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

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A2017-05676

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** March 23, 2017
- **Citation:** 82 FR 14944

## Text

DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 15-8]
Wesley Pope, M.D.; Decision and Order

On October 8, 2014, the former Deputy Assistant Administrator of the then-Office of Diversion Control, issued an Order to Show Cause to Wesley Pope, M.D. (hereinafter, Respondent), of Newcastle, Oklahoma. ALJ Ex. 1, at 1. The Show Cause Order proposed the denial of Respondent's application for a new Certificate of Registration as a practitioner in schedules II through V, on the ground that his registration would be “inconsistent with the public interest.”
Id.
(citing 21 U.S.C. 823(f)).

As support for the proposed denial, the Government alleged that “[f]rom on or about August 25, 2011 through on or about May 9, 2012, [Respondent] issued controlled substance prescriptions to [patient] B.B. in violation of Federal and Oklahoma . . . law.”
Id.
The Government specifically alleged that “on each of the occasions that [Respondent] issued controlled substance prescriptions to B.B.,” Respondent was “aware . . . that he presented a high risk of abuse and/or diversion of controlled substances, as evidenced by the red flags documented in his patient file, such as aberrant urine drug tests, a request for early refills, and a claim of stolen drugs.”
Id.
The Government then alleged that Respondent “failed to address and, in fact, ignored these red flags, continuing to issue B.B. controlled substances [sic] prescriptions in the face of mounting evidence that he was misusing, abusing, and/or diverting the controlled substances [he was] prescribing.”
Id.
The Government further alleged that “[t]he prescriptions [Respondent] issued to B.B. on each visit were below the standard of care in Oklahoma and fell outside the usual course of professional practice.”
Id.
at 1-2 (citing 21 CFR 1306.04(a); Okla. Admin. Code § 435:10-7-4;
id.
§ 435:70-7-11
1

; Okla. Bd. of Med. Lic. & Super.,
Use of Controlled Substances for the Treatment of Pain
(Mar. 10, 2005)). The Show Cause Order then alleged that on 11 different dates, Respondent issued to B.B. prescriptions for such drugs as hydrocodone/acetaminophen, Opana (oxymorphone), fentanyl patches, morphine sulfate, oxycodone/acetaminophen, and Soma (carisoprodol) which were “invalid.”
Id.
at 2-6. The Government also provided detailed factual allegations pertaining to each of the prescriptions.
Id.

1
This is an apparent typographical error as there is no such provision. The parties, however, spent considerable time arguing as to whether Respondent complied with Okla. Admin. Code § 435:10-7-11, which governs the “Use of Controlled Substances for the Management of Chronic Pain.”

Respondent requested a hearing on the allegations. The matter was then placed on the docket of the Office of Administrative Law Judges and assigned to Chief Administrative Law Judge John J. Mulrooney, II (hereinafter, CALJ). Following pre-hearing procedures, the CALJ conducted a hearing on April 7-8, 2015 in Oklahoma City, Oklahoma. During the hearing, both parties submitted documentary evidence; the Government elicited the testimony of several witnesses and Respondent testified on his own behalf.

On July 24, 2015, the CALJ issued his Recommended Decision (cited as R.D.). Therein, the CALJ found that the allegations were sustained only with respect to five of the dates on which Respondent prescribed (and with respect to four of these dates, only sustained in part).
See
R.D. 44, 46, 62, 64, 68. While the CALJ concluded that Respondent had issued these prescriptions outside of the course of professional practice and thus violated 21 CFR 1306.04(a),
id.
at 90, he further reasoned that Respondent's misconduct reflected “inattention to detail [and] not intentional diversion.”
Id.
at 82. He thus concluded that while the Government had made out a
prima facie
case to warrant some form of sanction, Respondent's conduct was not sufficiently egregious to warrant denial even though he found that “Respondent was irresponsible in continuing to prescribe to this patient in the face of red flags of diversion, and in failing to document or even possess the ability to persuasively convey a medically-based justification for prescribing new controlled medication.”
Id.
at 92-93. And even though Respondent had failed to accept responsibility and put forward no evidence of remedial measures he had undertaken, the CALJ recommended that he be granted a new registration subject to a one-year period of probation with various conditions.
Id.

The Government filed Exceptions to the Recommended Decision and Respondent filed a Response to the Government's Exceptions. Thereafter, the record was forwarded to my Office for Final Agency Action.

Having considered the record in its entirety including the Recommended Decision, the Government's Exceptions, and Respondent's Response to the Government's Exceptions, I agree with the CALJ's findings and legal conclusion with respect to the first prescribing event (August 25, 2011). While I agree with the CALJ's legal conclusions that Respondent acted outside of the usual course of professional practice when he prescribed controlled substances during the third, fourth, tenth, eleventh, and twelfth prescribing events, I hold that several of the exceptions raised by the Government are well taken and that additional relevant evidence should be considered in review of the record. Based on my consideration of the record as a whole, I, as the ultimate fact-finder, conclude that a preponderance of the evidence supports the conclusions that Respondent knowingly diverted controlled substances by issuing prescriptions in violation of 21 CFR 1306.04(a) when he prescribed various schedule II controlled substances on 11 occasions, beginning on September 22, 2011 and ending on May 9, 2012.

I further find that Respondent's misconduct is egregious and establishes a
prima facie
case for denial. Because I also agree with the CALJ that the record reflects Respondent's “almost dogged determination to accept no responsibility for any of his actions” and that he “has not presented even the most modest plan for any remedial action,” R.D. 92, I conclude that his application should be denied.

The Government's Exceptions

In its Exceptions, the Government raises multiple contentions, several of which warrant discussion prior to making factual findings. The first of these is that the CALJ erroneously concluded that the Oklahoma Medical Board's Standards “on which the Government relied were permissive rather than mandatory.” Exceptions, at 5. Indeed, in making his legal conclusions, the CALJ repeatedly declined to give weight to the Government Expert's testimony on material issues, reasoning that the Expert's testimony was premised on his misunderstanding that the Board's regulations, in particular its documentation and recordkeeping rules, were mandatory rather than permissive.

Second, the Government maintains that the CALJ erroneously held that the Government failed to provide adequate notice to Respondent of its intent to rely on the various aberrant drug tests as part of its proof that various prescriptions were issued in violation of 21 CFR 1306.04(a). With respect to this exception, the Government argues that not only did it provide adequate notice, the aberrant nature of the various urine drug screens (UDS) was litigated by consent. Exceptions, at 15-25. It also takes exception to the CALJ's finding

that several of the UDSs were not aberrant.

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

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

With respect to the evaluation of the patient, the Oklahoma Rule states:

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

Okla. Admin. Code § 435:10-7-11(1). And with respect to medical records, the Oklahoma Rule states in relevant part that “[r]ecords should remain current” and that “[t]he physician should keep accurate and complete records.”
Id.
§ 435:10-7-11(6). The records are “to include . . . the medical history and physical examination (including vital signs),” “diagnostic, therapeutic and laboratory results,” “evaluations, consultations and follow-up evaluations,” “treatment objectives,” “discussion of risks and benefits,” “informed consent,” “treatments,” “medications (included date, type, dosage and quantity prescribed),” “instructions and agreements and periodic reviews.”
Id.
In the CALJ's view, because the provisions of the Oklahoma regulation applicable to the documentation of the physician's evaluation of his patient and his recordkeeping use the word “should” in expressing the State's rules, the obligations they impose are “permissive.” R.D. at 16.

The CALJ, however, cited no authority from either the Board or the Oklahoma courts definitively interpreting the word “should” as used in the context of these two provisions as “permissive.”
See, e.g.,

id.
at 6. Indeed, the CALJ's conclusion appears to have been based entirely on the fact that the Board's prior version of its intractable pain rule used such words as “requires” and “must” in setting forth a practitioner's obligations with respect to documentation and recordkeeping.
See
R.D. 87 n.147 (quoting Okla. Admin. Code § 435:10-7-11(b) (2004): “[t]his rule requires that a diagnosis be documented” and
id.
§ 435:10-7-11(j): “[a]ccurate and complete records to document compliance with this section must be kept”). In the CALJ's view, “[t]he evolution of the [regulations] demonstrate [sic] that their permissive nature represents an intentional re-direction by Oklahoma.”
Id.

However, when the Board promulgated the current version of the rule in 2005, it simply noted that “[t]he rule is being updated based on recommendations from the Federation of State Medical Boards.” 22 Okla. Reg. 2096 (June 15, 2005);
see also
22 Okla. Reg. 379 (Notice of Rulemaking Intent; Feb. 1, 2005). In short, the CALJ's reliance on the Board's decision to adopt the Federation of State Medical Board's model rule simply proves too much.

Furthermore, although the word “should” is susceptible to different meanings, when used in the context of legal requirements, it generally does not connote “permission” but rather obligation or duty.
United States
v.
Anderson,
798 F.2d 919, 924 (7th Cir. 1986) (“The common interpretation of the word `should' is `shall' and thus a straight-forward construction of [the Code of Judicial Conduct] reveals that it imposes a mandatory rule of conduct upon a judge.”)
2

;
Wollschlaeger
v.
Farmer,
814 F.Supp.2d 1367, 1376 (S.D.Fl. 2011) (“Generally, laws that provide for disciplinary action in the cases of violations or noncompliance are mandatory, not precatory or hortatory. . . .”);
see also Bureau of Prisons
v.
FLRA,
737 F.3d 779, 787 (D.C. Cir. 2013) (“ `Should' is typically used to express an obligation or duty.”) (citing
Webster's Third International Dictionary
2104 (1976));
see also Webster's Third International Dictionary
2104 (defining “should” as “used in auxiliary function to express duty, obligation, necessity, propriety or expediency”).

2
As the Seventh Circuit also noted, “as listed in
Roget's Thesaurus,
[the word “should”] means `be obliged, must . . . have to.' The common interpretation of the word `should' is `shall.' ” 798 F.2d at 924.

Moreover, reading the Board's documentation and recordkeeping provisions as permissive cannot be squared with the Oklahoma Medical Practice Act.
Cf. Wollschlaeger,
814 F.Supp.2d at 1376 (rejecting interpretation that statute which used “should” was hortatory when State law provided that violations of provision constituted grounds for disciplinary action). Under the Medical Practice Act, a physician's “[f]ailure to maintain an office record for each patient which accurately reflects the evaluation, treatment, and medical necessity of treatment of the patient” constitutes “unprofessional conduct.” 50 Okla. Stat. Ann. § 509(18). Another provision of the Medical Practice Act states that “[a]dequate medical records to support diagnosis, procedures, treatment, or prescribed medications
must be produced and maintained.” Id.
§ 509(20) (emphasis added). And a further provision of the Medical Practice Act makes “[p]rescribing . . . controlled substances or narcotic drugs without medical need in accordance with published standards” “unprofessional conduct.”
Id.
§ 509(16).

Thus, construing the Board's documentation and recordkeeping rules as permissive would be fundamentally inconsistent with the Medical Practice Act's provisions on documentation and recordkeeping, which are clearly mandatory.
See Abramski
v.
United States,
134 S.Ct. 2259, 2267 n.6 (2014) (“[A] court should not interpret each word in a statute with blinders on, refusing to look at the word's function within the broader statutory context. As we have previously put the point, a `provision that may seem ambiguous in isolation is often clarified by the remainder of the statutory scheme . . . because only one of the permissible meanings produces a substantive effect that is compatible with the rest of the law.' ”) (quoting
United Sav. Assn. of Tex.
v.
Timbers of Inwood Forest Associates, Ltd.,
484 U.S. 365, 371 (1988)).
See also Jacobs
v.
New York Foundling Hosp.,
577 F.3d 93, 99 (2d Cir. 2009).

Accordingly, the Board's Intractable Pain Rule's documentation and recordkeeping provisions are not

reasonably read as being permissive.
3

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

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

In its Policy Statement, the Board also stated that it “will judge the validity of the physician's treatment of the patient based on available documentation.”
Id.
And finally, the Board stated that it “will not take disciplinary action against a physician for deviating from this policy when contemporaneous medical records document reasonable cause for deviation.”
Id.
It makes no sense to advise physicians that the validity of their treatment decisions will be based on documentation and recordkeeping requirements if those provisions are not requirements at all, but rather, merely hortatory and aspirational pronouncements.

Accordingly, I do not agree that the Government Expert's testimony as to the deficiencies in Respondent's evaluations of B.B. was based on the Expert's mistaken understanding of the scope of the Oklahoma Board's documentation and recordkeeping standards. Thus, while I fully agree with the CALJ that the Expert's “testimony predictably raised no issues regarding credibility,” I disagree with the CALJ's assertion that the Expert's “testimony was not without its own `red flags.' ” R.D. 18. I therefore find that this exception is well taken.

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

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

but simply applied the

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

4
According to the CALJ, in
Farmacia Yani,
“the Government's notice was deemed insufficient in that although the alleged misconduct was disclosed and pursued, it did not include the correct regulation subsection in its [Show Cause Order] and prehearing statement.” R.D. 66 (citing 80 FR at 29064 n.28). This, however, misstates the case.

At issue in footnote 28 of
Farmacia Yani
was the Government's allegation that the pharmacy had filled Suboxone prescriptions which were clearly issued for maintenance or detoxification purposes by two physicians but which did not contain the requisite identification number or good faith statement establishing that the physician was authorized to prescribe Suboxone for these purposes.
See
80 FR 29063-64. As the legal basis for the allegation, the Government cited 21 CFR 1306.04 and 1306.06. The first regulation includes,
inter alia,
subsection a, which makes it illegal for a pharmacist to knowingly fill a prescription issued outside of the usual course of professional practice and which lacks a legitimate medical purpose, and subsection c, which provides, in part, that a prescription may not be issued for maintenance or detoxification treatment unless “the practitioner is in compliance with the requirements” applicable to practitioners who prescribe Suboxone for maintenance or detoxification treatment.
See
21 CFR 1306.04(a) & (c);
id.
§ 1301.28 (requirements for prescribing Suboxone for this purpose);
see also id.
§ 1306.06 (“A prescription for a controlled substance may only be filled by a pharmacist, acting in the usual course of his professional practice. . . .”).

While the Decision noted that the Government had not identified the specific subsection of 1306.04 which it alleged was violated, it did not hold that the “notice was deemed insufficient.” R.D. 66. Indeed, while the Decision rejected the Government's contention that the pharmacist acted outside of the usual course of professional practice in violation of 1306.04(a) and 1306.06 for lack of evidence, 80 FR at 29064, and further noted that 1306.04(c) “impose[s] duties only on the issuer of [a] prescription which has been issued to provide maintenance or detoxification purposes,”
id.
at n.28, the Decision nonetheless found that the pharmacy had violated another provision of the Agency's regulations. Specifically, the Decision found a violation based on 21 CFR 1306.05(f), which imposes “[a] corresponding liability . . . upon the pharmacist . . . who fills a prescription not prepared in the form prescribed by DEA regulations, ” 21 CFR 1306.05(f), and 21 CFR 1306.05(b), which requires that such a prescription include either the prescriber's X number or good faith statement.
See
80 FR at 29064 & n.28 (citation omitted).

Indeed, notwithstanding that the Government cited the wrong provision of the regulations, the respondent's principal did not dispute that her conduct in filling these prescriptions was a violation.
See
Respondent's Proposed Findings of Fact and Conclusions of Law, at 11 (Proposed Conclusion of Law #11: “The second violation[] relates to buprenorphine prescriptions from two physicians who were not authorized to prescribe such prescriptions because they were not Data-waived practitioners. Physicians are issued a specific registration that is distinguished with an X number, and this number[] should be on the prescription. Farmacia Yani dispensed 29 prescriptions in total from these two doctors that did not have an X number.”) (citations omitted). Thus, this case does not support the CALJ's assertion that “recent Agency precedent has imposed significantly tighter notice requirements on the Government.” R.D. at 66.

The CALJ further asserted that “[i]n
Marjenhoff,
. . . the Agency refused to allow the Government to rely on noticed conduct alleged as a violation of the public interest factors because it failed to specify that the conduct would be specifically considered under factor 5.” R.D. 66 (citing 80 FR at 29068). Here again, this is a misstatement of the case.

Apparently, the CALJ's assertion refers to the Agency's declination to find that the respondent's conduct in intercepting a pharmacist's phone calls (who questioned the validity of a prescription the respondent had created for herself by forging the signature of the purported prescriber) constituted actionable misconduct under factor five. 21 U.S.C. 823(f)(5). This factor provides for liability based on “such other conduct which may threaten public health and safety.”
Id.

Significantly, the Show Cause Order made no such allegation, and while the Government disclosed in its pre-hearing statement that it intended to elicit testimony from the pharmacist regarding his attempt to verify the prescription after it was rejected for payment by respondent's insurer, at no point in the proceedings did the Government rely on the evidence other than as proof that the “[r]espondent illegally obtained hydrocodone on eleven occasions.”
See
Govt.'s Proposed Findings of Fact and Conclusion of Law, at 14 (discussing the pharmacist's testimony as evidence that respondent “forged and filled hydrocodone prescriptions to herself using [a PA's] DEA number. These actions constitute violations of 21 U.S.C. 843(a)(3) [and] 21

CFR 1306.04. . . .”). Moreover, in its discussion of Factor Five, the Government's arguments were confined to arguing that the “[r]espondent has failed to accept responsibility for her actions,” that she had not “present[ed] any mitigating evidence,” and that she “has demonstrated a pattern of actions that are against the public interest by inappropriately prescribing controlled substances . . . in 2005 and forging and filling prescriptions in 2011.”
Id.
at 15-16.

Thus, contrary to the CALJ's statement, the Government never relied on this conduct as a separate “violation of the public interest factors.” R.D. at 66. Nor could it have, as the public interest factors do not impose substantive rules of conduct but are simply “components of the public interest” that “shall be considered” in determining whether to grant an application for a registration.
Penick Corp., Inc.
v.
DEA,
491 F.3d 483, 490 (D.C. Cir. 2007) (citation omitted). Most importantly, at no point did the Government assert that this conduct should also be considered as a separate act of misconduct under Factor Five.

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

5
In
Campbell,
the ALJ noted that “ `the evidence indicate[d] that [the] [r]espondent did not follow adequate security procedures,' ” but then “declined to consider the evidence on the ground that the Government did not provide adequate notice in either the Show Cause Order or its Prehearing Statements, notwithstanding that [the] [r]espondent did not object to the testimony.” 80 FR at 41062 n.2 (other citation omitted). While the former Administrator observed that “the record arguably support[s] a finding that the issue was litigated by consent,” she did not consider the evidence because “the Government did not take exception to the ALJ's ruling.”
Id.

Here, by contrast, the Government has taken exception to the CALJ's rulings that the issue has not been litigated by consent.
See
Gov. Exceptions, at 24-25. As for the CALJ's assertion that the issue was “not timely” raised by the Government, given that: (1) Respondent never objected to the testimony nor argued in its post-hearing brief that it did not have fair notice that the June 1 drug screen would be at issue throughout the proceeding, and (2) the CALJ did not rule that the Government could not rely on this theory until he issued his Recommended Decision, it is unclear how the Government could have timely raised the issue until it received the Recommended Decision and filed its Exceptions.

“The primary function of notice is to afford [a] respondent an opportunity to prepare a defense by investigating the basis of the complaint and fashioning an explanation that refutes the charge of unlawful behavior.”
Pergament United Sales, Inc.
v.
NLRB,
920 F.2d 130, 135 (2d Cir. 1990) (citation omitted). Thus, as the courts have long noted, “ `[p]leadings in administrative proceedings are not judged by the standards applied to an indictment at common law.' ”
Aloha Airlines
v.
Civil Aeronautics Bd.,
598 F.2d 250, 262 (D.C. Cir. 1979) (quoted in
CBS Wholesale Distributors,
74 FR 36746, 36749 (2009));
accord Citizens State Bank of Marshfield
v.
FDIC,
751 F.2d 209, 213 (8th Cir. 1984). Moreover, an agency “is not burdened with the obligation to give every [Respondent] a complete bill of particulars as to every allegation that [he] will confront.”
Boston Carrier, Inc.
v.
ICC,
746 F.2d 1555, 1560 (D.C. Cir. 1984).

Accordingly, even where the Government fails to disclose an allegation in the Order to Show Cause, “an issue can be litigated if the Government otherwise timely notifies a [r]espondent of its intent to litigate the issue.”
CBS Wholesale,
74 FR at 36570. Moreover, while the Agency has held that “the parameters of the hearing are determined by the prehearing statements,” consistent with numerous court decisions, it has also recognized that even where an allegation was not raised in either the Show Cause Order or the pre-hearing statements, the parties may nonetheless litigate an issue by consent.
Pergament United Sales,
920 F.2d at 135-37;
see also Duane
v.
Department of Defense,
275 F.3d 988, 995 (10th Cir. 2002) (discussing
Facet Enterprises, Inc.,
v.
NLRB,
907 F.2d 963, 974 (10th Cir. 1990); “we held that the defendant had constructive notice of an alternate theory of liability not described in the formal charge when the agency detailed that theory during its opening argument and at other points during the hearing and when the defendant's conduct revealed that it understood and attempted to defend against that theory”).
6

6

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

To be sure, “[a]n agency may not base its decision upon an issue the parties tried inadvertently. Implied consent is not established merely because one party introduced evidence relevant to an unpleaded issue and the opposing party failed to object to its introduction. It must appear that the parties understood the evidence to be aimed at the unpleaded issue.”
Yellow Freight System, Inc.,
v.
Martin,
954 F.2d 353, 358 (6th Cir.1992) (citation omitted). Accordingly, where the Government's case “focus[es] on another issue and [the] evidence of [an] uncharged violation [is] `at most incidental,' ” the Government has not satisfied its constitutional obligation to provide a full and fair opportunity to litigate the issue and it cannot rely on the incidental issue as the basis for imposing a sanction.
Pergament,
920 F.2d at 136 (quoting
NLRB
v.
Majestic Weaving Co.,
355 F.2d 854, 861-62 (2d Cir. 1966)). However, the issue of whether an allegation “has been fully and fairly litigated [by consent] is so peculiarly fact-bound as to make every case unique.”
Id.
at 136.

Having reviewed the record, I find the Government's exception well taken and hold that the Government provided Respondent with adequate notice that both the aberrant nature of the June 1 drug test and his failure to address it would be at issue throughout the proceeding. Moreover, even if the Government failed to specifically reference the June 1 test by date in the Show Cause Order (and Pre-hearing Statements) with respect to several of the prescriptions, Respondent had adequate notice that it was at issue throughout the proceeding and indeed, had a full and fair opportunity to litigate the issue.

The Show Cause Order repeatedly provided notice that the aberrant nature of B.B.'s June 1 UDS and Respondent's failure to address it would be at issue in the proceeding. For example, paragraph 3 of the Show Cause order alleged that “[f]rom on or about
August 25, 2011 through on or about May 9, 2012,
[Respondent] issued controlled substance[] prescriptions to B.B. in violation of Federal . . . law.” ALJ Ex. 1, at 1 (emphasis added). The Show Cause Order then alleged that Respondent was “
aware on each of the occasions that [he] issued controlled substance[] prescriptions
to B.B. that he presented a high risk of abuse and/or diversion of controlled substances, as evidenced by the red flags documented in his patient file,

such as aberrant

urine drug tests.” Id.

(emphasis added). And the Order then alleged that Respondent “failed to address and, in fact, ignored these red flags, continuing to issue B.B controlled substance prescriptions in the face of mounting evidence that he was misusing, abusing, and/or diverting the controlled substances you were prescribing.”
Id.

In the allegations regarding the August 25, 2011 prescriptions, the Show Cause Order provided a detailed recitation of the factual basis for the allegation that the June 1, 2011 UDS was aberrant and that this “should have indicated . . . that B.B. may have been misusing/abusing the alprazolam by consuming more than he had been prescribed, or diverting it.”
Id.
at 2. As for the September 22, 2011 prescriptions, the Show Cause Order, after setting forth the factual basis for why the August 25 UDS was aberrant, proceeded to allege that Respondent “did not address with B.B.
the now second aberrant drug screen in an approximately three month period,
despite noting in the record that you had `extensively reviewed' B.B.'s `[p]ast medical history.' ”
Id.
at 3 (emphasis added). The Show Cause order then alleged that “[y]ou took no other steps to monitor B.B.'s controlled substance use, such as requiring him [to] take another drug screen
due to the two failed ones,
conducting a new [prescription monitoring report] check, or requiring him to submit to a pill count.”
Id.
(emphasis added).

In setting forth the allegations with respect to the October 6 and 20 prescriptions, the Show Cause Order alleged that “[y]ou still did not address with B.B.
the two aberrant drug screens”
and “[y]ou still had not confronted B.B. about
the two aberrant drug screens”
respectively.
Id.
at 4 (emphasis added). And with respect to the subsequent prescriptions, the Show Cause Order made multiple allegations such as that: (1) Respondent “did not take any steps to monitor [B.B.'s] controlled substance[ ] use despite his history of misusing, abusing, or diverting controlled substances” (Nov. 18, 2011 prescriptions); (2) “despite [B.B.'s] history of substance misuse, abuse, and/or diversion, you did not take appropriate steps to monitor his controlled substance use before issuing him these new prescriptions” (Jan. 19, 2012 prescriptions); and (3) Respondent again prescribed controlled substances “without taking appropriate steps to monitor [B.B.'s] controlled substance use despite the persistent red flags of abuse and diversion he previously presented” (Mar. 13, 2012 prescriptions).

Likewise, in its Pre-hearing Statement, the Government provided notice that “Dr. Owen [its Expert] will testify that [Respondent] should have been aware from documentation in B.B.'s file of red flags that B.B. may have been abusing or diverting controlled substances prior to transferring his treatment to” Respondent (the period in which the June 1 UDS was obtained), as well as notice setting forth the factual basis as for why the June 1 UDS was aberrant. ALJ Ex. 5, at 10, 12-13. With respect to the September 22, 2011 prescriptions, the Pre-hearing Statement provided notice that the medical file shows that Respondent “never addressed with B.B. this now second aberrant UDS in an approximately three month period, despite noting in the record that [he] had `extensively reviewed' B.B.'s past medical history” and that Respondent “took no other steps to monitor B.B.'s controlled substance use, such as requiring him to take another UDS
due to the two failed ones.” Id.
at 14 (emphasis added).

Moreover, with respect to the October 6 prescriptions, the Pre-hearing Statement provided notice that “Dr. Owen will testify that on this visit [Respondent] again failed to address with B.B. the two aberrant UDSs,” and with respect to the October 20, 2011 prescriptions, “the record lacks documentation that . . . he confronted B.B.
about the two aberrant UDSs.” Id.
at 15-16 (emphasis added). And with respect to the later prescriptions, the Pre-hearing Statement provided notice that Dr. Owen “will testify” that Respondent “also failed to take any steps to monitor B.B.'s controlled substances use despite B.B.'s history of misusing, abusing, or diverting controlled substances.”
Id.
at 16.
See also id.
at 17 (Jan. 19 prescriptions; “Dr. Owen will testify that despite the fact that this was B.B.'s first visit . . . in three months, and despite his history of substances misuse, abuse, and/or diversion, [Respondent] failed to take adequate steps to monitor B.B.'s controlled substance use before issuing him these new prescriptions”);
id.
at 19 (Mar. 13 prescriptions; providing notice that “Dr. Owen will testify” that Respondent again issued controlled substance prescriptions “without taking appropriate steps to monitor B.B.'s controlled substance use despite the persistent red flags of abuse and diversion he previously presented”).

Thus, the Show Cause Order's allegations and the Pre-Hearing Statement's disclosure of the expected testimony provided Respondent with more than adequate notice that the results of the June 1, 2011 UDS and his failure to address it would be at issue throughout the proceeding. And even if I concluded otherwise, the record is clear that the issue was litigated by consent.

Notably, during its direct examination of Dr. Owen regarding the September 22, 2011 prescriptions, the Government asked Dr. Owen the following questions:

Q. Would the aberrant urine drug test from June 1 have shown up in a review of the history?

A. Yes.

Q. Would the aberrant drug test from August 25, 2011, have shown up in the history?

A. Yes.

Q. And were those aberrant drug tests part of this medical file as you received it?

A. Yes, it [sic] was.

Q. What—how does [Respondent] address the aberrant drug tests in this 9/22 patient file note[]?

A. It's [sic] completely ignored.

Q. What steps should [Respondent] have taken regarding the aberrant drug screens?

A. He should have acknowledged their existence and then taken some corrective action.

. . . .

Q. Does it appear that [Respondent] took any safeguard regarding the potential for diversion or abuse with the aberrant drug screens?

A. No.

Tr. 132-33.

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

7

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

three previous.”);
id.
at 165-66 (Apr. 12, 2012 Rxs Q. “Did he address any of the previous aberrant drug screens?” A. “He did not.”). Significantly, at no point did Respondent object to the questioning or testimony.

Indeed, Respondent's counsel raised the issue when, in Respondent's case-in-chief, she asked him: `Do you recall if you looked back at the previous drug tests?”
Id.
at 283. Respondent answered: “I don't recall, but I doubt I did” and “I wouldn't expect myself to.”
Id.
Respondent's counsel then asked him if Dr. Schoelen had seen B.B.in June and July after the June 1 drug test, with Respondent answering “[t]hat's correct.”
Id.
Respondent then testified that the test was reported back to his former partner, who saw B.B. on June 29 and July 26, before testifying that he would have “routinely looked at two, three different notes.”
Id.
at 284.

Subsequently, on its cross-examination of Respondent with respect to what he looked at in the chart when he took over B.B.'s care, the Government asked: “Did you see the June 1, 2011, UD[S], urine drug test?”
Id.
at 390. Respondent's counsel raised no objection to the question and Respondent answered: “I don't believe I did.”
Id.
While Respondent then asserted that he “assume[d]” that Dr. Schoelen “addressed every UDS,” when pressed as to whether, based on his review of the file, Dr. Schoelen had ever addressed the June 1 UDS, Respondent answered: “I didn't review his part of the chart.”
Id.
at 390-91.

Thus, Respondent was clearly aware that his failure to address the June 1, 2011 drug test was at issue with respect to the entirety of his controlled substance prescribing to B.B. and in no sense was this “an incidental issue” in the case.
Pergament United Sales,
920 F.2d at 136 (citation omitted). He also had a full and fair opportunity to litigate the issues of whether the June 1 (as well other tests) were aberrant and whether he properly addressed them during the course of his prescribing to B.B. Accordingly, I find the Government's exception well taken and will consider this evidence.
8

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

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

Findings of Fact

Respondent is a family practice physician licensed by the Oklahoma State Board of Medical Licensure and Supervision. RX 1. Respondent graduated from the University of Oklahoma (OU) College of Medicine in 1989. Tr. 231. Thereafter, he did an internship through the OU “Tulsa/Bartlesville program” and “the last two years of his residency” in family medicine at OU in Oklahoma City.
Id.

Respondent testified that upon completing his residency, he practiced family medicine and obstetrics for several years at several rural clinics.
Id.
at 234-35. He further explained that while working at one of the clinics, he was asked to become the medical director of a nursing home for terminal AIDS patients, which he did for approximately five years, after which he and Dr. Steve Schoelen bought a practice in Newcastle, Oklahoma which they named “Tri-City Family Medicine.”
Id.
at 235-36.
9

Respondent practiced family medicine at Tri-City from approximately 2000 through 2012.
Id.
at 245. Respondent further testified that he was board certified in family medicine until 2015.
Id.
at 247. Respondent testified that he could not reapply for board certification because he had not practiced family medicine for several years and does not “qualify to show them my charts . . . to qualify to take the test.”
Id.
at 248.

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

Respondent testified that due to the expense of malpractice insurance for his OB/GYN activities, he stopped delivering babies and focused on family medicine.
Id.
at 249. Respondent testified that he started seeing chronic pain patients around this time, but that Dr. Schoelen mostly saw these patients as he “took much more of an interest in the pain patients and pain management.”
Id.
He further testified that within days of Dr. Schoelen “telling Medicaid that he would accept chronic pain patients on Medicaid, we were overwhelmed with referrals from the emergency rooms . . . in Oklahoma City.”
Id.
at 253. According to Respondent, in response, Dr. Schoelen took continuing medical education (CME) classes and joined the American Academy of Pain Management.
Id.
The clinic also started using a pain management contract and contracted with a company for urine drug testing.
Id.
at 254.

Respondent testified that he did drug screens “every three months” and that any patient who received more than two Lortabs (hydrocodone with acetaminophen) a day would be subject to “the guidelines of our pain management contract and rules.”
Id.
at 256. Respondent further asserted that “[s]ometimes we [would] send [patients] for a second opinion” or for a “modality that we didn't do” such as “an epidural or [a] further evaluation if something changed in their pain something changed neurologically.”
Id.
He testified that he would obtain a Prescription Monitoring Program report for “[e]very phone call for every prescription and every office visit.”
Id.
at 263. He also testified that the practice did not replace lost or stolen medications and that he had terminated a substantial number of patients over the years.
Id.
at 279-80.

The Investigation

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

In the meantime, the Chief Investigator, who was familiar with Respondent's background because the latter “was on probation at that time for an incident that involved sexual misconduct,” obtained a report from the Oklahoma Bureau of Narcotics Prescription Monitoring Program to “see any prescriptions that were prescribed by [Respondent] to” B.B.
Id.
at 18-19.

The report showed that Respondent had written “numerous controlled drug prescriptions” for B.B.
Id.
at 19.

After reviewing the PMP report, the Chief Investigator notified the Board's Executive Director of his findings,
id.
at 21, who, on May 11, 2012, ordered the summary suspension of Respondent's medical license.
Id.; see also
RX 3, at 3. The same day, the Chief Investigator went to Respondent's clinic to obtain B.B.'s record, interview Respondent, and serve the suspension order on him.
Id.
at 21. While Respondent was not at the clinic, the Chief Investigator spoke with him by phone and made arrangements to return on May 14 (a Monday); the Chief Investigator also took B.B.'s chart.
Id.

On May 11, 2012, the DI and two Detectives interviewed B.B., who “confirmed that he was” Respondent's patient.
Id.
at 48. B.B. admitted that “he used the Opanas [oxymorphone]
10

himself” but “denied that he snorted them.”
Id.
B.B. explained that “[h]e crushed them up and put them in an energy drink, which he had in his vehicle . . . when he was found” by the police.
Id.
B.B. also told the Investigators that “[n]ot only was he a user of it, he also sold the medications.”
Id.
After the interview, the DI was informed by the lead Detective that he had spoken to the Board's Chief Investigator and that the Board's Investigators were going to meet on Monday May 14 and go to Respondent's office.
Id.

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

On that day, the Chief Investigator (accompanied by another Board Investigator), the DI and the lead Detective went to Respondent's clinic to interview him.
Id.
25. During the interview, the Board's Chief Investigator confronted Respondent “with some of the sexually graphic text messages sent from his phone to the patient.” RX 3, at 3. While Respondent “admitted that he may have made social comments to [B.B.],” he “would not answer any more questions without contacting his attorney.”
11

Id.
“At that point,” the Chief Investigator asked Respondent “to allow him to examine” his phone “for text messages to” B.B.
Id.
Respondent stated that “his phone was not available because it had been run over with his tractor over the weekend.”
Id.
The Chief Investigator then served the Board's suspension order on Respondent. RX 3, at 3. The DI then informed Respondent that because he did not have state authority, he could not maintain his DEA registration and asked Respondent to voluntarily surrender his registration; Respondent agreed to do so. Tr. 49;
see also
GX 1, at 1.

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

On September 13, 2012, the Board lifted Respondent's suspension.
12

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

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

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

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

Dr. Owen obtained a Bachelor of Science in chemistry and biology from Texas State University in 1985 and a Doctor of Medicine from the University of Texas Health Science Center (Houston) in 1990.
Id.
at 89-90; GX 4, at 1-2. After obtaining his M.D., Dr. Owen did a one year internship in internal medicine followed by a three-year residency in Anesthesiology at the UT Health Science Center; he then did a one-year fellowship in Pain Management at the University of Pittsburg's Pain Evaluation and Treatment Center. GX 4, at 1. Dr. Owen holds a Texas medical license and is board certified by the American Board of Pain Management and American Board of Anesthesiology.
Id.
at 2. He is a member of the American Pain Society, the American Academy of Pain Medicine, the American Academy of Pain Management and the Texas Pain Society.
Id.
at 7. With respect to the latter organization, Dr. Owen served on its Board of Directors from 2009 through 2012 and served as its President from 2012 through 2014.
Id.
at 8. He has also served on the Society's Legislative Committee and on its Educational Committee for multiple years.
Id.

Dr. Owen's work experience includes more than 16 years at the Texas Pain Rehabilitation Institute (Sept. 1995 through Nov. 2011), which is an interdisciplinary pain management clinic.
Id.
at 2. Since February 2011, he has been a Peer Reviewer on Pain Medicine for the Journal of the American Academy of Pain Medicine.
Id.
He has also served as a member of the Medical Quality Review Panel and as an Arbiter on the Quality Assurance Panel of the Texas Department of Insurance, Division of Workers Compensation, Office of Medical Advisor.
Id.
He has written several articles and made more than 40 presentations on subjects related to pain management before both professional and governmental bodies, including on the use of urine drug testing in pain management.
Id.
at 4-9. The CALJ accepted Dr. Owen “as an expert in pain management in Oklahoma and Texas.” Tr. 91.

While Dr. Owen is licensed to practice medicine in Texas, he testified that he had reviewed Oklahoma's guidelines and policies.
Id.
at 93. Asked what the requirements are in Oklahoma for prescribing opioid controlled substances, Dr. Owen testified: “Well, first you have to do an appropriate history and physical exam for whatever the chief complaint is. You need to get all pertinent previous medical records pertaining to this chief complaint.”
Id.
at 94. As to why a physician needs to obtain the patient's medical records, Dr. Owen explained that: “You want to know what has previously been performed as far as treatment elements and what resulted from those

treatments,
and you also want to look for any previous aberrant behaviors.” Id.
(emphasis added).

The Government then asked Dr. Owen “what else is required?”
Id.
Dr. Owen explained: “So after you do an appropriate history and physical exam, you review the pertinent medical records. You may need to do consultations. You may need to do diagnostics, whether laboratory or imaging studies, and then you formulate a treatment plan based on the analysis of this information.”
Id.
at 94-95. Asked to explain “[w]hat's a treatment plan,” Dr. Owen testified: “A treatment plan is what we're going to do to move this person from wherever they are to the next place, and part of the treatment plan will be dictated by your treatment goals that you need to set up to try to get that person to the next place.”
Id.
at 95.

Subsequently, Dr. Owen explained that “there [are] three broad treatments in pain management: Interventional, rehabilitative, and pharmaceutical. So your treatment plan would list each of these categories if you're going to use elements of those categories in your treatment plan, and it would specifically define what your treatment plan is and how you tie it to your treatment goal.”
Id.
at 97. Dr. Owen further testified that while treatment goals are “tailor[ed] . . . to the individual” and would be different depending upon a patient's age, “you would primarily focus on functional improvements.”
Id.
at 99-100. With respect to someone of working age, Dr. Owen explained that “return[ing] to work” is “the gold standard for functionality in pain management.”
Id.
at 100.

Subsequently, Dr. Owen testified that a treatment plan can involve more than one of these approaches and that it evolves over the course of treating the patient if the treatment goals are not being achieved.
Id.
at 98-99. However, a physician “certainly would have [a treatment plan] on the initial visit.”
Id.
at 99. While Dr. Owen acknowledged that a treatment plan can be “tease[d] . . . out” of the patient's record “without necessarily a formal title” if “enough information” is documented in the record, he then explained what content the plan should contain:

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

Id.
at 98-99.

Asked whether the file for a patient being prescribed opioid controlled substances would contain anything else, Dr. Owen testified that you would “have an informed consent and a pain management agreement.”
Id.
at 99. Dr. Owen then explained that “[a]n informed consent is telling the patient what the risks and benefits are of this proposed treatment and what alternative treatments exist.”
Id.

As to why a physician treating a patient for pain would seek consultation with other specialists, Dr. Owen testified that “[t]hese are complex cases, and you can't be an expert of everything, and you may need help in narrowing your diagnosis or help in stabilizing comorbidities that are outside of your scope of practice.”
Id.
at 100. Dr. Owen further explained that the need to consult with particular specialists “depends on the [patient's] chief complaint and your differential diagnosis and what you're trying to achieve.”
Id.

Asked by the Government if “these requirements . . . are . . . best practices,” Dr. Owen testified that “some of them can be best practices, but most of them are standard of care items.”
Id.
at 100-01. Then asked if “when you say standard of care, are they required,” Dr. Owen explained that “they're required based on the context of the chief complaint and . . . the facts of the situation.”
Id.
at 101. When then asked “are they required by law,” Dr. Owen initially answered “no” before explaining that:

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

Id.

Dr. Owen testified that “comorbid psychiatric conditions” include “depression, anxiety, maladaptive coping mechanisms, such as catastrophization, fear avoidance, disability conviction, and a sense of injustice,” which are “all built on a foundation of cognitive distortions.”
Id.
at 101-02. He also testified that there are “personality disorders and a whole host of psychiatric conditions like PTSD, OCD, bipolar, schizophrenia, [and] other scenarios like that, that make it more difficult to treat” a pain patient.
Id.
at 102. Dr. Owen then explained that these conditions “might magnify [a patient's] perception of pain and disability and, in doing so, [a patient's] experience of suffering is aggravated or increased.”
Id.

The CALJ then asked Dr. Owen if the reason it is important to refer a pain patient to a mental health expert is so that the patient's “subjective complaint[] of pain” can be “properly gauged?”
Id.
at 103. Dr. Owen answered: “So that you can help understand the context of their pain and what might be distorting and magnifying their pain and suffering experience, because suffering is defined as your ability to cope with adversity, and everybody comes with different skill sets of how they cope with adversity.”
Id.
at 103-04. While Dr. Owen then acknowledged that “[p]ain is subjective,” he further explained that “function is objective, so that's why [a physician would] use functions as [the] primary baseline for measuring therapeutic influence.”
Id.
at 104.

The CALJ then asked Dr. Owen if “ask[ing] the patient about activities of daily living” is “one of the tools that you use?”
Id.
Dr. Owen answered “yes” and added “[t]hat's one of the things. Return to work, and you can do more global things like sitting tolerance, walking tolerance, standing tolerance, and then site-specific areas of functionality like range of motion and other physical exam measurements.”
Id.
at 104.

Dr. Owen was then asked to describe “the steps that a practitioner would take to determine whether a patient is truly experiencing chronic pain?”
Id.
at 106. He replied:

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

Id.
at 107.

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

treatment, noting that

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

13
Dr. Owen explained that “evidence-based studies are studies published in peer review articles that actually show positive outcomes for the treatment, and ideally these treatments are

compared to some kind of either non[-] treatment or a sham treatment.” Tr. 108.

Asked whether it is “permissible to taken on a patient who's already on high-risk treatment and to continue them on high-risk treatment,” Dr. Owen testified that while a physician “can do that,” the physician must “adequately document the justification for skipping steps,”
i.e.,
low-risk
14

and medium risk treatments, and must “make sure that [the patient is] obtaining a clinically meaningful and objective therapeutic outcome.”
Id.
at 109. He then explained that this means that the patient is “having functional improvement that is truly measurable” and that a patient's “subjective report is problematic.”
Id.
And later, Dr. Owen testified that even when the care of a patient is transferred from one doctor to another in the same practice, the new doctor “need[s] to make sure that any previous documentation deficiencies or standard of care violations are rectified by doing a proper evaluation.”
Id.
at 206.

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

Next, the CALJ asked Dr. Owen what, as a chronic pain specialist, he would look at to determine if a patient who was referred to him was being successfully treated with long-term opioid therapy.
Id.
at 109. Dr. Owen answered that he would “first go to the previous medical records to see what functionality was documented before [the patient was] started on that treatment and compare it to” the patient's current “functionality.”
Id.
Asked by the CALJ if “those would be subjective notes,” Dr. Owen explained that “if someone is not working and now they are working, although they're subjective notes, there is an objective measure to it” and that “[w]henever possible, I like information from friends or family that's with the patient about [the patient's] functionality and what it was like, so there's an independent assessment.”
Id.
at 109-10. Continuing, Dr. Owen explained that there are also “various psychometric tests on functionality, [including the] Oswestry Disability Inventory and other things like that, that measure your function in somewhat objective terms.”
Id.
at 110. However, Dr. Owen acknowledged that “it all comes down to [the patient's] self-report.”
Id.

The CALJ then asked Dr. Owen if there are “tests that are traditionally done in the office, such as . . . range of motion and other things . . . that have an objective sense to them?”
Id.
Dr. Owen answered that while “you can measure range of motion of the various joints and spine, and you can look at muscle strength and those kinds of issues . . . they don't always correlate to your ability to work and other more global functionality.”
Id.
Dr. Owen also explained that in evaluating the patient's functionality, “[y]ou want to look at [the] neurological assessment. You want to look at [the] straight leg raise. You want to look at spine range of motion, and you want to ask [the patient] how far can you walk; how long can you sit, and those kinds of functional assessments as well.”
Id.
at 111.

Next, the CALJ asked Dr. Owen if on taking over a long-term opioid therapy patient, it is “generally true that [the patient will be] continue[d] on the . . . regimen?”
Id.
In response, Dr. Owen testified that he would not continue the regimen if the patient is “not clinically improved from the results of this treatment.”
Id.
Continuing, he explained that “[a] lot of people deteriorate on chronic opioid therapy and they actually do better when they're taken off of opioids” because they have “opioid-induced hyperalgesia.”
Id.
Dr. Owen then explained that this “is a paradoxical response in which [a patient's] pain gets worse while [he/she is] on opioids, and when [the patient is] take[n] off of the opioids, [his/her] pain improves.”
Id.

Dr. Owen further testified that there is a difference between addiction and dependence.
Id.
at 112. After noting that “dependency will happen to anybody over time in which an abrupt cessation of the drug will cause withdrawal symptoms,” he explained that “addiction has three [additional] elements: Craving the drug, continued use despite its harms, and inability to self regulate” the use of the drug.
Id.
at 112-13. Asked how he would tell whether a patient he had “just assumed the care of” was dependent or addicted, Dr. Owen explained that an addicted patient “may have self-escalation of [his/her] drugs, and . . . run out early.”
Id.
at 113.

Dr. Owen then explained that a physician “would use urine drug testing to see if [the patient] ha[s] all the drugs that were prescribed in [his] urine.”
Id.
The physician would also look for “other aberrant drug-taking behaviors” such as “lost medicines” and use the prescription monitoring program to look for “doctor-shopping . . . or other concerning activities.”
Id.
Dr. Owen further explained that “[y]ou would, when possible, talk to the family and see how [the patient's] behavior is” as well as “look for volatile behavior . . . with your staff.”
Id.; see also id.
at 117-18 (testifying that “problematic behaviors” or “red flags” include “[l]ost or stolen medications, self-escalation of . . . medications without permission, aberrant urine drugs tests, [PMP] behaviors that look problematic,” and receiving reports that a patient is selling drugs).

While Dr. Owen acknowledged that the presence of suspicious behavior by a patient does not necessarily mean the patient is abusing or diverting controlled substances, it does require that the physician take “some type of corrective action.”
Id.
at 118. As for what type of action should be taken, Dr. Owen explained that “[i]t depends on the context” and that “there's a spectrum of corrective actions . . . you might take . . . from shortening the leash and seeing the patient more frequently, with less drugs per prescription,” to not treating with controlled substances, “to firing the patient.”
Id.
at 118-19.

Dr. Owen disputed the CALJ's suggestion that the use of urine drug screens is “pretty controversial in the pain management field,” stating that “[i]t's a standard of care.”
Id.
at 113. After explaining that he would set the frequency of drug testing based on a risk assessment of the patient, Dr. Owen acknowledged that the “point of care” enzyme-amino assay test is a “preliminary test” and that “[y]ou can't use the results with any confidence.”
Id.
at 114-15. Dr. Owen explained, however, that “the mass spectrometry test . . . is very reliable.”
Id.
at 115. Dr. Owen further testified that a physician would “want to test for common illicit substances, because you don't just want to know what you're prescribing” and would want to know if the patient is using “non-prescribed drugs or any street drugs.”
Id.

Asked how a practitioner should respond to an aberrant drug test, Dr. Owen testified that “first you need to document the presence of the aberrant . . . test. You need to document your rationale for your corrective actions. And then you explain what the corrective action is going to be.”
Id.
at 119. Dr. Owen then reiterated his earlier testimony that “the corrective action” could be “seeing the patient more frequently with less drugs”; referring the patient to see an addictionologist or a psychiatrist or psychologist “with experience in addiction medicine” for a consultation; having the patient see a physical medicine specialist “to look at more functional goals”; and in severe cases, terminating treatment with

controlled substances.
Id.
Dr. Owen also testified that “[t]here's no reason ever to ignore a red flag” and that a physician has a duty to resolve the red flag before prescribing.
Id.

Returning to the issue of what constitutes an adequate medical history, Dr. Owen testified that:

. . . it's a history that's appropriate for whatever the chief complaint is, for example, low back pain. It includes a who, what, when, why, where, and type of elements that you would do in most any kind of a journalism course.

So you'd say, how did you hurt yourself; where does it hurt; does the pain radiate down an extremity; if so, how far down; does it go past the knee; where does it end up; is there any numbness or weakness associated with it. And then you would talk about what treatments have you had or what diagnostics have you had.

And you'd gather as much of that information, and you'd ask . . . how's the pain affecting you physically and psychosocially. And that's part of the Oklahoma guidelines is that you assess the person functionally, physically and psychosocially.

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

Continuing, Dr. Owen explained that:

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

Id.
at 117.

Asked by the CALJ to explain what a pain management contract is, Dr. Owen testified that it's “a document informing the patient what the rules of the road are.”
Id.
at 120. Dr. Owen testified that the contract contains provisions that the patient “won't get drugs from anybody else . . . for th[e] condition,” the patient “will only go to one pharmacy,” that the patient “will use the drugs only as directed,” and the patient will “submit[ ] to urine or blood drug testing.”
Id.
Then asked by the CALJ if, in Oklahoma, the use of a pain management contract is a “best practice” or part of the “standard of care,” Dr. Owen testified that it “is part of the [Oklahoma] guidelines of [the] standard of care.”
Id.
Dr. Owen also testified that “when taking on a new patient,” a physician “needs to have a pain management contract and informed consent.”
Id.
at 121. Finally, when asked by the CALJ where “there is a difference” between the standard of care for “a pain management specialist and someone who is treating a patient . . . for pain symptoms,” Dr. Owen explained that “[t]here's only one standard of care.”
Id.
at 120-21.

On cross-examination, Dr. Owen was asked whether a prescriptive practice can “be within . . . legitimate medical practice and still be below the standard of care?”
Id.
at 181. In response, Dr. Owen testified that a physician “can violate the standard of care and still have a legitimate medical practice, but [cannot] be in the standard of care and have an illegitimate medical practice.”
Id.
When later asked “[w]hat goes into determining if the standard of care has been met,” Dr. Owen testified that “the standard of care is what a reasonable and prudent physician would do in the same or similar circumstances, and a reasonable, prudent physician would go to the evidence-based literature as a foundation for how to make decisions using critical thinking skills.”
Id.
at 183. When then asked “if there's a community standard of care in Oklahoma,” Dr. Owen answered that “[t]here's no such thing as a community standard of care anymore. It's a national standard of care, and it's based on our evolving body of knowledge, and as we learn new things, the standard changes.”
Id.
Dr. Owen then acknowledged that he did not know the Oklahoma Medicaid rules for when a patient can be referred.
Id.

On further cross-examination, Dr. Owen was asked whether the Oklahoma Guideline which addresses the need for consultation with an expert in the management of patients who have a history of substance abuse or a comorbid psychiatric disorder is mandatory as he had previously testified.
Id.
at 185-86. Dr. Owen acknowledged that the provision states that these two conditions “may require” consultation.
Id.
at 186. He then added, however, that a physician “should document why [he] deviate[d] from that recommendation.”
Id.

The Prescribing Events

The August 25, 2011 Prescriptions

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

GX 3, at 24.

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

B.B. was not seen by either Dr. Schoelen or Respondent on this day. GX 3, at 49. However, he was required to provide a urine sample, the results of which were reported by the lab on August 29, 2011.
16

Id.
at 99. While the lab results were expected with respect to the narcotics B.B. had previously been prescribed, the lab also detected the presence of nordiazepam, a metabolite of diazepam; oxazepam; and temazepam; none of these drugs had been prescribed to B.B.
17

Id.

16
On June 1, 2011, B.B. had also provided a urine sample. GX 3, at 103. This test, which was reported by the lab on June 6, 2011, yielded a negative result for alprazolam, even though B.B. was then being prescribed alprazolam by another physician.
Id.
According to a PMP report, B.B. had filled alprazolam prescriptions for a 30-day supply on both May 9 and June 6, 2011.
See id.
at 25.

17
While the lab results also noted that B.B. had tested positive for alpha-hydroxyalprazolam, a metabolite of alprazolam, and reported this result as “not expected based on prescribed medications,” B.B. had obtained a prescription for a 30-day supply of alprazolam on July 29, 2011 and filled the prescription the same day. GX 3, at 36.

While the Government alleged in the Order to Show Cause that the prescriptions Respondent issued on this day were “invalid” and violated 21 CFR 1306.04(a) and made extensive factual allegations to support this conclusion, it did not elicit any testimony from its Expert as to why. Moreover, Respondent testified that this was “a nurse-only visit” and that he issued the prescriptions because “Dr. Schoelen works half [a] day” and while Schoelen had issued one of the prescriptions, “he had missed the fact that—or the nurses had missed and not written the other two medications for him.” Tr. 389. The CALJ found this testimony credible. R.D. at 31.

As the Government put forward no evidence to support the conclusion that it was outside of the usual course of professional practice for Respondent to cover for his partner, nor cites to any state rule prohibiting prescribing under this circumstance, I find that the allegation is unsupported by substantial evidence.
18

18
In its Exceptions, the Government argues that the CALJ erred in finding the allegation with respect to the August 25, 2011 prescriptions not proved.
See
Exceptions, at 44-47. It argues that because Respondent issued the prescriptions without seeing B.B. on that date, without having

seen him previously, and without reviewing the PMP, and because he testified that he reviewed only B.B.'s “medical history and the last two office visit notes” made by Dr. Schoelen, the “issuance of the two prescriptions fell far below the standard of care and outside the usual course of practice.”
Id.
at 46.

As noted above, the Government elicited no testimony from Dr. Owen as to whether Respondent's issuance of the prescriptions was below the standard of care or outside of the usual course of professional practice. Apparently, the Government relies on subsection 1 of the Board's chronic pain rule,
see
Okla. Admin. Code § 435:10-7-11(1), which requires that “[a] medical history and physical examination . . . be obtained, evaluated and documented in the medical record” in order to prescribe a controlled substance.
See
Exceptions, at 45 (arguing that “the OK Pain Rule sets forth the standard of care for Oklahoma prescribing controlled substances . . . for the treatment of pain”).

However, in 2014, the Board promulgated an exception to the requirement that “[t]he physician/patient relationship shall include a medically appropriate, timely-scheduled, face-to-face encounter with the patient,” which allows “providers covering the practice of another provider [to] approve refills of previously ordered medications if they have access to the medical file of the patient.” Okla. Admin. Code § 435:10-7-12(1). While this rule was not in effect when Respondent issued the prescriptions, it strains credulity to suggest that providing prescriptions under the circumstances of covering for a partner violated the standard of care two years earlier when Respondent issued the prescriptions. While the Government speculates that Dr. Schoelen “may not have issued B.B. these two prescriptions purposefully pending the results of the new UDS,” Exceptions at 46, and argues that Respondent was required to call Dr. Schoelen as a witness to corroborate his testimony, the Government ignores that it had the burden of proof on this issue.

The September 22, 2011 Visit and Prescriptions

On some date after August 25, 2011, the State Board suspended Dr. Schoelen's medical license and Respondent took over the treatment of B.B., who came for an office visit on September 22, 2011. Tr. 290; GX 3, at 48.
19

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

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

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

Id.
at 28.

20
In contrast to this document which contains a single box in which Respondent and Dr. Schoelen would write a number for B.B's pain (the “Patient Completed . . . updated pain scale”), B.B.'s file contains a “Patient Comfort Assessment Guide” form which B.B. completed on September 2, 2009. GX 3, at 32-33. On this form, B.B. circled various words such as “aching,” “throbbing,” “shooting” and “stabbing” to describe his pain which he maintained was “continuous” and at its worst in the “afternoon” and “evening.”
Id.
The form also contains four instructions which directed B.B. to rate his pain on a numeric scale of 0 to 10 (with 0 being “no pain” and 10 being “[p]ain as bad as you can imagine”), at its worst,” “its least,” and “on average in the last month,” as well as “right now.”
Id.
at 32. In addition, the form asked “[w]hat makes your pain better,” “what makes your pain worse,” as well as “what treatments or medicines are you receiving for your pain,” and it further instructed the patient to numerically rate the relief he obtained (again on a 0 for “no relief', to 10 for “complete relief” scale) from the treatment or medicine.
Id.

On the form's second page, it asked “[w]hat side effects or symptoms are you having,” and directed B.B. to “[c]ircle the number that best describes your experience during the past week,” again using a 0 (“Barely Noticeable”) to 10 (“Severe Enough to Stop Medicine”) scale for 10 side effects and symptoms such as nausea, vomiting, constipation, lack of appetite, difficulty thinking and insomnia. And finally, the form directed B.B. to “[c]ircle the one number”—on a scale of 0 for “not [i]nterfer[ing]” to 10 for “[c]ompletely [i]nterfering”—which “describes how during the past week pain has interfered with” his “[g]eneral [a]ctivity,” “[m]ood,” “[n]ormal work,” “[s]leep,” “[e]njoyment of [l]ife,” “[a]bility to [c]oncentrate,” and “[r]elations with [o]ther [p]eople.”
Id.
Of note, there is no evidence that B.B. was required to complete this form at any subsequent visit.

Dr. Owen testified that because this was B.B.'s first visit with Respondent, Respondent should have “do[ne] a proper history and physical exam and review[ed] previous treatments and everything that typically is expected for a new patient evaluation.” Tr. 131. According to Dr. Owen, this included reviewing B.B.'s patient file which included the aberrant June 1 and August 25, 2011 drug tests.
Id.
at 132.

With respect to the August 25 drug test, Dr. Owen testified that B.B. had previously received prescriptions for alprazolam, hydrocodone, Soma (carisoprodol) and oxymorphone.
Id.
at 130. As found above, each of these drugs (or its metabolites) was detected by this test.
Id.
Dr. Owen then noted, however, that there were “no prescriptions for the metabolites of diazepam, which is nordiazepam, or oxazepam or temazepam.”
Id.
And he further noted that in the comment section with respect to these three drugs, the lab report stated that “[t]hese test results were not expected based on the [prescribed] medications.”
Id.

Dr. Owen testified that Respondent “completely ignored” the aberrant drug screens and “should have acknowledged their existence and then taken some type of corrective action.”
Id.
at 132. Dr. Owen also testified that the patient file did not reflect that Respondent had consulted or discussed B.B. with past or current prescribers and that it did not appear that Respondent had taken any “safeguards regarding the potential” for diversion or abuse presented by the aberrant drug screens.
Id.
at 132-33.

Dr. Owen then testified that the patient record did not justify the prescribing of controlled substances as it did not “establish medical necessity for this type of treatment.”
Id.
at 133. As the basis for his conclusion, Dr. Owen explained that:

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

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

looked at being much more careful and objective about how [he] measure[d] a therapeutic benefit with the controlled substances.”
Id.
Dr. Owen thus opined that the prescriptions Respondent provided at this visit were not issued in the usual course of professional practice and lacked a legitimate medical purpose.
Id.
at 133.

On cross-examination, Dr. Owen was asked if he considered Respondent's ordering of an MRI at this visit to be “a safeguard.”
Id.
at 188. Dr. Owen initially answered “no,” before explaining that “[i]t depends [on] if you clinically need the MRI, and you only need the MRI if you're looking for something that has potentially a surgically correctable lesion,” and that absent “a clinical finding” that suggests “an MRI is needed to confirm a lesion that's surgically reversible . . . you don't have medical necessity to get an MRI.”
Id.
Dr. Owen further explained that “MRIs have high false positive rates” and that “[a]bnormalities are commonly found in asymptomatic people.”
Id.
On questioning by the CALJ as to whether when a patient complains of “a high subjective level of pain,” an MRI could “at least confirm [if] there was some objective basis for it,” Dr. Owen explained that “without a neurological finding,” it is “rarely . . . valuable to get an MRI.”
Id.
at 189. He further explained that MRIs show “abnormalities that are nonspecific” leading to “overtreatment,” and thus a physician “need[s] something more objective from a physical exam finding to get an MRI.”
Id.

In response to a further question by the CALJ which posited whether an MRI would provide an objective basis such as “foraminal narrowing” or “spondylosis” for concluding that a patient “may be having a spine issue” and is not “making it up,” Dr. Owen explained that “foraminal stenosis or foraminal narrowing are common in asymptomatic people.”
Id.
at 190. Dr. Owen then explained that “[t]he only reason it would be important is if you have a radiculopathy you've identified on clinical exam . . . and that would be pain going down the leg in a dermatome distribution, typically below the knee.”
Id.
Continuing, Dr. Owen explained that there may be “numbness” and there may be “weakness associated with the isolated nerve that's being entrapped, and you would have a positive straight leg raise.”
Id.

Dr. Owen further noted that “almost all the exams” on B.B. “said it was negative straight leg raise” and that this is “the most sensitive physical finding for low back pain.”
Id.
Dr. Owen then explained that “a sensitive test means that if you don't have a positive finding you don't have that diagnosis.”
Id.
Moreover, Dr. Owen testified that even if a patient reported symptoms consistent with radiculopathy, “you'd want physical exam findings, with the most important being the straight leg raise, according to the North American Spine Society.”
Id.
at 191. Dr. Owen further explained that “if you had a negative straight leg raise, then you don't have radiculopathy, and if you don't have radiculopathy . . . you really don't need to get an MRI, because it's just going to lead to finding things that send you on a garden path of overinterpreting the diagnosis.”
Id.

Regarding B.B.'s September 22, 2011 visit and the prescriptions he issued, Respondent testified that the first thing he would do when entered the exam room is look at the Pain Management Treatment Plan (GX 3, at 28) after which he would “look[ ] at his previous notes.”
21

Tr. 286. According to Respondent, he would ask the patient if he had “achieved [his] objective in the pain medicine contract” and “what [the patient's] pain level is on medicine” and use “a scale of 1 to 10.”
Id.
Continuing, Respondent testified that “then we [would] talk about what their medicines are and what utilization that we would use, what the risks are using the medicines . . . what our plans are, what treatment, what goal we're going to go for, and what we might need to change or initiate in the treatment, and then decide whether [to do] a urine drug screen.”
Id.
at 286-87. Respondent then testified that B.B. “basically said that he had achieved his pain goal and that he was only a 3 to 5 out of 10, that he preferred that we not make any changes or any type of referral at that time, and I did a urine drug screen.”
Id.
at 287. There is, however, no evidence that Respondent did a urine drug screen at this visit.
See
GX 3.

21
However, in discussing the August 25 prescriptions, Respondent testified that “[a]nytime I had to do anything with the chart of Dr. Schoelen's or pain management or anyone that I hadn't seen before, I would look at their last two office notes, and I'd look at their past medical history sheet on the front that's filled out by the physician . . . and then I would look at the PMP.” Tr. 281.

Asked with respect to the August 25 prescriptions if he “looked back at the previous drug tests,” Respondent answered: “I don't recall, but I doubt I did. . . . I wouldn't expect myself to.”
Id.
at 283.

Respondent was then asked by his counsel if he looked back at the August 25 drug screen. Tr. 287. Respondent testified that he “would not” have discussed the results with B.B. because “[b]asically he was on all the medicines he was prescribed, and according to [the lab], if you're on one benzodiazepine, all the other benzodiazepines can appear positive within the drug screen.”
Id.
Respondent then testified that B.B. was “on Xanax [alprazolam] by another provider, and he was also on Ambien.”
Id.
Asked how he knew that B.B. was on both drugs, Respondent testified that B.B. had listed the alprazolam on the intake form he completed at his first visit and while the Ambien was not listed “on his past medical sheet, [it] was on the PMP.”
Id.
Respondent then added that the Ambien was prescribed by B.B.'s psychiatrist.
Id.
at 289. He further maintained that when the practice “started doing pain management, we were getting multiple episodes where patients were denying that they had taken other benzodiazepines,” and when they contacted the lab, the lab told them that Xanax can cross-react and cause a positive result on the mass spectrometry for other benzodiazepines.
Id.
Thus, Respondent maintained that he did not believe this to be an aberrant drug screen.
Id.

Respondent further testified that although he took over the care of B.B., he did not simply continue the same treatment that Dr. Schoelen provided.
Id.
at 290. Rather, he testified that based on his “education and . . . experience, especially with Lortab . . . I found it too addicting to keep people on short-acting pain medicines.”
Id.
at 291. Respondent told B.B. “that there would have to be . . . a change in his treatment, and that I would have to use a long-acting pain medicine and a short-acting only for breakthrough” pain.
Id.
While Respondent continued B.B. on carisoprodol and Opana, he took B.B. off of Lortab “and gave him a two-week trial of the Duragesic patch.”
Id.

Respondent also maintained that B.B.'s “reported pain and his objective” were consistent with the findings on physical examination.
Id.
at 292. He also testified that he had discussed the use of Duragesic and that it, as well as morphine and Opana ER, were the “only long-acting pain medications that” the Oklahoma Medicaid program “would cover” and that Medicaid would only pay for three prescriptions a month.
22

Id.
Respondent further

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

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

testimony as to whether Medicare used the same formulary as the Oklahoma Medicaid program.

As for why he ordered the MRI, Respondent testified that it was the “[s]tandard of care in Oklahoma,” and that while “[h]e had an X-ray done in 2009 that was consistent with his finding . . . [i]f you treat chronic pain . . . patients and [are] audited by the Board or your insurance company [and] you don't have an objective finding in the chart, such as X-rays and MRIs, you're quite . . . the outlier.”
23

Id.
Respondent added that he “wanted to make sure that [B.B.] was consistent with . . . [w]hat he was being treated for and what his exam [sic] and the fact that he was on a Schedule II narcotic.”
Id.
at 293. Respondent then explained that while an MRI might give a false positive, “[if] the pain is consistent with it, it's just one more piece of evidence that gives you a reason to believe that the patient's legitimate and that you're legitimately treating his condition.”
Id.
at 294. Respondent also testified that an MRI provides a baseline should his exam change at a late date.
Id.

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

The October 6, 2011 Visit

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

Id.

24
Respondent found, however, that B.B. was “[a]lert and oriented and in no apparent distress.” GX 3, at 47.

At the visit, Respondent prescribed 30 tablets of Morphine Sulfate ER15 mg B.I.D. (one tablet twice per day), for a 15-day supply. GX 5, at 25. Respondent also recommended that B.B. “[w]ear a corset if at all possible” for his hernia. GX 3, at 47.

Regarding the prescription, Dr. Owen testified (in the words of Government counsel) that it is not “normal practice . . . for patients to dictate the controlled substances they're prescribed.” Tr. 135. Asked “why not,” he explained that a physician must “safeguard the patient against addiction, and you need to do things that are medically necessary, not what patients want.”
Id.
at 135-36. Dr. Owen further testified that “it's a yellow flag for a patient to ask for a drug specifically,” but not necessarily “a red flag” as “it could mean [the patient] had a previous experience with the drug and either found it helpful, or they've had previous experience from the drug from an illicit means.”
Id.
However, because Respondent did not document that he addressed “B.B.'s previous history with morphine” B.B.'s request was “elevate[d] to a red flag.”
Id.
at 136.

Asked what steps Respondent should have taken, Dr. Owen testified that “just the fact that the aberrant urine drug tests were there means that you should get some consultations, because . . . this is a complex issue, and there's behaviors going on that you can't quite understand without a more thorough assessment by mental health providers or addictionologists.”
Id.
at 136-37. According to Dr. Owen, this was so even if B.B. had not asked for morphine.
Id.
at 137.

Here again, Dr. Owen testified that the medical record did not justify the prescribing of controlled substances.
Id.
He explained that:

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

Id.
And again, Dr. Owen opined that the prescriptions “were not” issued in the usual course of professional practice and “were not” for a legitimate medical purpose.
Id.
at 137-38.

Regarding this visit, Respondent testified that B.B. had “report[ed] that his objectives were only fair” and that “[h]is pain level had gone up to a 6 out of 10 on the Duragesic.”
Id.
at 295. Respondent further testified that “[w]e again went over what the rules were and what the Medicaid and the Duragesic and what the risk benefits were. We talked about whether we needed to make a referral at that point or make any other changes.”
Id.
Respondent also testified that B.B. “had a full exam” but that “[t]he MRI was not back yet.”
Id.

As for the statement in the progress note that B.B. “would like to try the Morphine,” GX 3, at 47, Respondent testified that B.B. “did not believe the Duragesic was sufficient and that he wanted to try one of the other medicines that was on the formulary.” Tr. 296. Respondent testified that he did not believe this to be a “red flag” in B.B.'s case because he “had made it very clear to [B.B.] what our choices were” under the Medicaid formulary and “the majority of patients are very concerned [because] Duragesic and morphine are used for dying cancer patients, and why are we putting them on medications for dying.”
Id.
Respondent then testified that he was “sure I told [B.B. that] Duragesic, morphine and Opana ER” were his options.
Id.

The CALJ, observing that “saying the patient requested morphine . . . is kind of a remarkable note,” asked Respondent how his conversation with B.B. went.
Id.
at 298. Respondent answered: “Probably that I didn't like the Duragesic and you suggested that morphine was an option. Can we try the morphine this time. Probably something like that.”
Id.
at 299. Respondent added that B.B. “was not pleased . . . that we changed the Lortab and the Opana, so the fact that I made him do the Duragesic, he was not happy.”
Id.
at 300. Respondent further noted that he “did his exam” and “[i]t was still consistent that he did have left abdominal wall weakness.”
Id.
Respondent explained that “[h]is diagnosis was lumbar disc disease, anxiety, and a questionable upper respiratory infection” and that he “placed [B.B.] on antibiotics.”
Id.
As for his abdominal wall pain, Respondent discussed with B.B. “wearing a corset if at all possible” because he did not “want to confuse his . . . abdominal pain[] with his level of pain because of my change in his pain regimen.”
Id.
Respondent further explained that B.B. “would follow up . . . in two weeks” and was given only “a two week supply of his new Schedule II medicine.”
Id.
According to Respondent, “anytime [he] made a large change in [a patient's] medications, [he] would only give a two-week” supply in the event the patient was “allergic to it,” was “going to abuse it,” or “got no pain relief whatsoever.”
Id.
at 302.

Respondent also testified that he had given B.B. a shot of Decadron, a steroid, which “sometimes” provides patients in “severe pain” with “significant relief” and is “a great indicator that [the patient's] pain was more inflammatory than other nature.”
Id.
at 301.

The October 20, 2011 Visit

B.B. again saw Respondent on October 20, 2011. GX 3, at 46. According to the progress note, B.B. reported that “his stress [was] up,” that he had “los[t] his father, and “he [was] having a lot of grief.”
25

Id.
Respondent again noted that B.B.'s “[p]ast medical history [was] extensively reviewed and placed in chart.”
Id.

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

As for the physical exam, Respondent noted that B.B. had “[l]ow back paraspinal and spinal tenderness” and a “[n]egative straight leg raise, but [that] lying down and sitting up cause him a lot of pain.”
Id.
He also noted “[n]euro intact.”
Id.
Respondent again diagnosed B.B. with “[l]umbar disc disease” and added a further diagnosis of “[a]cute grief.”
Id.
Respondent documented that he discussed the “[a]ddictive, dependence, and tolerance nature of the medicines as well as alternatives,” that he suggested “[n]on-medicinal pain-relieving modalities,” and that the follow-up would be either “p.r.n.” (as needed) or “three months per his pain contract.”
Id.
Respondent also issued B.B. new prescriptions for 120 Opana 10 (one tablet every 6 hours P.R.N. for breakthrough pain) and 90 Morphine Sulfate ER 15, increasing the dosing of the latter drug to one tablet in the morning and two tablets in the evening.
Id.; see also
GX 5, at 19, 22.

With respect to the statement in the progress note that B.B. was having a lot of stress and grief, Dr. Owen testified that this “magnifies the perception of pain and disability” and that because there were previous “aberrant behaviors going on and now . . . another stressor in [B.B.'s] life,” this “increase[d] the risk” that B.B. would “use [the] drugs to chemically cope.” Tr. 139. Dr. Owen then explained that Respondent should have “sought psychological counseling for” B.B.
Id.
Based on there being “no documentation of [Respondent] taking additional steps,” Dr. Owen concluded that he “did not” do that.
Id.
at 140.

Dr. Owen also testified that Respondent's notation that “[n]onmedicinal pain-relieving modalities suggested” lacked sufficient detail before rhetorically asking: “What does that mean, nonmedicinal modalities suggested?”
Id.
at 209-10. Continuing, Dr. Owen explained:

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

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

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

Id.

Regarding this visit, the CALJ asked Dr. Owen if Respondent's notation that “[n]egative straight leg raise, but lying down and sitting up causes him a lot of pain” had “any significance?”
Id.
Dr. Owen replied: “[I]t doesn't—it's not objective [in a] neurological kind of sense, but it definitely contributes to the idea that it's not therapeutic on his controlled substances, because he's having a lot of pain, lying down and sitting.”
Id.
When then asked by the CALJ, “[h]ow about the negative straight leg raise part of it?” Dr. Owen answered: “[t]hat means he cannot have a radiculopathy. There's not likely anything surgically going on.”
Id.
at 211.

Dr. Owen again testified that the medical record did not support the prescribing of controlled substances.
Id.
at 140. He testified that: “[a]s previously discussed, there's an inadequate evaluation going on. There's a lack of medical necessity to continue treatment with controlled substances since there's no therapeutic benefit. And if you don't have medical necessity, you can't have a legitimate medical purpose for using controlled substances.”
Id.

Respondent testified that the “most remarkable” thing in the October 20 progress note was that B.B.'s blood pressure had gone up and that B.B. was also “wanting to know about his MRI report.”
26

Tr. 305. Respondent then testified as to the various entries in the October 20 note including B.B.'s report of having “lost his father” and “having a lot of grief.”
Id.
According to Respondent, B.B.'s “exam was still exactly like before, with low back paraspinal and spinal tenderness, but he still had the negative straight leg raises. But laying down and sitting up still caused him a lot of pain.”
Id.

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

Continuing, Respondent testified that he diagnosed B.B. with acute grief and lumbar disc disease and that he increased his Morphine to two pills or 30 milligrams in the evening while keeping his Opana for breakthrough pain.
Id.
He also testified that he warned B.B. about “the addictive, dependence and tolerance natures” of the medications and “suggested that he continue using his non-pain [sic] relieving modalities.”
Id.
Respondent did not, however, offer any further explanation as to what those modalities involved. Respondent then testified that he determined the follow-up would be in “three months” as he “felt like [B.B.] could really go into the three-month” schedule for being seen by him.
Id.
at 305-06. However, at this visit, Respondent did not document whether B.B. was achieving his treatment objective or that he had obtained a numeric rating from B.B. as to his pain.
See
GX 3, at 28.

On October 21, 2011, the day after this visit, B.B. had an MRI done of his lumbar spine.
Id.
at 19. The Radiologist reported his impression as follows: “Degenerative changes of the lower lumbar spine as above. Most affected level is at L5-S1 where a left paracentral disc protrusion contacts the descending S1 nerve root in the lateral recess.”
27

Id.
at 20.

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

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

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

The November 18, 2011 and December 15, 2011 Prescriptions

On November 18, 2011, Respondent wrote new prescriptions with the same dosing instructions for 90 Morphine Sulfate ER 15 mg and 120 Opana 10 mg; each of these was for a 30-day supply. GX 5, at 17, 21; GX 3, at 23. B.B. filled the prescriptions the same day. While B.B.'s file contains photocopies of the prescriptions, it contains no documentation of a visit with either Respondent or a nurse on this date.
See generally
GX 3; Tr. 142.

Likewise, on December 15, 2011, Respondent wrote new prescriptions with the same dosing instructions for 90 Morphine Sulfate ER 15 mg and 120 Opana 10 mg, each of these being for a 30-day supply. GX 3, at 67, 90. Respondent filled these prescriptions the same day.
Id.
at 23. Here again, there is no documentation of a visit with either Respondent or a nurse on this date.
See generally
GX 3; Tr. 142.

Dr. Owen testified that “[e]specially in the context of the previous aberrant urine drug testing and the lack of any clear medical necessity or therapeutic benefit,” Respondent “should have” seen B.B. in his office prior to prescribing the drugs on both dates. Tr. 142. Dr. Owen further testified that notwithstanding that at the October 20 visit, B.B. had reported that “his stress is up” and that “he [was] having a lot of grief,” there is no notation in B.B.'s file as to how B.B. was dealing with these issues.
Id.
Dr. Owen also noted that there was no notation in the file that Respondent had discussed the results of the aberrant drugs tests with B.B.
Id.
at 143. Dr. Owen then testified that Respondent had “never” established “a medical necessity . . . to continue these treatments” and that this would require an in-office visit.
Id.

After explaining that the aberrant drugs tests and mention of B.B.'s life stressors supported the need for psychological counselling and consultations with a psychologist or addictionologist, Dr. Owen was asked what risk was created by prescribing these drugs to B.B. without requiring an office visit.
Id.
Dr. Owen testified that “[t]he risk is that he continues to self-escalate these medications, and [is] either chemically coping or becomes—or is addicted to it.”
Id.
Dr. Owen then opined that Respondent had never established the “medical necessity” of the prescriptions he issued to B.B. on these two dates, that the prescriptions lacked a legitimate medical purpose, and that Respondent acted outside of the usual course of professional practice in issuing them.
Id.
at 144.

On cross-examination, Dr. Owen was asked whether he was aware that under DEA's regulation which allows a physician to “issue multiple prescriptions authorizing the patient to receive . . . up to a 90-day supply of a schedule II controlled substance, provided [various] conditions are met,” “it was okay . . . to only see a patient once . . . every 90 days?”
Id.
at 195-96;
see also
21 CFR 1306.12(b). While Dr. Owen answered “yes,” he added that a physician must have “established medical necessity and legitimate therapeutic benefit from previous documentation and [that] a patient doesn't have a high risk of abuse.” Tr. 196. Dr. Owen then re-iterated that B.B. “already had multiple aberrant urine drug tests before those prescriptions were issued.”
Id.

Regarding these prescriptions, Respondent testified that he did not understand that he had to see B.B. “every 30 days” and that “[w]e saw him every 90 days.”
Id.
at 307. Respondent further testified that “[a]t the time there was debate within the state as to whether” patients “could be seen” even “every four months” and “we had chosen every three months, so we never gave more than two refills on a II or above.”
Id.
Respondent then explained that the patients “would call one to two days ahead, a lot of times to the pharmacy, and the pharmacist faxes the request.”
Id.
at 307-08. Continuing, Respondent testified that “[a] PMP would be pulled, and then the chart would be pulled. And then we would write a prescription for the person and leave it up front for them to pick up and sign for.”
Id.
at 308. Respondent further testified that the November 18 prescriptions were issued 29 days after the previous prescriptions.
Id.
at 311. Respondent did not, however, address Dr. Owen's criticism that B.B. presented a high risk of escalating the use of the controlled substances and should have been seen prior to prescribing on each of these dates.
See id.
at 306-13.

The January 19, 2012 Visit and Prescriptions

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

According to Respondent's exam notes, B.B. was “[a]lert and oriented and in no apparent distress.”
Id.
While other portions of the exam were normal, Respondent again documented that B.B. had “[l]ow back paraspinal tenderness,” a “[n]egative straight leg raise,” and “[n]euro intact.”
Id.
He also documented that B.B. “has very tight right calf.”
Id.
However, no mention was made of B.B.'s hernia which had been noted at previous visits.
Id.

Respondent diagnosed B.B. with “lumbar disc disease,” “exposure to infectious disease,” and “[r]ight calf pain.”
Id.
He further documented that he discussed the “[a]ddictive dependence, and tolerance nature of the medicines as well as alternatives,” that he suggested “[n]on-medicinal pain-relieving modalities,” and that the “[f]ollowup will be [in] three months.”
Id.
Respondent then issued B.B. new prescriptions for Morphine Sulfate ER 15 mg and Opana 10 mg with the same dosing instructions, thus providing a 30-day supply for each drug if taken as directed.
Id.

At this visit, B.B. was required to provide a urine drug screen. While the results were not reported until January 31, 2012, the lab reported that morphine was “not detected” and that this result was “not expected with prescribed medications.” GX 3, at 97. Moreover, while the lab detected the presence of alpha-hydroxyalprazolam, a metabolite of alprazolam, the lab also detected the presence of nordiazepam, the metabolite of diazepam, as well as the presence of oxazepam, and temazepam.
Id.
With respect to the presence of the latter three drugs, the lab reported that these three results were “not expected with prescribed medications.”
Id.
Of further note, the lab report bears the handwritten but undated notation: “Pt counseled to only take what is prescribed[.]”
Id.

Dr. Owen testified that while “oxazepam can be a metabolite of several other benzodiazepines,” this was an aberrant drug test because non-prescribed drugs were detected and prescribed drugs were not detected. Tr. 150-51. As for the drugs that were detected but were not prescribed, Dr. Owen testified that B.B. was either “getting [them] from the illicit . . . market or from a friend.”
Id.
at 151. As for the morphine, which was prescribed

but not detected, Dr. Owen explained that “[e]ither [B.B. was] selling it on the street or he self-escalated and ran out of his sup

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2017-05676. Public record. Not legal advice.