-
reactions, ``a patient taking any benzodiazepine may test positive for 
any other benzodiazepine.''
    Thus, Respondent's testimony was hearsay which was uncorroborated 
by either the testimony of a lab employee, an expert in drug testing, 
or articles from scientific or medical journals. The CALJ did not, 
however, analyze the reliability of the hearsay statements recounted by 
Respondent.\39\ See R.D. at 37-40.
---------------------------------------------------------------------------

    \39\ In multiple decisions, the Agency has made clear that the 
reliability of a hearsay statement should be evaluated by reference 
to the decisional law of the courts of appeals that would have 
jurisdiction over a subsequent petition for review; this includes 
the D.C. Circuit and the Tenth Circuit. As the D.C. Circuit has 
explained, ``hearsay may constitute substantial evidence depending 
upon its probative value and reliability, considering inter alia, 
possible bias of the declarant, whether [the] statements are signed 
and sworn to, whether they are contradicted by direct testimony, 
whether the declarant is available, and whether the hearsay is 
corroborated.'' Hoska v. Department of the Army, 677 F.2d 131, 138 
(D.C. Cir. 1982) (quoted in Mireille Lalanne, 78 FR 47750, 47752 
(2013)). By contrast, the Tenth Circuit does not appear to have set 
forth a set of factors for evaluating the reliability of hearsay in 
administrative proceedings. See Roach v. NTSB, 804 F.2d 1147, 1160 
(10th Cir. 1986); Cf. Bennett v. NTSB, 66 F.3d 1130, 1137 (10th Cir. 
1995) (declining to decide if uncorroborated hearsay can constitute 
substantial evidence in administrative proceeding ``given the 
existence of ample corroborative evidence-both nonhearsay and 
hearsay exceptions''); Sorenson v. NTSB, 684 F.2d 683, 686 (10th 
Cir. 1982) (declining to decide ``whether uncorroborated hearsay can 
constitute substantial evidence in administrative proceedings'').
    Applying the Hoska factors, I conclude that the statement is not 
entitled to weight. Even assuming that the lab employee who made the 
statement was not biased, the statement was neither signed nor sworn 
to, Respondent did not identify the employee by name, and Respondent 
did not disclose that he intended to testify to the lab's statement 
in advance of the hearing notwithstanding that the CALJ's Order for 
Prehearing Statements directed that Respondent was ``to indicate 
clearly each and every matter as to which he intends to introduce 
evidence in opposition'' and the summary of each witness' testimony 
was ``to state what the testimony will be.'' ALJ Ex. 4, at 2. 
Moreover, that Order then stated ``that testimony not disclosed in 
the prehearing statement or pursuant to subsequent rulings is likely 
to be excluded at the hearing.'' Id. Given that Respondent did not 
disclose this testimony in advance of the hearing, I find that the 
declarant was not available. Moreover, as explained above, 
Respondent offered no other evidence to corroborate the lab's 
statement and the statement was contradicted in part by Respondent's 
testimony regarding the temazepam positive on the January 19 drug 
test.
---------------------------------------------------------------------------

    Notably, in his Response to the Government's Exceptions, Respondent 
does not maintain that this testimony was offered for the non-hearsay 
purpose of showing Respondent's state of mind when he failed to address 
the August 25 drug test with B.B. Response to Exceptions, at 4-6. 
Indeed, in his brief, Respondent argues only that ``there is no 
evidence that the written test results provided by . . . the drug 
testing company . . . are unreliable and inadmissible or that the 
results themselves are unreliable.'' Id. at 5. However, neither the 
August 25 nor the January 19, 2012 lab reports--each of which detected 
the presence of nordiazepam, oxazepam, and temazepam in addition to the 
metabolite of alprazolam--contain any statements to the effect that 
because of cross-reactions, taking alprazolam could result in a 
positive finding for the other three drugs. And as for Respondent's 
contention that there is no evidence that the test results are 
unreliable, that is the very point made by the Government. Id.
    Moreover, even were I to consider Respondent's testimony on the 
issue of his state of mind--which would seem to require a finding that 
he did see the lab

[[Page 14969]]

report--as ultimate factfinder, I would not give it weight. While the 
Agency must accord some deference to an ALJ's findings on credibility 
issues where an ALJ observes the demeanor of the witness, ``[t]he 
findings of the [ALJ] are to be considered along with the consistency 
and inherent probability of [the] testimony.'' Universal Camera Corp. 
v. NLRB, 340 U.S. 474, 496 (1951).
    Of consequence, B.B.'s January 19, 2012 drug test also detected the 
presence (in addition to that of alpha-hydroxyalprazolam, the 
metabolite of alprazolam) of nordiazepam, oxazepam, and temazepam. GX 
3, at 97. Yet on this occasion, Respondent noted on the Lab Report that 
he had ``counseled [B.B.] to only take what is prescribed.'' GX 3, at 
97. And in his testimony regarding the January 19 drug test results, 
Respondent stated that he made the notation because ``[t]he 
nordiazepam, the oxazepam, and then the Xanax, the lab always said that 
if . . . Xanax [alprazolam] was positive, that they could all three be 
positive. The temazepam, in our practice usually didn't show up, and 
temazepam is [a] sleeping pill called Restoril.'' Tr. 335; see also GX 
3, at 105 (lab report of Dec. 7, 2010 in B.B.'s file reporting presence 
of alpha-hydroxyalprazolam but no other benzodiazepines even though the 
drugs screened for included diazepam, oxazepam, and temazepam).
    Respondent offered no explanation for the inconsistency between his 
testimony regarding why he ``would not consider'' the August 25 drug 
test to be aberrant and his testimony as to why he deemed the January 
19 drug test as aberrant, even though both tests reported the presence 
of the same four benzodiazepines, and in particular, temazepam. Most 
significantly, the CALJ did not address the inconsistency between 
Respondent's testimony regarding the August 25 and January 19 drug 
tests in making his credibility finding. See R.D. at 38.
    I conclude, however, that for the same reason that Respondent 
deemed the January 19 test to be aberrant, I reject his testimony that 
he does not believe the August 25 test was aberrant and find that it 
was. I further find that this was now the second aberrant drug test 
that B.B. had provided in the previous four months.
    I am also unpersuaded by the CALJ's reasoning for rejecting Dr. 
Owen's testimony as to the adequacy of Respondent's evaluation of B.B. 
The CALJ reasoned that the deficiencies identified by Dr. Owen 
``generally relate to a paucity of documented proof in the chart 
entries'' as to whether Respondent had adequately evaluated B.B.'s 
chief complaint, the treatments he had previously undergone, his 
physical and psychosocial function, and whether the prescribing of 
controlled substances provided a therapeutic benefit. R.D. at 35-36. As 
explained above, the CALJ declined to give weight to Dr. Owen's 
testimony based on the erroneous legal conclusion that the Board's 
documentation and recordkeeping standards are permissive and not 
mandatory. The CALJ apparently credited Respondent's testimony in 
finding that ``B.B. reported pain, which was consistent with the 
findings of the exam the Respondent conducted on that date.'' Id. at 
37. The CALJ also gave weight to Respondent's decision to change B.B's 
medications from Lortab, a short-acting medication which Dr. Schoelen 
had prescribed, to Duragesic (fentanyl) patches, which are long-acting, 
because in his view, short-acting medications are too addicting. Id. 
And the CALJ also reasoned that Respondent ``explained that he did not 
have B.B. undergo physical therapy because that approach had been tried 
without success . . . in the past.'' Id. at 38 (citing Tr. 392).
    As to Respondent's claim that B.B. had undergone physical therapy 
for some time, Respondent admitted that this was not documented in the 
patient file. Tr. 392. Indeed, a review of the progress notes prepared 
by Dr. Schoelen finds no mention of B.B.'s having been referred to 
physical therapy, but rather, mentions only Dr. Schoelen's 
recommendations of such modalities as gentle stretching, low back 
strengthening exercises, heat, and low back range of motion exercises. 
See GX 3, at 51-54, 56, 59. Likewise, B.B.'s file does not contain 
either a copy of any referral or prescription for physical therapy, or 
a copy of any physical therapist's notes. Indeed, while Respondent 
cited to the Patient History Form in B.B's file (GX 3, at 34) and 
testified that ``[i]t says that under pain management, that he was in 
therapy every month on his past medical history,'' Tr. 392, that form 
does not even use the words ``pain management.'' See GX 3, at 34. 
Instead, the form contains a column with the heading of ``Chronic 
Problems,'' under which the entries state: ``Depression,'' ``Anxiety'' 
and then ``Therapy every month.'' Id. Patients in physical therapy, 
however, typically receive treatment several times a week and not 
``every month.'' Cf. United States v. Armstrong, 550 F.3d 382, 389 (5th 
Cir. 2008) (explaining that ``[j]urors have had a wide variety of their 
own experiences in doctors' care over their lives,'' and can rely on 
those experiences when assessing evidence as to whether a physician 
lawfully prescribed controlled substances). And as noted previously, 
other evidence of record establishes that B.B. was seeing a 
psychiatrist and receiving alprazolam prescriptions on a monthly basis.
    Accordingly, I do not find credible Respondent's testimony that he 
did not have B.B. go to physical therapy because B.B. ``had been on 
physical therapy monthly for quite some time and didn't feel that it 
was of any benefit at all.'' Tr. 392. Here too, because Respondent's 
testimony is inconsistent with the evidence (and lack thereof), I 
decline to adopt the CALJ's apparent credibility finding as to this 
testimony. I further agree with Dr. Owen's assessment that Respondent 
failed to properly assess whether B.B. had undergone conservative 
treatments.
    As explained above, Dr. Owen also provided extensive testimony as 
to the standard of care for evaluating the history of a patient's pain 
complaint and the effect of the pain on a patient's physical and 
psychosocial functioning. Tr. 116. In his testimony, Dr. Owen 
identified various questions that Respondent should have asked B.B. and 
for which Respondent's September 22 visit note contains no evidence 
that he did so. See id. (``[H]ow did you hurt yourself; where does it 
hurt; does the pain radiate down an extremity; if so, how far down; 
does it go past the knee; where does it end up; is any numbness or 
weaknesses associated with it?''); see also id. (``And then you talk 
about what treatments have you had or what diagnostics have you had''). 
And with respect to the assessment of the effect of pain on a patient's 
functioning, Dr. Owen, after explaining that function is the ``primary 
baseline for measuring therapeutic influence,'' id. at 104, testified 
that a physician should ask a patient about his activities of daily 
living such as his ability to work and his ability to tolerate sitting, 
walking and standing. Id. at 106, 111. See also GX 3, at 33 (Patient 
Comfort Assessment Guide completed by B.B. on Sept. 2, 2009 which asked 
questions as to how pain interfered with his general activity, mood, 
sleep, enjoyment of life, ability to concentrate, and relations with 
other people). He also noted that in evaluating functionality, a 
physician would perform a neurological assessment, do a straight leg 
raise test, and look at the range of motion of the patient's spine. Id. 
at 111.
    Respondent's note for this visit is totally devoid of any 
documentation that he asked B.B. how he hurt himself; whether his pain 
radiated down his extremities and if so, how far down; if the pain went 
past his knee; if he had

[[Page 14970]]

any weakness or numbness; how the pain effected various activities of 
daily living such as his ability to work, as well as his ability to 
tolerate sitting, walking and standing.\40\ GX 3, at 48. Indeed, the 
only documentation Respondent made pertinent to B.B.'s ability to 
function was to note ``yes'' for whether he had achieved his treatment 
objective and the numbers ``3-5'' in the pain scale column. Id. at 28. 
See Okla. Admin. Code Sec.  435:10-7-11(1) (``The medical record should 
document the nature and intensity of the pain, current and past 
treatment for pain, underlying or coexisting diseases or conditions, 
the effect of the pain on physical and psychological function and 
history of substance abuse.'').
---------------------------------------------------------------------------

    \40\ There is likewise no evidence that Respondent had B.B. 
complete a new Patient Comfort Assessment Guide or that he asked him 
as to how the pain interfered with his general activity, mood, 
sleep, enjoyment of life, ability to concentrate and relations with 
other people.
---------------------------------------------------------------------------

    Against this evidence, Respondent testified that B.B. reported pain 
which was consistent with the exam he conducted at this visit. Tr. 292. 
He also explained that he ordered an MRI because he ``wanted to make 
sure that'' the results were ``consistent with his pain,'' his physical 
exam, and ``the fact that he was on a schedule II narcotic.'' Id. at 
293. Respondent also testified that he did not continue B.B. on Lortab 
(hydrocodone/acetaminophen) and prescribed fentanyl patches (a long-
acting) narcotic medication because of the risk of abuse and addiction 
present with short-acting medications. Id. at 291.
    While Respondent may have palpated B.B.'s lumbar region, he offered 
no testimony or other evidence refuting Dr. Owen's testimony that the 
straight leg raise test is ``the most sensitive physical finding for 
low back pain,'' and that ``if you don't have a positive finding you 
don't have that diagnosis.'' Id. at 190. While the CALJ acknowledged 
this testimony, see R.D. at 35 nn.68-69, he did not explain why the 
testimony was not entitled to weight in determining whether Respondent 
established medical necessity to prescribe controlled substances. As 
this testimony stands unrefuted, I conclude that Respondent did not 
establish a diagnosis.
    As for Respondent's having changed B.B.'s medication from Lortab to 
Fentanyl patches, even long-acting schedule II medications are 
susceptible to abuse. Moreover, because Respondent performed only a 
superficial evaluation and did not establish a diagnosis and medical 
necessity to prescribe controlled substances, let alone two schedule II 
controlled substances, this evidence is entitled to no weight.\41\
---------------------------------------------------------------------------

    \41\ In his discussion as to why the Government had not proved 
that Respondent violated 21 CFR 1306.04(a) in issuing the September 
22, 2011 prescriptions, the CALJ also explained that ``Dr. Owen's 
views about the relative merits of an MRI versus an X-ray or some 
other treatment is a medical treatment dispute that falls squarely 
outside the bounds of DEA's expertise and jurisdiction.'' R.D. 39 
(citing Gonzales v. Oregon, 546 U.S. 243, 274 (2006)). However, 
while Dr. Owen criticized Respondent's decision to order an MRI in 
response to questioning on cross-examination and by the CALJ because 
there was no clinical justification for doing so and MRIs lead to 
over-diagnosis, his opinion that Respondent did not establish 
medical necessity for the September 22 prescriptions was not based 
on Respondent's decision to order an MRI, but rather, the inadequacy 
of the evaluation of B.B.'s pain complaint, the failure to address 
the two aberrant drug screens, the lack of a positive finding on the 
straight leg raise test and the failure to exhaust conservative 
treatments.
     So too, the CALJ took issue with Dr. Owen's testimony regarding 
``Respondent's failure to make referral to other specialists.'' R.D. 
39. However, Dr. Owen's opinion that Respondent did not establish 
medical necessity for the September 22 prescriptions was based on 
Respondent's superficial evaluation of B.B.'s pain and function, 
Respondent's failure to exhaust conservative treatments, and the 
lack of evidence of a therapeutic benefit. Tr. 133-34. While Dr. 
Owen did suggest that based on the two aberrant drug tests, 
Respondent ``could have sent'' B.B. to an evaluation by an 
addictionologist or a psychiatrist/psychologist with experience in 
addiction medicine, he also testified that there was a further 
alternative step that Respondent could have taken: he could have 
been ``much more careful and objective [as to] how [he] measure[d] a 
therapeutic benefit.'' Id. at 134. Thus, Dr. Owen's testimony is not 
fairly read as saying that such a referral was mandated at this 
visit.
---------------------------------------------------------------------------

    I further hold that Respondent's issuance of the prescriptions for 
the fentanyl patches and Opana (oxymorphone) prescriptions was not 
merely malpractice. Rather, I conclude that the evidence supports the 
conclusion that Respondent acted outside of the usual course of 
professional practice and lacked a legitimate medical purpose when he 
prescribed these drugs to B.B. Here, not only did Respondent do a 
superficial evaluation as to B.B.'s purported pain complaint, his 
medical history, and the effect of the pain on his ability to function, 
he also performed a cursory examination which did not support his 
diagnosis, id. at 190, and ignored the results of the two aberrant 
drugs tests. As for the June 1 UDS, as the CALJ noted, ``Respondent 
never addressed the absence of [the alprazolam and] presented no 
explanation for his failure to react to the June 1 UDS.'' R.D. 36.
    Moreover, even were I to credit Respondent's testimony that he 
``doubt[ed]'' that he reviewed the drug tests performed by Dr. Schoelen 
and ``wouldn't expect [him]self to,'' Tr. 283, the evidence shows that 
Respondent clearly knew that B.B. was a chronic pain patient who was on 
multiple narcotics and was subject to drug testing. Dr. Owen credibly 
testified as to the importance of reviewing a patient's medical records 
to determine if the patient has a history of aberrant behaviors, id. at 
94, yet Respondent maintained that he did not do so. Accordingly, I 
conclude that Respondent did not establish medical necessity to 
prescribe controlled substances and that he lacked a legitimate medical 
purpose and acted outside of the usual course of professional practice 
when he issued the Opana and Duragesic prescriptions. See 21 CFR 
1306.04(a).

The October 6 Prescriptions

    Here again, Dr. Owen testified that the medical record did not 
justify the prescribing of controlled substances. Tr. 137. Dr. Owen 
then explained that Respondent's evaluation of B.B. was superficial in 
that there was no assessment of B.B.'s pain and his physical and 
psychosocial functioning. Dr. Owen thus concluded that once again, 
Respondent had not established medical necessity to prescribe 
controlled substances and thus, he opined that the prescriptions ``were 
not'' issued in the usual course of professional practice and ``were 
not'' for a legitimate medical purpose. Id. at 137-38. Dr. Owen further 
explained that based on the aberrant drug tests, Respondent should have 
obtained consultations with mental health providers or 
addictionologists. Id. at 137. And based on the notation in the visit 
note that ``[n]ow, B.B. would like to try the morphine,'' Dr. Owen 
further faulted Respondent for not properly addressing B.B.'s request 
to try morphine. Id. at 135.
    Explaining that ``[t]he principal issue raised by Dr. Owen and 
noticed by the Government'' with respect to these prescriptions 
``centers on'' this notation, the CALJ found credible Respondent's 
testimony regarding B.B.'s request to try morphine, characterizing the 
notation as ``a poorly-worded memorialization of a longer conversation 
wherein he got medication efficacy input from B.B. and outlined several 
medication options based on the existing Oklahoma Medicaid formulary.'' 
R.D. 43. The CALJ then explained that ``[t]he progress notes related to 
issues regarding the Respondent's evaluation and treatment of a 
suspected upper respiratory ailment are likewise more consistent with a 
conscientious practitioner than a pill mill operator.'' Id.
    Next, while the CALJ rejected the Government's contention that the

[[Page 14971]]

August 25 UDS was anomalous based on ``Respondent's plausible and 
credible explanation,'' he then found that ``[t]he aberrant nature of 
the June 1 UDS is uncontroverted by the evidence.'' Id. The CALJ 
further found that the Government had proved that ``Respondent's 
actions in continuing to prescribe controlled medications without 
acting to investigate or institute safeguards upon encountering an 
anomalous UDS . . . fell below the standard expected of a prudent 
controlled substances prescriber.'' Id.
    As explained previously, with respect to those instances in which 
he found violations, the CALJ simply concluded that Respondent's 
actions were neglectful. However, even accepting the CALJ's credibility 
finding with respect to Respondent's testimony regarding B.B.'s request 
to try morphine, I find that the evidence still supports the conclusion 
that Respondent violated 21 CFR 1306.04(a) in issuing the prescriptions 
for both morphine ER and Opana (oxymorphone).
    As explained in my discussion of the September 22nd prescriptions, 
I conclude that the August 25, 2011 UDS was anomalous. And as also 
discussed previously, I find that the Board's documentation and 
recordkeeping provisions are mandatory and thus, Dr. Owen's testimony 
should be given weight.
    In refutation of Dr. Owen's testimony that Respondent's evaluation 
was inadequate, Respondent testified that B.B. reported that ``his 
objectives were only fair'' and that his pain level had increased to a 
six out of ten. Respondent further noted that he did ``a full exam'' 
but that ``[t]he MRI was not back yet.'' Tr. 295.
    As the CALJ noted, Respondent ``admitted that this part of the 
patient visit went very quickly, and that a patient may not remember 
the treatment goal when asked this.'' R.D. 41 n.80. Indeed, after 
admitting that ``that part would be very quick in my office,'' 
Respondent added that ``I wouldn't ask him what he was actually doing 
to achieve that.'' Tr. 393. He also testified that he was not sure as 
to why, when the question was ``has patient achieved treatment 
objective'' and was, in essence, a yes or no question, and the patient 
may not even remember what his treatment objective was, B.B. would have 
answered ``fair.'' Id. at 395. Given that Respondent offered no further 
testimony as to other questions he asked B.B. to ascertain how the pain 
was effecting his ability to function in various aspects of his life 
activities, nor maintained that he asked any other questions about 
B.B.'s pain level, I give weight to Dr. Owen's testimony that 
Respondent's evaluation of B.B.'s pain and ability to function was 
superficial.
    Although Respondent maintained that he did a full physical exam, 
once again he found that B.B.'s straight leg raise was negative. As Dr. 
Owen testified, without a positive finding on this test, Respondent did 
not have a diagnosis for lumbar disc disease. And as for the 
Respondent's testimony that ``the MRI results were not back yet,'' B.B. 
had not even gone for the MRI as of this date.
    Nor do I find persuasive the reasoning that Respondent's treatment 
of B.B.'s upper respiratory ailment was ``more consistent'' with the 
treatment provided by ``a conscientious practitioner than a pill mill 
operator.'' R.D. 43. Putting aside that there is no evidence as to how 
a conscientious practitioner would treat a patient who complains of a 
potential upper respiratory ailment, even patients who engage in the 
abuse or diversion of controlled substances may seek treatment for 
legitimate health conditions. So too, a physician may nonetheless 
divert controlled substances to some patients without being a pill mill 
operator. Thus, even assuming that Respondent properly evaluated and 
treated B.B. for this condition, this has no bearing on whether he 
properly evaluated B.B. to determine whether he had a legitimate pain 
condition which warranted the prescription of controlled 
substances.\42\
---------------------------------------------------------------------------

    \42\ To be sure, the visit note also stated that B.B. had ``a 
left abdominal wall hernia'' and Respondent recommended that he 
``wear a corset if at all possible.'' GX 3, at 47. While Respondent 
testified that he suggested the use of a corset because he didn't 
want B.B. to confuse his abdominal pain with his level of pain 
because of his having changed B.B.'s pain regimen, here again, there 
is no evidence that he evaluated the cause of the hernia, how much 
pain it was generating, and how it was effecting B.B.'s ability to 
function. Tr. 300.
     Notably, B.B. returned for another office visit only two weeks 
later. GX 3, at 46. Yet the note for the visit contains no mention 
of the hernia. Id. Nor is the hernia mentioned in the visit notes 
for B.B.'s later visits. See id. at 42, 44-45. And in his testimony, 
Respondent offered no explanation as to what happened to B.B's 
hernia such that it was no longer mentioned in subsequent visit 
notes.
---------------------------------------------------------------------------

    In sum, because I agree with Dr. Owen that Respondent still had not 
established medical necessity for the prescriptions and had still 
failed to address the two aberrant drug tests, I conclude that the 
prescriptions lacked a legitimate medical purpose and that Respondent 
acted outside of the usual course of professional practice in issuing 
them. 21 CFR 1306.04(a).

The October 20 Prescriptions

    At this visit, Respondent noted that B.B. reported that ``his 
stress [was] up'' and that he had ``lo[st] his father'' and was 
``having a lot of grief.'' GX 3, at 46. He made similar physical exam 
findings as at the previous visit, again noting that B.B.'s straight 
leg raise was negative but that ``lying down and sitting up cause him a 
lot of pain.'' Id.; see also Tr. 305 (Respondent's testimony that 
B.B.'s ``exam was still exactly like before, with low back paraspinal 
and spinal tenderness, but he still had the negative straight leg 
raises. But lying down and sitting up still caused him a lot of 
pain.''). Respondent did not even obtain a numerical pain rating at 
this visit nor note whether B.B. was achieving his treatment objective. 
Respondent diagnosed B.B. as having both acute grief and lumbar disc 
disease.
    Dr. Owen testified that B.B.'s having a lot of stress and grief 
would magnify B.B.'s ``perception of pain and disability.'' Tr. 139. He 
further explained that because of B.B.'s previous aberrant behaviors 
and the new stressors in B.B.'s life, he was at increased risk to ``use 
[the] drugs to chemically cope'' and that Respondent should have 
``sought psychological counselling for'' him but did not do so. Id.
    Dr. Owen also took issue with Respondent's notation in the visit 
note that he suggested nonmedicinal modalities for two reasons. Id. at 
209-10. First, he explained that ``good medicine would be [that] if you 
haven't done nonmedicinal pain-relieving modalities,'' Respondent 
should have ``wean[ed] [B.B.] off these controlled substances and 
tr[ied] these other treatments first.'' Id. at 210. Second, he 
explained that the note did not provide an adequate level of detail 
such that any person who took over B.B.'s care or was asked to provide 
a consultation would be able to ``understand what was happening with 
this patient at that point.'' Id.
    As for Respondent's notations that the straight leg raise test was 
negative but that lying down and sitting up caused B.B. a lot of pain, 
Dr. Owen testified that these were not objective findings in a 
neurological sense in that B.B. could not ``have a radiculopathy'' 
absent a positive straight leg raise test. Id. at 210-11. As for the 
pain that B.B. had lying down and sitting up, Dr. Owen testified that 
this contributed to the idea that the controlled substances did not 
provide a therapeutic benefit and thus did not warrant the continued 
prescribing of controlled substances. Id. at 210.
    The CALJ declined to give weight to much of Dr. Owen's testimony, 
reasoning that his ``view of the level of documentation detail required 
in Oklahoma, as well as his description of

[[Page 14972]]

a mandatory mental health referral requirement, is [sic] not consonant 
with the requirement of the Oklahoma Pain Management Regulations.'' 
R.D. 46. With respect to Respondent's recordkeeping, the CALJ explained 
that ``[t]here was sufficient detail to support the proposition that 
the office visit that was conducted in conjunction with this 
prescribing event presented efforts on the part of the Respondent to 
treat B.B.'' Id. (emphasis added). However, as he did with the October 
6 prescriptions, the CALJ found that the August 25 UDS was not 
anomalous (based on Respondent's uncorroborated hearsay testimony) but 
nonetheless found that the June 1 UDS was aberrant and that 
``Respondent's continued controlled substance prescribing under these 
circumstances . . . fell outside the course of a professional medical 
practice, and fell short of his obligations as a DEA registrant to 
safeguard against diversion.'' Id.
    I do not read Dr. Owen's testimony as categorically stating that 
the Oklahoma regulation imposes a mandatory requirement of obtaining a 
consultation when a patient presents with a co-morbid psychiatric 
disorder. While Dr. Owen testified that one of the provisions in 
Oklahoma's ``policies and guidelines . . . that stood out is if 
somebody's a complex pain patient with psychological or psychiatric 
comorbidities, they should get consultations with a pain management 
physician with expertise in these complex cases,'' Tr. 101, he 
acknowledged that the Board's rule used the words ``may require'' but 
that a physician ``should document why [he] deviate[s] from that 
recommendation.'' Id. at 186.
    Thus, Dr. Owen's testimony is not fairly read as asserting that 
Oklahoma imposes a mandatory requirement of obtaining a consultation in 
all instances in which a patient presents with a comorbid psychiatric 
disorder. Moreover, even if I agreed with the CALJ's characterization 
of Dr. Owen's testimony on this issue, the Board's standard is 
nonetheless evidence that the standard of care may require referral or 
consultation depending on the circumstances presented by the patient, 
and there is ample evidence to support Dr. Owen's conclusion that 
Respondent breached the standard of care when he failed to even consult 
with B.B.'s mental health providers.
    Dr. Owen testified that patients who present with comorbid 
psychiatric conditions present a heightened risk of abusing controlled 
substances because these conditions may magnify a patient's perception 
of pain and disability and aggravate a patient's experience of 
suffering, id. 102-04, and Respondent agreed with Dr. Owen. Id. at 409 
(Respondent's testimony that ``having chronic pain [can] lead to worse 
anxiety and depression'' and that ``uncontrolled anxiety or depression 
[can] lead[] to more pain.''). And throughout his testimony, Dr. Owen 
repeatedly noted that based on B.B.'s aberrant behavior alone, 
Respondent should have obtained consultations with mental health 
providers or addictionologists to obtain a more thorough assessment of 
B.B.'s behavior. Thus, Dr. Owen opined that Respondent should have 
sought psychological counselling for B.B. based on his presentation of 
suffering from greater stress and acute grief at this visit. Id. at 
139.
    To be sure, the evidence shows that B.B. was already seeing a 
mental health professional during this period. However, Respondent 
admitted that he never even consulted with the mental health 
professionals who were simultaneously prescribing controlled substances 
to B.B., whether in response to B.B.'s report of increased stress and 
grief at this visit, or at any point during the course of his 
prescribing to B.B. Id. at 408. Notably, when Respondent was asked if 
it was within the standard of care for him and B.B.'s mental health 
provider to keep treating B.B. ``without talking to each other,'' 
Respondent explained that ``the mental health providers are very good 
about speaking to us about patients.'' Id. at 409. When then asked if 
he would ordinarily consult with a patient's mental health provider if 
the latter is simultaneously prescribing controlled substances, 
Respondent offered the unresponsive answer that ``[w]e've become quite 
reliant on the PMP [reports] now'' and that ``[b]efore the PMP, there 
was quite a bit of cross-talk, because . . . pharmacists would call'' 
and tell him that a patient was seeing another physician. Id. at 409-
10. However, the PMP reports in the record show that they did not 
contain any medical information for B.B. other than the controlled 
substance prescriptions he obtained and filled and the names of the 
prescribers.
    When then asked if two practitioners who are simultaneously 
prescribing controlled substances to the same patient wouldn't ``talk 
to each other about'' their joint prescribing, Respondent initially 
answered ``absolutely.'' Id. at 410. However, notwithstanding his 
earlier testimony that ``[t]he mental health providers are very good 
about speaking to us about patients,'' he then asserted that ``[i]n 
every other field but mental health we do do that,'' and added that 
consulting with his patient's mental health professionals ``doesn't 
happen very often.'' Id. In short, none of this testimony refutes Dr. 
Owen's testimony that a patient with a comorbid psychiatric disorder is 
at a higher risk of abusing controlled substances to cope, that 
consultations are important to obtain a better understanding of such a 
patient's behavior, and that based on the aberrant drug screens and his 
report of acute grief, Respondent should have consulted with either 
B.B.'s mental health providers or an addictionologist.
    While, when considered in isolation, Respondent's failure to 
consult with B.B.'s mental health providers would not establish a 
violation of 21 CFR 1306.04(a), Dr. Owen again explained that 
Respondent's evaluation was ``inadequate'' and did not support a 
finding of medical necessity to continue prescribing controlled 
substances. Id. at 140. Moreover, while Respondent testified that lying 
down and sitting up caused B.B. a lot of pain, B.B. had been on 
controlled substances for more than two and a half years at this point 
and was receiving prescriptions for even more potent narcotics and in 
larger doses (morphine and oxymorphone, both schedule II drugs) and yet 
he had never been referred for physical therapy. Thus, as Dr. Owen 
explained, Respondent's findings that B.B. was having a lot of pain 
lying down and sitting up supported the finding that prescribing 
controlled substances was not providing a therapeutic benefit. Id. at 
211.
    As before, Respondent's failure to address the aberrant drug 
screens as well as Dr. Owen's testimony that the evaluation was 
inadequate, that prescribing controlled substances did not provide a 
therapeutic benefit, and that Respondent did not establish medical 
necessity to continue prescribing controlled substances, are sufficient 
to support a finding that Respondent violated 21 CFR 1306.04(a). 
Respondent's failure to consult with B.B.'s mental health providers 
given B.B.'s report of increased stress and grief provides additional 
support for this conclusion.

The November 18 and December 15, 2011 Prescriptions

    On both dates, Respondent issued B.B. prescriptions for 90 Morphine 
Sulfate ER 15 mg and 120 Opana 10 mg without requiring that B.B. appear 
for an office visit with him. Dr. Owen again found that Respondent 
should have seen B.B. prior to issuing the prescriptions and that 
Respondent still

[[Page 14973]]

had not established medical necessity to continue to prescribe 
controlled substances. Tr. 142. Dr. Owen also noted that Respondent 
still had not addressed the aberrant drug screens. Id. at 143. He 
further observed that notwithstanding B.B.'s report of increased stress 
and grief at the previous visit and that B.B. presented a high risk of 
escalating his medications and abusing them, Respondent obviously did 
not discuss these issues with B.B. Id.
    Dr. Owen acknowledged that under a DEA regulation (21 CFR 
1306.12(b)), a practitioner may issue multiple prescriptions for a 
schedule II drug to provide up to a 90-day supply of the drug based on 
only seeing the patient once every 90 days. However, Dr. Owen explained 
that a physician who does so must have ``established medical necessity 
and legitimate therapeutic benefit . . . and [that] a patient doesn't 
have a high risk of abuse,'' but that B.B. already had provided two 
aberrant drug screens before Respondent issued the prescriptions. Id. 
at 196.
    In refutation, Respondent offered only that after the October 20 
visit, he ``felt like [B.B.] could really go into the three-month'' and 
that he did not understand that he had to see B.B. ``every 30 days.'' 
Id. at 307. Respondent further asserted that when a patient requested a 
new schedule II prescription, a PMP report would be obtained, the 
patient's file would be pulled, and that he would write the 
prescription and leave it ``up front.'' Id. at 308. Respondent did not 
offer any testimony refuting Dr. Owen's testimony that B.B. presented a 
high risk of escalating the use of controlled substances and should 
have been seen prior to the issuance of the prescriptions on both 
dates.
    The CALJ found the allegations ``not sustained'' with respect to 
both the November 18 and December 15 prescriptions. R.D. at 51. In the 
CALJ's view, although the June 1 UDS was aberrant, it was not 
adequately noticed with respect to these two prescribing events, and as 
for the August 25 UDS, ``the record evidence [did] not support a 
finding that the . . . results [were] aberrant.'' Id. The CALJ again 
rejected Dr. Owen's testimony as to the lack of therapeutic benefit and 
medical necessity, on the ground that Dr. Owen's view as to the 
required level of documentation ``is at odds with the requirements of 
the Oklahoma Pain Management Regulations.'' Id. at 48. And finally, the 
CALJ rejected Dr. Owen's testimony regarding Respondent's failure to 
require an office visit, reasoning that DEA's regulation allows for the 
issuance of multiple prescriptions for up to a 90-day supply of a 
schedule II drug and that Dr. Owen's opinion was ``based on his 
assumptions that the chart contains insufficient documentation detail 
and two aberrant UDS lab results.'' Id.
    I find, however that on both dates, Respondent acted outside of the 
usual course of professional practice and lacked a legitimate medical 
purpose in issuing the morphine and Opana prescriptions without 
requiring an office visit. As previously explained, the Show Cause 
Order provided Respondent with fair notice that the aberrant June 1 
drug test would be at issue throughout this proceeding, including with 
respect to the prescriptions he issued on November 18 and December 15, 
2011. See supra discussion at 72-77. With respect to the August 25 drug 
test, the CALJ's reasoning makes clear that he considered Respondent's 
testimony as to what he was told by the lab to prove the truth of the 
matter asserted. As explained previously, his testimony is 
uncorroborated hearsay and thus unreliable. Moreover, Respondent's 
testimony that he did not consider the positive test results for the 
other benzodiazepines including the temazepam positive to be aberrant 
is amply refuted by his testimony regarding the January 19, 2012, which 
he deemed aberrant.
    So too, for reasons explained previously, I reject the CALJ's 
interpretation of the documentation requirements imposed by the 
Oklahoma regulations. In any event, in his testimony regarding his 
evaluation of B.B., Respondent simply read aloud what he had documented 
in the visit notes and in the Treatment Objective Evaluation section of 
the Treatment Plan (GX 3, at 28) and never identified additional 
measures he took to evaluate B.B.'s pain and how it affected his 
ability to function.\43\ Thus, I give weight to Dr. Owen's testimony 
that Respondent did not establish medical necessity to continue to 
prescribe controlled substances.
---------------------------------------------------------------------------

    \43\ While Respondent had received the MRI results before he 
issued the November prescriptions, GX 3, at 20; Dr. Owen testified 
that the MRI ``did not show any specific problems that would be 
attributable for this kind of pain complaint[], nor was it 
significant to cause the perceived disability that this 26-year-old 
gentleman considers himself'' to have. Tr. 207. At no point in his 
testimony did Respondent refute Dr. Owen's review of the MRI 
results.
---------------------------------------------------------------------------

    As for the CALJ's reliance on the regulation which allows a 
practitioner to issue to a patient multiple schedule II prescriptions 
for up to a 90-day supply at one time, provided the practitioner meets 
certain conditions, the rationale underlying this provision does not 
provide a safe harbor to Respondent.\44\ Of relevance here, these 
conditions include, inter alia, that: ``[e]ach separate prescription is 
issued for a legitimate medical purpose by an individual practitioner 
acting in the usual course of professional practice''; and ``[t]he 
individual practitioner concludes that providing the patient with 
multiple prescriptions in this manner does not create an undue risk of 
diversion or abuse.'' 21 CFR 1306.12(b)(i) and (iii). As found above, 
based on my conclusions that the prescriptions Respondent issued at the 
three previous office visits were issued outside of the usual course of 
professional practice and lacked a legitimate medical purpose, 
Respondent did not meet the first condition. Moreover, based on 
Respondent's testimony that he did not remember whether he reviewed 
either the June 1 or August 25 drug test results, that he doubted that 
he did and ``wouldn't expect [him]self to'' have done so even though he 
knew his partner had instituted drug testing of the clinic's chronic 
pain patients (Tr. 283, 397), Respondent failed to determine whether 
issuing the prescriptions created an undue risk of diversion. Thus, the 
rationale underlying this regulation provides no basis to reject Dr. 
Owen's testimony that these prescriptions were issued outside of the 
usual course of professional practice and lacked a legitimate medical 
purpose. 21 CFR 1306.04(a).
---------------------------------------------------------------------------

    \44\ As this provision contemplates the issuance of multiple 
prescriptions at one time provided the prescriptions ``indicat[e] 
the earliest date on which a pharmacy may fill each prescription,'' 
it is not directly applicable here. However, as to the frequency of 
office visits, the regulation states that a physician ``must 
determine . . . based on sound medical judgment, and in accordance 
with established medical standards, whether it is appropriate to 
issue multiple prescriptions and how often to see their patients 
when doing so.'' 21 CFR 1306.12(b)(2).
---------------------------------------------------------------------------

The January 19, 2012 Prescriptions

    On January 19, 2012, B.B. again saw Respondent. B.B. reported that 
he had gone to the emergency room ``two weeks ago with right leg 
swelling'' but that ``[h]is ultrasound was negative''; he complained of 
``some calf pain'' and that ``[h]e still feels very tight.'' GX 3, at 
45. Respondent also noted that B.B. ``goes to a psychiatrist'' and 
``reports severe lumbar disc disease.'' Id. In addition, Respondent 
documented that B.B. reported that ``he ha[d] been exposed to someone 
with HPV'' and ``would like an exam.'' Id. Respondent further noted 
that B.B.'s ``[p]ast medical history [was] extensively reviewed'' and 
``placed in chart.'' Id.

[[Page 14974]]

    According to Respondent's exam notes, B.B. was ``[a]lert and 
oriented and in no apparent distress.'' Id. While other portions of the 
exam were normal, Respondent again documented that B.B. had ``[l]ow 
back paraspinal tenderness,'' a ``[n]egative straight leg raise,'' and 
``[n]euro intact.'' Id. He also documented that B.B. ``has very tight 
right calf.'' Id. However, no mention was made of B.B.'s hernia which 
had been noted at previous visits. Id.
    Respondent diagnosed B.B. with ``lumbar disc disease,'' ``exposure 
to infectious disease,'' and ``[r]ight calf pain.'' Id. He further 
documented that he discussed the ``[a]ddictive dependence, and 
tolerance nature of the medicines as well as alternatives,'' that he 
suggested ``[n]on-medicinal pain-relieving modalities,'' and that the 
``[f]ollowup will be [in] three months.'' Id. Respondent then issued 
B.B. new prescriptions for Morphine Sulfate ER 15 mg and Opana 10 mg 
with the same dosing instructions, thus providing a 30-day supply for 
each drug if taken as directed. Id.
    Dr. Owen testified that when a patient reports having gone to the 
emergency room, he would get the record to find out both ``what the 
problem was'' as well as if ``any additional medication [was] 
prescribed.'' Tr. 147. B.B.'s file does not, however, contain a note 
from the emergency room. Id.; see also GX 3. Moreover, after observing 
that the visit note contains no mention that Respondent addressed 
either of the two prior urine screens during this visit, Dr. Owen again 
testified that Respondent had failed to establish medical necessity for 
the prescriptions ``by doing a proper history and physical exam, by 
defining a therapeutic benefit, by explaining what previous treatments 
have or have not worked . . . and . . . addressing the previous 
aberrant urine drug tests.'' Id. at 148. Thus, Dr. Owen opined that the 
Respondent acted outside of the usual course of professional practice 
in issuing the prescriptions and that the prescriptions lacked a 
legitimate medical purpose. Id.
    In refutation of Dr. Owen's testimony, Respondent asserted that 
B.B. did not report anything other than his calf pain and his new 
conditions (apparently a reference to his exposure to someone with 
HPV). Id. at 314, 317. He further testified that there was nothing in 
the PMP report that showed that B.B. had been prescribed anything 
during his emergency room visit. Id. at 314. He also acknowledged that 
during the physical exam, he again found that B.B. had a negative 
straight leg raise test and thus did not have radiculopathy but that 
this did not mean that B.B. did not have paraspinal or muscular 
skeletal pain. Id. at 318-19. However, in contrast to the last visit 
where Respondent documented that lying down and sitting up was causing 
B.B. a lot of pain, Respondent made no such note in the visit note. GX 
3, at 45.
    While Respondent agreed that his visit notes were unremarkable 
given the high amount of narcotics he was prescribing and asserted he 
could have done a better job dictating his notes (which he attributed 
to seeing 40 to 45 patients a day and dictating the notes), he 
maintained that because B.B. ``just continued to have the same pain 
that he had before . . . I didn't go into details on it.'' Tr. 315. 
However, notwithstanding that he had not seen B.B. in three months, he 
did not document whether B.B. had achieved his treatment objective nor 
document a numeric pain rating. GX 3, at 28.
    The CALJ rejected the Government's contention that the controlled 
substance prescriptions Respondent issued at this visit violated 21 CFR 
1306.04(a). Again, the CALJ concluded that the Government did not 
provide adequate notice regarding its reliance on the June 1 UDS and 
that the record does not support a finding that the August 25 UDS 
result was aberrant. R.D. at 51. And again, the CALJ reasoned that Dr. 
Owen's view of the level of documentation required findings of 
therapeutic benefit and medical necessity, as well as his conclusion 
that Respondent did not adequately document B.B.'s visit to the 
emergency room and should have obtained the record of that visit, were 
``at odds with the requirements of the'' Board's rules. Id. Finally, 
the CALJ asserted that ``Respondent's testimony provide[s] convincing 
evidence that the Respondent was engaged in bona fide attempts to treat 
B.B., not act as a drug supplier. The same can be said of the evidence 
that the Respondent was seeing B.B. for maladies beyond his pain 
complaints.'' Id.
    For reasons explained previously, I find that Respondent was 
provided adequate notice regarding the Government's reliance on the 
June 1 UDS and that the record supports a finding that the August 25 
UDS was aberrant. As also explained previously, because I do not agree 
with the conclusion that Dr. Owen's understanding of the Oklahoma 
documentation requirement is ``at odds'' with the permissive nature of 
the State's regulations, R.D. 51, and agree with the CALJ's conclusion 
that Dr. Owen's testimony ``predictably raised no issues regarding 
credibility,'' I give weight to Dr. Owen's testimony that Respondent 
did not establish medical necessity to issue the prescriptions.
    As for Dr. Owen's criticism of Respondent for failing to obtain the 
emergency room record, Respondent testified that he checked the PMP and 
found no evidence that B.B. had been prescribed controlled substances. 
Moreover, even if the standard of care does require a pain management 
physician to obtain an ER record for his patient, it not clear how 
quickly that record could have been obtained on the date of this visit. 
Nor is it clear why, if a physician has otherwise properly evaluated 
his patient, his failure to obtain an ER record on that date would 
preclude his issuance of controlled substance prescriptions.
    However, Dr. Owen provided credible testimony that when Respondent 
issued the January 19 prescriptions, he still did not perform an 
adequate evaluation of B.B.'s pain complaint by doing a proper history 
and physical exam, nor determined whether there was a therapeutic 
benefit to justify the continued prescribing of controlled substances, 
nor addressed the previous aberrant drugs tests. Dr. Owen's testimony 
provides substantial evidence to conclude that Respondent acted outside 
of the usual course of professional practice and lacked a legitimate 
medical purpose when he issued the prescriptions.
    In discussing Respondent's testimony regarding the notes he made 
after B.B.'s January 27 office visit (on which occasion he did not 
prescribe controlled substances), the CALJ stated that ``Respondent 
noted that B.B. was on Social Security disability, and objective data 
had confirmed that he had chronic pain.'' R.D. at 50 (citing Tr. 324). 
However, Respondent did not identify what the ``objective data'' were. 
See Tr. 324-25.
    The CALJ also found that in the Respondent's view, B.B. had not 
behaved in a way that set off alarms, and was stable on his 
medications.'' R.D. at 50. However, as found previously, Respondent 
testified that he probably never even looked at the UDS results that 
were in B.B.'s chart and didn't expect that he would have done so. Yet 
Respondent also testified that Dr. Schoelen had instituted urine drug 
testing for the clinic's chronic pain patients and thus Respondent 
obviously knew that B.B.'s file likely contained UDS results. And the 
evidence also shows that Respondent did not conduct a drug test of B.B. 
at any of his first three visits and yet concluded that he only needed 
to see B.B. once every three months. Thus, to the extent Respondent 
claims that B.B's behavior did not set off

[[Page 14975]]

alarm bells, it is because Respondent deliberately ignored relevant 
evidence and failed to monitor his patient.
    The CALJ apparently also credited Respondent's testimony to the 
effect that ``[m]uch more went on in the office than what's written'' 
in the visit notes and that he ``definitely knew what was going on in 
[B.B's] life from each visit, and I just failed to dictate that.'' Tr. 
326. And the CALJ further asserted that ``Respondent provided details 
to demonstrate that he knew his patient,'' R.D. 50, and apparently 
credited Respondent's testimony that he ``was talking to [B.B] about 
those things and what all he did in a day, and he was not able to 
work.'' Tr. 327 (cited at R.D. 51).
    Yet, on the occasion of the January 19 visit, during which he 
issued B.B. new prescriptions for morphine and oxymorphone, Respondent 
did not even document in the Treatment Objective Evaluation section on 
the Treatment Plan if B.B. was meeting his treatment objectives and did 
not obtain a pain rating. Of note, the former was typically documented 
with a handwritten one-word answer of either ``yes'' or ``fair,'' and 
the latter was documented with a handwritten notation of a number; thus 
neither of these inquiries required dictation at all.\45\
---------------------------------------------------------------------------

    \45\ Indeed, on each of the dates on which Respondent made 
notations in this section of the chart, each of the entries was 
handwritten.
---------------------------------------------------------------------------

    Moreover, when asked by the CALJ how he knew how the meds he 
prescribed ``were doing,'' Respondent replied that his evaluation was 
``purely subjective, and if they were needing more or less pain meds.'' 
Only after a further question as to whether he asked objective 
questions in assessing how B.B. was responding to the medications did 
Respondent maintain that he was aware of what B.B. did all day and that 
he had not returned to work.
    Dr. Owen provided unrefuted testimony that ``return[ing] to work'' 
is ``the gold standard for functionality in pain management.'' Tr. 100. 
Given this, it is telling that Respondent never documented whether B.B. 
had returned to work in the progress notes he prepared for the various 
visits. Moreover, given that B.B.'s treatment objective was to return 
to work without pain and yet B.B. never returned to work during the 
course of Respondent's prescribing to him, id. at 353, it is hard to 
understand why Respondent wrote ``fair'' for whether B.B. was meeting 
his treatment objective.
    As for why he did so, Respondent testified that he would ask his 
patients if they were meeting their treatment objective and he would 
write down what the patient told him. Tr. 392. However, Respondent 
further testified that ``[a]ctually that part [of the visit] would be 
very quick in my office. I wouldn't ask him what he was actually doing 
to achieve that.'' Id. at 393.
    Respondent ``absolutely'' agreed with the CALJ that he would ask 
his patients ``[h]ave you achieved your treatment objective?'' only to 
then acknowledge that his patients ``may not'' remember what their 
treatment objective was. Tr. 394. And while this question appears to 
have been directed at assessing a patient's function, Respondent 
testified that the question was intended to elicit ``[b]asically if 
they were satisfied with the care or the standard that they meet.'' Id. 
When then asked why B.B. would answer ``fair'' to what seemed to be ``a 
yes or no question,'' Respondent testified that he was ``not sure'' why 
the answer would come out as ``fair.'' Id. at 395.
    Tellingly, at another point during his testimony on this issue, 
Respondent explained:

    They [the patients] were very well trained by the time this was 
here. Whenever we walked in, they knew the questions before we asked 
them. You know, are you meeting your objective? What's your pain 
level? And do you wish to change? Do you think we should make a 
referral? We asked it every time, just like clockwork.

Tr. 394-95.
    I disagree with the CALJ that ``Respondent's testimony provides 
convincing evidence that he was engaged in bona fide attempts to treat 
B.B., not act as a drug supplier.'' On the issue of how he evaluated 
B.B.'s function, Respondent offered only the vague testimony that he 
``was talking to B.B about those things and what all he did in a day.'' 
Yet Respondent never documented any such findings other than to make 
the nonsensical notation of ``fair'' for whether B.B. was achieving his 
treatment objective, and even at the hearing, Respondent still could 
not explain why he did so even though he did so on multiple occasions. 
As for his assessment of B.B.'s pain level, Respondent testified to 
only asking ``what's your pain level''--as if over the course of the 
preceding 90-day period, a patient's pain level would not fluctuate 
depending upon the activities engaged in by the patient. While I am 
mindful that the CALJ's finding was based on his credibility 
determination, it is noteworthy that in his decision, the CALJ did not 
discuss this portion of Respondent's testimony (Tr. 392-95), which is 
clearly relevant and probative on the issue of the scope of his 
evaluation of B.B.\46\
---------------------------------------------------------------------------

    \46\ While Respondent also asserted that B.B. ``basically was 
stuck in the house all day,'' that obviously was not the case when 
B.B. was found semiconscious and in an apparent state of 
intoxication in a vehicle parked on the median strip of I-35. As far 
as B.B.'s inability to work, the evidence shows that he was working 
by ``illegally buying and selling prescriptions drugs.'' RX 3, at 3 
(stipulated findings of fact of the March 8, 2013 Board Order).
---------------------------------------------------------------------------

    As noted previously, in its Policy Statement, the Board stated that 
it ``will judge the validity of the physician's treatment of the 
patient based on available documentation'' and that ``[t]he goal is to 
control the patient's pain while effectively addressing other aspects 
of the patient's functioning, including physical, psychological, social 
and work-related factors.'' Policy Statement, at 2 (emphasis added). 
Given that Respondent's documentation was confined to the two 
superficial notations in the Treatment Objective Evaluation section of 
the Treatment Plan and given the emphasis which the Board's Policy 
Statement places on the available documentation in judging the validity 
of treatment, as well as Respondent's testimony as to the scope of the 
questions he would ask, I conclude that Respondent has not refuted Dr. 
Owen's testimony that he failed to adequately evaluate whether there 
was a medical necessity to prescribe controlled substances to B.B.
    In concluding so, I am mindful that while the Board initially 
charged Respondent with ``fail[ing] to maintain adequate medical 
records to support diagnosis . . . treatment or prescribed medications, 
in violation of 59 O.S. Sec.  509(20),'' RX 1, at 4, the Board 
ultimately entered into a settlement with him prior to hearing which 
did not include a finding that he violated this provision. There is, 
however, nothing unusual about prosecutors agreeing to enter settlement 
agreements in which they waive meritorious allegations and, as the 
voluntary settlement agreement offers no explanation as to why the 
Board did not rely on this specific allegation, I place no weight on 
the failure of the Board to find that Respondent violated the 
provision.
    I am also mindful of the CALJ's criticism that Dr. Owen is not 
licensed to practice in Oklahoma and has never practiced there, as well 
as that Dr. Owen's ``representation that the controlled substance 
prescribing standards in his home state of Texas are similar to, but 
less restrictive than Oklahoma, is flat out wrong,'' and that this 
diminishes the weight to be given to his testimony. R.D. 89 (citing Tr. 
87, 94, 105-06).

[[Page 14976]]

    It is true that in several respects the Texas Board's standards are 
more restrictive than Oklahoma's, and thus, Dr. Owen's testimony that 
Texas's standards are less restrictive was erroneous. However, on the 
critical issues of the scope of the evaluation of the patient and the 
documentation required, as explained previously, I conclude that the 
Oklahoma Board's standards on these issues are mandatory. While the 
Texas Board uses even more emphatic language to express the mandatory 
nature of these requirements, I conclude that there is no material 
difference between the standards of Oklahoma and Texas.
    Moreover, Dr. Owen provided additional evidence to support the view 
that the standards of medical practice require the documentation of 
considerably more information than found in B.B.'s progress notes. As 
he explained:

the purpose of documentation is for continuity of care. Not only 
continuity of care for this same provider from visit to visit but 
continuity of care should somebody else assume the care later on 
down the road or should you need to get a consultation, that the 
consultant can read your notes and understand what was happening 
with this patient at this point in time.

Tr. 210.
    Notably, Respondent put on no evidence showing that Oklahoma's 
standard was materially different than what Dr. Owen testified to on 
the issue of the adequacy of the evaluation and required level of 
documentation. See United States v. Joseph, 709 F.3d 1082, 1096 (11th 
Cir. 2013) (upholding criminal conviction for violation 21 CFR 
1306.04(a); ``[e]ven if the district court should have instructed the 
jury to evaluate the conduct of the defendants against only a Georgia 
standard of medical practice, the defendants failed to offer any proof 
that the Georgia standard differs at all from any national standard 
that the jury purportedly considered'').
    Moreover, while States have the primary responsibility for the 
regulation of the medical profession, many of the profession's norms 
were created by the profession itself. Thus, on such issues as the 
adequacy of a clinical evaluation for a particular pain complaint and 
the necessary documentation to support the prescribing of controlled 
substances, the standard of medical practice would not seem to vary to 
any material degree between States, especially between States that 
border each other.
    Finally, unlike Respondent, Dr. Owen is board certified in pain 
management, is a member of multiple pain management professional 
organizations, including the American Academy of Pain Medicine and the 
American Academy of Pain Management, has practiced pain management for 
more than sixteen years, serves as a peer reviewer on pain medicine for 
the Journal of the American Academy of Pain Medicine, and has made 
numerous presentations on pain-management. In light of his extensive 
professional credentials, I conclude that even though he has not 
practiced in Oklahoma, I find persuasive his testimony as to the 
inadequacy of Respondent's evaluations of B.B. and Respondent's failure 
to establish a medical necessity for the prescriptions. I thus conclude 
that the January 19, 2012 Morphine and Opana prescriptions lacked a 
legitimate medical purpose and that Respondent acted outside of the 
usual course of professional practice in issuing them. 21 CFR 
1306.04(a).

The February 13, 2013 Prescriptions

    On this date, Respondent issued B.B. new prescriptions for 120 
Opana 10 and 90 Morphine Sulfate ER 15. Moreover, by this date, 
Respondent likely had the results of the January 19 UDS, which showed 
that Morphine Sulfate was not detected and that B.B. had tested 
positive for nordiazepam, oxazepam and temazepam (as well as 
alprazolam). On the lab report, Respondent wrote that B.B. was 
``counsel[led] to only take what is prescribed.'' Respondent did not 
require that B.B. appear for an office visit.
    Dr. Owen testified that Respondent should have required an office 
visit because of B.B.'s previous aberrant drug-taking behaviors and 
because Respondent still needed to establish that there was a medical 
necessity to prescribe controlled substances and a therapeutic benefit. 
Tr. 154. While Dr. Owen acknowledged Respondent's notation that he had 
counseled B.B., Dr. Owen testified that this was not an adequate 
safeguard to prevent abuse or diversion because this was B.B.'s third 
aberrant drug test. Id. Dr. Owen further testified that Respondent 
``need[ed] to have a long discussion with [B.B.] about the risk of 
addiction'' and obtain a consultation by a specialist in addiction.
    In refutation, Respondent maintained that ``the morphine said not 
detected, but the oxymorphone was positive, so that was explainable.'' 
Id. at 335. And he again maintained that ``the lab always said that if 
``the Xanax was positive,'' then nordiazepam, oxazepam and Xanax 
``could all three be positive.'' Id. Continuing, Respondent testified 
that ``temazepam, in our practice, usually didn't show up,'' so he 
checked B.B.'s PMP report to see if he had been prescribed Restoril 
(the name of the legend drug) but ``couldn't find it on the PMP.'' Id. 
Respondent then maintained that ``Dr. Schoelen didn't mind his pain 
patient being on Restoril,'' but ``I did, and so I wanted to make sure, 
has he been prescribed Restoril.'' Id. at 335-36. Respondent then 
testified that he was ``sure'' that he told B.B. that if he had ``an 
old Restoril or some other doctor, I do consider that breaking our 
rules, and so you can't take it.'' Id. at 336.
    The CALJ again rejected the Government's contention that Respondent 
violated 21 CFR 1306.04(a) when he issued the prescriptions, reasoning 
that ``the record evidence does not support a finding that the August 
25 or January 19 UDS results are aberrant.'' R.D. at 54. While the CALJ 
again explained that ``it is beyond argument that the June 1 UDS does 
present an anomaly, reliance on that event [was] not adequately notice 
by the Government in support'' of its contentions regarding these 
prescriptions. Id.
    In addition, the CALJ found that Respondent ``provided a thoughtful 
and reasoned explanation (based on his professional experience and 
knowledge of operating Tri-City) of why B.B. may have tested positive 
for temazepam despite not having been prescribed it.'' Id. at 54-55. 
Taking the January 19 UDS in isolation, the CALJ explained that the 
Government did not ``establish that the Respondent's counseling B.B. to 
`only take what is prescribed' fell below the standard of care in 
Oklahoma.'' Id. at 55. The CALJ then rejected Dr. Owen's testimony that 
Respondent should have referred B.B. to an addictionologist, explaining 
that ``the existence of the UDS reports that are unavailable to the 
Government and/or unsupported by the evidence were integral to that 
recommendation, and their absence from a useful role in the record 
likewise undermines his testimony in this regards [sic].'' Id.
    However, as explained above, even though the June 1 UDS was not 
specifically referenced in the Show Cause Order with respect to the 
February 13 prescriptions, the issues of the aberrant nature of the 
June 1 test (as well as the August 25 test) were litigated by consent. 
As for the CALJ's assertion that the record does not support a finding 
that the August 25 and January 19 UDS results were aberrant, 
Respondent's testimony and the notation he placed on the report of the 
January 19 test establish that both tests were aberrant in that B.B. 
was taking a medication which Respondent had not prescribed to him and 
which was not listed on the PMP reports, including one

[[Page 14977]]

that went back as far as August 27, 2010. Moreover, none of Dr. 
Schoelen's progress notes ever mentioned that B.B. was taking Restoril 
or temazepam, whether prescribed by Dr. Schoelen or another authorized 
prescriber. And while the CALJ noted that Respondent provided a 
thoughtful and reasoned explanation as to ``why B.B. may have tested 
positive for temazepam,'' the fact of the matter is that in his 
testimony, Respondent never maintained that he even asked B.B. if he 
had an old prescription for the drug and who prescribed it to him. 
Thus, B.B. may have tested positive for the drug because he was 
obtaining it without a prescription.
    As for the CALJ's assertion that the Government provided no 
evidence that Respondent's action in counseling B.B. to take only what 
he was prescribed fell below the standard of care, the CALJ's reasoning 
rests on the erroneous premise that this was B.B.'s first aberrant drug 
test. However, for reasons explained previously, it was his third 
aberrant test in less than eight months, and each of his last three 
tests produced an aberrational result.\47\
---------------------------------------------------------------------------

    \47\ However, I do not rely on the January 19 UDS result that 
morphine was not detected. In contrast to the results which showed 
the presence of drugs which B.B. had not been prescribed, B.B. was 
five days past 30 days (the number of days the morphine prescription 
would have lasted if taken as directed), and the Government put 
forward no evidence that morphine would still be detectable five 
days later. While B.B.'s having been five days late raises other 
issues (such as whether he should have been going through withdrawal 
by January 19), the Government elicited no such testimony from Dr. 
Owen.
---------------------------------------------------------------------------

    In rejecting Dr. Owen's testimony that Respondent needed to obtain 
a consultation, the CALJ further asserted that Oklahoma's referral 
standard (which uses the language ``may require'') is ``permissive'' 
and not ``directive.'' R.D. at 55. The provision is, however, more 
appropriately read as conferring a degree of discretion which must be 
exercised within the bounds of ``sound clinical judgment,'' Policy 
Statement, at 2; and which is necessarily dependent on the facts and 
circumstances presented by the patient.
    Thus, in contrast to the CALJ, I give weight to Dr. Owen's 
testimony that based on B.B.'s multiple aberrational tests, Respondent 
needed to obtain a consultation with a specialist in addiction. 
Moreover, as Respondent did not require an office visit, I also give 
weight to Dr. Owen's testimony that Respondent had still not 
established medical necessity to justify the continued prescribing of 
controlled substances. Accordingly, I conclude that the Opana and 
Morphine prescriptions lacked a legitimate medical purpose and that 
Respondent acted outside of the usual course of professional practice 
in issuing them. 21 CFR 1306.04(a).

The March 13, 2012 Prescriptions

    On March 13, 2012, Respondent issued B.B. new prescriptions for 
both 120 Opana 10 and 90 Morphine Sulfate ER 15. See GX 5, at 10, 24. 
Respondent issued the prescriptions without requiring an office visit 
by B.B. Tr. 156; see generally GX 3, at 42-62 (visit notes for B.B.). 
Nor is there any notation on any of the visit notes regarding 
Respondent's issuance of these prescriptions.\48\
---------------------------------------------------------------------------

    \48\ As found above, on the January 27, 2012 visit note, 
Respondent had written that on ``2/13/12'' he prescribed ``Zpack, 
Prednisone 10 mg # 28, Phenergan.'' GX 3, at 44. The same visit note 
contains a further entry for ``2-22-12'' documenting the issuance of 
a prescription for 60 tablets of Soma (carisoprodol) 350 mg. Id.
---------------------------------------------------------------------------

    Dr. Owen testified that Respondent should have required an office 
visit before issuing these prescriptions, reiterating that Respondent 
still had not established ``medical necessity for'' prescribing 
controlled substances to B.B. Tr. 155. Asked to again identify the 
deficiencies which led him to conclude that Respondent had not 
established medical necessity, Dr. Owen explained:

    Reviewing all the pertinent previous medical records, including 
what previous treatments have been performed, an adequate history 
and physical exam, consultations as medically appropriate, 
establishing a clinically meaningful and objective therapeutic 
benefit, and addressing any aberrant drug-taking behaviors.

Id. at 157. Dr. Owen again noted that there were three previous 
incidents of aberrant drug-taking behaviors, and that ``[t]he only 
treatment plan has been continuing the controlled substances without 
medical necessity.'' Id. at 158. And once again, Dr. Owen testified 
that the prescriptions lacked a legitimate medical purpose and ``were 
not'' issued in the usual course of professional practice. Id.
    In his direct testimony, Respondent did not address his reasons for 
issuing the March 13 Opana and morphine prescriptions. See Tr. at 338-
39. Instead, the questioning centered on the issue of why he wrote a 
prescription on March 14 for Nexium, ``a stomach medicine'' and a non-
controlled drug (``I have no idea'') after which the questioning moved 
on to the next set of prescriptions. Id.
    Here again, the CALJ concluded that the Government's evidence was 
not sufficient to sustain the allegations that Respondent violated 21 
CFR 1306.04(a) in issuing the prescriptions. According to the CALJ, 
``there [was] no persuasive evidence to support the conclusion that the 
absence of an office visit by B.B., standing alone, render[ed] this 
prescribing event below the prevailing medical standard in Oklahoma.'' 
R.D. at 56. Again noting that under 21 CFR 1306.12(b), which allows for 
the issuance of multiple schedule II prescriptions to provide up to a 
90-day supply provided certain conditions are met, the CALJ concluded 
that ``without persuasive expert or state regulatory guidance, evidence 
[of] the failure to conduct an in-person office visit does not 
establish that this prescribing event fell below the standard of care 
required in Oklahoma.'' Id. And in rejecting the allegations, the CALJ 
further cited the purported permissive nature of the State's 
documentation standard and asserted that ``none of the UDS results 
raised by Dr. Owen in his testimony were adequately noticed by the 
Government regarding this prescribing event.'' Id.
    As for the CALJ's assertion that the UDS results were not 
adequately noticed, in the Show Cause Order, the Government alleged 
with respect to these prescriptions that Respondent ``once again issued 
[B.B.] controlled substance prescriptions . . . without taking 
appropriate steps to monitor his controlled substances use despite the 
persistent red flags of abuse and diversion he previously presented.'' 
ALJ Ex. 1, at 5 (] 3h). Even if this was not enough to provide 
Respondent with notice that the three UDSs would be at issue with 
respect to these prescriptions, Respondent did not object when the 
Government asked Dr. Owen: ``[a]re there any aberrant drug-taking 
behaviors here?'' and he answered: ``[t]here has [sic] been three 
previous.'' Tr. 158. I thus conclude that Respondent consented to the 
litigation of the issue.
    As for the CALJ's assertion that there is no persuasive evidence 
that standing alone, the absence of an office visit rendered these 
prescriptions below the prevailing medical standard, the Respondent's 
prescribing without requiring an office visit does not stand alone. 
Rather, Dr. Owen credibly identified multiple deficiencies in 
Respondent's evaluation of B.B.'s pain complaint, including his failure 
to perform an adequate history and physical, his failure to properly 
evaluate how B.B.'s pain was effecting his ability to function, his 
failure to determine if the controlled substances were providing a 
therapeutic benefit and to try conservative treatments, and his failure 
to address the multiple instances of aberrant behavior. Of further 
note, Respondent offered no evidence refuting

[[Page 14978]]

Dr. Owen's testimony regarding these prescriptions. I thus conclude 
that these prescriptions lacked a legitimate medical purpose and that 
Respondent acted outside of the usual course of professional practice 
in issuing them. 21 CFR 1306.04(a).

The April 12 Prescriptions

    On April 12, 2012, B.B. saw Respondent for an office visit. GX 3, 
at 42. According to the visit note, B.B. ``report[ed] his pain has been 
worse,'' that ``[h]e has run out of his medicines; he had them 
stolen,'' and that ``[h]e has done fairly well.'' Id. Moreover, on the 
Treatment Objective Evaluation section of the Treatment Plan, 
Respondent wrote ``fair [rarr] yes'' and made an arrow pointing to 
``yes'' in the block for ``Has patient achieved treatment objective?'' 
and ``6'' in the block for ``Patient Completed . . . update [sic] pain 
scale.'' Id. at 28.
    In the visit note, Respondent wrote that B.B. ``still has severe 
anxiety and depression'' and has been ``exposed to someone with HPV''; 
Respondent then wrote: ``[h]e is also wanting to switch his medicines 
because he is having trouble finding the OPANA.'' Id. Respondent also 
noted: ``[p]ast medical history extensively reviewed and placed in 
chart.'' Id.
    In his exam findings, Respondent noted ``[l]ow back paraspinal and 
spinal tenderness,'' ``[n]egative straight leg raise,'' and ``[n]euro 
intact.'' Id. Respondent listed his diagnoses as ``[l]umber disc 
disease,'' ``[a]nxiety and depression'' and ``[e]xposure to infectious 
disease'' although he ``doubt[ed] that it was HPV.'' Id. Respondent 
then changed B.B.'s medications to Opana ER (extended release) 20 mg, 
b.i.d. (twice per day) and Percocet 10 mg (q. 12h) p.r.n. (as needed) 
for acute pain. Id.; see also Tr. 340. He also prescribed Soma 
(carisoprodol) one tablet b.i.d. GX 3, at 42.
    Respondent further documented that he discussed the ``[a]ddictive, 
dependence, and tolerance nature of the medicines, as well as 
alternatives.'' Id. He noted that he ``suggested'' ``[n]on-medicinal 
pain and anxiety-relieving modalities.'' Id.
    During this visit, Respondent also required B.B. to provide a UDS. 
The preliminary screening found that B.B. was negative for opiates and 
morphine. And according to the confirmatory testing done by the lab, 
which was reported back to Respondent on April 17, 2012, B.B. tested 
positive for oxymorphone, which was expected based on Respondent's 
having prescribed Opana to him. Id. He also tested positive for 
meprobamate, which was expected based on Respondent's having prescribed 
carisoprodol to B.B. Id. However, the lab further found that morphine 
was ``not detected,'' a result which was ``not expected'' because 
Respondent had prescribed morphine sulfate ER to B.B. on March 13, 
2012. Id. Dr. Owen also noted that while ``the confirmed . . . drug 
test [was] positive for some of these drugs,'' Respondent had reported 
that he had run out of his medicines and that there was a ``lack of 
documentation of what he ran out of and what he should still be on.'' 
Tr. 167.
    Dr. Owen found it problematic that B.B. had told Respondent that 
his pain was worse, that he had run out of his medicines and had them 
stolen. Id. at 159. As he explained:

    Well, one, his pain is worse, so why is it worse? Two is he's 
run out of his medications, and then he had them stolen. What is it? 
Did you run out of them because you self-escalated, or were they 
stolen and you ran out of them? It needs clarification. But either 
event, self-escalation or having them stolen, is a red flag.

Id.
    Regarding B.B.'s report that his medications were stolen, Dr. Owen 
testified that because there had ``been the aberrant urine drug tests 
before . . . this, there is [sic] enough aberrant behaviors that'' 
Respondent needed ``to get the person to an addictionologist or a 
psychologist, or just stop prescribing these controlled substances 
since there's no evidence they're helping this gentleman.'' Id. at 212-
13.
    Dr. Owen also found problematic the notations in the visit note 
that B.B. reported that ``his pain has been was worse'' and that ``[h]e 
has done fairly well.'' Id. at 160. As Dr. Owen testified, the 
statement that ``[h]e has done fairly well . . . kind of conflicts with 
his pain is worse and the aberrant drug-taking behavior, so that's an 
unreliable statement.'' Id. Dr. Owen also explained that B.B.'s having 
``severe anxiety and depression . . . are relative contraindications to 
prescribing controlled substances . . . [b]ecause it magnifies [the] 
perception of pain and disability.'' Id. Dr. Owen then testified that 
because of these conditions, Respondent should have requested a 
``consultation by a psychologist'' but did not. Id. at 160-61.
    Dr. Owen further testified that Respondent ``did not'' address 
B.B.'s ``ongoing stress and anxiety issues'' and that ``[h]e did not'' 
conduct a thorough patient history. Id. at 166. He then testified that 
Respondent had changed B.B.'s treatment plan by adding Percocet, but 
that Respondent ``change[d] the medications without ever . . . 
documenting [a] medical rationale to add any new medication.'' Id. 
Asked by the CALJ ``why would someone add Percocet,'' Dr. Owen 
testified that it is a short-acting opioid that could be added ``for 
break-through pain, if that's not being controlled well.'' Id. at 167.
    Dr. Owen reiterated his earlier testimony that the patient record 
was ``not adequate'' to establish ``medical necessity'' for prescribing 
the controlled substances on this date and that between September 22, 
2011 (when he assumed the care of B.B.) and April 12, 2012, Respondent 
had never established medical necessity for prescribing controlled 
substances to B.B. Id. at 173-74. He then opined that the prescriptions 
Respondent issued at this visit were issued outside of the usual course 
of professional practice and lacked a legitimate medical purpose. Id. 
at 174.
    The CALJ sustained the Government's allegations only with respect 
to its contention that Respondent ignored the PMP data showing that 
B.B. was obtaining early refills of alprazolam and failed to take any 
action in response to this information, such as contacting the other 
prescribers or cautioning B.B. in response to this information. R.D. at 
61-62. For reasons explained previously, the evidence does not support 
the contention that B.B. exhibited a pattern of obtaining early refills 
as of this visit. I also agree with the CALJ that the evidence does not 
support a finding that Respondent provided B.B. with an early refill of 
his pain medications.
    However, for many of the same reasons previously discussed, the 
CALJ rejected the other evidence offered by the Government to prove 
that the prescriptions violated 21 CFR 1306.04(a). For example, the 
CALJ again reasoned that ``the UDS results prior to the April 12 amino 
assay UDS'' were not ``adequately noticed by the Government . . . 
regarding this prescribing event [and] are unavailable to support its 
expert's opinion here.'' R.D. at 60. And the CALJ further asserted that 
the Government could not rely on litigation by consent because it did 
``not timely and affirmatively raise[]'' this theory. Id. However, as 
discussed previously, paragraph 3 of the Show Cause Order provided 
adequate notice that various aberrant drug tests would be at issue 
throughout the proceeding.\49\ And even

[[Page 14979]]

if it did not, the record fully supports the conclusion that the issue 
was litigated by consent as, given the absence of an objection, the 
Government had no obligation to affirmatively raise the argument (which 
it did in its Exceptions) until the CALJ issued his Recommended 
Decision.
---------------------------------------------------------------------------

    \49\ As the Show Cause Order alleged:
     From on or about August 25, 2011 through on or about May 9, 
2012, you issued controlled substance[] prescriptions to B.B. in 
violation of Federal and Oklahoma state law. You were aware on each 
of the occasions that you issued controlled substance[] 
prescriptions to B.B. that he presented a high risk of abuse and/or 
diversion of controlled substances, as evidenced by the red flags 
documented in his patient file, such as aberrant urine drug tests, a 
request for early refills, and a claim of stolen drugs. You failed 
to address and, in fact, ignored these red flags, continuing to 
issue B.B. controlled substance prescriptions in the face of 
mounting evidence that he was misusing, abusing, and/or diverting 
the controlled substances you were prescribing.
    ALJ Ex. 1, at 1 ] 3.
---------------------------------------------------------------------------

    The CALJ also failed to give weight to Dr. Owen's testimony that 
Respondent should have either referred B.B. to a specialist in 
addiction or spoken with his mental health professional, asserting that 
the Government did ``not establish[ ] that good medical practice in 
Oklahoma require[d] that.'' R.D. at 60. However, Dr. Owen is board-
certified in pain management, a member of multiple national 
professional societies which focus on pain medicine and is a peer 
reviewer on pain medicine for the Journal of Pain Management. As 
previously explained, while the Oklahoma referral provision does not 
categorically require that a physician refer a patient to a specialist 
in addiction or consult with other providers, it clearly contemplates 
that a physician will use sound clinical judgment in determining 
whether a referral or consultation is necessary. And as to whether 
Respondent exercised sound clinical judgment when he neither referred 
B.B. to an addictionologist nor consulted with his mental health 
providers, Respondent produced no evidence showing that the standard of 
care in Oklahoma is materially different from the standard in Texas or 
the standard that is generally recognized by pain management 
practitioners. See United States v. Joseph, 709 F.3d at 1096.
    In rejecting the Government's evidence, the CALJ also explained 
that the Government did not establish that ``good medical practice in 
Oklahoma require[d]'' that Respondent ``document[] in any specific 
level of detail the Respondent's discussion with B.B. about . . . [his] 
success on the treatment plan.'' R.D. at 60. Yet the Board's Regulation 
directs that ``[t]he physician should periodically review the course of 
pain treatment'' and ``[c]ontinuation or modification of controlled 
substances for pain management therapy depends on the physician's 
evaluation of progress toward treatment objectives. Satisfactory 
response to treatment may be indicated by the patient's decreased pain, 
increased level of function or improved quality of life. Objective 
evidence of improved or diminished function should be monitored . . . 
'' Okla. Admin. Code Sec.  435:10-7-11(4). Moreover, another provision 
of the regulation requires physicians to ``keep accurate and complete 
records to include . . . follow-up evaluations . . . . [and] periodic 
reviews.'' Id. Sec.  435:10-7-11(6). And the Board's Policy Statement 
explains that ``[a]ll such prescribing must be based on clear 
documentation of unrelieved pain'' and that ``the validity of the 
physician's treatment of the patient'' will be judged ``based on 
available documentation.'' Policy Statement, at 2.
    Moreover, even if the Board's rule does not mandate ``any specific 
level of detail,'' Dr. Owen offered credible testimony as to why the 
standard of care clearly requires more documentation than that made by 
Respondent. As he explained, ``the purpose of documentation is for 
continuity of care. Not only continuity of care for this same provider 
from visit to visit but continuity of care should somebody else assume 
the care later on down the road or should you need to get a 
consultation, that the consultant can read your notes and understand 
what was happening with this patient at this point in time.'' Tr. 210.
    Notably, while B.B.'s treatment objective was to return to work 
without pain, B.B. had not returned to work as of the April 12 visit 
(and never did during the course of Respondent's prescribing) and yet 
in the box for documenting whether he was meeting his treatment 
objective, Respondent wrote the words ``fair'' and ``yes.'' Yet at the 
hearing, Respondent did not recall why he wrote ``yes,'' just as he was 
``unsure'' as to why he had written ``fair'' in the box at previous 
visits. As Respondent could not even explain why he made these entries, 
it is clear that no other physician who subsequently took over B.B.'s 
care could ``understand what was happening with'' B.B. at various 
points. So too, as Respondent could not explain the inconsistency 
between his having noted in B.B.'s progress note that ``his pain was 
worse'' while B.B. reported a decrease in his numeric pain rating and 
that ``he has done fairly well,'' I give weight to Dr. Owen's testimony 
that Respondent's notes fell below the standard of care.
    Finally, the CALJ declined to give weight to Dr. Owen's testimony 
regarding Respondent's failure to address the aberrant immunoassay drug 
test result once again asserting that the Board's regulations ``contain 
no specific directive to mandate such a notation.'' R.D. at 61. 
However, as the CALJ noted, ``Respondent did not address this issue in 
his testimony'' and thus, there is no dispute that he took no action 
other than to send the specimen in for confirmatory testing. While it 
is true that Dr. Owen testified that the immunoassay test has 
reliability problems and thus, by sending the specimen to the lab for 
further testing ``it could not be said that [Respondent] took no 
action,'' what is notable is that Respondent offered no testimony that 
he ever asked B.B. which drugs had been purportedly stolen and when 
they had been stolen. Obviously, without determining and documenting 
what drugs had been stolen, Respondent could not evaluate whether the 
lab's finding (using GC-MS testing) that B.B. had tested negative for 
morphine was aberrational.\50\
---------------------------------------------------------------------------

    \50\ While Respondent offered testimony to the effect that pain 
patients will maintain ``a stash'' of controlled substances in the 
event their medications are stolen, and asserted that B.B. did this 
as well, he offered no explanation as to how B.B. could have 
accumulated a stash of extended release medications (such as 
Morphine Sulfate ER, the drug which was not detected) while still 
managing pain.
---------------------------------------------------------------------------

    Moreover, even crediting Respondent's testimony regarding the 
notation that B.B. wanted to switch medications because he was having 
troubling finding immediate release Opana, his testimony regarding the 
limitations imposed by the Medicaid formulary, and his explanation for 
why he provided B.B. with Percocet, I still conclude that the 
Government has proved that Respondent violated 21 CFR 1306.04(a) when 
he issued the Opana 20 ER and Percocet 10 prescriptions at this visit. 
As Dr. Owen testified, Respondent still had not done a thorough patient 
history and evaluation of B.B.'s pain complaint; failed to properly 
address multiple instances of aberrant behavior including the three 
previous UDSs and the other red flags he presented (i.e., the claims of 
stolen medications and having run out of them); never consulted with 
B.B.'s mental health providers notwithstanding Respondent's finding 
that B.B. had severe anxiety and depression and that these are relative 
contraindications to prescribing controlled substances; never 
determined which drugs were stolen from B.B. or which drugs he ran out 
of thus rendering the UDS he obtained at this visit useless; never 
resolved inconsistencies in B.B.'s report of pain; and never 
established that the controlled substances provided a therapeutic 
benefit and that there was a

[[Page 14980]]

medical necessity for the prescriptions. Also, while Dr. Owen did not 
specifically cite Respondent's failure to try conservative treatments 
such as physical therapy when he testified regarding these two 
prescriptions, the evidence shows that Respondent never referred B.B. 
for physical therapy.
    Of further note, Respondent could not explain why he made the 
entries of ``fair'' and ``yes'' for whether B.B. was meeting his 
treatment objective, when he acknowledged that B.B.'s treatment 
objective was to return to work but never did so. And while he 
essentially agreed with Dr. Owen's testimony that a patient with 
depression and anxiety has a higher perception of pain and is at 
greater risk of self-escalating his use of controlled substances, he 
nonetheless maintained that while ``[i]n every other field but mental 
health we do'' consult with the patient's other practitioners, 
consulting with mental health practitioners who are ``also prescribing 
controlled substances . . . [t]hat doesn't happen very often.'' Tr. 
410. I thus conclude that Respondent acted outside of the usual course 
of professional practice and lacked a legitimate medical purpose when, 
on this date, he issued the Opana and Percocet prescriptions to B.B. 21 
CFR 1306.04(a).

The April 25 Prescriptions

    On April 25, 2012, Respondent provided B.B. with a prescription for 
30 Roxicodone (oxycodone) 15 mg. GX 5, at 4. B.B.'s file contains no 
documentation that there was an office visit, and notwithstanding that 
this was a change in medication from what Respondent had prescribed at 
the previous visit, there is no notation in the progress notes as to 
why he changed the prescription. See generally GX 3; see also Tr. 174-
75. Moreover, while Respondent testified that he would ``routinely'' 
make an entry in the Treatment Objective Evaluation section of the Pain 
Management Treatment Plan ``if we were making a change in a 
medication,'' Tr. 357, no such entry was made on this date. See GX 3, 
at 28. Nor is there any documentation in the patient file that 
Respondent addressed with B.B. the aberrant drug test result (the non-
detection of morphine) which had been reported to him on April 17. See 
generally GX 3.
    According to Dr. Owen, when adding a new drug to a patient's 
regimen of pain medications, a physician ``would have to establish 
medical necessity with some type of note, using sound medical 
rationale.'' Tr. 175. Dr. Owen further testified that making such a 
notation is ``a standard of care, and it's part of the documentation 
guidelines that are issued across every state for the most part.'' Id. 
Asked if he could think of a reason why a physician ``would add a drug 
for the first time without seeing a patient,'' Dr. Owen answered: ``No. 
Or at least documenting the medical rationale and establishing medical 
necessity.'' Id. at 176. Dr. Owen then testified that Respondent did 
not take appropriate steps to establish medical necessity for the 
prescription, reiterating his earlier testimony that Respondent had not 
demonstrated that conservative care had been tried and been 
unsuccessful, as well as that there was a ``clinically meaningful and 
objective therapeutic benefit from the previous use of controlled 
substances.'' Id. He again opined that the prescription was not issued 
in the usual course of professional practice and lacked a legitimate 
medical purpose. Id.
    Regarding the Roxicodone prescription, Respondent asserted that he 
``was just doing a two-week trial, trying to figure out his dose, and 
at the time, most likely the patient didn't have any punches on his 
card left, and Roxicodone is much cheaper than Percocet, and it's the 
same medication.'' Id. at 355. However, Respondent did not document any 
of this in B.B.'s record. Nor did he explain why he failed to follow 
his routine of making an entry in the Treatment Objective Evaluation 
section of the Pain Management Treatment Plan given that he had changed 
B.B.'s medication.
    As for the April 12 UDS lab report, which he had obtained prior to 
issuing the prescription and which found that morphine was not detected 
and that this result was not expected based on the prescribed 
medications, Respondent testified that in his opinion the result was 
not aberrant. Respondent did not explain whether this was based on his 
previous claim that the oxymorphone is a metabolite of morphine or 
because B.B. had reported that his medications were stolen. Tr. 364-66.
    As Respondent offered no testimony that he asked B.B which of his 
drugs were stolen and was told that it was the morphine, B.B.'s claim 
of stolen drugs does not render the test non-aberrant. Moreover, the 
lab reports noted various instances in which the presence of various 
metabolites was consistent with prescribed medications and that the 
particular substances were metabolites of prescribed drugs but included 
no such notation with respect to oxymorphone and morphine. Finally, 
Respondent's testimony is contradicted by science and he offered no 
evidence which would support a finding that he had a good faith but 
mistaken belief that oxymorphone is a metabolite of morphine. Based on 
these reasons, I find that the April 12 UDS was aberrant and that 
Respondent knew it to be.
    While the CALJ concluded that the Government could not rely on the 
four UDS reports, he nonetheless found that the evidence supported the 
Government's contention that Respondent acted outside of the usual 
course of professional practice in issuing the prescriptions. R.D. at 
64. While the CALJ accepted Respondent's assertion that Percocet and 
Roxicodone are similar drugs in that they both contain oxycodone 
(although he noted that Roxicodone does not contain acetaminophen and 
contains only oxycodone), id. at n.119, he explained that Respondent 
did not merely provide a refill but was changing B.B.'s medications. 
Id. at 63-64. While the CALJ then noted Dr. Owen's opinion that the 
standard of care required the ``establish[ment] of medical necessity 
with some type of note, using sound medical rationale,'' the CALJ then 
explained that ``it is not the documentation of the medical 
determination that carries the day here. Rather, it is whether the 
evidence or record supports the Respondent's proposition that he made 
such a determination; and it does not.'' Id. at 64. And while again 
asserting erroneously that the Oklahoma regulation stating that ``[t]he 
medical record . . . should document the presence of one or more 
recognized medical indications for the use of a controlled substance'' 
is permissive, id. (emphasis added by CALJ), he concluded that 
Respondent acted outside of the usual course of professional practice 
because he neither documented an indication for a medication change nor 
could ``remember it in a way that is persuasive.'' \51\ Id.
---------------------------------------------------------------------------

    \51\ Unexplained by the CALJ is why he did not apply the same 
reasoning to Respondent's testimony that he was ``unsure'' as to 
why, on various occasions, he wrote ``fair'' in the block for noting 
whether B.B. had achieved his treatment objective as well as to why 
he wrote ``yes'' when B.B never returned to work during the course 
of Respondent's prescribing to him.
---------------------------------------------------------------------------

    While I agree with the CALJ that Respondent's testimony was 
unpersuasive, I also give weight to Dr. Owen's testimony that 
Respondent had not established medical necessity for prescribing 
controlled substances by demonstrating that conservative treatments had 
been tried and been unsuccessful and by establishing an ``objective 
therapeutic benefit from the previous use of controlled substances.'' 
Tr. 176. Moreover, Dr. Owen's testimony as to the other reasons why

[[Page 14981]]

the Respondent did not establish a medical necessity for the previous 
prescriptions likewise applies to the Roxicodone prescription issued on 
this date. Finally, once again B.B. provided an aberrant drug test 
which Respondent ignored (and could not properly evaluate). I therefore 
conclude that Respondent acted outside of the usual course of 
professional practice and lacked a legitimate medical purpose when he 
prescribed Roxicodone to B.B. on this date.

The May 9, 2012 Prescriptions

    On May 9, 2012, Respondent wrote B.B. a prescription for 60 Opana 
ER 20 mg. GX 3, at 93; GX 5, at 27. Respondent did not require an 
office visit, and he made no notations in the progress notes regarding 
the prescription. See generally GX 3; see also Tr. 177-78. Regarding 
the prescription, Dr. Owen again testified that Respondent ``needed to 
establish medical necessity for continuation of controlled substances'' 
and ``did not.'' Id. at 178.
    Asked to provide his opinion as to Respondent's prescribing of 
controlled substances from September 2011 through May 9, 2012, Dr. Owen 
opined that Respondent did not adequately review B.B.'s medical 
history. Id. He further opined that the treatment plan ``would have the 
logic behind the treatment'' and would have ``establish[ed] that 
conservative care has not been helpful and that [an] objective and 
clinically meaningful therapeutic benefit from the use of controlled 
substances has been established, if [they] ha[d] previously been 
used.'' Id. Dr. Owen then testified that none of the controlled 
substance prescriptions Respondent issued to B.B. were issued in the 
usual course of professional practice and for a legitimate medical 
purpose. Id. at 178-79.
    Asked why he refilled the prescriptions,\52\ Respondent testified 
that ``I got a phone call that he was wanting his medicines refilled 
and that the [R]oxicodone had worked for him and et cetera, so we were 
converting him back into the one-month prescriptions in the Schedule 
IIs and going back to this three-month office visit.'' Tr. 356. 
Respondent offered no testimony addressing Dr. Owen's criticism that he 
still had not established that there was a medical necessity for 
prescribing controlled substances, which included the Opana. See 
generally id. at 356-57.
---------------------------------------------------------------------------

    \52\ In her questioning of Respondent, Respondent's counsel 
referred to a Roxicodone prescription as having been issued on May 
9, 2012, and in his testimony regarding the prescriptions he wrote 
on that date, Respondent referred to both a Roxicodone prescription 
and an Opana ER 20 mg prescription. Tr. 356. While GX 5 contains a 
legible copy of the May 9, 2012 Opana ER prescription, see GX 5, at 
27, it does not contain a copy of a Roxicodone prescription, and as 
for GX 3, the copy of the purported Roxicodone prescription is 
illegible. GX 3, at 93.
     Moreover, at no point did the Government put in issue whether 
Respondent violated 21 CFR 1306.04(a) when he issued the Roxicodone 
prescription. The Government did not mention this prescription in 
the specific allegation it made in the Show Cause Order regarding 
the events of May 9, 2012, see ALJ Ex. 1, at 6 ] 3(j); it did not 
mention the prescription in its Pre-hearing Statement, see ALJ Ex. 
5, at 21; it did not question Dr. Owen about this prescription, see 
Tr. 177-78; and even after Respondent testified about it, the 
Government did not argue in its post-hearing brief that Respondent 
issued this Roxicodone prescription in violation of 21 CFR 
1306.04(a). Thus, I do not consider the prescription.
---------------------------------------------------------------------------

    The CALJ found that because he ``had PMP data indicating that B.B. 
had previously engaged in a pattern of procuring early refills from 
multiple prescribers,'' Respondent's issuance of the prescription was 
``a breach of [his] obligation as a registrant to guard against the 
diversion of controlled substances.'' R.D. at 67-68. The CALJ thus 
concluded that Respondent acted outside of the course of professional 
practice in issuing the Opana prescription.\53\ Id. at 68.
---------------------------------------------------------------------------

    \53\ In his decision, the CALJ explained that ``[a]lthough the 
Government's pleadings do not specifically refer to the early 
refills in support of this prescribing event, the [Show Cause Order] 
alleges that the prescribing was effected `despite previous 
indications that B.B. was at risk for abuse or diversion of 
controlled substance[s].''' R.D. 67-68 n.124 (quoting ALJ Ex. 1, at 
6). The CALJ also noted that ``[t]he Government Prehearing Statement 
alleges that the prescription for Opana was issued `despite previous 
indications that B.B. was at risk for abuse or diversion of 
controlled substances[s] . . . .''' Id. (quoting ALJ Ex. 5, at 21). 
The CALJ then explained that ``[t]hese broadly-worded phrases supply 
sufficient notice . . . to constitute sufficient notice to use the 
PMP early refill evidence in support of this prescribing event.'' 
Id.
     I am, however, left to wonder why the same reasoning did not 
apply to the multiple instances in which the CALJ asserted that the 
Government did not provide sufficient notice that it intended to 
rely on the various UDSs. Notably, paragraph 3 of the Show Cause 
Order alleged that:
    [f]rom on or about August 25, 2011 through on or about May 9, 
2012, you issued controlled substance[] prescriptions to B.B. in 
violation of Federal and Oklahoma state law. You were aware on each 
of the occasions that you issued controlled substance[] 
prescriptions to B.B. that he presented a high risk of abuse and/or 
diversion of controlled substances, as evidenced by the red flags 
documented in his patient file, such as aberrant urine drug tests. . 
. . You failed to address and, in fact, ignored these red flags, 
continuing to issue B.B. controlled substance prescriptions in the 
face of mounting evidence that he was misusing, abusing, and/or 
diverting the controlled substances you were prescribing.
    ALJ Ex. 1, at 1. See also, e.g., id. at 3 (Sept. 22, 2011 Rxs: 
``You did not address with B.B. the now second aberrant drug screen 
in an approximately three month period'' and ``[y]ou took no other 
steps to monitor B.B's controlled substance use, such as requiring 
him [to] take another drug screen due to the two failed ones''); id. 
at 4 (Nov. 18 and Dec. 15 Rxs: alleging that ``you did not take any 
steps to monitor [B.B.'s] controlled substances use despite his 
history of misusing, abusing, or diverting controlled substances''); 
id. at 5 (Mar. 13, 2012 Rxs: ``you once again issued him controlled 
substance[] prescriptions . . . without taking appropriate steps to 
monitor his controlled substance use despite the persistent red 
flags of abuse and diversion he previously presented'').
---------------------------------------------------------------------------

    While I agree with the CALJ that Respondent violated 21 CFR 
1306.04(a) in issuing the prescription, I do so for reasons other than 
that B.B. had ``engaged in a pattern of early refills.'' As Respondent 
did not see B.B. on this date, I give weight to Dr. Owen's testimony 
that Respondent did not establish medical necessity for the 
prescription (or any of the prescriptions for that matter) for the 
reasons he explained throughout his testimony as well as for the other 
reasons discussed in this Decision.
    * * *
    In his Recommended Decision, the CALJ alleges that the Agency ``has 
been engaged in a deliberate winnowing of the scope of Factor 2, to the 
extent that . . . it now largely mirrors the considerations found in 
Factor 4.'' R.D. 77. He further asserts that the Agency's rejection of 
dicta which has appeared in various recommended decisions to the effect 
that Factor 2 ``manifests Congress's acknowledgement that . . . the 
quantitative volume in which an applicant has engaged in the dispensing 
of controlled substances may be [a] significant factor'' in the public 
interest determination, see JM Pharmacy Group, Inc., 80 FR 28667, 28684 
(2015), is inconsistent with the plain meaning of Factor 2. R.D. 77-81.
    Congress did not, however, define the term ``experience'' in the 
CSA, and as the Administrator has explained at length, the word has 
multiple meanings, none of which ``compels the conclusion that Congress 
acknowledged that the quantitative volume of an applicant's dispensing 
may be a significant consideration under this factor, and certainly 
none [of these definitions] suggests that the Agency is required to 
count up the number of times an applicant or registrant has dispensed 
controlled substances,'' JM Pharmacy Group, 80 FR at 28667 n.1, let 
alone compare the number of lawful dispensings against those shown to 
be unlawful, as some registrants have argued. See, e.g., Syed-Jawed 
Akhtar-Zaidi, 80 FR 42961, 42967 (2015) (arguing that physician was 
denied a ``fair adjudication'' where the Government based its case only 
on undercover visits but had seized 400 patient files from physician's 
office and yet ``failed to present any evidence . . .

[[Page 14982]]

that the treatment of those patients failed to meet the standard of 
care,'' as well as any evidence regarding the treatment of ``over 400 
additional patients''' whose charts were not seized), pet. for rev. 
denied, 841 F.3d 707, 713 (6th Cir. 2016).
    Notably, the CALJ does not cite to any of the sources typically 
invoked by the courts in cases which have held that a statute has a 
plain meaning.\54\ See, e.g.,Williams v. Taylor, 529 U.S. 420, 431-32 
(2000) (giving statutory text its ``ordinary, contemporary, common 
meaning'' based on definitions from Webster's New International 
Dictionary and Black's Law Dictionary); United States v. Labonte, 520 
U.S. 751, 757-58 (1997) (giving statutory text ordinary meaning by 
reference to same dictionaries); Levorsen v. Octapharma Plasma, Inc., 
828 F.3d 1227, 1231 (10th Cir. 2016) (relying on Webster's Third New 
International Dictionary for meaning of statutory terms). And while 
``[t]he plainness or ambiguity of statutory language is [also] 
determined by reference to the . . . specific context in which that 
language is used, and the broader context of the statute as a whole,'' 
Yates v. United States, 135 S.Ct. 1074, 1082 (2015), nothing in the 
context of providing factors for determining the public interest 
supports the notion that the term ``experience'' requires a 
consideration of the quantitative volume of an applicant's dispensing.
---------------------------------------------------------------------------

    \54\ As the Administrator noted in JM Pharmacy, the word 
``experience'' has multiple meanings. Among those most relevant in 
assessing its meaning as used in the context of Factor Two are: (1) 
The ``direct observation of or participation in events as a basis 
for knowledge,'' (2) ``the fact or state of having been affected by 
or gained knowledge through direct observation or participation,'' 
(3) ``practical knowledge, skill, or practice derived from direct 
observation of or participation in events or in a particular 
activity,'' and (4) ``the length of such participation.'' See 
Merriam-Webster's Collegiate Dictionary 409 (10th ed. 1998); see 
also The Random House Dictionary of the English Language 681 (2d ed. 
1987) (defining experience to include ``the process or fact of 
personally observing encountering, or undergoing something,'' ``the 
observing, encountering, or undergoing of things generally as they 
occur in the course of time,'' ``knowledge or practical wisdom 
gained from what one has observed, encountered, or undergone'').
---------------------------------------------------------------------------

    As previously explained, Congress enacted the public interest 
standard to provide DEA with additional authority to address the 
diversion of controlled substances because prior to the 1984 amendment 
of section 823(f), the Agency's authority to deny an application or 
revoke a registration was limited to cases in which a practitioner: (1) 
Had materially falsified an application, (2) had been convicted of a 
State or Federal felony offense related to controlled substances, or 
(3) had his State license or registration suspended, revoked, or 
denied. See S. Rep. No. 98-225, at 266 (1983), as reprinted in 1984 
U.S.C.C.A.N. 3182, 3448. Finding that the ``[i]mproper diversion of 
controlled substances'' was ``one of the most serious aspects of the 
drug abuse problem,'' and yet ``effective Federal action against 
practitioners ha[d] been severely inhibited by the [then] limited 
authority to deny or revoke practitioner registrations,'' id., Congress 
concluded that ``the overly limited bases in current law for denial or 
revocation of a practitioner's registration do not operate in the 
public interest.'' Id.
    The Senate Report thus explained that ``the bill would amend 21 
U.S.C. 824(f) [sic] to expand the authority of the Attorney General to 
deny a practitioner's registration application.'' Id. The Report 
further explained that ``in those cases in which registration is 
clearly contrary to the public interest, the amendment would allow a 
swift and sure response to the danger posed to the public health and 
safety by the registration of the practitioner in question.'' Id. at 
267, as reprinted in 1984 U.S.C.C.A.N. at 3449. Accordingly, section 
823(f) was amended to provide the Agency with authority to deny an 
application based upon a finding that the issuance of a registration 
``would be inconsistent with the public interest,'' upon consideration 
of the five public interest factors, including the experience factor. 
Id. See also 21 U.S.C. 824(a)(4). Nowhere in the Report's discussion of 
the amendments to sections 823 and 824 is there any support for the 
notion that Congress deemed the quantitative volume of a practitioner's 
dispensings to be a significant consideration in making findings under 
the experience factor.\55\
---------------------------------------------------------------------------

    \55\ As the CALJ noted, one of the House Reports explained that 
``[t]he second factor shall not, of course, be construed in anyway 
to hinder registration of recent graduates of professional schools 
who may have no professional experience dispensing or conducting 
research with controlled substances.'' H.R. Rep. No. 98-835, Pt. 1, 
at 14. Obviously, if Factor Two's meaning was so plain, the 
Judiciary Committee had no need to express that it should not be 
construed to deny registrations to newly-licensed practitioners, 
most of whom can point to no volume of dispensings other than by 
observing a physician during clinical rotations. Thus, the 
Committee's direction refutes the notion that the quantitative 
volume of an applicant's dispensings may be a significant 
consideration under the factor.
---------------------------------------------------------------------------

    Indeed, as Krishna-Iyer explained, because the CSA limits 
registration to those practitioners who possess authority under state 
law 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, 459 FR at 
463. Thus, in past cases, this Agency has given no more than nominal 
weight to a practitioner's evidence that he has dispensed controlled 
substances to thousands of patients in circumstances which did not 
involve diversion. See, e.g., Caragine, 63 FR at 51599 (``[T]he 
Government does not dispute that during Respondent's 20 years in 
practice he has seen over 15,000 patients. At issue in this proceeding 
is Respondent's controlled substance prescribing to 18 patients.''); 
id. at 51600 (``[E]ven though the patients at issue are only a small 
portion of Respondent's patient population, his prescribing of 
controlled substances to these individuals raises serious concerns 
regarding [his] ability to responsibly handle controlled substances in 
the future.''); see also Medicine Shoppe--Jonesborough, 73 FR 364, 386 
& n.56 (2008) (noting that pharmacy ``had 17,000 patients,'' but that 
``[n]o amount of legitimate dispensings can render . . . flagrant 
violations [acts which are] `consistent with the public interest.'''), 
pet. for review denied, Medicine Shoppe-Jonesborough v. DEA, slip. op. 
at 11 (6th Cir. Nov. 13, 2008).
    As in past cases, the parties may continue to introduce evidence as 
to the extent of both a practitioner's lawful or unlawful dispensing 
activities. However, under Agency precedent, proof of a single act of 
intentional or knowing diversion remains sufficient to satisfy the 
Government's prima facie burden and to impose on a respondent the 
obligation to produce evidence to show that it can be entrusted with a 
registration. See Krishna-Iyer, 74 FR 459, 463 (2009); see also Alan H. 
Olefsky, 57 FR 928, 928-29 (1992) (revoking registration based on 
physician's presentation of two fraudulent prescriptions to pharmacy 
and noting that the respondent ``refuses to accept responsibility for 
his actions and does not even acknowledge the criminality of his 
behavior'').
    The CALJ further alleges that on remand in Krishna-Iyer, the Agency 
failed to follow the Eleventh Circuit's unpublished decision, in which 
the Administrator was directed to consider 12 additional patient files 
as well as the ``entire corpus'' of the physician's controlled 
substance dispensing for evidence of the physician's ``positive 
experience'' in dispensing controlled substances. R.D. 79. However, the 
Administrator carefully reviewed those files, and noted that the files 
``included

[[Page 14983]]

numerous instances in which [the physician] appear[ed] to have ignored 
warning signs that the patient was either abusing or diverting 
controlled substance''; she also made findings with respect to multiple 
incidents. 74 FR at 460-61 n.3. And as for the ``entire corpus'' of the 
physician's prescribing, notwithstanding the physician had not 
introduced any evidence as to the propriety of her prescribing to the 
``thousands of other patients'' she had treated, the Administrator 
assumed that every one of those prescriptions was lawfully issued. Id. 
at 461. However, as the Administrator explained, even if those 
prescriptions were lawfully issued, they did not negate the 
Government's prima facie showing that the physician had knowingly 
diverted drugs to others. Id. at 462-63. And while the Administrator 
granted the physician a new registration, she made clear that had the 
physician not acknowledged her misconduct, she would have again revoked 
the physician's registration. Id. at 463.
    Not mentioned by the CALJ is that several years later, the exact 
same arguments were raised before the Eleventh Circuit by two different 
physicians and rejected without any discussion. In Lynch v. DEA, a 
physician whose registration was revoked by the Agency for unlawful 
prescribing,\56\ argued that the Agency's Decision arbitrarily 
``limited its consideration of [his] experience to only ten 
prescriptions issued to out of state patients, the two undercover 
patients, and the use of a rubber stamp on nine prescriptions . . . and 
did not consider the evidence that he had been dispensing controlled 
substances for over twenty years,'' and thus ``fail[ed] to consider the 
overwhelming evidence of positive experience.'' See Brief of Petitioner 
31-32, Lynch v. DEA, No. 11-10207-EE (11th Cir. 2011) (citing Krishna-
Iyer, M.D., v. DEA, 249 Fed. Appx. 159, 161 (11th Cir. 2007) 
(unpublished)). Notably, the Eleventh Circuit denied the physician's 
petition for review, holding that the revocation of the physician's 
registration ``was not arbitrary, capricious, an abuse of discretion or 
contrary to law.'' Lynch v. DEA, Slip. Op. at 4 (11th Cir. May 22, 
2012) (per curiam). Indeed, the Court of Appeals did not even deem the 
respondent's argument to warrant discussion. See id. at 2-4.
---------------------------------------------------------------------------

    \56\ See Ronald Lynch, 75 FR 78745 (2010).
---------------------------------------------------------------------------

    So too, in McNichol v. DEA, another physician whose registration 
was revoked for issuing unlawful prescriptions to four undercover 
officers relied on Krishna-Iyer to argue that the Agency's final 
decision was arbitrary and capricious because the investigation 
``failed to take into account any positive conduct on [his] part'' and 
``intentionally ignored any evidence not specifically related to the 
undercover patients.'' Brief of Petitioner 21-23, McNichol v. DEA, No. 
12-15292 (11th Cir. 2013) (citing Krishna-Iyer, 249 Fed. Appx. at 161). 
Of note, the Agency's Decision specifically rejected the ALJ's 
assertion that the Government was required to review the patient charts 
for patients other than the undercover officers and look for evidence 
of the physician's ``positive prescribing practices'' so as to 
``develop evidence to enlighten the administrative record.'' T.J. 
McNichol, 77 FR 57133, 57146 (2012). The Administrator further 
explained that ``[h]aving garnered evidence of what it believed to be 
unlawful prescriptions issued to the four undercover officers, the 
Government was entitled to go to hearing with that evidence.'' Id.
    Again, the Eleventh Circuit denied the physician's petition for 
review, holding that ``the record supports that the administrator 
considered all aspects of the evidence in light of the applicable 
statutory factors and . . . [her] decision was not arbitrary and 
capricious. . . . [w]e also agree with the administrator's conclusion 
that [the physician's] continued registration would be inconsistent 
with the public interest.'' McNichol v. DEA, Slip. Op. at 4 (11th Cir. 
Oct. 17, 2013) (per curiam). Here again, the Court did not deem 
Respondent's argument to warrant discussion.
    The CALJ also dismisses the published decision of the Tenth Circuit 
in MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011), asserting that ``the 
Agency's view of Factor 2 was not a focus of the court's decision.'' 
R.D. 80 (emphasis added). Therein, after the Agency revoked the 
physician's registration based on his unlawful prescribing to two 
patients, the physician argued on review that:

    The DEA must consider the totality of the experiences a 
physician has, including: the interaction reflected in each of the 
medical charts of patients that were seized by the DEA, the 
``thousands of other patients . . . [and] positive experience'' with 
dispensing controlled substances and not merely the testimony of 
people trying to make a case against the physician.
    The DEA, in fact, flat out disregarded the substantial 
experience Dr. MacKay has had with dispensing controlled substances. 
The law requires the DEA to consider evidence that reflects that the 
physician is not a danger to the public and delineates how the DEA 
must do so.

    Brief of Petitioner, 13-14, MacKay v. DEA. Moreover, after 
discussing the affidavits of several patients who testified that Dr. 
MacKay had provided medically appropriate, and in some instances, 
beneficial treatment for their pain, Respondent argued that ``[t]he DEA 
decision is based only on the medical charts of a few patients out of 
thousands Dr. MacKay has successfully treated over the years. In fact . 
. . the DEA's expert only reviewed twelve patient files and testified 
about even fewer.'' Id. at 20.
    Notwithstanding that the Agency's decision was based entirely on 
the evidence with respect to two patients (K.R. and M.R.), see Dewey C. 
MacKay, 75 FR 49956, 49972 (2009); the Tenth Circuit rejected 
Respondent's contention that the Agency had failed to consider his 
``positive experience'' evidence. As the Court of Appeals explained:

    Despite Dr. MacKay's claim to the contrary, the Deputy 
Administrator considered the entire record, including the evidence 
in Dr. MacKay's favor. She determined, however, that none of Dr. 
MacKay's evidence negated the DEA's prima facie showing that Dr. 
MacKay had intentionally diverted drugs to K.D. and M.R. Indeed, she 
found that even if Dr. MacKay had provided proper medical care to 
all of his other patients, that fact would not overcome the 
government's evidence with regard to M.R. and K.D.
    None of the evidence presented by Dr. MacKay undermines the 
evidence relating to M.R. and K.D. Although numerous patients and 
colleagues of Dr. MacKay related their positive experiences with 
him, none had any personal knowledge regarding his treatment of M.R. 
and K.D. Notably, Dr. MacKay's medical expert . . . failed to 
specifically discuss and justify Dr. MacKay's treatment of M.R. and 
K.D. As a result, none of Dr. MacKay's evidence contradicts the 
testimony and evidence presented by the DEA relating to the knowing 
diversion of drugs to these two patients.

664 F.3d at 819.
    The Court of Appeals then rejected MacKay's contention that the 
Deputy Administrator had misweighed the public interest factors. As the 
Court explained: ``[i]n light of Dr. MacKay's misconduct relating to 
factors two and four, the government made a prima facie showing that 
[his] continued registration is inconsistent with the public 
interest.'' Id. (citing 75 FR at 49977). And the Court further 
explained that ``[a]lthough Dr. MacKay may have engaged in the 
legitimate practice of pain medicine for many of his patients, the 
conduct found by the Deputy Administrator with respect to K.D. and M.R. 
is sufficient to support her determination that his continued 
registration is inconsistent with the public interest.'' Id.

[[Page 14984]]

    The CALJ further asserts that ``to the extent that the ever-
widening range of activity that the Agency considers `positive 
experience' is banned, Factor 2 analysis, in the majority of Agency 
cases, will largely consist of a reprise of evidence also considered 
under Factor 4.'' R.D. 81. Continuing, the CALJ contends that ``[t]he 
Government's ability to introduce alleged acts of malfeasance will 
warrant double consideration under Factor 2 and again under Factor 4, 
but respondents will remain unable to demonstrate that a transgression 
constituted an isolated occurrence when compared with even many years 
of compliant practice as a registrant.'' Id.
    The CALJ is mistaken. As JM Pharmacy made clear, ``[a]s in past 
cases, the parties may continue to introduce evidence as to the extent 
of both a practitioner's lawful or unlawful dispensing activities.'' 80 
FR at 28668 n.2. Indeed, in these proceedings, the Agency will assume, 
without requiring the production of any evidence by a respondent, that 
the practitioner has lawfully issued every prescription other than 
those alleged by the Government to be unlawful. And contrary to the 
CALJ's understanding, notwithstanding the Agency's rejection of the 
notion that ``the plain meaning'' of Factor 2 mandates the 
consideration of ``the quantitative volume'' of a respondent's 
dispensing, a respondent may still argue that his conduct was ``an 
isolated occurrence when compared with even many years of compliant 
practice'' or an ``aberration.'' R.D. 81-82.
    Equally misplaced is the CALJ's assertion that the Government's 
evidence of unlawful prescribing will hence be given double 
consideration in the public interest determination. Id. at 82. While 
evidence of a respondent's unlawful prescribing is clearly relevant in 
assessing both his/her experience in dispensing controlled substances 
and compliance with applicable laws related to controlled substances 
and thus typically discussed under both factors--indeed, because of the 
overlap between the factors, the Agency has long discussed both factors 
together--this does not mean that the prescriptions have been double 
weighted. See, e.g., Albert Lepis, 51 FR 17555, 17555-56 (1986).
    As the Agency's decision on remand in Krishna-Iyer explained, 
``[w]hether this conduct is evaluated under factor two . . . or factor 
four, or both [factors], is of no legal consequence. In establishing 
[the Government's] prima facie case, the fundamental question is 
whether [a] [r]espondent `has committed such acts as would render [his] 
registration inconsistent with the public interest.' '' \57\ 74 FR at 
462 (quoting 21 U.S.C. 824(a)(4)). Moreover, as both the Agency and 
federal courts have recognized, findings under a single factor can 
support the denial of an application or the revocation of a 
registration. See MacKay, 664 F.3d at 821 (quoting Krishna-Iyer, 74 FR 
at 462).
---------------------------------------------------------------------------

    \57\ While Krishna-Iyer involved a revocation proceeding, the 
public interest inquiry is essentially the same where the Agency 
proposes the denial of an application.
---------------------------------------------------------------------------

    While the Agency has explained that proof of a single act of 
intentional or knowing diversion remains sufficient to satisfy the 
Government's prima facie burden and to impose on a respondent the 
obligation to produce evidence to show that he can be entrusted with a 
registration, this is not the result of double weighting the 
misconduct. See Krishna-Iyer, 74 FR at 463; see also MacKay, 664 F.3d 
at 819. Rather, it is based on the recognition that a violation of the 
prescription requirement (21 CFR 1306.04(a)) ``strikes at the CSA's 
core purpose of preventing the abuse and diversion of controlled 
substances.'' Samuel Mintlow, 80 FR 3630, 3653 (2015); accord David A. 
Ruben, 78 FR 38363, 38386 (2013). Accordingly, the Agency has held that 
where the Government proves that a practitioner has engaged in knowing 
or intentional diversion, a respondent is not entitled to be registered 
(or maintain an existing registration) absent a credible acceptance of 
responsibility.\58\ As the Tenth Circuit has recognized:
---------------------------------------------------------------------------

    \58\ In Krishna-Iyer, the Agency explained that ``while some 
isolated decisions . . . may suggest that a practitioner who 
committed only a few acts of diversion was entitled to regain his 
registration even without having to accept responsibility for his 
misconduct, see Anant N. Mauskar, 63 FR 13687, 13689 (1998), the 
great weight of the Agency's decisions are to the contrary.'' 74 FR 
at 464. Noting that ``[t]he diversion of controlled substances has 
become an increasingly grave threat to this nation's public health 
and safety,'' the Agency clarified its policy and explained that 
``[t]o the extent Mauskar, or any other decision of this Agency 
suggests otherwise, it [wa]s overruled.'' Id. at 464 n.9. 
Continuing, the Agency explained that because of the grave and 
increasing harm to public health and safety caused by the diversion 
of prescription controlled substances, even where the Agency's proof 
establishes that a practitioner has committed only a few acts of 
knowing or intentional diversion, this Agency will not grant or 
continue the practitioner's registration unless he accepts 
responsibility for his misconduct. Id. at 464.

. . . the DEA may properly consider whether a physician admits fault 
in determining if the physician's registration should be revoked. 
When faced with evidence that a doctor has a history of distributing 
controlled substances unlawfully, it is reasonable for the . . . 
Administrator to consider whether that doctor will change his or her 
behavior in the future. And that consideration is vital to whether 
continued registration is in the public interest. Without Dr. 
MacKay's testimony, the Deputy Administrator had no evidence that 
Dr. MacKay recognized the extent of his misconduct and was prepared 
---------------------------------------------------------------------------
to remedy his prescribing practices.

MacKay, 664 F.3d at 820 (citing Hoxie v. DEA, 419 F.3d 477, 483 
(2005)).
    Thus, contrary to the CALJ's understanding, a respondent can still 
argue (as he/she always could) that his/her misconduct in knowingly or 
intentionally diverting controlled substances was ``an isolated 
occurrence'' or an ``aberration'' in his/her years of otherwise 
compliant professional practice. However, one cannot argue that his/her 
conduct was ``an isolated occurrence'' or ``an aberration'' without 
first acknowledging that he/she has engaged in unlawful conduct.\59\ 
And in any case, Respondent has made no such argument.
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    \59\ The CALJ also asserts that in JM Pharmacy, ``the Agency 
determined in clear terms that it will no longer consider whether 
established misconduct presented an isolated piece of an applicant's 
record, irrespective of whether the misconduct is intentional or 
otherwise.'' R.D. at 82 (emphasis added). To the contrary, in JM 
Pharmacy, the Administrator denied two applications for pharmacy 
registrations, expressly adopting the CALJ's conclusion that the 
owner of the two pharmacies had ``knowingly and materially falsified 
the applications he submitted.'' 80 FR at 28669; see also id. at 
28683 (CALJ's Recommended Decision: ``It is clear that the 
Respondents, through their common owner . . . knew or should have 
known that the answers provided to Question 2 were false, and that 
their . . . applications contained material falsifications. The 
absence of any logical basis for confusion and the past experience 
of [their owner] as a registrant holder and pharmacist 
preponderantly support a finding that the misrepresentations were 
intentional, not negligent. . . . [E]ven standing alone, the denial 
of the Respondent's . . . applications is adequately supported on 
this record based on the material falsifications set forth in the 
filed applications.'') (emphasis added); id. at 28689 (CALJ noting 
that owner's ``insistence that his false response to an application 
query . . . was simply not credible and defeats the Respondents' 
efforts to meet the Government's case. The false 
misrepresentation[s] . . . are sufficiently egregious on their face 
to warrant sanction''). Thus, JM Pharmacy does not support the 
CALJ's assertion that the Agency does not consider a respondent's 
level of culpability in committing misconduct.
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Summary of Factors Two and Four

    While Respondent put on no evidence as to the lawfulness of his 
controlled substance prescribing to patients other than B.B., I have 
assumed that every other prescription he has issued in the course of 
his professional career complied with 21 CFR 1306.04(a).\60\ 
Nonetheless, as found above,

[[Page 14985]]

Respondent issued multiple prescriptions for various schedule II 
narcotics outside the course of professional practice and which lacked 
a legitimate medical purpose. 21 CFR 1306.04(a). Moreover, the evidence 
in no sense shows that Respondent was merely neglectful, but rather 
supports a finding that Respondent acted with knowledge that B.B. was 
abusing and/or diverting the controlled substances he prescribed. And 
while the evidence of record does not support a finding that Respondent 
unlawfully prescribed to any other patient, it is significant that his 
misconduct went on for eight months and involved 19 prescriptions for 
schedule II narcotics alone. Thus, I conclude that Respondent has 
engaged in egregious misconduct which supports the denial of his 
registration. See MacKay, 75 FR at 49997; Krishna-Iyer, 74 FR at 463; 
Olefsky, 57 FR at 928-29.
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    \60\ This assumption may actually be more favorable to 
Respondent than what is warranted with respect to his experience in 
dispensing controlled substances. In 2008, Respondent was sanctioned 
by the Board for ``prescribing controlled dangerous substances'' 
over the course of a three-year period to a patient with whom he had 
sexual relations. RX 3, at 2.
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    I therefore hold that the Government has established its prima 
facie case that Respondent's registration ``would be inconsistent with 
the public interest.'' 21 U.S.C. 823(f).

Sanction

    Where, as here,\61\ the Government has met its prima facie burden 
of showing that issuing a new registration to the applicant would be 
inconsistent with the public interest, a respondent must come forward 
with `````sufficient mitigating evidence''''' to show why he can be 
entrusted with a new 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 MacKay v. DEA, 664 F.3d at 
820; 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).
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    \61\ So too, the egregiousness and extent of a registrant's 
misconduct are significant factors in determining the appropriate 
sanction. See Jacobo Dreszer, 76 FR 19386, 19387-88 (2011) 
(explaining that a respondent can ``argue that even though the 
Government has made out a prima facie case, his conduct was not so 
egregious as to warrant revocation''); Paul H. Volkman, 73 FR 30630, 
30644 (2008); see also Paul Weir Battershell, 76 FR 44359, 44369 
(2011) (imposing six-month suspension, noting that the evidence was 
not limited to security and recordkeeping violations found at first 
inspection and ``manifested a disturbing pattern of indifference on 
the part of [r]espondent to his obligations as a registrant''); 
Gregory D. Owens, 74 FR 36751, 36757 n.22 (2009). As explained 
above, Respondent's misconduct in knowingly issuing multiple 
prescriptions in violation of 21 CFR 1306.04(a) is egregious and 
supports the denial of his registration and not the issuance of a 
registration subject to conditions. Indeed, this is not a close 
call.
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    Finally, the Agency has also held that ```[n]either Jackson, nor 
any other agency decision, holds . . . that the Agency cannot consider 
the deterrent value of a sanction in deciding whether a registration 
should be [suspended or] revoked.''' Joseph Gaudio, 74 FR 10083, 10094 
(2009) (quoting Southwood Pharmaceuticals, Inc., 72 FR 36487, 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'').
    Even with respect to the violations which he found proven, the CALJ 
found that ``one clear and consistent aspect of the record is the 
Respondent's almost dogged determination to accept no responsibility 
for his actions.'' R.D. 92. This holds equally true with respect to 
each of the controlled substance prescriptions he issued in violation 
of 21 CFR 1306.04(a), as other than his meager acknowledgement that his 
documentation on certain progress notes could have been better, 
Respondent has not accepted responsibility for his misconduct with 
respect to any of the controlled substance prescriptions he unlawfully 
issued to B.B. beginning on September 22, 2011 and ending on May 9, 
2012. And as explained above, the evidence supports the conclusion that 
Respondent was not merely neglectful, but that he engaged in knowing 
misconduct when he issued the prescriptions. As the Tenth Circuit has 
recognized, Respondent's failure to acknowledge his misconduct 
establishes that he is not prepared to remedy his unlawful prescribing 
practices. MacKay, 664 F.3d at 820. This alone supports the conclusion 
that he cannot be entrusted with a new registration.\62\
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    \62\ Even if Respondent had credibly accepted responsibility for 
his misconduct, he has offered no evidence of any remedial training 
he has undertaken in controlled substance prescribing. While the CSA 
does not impose a time bar on a practitioner's ability to reapply 
for a registration, the rules of the Agency are clear. Thus, to 
obtain favorable consideration of any new application, Respondent 
must both credibly acknowledge his misconduct in prescribing to B.B. 
and provide evidence of remedial training he has undertaken in the 
proper prescribing of controlled substances.
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    So too, while the Agency's interest in specific deterrence is not 
triggered (because I deny his application), as found above, 
Respondent's misconduct is egregious and the Agency has a manifest 
interest in deterring similar misconduct by other practitioners. This 
interest would be compelling even if it was not the case that the 
nation was confronting an epidemic of opioid abuse. I therefore 
conclude that granting Respondent's application ``would be inconsistent 
with the public interest.'' 21 U.S.C. 823(f). Accordingly, I will deny 
his application.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 
CFR 0.100(b), I order that the application of Wesley Pope, M.D., for a 
DEA Certificate of Registration as a practitioner, be, and it hereby 
is, denied. This Order is effective immediately.

    Dated: March 16, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-05676 Filed 3-22-17; 8:45 am]
 BILLING CODE 4410-09-P