Wesley Pope, M.D.; Decision and Order

Federal RegisterMar 23, 2017

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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 § 435:10-7-4;

id.

§ 435:70-7-11

; 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.

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.”

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

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 § 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 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 § 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 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

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.”)

;

Wollschlaeger

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

GX 1, at 1.

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.

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.

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.

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

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

treatment, noting that

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.

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

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.

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

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.

GX 3, at 24.

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)

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.

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.

Id.

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.

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.

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 § 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.

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.

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.

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.

Id.

at 28.

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

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.”

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.

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.

Id.

Respondent further

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.

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

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

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.

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.

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

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

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.

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

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.

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 → 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

“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.”

Id.

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.”

Id.

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

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 be

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