Wesley Pope, M.D.; Decision and Order
Citation: "82 FR 14944"
Document Number: "Docket No. 15-8"
Page Number: "14944"
"Notices"
On
As support for the proposed denial, the Government alleged that "[f]rom on or about
FOOTNOTE 1 This is an apparent typographical error as there is no such provision. The parties, however, spent considerable time arguing as to whether Respondent complied with Okla. Admin. Code
Respondent requested a hearing on the allegations. The matter was then placed on the docket of the
On
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
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 (
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
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
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
The CALJ, however, cited no authority from either the Board or the
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
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.
FOOTNOTE 2 As the Seventh Circuit also noted, "as listed in Roget's Thesaurus, [the word "should"] means `be obliged, must . . . have to.' The common interpretation of the word `should' is `shall.' " 798 F.2d at 924. END FOOTNOTE
Moreover, reading the Board's documentation and recordkeeping provisions as permissive cannot be squared with the Oklahoma Medical Practice Act. Cf. Wollschlaeger, 814 F.Supp.2d at 1376 (rejecting interpretation that statute which used "should" was hortatory when State law provided that violations of provision constituted grounds for disciplinary action). Under the Medical Practice Act, a physician's "[f]ailure to maintain an office record for each patient which accurately reflects the evaluation, treatment, and medical necessity of treatment of the patient" constitutes "unprofessional conduct." 50 Okla. Stat. Ann.
Thus, construing the Board's documentation and recordkeeping rules as permissive would be fundamentally inconsistent with the Medical Practice Act's provisions on documentation and recordkeeping, which are clearly mandatory. See Abramski v.
Accordingly, the Board's Intractable Pain Rule's documentation and recordkeeping provisions are not reasonably read as being permissive. /3/ Indeed, in the Policy Statement it issued contemporaneously with the promulgation of the Rule, the Board provided further evidence that the documentation and recordkeeping requirements are not permissive. For example, the Board explained that "[a]ll such prescribing [of controlled substances for pain] must be based on clear documentation of unrelieved pain. To be within the usual course of professional practice, a physician-patient relationship must exist and the prescribing should be based on a diagnosis and documentation of unrelieved pain." Policy Statement, at 2 (emphasis added). Were the CALJ's interpretation correct, what the Board required in the first sentence was then rendered permissive by the use of the word "should" in the following sentence. Indeed, if the word "should" rendered the rules permissive, a physician could prescribe controlled substances to his patient without even having formulated a diagnosis. This makes no sense and thus, the better view is that the words "must" and "should" have the same meaning: they impose mandatory obligations.
FOOTNOTE 3 In a series of cases involving the
In its Policy Statement, the Board also stated that it "will judge the validity of the physician's treatment of the patient based on available documentation." Id. And finally, the Board stated that it "will not take disciplinary action against a physician for deviating from this policy when contemporaneous medical records document reasonable cause for deviation." Id. It makes no sense to advise physicians that the validity of their treatment decisions will be based on documentation and recordkeeping requirements if those provisions are not requirements at all, but rather, merely hortatory and aspirational pronouncements.
Accordingly, I do not agree that the Government Expert's testimony as to the deficiencies in Respondent's evaluations of B.B. was based on the Expert's mistaken understanding of the scope of the
The CALJ's Rulings That the Government Failed To Provide Adequate Notice of Its Intent To Rely on Various Urine Drug Screen Results as Probative Evidence of the Illegality of the Prescriptions
Throughout his Recommended Decision, the CALJ repeatedly declined to consider the Government's evidence that Respondent failed to address an aberrant urine drug screen which showed that his patient B.B. was not taking a controlled substance that had been prescribed to him. See, e.g., R.D. at 38-39 n.75. In the CALJ's view, the Government did not provide adequate notice of its intent to rely on Respondent's failure to address an aberrant June 1UDS in either the Show Cause Order or its Pre-hearing Statements with respect to multiple prescriptions. See id. at 38-39 (
FOOTNOTE 4 According to the CALJ, in Farmacia Yani, "the Government's notice was deemed insufficient in that although the alleged misconduct was disclosed and pursued, it did not include the correct regulation subsection in its [Show Cause Order] and prehearing statement." R.D. 66 (citing 80 FR at 29064 n.28). This, however, misstates the case.
At issue in footnote 28 of Farmacia Yani was the Government's allegation that the pharmacy had filled Suboxone prescriptions which were clearly issued for maintenance or detoxification purposes by two physicians but which did not contain the requisite identification number or good faith statement establishing that the physician was authorized to prescribe Suboxone for these purposes. See 80 FR 29063-64. As the legal basis for the allegation, the Government cited 21 CFR 1306.04 and 1306.06. The first regulation includes, inter alia, subsection a, which makes it illegal for a pharmacist to knowingly fill a prescription issued outside of the usual course of professional practice and which lacks a legitimate medical purpose, and subsection c, which provides, in part, that a prescription may not be issued for maintenance or detoxification treatment unless "the practitioner is in compliance with the requirements" applicable to practitioners who prescribe Suboxone for maintenance or detoxification treatment. See 21 CFR 1306.04(a) & (c); id.
While the Decision noted that the Government had not identified the specific subsection of 1306.04 which it alleged was violated, it did not hold that the "notice was deemed insufficient." R.D. 66. Indeed, while the Decision rejected the Government's contention that the pharmacist acted outside of the usual course of professional practice in violation of 1306.04(a) and 1306.06 for lack of evidence, 80 FR at 29064, and further noted that 1306.04(c) "impose[s] duties only on the issuer of [a] prescription which has been issued to provide maintenance or detoxification purposes," id. at n.28, the Decision nonetheless found that the pharmacy had violated another provision of the Agency's regulations. Specifically, the Decision found a violation based on 21 CFR 1306.05(f), which imposes "[a] corresponding liability . . . upon the pharmacist . . . who fills a prescription not prepared in the form prescribed by DEA regulations, " 21 CFR 1306.05(f), and 21 CFR 1306.05(b), which requires that such a prescription include either the prescriber's X number or good faith statement. See 80 FR at 29064 & n.28 (citation omitted).
Indeed, notwithstanding that the Government cited the wrong provision of the regulations, the respondent's principal did not dispute that her conduct in filling these prescriptions was a violation. See Respondent's Proposed Findings of Fact and Conclusions of Law, at 11 (Proposed Conclusion of Law #11: "The second violation[] relates to buprenorphine prescriptions from two physicians who were not authorized to prescribe such prescriptions because they were not Data-waived practitioners. Physicians are issued a specific registration that is distinguished with an X number, and this number[] should be on the prescription. Farmacia Yani dispensed 29 prescriptions in total from these two doctors that did not have an X number.") (citations omitted). Thus, this case does not support the CALJ's assertion that "recent Agency precedent has imposed significantly tighter notice requirements on the Government." R.D. at 66.
The CALJ further asserted that "[i]n Marjenhoff, . . . the Agency refused to allow the Government to rely on noticed conduct alleged as a violation of the public interest factors because it failed to specify that the conduct would be specifically considered under factor 5." R.D. 66 (citing 80 FR at 29068). Here again, this is a misstatement of the case.
Apparently, the CALJ's assertion refers to the Agency's declination to find that the respondent's conduct in intercepting a pharmacist's phone calls (who questioned the validity of a prescription the respondent had created for herself by forging the signature of the purported prescriber) constituted actionable misconduct under factor five. 21 U.S.C. 823(f)(5). This factor provides for liability based on "such other conduct which may threaten public health and safety." Id.
Significantly, the Show Cause Order made no such allegation, and while the Government disclosed in its pre-hearing statement that it intended to elicit testimony from the pharmacist regarding his attempt to verify the prescription after it was rejected for payment by respondent's insurer, at no point in the proceedings did the Government rely on the evidence other than as proof that the "[r]espondent illegally obtained hydrocodone on eleven occasions." See Govt.'s Proposed Findings of Fact and Conclusion of Law, at 14 (discussing the pharmacist's testimony as evidence that respondent "forged and filled hydrocodone prescriptions to herself using [a PA's] DEA number. These actions constitute violations of 21 U.S.C. 843(a)(3) [and] 21 CFR 1306.04. . . ."). Moreover, in its discussion of Factor Five, the Government's arguments were confined to arguing that the "[r]espondent has failed to accept responsibility for her actions," that she had not "present[ed] any mitigating evidence," and that she "has demonstrated a pattern of actions that are against the public interest by inappropriately prescribing controlled substances . . . in 2005 and forging and filling prescriptions in 2011." Id. at 15-16.
Thus, contrary to the CALJ's statement, the Government never relied on this conduct as a separate "violation of the public interest factors." R.D. at 66. Nor could it have, as the public interest factors do not impose substantive rules of conduct but are simply "components of the public interest" that "shall be considered" in determining whether to grant an application for a registration.
The CALJ also held that the Government could not rely on this evidence under the doctrine of litigation by consent--even though Respondent never objected to the Expert's testimony that the
FOOTNOTE 5 In Campbell, the ALJ noted that " `the evidence indicate[d] that [the] [r]espondent did not follow adequate security procedures,' " but then "declined to consider the evidence on the ground that the Government did not provide adequate notice in either the Show Cause Order or its Prehearing Statements, notwithstanding that [the] [r]espondent did not object to the testimony." 80 FR at 41062 n.2 (other citation omitted). While the former Administrator observed that "the record arguably support[s] a finding that the issue was litigated by consent," she did not consider the evidence because "the Government did not take exception to the ALJ's ruling." Id.
Here, by contrast, the Government has taken exception to the CALJ's rulings that the issue has not been litigated by consent. See Gov. Exceptions, at 24-25. As for the CALJ's assertion that the issue was "not timely" raised by the Government, given that: (1) Respondent never objected to the testimony nor argued in its post-hearing brief that it did not have fair notice that the
"The primary function of notice is to afford [a] respondent an opportunity to prepare a defense by investigating the basis of the complaint and fashioning an explanation that refutes the charge of unlawful behavior."
Accordingly, even where the Government fails to disclose an allegation in the Order to Show Cause, "an issue can be litigated if the Government otherwise timely notifies a [r]espondent of its intent to litigate the issue." CBS Wholesale, 74 FR at 36570. Moreover, while the Agency has held that "the parameters of the hearing are determined by the prehearing statements," consistent with numerous court decisions, it has also recognized that even where an allegation was not raised in either the Show Cause Order or the pre-hearing statements, the parties may nonetheless litigate an issue by consent. Pergament United Sales, 920 F.2d at 135-37; see also Duane v.
FOOTNOTE 6 See also Grider Drug #1 & Grider Drug #2, 77 FR 44070, 44077 n.23 (2012) (holding that while the Government did not provide adequate notice of its intent to litigate an allegation in either the Show Cause Order or its pre-hearing statements, where respondents "did not object that the allegation was beyond the scope of the proceeding and that they were denied adequate notice of it" and "fully litigated the issue," the allegation was litigated by consent) (citing
To be sure, "[a]n agency may not base its decision upon an issue the parties tried inadvertently. Implied consent is not established merely because one party introduced evidence relevant to an unpleaded issue and the opposing party failed to object to its introduction. It must appear that the parties understood the evidence to be aimed at the unpleaded issue."
Having reviewed the record, I find the Government's exception well taken and hold that the Government provided Respondent with adequate notice that both the aberrant nature of the
The Show Cause Order repeatedly provided notice that the aberrant nature of B.B.'s
In the allegations regarding the
In setting forth the allegations with respect to the
Likewise, in its Pre-hearing Statement, the Government provided notice that "
Moreover, with respect to the
Thus, the Show Cause Order's allegations and the Pre-Hearing Statement's disclosure of the expected testimony provided Respondent with more than adequate notice that the results of the
Notably, during its direct examination of
Q. Would the aberrant urine drug test from
A. Yes.
Q. Would the aberrant drug test from
A. Yes.
Q. And were those aberrant drug tests part of this medical file as you received it?
A. Yes, it [sic] was.
Q. What--how does [Respondent] address the aberrant drug tests in this 9/22 patient file note[]?
A. It's [sic] completely ignored.
Q. What steps should [Respondent] have taken regarding the aberrant drug screens?
A. He should have acknowledged their existence and then taken some corrective action.
* . . .
Q. Does it appear that [Respondent] took any safeguard regarding the potential for diversion or abuse with the aberrant drug screens?
A. No.
Tr. 132-33.
Notably, Respondent did not object to any of this testimony. See id. Moreover, the Government asked similar questions of
FOOTNOTE 7 See also Tr. 143 (
Indeed, Respondent's counsel raised the issue when, in Respondent's case-in-chief, she asked him: `Do you recall if you looked back at the previous drug tests?" Id. at 283. Respondent answered: "I don't recall, but I doubt I did" and "I wouldn't expect myself to." Id. Respondent's counsel then asked him if
Subsequently, on its cross-examination of Respondent with respect to what he looked at in the chart when he took over B.B.'s care, the Government asked: "Did you see the
Thus, Respondent was clearly aware that his failure to address the
FOOTNOTE 8 The Government's remaining exceptions are discussed throughout this decision. END FOOTNOTE
Based on the preponderance of the evidence, I make the following findings.
Findings of Fact
Respondent is a family practice physician licensed by the
Respondent testified that upon completing his residency, he practiced family medicine and obstetrics for several years at several rural clinics. Id. at 234-35. He further explained that while working at one of the clinics, he was asked to become the medical director of a nursing home for terminal AIDS patients, which he did for approximately five years, after which he and Dr.
FOOTNOTE 9 Respondent also testified that for approximately three years (which are not specified in the record) and during which he was still practicing at his clinic, he was also the medical director of Unicare of
Respondent testified that due to the expense of malpractice insurance for his OB/GYN activities, he stopped delivering babies and focused on family medicine. Id. at 249. Respondent testified that he started seeing chronic pain patients around this time, but that
Respondent testified that he did drug screens "every three months" and that any patient who received more than two Lortabs (hydrocodone with acetaminophen) a day would be subject to "the guidelines of our pain management contract and rules." Id. at 256. Respondent further asserted that "[s]ometimes we [would] send [patients] for a second opinion" or for a "modality that we didn't do" such as "an epidural or [a] further evaluation if something changed in their pain something changed neurologically." Id. He testified that he would obtain a Prescription Monitoring Program report for "[e]very phone call for every prescription and every office visit." Id. at 263. He also testified that the practice did not replace lost or stolen medications and that he had terminated a substantial number of patients over the years. Id. at 279-80.
The Investigation
Respondent came to the attention of the authorities on or about
In the meantime, the Chief Investigator, who was familiar with Respondent's background because the latter "was on probation at that time for an incident that involved sexual misconduct," obtained a report from the
After reviewing the PMP report, the Chief Investigator notified the Board's Executive Director of his findings, id. at 21, who, on
On
FOOTNOTE 10 As discussed more fully below, Respondent issued B.B. prescriptions for Opana 10 mg. on multiple occasions, including on
On that day, the Chief Investigator (accompanied by another Board Investigator), the DI and the lead Detective went to Respondent's clinic to interview him. Id. 25. During the interview, the Board's Chief Investigator confronted Respondent "with some of the sexually graphic text messages sent from his phone to the patient." RX 3, at 3. While Respondent "admitted that he may have made social comments to [B.B.]," he "would not answer any more questions without contacting his attorney." /11/ Id. "At that point," the Chief Investigator asked Respondent "to allow him to examine" his phone "for text messages to" B.B. Id. Respondent stated that "his phone was not available because it had been run over with his tractor over the weekend." Id. The Chief Investigator then served the Board's suspension order on Respondent. RX 3, at 3. The DI then informed Respondent that because he did not have state authority, he could not maintain his DEA registration and asked Respondent to voluntarily surrender his registration; Respondent agreed to do so. Tr. 49; see also GX 1, at 1.
FOOTNOTE 11 Subsequently, Respondent denied that he had exchanged these messages and attributed this conduct to his partner at the time, stating that he had allowed his partner to have "access to his cell phone." RX 3, at 3; see also Tr. 415. END FOOTNOTE
On
FOOTNOTE 12 On
Thereafter, a Diversion Investigator obtained a copy of B.B.'s patient file from the Board and provided it to
The Government's Expert's Testimony as to the Standards of Medical Practice Applicable to the Prescribing of Controlled Substances To
Dr. Owen obtained a Bachelor of Science in chemistry and biology from
Dr. Owen's work experience includes more than 16 years at the
While
The Government then asked
Subsequently,
Subsequently,
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,
As to why a physician treating a patient for pain would seek consultation with other specialists,
Asked by the Government if "these requirements . . . are . . . best practices,"
Well, I'm not a lawyer. I would say that the policies and guidelines that I was sent for
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.
The CALJ then asked
The CALJ then asked
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.
FOOTNOTE 13 Dr. Owen explained that "evidence-based studies are studies published in peer review articles that actually show positive outcomes for the treatment, and ideally these treatments are compared to some kind of either non[-] treatment or a sham treatment." Tr. 108. END FOOTNOTE
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,"
FOOTNOTE 14 Dr. Owen testified that low-risk, evidence-based treatments include physical therapy, occupational therapy and cognitive behavioral therapy. END FOOTNOTE
Next, the CALJ asked
The CALJ then asked
Next, the CALJ asked
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 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.
While
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,
Asked how a practitioner should respond to an aberrant drug test,
Returning to the issue of what constitutes an adequate medical history,
* . . 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
Id. at 115-16.
Continuing,
* . . 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,
On cross-examination,
On further cross-examination,
The Prescribing Events
The
B.B.'s patient file reflects that from the date of his first visit on or about
FOOTNOTE 15 At the time carisoprodol was not controlled under the CSA. However, a proceeding to control the drug was then ongoing and the drug became federally controlled effective on
B.B. was not seen by either
FOOTNOTE 16 On
FOOTNOTE 17 While the lab results also noted that B.B. had tested positive for alpha-hydroxyalprazolam, a metabolite of alprazolam, and reported this result as "not expected based on prescribed medications," B.B. had obtained a prescription for a 30-day supply of alprazolam on
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 "
As the Government put forward no evidence to support the conclusion that it was outside of the usual course of professional practice for Respondent to cover for his partner, nor cites to any state rule prohibiting prescribing under this circumstance, I find that the allegation is unsupported by substantial evidence. /18/
FOOTNOTE 18 In its Exceptions, the Government argues that the CALJ erred in finding the allegation with respect to the
As noted above, the Government elicited no testimony from
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
The
On some date after
FOOTNOTE 19 According to a PMP report in B.B.'s patient file, he had filled a prescription for a 30-day supply of alprazolam on
B.B.'s file also contains a Pain Management Treatment Plan, which includes a section bearing the caption: "Treatment Objective Evaluation." GX 3, at 28. This form lists several questions, with boxes for documenting by date, various findings which included: "Has patient achieved treatment objective?"; "Patient completed . . . updated pain scale"; "Re-review benefits and risks of using medications"; "Consider referral to another physician for second opinion or further treatment options"; "Changes to Treatment Plan"; and the "[p]hysician's initials." Id. For this visit, Respondent wrote "yes" as to whether B.B. had achieved the treatment objective (which was documented as "to be able to work without pain," id. at 29), wrote the number "3-5" in the pain scale block, and noted "yes" with respect to both whether he had re-reviewed the risks and benefits of controlled substances and considered a referral to another physician. /20/ Id. at 28.
FOOTNOTE 20 In contrast to this document which contains a single box in which Respondent and
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. END FOOTNOTE
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
With respect to the
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 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,
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.
On cross-examination,
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 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.
Regarding B.B.'s
FOOTNOTE 21 However, in discussing the
Asked with respect to the
Respondent was then asked by his counsel if he looked back at the
Respondent further testified that although he took over the care of B.B., he did not simply continue the same treatment that
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
FOOTNOTE 22 It is unclear, however, whether B.B. was on
As for why he ordered the MRI, Respondent testified that it was the "[s]tandard of care in
FOOTNOTE 23 A progress note for B.B.'s
The
On
FOOTNOTE 24 Respondent found, however, that B.B. was "[a]lert and oriented and in no apparent distress." GX 3, at 47. END FOOTNOTE
At the visit, Respondent prescribed 30 tablets of Morphine Sulfate ER15 mg B.I.D. (one tablet twice per day), for a 15-day supply. GX 5, at 25. Respondent also recommended that B.B. "[w]ear a corset if at all possible" for his hernia. GX 3, at 47.
Regarding the prescription,
Asked what steps Respondent should have taken,
Here again,
This is a superficial evaluation that does not properly address the chief complaint of low back pain or establish medical necessity for treating with controlled substances. There's no assessment of pain, physical or psychosocial function, and therefore, there's no medical necessity to continue treatment with controlled substances, and if you don't have medical necessity, you don't have a legitimate purpose to treat.
Id. And again,
Regarding this visit, Respondent testified that B.B. had "report[ed] that his objectives were only fair" and that "[h]is pain level had gone up to a 6 out of 10 on the Duragesic." Id. at 295. Respondent further testified that "[w]e again went over what the rules were and what the
As for the statement in the progress note that B.B. "would like to try the Morphine," GX 3, at 47, Respondent testified that B.B. "did not believe the Duragesic was sufficient and that he wanted to try one of the other medicines that was on the formulary." Tr. 296. Respondent testified that he did not believe this to be a "red flag" in B.B.'s case because he "had made it very clear to [B.B.] what our choices were" under the
The CALJ, observing that "saying the patient requested morphine . . . is kind of a remarkable note," asked Respondent how his conversation with B.B. went. Id. at 298. Respondent answered: "Probably that I didn't like the Duragesic and you suggested that morphine was an option. Can we try the morphine this time. Probably something like that." Id. at 299. Respondent added that B.B. "was not pleased . . . that we changed the Lortab and the Opana, so the fact that I made him do the Duragesic, he was not happy." Id. at 300. Respondent further noted that he "did his exam" and "[i]t was still consistent that he did have left abdominal wall weakness." Id. Respondent explained that "[h]is diagnosis was lumbar disc disease, anxiety, and a questionable upper respiratory infection" and that he "placed [B.B.] on antibiotics." Id. As for his abdominal wall pain, Respondent discussed with B.B. "wearing a corset if at all possible" because he did not "want to confuse his . . . abdominal pain[] with his level of pain because of my change in his pain regimen." Id. Respondent further explained that B.B. "would follow up . . . in two weeks" and was given only "a two week supply of his new Schedule II medicine." Id. According to Respondent, "anytime [he] made a large change in [a patient's] medications, [he] would only give a two-week" supply in the event the patient was "allergic to it," was "going to abuse it," or "got no pain relief whatsoever." Id. at 302.
Respondent also testified that he had given B.B. a shot of Decadron, a steroid, which "sometimes" provides patients in "severe pain" with "significant relief" and is "a great indicator that [the patient's] pain was more inflammatory than other nature." Id. at 301.
The
B.B. again saw Respondent on
FOOTNOTE 25 Yet Respondent also noted that B.B. was "[a]lert and oriented and in no apparent distress." GX 3, at 46. END FOOTNOTE
As for the physical exam, Respondent noted that B.B. had "[l]ow back paraspinal and spinal tenderness" and a "[n]egative straight leg raise, but [that] lying down and sitting up cause him a lot of pain." Id. He also noted "[n]euro intact." Id. Respondent again diagnosed B.B. with "[l]umbar disc disease" and added a further diagnosis of "[a]cute grief." Id. Respondent documented that he discussed the "[a]ddictive, dependence, and tolerance nature of the medicines as well as alternatives," that he suggested "[n]on-medicinal pain-relieving modalities," and that the follow-up would be either "p.r.n." (as needed) or "three months per his pain contract." Id. Respondent also issued B.B. new prescriptions for 120 Opana 10 (one tablet every 6 hours P.R.N. for breakthrough pain) and 90 Morphine Sulfate ER 15, increasing the dosing of the latter drug to one tablet in the morning and two tablets in the evening. Id.; see also GX 5, at 19, 22.
With respect to the statement in the progress note that B.B. was having a lot of stress and grief,
Dr. Owen also testified that Respondent's notation that "[n]onmedicinal pain-relieving modalities suggested" lacked sufficient detail before rhetorically asking: "What does that mean, nonmedicinal modalities suggested?" Id. at 209-10. Continuing,
First, you don't suggest treatment. Your job as a physician is to advise the patient of what good medicine is, and good medicine would be if you haven't done nonmedicinal pain-relieving modalities, we need a back-up, wean you off these controlled substances and try these other treatments first.
Id. at 210. Then asked what the purpose is "of providing that level of detail in a patient file,"
Well, the purpose of documentation is for continuity of care. Not only continuity of care for this same provider from visit to visit but continuity of care should somebody else assume the care later on down the road or should you need to get a consultation, that the consultant can read your notes and understand what was happening with this patient at this point in time.
Id.
Regarding this visit, the CALJ asked
Dr. Owen again testified that the medical record did not support the prescribing of controlled substances. Id. at 140. He testified that: "[a]s previously discussed, there's an inadequate evaluation going on. There's a lack of medical necessity to continue treatment with controlled substances since there's no therapeutic benefit. And if you don't have medical necessity, you can't have a legitimate medical purpose for using controlled substances." Id.
Respondent testified that the "most remarkable" thing in the
FOOTNOTE 26 However, while the visit includes the handwritten notation "Question about MRI," GX 3, at 46, B.B. did not undergo the MRI until the next day. See id. at 19. END FOOTNOTE
Continuing, Respondent testified that he diagnosed B.B. with acute grief and lumbar disc disease and that he increased his Morphine to two pills or 30 milligrams in the evening while keeping his Opana for breakthrough pain. Id. He also testified that he warned B.B. about "the addictive, dependence and tolerance natures" of the medications and "suggested that he continue using his non-pain [sic] relieving modalities." Id. Respondent did not, however, offer any further explanation as to what those modalities involved. Respondent then testified that he determined the follow-up would be in "three months" as he "felt like [B.B.] could really go into the three-month" schedule for being seen by him. Id. at 305-06. However, at this visit, Respondent did not document whether B.B. was achieving his treatment objective or that he had obtained a numeric rating from B.B. as to his pain. See GX 3, at 28.
On
FOOTNOTE 27 Other findings included that L1-L2, L2-L3, and L3-L4 were all normal, as well as that the alignment of his vertebrae was normal. GX 3, at 19. At L4-L5, the MRI found a "[s]mall left paracentral disc protrusion with no significant spinal canal with mild left neural foraminal and no significant right neural foraminal stenosis." Id. At L5-S1, the MRI found a "[s]mall left paracentral disc protrusion measuring 8 mm in [the] AP dimension results in moderate subarticular recess narrowing, with contact of the descending S1 nerve root. There is mild left neural foraminal stenosis with no significant right neural foraminal stenosis." Id. END FOOTNOTE
Regarding the MRI,
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Likewise, on
Dr. Owen testified that "[e]specially in the context of the previous aberrant urine drug testing and the lack of any clear medical necessity or therapeutic benefit," Respondent "should have" seen B.B. in his office prior to prescribing the drugs on both dates. Tr. 142.
After explaining that the aberrant drugs tests and mention of B.B.'s life stressors supported the need for psychological counselling and consultations with a psychologist or addictionologist,
On cross-examination,
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
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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
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,
Regarding this visit,
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
FOOTNOTE 28 Indeed, the writing bears a strong semblance to the number 3 as written by Respondent in listing his registration number (BP2423440) on various prescriptions. Compare GX 3, at 28, with GX 5, at 23; see also GX 1, at 1. END FOOTNOTE
According to the progress note for the
The CALJ also asked Respondent whether he thought the
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
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.
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On
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,
FOOTNOTE 29 Dr. Owen was not asked to provide details as to what specific areas would be discussed in such a conversation. END FOOTNOTE
Moreover,
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
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
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
However, as found above, B.B. had last obtained a morphine prescription on
The
On
FOOTNOTE 30 As found above, on the
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,
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.
In his direct testimony, Respondent did not address his reasons for issuing the
The
On
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,
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
Dr. Owen testified that Respondent did not address the aberrant preliminary drug screen conducted on
The Government also asked
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 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 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,"
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 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
FOOTNOTE 31 The Government attempted to make the same point with respect to the alprazolam prescriptions issued by R.H. on
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,
Continuing,
Regarding the
Respondent also testified that "[h]is pain had gone from a 7 in January to a 6." Id. at 339. Later, he testified that "[m]y subjective said his pain was worse, but it was a 6, and my last note said it was a 7." Id. at 353. Respondent then asserted that B.B.'s pain rating "was still above the 4 to 5 [that] the Joint Commission says . . . needs to be addressed." /32/ Id.
FOOTNOTE 32 Respondent also testified as to the contents of the visit note, largely reading into the record what the notes contained. However, he noted, inter alia, that B.B. had "reported subjectively . . . that his pain had been a little worse," as well as that his straight leg raise was now negative and not "questionable" as he noted at the previous visit. Id. at 340. END FOOTNOTE
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
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
The
On
According to
Regarding the Roxicodone prescription, Respondent asserted that he "was just doing a two-week trial, trying to figure out his dose, and at the time, most likely the patient didn't have any punches on his card left, and Roxicodone is much cheaper than Percocet, and it's the same medication." Id. at 355. However, Respondent documented none of this in B.B.'s record. Nor did he explain why he failed to follow his routine of making an entry in the Treatment Objective Evaluation section of the Pain Management Treatment Plan given that he had changed B.B.'s medication.
As for why he did not take any action with regard to the lab's finding that the
Pursuant to 5 U.S.C. 556(e), I take official notice that morphine does not metabolize into oxymorphone. See
FOOTNOTE 33 Under the Administrative Procedure Act (APA), an agency "may take official notice of facts at any stage in a proceeding--even in the final decision." U.S.
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Asked why he refilled the prescriptions, /34/ Respondent testified that "I got a phone call that he was wanting his medicines refilled and that the [R]oxicodone had worked for him and et cetera, so we were converting him back into the one-month prescriptions in the Schedules IIs and going back to this three-month office visit." Tr. 356. Respondent offered no testimony addressing
FOOTNOTE 34 In her questioning of Respondent, his counsel referred to a Roxicodone prescription as having been issued on
Asked to provide his opinion as to Respondent's prescribing of controlled substances from
Respondent's Evidence in Remediation
Respondent offered only vague testimony that he has taken "extreme CME [continuing medical education] . . . in hospice care and pain medicine" in 1995 and had done some "reading" on pain management. Tr. 235, 381. Respondent offered no further detail as to the subject matter of the CME course[s] he took. See id. As for his assertions that he had read articles on pain management and that he kept current with those articles, he admitted that he had not "read anything in a couple of years" and could not recall any articles he had read on pain management. Id. at 385-86.
Discussion
Section 303(f) of the Controlled Substances Act (CSA) provides that "[t]he Attorney General may deny an application for [a practitioner's] registration . . . if the Attorney General determines that the issuance of such registration . . . would be inconsistent with the public interest." 21 U.S.C. 823(f). With respect to a practitioner, the Act requires the consideration of the following factors in making the public interest determination:
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing . . . controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
Id.
"[T]hese factors are . . . considered in the disjunctive."
FOOTNOTE 35 In short, this is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest; what matters is the seriousness of the registrant's misconduct.
The Government has the burden of proving, by a preponderance of the evidence, that the requirements for denial of an application pursuant to 21 U.S.C. 823(f) are met. 21 CFR 1301.44(d). However, once the Government has made a prima facie showing that issuing a new registration to the applicant would be inconsistent with the public interest, an applicant must then present sufficient mitigating evidence to show why he can be entrusted with a new registration. Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008) (citing cases)); see also MacKay, 664 F.3d at 817.
Having considered all of the factors, I find that the Government's evidence with respect to Factors Two and Four satisfies its prima facie burden of showing that granting Respondent's application would be inconsistent with the public interest. /36/ I further find that Respondent has failed to produce sufficient evidence to rebut the Government's prima facie case.
FOOTNOTE 36 As to factor one, while the
To be sure, the Agency's case law contains some older decisions which can be read as giving more than nominal weight in the public interest determination to a
Of note, these cases cannot be squared with the Agency's longstanding holding that "[t]he Controlled Substances Act requires that the Administrator . . . make an independent determination [from that made by state officials] as to whether the granting of controlled substance privileges would be in the public interest." Levin, 57 FR at 8681. Indeed, neither of these cases even acknowledged the existence of Levin, let alone attempted to reconcile the weight it gave the state board's action with Levin. While in other cases, the Agency has given some weight to a Board's action in allowing a practitioner to retain his state authority even in the absence of an express recommendation, see
As to factor three, I acknowledge that there is no evidence that Respondent has been convicted of an offense under either federal or
While I have considered factor five, I deem it unnecessary to make any findings. END FOOTNOTE
Factors Two and Four--Respondent's Experience in Dispensing Controlled Substances and Record of Compliance With Applicable Controlled Substance Laws
Under a longstanding DEA regulation, a prescription for a controlled substance is not "effective" unless it is "issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice." 21 CFR 1306.04(a). Under the CSA, it is fundamental that a practitioner must establish a bonafide doctor-patient relationship in order to act "in the usual course of . . . professional practice" and to issue a prescription for a "legitimate medical purpose." See United States v. Moore,
As the
Both this Agency and the federal courts have held that "establishing a violation of the prescription requirement `requires proof that the practitioner's conduct went "beyond the bounds of any legitimate medical practice, including that which would constitute civil negligence." ' "
However, as the Agency has held in multiple cases, "the Agency's authority to deny an application [and] to revoke an existing registration . . . is not limited to those instances in which a practitioner intentionally diverts a controlled substance."
"Accordingly, under the public interest standard, DEA has authority to consider those prescribing practices of a physician, which, while not rising to the level of intentional or knowing misconduct, nonetheless create a substantial risk of diversion." MacKay, 75 FR at 49974; see also
In
will refer to current clinical practice guidelines and expert review in approaching cases involving management of pain. The medical management of pain should consider current clinical knowledge and scientific research and the use of pharmacological and non-pharmacological modalities according to the judgment of the physician. Pain should be assessed and treated promptly and the quantity and frequency of doses should be adjusted according to the intensity, duration of the pain and treatment outcomes.
* . . .
* . . The Board will consider prescribing, ordering, dispensing or administering controlled substances for pain to be for a legitimate medical purpose if based on sound clinical judgment. All such prescribing must be based on clear documentation of unrelieved pain. To be within the usual course of professional practice, a physician-patient relationship must exist and the prescribing should be based on a diagnosis and documentation of unrelieved pain. Compliance with applicable state and/or federal law is required.
The Board will judge the validity of the physician's treatment of the patient based on available documentation, rather than solely on the quantity and duration of medication administration. The goal is to control the patient's pain while effectively addressing other aspect of the patient's functioning, including physical, psychological, social and work-related factors. /37/
FOOTNOTE 37 See also Policy Statement, at 2 ("Allegations of inappropriate pain management will be evaluated on an individual basis. The Board will not take disciplinary action against a physician for deviating from this policy when contemporaneous medical records document reasonable cause for deviation. The physician's conduct will be evaluated to a great extent by the outcome of pain treatment, recognizing that some types of pain cannot be completely relieved, and by taking into account whether the drug used is appropriate for the diagnosis, as well as improvement in patient functioning and/or quality of life."). END FOOTNOTE
Id. at 1-2.
Simultaneously with the issuance of its Policy Statement, the Board promulgated its regulation on the "[u]se of controlled substances for the management of chronic pain." Okla. Admin. Code
With respect to the evaluation of the patient, the Rule states:
A medical history and physical examination must be obtained, evaluated and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.
Id.
The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.
Id.
After providing the criteria for informed consent and agreement for treatment, which states, inter alia, that "[t]he physician should discuss the risks and benefits of the use of controlled substances with the patient," id.
The physician should periodically review the course of pain treatment and any new information about the etiology of the pain or the patient's state of health. Continuation or modification of controlled substances for pain management therapy depends on the physician's evaluation of progress toward treatment objectives. Satisfactory response to treatment may be indicated by the patient's decreased pain, increased level of function or improved quality of life. Objective evidence of improved or diminished function should be monitored and information from family members or other caregivers should be considered in determining the patient's response to treatment. If the patient's progress is unsatisfactory, the physician should assess the appropriateness of continued uses of the current treatment plan and consider the use of other therapeutic modalities.
Id.
With respect to consultation, the Rule provides:
The physician should be willing to refer the patient, as necessary, for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those patients with pain who are at risk for medication misuse, abuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation and consultations with or referral to an expert in the management of such patients.
Id.
And finally, with respect to medical records, the Rule states in relevant part that "[r]ecords should remain current" and that "[t]he physician should keep accurate and complete records." Id.
The CALJ rejected the bulk of the Government's case, finding the allegations proven only "in part" and only with respect to the prescriptions Respondent issued on
I conclude, however, that the Government has proved additional violations of 21 CFR 1306.04(a) beyond those found by the CALJ, and I further conclude that the evidence does not simply reflect "inattention to detail" on Respondent's part--a finding which is legally insufficient to support the conclusion that he violated 21 CFR 1306.04(a)--but rather, that he knowingly diverted drugs to B.B. I am mindful of the various credibility findings made by the CALJ, particularly with respect to the testimony of Respondent, as well as his finding that "
The
The CALJ rejected the Government's allegation that the Duragesic and Opana prescriptions issued by Respondent on this date violated 21 CFR 1306.04(a) because they were issued outside of the usual course of professional practice and lacked a legitimate medical purpose. /38/ As found above,
FOOTNOTE 38 The CALJ asserted that in the Show Cause Order and its Prehearing Statement, "the Government noticed a theory based in the issuance of prescriptions outside the course of a professional practice under 21 CFR 1306.04(a), not that any prescriptions were not issued for a legitimate medical purpose." R.D. 87-88. While then noting that "the Government did sporadically elicit testimony from its expert in this regard ([citing] Tr. 93, 123, 133-34, 137-38, 140, 144, 148, 155-56, 158, 174, 176, 179) and did espouse this theory in its closing brief," the CALJ again asserted that this theory was unavailable to the Government because it raised the issue for the first time in its post-hearing brief. Id. at 88 n.150 (citing
I decline to adopt this ruling for multiple reasons. First, as several federal appeals courts have recognized, there is no material difference between the phrases "usual course of professional practice" and "legitimate medical purpose," and thus the courts have sustained convictions for violating the regulation and 21 U.S.C. 841(a)(1), notwithstanding that an indictment charged the defendant "with dispensing of a controlled substance not in the usual course of professional practice" but did not allege that the dispensing lacked a legitimate medical purpose, as well as where the jury instructions only referenced the "usual course of professional practice" and did not require the jury to find that the defendant "dispensed without a legitimate medical purpose." See United States v. Fuchs, 467 F.3d 889, 898-901 (5th Cir. 2006) (noting earlier decision that "appears to use the phrases . . . interchangeably").
Likewise, in
Furthermore, even if these were two distinct theories for proving a violation of 21 CFR 1306.04(a), the record supports a finding of litigation by consent. The Government did not "sporadically elicit testimony from its expert" on this issue, but rather, asked
Dr. Owen further noted that Respondent documented that B.B. had a negative straight leg raise and that this is "the most sensitive physical finding for low back pain." Id. at 190. He then explained that "a sensitive test means that if you don't have a positive finding you don't have that diagnosis." Id.
Dr. Owen further testified that Respondent's patient file contained two aberrant drug tests, the
The CALJ found uncontroverted
As for the aberrant drug tests, the CALJ asserted that "there is little doubt that the
Accordingly, I find that the
In rejecting the Government's contention that the
Instead, the CALJ reasoned that "Respondent credibly testified that, based on his professional opinion and his conversations with personnel at the testing lab, a patient taking any benzodiazepine may test positive for any other benzodiazepine[,] [and] [t]hus, the Respondent did not, and does not view the
However, if, in fact, Respondent did not review the UDSs prior to prescribing (notwithstanding the notation that he "extensively reviewed" B.B.'s medical history),
Moreover, if it is the case that Respondent did not review the
Thus, Respondent's testimony was hearsay which was uncorroborated by either the testimony of a lab employee, an expert in drug testing, or articles from scientific or medical journals. The CALJ did not, however, analyze the reliability of the hearsay statements recounted by Respondent. /39/ See R.D. at 37-40.
FOOTNOTE 39 In multiple decisions, the Agency has made clear that the reliability of a hearsay statement should be evaluated by reference to the decisional law of the courts of appeals that would have jurisdiction over a subsequent petition for review; this includes the D.C. Circuit and the Tenth Circuit. As the D.C. Circuit has explained, "hearsay may constitute substantial evidence depending upon its probative value and reliability, considering inter alia, possible bias of the declarant, whether [the] statements are signed and sworn to, whether they are contradicted by direct testimony, whether the declarant is available, and whether the hearsay is corroborated." Hoska v.
Applying the Hoska factors, I conclude that the statement is not entitled to weight. Even assuming that the lab employee who made the statement was not biased, the statement was neither signed nor sworn to, Respondent did not identify the employee by name, and Respondent did not disclose that he intended to testify to the lab's statement in advance of the hearing notwithstanding that the CALJ's Order for Prehearing Statements directed that Respondent was "to indicate clearly each and every matter as to which he intends to introduce evidence in opposition" and the summary of each witness' testimony was "to state what the testimony will be." ALJ Ex. 4, at 2. Moreover, that Order then stated "that testimony not disclosed in the prehearing statement or pursuant to subsequent rulings is likely to be excluded at the hearing." Id. Given that Respondent did not disclose this testimony in advance of the hearing, I find that the declarant was not available. Moreover, as explained above, Respondent offered no other evidence to corroborate the lab's statement and the statement was contradicted in part by Respondent's testimony regarding the temazepam positive on the
Notably, in his Response to the Government's Exceptions, Respondent does not maintain that this testimony was offered for the non-hearsay purpose of showing Respondent's state of mind when he failed to address the
Moreover, even were I to consider Respondent's testimony on the issue of his state of mind--which would seem to require a finding that he did see the lab report--as ultimate factfinder, I would not give it weight. While the Agency must accord some deference to an ALJ's findings on credibility issues where an ALJ observes the demeanor of the witness, "[t]he findings of the [ALJ] are to be considered along with the consistency and inherent probability of [the] testimony."
Of consequence, B.B.'s
Respondent offered no explanation for the inconsistency between his testimony regarding why he "would not consider" the
I conclude, however, that for the same reason that Respondent deemed the
I am also unpersuaded by the CALJ's reasoning for rejecting
As to Respondent's claim that B.B. had undergone physical therapy for some time, Respondent admitted that this was not documented in the patient file. Tr. 392. Indeed, a review of the progress notes prepared by
Accordingly, I do not find credible Respondent's testimony that he did not have B.B. go to physical therapy because B.B. "had been on physical therapy monthly for quite some time and didn't feel that it was of any benefit at all." Tr. 392. Here too, because Respondent's testimony is inconsistent with the evidence (and lack thereof), I decline to adopt the CALJ's apparent credibility finding as to this testimony. I further agree with
As explained above,
Respondent's note for this visit is totally devoid of any documentation that he asked B.B. how he hurt himself; whether his pain radiated down his extremities and if so, how far down; if the pain went past his knee; if he had any weakness or numbness; how the pain effected various activities of daily living such as his ability to work, as well as his ability to tolerate sitting, walking and standing. /40/ GX 3, at 48. Indeed, the only documentation Respondent made pertinent to B.B.'s ability to function was to note "yes" for whether he had achieved his treatment objective and the numbers "3-5" in the pain scale column. Id. at 28. See Okla. Admin. Code
FOOTNOTE 40 There is likewise no evidence that Respondent had B.B. complete a new Patient Comfort Assessment Guide or that he asked him as to how the pain interfered with his general activity, mood, sleep, enjoyment of life, ability to concentrate and relations with other people. END FOOTNOTE
Against this evidence, Respondent testified that B.B. reported pain which was consistent with the exam he conducted at this visit. Tr. 292. He also explained that he ordered an MRI because he "wanted to make sure that" the results were "consistent with his pain," his physical exam, and "the fact that he was on a schedule II narcotic." Id. at 293. Respondent also testified that he did not continue B.B. on Lortab (hydrocodone/acetaminophen) and prescribed fentanyl patches (a long-acting) narcotic medication because of the risk of abuse and addiction present with short-acting medications. Id. at 291.
While Respondent may have palpated B.B.'s lumbar region, he offered no testimony or other evidence refuting
As for Respondent's having changed B.B.'s medication from Lortab to Fentanyl patches, even long-acting schedule II medications are susceptible to abuse. Moreover, because Respondent performed only a superficial evaluation and did not establish a diagnosis and medical necessity to prescribe controlled substances, let alone two schedule II controlled substances, this evidence is entitled to no weight. /41/
FOOTNOTE 41 In his discussion as to why the Government had not proved that Respondent violated 21 CFR 1306.04(a) in issuing the
So too, the CALJ took issue with
I further hold that Respondent's issuance of the prescriptions for the fentanyl patches and Opana (oxymorphone) prescriptions was not merely malpractice. Rather, I conclude that the evidence supports the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed these drugs to B.B. Here, not only did Respondent do a superficial evaluation as to B.B.'s purported pain complaint, his medical history, and the effect of the pain on his ability to function, he also performed a cursory examination which did not support his diagnosis, id. at 190, and ignored the results of the two aberrant drugs tests. As for the
Moreover, even were I to credit Respondent's testimony that he "doubt[ed]" that he reviewed the drug tests performed by
The
Here again,
Explaining that "[t]he principal issue raised by
Next, while the CALJ rejected the Government's contention that the
As explained previously, with respect to those instances in which he found violations, the CALJ simply concluded that Respondent's actions were neglectful. However, even accepting the CALJ's credibility finding with respect to Respondent's testimony regarding B.B.'s request to try morphine, I find that the evidence still supports the conclusion that Respondent violated 21 CFR 1306.04(a) in issuing the prescriptions for both morphine ER and Opana (oxymorphone).
As explained in my discussion of the
In refutation of
As the CALJ noted, Respondent "admitted that this part of the patient visit went very quickly, and that a patient may not remember the treatment goal when asked this." R.D. 41 n.80. Indeed, after admitting that "that part would be very quick in my office," Respondent added that "I wouldn't ask him what he was actually doing to achieve that." Tr. 393. He also testified that he was not sure as to why, when the question was "has patient achieved treatment objective" and was, in essence, a yes or no question, and the patient may not even remember what his treatment objective was, B.B. would have answered "fair." Id. at 395. Given that Respondent offered no further testimony as to other questions he asked B.B. to ascertain how the pain was effecting his ability to function in various aspects of his life activities, nor maintained that he asked any other questions about B.B.'s pain level, I give weight to
Although Respondent maintained that he did a full physical exam, once again he found that B.B.'s straight leg raise was negative. As
Nor do I find persuasive the reasoning that Respondent's treatment of B.B.'s upper respiratory ailment was "more consistent" with the treatment provided by "a conscientious practitioner than a pill mill operator." R.D. 43. Putting aside that there is no evidence as to how a conscientious practitioner would treat a patient who complains of a potential upper respiratory ailment, even patients who engage in the abuse or diversion of controlled substances may seek treatment for legitimate health conditions. So too, a physician may nonetheless divert controlled substances to some patients without being a pill mill operator. Thus, even assuming that Respondent properly evaluated and treated B.B. for this condition, this has no bearing on whether he properly evaluated B.B. to determine whether he had a legitimate pain condition which warranted the prescription of controlled substances. /42/
FOOTNOTE 42 To be sure, the visit note also stated that B.B. had "a left abdominal wall hernia" and Respondent recommended that he "wear a corset if at all possible." GX 3, at 47. While Respondent testified that he suggested the use of a corset because he didn't want B.B. to confuse his abdominal pain with his level of pain because of his having changed B.B.'s pain regimen, here again, there is no evidence that he evaluated the cause of the hernia, how much pain it was generating, and how it was effecting B.B.'s ability to function. Tr. 300.
Notably, B.B. returned for another office visit only two weeks later. GX 3, at 46. Yet the note for the visit contains no mention of the hernia. Id. Nor is the hernia mentioned in the visit notes for B.B.'s later visits. See id. at 42, 44-45. And in his testimony, Respondent offered no explanation as to what happened to B.B's hernia such that it was no longer mentioned in subsequent visit notes. END FOOTNOTE
In sum, because I agree with
The
At this visit, Respondent noted that B.B. reported that "his stress [was] up" and that he had "lo[st] his father" and was "having a lot of grief." GX 3, at 46. He made similar physical exam findings as at the previous visit, again noting that B.B.'s straight leg raise was negative but that "lying down and sitting up cause him a lot of pain." Id.; see also Tr. 305 (Respondent's testimony that B.B.'s "exam was still exactly like before, with low back paraspinal and spinal tenderness, but he still had the negative straight leg raises. But lying down and sitting up still caused him a lot of pain."). Respondent did not even obtain a numerical pain rating at this visit nor note whether B.B. was achieving his treatment objective. Respondent diagnosed B.B. as having both acute grief and lumbar disc disease.
Dr. Owen testified that B.B.'s having a lot of stress and grief would magnify B.B.'s "perception of pain and disability." Tr. 139. He further explained that because of B.B.'s previous aberrant behaviors and the new stressors in B.B.'s life, he was at increased risk to "use [the] drugs to chemically cope" and that Respondent should have "sought psychological counselling for" him but did not do so. Id.
Dr. Owen also took issue with Respondent's notation in the visit note that he suggested nonmedicinal modalities for two reasons. Id. at 209-10. First, he explained that "good medicine would be [that] if you haven't done nonmedicinal pain-relieving modalities," Respondent should have "wean[ed] [B.B.] off these controlled substances and tr[ied] these other treatments first." Id. at 210. Second, he explained that the note did not provide an adequate level of detail such that any person who took over B.B.'s care or was asked to provide a consultation would be able to "understand what was happening with this patient at that point." Id.
As for Respondent's notations that the straight leg raise test was negative but that lying down and sitting up caused B.B. a lot of pain,
The CALJ declined to give weight to much of
I do not read
Thus,
Dr. Owen testified that patients who present with comorbid psychiatric conditions present a heightened risk of abusing controlled substances because these conditions may magnify a patient's perception of pain and disability and aggravate a patient's experience of suffering, id. 102-04, and Respondent agreed with
To be sure, the evidence shows that B.B. was already seeing a mental health professional during this period. However, Respondent admitted that he never even consulted with the mental health professionals who were simultaneously prescribing controlled substances to B.B., whether in response to B.B.'s report of increased stress and grief at this visit, or at any point during the course of his prescribing to B.B. Id. at 408. Notably, when Respondent was asked if it was within the standard of care for him and B.B.'s mental health provider to keep treating B.B. "without talking to each other," Respondent explained that "the mental health providers are very good about speaking to us about patients." Id. at 409. When then asked if he would ordinarily consult with a patient's mental health provider if the latter is simultaneously prescribing controlled substances, Respondent offered the unresponsive answer that "[w]e've become quite reliant on the PMP [reports] now" and that "[b]efore the PMP, there was quite a bit of cross-talk, because . . . pharmacists would call" and tell him that a patient was seeing another physician. Id. at 409-10. However, the PMP reports in the record show that they did not contain any medical information for B.B. other than the controlled substance prescriptions he obtained and filled and the names of the prescribers.
When then asked if two practitioners who are simultaneously prescribing controlled substances to the same patient wouldn't "talk to each other about" their joint prescribing, Respondent initially answered "absolutely." Id. at 410. However, notwithstanding his earlier testimony that "[t]he mental health providers are very good about speaking to us about patients," he then asserted that "[i]n every other field but mental health we do do that," and added that consulting with his patient's mental health professionals "doesn't happen very often." Id. In short, none of this testimony refutes
While, when considered in isolation, Respondent's failure to consult with B.B.'s mental health providers would not establish a violation of 21 CFR 1306.04(a),
As before, Respondent's failure to address the aberrant drug screens as well as
The
On both dates, Respondent issued B.B. prescriptions for 90 Morphine Sulfate ER 15 mg and 120 Opana 10 mg without requiring that B.B. appear for an office visit with him.
Dr. Owen acknowledged that under a DEA regulation (21 CFR 1306.12(b)), a practitioner may issue multiple prescriptions for a schedule II drug to provide up to a 90-day supply of the drug based on only seeing the patient once every 90 days. However,
In refutation, Respondent offered only that after the
The CALJ found the allegations "not sustained" with respect to both the
I find, however that on both dates, Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing the morphine and Opana prescriptions without requiring an office visit. As previously explained, the Show Cause Order provided Respondent with fair notice that the aberrant
So too, for reasons explained previously, I reject the CALJ's interpretation of the documentation requirements imposed by the
FOOTNOTE 43 While Respondent had received the MRI results before he issued the November prescriptions, GX 3, at 20;
As for the CALJ's reliance on the regulation which allows a practitioner to issue to a patient multiple schedule II prescriptions for up to a 90-day supply at one time, provided the practitioner meets certain conditions, the rationale underlying this provision does not provide a safe harbor to Respondent. /44/ Of relevance here, these conditions include, inter alia, that: "[e]ach separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice"; and "[t]he individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse." 21 CFR 1306.12(b)(i) and (iii). As found above, based on my conclusions that the prescriptions Respondent issued at the three previous office visits were issued outside of the usual course of professional practice and lacked a legitimate medical purpose, Respondent did not meet the first condition. Moreover, based on Respondent's testimony that he did not remember whether he reviewed either the
FOOTNOTE 44 As this provision contemplates the issuance of multiple prescriptions at one time provided the prescriptions "indicat[e] the earliest date on which a pharmacy may fill each prescription," it is not directly applicable here. However, as to the frequency of office visits, the regulation states that a physician "must determine . . . based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so." 21 CFR 1306.12(b)(2). END FOOTNOTE
The
On
According to Respondent's exam notes, B.B. was "[a]lert and oriented and in no apparent distress." Id. While other portions of the exam were normal, Respondent again documented that B.B. had "[l]ow back paraspinal tenderness," a "[n]egative straight leg raise," and "[n]euro intact." Id. He also documented that B.B. "has very tight right calf." Id. However, no mention was made of B.B.'s hernia which had been noted at previous visits. Id.
Respondent diagnosed B.B. with "lumbar disc disease," "exposure to infectious disease," and "[r]ight calf pain." Id. He further documented that he discussed the "[a]ddictive dependence, and tolerance nature of the medicines as well as alternatives," that he suggested "[n]on-medicinal pain-relieving modalities," and that the "[f]ollowup will be [in] three months." Id. Respondent then issued B.B. new prescriptions for Morphine Sulfate ER 15 mg and Opana 10 mg with the same dosing instructions, thus providing a 30-day supply for each drug if taken as directed. Id.
Dr. Owen testified that when a patient reports having gone to the emergency room, he would get the record to find out both "what the problem was" as well as if "any additional medication [was] prescribed." Tr. 147. B.B.'s file does not, however, contain a note from the emergency room. Id.; see also GX 3. Moreover, after observing that the visit note contains no mention that Respondent addressed either of the two prior urine screens during this visit,
In refutation of
While Respondent agreed that his visit notes were unremarkable given the high amount of narcotics he was prescribing and asserted he could have done a better job dictating his notes (which he attributed to seeing 40 to 45 patients a day and dictating the notes), he maintained that because B.B. "just continued to have the same pain that he had before . . . I didn't go into details on it." Tr. 315. However, notwithstanding that he had not seen B.B. in three months, he did not document whether B.B. had achieved his treatment objective nor document a numeric pain rating. GX 3, at 28.
The CALJ rejected the Government's contention that the controlled substance prescriptions Respondent issued at this visit violated 21 CFR 1306.04(a). Again, the CALJ concluded that the Government did not provide adequate notice regarding its reliance on the
For reasons explained previously, I find that Respondent was provided adequate notice regarding the Government's reliance on the
As for
However,
In discussing Respondent's testimony regarding the notes he made after B.B.'s January 27 office visit (on which occasion he did not prescribe controlled substances), the CALJ stated that "Respondent noted that B.B. was on
The CALJ also found that in the Respondent's view, B.B. had not behaved in a way that set off alarms, and was stable on his medications." R.D. at 50. However, as found previously, Respondent testified that he probably never even looked at the UDS results that were in B.B.'s chart and didn't expect that he would have done so. Yet Respondent also testified that
The CALJ apparently also credited Respondent's testimony to the effect that "[m]uch more went on in the office than what's written" in the visit notes and that he "definitely knew what was going on in [B.B's] life from each visit, and I just failed to dictate that." Tr. 326. And the CALJ further asserted that "Respondent provided details to demonstrate that he knew his patient," R.D. 50, and apparently credited Respondent's testimony that he "was talking to [B.B] about those things and what all he did in a day, and he was not able to work." Tr. 327 (cited at R.D. 51).
Yet, on the occasion of the January 19 visit, during which he issued B.B. new prescriptions for morphine and oxymorphone, Respondent did not even document in the Treatment Objective Evaluation section on the Treatment Plan if B.B. was meeting his treatment objectives and did not obtain a pain rating. Of note, the former was typically documented with a handwritten one-word answer of either "yes" or "fair," and the latter was documented with a handwritten notation of a number; thus neither of these inquiries required dictation at all. /45/
FOOTNOTE 45 Indeed, on each of the dates on which Respondent made notations in this section of the chart, each of the entries was handwritten. END FOOTNOTE
Moreover, when asked by the CALJ how he knew how the meds he prescribed "were doing," Respondent replied that his evaluation was "purely subjective, and if they were needing more or less pain meds." Only after a further question as to whether he asked objective questions in assessing how B.B. was responding to the medications did Respondent maintain that he was aware of what B.B. did all day and that he had not returned to work.
Dr. Owen provided unrefuted testimony that "return[ing] to work" is "the gold standard for functionality in pain management." Tr. 100. Given this, it is telling that Respondent never documented whether B.B. had returned to work in the progress notes he prepared for the various visits. Moreover, given that B.B.'s treatment objective was to return to work without pain and yet B.B. never returned to work during the course of Respondent's prescribing to him, id. at 353, it is hard to understand why Respondent wrote "fair" for whether B.B. was meeting his treatment objective.
As for why he did so, Respondent testified that he would ask his patients if they were meeting their treatment objective and he would write down what the patient told him. Tr. 392. However, Respondent further testified that "[a]ctually that part [of the visit] would be very quick in my office. I wouldn't ask him what he was actually doing to achieve that." Id. at 393.
Respondent "absolutely" agreed with the CALJ that he would ask his patients "[h]ave you achieved your treatment objective?" only to then acknowledge that his patients "may not" remember what their treatment objective was. Tr. 394. And while this question appears to have been directed at assessing a patient's function, Respondent testified that the question was intended to elicit "[b]asically if they were satisfied with the care or the standard that they meet." Id. When then asked why B.B. would answer "fair" to what seemed to be "a yes or no question," Respondent testified that he was "not sure" why the answer would come out as "fair." Id. at 395.
Tellingly, at another point during his testimony on this issue, Respondent explained:
They [the patients] were very well trained by the time this was here. Whenever we walked in, they knew the questions before we asked them. You know, are you meeting your objective? What's your pain level? And do you wish to change? Do you think we should make a referral? We asked it every time, just like clockwork.
Tr. 394-95.
I disagree with the CALJ that "Respondent's testimony provides convincing evidence that he was engaged in bona fide attempts to treat B.B., not act as a drug supplier." On the issue of how he evaluated B.B.'s function, Respondent offered only the vague testimony that he "was talking to B.B about those things and what all he did in a day." Yet Respondent never documented any such findings other than to make the nonsensical notation of "fair" for whether B.B. was achieving his treatment objective, and even at the hearing, Respondent still could not explain why he did so even though he did so on multiple occasions. As for his assessment of B.B.'s pain level, Respondent testified to only asking "what's your pain level"--as if over the course of the preceding 90-day period, a patient's pain level would not fluctuate depending upon the activities engaged in by the patient. While I am mindful that the CALJ's finding was based on his credibility determination, it is noteworthy that in his decision, the CALJ did not discuss this portion of Respondent's testimony (Tr. 392-95), which is clearly relevant and probative on the issue of the scope of his evaluation of B.B. /46/
FOOTNOTE 46 While Respondent also asserted that B.B. "basically was stuck in the house all day," that obviously was not the case when B.B. was found semiconscious and in an apparent state of intoxication in a vehicle parked on the median strip of I-35. As far as B.B.'s inability to work, the evidence shows that he was working by "illegally buying and selling prescriptions drugs." RX 3, at 3 (stipulated findings of fact of the March 8, 2013 Board Order). END FOOTNOTE
As noted previously, in its Policy Statement, the Board stated that it "will judge the validity of the physician's treatment of the patient based on available documentation " and that "[t]he goal is to control the patient's pain while effectively addressing other aspects of the patient's functioning, including physical, psychological, social and work-related factors." Policy Statement, at 2 (emphasis added). Given that Respondent's documentation was confined to the two superficial notations in the Treatment Objective Evaluation section of the Treatment Plan and given the emphasis which the Board's Policy Statement places on the available documentation in judging the validity of treatment, as well as Respondent's testimony as to the scope of the questions he would ask, I conclude that Respondent has not refuted
In concluding so, I am mindful that while the Board initially charged Respondent with "fail[ing] to maintain adequate medical records to support diagnosis . . . treatment or prescribed medications, in violation of 59 O.S.
I am also mindful of the CALJ's criticism that
It is true that in several respects the
Moreover,
the purpose of documentation is for continuity of care. Not only continuity of care for this same provider from visit to visit but continuity of care should somebody else assume the care later on down the road or should you need to get a consultation, that the consultant can read your notes and understand what was happening with this patient at this point in time.
Tr. 210.
Notably, Respondent put on no evidence showing that
Moreover, while States have the primary responsibility for the regulation of the medical profession, many of the profession's norms were created by the profession itself. Thus, on such issues as the adequacy of a clinical evaluation for a particular pain complaint and the necessary documentation to support the prescribing of controlled substances, the standard of medical practice would not seem to vary to any material degree between States, especially between States that border each other.
Finally, unlike Respondent,
The February 13, 2013 Prescriptions
On this date, Respondent issued B.B. new prescriptions for 120 Opana 10 and 90 Morphine Sulfate ER 15. Moreover, by this date, Respondent likely had the results of the January 19 UDS, which showed that Morphine Sulfate was not detected and that B.B. had tested positive for nordiazepam, oxazepam and temazepam (as well as alprazolam). On the lab report, Respondent wrote that B.B. was "counsel[led] to only take what is prescribed." Respondent did not require that B.B. appear for an office visit.
Dr. Owen testified that Respondent should have required an office visit because of B.B.'s previous aberrant drug-taking behaviors and because Respondent still needed to establish that there was a medical necessity to prescribe controlled substances and a therapeutic benefit. Tr. 154. While
In refutation, Respondent maintained that "the morphine said not detected, but the oxymorphone was positive, so that was explainable." Id. at 335. And he again maintained that "the lab always said that if "the Xanax was positive," then nordiazepam, oxazepam and Xanax "could all three be positive." Id. Continuing, Respondent testified that "temazepam, in our practice, usually didn't show up," so he checked B.B.'s PMP report to see if he had been prescribed Restoril (the name of the legend drug) but "couldn't find it on the PMP." Id. Respondent then maintained that "
The CALJ again rejected the Government's contention that Respondent violated 21 CFR 1306.04(a) when he issued the prescriptions, reasoning that "the record evidence does not support a finding that the August 25 or January 19 UDS results are aberrant." R.D. at 54. While the CALJ again explained that "it is beyond argument that the June 1 UDS does present an anomaly, reliance on that event [was] not adequately notice by the Government in support" of its contentions regarding these prescriptions. Id.
In addition, the CALJ found that Respondent "provided a thoughtful and reasoned explanation (based on his professional experience and knowledge of operating Tri-City) of why B.B. may have tested positive for temazepam despite not having been prescribed it." Id. at 54-55. Taking the January 19 UDS in isolation, the CALJ explained that the Government did not "establish that the Respondent's counseling B.B. to `only take what is prescribed' fell below the standard of care in
However, as explained above, even though the June 1 UDS was not specifically referenced in the Show Cause Order with respect to the February 13 prescriptions, the issues of the aberrant nature of the June 1 test (as well as the August 25 test) were litigated by consent. As for the CALJ's assertion that the record does not support a finding that the August 25 and January 19 UDS results were aberrant, Respondent's testimony and the notation he placed on the report of the January 19 test establish that both tests were aberrant in that B.B. was taking a medication which Respondent had not prescribed to him and which was not listed on the PMP reports, including one that went back as far as August 27, 2010. Moreover, none of
As for the CALJ's assertion that the Government provided no evidence that Respondent's action in counseling B.B. to take only what he was prescribed fell below the standard of care, the CALJ's reasoning rests on the erroneous premise that this was B.B.'s first aberrant drug test. However, for reasons explained previously, it was his third aberrant test in less than eight months, and each of his last three tests produced an aberrational result. /47/
FOOTNOTE 47 However, I do not rely on the January 19 UDS result that morphine was not detected. In contrast to the results which showed the presence of drugs which B.B. had not been prescribed, B.B. was five days past 30 days (the number of days the morphine prescription would have lasted if taken as directed), and the Government put forward no evidence that morphine would still be detectable five days later. While B.B.'s having been five days late raises other issues (such as whether he should have been going through withdrawal by January 19), the Government elicited no such testimony from
In rejecting
Thus, in contrast to the CALJ, I give weight to
The March 13, 2012 Prescriptions
On March 13, 2012, Respondent issued B.B. new prescriptions for both 120 Opana 10 and 90 Morphine Sulfate ER 15. See GX 5, at 10, 24. Respondent issued the prescriptions without requiring an office visit by B.B. Tr. 156; see generally GX 3, at 42-62 (visit notes for B.B.). Nor is there any notation on any of the visit notes regarding Respondent's issuance of these prescriptions. /48/
FOOTNOTE 48 As found above, on the January 27, 2012 visit note, Respondent had written that on "2/13/12" he prescribed "Zpack, Prednisone 10 mg # 28, Phenergan." GX 3, at 44. The same visit note contains a further entry for "2-22-12" documenting the issuance of a prescription for 60 tablets of Soma (carisoprodol) 350 mg. Id. END FOOTNOTE
Dr. Owen testified that Respondent should have required an office visit before issuing these prescriptions, reiterating that Respondent still had not established "medical necessity for" prescribing controlled substances to B.B. Tr. 155. Asked to again identify the deficiencies which led him to conclude that Respondent had not established medical necessity,
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.
In his direct testimony, Respondent did not address his reasons for issuing the March 13 Opana and morphine prescriptions. See Tr. at 338-39. Instead, the questioning centered on the issue of why he wrote a prescription on March 14 for Nexium, "a stomach medicine" and a non-controlled drug ("I have no idea") after which the questioning moved on to the next set of prescriptions. Id.
Here again, the CALJ concluded that the Government's evidence was not sufficient to sustain the allegations that Respondent violated 21 CFR 1306.04(a) in issuing the prescriptions. According to the CALJ, "there [was] no persuasive evidence to support the conclusion that the absence of an office visit by B.B., standing alone, render[ed] this prescribing event below the prevailing medical standard in
As for the CALJ's assertion that the UDS results were not adequately noticed, in the Show Cause Order, the Government alleged with respect to these prescriptions that Respondent "once again issued [B.B.] controlled substance prescriptions . . . without taking appropriate steps to monitor his controlled substances use despite the persistent red flags of abuse and diversion he previously presented." ALJ Ex. 1, at 5 ( [paragraph] 3h). Even if this was not enough to provide Respondent with notice that the three UDSs would be at issue with respect to these prescriptions, Respondent did not object when the Government asked
As for the CALJ's assertion that there is no persuasive evidence that standing alone, the absence of an office visit rendered these prescriptions below the prevailing medical standard, the Respondent's prescribing without requiring an office visit does not stand alone. Rather,
The April 12 Prescriptions
On April 12, 2012, B.B. saw Respondent for an office visit. GX 3, at 42. According to the visit note, B.B. "report[ed] his pain has been worse," that "[h]e has run out of his medicines; he had them stolen," and that "[h]e has done fairly well." Id. Moreover, on the Treatment Objective Evaluation section of the Treatment Plan, Respondent wrote "fair --> yes" and made an arrow pointing to "yes" in the block for "Has patient achieved treatment objective?" and "6" in the block for "Patient Completed . . . update [sic] pain scale." Id. at 28.
In the visit note, Respondent wrote that B.B. "still has severe anxiety and depression" and has been "exposed to someone with HPV"; Respondent then wrote: "[h]e is also wanting to switch his medicines because he is having trouble finding the OPANA." Id. Respondent also noted: "[p]ast medical history extensively reviewed and placed in chart." Id.
In his exam findings, Respondent noted "[l]ow back paraspinal and spinal tenderness," "[n]egative straight leg raise," and "[n]euro intact." Id. Respondent listed his diagnoses as "[l]umber disc disease," "[a]nxiety and depression" and "[e]xposure to infectious disease" although he "doubt[ed] that it was HPV." Id. Respondent then changed B.B.'s medications to Opana ER (extended release) 20 mg, b.i.d. (twice per day) and Percocet 10 mg (q. 12h) p.r.n. (as needed) for acute pain. Id.; see also Tr. 340. He also prescribed Soma (carisoprodol) one tablet b.i.d. GX 3, at 42.
Respondent further documented that he discussed the "[a]ddictive, dependence, and tolerance nature of the medicines, as well as alternatives." Id. He noted that he "suggested" "[n]on-medicinal pain and anxiety-relieving modalities." Id.
During this visit, Respondent also required B.B. to provide a UDS. The preliminary screening found that B.B. was negative for opiates and morphine. And according to the confirmatory testing done by the lab, which was reported back to Respondent on April 17, 2012, B.B. tested positive for oxymorphone, which was expected based on Respondent's having prescribed Opana to him. Id. He also tested positive for meprobamate, which was expected based on Respondent's having prescribed carisoprodol to B.B. Id. However, the lab further found that morphine was "not detected," a result which was "not expected" because Respondent had prescribed morphine sulfate ER to B.B. on March 13, 2012. Id.
Dr. Owen found it problematic that B.B. had told Respondent that his pain was worse, that he had run out of his medicines and had them stolen. Id. at 159. As he explained:
Well, one, his pain is worse, so why is it worse? Two is he's run out of his medications, and then he had them stolen. What is it? Did you run out of them because you self-escalated, or were they stolen and you ran out of them? It needs clarification. But either event, self-escalation or having them stolen, is a red flag.
Id.
Regarding B.B.'s report that his medications were stolen,
Dr. Owen also found problematic the notations in the visit note that B.B. reported that "his pain has been was worse" and that "[h]e has done fairly well." Id. at 160. As
Dr. Owen 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 reiterated his earlier testimony that the patient record was "not adequate" to establish "medical necessity" for prescribing the controlled substances on this date and that between September 22, 2011 (when he assumed the care of B.B.) and April 12, 2012, Respondent had never established medical necessity for prescribing controlled substances to B.B. Id. at 173-74. He then opined that the prescriptions Respondent issued at this visit were issued outside of the usual course of professional practice and lacked a legitimate medical purpose. Id. at 174.
The CALJ sustained the Government's allegations only with respect to its contention that Respondent ignored the PMP data showing that B.B. was obtaining early refills of alprazolam and failed to take any action in response to this information, such as contacting the other prescribers or cautioning B.B. in response to this information. R.D. at 61-62. For reasons explained previously, the evidence does not support the contention that B.B. exhibited a pattern of obtaining early refills as of this visit. I also agree with the CALJ that the evidence does not support a finding that Respondent provided B.B. with an early refill of his pain medications.
However, for many of the same reasons previously discussed, the CALJ rejected the other evidence offered by the Government to prove that the prescriptions violated 21 CFR 1306.04(a). For example, the CALJ again reasoned that "the UDS results prior to the April 12 amino assay UDS" were not "adequately noticed by the Government . . . regarding this prescribing event [and] are unavailable to support its expert's opinion here." R.D. at 60. And the CALJ further asserted that the Government could not rely on litigation by consent because it did "not timely and affirmatively raise[]" this theory. Id. However, as discussed previously, paragraph 3 of the Show Cause Order provided adequate notice that various aberrant drug tests would be at issue throughout the proceeding. /49/ And even if it did not, the record fully supports the conclusion that the issue was litigated by consent as, given the absence of an objection, the Government had no obligation to affirmatively raise the argument (which it did in its Exceptions) until the CALJ issued his Recommended Decision.
FOOTNOTE 49 As the Show Cause Order alleged:
From on or about August 25, 2011 through on or about May 9, 2012, you issued controlled substance[] prescriptions to B.B. in violation of Federal and
ALJ Ex. 1, at 1 [paragraph] 3. END FOOTNOTE
The CALJ also failed to give weight to
In rejecting the Government's evidence, the CALJ also explained that the Government did not establish that "good medical practice in
Moreover, even if the Board's rule does not mandate "any specific level of detail,"
Notably, while B.B.'s treatment objective was to return to work without pain, B.B. had not returned to work as of the April 12 visit (and never did during the course of Respondent's prescribing) and yet in the box for documenting whether he was meeting his treatment objective, Respondent wrote the words "fair" and "yes." Yet at the hearing, Respondent did not recall why he wrote "yes," just as he was "unsure" as to why he had written "fair" in the box at previous visits. As Respondent could not even explain why he made these entries, it is clear that no other physician who subsequently took over B.B.'s care could "understand what was happening with" B.B. at various points. So too, as Respondent could not explain the inconsistency between his having noted in B.B.'s progress note that "his pain was worse" while B.B. reported a decrease in his numeric pain rating and that "he has done fairly well," I give weight to
Finally, the CALJ declined to give weight to
FOOTNOTE 50 While Respondent offered testimony to the effect that pain patients will maintain "a stash" of controlled substances in the event their medications are stolen, and asserted that B.B. did this as well, he offered no explanation as to how B.B. could have accumulated a stash of extended release medications (such as Morphine Sulfate ER, the drug which was not detected) while still managing pain. END FOOTNOTE
Moreover, even crediting Respondent's testimony regarding the notation that B.B. wanted to switch medications because he was having troubling finding immediate release Opana, his testimony regarding the limitations imposed by the
Of further note, Respondent could not explain why he made the entries of "fair" and "yes" for whether B.B. was meeting his treatment objective, when he acknowledged that B.B.'s treatment objective was to return to work but never did so. And while he essentially agreed with
The April 25 Prescriptions
On April 25, 2012, Respondent provided B.B. with a prescription for 30 Roxicodone (oxycodone) 15 mg. GX 5, at 4. B.B.'s file contains no documentation that there was an office visit, and notwithstanding that this was a change in medication from what Respondent had prescribed at the previous visit, there is no notation in the progress notes as to why he changed the prescription. See generally GX 3; see also Tr. 174-75. Moreover, while Respondent testified that he would "routinely" make an entry in the Treatment Objective Evaluation section of the Pain Management Treatment Plan "if we were making a change in a medication," Tr. 357, no such entry was made on this date. See GX 3, at 28. Nor is there any documentation in the patient file that Respondent addressed with B.B. the aberrant drug test result (the non-detection of morphine) which had been reported to him on April 17. See generally GX 3.
According to
Regarding the Roxicodone prescription, Respondent asserted that he "was just doing a two-week trial, trying to figure out his dose, and at the time, most likely the patient didn't have any punches on his card left, and Roxicodone is much cheaper than Percocet, and it's the same medication." Id. at 355. However, Respondent did not document any of this in B.B.'s record. Nor did he explain why he failed to follow his routine of making an entry in the Treatment Objective Evaluation section of the Pain Management Treatment Plan given that he had changed B.B.'s medication.
As for the April 12 UDS lab report, which he had obtained prior to issuing the prescription and which found that morphine was not detected and that this result was not expected based on the prescribed medications, Respondent testified that in his opinion the result was not aberrant. Respondent did not explain whether this was based on his previous claim that the oxymorphone is a metabolite of morphine or because B.B. had reported that his medications were stolen. Tr. 364-66.
As Respondent offered no testimony that he asked B.B which of his drugs were stolen and was told that it was the morphine, B.B.'s claim of stolen drugs does not render the test non-aberrant. Moreover, the lab reports noted various instances in which the presence of various metabolites was consistent with prescribed medications and that the particular substances were metabolites of prescribed drugs but included no such notation with respect to oxymorphone and morphine. Finally, Respondent's testimony is contradicted by science and he offered no evidence which would support a finding that he had a good faith but mistaken belief that oxymorphone is a metabolite of morphine. Based on these reasons, I find that the April 12 UDS was aberrant and that Respondent knew it to be.
While the CALJ concluded that the Government could not rely on the four UDS reports, he nonetheless found that the evidence supported the Government's contention that Respondent acted outside of the usual course of professional practice in issuing the prescriptions. R.D. at 64. While the CALJ accepted Respondent's assertion that Percocet and Roxicodone are similar drugs in that they both contain oxycodone (although he noted that Roxicodone does not contain acetaminophen and contains only oxycodone), id. at n.119, he explained that Respondent did not merely provide a refill but was changing B.B.'s medications. Id. at 63-64. While the CALJ then noted
FOOTNOTE 51 Unexplained by the CALJ is why he did not apply the same reasoning to Respondent's testimony that he was "unsure" as to why, on various occasions, he wrote "fair" in the block for noting whether B.B. had achieved his treatment objective as well as to why he wrote "yes" when B.B never returned to work during the course of Respondent's prescribing to him. END FOOTNOTE
While I agree with the CALJ that Respondent's testimony was unpersuasive, I also give weight to
The May 9, 2012 Prescriptions
On May 9, 2012, Respondent wrote B.B. a prescription for 60 Opana ER 20 mg. GX 3, at 93; GX 5, at 27. Respondent did not require an office visit, and he made no notations in the progress notes regarding the prescription. See generally GX 3; see also Tr. 177-78. Regarding the prescription,
Asked to provide his opinion as to Respondent's prescribing of controlled substances from September 2011 through May 9, 2012,
Asked why he refilled the prescriptions, /52/ Respondent testified that "I got a phone call that he was wanting his medicines refilled and that the [R]oxicodone had worked for him and et cetera, so we were converting him back into the one-month prescriptions in the Schedule IIs and going back to this three-month office visit." Tr. 356. Respondent offered no testimony addressing
FOOTNOTE 52 In her questioning of Respondent, Respondent's counsel referred to a Roxicodone prescription as having been issued on May 9, 2012, and in his testimony regarding the prescriptions he wrote on that date, Respondent referred to both a Roxicodone prescription and an Opana ER 20 mg prescription. Tr. 356. While GX 5 contains a legible copy of the May 9, 2012 Opana ER prescription, See GX 5, at 27, it does not contain a copy of a Roxicodone prescription, and as for GX 3, the copy of the purported Roxicodone prescription is illegible. GX 3, at 93.
Moreover, at no point did the Government put in issue whether Respondent violated 21 CFR 1306.04(a) when he issued the Roxicodone prescription. The Government did not mention this prescription in the specific allegation it made in the Show Cause Order regarding the events of May 9, 2012, See ALJ Ex. 1, at 6 [paragraph] 3(j); it did not mention the prescription in its Pre-hearing Statement, See ALJ Ex. 5, at 21; it did not question Dr. Owen about this prescription, See Tr. 177-78; and even after Respondent testified about it, the Government did not argue in its post-hearing brief that Respondent issued this Roxicodone prescription in violation of 21 CFR 1306.04(a). Thus, I do not consider the prescription. END FOOTNOTE
The CALJ found that because he "had PMP data indicating that B.B. had previously engaged in a pattern of procuring early refills from multiple prescribers," Respondent's issuance of the prescription was "a breach of [his] obligation as a registrant to guard against the diversion of controlled substances." R.D. at 67-68. The CALJ thus concluded that Respondent acted outside of the course of professional practice in issuing the Opana prescription. /53/ Id. at 68.
FOOTNOTE 53 In his decision, the CALJ explained that "[a]lthough the Government's pleadings do not specifically refer to the early refills in support of this prescribing event, the [Show Cause Order] alleges that the prescribing was effected `despite previous indications that B.B. was at risk for abuse or diversion of controlled substance[s].'" R.D. 67-68 n.124 (quoting ALJ Ex. 1, at 6). The CALJ also noted that "[t]he Government Prehearing Statement alleges that the prescription for Opana was issued `despite previous indications that B.B. was at risk for abuse or diversion of controlled substances[s] . . . .'" Id. (quoting ALJ Ex. 5, at 21). The CALJ then explained that "[t]hese broadly-worded phrases supply sufficient notice . . . to constitute sufficient notice to use the PMP early refill evidence in support of this prescribing event." Id.
I am, however, left to wonder why the same reasoning did not apply to the multiple instances in which the CALJ asserted that the Government did not provide sufficient notice that it intended to rely on the various UDSs. Notably, paragraph 3 of the Show Cause Order alleged that:
[f]rom on or about August 25, 2011 through on or about May 9, 2012, you issued controlled substance[] prescriptions to B.B. in violation of Federal and Oklahoma state law. You were aware on each of the occasions that you issued controlled substance[] prescriptions to B.B. that he presented a high risk of abuse and/or diversion of controlled substances, as evidenced by the red flags documented in his patient file, such as aberrant urine drug tests. . . . You failed to address and, in fact, ignored these red flags, continuing to issue B.B. controlled substance prescriptions in the face of mounting evidence that he was misusing, abusing, and/or diverting the controlled substances you were prescribing.
ALJ Ex. 1, at 1. See also, e.g., id. at 3 (Sept. 22, 2011 Rxs: "You did not address with B.B. the now second aberrant drug screen in an approximately three month period" and "[y]ou took no other steps to monitor B.B's controlled substance use, such as requiring him [to] take another drug screen due to the two failed ones"); id. at 4 (Nov. 18 and Dec. 15 Rxs: alleging that "you did not take any steps to monitor [B.B.'s] controlled substances use despite his history of misusing, abusing, or diverting controlled substances"); id. at 5 (Mar. 13, 2012 Rxs: "you once again issued him controlled substance[] prescriptions . . . without taking appropriate steps to monitor his controlled substance use despite the persistent red flags of abuse and diversion he previously presented"). END FOOTNOTE
While I agree with the CALJ that Respondent violated 21 CFR 1306.04(a) in issuing the prescription, I do so for reasons other than that B.B. had "engaged in a pattern of early refills." As Respondent did not see B.B. on this date, I give weight to Dr. Owen's testimony that Respondent did not establish medical necessity for the prescription (or any of the prescriptions for that matter) for the reasons he explained throughout his testimony as well as for the other reasons discussed in this Decision.
* * *
In his Recommended Decision, the CALJ alleges that the Agency "has been engaged in a deliberate winnowing of the scope of Factor 2, to the extent that . . . it now largely mirrors the considerations found in Factor 4." R.D. 77. He further asserts that the Agency's rejection of dicta which has appeared in various recommended decisions to the effect that Factor 2 "manifests Congress's acknowledgement that . . . the quantitative volume in which an applicant has engaged in the dispensing of controlled substances may be [a] significant factor" in the public interest determination, see JM Pharmacy Group, Inc., 80 FR 28667, 28684 (2015), is inconsistent with the plain meaning of Factor 2. R.D. 77-81.
Congress did not, however, define the term "experience" in the CSA, and as the Administrator has explained at length, the word has multiple meanings, none of which "compels the conclusion that Congress acknowledged that the quantitative volume of an applicant's dispensing may be a significant consideration under this factor, and certainly none [of these definitions] suggests that the Agency is required to count up the number of times an applicant or registrant has dispensed controlled substances," JM Pharmacy Group, 80 FR at 28667 n.1, let alone compare the number of lawful dispensings against those shown to be unlawful, as some registrants have argued. See, e.g., Syed-Jawed Akhtar-Zaidi, 80 FR 42961, 42967 (2015) (arguing that physician was denied a "fair adjudication" where the Government based its case only on undercover visits but had seized 400 patient files from physician's office and yet "failed to present any evidence . . . that the treatment of those patients failed to meet the standard of care," as well as any evidence regarding the treatment of "over 400 additional patients'" whose charts were not seized), pet. for rev. denied, 841 F.3d 707, 713 (6th Cir. 2016).
Notably, the CALJ does not cite to any of the sources typically invoked by the courts in cases which have held that a statute has a plain meaning. /54/ See, e.g.,Williams v. Taylor, 529 U.S. 420, 431-32 (2000) (giving statutory text its "ordinary, contemporary, common meaning" based on definitions from Webster's New International Dictionary and Black's Law Dictionary); United States v. Labonte, 520 U.S. 751, 757-58 (1997) (giving statutory text ordinary meaning by reference to same dictionaries); Levorsen v. Octapharma Plasma, Inc., 828 F.3d 1227, 1231 (10th Cir. 2016) (relying on Webster's Third New International Dictionary for meaning of statutory terms). And while "[t]he plainness or ambiguity of statutory language is [also] determined by reference to the . . . specific context in which that language is used, and the broader context of the statute as a whole," Yates v. United States, 135 S.Ct. 1074, 1082 (2015), nothing in the context of providing factors for determining the public interest supports the notion that the term "experience" requires a consideration of the quantitative volume of an applicant's dispensing.
FOOTNOTE 54 As the Administrator noted in JM Pharmacy, the word "experience" has multiple meanings. Among those most relevant in assessing its meaning as used in the context of Factor Two are: (1) The "direct observation of or participation in events as a basis for knowledge," (2) "the fact or state of having been affected by or gained knowledge through direct observation or participation," (3) "practical knowledge, skill, or practice derived from direct observation of or participation in events or in a particular activity," and (4) "the length of such participation." See Merriam-Webster's Collegiate Dictionary 409 (10th ed. 1998); see also The Random House Dictionary of the English Language 681 (2d ed. 1987) (defining experience to include "the process or fact of personally observing encountering, or undergoing something," "the observing, encountering, or undergoing of things generally as they occur in the course of time," "knowledge or practical wisdom gained from what one has observed, encountered, or undergone"). END FOOTNOTE
As previously explained, Congress enacted the public interest standard to provide DEA with additional authority to address the diversion of controlled substances because prior to the 1984 amendment of section 823(f), the Agency's authority to deny an application or revoke a registration was limited to cases in which a practitioner: (1) Had materially falsified an application, (2) had been convicted of a State or Federal felony offense related to controlled substances, or (3) had his State license or registration suspended, revoked, or denied. See S. Rep. No. 98-225, at 266 (1983), as reprinted in 1984 U.S.C.C.A.N. 3182, 3448. Finding that the "[i]mproper diversion of controlled substances" was "one of the most serious aspects of the drug abuse problem," and yet "effective Federal action against practitioners ha[d] been severely inhibited by the [then] limited authority to deny or revoke practitioner registrations," id., Congress concluded that "the overly limited bases in current law for denial or revocation of a practitioner's registration do not operate in the public interest." Id.
The Senate Report thus explained that "the bill would amend 21 U.S.C. 824(f) [sic] to expand the authority of the Attorney General to deny a practitioner's registration application." Id. The Report further explained that "in those cases in which registration is clearly contrary to the public interest, the amendment would allow a swift and sure response to the danger posed to the public health and safety by the registration of the practitioner in question." Id. at 267, as reprinted in 1984 U.S.C.C.A.N. at 3449. Accordingly, section 823(f) was amended to provide the Agency with authority to deny an application based upon a finding that the issuance of a registration "would be inconsistent with the public interest," upon consideration of the five public interest factors, including the experience factor. Id. See also 21 U.S.C. 824(a)(4). Nowhere in the Report's discussion of the amendments to sections 823 and 824 is there any support for the notion that Congress deemed the quantitative volume of a practitioner's dispensings to be a significant consideration in making findings under the experience factor. /55/
FOOTNOTE 55 As the CALJ noted, one of the House Reports explained that "[t]he second factor shall not, of course, be construed in anyway to hinder registration of recent graduates of professional schools who may have no professional experience dispensing or conducting research with controlled substances." H.R. Rep. No. 98-835, Pt. 1, at 14. Obviously, if Factor Two's meaning was so plain, the Judiciary Committee had no need to express that it should not be construed to deny registrations to newly-licensed practitioners, most of whom can point to no volume of dispensings other than by observing a physician during clinical rotations. Thus, the Committee's direction refutes the notion that the quantitative volume of an applicant's dispensings may be a significant consideration under the factor. END FOOTNOTE
Indeed, as Krishna-Iyer explained, because the CSA limits registration to those practitioners who possess authority under state law to dispense controlled substances in the course of professional practice, and patients with legitimate medical conditions routinely seek treatment from licensed medical professionals, every registrant can undoubtedly point to an extensive body of legitimate prescribing over the course of his professional career. See Krishna-Iyer, 459 FR at 463. Thus, in past cases, this Agency has given no more than nominal weight to a practitioner's evidence that he has dispensed controlled substances to thousands of patients in circumstances which did not involve diversion. See, e.g., Caragine, 63 FR at 51599 ("[T]he Government does not dispute that during Respondent's 20 years in practice he has seen over 15,000 patients. At issue in this proceeding is Respondent's controlled substance prescribing to 18 patients."); id. at 51600 ("[E]ven though the patients at issue are only a small portion of Respondent's patient population, his prescribing of controlled substances to these individuals raises serious concerns regarding [his] ability to responsibly handle controlled substances in the future."); see also Medicine Shoppe--Jonesborough, 73 FR 364, 386 & n.56 (2008) (noting that pharmacy "had 17,000 patients," but that "[n]o amount of legitimate dispensings can render . . . flagrant violations [acts which are] `consistent with the public interest.'"), pet. for review denied, Medicine Shoppe-Jonesborough v. DEA, slip. op. at 11 (6th Cir. Nov. 13, 2008).
As in past cases, the parties may continue to introduce evidence as to the extent of both a practitioner's lawful or unlawful dispensing activities. However, under Agency precedent, proof of a single act of intentional or knowing diversion remains sufficient to satisfy the Government's prima facie burden and to impose on a respondent the obligation to produce evidence to show that it can be entrusted with a registration. See Krishna-Iyer, 74 FR 459, 463 (2009); see also Alan H. Olefsky, 57 FR 928, 928-29 (1992) (revoking registration based on physician's presentation of two fraudulent prescriptions to pharmacy and noting that the respondent "refuses to accept responsibility for his actions and does not even acknowledge the criminality of his behavior").
The CALJ further alleges that on remand in Krishna-Iyer, the Agency failed to follow the Eleventh Circuit's unpublished decision, in which the Administrator was directed to consider 12 additional patient files as well as the "entire corpus" of the physician's controlled substance dispensing for evidence of the physician's "positive experience" in dispensing controlled substances. R.D. 79. However, the Administrator carefully reviewed those files, and noted that the files "included numerous instances in which [the physician] appear[ed] to have ignored warning signs that the patient was either abusing or diverting controlled substance"; she also made findings with respect to multiple incidents. 74 FR at 460-61 n.3. And as for the "entire corpus" of the physician's prescribing, notwithstanding the physician had not introduced any evidence as to the propriety of her prescribing to the "thousands of other patients" she had treated, the Administrator assumed that every one of those prescriptions was lawfully issued. Id. at 461. However, as the Administrator explained, even if those prescriptions were lawfully issued, they did not negate the Government's prima facie showing that the physician had knowingly diverted drugs to others. Id. at 462-63. And while the Administrator granted the physician a new registration, she made clear that had the physician not acknowledged her misconduct, she would have again revoked the physician's registration. Id. at 463.
Not mentioned by the CALJ is that several years later, the exact same arguments were raised before the Eleventh Circuit by two different physicians and rejected without any discussion. In Lynch v. DEA, a physician whose registration was revoked by the Agency for unlawful prescribing, /56/ argued that the Agency's Decision arbitrarily "limited its consideration of [his] experience to only ten prescriptions issued to out of state patients, the two undercover patients, and the use of a rubber stamp on nine prescriptions . . . and did not consider the evidence that he had been dispensing controlled substances for over twenty years," and thus "fail[ed] to consider the overwhelming evidence of positive experience." See Brief of Petitioner 31-32, Lynch v. DEA, No. 11-10207-EE (11th Cir. 2011) (citing Krishna-Iyer, M.D., v. DEA, 249 Fed. Appx. 159, 161 (11th Cir. 2007) (unpublished)). Notably, the Eleventh Circuit denied the physician's petition for review, holding that the revocation of the physician's registration "was not arbitrary, capricious, an abuse of discretion or contrary to law." Lynch v. DEA, Slip. Op. at 4 (11th Cir. May 22, 2012) (per curiam). Indeed, the Court of Appeals did not even deem the respondent's argument to warrant discussion. See id. at 2-4.
FOOTNOTE 56 See Ronald Lynch, 75 FR 78745 (2010). END FOOTNOTE
So too, in McNichol v. DEA, another physician whose registration was revoked for issuing unlawful prescriptions to four undercover officers relied on Krishna-Iyer to argue that the Agency's final decision was arbitrary and capricious because the investigation "failed to take into account any positive conduct on [his] part" and "intentionally ignored any evidence not specifically related to the undercover patients." Brief of Petitioner 21-23, McNichol v. DEA, No. 12-15292 (11th Cir. 2013) (citing Krishna-Iyer, 249 Fed. Appx. at 161). Of note, the Agency's Decision specifically rejected the ALJ's assertion that the Government was required to review the patient charts for patients other than the undercover officers and look for evidence of the physician's "positive prescribing practices" so as to "develop evidence to enlighten the administrative record." T.J. McNichol, 77 FR 57133, 57146 (2012). The Administrator further explained that "[h]aving garnered evidence of what it believed to be unlawful prescriptions issued to the four undercover officers, the Government was entitled to go to hearing with that evidence." Id.
Again, the Eleventh Circuit denied the physician's petition for review, holding that "the record supports that the administrator considered all aspects of the evidence in light of the applicable statutory factors and . . . [her] decision was not arbitrary and capricious. . . . [w]e also agree with the administrator's conclusion that [the physician's] continued registration would be inconsistent with the public interest." McNichol v. DEA, Slip. Op. at 4 (11th Cir. Oct. 17, 2013) (per curiam). Here again, the Court did not deem Respondent's argument to warrant discussion.
The CALJ also dismisses the published decision of the Tenth Circuit in MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011), asserting that "the Agency's view of Factor 2 was not a focus of the court's decision." R.D. 80 (emphasis added). Therein, after the Agency revoked the physician's registration based on his unlawful prescribing to two patients, the physician argued on review that:
The DEA must consider the totality of the experiences a physician has, including: the interaction reflected in each of the medical charts of patients that were seized by the DEA, the "thousands of other patients . . . [and] positive experience" with dispensing controlled substances and not merely the testimony of people trying to make a case against the physician.
The DEA, in fact, flat out disregarded the substantial experience Dr. MacKay has had with dispensing controlled substances. The law requires the DEA to consider evidence that reflects that the physician is not a danger to the public and delineates how the DEA must do so.
Brief of Petitioner, 13-14, MacKay v. DEA. Moreover, after discussing the affidavits of several patients who testified that Dr. MacKay had provided medically appropriate, and in some instances, beneficial treatment for their pain, Respondent argued that "[t]he DEA decision is based only on the medical charts of a few patients out of thousands Dr. MacKay has successfully treated over the years. In fact . . . the DEA's expert only reviewed twelve patient files and testified about even fewer." Id. at 20.
Notwithstanding that the Agency's decision was based entirely on the evidence with respect to two patients (K.R. and M.R.), see Dewey C. MacKay, 75 FR 49956, 49972 (2009); the Tenth Circuit rejected Respondent's contention that the Agency had failed to consider his "positive experience" evidence. As the Court of Appeals explained:
Despite Dr. MacKay's claim to the contrary, the Deputy Administrator considered the entire record, including the evidence in Dr. MacKay's favor. She determined, however, that none of Dr. MacKay's evidence negated the DEA's prima facie showing that Dr. MacKay had intentionally diverted drugs to K.D. and M.R. Indeed, she found that even if Dr. MacKay had provided proper medical care to all of his other patients, that fact would not overcome the government's evidence with regard to M.R. and K.D.
None of the evidence presented by Dr. MacKay undermines the evidence relating to M.R. and K.D. Although numerous patients and colleagues of Dr. MacKay related their positive experiences with him, none had any personal knowledge regarding his treatment of M.R. and K.D. Notably, Dr. MacKay's medical expert . . . failed to specifically discuss and justify Dr. MacKay's treatment of M.R. and K.D. As a result, none of Dr. MacKay's evidence contradicts the testimony and evidence presented by the DEA relating to the knowing diversion of drugs to these two patients.
664 F.3d at 819.
The Court of Appeals then rejected MacKay's contention that the Deputy Administrator had misweighed the public interest factors. As the Court explained: "[i]n light of Dr. MacKay's misconduct relating to factors two and four, the government made a prima facie showing that [his] continued registration is inconsistent with the public interest." Id. (citing 75 FR at 49977). And the Court further explained that "[a]lthough Dr. MacKay may have engaged in the legitimate practice of pain medicine for many of his patients, the conduct found by the Deputy Administrator with respect to K.D. and M.R. is sufficient to support her determination that his continued registration is inconsistent with the public interest." Id.
The CALJ further asserts that "to the extent that the ever-widening range of activity that the Agency considers `positive experience' is banned, Factor 2 analysis, in the majority of Agency cases, will largely consist of a reprise of evidence also considered under Factor 4." R.D. 81. Continuing, the CALJ contends that "[t]he Government's ability to introduce alleged acts of malfeasance will warrant double consideration under Factor 2 and again under Factor 4, but respondents will remain unable to demonstrate that a transgression constituted an isolated occurrence when compared with even many years of compliant practice as a registrant." Id.
The CALJ is mistaken. As JM Pharmacy made clear, "[a]s in past cases, the parties may continue to introduce evidence as to the extent of both a practitioner's lawful or unlawful dispensing activities." 80 FR at 28668 n.2. Indeed, in these proceedings, the Agency will assume, without requiring the production of any evidence by a respondent, that the practitioner has lawfully issued every prescription other than those alleged by the Government to be unlawful. And contrary to the CALJ's understanding, notwithstanding the Agency's rejection of the notion that "the plain meaning" of Factor 2 mandates the consideration of "the quantitative volume" of a respondent's dispensing, a respondent may still argue that his conduct was "an isolated occurrence when compared with even many years of compliant practice" or an "aberration." R.D. 81-82.
Equally misplaced is the CALJ's assertion that the Government's evidence of unlawful prescribing will hence be given double consideration in the public interest determination. Id. at 82. While evidence of a respondent's unlawful prescribing is clearly relevant in assessing both his/her experience in dispensing controlled substances and compliance with applicable laws related to controlled substances and thus typically discussed under both factors--indeed, because of the overlap between the factors, the Agency has long discussed both factors together--this does not mean that the prescriptions have been double weighted. See, e.g., Albert Lepis, 51 FR 17555, 17555-56 (1986).
As the Agency's decision on remand in Krishna-Iyer explained, "[w]hether this conduct is evaluated under factor two . . . or factor four, or both [factors], is of no legal consequence. In establishing [the Government's] prima facie case, the fundamental question is whether [a] [r]espondent `has committed such acts as would render [his] registration inconsistent with the public interest.' " /57/ 74 FR at 462 (quoting 21 U.S.C. 824(a)(4)). Moreover, as both the Agency and federal courts have recognized, findings under a single factor can support the denial of an application or the revocation of a registration. See MacKay, 664 F.3d at 821 (quoting Krishna-Iyer, 74 FR at 462).
FOOTNOTE 57 While Krishna-Iyer involved a revocation proceeding, the public interest inquiry is essentially the same where the Agency proposes the denial of an application. END FOOTNOTE
While the Agency has explained that proof of a single act of intentional or knowing diversion remains sufficient to satisfy the Government's prima facie burden and to impose on a respondent the obligation to produce evidence to show that he can be entrusted with a registration, this is not the result of double weighting the misconduct. See Krishna-Iyer, 74 FR at 463; see also MacKay, 664 F.3d at 819. Rather, it is based on the recognition that a violation of the prescription requirement (21 CFR 1306.04(a)) "strikes at the CSA's core purpose of preventing the abuse and diversion of controlled substances." Samuel Mintlow, 80 FR 3630, 3653 (2015); accord David A. Ruben, 78 FR 38363, 38386 (2013). Accordingly, the Agency has held that where the Government proves that a practitioner has engaged in knowing or intentional diversion, a respondent is not entitled to be registered (or maintain an existing registration) absent a credible acceptance of responsibility. /58/ As the Tenth Circuit has recognized:
FOOTNOTE 58 In Krishna-Iyer, the Agency explained that "while some isolated decisions . . . may suggest that a practitioner who committed only a few acts of diversion was entitled to regain his registration even without having to accept responsibility for his misconduct, see Anant N. Mauskar, 63 FR 13687, 13689 (1998), the great weight of the Agency's decisions are to the contrary." 74 FR at 464. Noting that "[t]he diversion of controlled substances has become an increasingly grave threat to this nation's public health and safety," the Agency clarified its policy and explained that "[t]o the extent Mauskar, or any other decision of this Agency suggests otherwise, it [wa]s overruled." Id. at 464 n.9. Continuing, the Agency explained that because of the grave and increasing harm to public health and safety caused by the diversion of prescription controlled substances, even where the Agency's proof establishes that a practitioner has committed only a few acts of knowing or intentional diversion, this Agency will not grant or continue the practitioner's registration unless he accepts responsibility for his misconduct. Id. at 464. END FOOTNOTE
* . . the DEA may properly consider whether a physician admits fault in determining if the physician's registration should be revoked. When faced with evidence that a doctor has a history of distributing controlled substances unlawfully, it is reasonable for the . . . Administrator to consider whether that doctor will change his or her behavior in the future. And that consideration is vital to whether continued registration is in the public interest. Without Dr. MacKay's testimony, the Deputy Administrator had no evidence that Dr. MacKay recognized the extent of his misconduct and was prepared to remedy his prescribing practices.
MacKay, 664 F.3d at 820 (citing Hoxie v. DEA, 419 F.3d 477, 483 (2005)).
Thus, contrary to the CALJ's understanding, a respondent can still argue (as he/she always could) that his/her misconduct in knowingly or intentionally diverting controlled substances was "an isolated occurrence" or an "aberration" in his/her years of otherwise compliant professional practice. However, one cannot argue that his/her conduct was "an isolated occurrence" or "an aberration" without first acknowledging that he/she has engaged in unlawful conduct. /59/ And in any case, Respondent has made no such argument.
FOOTNOTE 59 The CALJ also asserts that in JM Pharmacy, "the Agency determined in clear terms that it will no longer consider whether established misconduct presented an isolated piece of an applicant's record, irrespective of whether the misconduct is intentional or otherwise." R.D. at 82 (emphasis added). To the contrary, in JM Pharmacy, the Administrator denied two applications for pharmacy registrations, expressly adopting the CALJ's conclusion that the owner of the two pharmacies had "knowingly and materially falsified the applications he submitted." 80 FR at 28669; see also id. at 28683 (CALJ's Recommended Decision: "It is clear that the Respondents, through their common owner . . . knew or should have known that the answers provided to Question 2 were false, and that their . . . applications contained material falsifications. The absence of any logical basis for confusion and the past experience of [their owner] as a registrant holder and pharmacist preponderantly support a finding that the misrepresentations were intentional, not negligent.. . . [E]ven standing alone, the denial of the Respondent's . . . applications is adequately supported on this record based on the material falsifications set forth in the filed applications.") (emphasis added); id. at 28689 (CALJ noting that owner's "insistence that his false response to an application query . . . was simply not credible and defeats the Respondents' efforts to meet the Government's case. The false misrepresentation[s] . . . are sufficiently egregious on their face to warrant sanction"). Thus, JM Pharmacy does not support the CALJ's assertion that the Agency does not consider a respondent's level of culpability in committing misconduct. END FOOTNOTE
Summary of Factors Two and Four
While Respondent put on no evidence as to the lawfulness of his controlled substance prescribing to patients other than B.B., I have assumed that every other prescription he has issued in the course of his professional career complied with 21 CFR 1306.04(a). /60/ Nonetheless, as found above, Respondent issued multiple prescriptions for various schedule II narcotics outside the course of professional practice and which lacked a legitimate medical purpose. 21 CFR 1306.04(a). Moreover, the evidence in no sense shows that Respondent was merely neglectful, but rather supports a finding that Respondent acted with knowledge that B.B. was abusing and/or diverting the controlled substances he prescribed. And while the evidence of record does not support a finding that Respondent unlawfully prescribed to any other patient, it is significant that his misconduct went on for eight months and involved 19 prescriptions for schedule II narcotics alone. Thus, I conclude that Respondent has engaged in egregious misconduct which supports the denial of his registration. See MacKay, 75 FR at 49997; Krishna-Iyer, 74 FR at 463; Olefsky, 57 FR at 928-29.
FOOTNOTE 60 This assumption may actually be more favorable to Respondent than what is warranted with respect to his experience in dispensing controlled substances. In 2008, Respondent was sanctioned by the Board for "prescribing controlled dangerous substances" over the course of a three-year period to a patient with whom he had sexual relations. RX 3, at 2. END FOOTNOTE
I therefore hold that the Government has established its prima facie case that Respondent's registration "would be inconsistent with the public interest." 21 U.S.C. 823(f).
Sanction
Where, as here, /61/ the Government has met its prima facie burden of showing that issuing a new registration to the applicant would be inconsistent with the public interest, a respondent must come forward with "`"sufficient mitigating evidence"'" to show why he can be entrusted with a new registration. Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008) (quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988))). "Moreover, because `past performance is the best predictor of future performance,' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.1995), [DEA] has repeatedly held that where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for [his] actions and demonstrate that [he] will not engage in future misconduct." Medicine Shoppe, 73 FR at 387; see also Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006); Prince George Daniels, 60 FR 62884, 62887 (1995). See also MacKay v. DEA, 664 F.3d at 820; Hoxie v. DEA, 419 F.3d at 483 ("admitting fault" is "properly consider[ed]" by DEA to be an "important factor[]" in the public interest determination).
FOOTNOTE 61 So too, the egregiousness and extent of a registrant's misconduct are significant factors in determining the appropriate sanction. See Jacobo Dreszer, 76 FR 19386, 19387-88 (2011) (explaining that a respondent can "argue that even though the Government has made out a prima facie case, his conduct was not so egregious as to warrant revocation"); Paul H. Volkman, 73 FR 30630, 30644 (2008); see also Paul Weir Battershell, 76 FR 44359, 44369 (2011) (imposing six-month suspension, noting that the evidence was not limited to security and recordkeeping violations found at first inspection and "manifested a disturbing pattern of indifference on the part of [r]espondent to his obligations as a registrant"); Gregory D. Owens, 74 FR 36751, 36757 n.22 (2009). As explained above, Respondent's misconduct in knowingly issuing multiple prescriptions in violation of 21 CFR 1306.04(a) is egregious and supports the denial of his registration and not the issuance of a registration subject to conditions. Indeed, this is not a close call. END FOOTNOTE
Finally, the Agency has also held that "`[n]either Jackson, nor any other agency decision, holds . . . that the Agency cannot consider the deterrent value of a sanction in deciding whether a registration should be [suspended or] revoked.'" Joseph Gaudio, 74 FR 10083, 10094 (2009) (quoting Southwood Pharmaceuticals, Inc., 72 FR 36487, 36504 (2007)); see also Robert Raymond Reppy, 76 FR 61154, 61158 (2011); Michael S. Moore, 76 FR 45867, 45868 (2011). This is so, both with respect to the respondent in a particular case and the community of registrants. See Gaudio, 74 FR at 10095 (quoting Southwood, 71 FR at 36503). Cf. McCarthy v. SEC, 406 F.3d 179, 188-89 (2d Cir. 2005) (upholding SEC's express adoptions of "deterrence, both specific and general, as a component in analyzing the remedial efficacy of sanctions").
Even with respect to the violations which he found proven, the CALJ found that "one clear and consistent aspect of the record is the Respondent's almost dogged determination to accept no responsibility for his actions." R.D. 92. This holds equally true with respect to each of the controlled substance prescriptions he issued in violation of 21 CFR 1306.04(a), as other than his meager acknowledgement that his documentation on certain progress notes could have been better, Respondent has not accepted responsibility for his misconduct with respect to any of the controlled substance prescriptions he unlawfully issued to B.B. beginning on September 22, 2011 and ending on May 9, 2012. And as explained above, the evidence supports the conclusion that Respondent was not merely neglectful, but that he engaged in knowing misconduct when he issued the prescriptions. As the Tenth Circuit has recognized, Respondent's failure to acknowledge his misconduct establishes that he is not prepared to remedy his unlawful prescribing practices. MacKay, 664 F.3d at 820. This alone supports the conclusion that he cannot be entrusted with a new registration. /62/
FOOTNOTE 62 Even if Respondent had credibly accepted responsibility for his misconduct, he has offered no evidence of any remedial training he has undertaken in controlled substance prescribing. While the CSA does not impose a time bar on a practitioner's ability to reapply for a registration, the rules of the Agency are clear. Thus, to obtain favorable consideration of any new application, Respondent must both credibly acknowledge his misconduct in prescribing to B.B. and provide evidence of remedial training he has undertaken in the proper prescribing of controlled substances. END FOOTNOTE
So too, while the Agency's interest in specific deterrence is not triggered (because I deny his application), as found above, Respondent's misconduct is egregious and the Agency has a manifest interest in deterring similar misconduct by other practitioners. This interest would be compelling even if it was not the case that the nation was confronting an epidemic of opioid abuse. I therefore conclude that granting Respondent's application "would be inconsistent with the public interest." 21 U.S.C. 823(f). Accordingly, I will deny his application.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 CFR 0.100(b), I order that the application of Wesley Pope, M.D., for a DEA Certificate of Registration as a practitioner, be, and it hereby is, denied. This Order is effective immediately.
Dated: March 16, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-05676 Filed 3-22-17; 8:45 am]
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