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

Federal RegisterJun 26, 2013

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 11-39]

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

On February 7, 2011, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause to David A. Ruben, M.D. (hereinafter, Respondent), of Tucson, Arizona. The Show Cause Order proposed the revocation of Respondent's DEA Certificate of Registration, which authorizes him to dispense controlled substances as a practitioner, and the denial of any pending applications to renew or modify his registration, on the ground that his “continued registration is inconsistent with the public interest.” ALJ Ex. 1, at 1 (citing 21 U.S.C. 823(f) and 824(a)(4)).

More specifically, the Show Cause Order alleged that between April 9 and June 6, 2008, two cooperating sources (CS), who posed as patients, made four visits to Respondent's office seeking controlled substances.

Id.

The Order further alleged that at each visit, Respondent issued the CSs prescriptions for schedule II controlled substances without performing a physical examination, without taking a medical history, without reviewing or obtaining any medical records or test results, and without providing a diagnosis.

Id.

at 1-2. The Order thus alleged that Respondent lacked “a legitimate medical purpose” and acted “outside of the usual course of professional practice” in issuing the prescriptions and thus violated both federal and state law.

Id.

at 1 (citing 21 CFR 1306.04(a); Ariz. Rev. Stat. § 32-1401(27)(ss)).

The Show Cause Order further alleged that on June 10, 2010, the Arizona Medical Board (AMB or Board) issued an order which found that Respondent had “deviated from the standard of care in [his] treatment of multiple patients from 2006 to early 2009.”

Id.

at 2. The Show Cause Order alleged that the AMB found that Respondent “[f]ail[ed] to perform adequate examinations/evaluations prior to prescribing controlled substances”; that he “[f]ailed to develop an adequate treatment plan prior to prescribing controlled substances”; that he “[f]ailed to perform tests and assessments to confirm diagnoses and the necessity of treatment with controlled substances”; that he “[f]ailed to obtain or review patients' medical records”; that he “[f]ailed to offer patients adjunct treatments that included non-controlled substances and/or physical therapy”; that he “[f]ailed to address patients' aberrant drug seeking behaviors”; and that he “[f]ailed to address or investigate patients' abnormal urinalysis results.”

Id.

The Show Cause Order further alleged that based on these findings, the AMB had barred Respondent “from prescribing, administering or dispensing any opioids for a period of one year.”

Id.

On March 28, 2011, Respondent requested an extension of time to respond to the Show Cause Order, which was unopposed by the Government. ALJ Ex. 2. The matter was then placed on the docket of the Office of Administrative Law Judges (ALJ) and assigned to ALJ Wing. While the ALJ initially denied Respondent's request because neither party had established the date of service, on March 30, 2011, Respondent filed a Request for Reconsideration, which was also unopposed by the Government, and which showed that Respondent had not been served until February 25, 2008.

ALJ Exs. 3 & 4. While Respondent sought an additional thirty days to respond to the Order to Show Cause, on April 1, 2011, the ALJ granted Respondent one additional week to do so. ALJ Ex. 5.

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

On April 7, 2011, Respondent requested a hearing on the allegations. ALJ Ex. 6. Following pre-hearing procedures, the ALJ conducted a hearing in Phoenix, Arizona on January 10-12, 2012, at which both parties elicited the testimony of multiple witnesses and introduced various exhibits into the record. Following the hearing, both parties submitted briefs containing their proposed findings of fact, conclusions of law, and argument.

Thereafter, the ALJ issued his Recommended Decision (hereinafter, cited at R.D.). Therein, the ALJ found that the Government had “established by substantial evidence a

prima facie

case that Respondent has committed acts inconsistent with the public interest between 2006 and 2009.” R.D. at 65. However, the ALJ further found that “Respondent has fully accepted responsibility for his past misconduct and credibly demonstrated that he will not engage in future misconduct.”

Id.

With respect to factor one—the recommendation of the state licensing board—the ALJ found that while Respondent currently has a valid Arizona medical license, he has twice been the subject of disciplinary action by the AMB, which found that he had engaged in “ `unprofessional conduct,' ” as well as “ `any conduct or practice that is or might be harmful or dangerous to the health of the patient or the public. '” R.D. at 47 (quoting Ariz. Rev. Stat. § 32-1401(27)(q)). In addition, the ALJ found that Respondent had also committed unprofessional conduct by “ `failing or refusing to maintain adequate records on a patient.' ”

Id.

(quoting Ariz. Rev. Stat. § 32-1401(27)(e)). However, because in August 2011, the AMB had fully restored Respondent's prescribing privileges, the ALJ concluded that while not dispositive, the Board's action “weigh[s] against a finding that Respondent's continued registration subject to conditions would be inconsistent with the public interest.”

Id.

at 48.

With respect to factor three—Respondent's conviction record under federal and state laws relating to the manufacture, distribution, or dispensing of controlled substances—the ALJ noted

that there was no evidence that Respondent has been convicted of such an offense. R.D. at 48. The ALJ thus concluded that while this factor is also not dispositive, it weighed against a finding that Respondent's “registration would be inconsistent with the public interest.”

Id.

The ALJ then considered the evidence with respect to factors two—Respondent's experience in dispensing controlled substances—and four—Respondent's compliance with federal, state, and local laws relating to controlled substances—together. With regard to the allegation that Respondent had “deviated from the standard of care in [his] treatment of multiple patients from 2006 to early 2009,” the ALJ noted that the Government's evidence “rested primarily on the findings by the Board in the 2009 Agreement and 2010 Order” and that the Government had offered “[n]o evidence in the form of patient charts or related medical expert testimony” in either its case-in-chief or in rebuttal of the testimony offered by Respondent and his expert witness.

Id.

at 49-50.

However, the ALJ noted that the 2009 AMB Order found that between “November 17, 2006 and October 2007[,] `Respondent deviated from the standard of care by prescribing high dose opioids to DK without proper indications . . . [and] by failing to timely use objective measures, such as urine drug tests, to assess DK's compliance with her treatment even after he was aware of her cocaine addiction.' ” R.D. at 50. The ALJ further found that the 2010 AMB order “established that Respondent's care and treatment of eleven patients . . . on various dates between 2006 and September 2009, constituted unprofessional conduct contrary to Ariz. Rev. Stat. § 32-1401(27)(e) and (q).”

Id.

The ALJ then noted some, but not all, of the specific findings made by the AMB with respect to the various patients.

Id.

at 50-51.

With respect to the Board's findings, the ALJ further found that Respondent testified “that he did not agree with all of the Board's findings with regard to the 2009 Agreement, but otherwise agreed with the sanctioning imposed by the Board.”

Id.

at 53. With respect to the 2010 AMB order, the ALJ found that “Respondent credibly testified . . . that he agreed from a regulatory standpoint why the Board censured him, but disagreed with some of the specific factual findings.”

Id.

Based on the two AMB orders, the ALJ nonetheless concluded that “Respondent issued controlled substance prescriptions to multiple patients . . . for other than a legitimate medical purpose and outside the usual course of professional practice in violation of applicable state and federal law.”

Id.

at 54-55 (citing 21 CFR 1306.04(a); Ariz. Rev. Stat. § 32-1401(27)(a), (e), and (q)). However, the ALJ rejected the Government's allegation based on the four visits of the two CSs, finding that Respondent “credibly testified” regarding his treatment of them, and that his testimony was “supported by patient files.”

Id.

at 56. In addition, the ALJ noted that Respondent's Expert credibly testified that his prescribing to the two CSs was “ `well within the standard of care.' ”

Id.

(quoting Tr. 618).

The ALJ further found that Respondent had presented evidence of “more recent conduct” [which] weigh[s] significantly” in his “favor.”

Id.

at 60. More specifically, the ALJ noted that Respondent testified that he had been in compliance with the AMB's Order, that he had “successfully completed” the one year suspension of his authority to prescribe opioids, and that there was no evidence that he “has not been fully compliant with state and federal law since the 2010 Order.”

Id.

Moreover, the ALJ noted Respondent's evidence that he had made improvements in his controlled-substance prescribing practices since the 2010 Order.

Id.

Thus, the ALJ found that the Government had demonstrated that “Respondent's prescribing practices and compliance with applicable state and federal law between 2006 and 2009 was inconsistent with the public interest” and supported a finding that his “continued registration would be inconsistent with the public interest, at least as of 2010.”

Id.

at 63. However, the ALJ further found “that Respondent's recent positive improvements in his prescribing practices and compliance with applicable state and federal law weigh in [his] favor.”

Id.

As for factor five—such other conduct which may threaten public health and safety—the ALJ noted that the Government had not alleged, and the evidence did not support a finding that Respondent had engaged in “any `other conduct' . . . that is inconsistent with the public interest.”

Id.

at 64. The ALJ then found that Respondent “ha[d] credibly accepted responsibility for his past misconduct,” explaining that “Respondent testified at various points that he acknowledged and accepted the Board's disciplinary actions.”

Id.

Also noting the evidence as to Respondent's efforts to improve his prescribing practices, the ALJ concluded that factor five supported “a finding that Respondent's continued registration would be consistent with the public interest.”

Id.

at 65.

The ALJ thus concluded that Respondent had rebutted the Government's

prima facie

case.

Id.

He then recommended that Respondent's registration be continued and that any pending applications be renewed subject to two conditions: 1) that Respondent “comply with all of the terms and conditions specified in the” AMB's June 2010 order, and 2) that “Respondent shall promptly forward to the DEA regional office any changes to the terms and conditions of his probation.”

Id.

at 65-66.

The Government filed Exceptions to the R.D. Thereafter, the record was forwarded to me for Final Agency Action.

Having considered the entire record, I adopt the ALJ's finding that Respondent committed acts which were inconsistent with the public interest during the 2006 through 2009 time period. While I also accept the ALJ's finding that Respondent has accepted responsibility for his misconduct and produced substantial evidence of various remedial measures he has implemented, I nonetheless reject the ALJ's recommended sanction because the ALJ failed to consider both the egregiousness of the violations and the Agency's interest in deterring similar misconduct by Respondent in the future as well as on the part of others.

See, e.g.,

Joseph Gaudio,

74 FR 10083, 10094 (2009).

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

Before proceeding to make factual findings, a discussion of the ALJ's ruling on the Government's Motion in Limine To Exclude Evidence is warranted. During the course of the pre-hearing procedures, Respondent provided notice that he intended to call several physicians to testify, in part, regarding their review of the medical charts of those patients which were the subject of the AMB's 2009 and 2010 orders. ALJ Ex. 46. Respondent also provided notice that he intended to introduce into evidence various letters written by these physicians based on their review of various patient charts which were reviewed by the AMB and discussed in the two orders.

Id.

Relevant to the Government's motion, Respondent proffered Dr. Jennifer Schneider to testify that she had reviewed the medical charts of patients LP, WO, JF, JR, CJ, ML, AM, MF, DD, and SS, all of which were reviewed by the AMB's consultant as part of the Board's investigation. ALJ Ex. 9, at 5 (Resp. Prehearing Statement). Respondent further proffered that Dr.

Schneider “will explain that the AMB consultant had missed items in the charts for which Respondent was inaccurately criticized.”

Id.

Finally, Respondent proffered that Dr. Schneider “will testify in conformance with information about [Respondent] and Pain Management practices in Arizona in general as the author of Proposed Exhibits 4, 5, and 6.”

Id.

Respondent also proffered the testimony of Dr. Bennet Davis to “testify regarding his review of a chart involving patient DK and his review and evaluation of patient ML, who has a complex set of issues.”

Id.

Respondent further proffered that Dr. Davis would testify that, “[i]n his opinion, the AMB consultant did not properly define the standard of care for which Respondent was issued a reprimand per [the 2009] Consent Agreement,” and that Respondent adhered to a `reasonable standard [of] care in all aspects of treating . . . [DK].' ”

Id.

at 5-6. Respondent also proffered that “Dr. Davis was able to synthesize his own evaluation and compare it with the notes and records provided by Respondent [and] will testify that Respondent met the standard of care in his evaluation of Respondent's chart of ML.”

Id.

at 6.

Finally, Respondent proffered the testimony of Dr. Kevin Goeta-Kreisler, who was to “explain that . . . he reviewed the complaints and the charts on patients `AL, KF, and JF.' ”

Id.

Respondent further proffered that Dr. Goeta-Kreisler “will testify that he and Respondent both agreed that the early charting was `insufficient for another practitioner to assume continuity of the patients' care' even though the documentation met the standard of practice at the earlier time.”

Id.

Thereafter, the Government filed a motion in limine to exclude this evidence, arguing that “[t]he doctrine of

res judicata

bars the relitigation of the factual findings and conclusion of law of the prior proceedings before the AMB.” Motion in Limine to Exclude Evidence (ALJ Ex. 46, at 3). The Government argued that “[e]ach of Respondent's proposed experts' testimony and their [sic] related documentary evidence . . . are [sic] an attempt to relitigate the factual findings and conclusions of law by the AMB,” and therefore, “Respondent should be precluded from presenting such evidence.”

Id.

As support for its position, the Government cited numerous authorities, including cases of both federal and state courts and the Agency.

See id.

(citing

Misischia v. Pirie,

60 F.3d 626, 629-30 (9th Cir. 1995);

Marie Y. v. General Star Indem. Co.,

2 Cal. Rptr. 3d 135, 155 (Cal. Ct. App. 2003);

Robert L. Dougherty,

76 FR 16823, 16830 (2011);

Alan H. Olefsky,

76 FR 20025, 20031 (2011);

Christopher Henry Lister,

75 FR 28068, 28069 (2010).

Respondent opposed the motion on multiple grounds.

See

ALJ Ex. 47. More specifically, Respondent argued: (1) That the motion was untimely,

id.

at 1-2; (2) that the AMB Orders were the result of consent agreements, which stated that his “admissions are not intended or made for any other use, such as in the context of another state or federal government regulatory agency proceeding,” and that he “never agreed that all of the conduct set forth in the findings was accurate,”

id.

at 2-3; and (3) that DEA could not invoke the doctrine of

res judicata

because it was not a party to the consent agreements and was not in privity with the AMB.

Id.

at 4-5.

The ALJ denied the Government's motion for two reasons. First, noting that the Government had not filed its motion until approximately eight months after Respondent had provided notice as to its witnesses and their anticipated testimony, the ALJ held that the Government had not established good cause for the untimely filing of the motion. ALJ Ex. 48, at 2-3. Second, the ALJ held that because the Agency was not a party to the proceeding before the AMB, and the AMB did not consider the issue of whether Respondent's DEA registration should be revoked under the public interest standard, the doctrine of

res judicata

could not be invoked to bar the introduction of the proposed testimony and reports.

Id.

at 3-4. However, the ALJ further noted that his ruling was “not intended to limit the parties from making evidentiary objections at the time the evidence is offered.”

Id.

at 4 n.3.

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

See

Tr. 578, 591, 596, and 603.

As for the first of the ALJ's reasons, the Agency's regulations clearly grant the ALJ authority “to take all necessary action to avoid delay.” 21 CFR 1316.52. Moreover, this regulation provides that the ALJ “shall have all powers necessary to these ends, including (but not limited to) the power to . . . [r]eceive, rule on, exclude, or limit evidence.”

Id.

§ 1316.52(f). This power clearly includes the authority to set reasonable time periods for the filing of motions. Given that the Government's motion was filed eight months late, the Government's motion was clearly untimely.

However, notwithstanding that the motion was untimely, the ALJ considered it on the merits. Moreover, after the parties filed their respective prehearing statements, the ALJ clearly was aware that the Government intended to introduce the AMB Orders and that Respondent intended to challenge the validity of their findings. Indeed, on June 24, 2011, Respondent filed a motion to preclude the Government from introducing the two AMB Orders.

See

ALJ Ex. 20. Thus, even though the Government did not raise issue in its response to Respondent's motion to preclude, the ALJ was obligated (and remained so throughout the proceeding) to apply the law of the Agency. Accordingly, the ALJ should have raised,

sua sponte,

the issue of whether the findings of the AMB Orders were entitled to preclusive effect.

I therefore conclude that it is appropriate to consider whether the ALJ's ruling on the merits was correct.

Under Agency regulations, at the hearing, the ALJ “shall admit only evidence that is competent [and] relevant.” 21 CFR 1316.59(a). If, as the Government argues, such evidence was barred by the doctrine of

res judicata

(or more precisely, collateral estoppel) the admission of such evidence was a violation of the above regulation.

While the ALJ correctly noted that the Agency has applied the doctrine of

res judicata

in proceedings brought under 21 U.S.C. 823 and 824, he then misapplied Agency precedent. To be sure, the application of

res judicata

itself requires that the parties in the subsequent proceeding be the same parties (or privies of the parties) in the earlier proceedings and that the proceedings involve the same claim. However, this Agency has also long held that the doctrine of collateral estoppel precludes a party from re-litigating adverse findings rendered against him in either a state board proceeding or a federal/state judicial proceeding.

See

Robert L. Dougherty,

76 FR 16823, 16830-31 (2011);

Robert A. Leslie,

60 FR 14004, 14005 (1995). Contrary to the ALJ's misunderstanding, the Agency was not required to be a party or privy of a party in the AMB proceedings to collaterally estop Respondent from re-litigating the findings of the AMB Orders.

So too, that the State Board proceeding did not involve the same claim as this proceeding (whether Respondent's registration is consistent with the public interest), does not preclude the Agency from relying on those findings of the Board which are relevant and material to the Agency's public interest determination.

While the Government argued that “[t]he doctrine of

res judicata

bars the relitigation of the factual findings and conclusions of law of the prior proceedings before the AMB,” ALJ Ex. 46, at 3, as the above passage (as well as other portions of its motion) made clear, it actually sought to invoke collateral estoppel against the Respondent.

See also id.

(quoting

Marie Y.

General Star Indem. Co.,

2 Cal. Rptr. 3d 135, 155 (Cal. Ct. App. 2003) (“When an administrative agency acts in a judicial capacity to resolve disputed issues of fact properly before it which the parties have had an adequate opportunity to litigate, its decision will collaterally estop a party to the proceeding from relitigating those issues.”). As further support for its position, the Government cited Section 29 of the

Restatement (Second) of Judgments. See id.

Notably, this section is entitled “Issue Preclusion in Subsequent Litigation With Others.”

While in his ruling, the ALJ noted that “the Agency has stated that `the doctrine of

res judicata

bars the relitigation of the findings of the [state medical board]'s final order,' ” ALJ Ex. 48 at 4 n.2 (quoting

Dougherty,

76 FR at 16830), he then “declined to extend this dicta [sic] to the facts in the present case for the reasons discussed above.”

Id.

Contrary to the ALJ's understanding, the passage in

Dougherty

was not a dictum but rather a holding, as the Agency's decision relied on numerous findings of the state medical board's order in support of its finding that Respondent had committed acts which rendered his registration inconsistent with the public interest and squarely rejected the physician's attempts to relitigate the state board's findings.

See

76 FR at 16831. As I explained:

All of Respondent's testimony could have been, and should have been presented in the MBC proceeding. Here again, it is clear that Respondent is simply trying to relitigate the findings of the MBC proceeding. Having failed to establish that the MBC proceeding did not provide him with a full and fair opportunity to litigate these issues, the doctrine of

res judicata

precludes Respondent from relitigating them in this proceeding.

Id.

Thus, contrary to the ALJ's reasoning, there was no dictum “to extend” but only a holding to apply; his reasons for ignoring Agency precedent reflect a fundamental misunderstanding of the differences between claim preclusion and issue preclusion.

As support for his reasoning, the ALJ also cited the Agency decision in

Robert Raymond Reppy,

76 FR 61154, 61159-60 (2011), noting that the decision “refus[ed] to apply

res judicata

because, although a prior Agency decision was a final judgment on the merits, the respondent was not a party to the prior litigation.” ALJ Ex 48, at 3. The ALJ ignored, however, the fundamental difference between

Reppy

and this matter, that being that the Government sought preclusion against Dr. Reppy based on findings made in a matter involving the pharmacy for which he worked, and did so notwithstanding that he was not a party to the pharmacy's proceeding. By contrast, here the Government seeks preclusion against Respondent based on findings made in a proceeding in which he was a party.

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

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

ALJ Ex. 47, at 2 (quoting GX Ex. 17, at 2 (2009 AMB Order) and GX 18, at 20-21 (2010 AMB Order). Respondent argues that he “and his counsel had to consider whether there was a reasonable basis to conclude that there was at least some evidence that would lead to a conclusion that some of the allegations made would be sustained.”

Id.

He contends that “[h]e bargained for and received an agreement to enter each of these consent agreements, on the basis of that recognition, on his agreement that he would indeed follow the requirements of any discipline authorized as a result of the Agreement, but that outside of the required discipline set forth, the stated findings and conclusions could not be used in a non-AMB proceeding, including a `federal government regulatory agency proceeding[,]' such as this one.”

Id.

at 2-3. Respondent further argues that he “never agreed that all of the conduct set forth in the findings was accurate,” and that both he and the AMB “agreed that [his] concessions there were not to be given substantive weight outside of the Arizona professional proceedings.”

Id.

at 3.

In the 2010 Order, however, Respondent also “agree[d] not to contest the validity of the Findings of Fact and Conclusions of Law contained in the Order in any present or future administrative proceedings before the Board (or any other state agency in the State of Arizona, concerning the denial or issuance of any license or registration required by the state to engage in the practice or any business or profession.)” GX 18, at 20. Moreover, he also “voluntarily relinquishe[d] any rights to a hearing or judicial review in state or federal court on the matters alleged, or to challenge th[e] Order in its entirety as issued by the Board, and waive[d] any other cause of action related thereto or arising from said Order.”

Id.

Finally, he agreed that the “Order is a public record that will be publicly disseminated

as a formal disciplinary action of the Board

and will be reported to the National Practitioner's Data Bank and on the Board's Web site as a disciplinary action.”

Id.

at 21 (emphasis added).

Likewise, the 2009 Order provided that “[b]y entering into this Consent Agreement, Respondent voluntarily relinquishes any rights to a hearing or judicial review in state or federal court on the matters alleged, or to challenge this Consent Agreement in its entirety as used by the Board, and waives any other cause of action related thereto or arising from said Consent Agreement.” GX 17, at 1. Also, the 2009 Order provided that “[t]his Consent Agreement, or any part thereof, may be considered in any future disciplinary action against Respondent,” and that upon its approval and signing, was “a public record that will be publicly disseminated as a formal action of the Board” which would be reported to the National Practitioner's Data Bank and on the AMB's Web site.

Id.

at 1-2.

Respondent does not contend that he lacked a full and fair opportunity to litigate the allegations that were the subject of the 2009 and 2010 Orders. And while both Orders were the result of consent agreements in which the findings were not actually litigated, the Supreme Court of Arizona has explained that even where a judgment has been entered by stipulation or consent, it “may be conclusive, with respect to one or more issues, if the parties have entered an agreement manifesting such intention.”

Chaney Building Co.,

City of Tuscon,

716 P.2d 28, 30 (Ariz. 1986) (en banc) (citing

Restatement (Second) of Judgments

§ 27 comment e).

See also id.

§ 32-1403(A) (“The primary duty of the board is to protect the public from unlawful, incompetent, unqualified, impaired, or unprofessional practitioners of allopathic medicine through licensure, regulation and rehabilitation of the profession in this state.”). Under Arizona law, eight of the Board's twelve members must “be actively practicing medicine,” and “[e]ach doctor of medicine who is appointed to the board [must] have been a resident of this state and actively engaged in the practice of medicine as a licensed physician for at least the five years before appointment.”

Id.

§ 32-1402(A) and (B).

Respondent could have presented this evidence to the Board, but did not. Most significantly, to even entertain such evidence undermines fundamental values of federalism. As

Gonzales

Oregon

makes clear, “[t]he structure and operation of the CSA presume and rely upon a functioning medical profession regulated under the States' police powers.”

Gonzales

Oregon,

546 U.S. 243, 279 (2006). Where, as here, a state medical board has determined that a practitioner's conduct violated the standard of care, its findings of fact and conclusions of law are not subject to relitigation before the Agency. Rather, the only question is whether those findings also establish whether a practitioner has committed acts which render his registration inconsistent with the public interest within the meaning of the CSA.

With respect to DK, Respondent testified that he recognized the AMB's criticism of his failure to get her records “originally.” Tr. 850-51. Indeed, other than a then-five year old MRI, which DK did not produce until more than a year after she had begun seeing Respondent and which had negative findings (

see

RX 30, at 11), Respondent did not obtain any records from DK's prior treating physicians, notwithstanding that at the first visit, Respondent noted in his evaluation that “[h]er most recent treatment has been OxyContin 160 mg t.i.d. (three times a day) and oxycodone 30 mg two tablets, one to two times daily which she currently takes. She also takes Valium, 10mg. one p.o. at h.s.” RX 30, at 40.

Respondent maintained, however, that:

Respondent also noted that DK “was previously treated with methadone, five to six years ago, and also received Percocet in the past. She has also a history of diazepam for muscle spasms.”

See

RX 30, at 40. Respondent also noted that DK had undergone physical therapy and “some psychiatric counseling.”

Id.

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

Tr. 851-52.

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

Id.

Moreover, shortly after DF questioned the OxyContin 80 mg prescription (in early October 2007), Respondent was provided with a copy of a letter (dated 9-13-07) written by another physician (Dr. P.), which stated that Dr. P. had fired DK for breaking her pain contract, specifically citing DK's use of cocaine and narcotics. RX 30, at 20. Respondent noted in DK's record that the patient, who provided him with this letter, had observed that DK, who had recently stayed in the patient's residence, had “not be[en] compliant with her medications,” and that this was corroborated by the reporting patient's relative.

Id.

at 21.

On October 19, 2007, Respondent sent out a Fax Net

cancelling the narcotic prescriptions he had issued to DK earlier that day.

Id.

at 19. However, the following month, he resumed prescribing both OxyContin and oxycodone to DK.

Id.

at 46. Respondent also noted in DK's chart that his plan was “to contact Dr. [P's] office, receive prior treatment information from [DK] and review this with prior providers, review this with [DK] before making a decision to continuing care for her. In the event, opioid medication care is not continued, she will be supported with detoxification medication and referral to appropriate treatment.”

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

See

RX 30, at 19.

Respondent testified that he corroborated with DK's previous physician that she had “violated the pain contract.” Tr. 844. However, he concluded that he “was her physician and she obviously needed additional care.”

Id.

According to Respondent, he told DK that “in order to continue treatment she would have to get treatment at the Behavioral Health Center for this drug problem,” and that he “coordinated with Behavioral Health Center” and “required records back.”

Id.

at 844-45. Respondent then maintained that they “requested actually that I continue the care” as DK “continued to have pain and needed treatment for that and that was how we proceeded.”

Id.

at 845.

Respondent then explained that he did not fire her at that point because:

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

Id.

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

Id.

at 848.

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

Id.

DK, however, had tested positive for cocaine on June 3, 2008.

Id.

at 3; Tr. 1013.

While Respondent acknowledged that DK was prescribed 45 dosage units of oxycodone 30 mg on June 30, 2008, Tr. 1013, he then testified that:

[m]y progress notes only go to June 4th, so I don't know anything more than the record reflects that she was prescribed that. It may or may not have been me. My last progress note in this is June 4, 2008 and then there's one additional note, August 27, `08 which has really no record except it was a rewrite for a methadone script.

Tr. 1013. While on further questioning, Respondent again testified that he did not know whether he or another doctor wrote the script, he acknowledged that his office had continued to prescribe oxycodone to DK even after her positive test for cocaine. Tr. 1015.

Notwithstanding his testimony that on June 4, 2008, DK “was given a three day supply of oxycodone, 40 to 60 milligrams a day, and then it was to be reduced,”

id.

at 1014, Respondent later acknowledged that between June 4 and August 27, 2008, DK's oxycodone prescription was “increased” from 15-30 mg per day to thirty mg, twice a day.

Id.

at 1016. Respondent then maintained that RX 30, an exhibit he introduced into the record (and which was denominated as “Copy of DK Medical

Records in Possession of [Respondent],” was “apparently not” DK's complete patient file, but rather only “the med log” as “the notes aren't there that would explain in detail what was going on.”

Id.

at 1017.

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

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

See generally

RX 30.

Of note, DK's medical record contains the results of a single urine drug screen, which did not occur until June 3, 2008.

Yet even after this screen showed that DK tested positive for cocaine, Respondent continued to prescribe to her.

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

On cross-examination, Respondent testified that “we didn't have all the perfect records.” Tr. 1027. However, he then asserted that DK “wouldn't tell us or couldn't tell what they were.”

Id.

When asked if he accepted the AMB's judgment regarding his treatment of DK, Respondent testified that “I accept that I didn't do a urine screen early on, which we would always do now.”

Id.

at 1028. As for the AMB's findings that he failed to obtained DK's records, Respondent testified that “I accept that I didn't get old records, which we would handle as we handled,”

id.

whatever that means.

As for the Board's findings related to his continued prescribing to DK, even after he had referred her to substance abuse treatment and even after “she had completed inpatient opioid detoxification treatment,” (AMB Finding #7), Respondent testified that he did not accept the Board's finding. Tr. 1028. According to Respondent, “they said I referred her to treatment and that was great that I followed her. She continued . . . to have pain and I did that treatment at much, much lower doses in conjunction with . . . her behavioral health center and at their request. So I think that was appropriate. But that's [sic] everybody has differences of opinions.”

Id.

The 2010 AMB Order

As set forth above, under the terms of the 2009 AMB order, Respondent was required “to participate in the periodic review of his patients' charts.” GX 18, at 14; GX 17, at 6. The Board's staff selected three charts at random and provided them to a medical consultant who reviewed them and “found deviations from the standard of care in each case,” as well as “medical recordkeeping issues.” GX 18, at 14. The 2010 AMB Order set forth extensive findings regarding three patients, JR, LP, and ML.

Id.

at 14-16.

Based on several complaints the Board received regarding his treatment and care of multiple patients, the AMB initiated additional cases.

See generally id.

at 2-17. In its 2010 Order, the AMB made extensive findings regarding Respondent's treatment of patients AL, KF, JF, DD, SS, AM, MF, ML, WO and CJ.

See id.

at 2-13, 17. Based on these findings, the AMB concluded that Respondent had engaged in unprofessional conduct, both by “[f]ailing or refusing to maintain adequate records on a patient,” and by engaging in “[a]ny conduct or practice that is or might be harmful or dangerous to the health of the patient or the public.”

Id.

at 17 (citing Ariz. Rev. Stat. §§ 32-1401(27)(e) and (q)).

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

The Board found that Respondent treated JR for reported neck and back pain from July 2007 until September 2009. GX 18, at 14. No previous medical records were obtained prior to Respondent prescribing oxycodone, Xanax and Subutex.

Id.

Despite normal CT scans of JR's head and neck on February 18, 2008, Respondent continued to prescribe oxycodone on numerous occasions until August 2009.

Id.

Respondent changed JR's medication on several occasions without documenting his reasoning and refilled JR's medication after he reported that it had been stolen.

Id.

According to the Board, when treating a patient for chronic pain, the standard of care requires a physician to obtain prior records pertaining to the past treatment of the patient, and to obtain any objective measures for the cause of pain.

Id.

The Board found that Respondent deviated from the standard of care because he did not obtain JR's previous medical and/or treatment records prior to prescribing opioid medication for reported chronic pain, and that he failed to obtain objective measures for the cause of JR's pain.

Id.

It further found that Respondent's conduct could result in an overdose and/or perpetuation of drug seeking behavior and addiction.

Id.

The Board also found that Respondent's records were inadequate because they failed to document a treatment plan and reasoning for high dose opioids in a patient with a history of substance abuse, lost/stolen medications and positive drug-screen findings.

Id.

at 15. Further, his records failed to adequately document the reasoning for, and the results of, his prescribing of Adderall.

Id.

Regarding JR, as well as LP, CJ, WO and JF, Respondent's Expert testified that she believed that Respondent was “practicing with skill and safety,” (as she had written in her June 7, 2010 letter to the AMB) in that “[t]he dosage he prescribed for the patients initially based on their symptoms, which of course are subjective, were reasonable. When he raised the doses subsequently, he did it in a careful manner, and he didn't increase them sufficiently to risk the patient's health. So I felt that he was skillful and he was taking into consideration the safety of the patient.” Tr. 592-93. Yet in her letter, Dr. Schneider noted “it is difficult at times to reconstruct his reasoning because his documentation, although typical of psychiatric patients, needs to be more detailed when dealing with chronic pain patients.” RX 4, at 1. And subsequently, Dr. Schneider testified that she “remember[ed] that I read some of [Respondent's] records where he didn't do a physical exam on the first visit and things like that.”

Id.

at 597. Thus, even if the Board's findings were subject to relitigation in this proceeding, Dr. Schneider's testimony provides no reason to reject the Board's findings.

Dr. Schneider also took issue with several of the AMB findings, asserting that in the case of one patient (AM), “the consultant alleged” that Respondent “did not get prior imaging studies” when “those records were in the chart”; that in the case of MF, “the consultant alleged that [he] did not try alternative non-opioid treatment before initiating opioid treatment,” as well as that he did not get imaging studies when “a CT of the thorax was in the chart”; and that “the consultant alleged” that he did not physically examine patient SS at the initial visit, when the results were in the chart. RX 4, at 2.

Here again, Respondent could have raised these contentions with the Board. Moreover, even if the Board's findings were subject to relitigation, the Board made findings with respect to fourteen patients. Thus, even if I were to place no weight on the Board's findings with respect to these three patients, the Board's findings were essentially unchallenged with respect to most of the other patients.

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

pain, DJD, musculoskeletal pain, chronic depression, PTSD, Lupus and ADD.

Id.

On the first as well as subsequent visits, Respondent prescribed OxyContin and oxycodone without obtaining past medical records.

Id.

The Board noted that objective data in the records such as x-rays were documented as normal; however, Respondent continued to treat LP with opioids and/or methadone through October 2009 without a documented treatment plan.

Id.

Respondent increased LP's medications, as well as changed them at times without documented reasoning.

Id.

According to the Board, the standard of care when treating a patient for chronic pain requires a physician to obtain objective measures as to the cause of pain.

Id.

The Board found that Respondent deviated from the standard of care in that he continued to treat LP's reported pain with high-dose opioid medications without obtaining objective measures as to the cause of the reported pain.

Id.

The Board further found that Respondent's conduct could result in an overdose or perpetuation of drug seeking behavior and addiction.

Id.

at 16.

The Board also noted that Respondent's records were inadequate because they fail to adequately document the initial visit, treatment plan and reasoning for high dose opioids and changes in medications, in violation of Ariz. Rev. Stat. § 32-1401(2).

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

Id.

at 9, 16.

This individual is not the same person as the confidential source who made undercover visits to Respondent on May 2 and June 6, 2008, and was also referred to by the initials ML.

Respondent also elicited testimony from an individual with the same initials, who testified that he was treated by Respondent for spondylolisthesis. Tr. 464-94. The testimony of this individual suggests he may well have been the same ML as discussed in the AMB's 2010 Order.

Compare

GX 18, at 9 (discussing ML's treatment at methadone facility)

with

Tr. 474, 484-8 (ML testifying about his treatment by methadone program). The record does not, however, definitively establish if the ML who testified and the ML discussed in the AMB's Order are one and the same.

The Board found that in October 2006, Respondent diagnosed ML with spondylolisthesis based on his reported history and that he prescribed oxycodone, but that he did not perform a facet, sacroiliac joint, myofascial pain or neural flexes examination on ML, nor did he test him for weakness or numbness.

Id.

at 9. The Board also found that Respondent did not order flexion extension films to assess spinal instability from spondylolisthesis or an MRI scan to assess for neural compression.

Id.

Moreover, in the course of its chart review, the Board found that there was an x-ray in the chart dated February 18, 2008, which stated: “NO evidence of spondylolisthesis.”

Id.

at 16.

The Board found that in November 2007, Respondent documented that ML had, on his own, increased the oxycodone medication.

Id.

at 9. However, there was no documentation that Respondent cautioned ML to adhere to his dosing instructions.

Id.

The Board also found that from January through December 2007, Respondent prescribed multiple early refills of oxycodone, that he added hydrocodone to the regime in January but discontinued it in March without indication, and that from February through December 2008 Respondent prescribed multiple early refills of oxycodone.

Id.

It also found that in June 2008 Respondent was notified that ML was undergoing methadone treatment at a facility; however, Respondent he did not obtain ML's medical records from that facility.

Id.

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

Next, the Board found that Respondent discharged ML from opioid therapy in January 2009, but restarted opioids in March 2009, without documenting an explanation.

Id.

Moreover, the Board found that even after he was placed on probation pursuant to the 2009 Order, “Respondent continued to prescribe high-dose opioids to ML for pain secondary to spondylolisthesis” until September 2009.

Id.

at 16. The Board noted that during the course of Respondent's treatment of ML there was no further documentation that he performed any examinations prior to prescribing the medications, or that he obtained ML's past medical records or diagnostic studies.

Id.

at 9-10.

According to the Board, prior to initiating high dose opiate therapy, the standard of care requires a physician to perform an adequate exam for pain generators, obtain the patient's past medical records and diagnostic studies, offer the patient adjunct treatments that include non-opioid medications and physical therapy, address aberrant drug seeking behaviors, and refrain from prescribing more than one month of Schedule II prescriptions at a time.

Id.

The Board found that Respondent deviated from the standard of care because he did not perform an adequate exam prior to initiating high dose opiate therapy, did not obtain ML's past medical records and diagnostic studies, did not offer adjunct treatments, did not address ML's aberrant drug-seeking behaviors, and did not refrain from prescribing more than one month of schedule II prescriptions at a time.

Id.

As it noted with the previously discussed patients, the Board also found that when treating a patient for chronic pain, the standard of care requires a physician to obtain objective measures as to the cause of pain.

Id.

at 16. The Board thus found that Respondent violated the standard of care by continuing to treat ML's reported pain with high-dose opioids without obtaining objective measures for the cause of his pain, and that his conduct could result in the perpetuation of ML's drug-seeking behavior/addiction or an overdose.

Id.

In addition, the Board found that there was potential for diversion or abuse of the oxycodone.

Id.

at 10.

Finally, the Board found that “[a] physician is required to maintain adequate legible medical records containing, at a minimum, sufficient information to identify the patient, support the diagnosis, justify the treatment, accurately document the results, indicate [the] advice and cautionary warnings provided to the patient and provide sufficient information for another practitioner to assume continuity of the patient's care at any point in the course of treatment.”

Id.

at 11 (citing Ariz. Rev. Stat. § 32-1401(2)). The Board thus found that “Respondent's records were inadequate[,] because there was no documentation that [he] performed any [neurologic] and musculoskeletal examinations prior to prescribing opioid therapy, no documentation that he cautioned ML to stay within the prescribing instructions, no documented rationale for re-starting opiates again later[,] and that [he] did not obtain ML's medical records from the treatment facility or from his previous treating physicians.”

Id.

During the hearing, Respondent's expert did not dispute the Board's findings with respect to Respondent's multiple early refills for ML. Tr. 675. She also did not dispute that notwithstanding that ML had tested positive for both marijuana and cocaine, as well as benzodiazepines which Respondent had not prescribed on previous visits, Respondent continued to prescribe oxycodone to him.

Id.

at 675-76. Nor did she dispute that ML

had tested negative for oxycodone even though Respondent had prescribed the drug to him at the preceding visit.

Id.

at 677. While Dr. Schneider testified that there might be a valid reason why a short acting opioid might not turn up in a urine drug screen (depending upon when it was taken), she testified that the physician “need[s] to find out when the patient took their last dose so that you can find out if there's some legitimate reasons for why they[sic] tested negative when one would have expected it to be positive.”

Id.

at 679. And notwithstanding that the ALJ allowed Respondent to relitigate the Board's findings, Respondent offered no evidence as to whether ML had a legitimate reason for testing negative for oxycodone.

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

Following its receipt of a complaint from a pharmacy alleging inappropriate prescribing by Respondent, the Board investigated his treatment of CJ. GX 18, at 17. The Board found that Respondent “prescribed large amounts of opioids to . . . CJ with an inadequate treatment plan,” and that he did so even though “CJ had a history of testing positive for [h]eroine [sic], [o]xycodone, [m]orphine and [c]ocaine.”

Id.

The Board also found that “on two occasions, CJ tested positive for narcotics that were not prescribed by Respondent.”

Id.

According to the Board, “[t]he standard of care is to develop an adequate treatment plan prior to prescribing opioids and to treat the patient's substance abuse problem before treating pain.”

Id.

The Board found that Respondent violated this standard when he “prescribed opioids to CJ without an adequate treatment plan,” and that he “exposed the patient to possible drug overdose and drug diversion.”

Id.

The Board found that on November 6, 2006, AL, who was then an eighteen year old female, presented to Respondent complaining of moodiness and irritability.

Id.

at 2. Respondent diagnosed AL as having Attention Deficit Hyperactivity Disorder and prescribed Adderall (a schedule II stimulant) to her, but did not document the prescription in AL's record.

Id.

The Board found that there was no documentation that Respondent performed an adequate psychiatric evaluation, which included ordering laboratory studies; that he had obtained her past medical records, her history of alcohol or substance abuse, and her psychiatric history; or that he performed a functional assessment to support his diagnosis and prescription.

Id.

The Board also found that there was no initial treatment plan documented in the record.

Id.

The Board further found that “[f]rom November 2006 through February 2009, Respondent provided AL with frequent, early and escalated doses of Adderall without documenting any rationale for doing so.”

Id.

Moreover, the Board found that “[o]n several occasions[,] AL attempted to refill her Adderall prescription early. There was, however, no documentation that Respondent investigated or addressed AL's rationale for doing so.

Id.

Next, the Board further found that during the course of AL's treatment, Respondent added Prozac, Cymbalta, Lorazepam, and Zoloft

to her medication regime but did not document his rationale for the medications or whether he discussed the risks and benefits of taking them.

Id.

There was also no documentation that he ordered any laboratory studies to support his continued prescribing of Adderall, or urine drug screens to determine whether AL was taking the medications as prescribed and/or any illicit substances.

Id.

Further, several of Respondent's progress notes were illegible.

Id.

Of these drugs, only Lorazepam is controlled.

See

21 CFR 1308.14(c).

The Board found that the standard of care requires a psychiatrist to perform adequate psychiatric evaluations prior to commencing treatment, and that when prescribing Adderall, a physician is required to perform tests to confirm the diagnosis and the necessity of the medication, and to monitor the patient's use of the medication.

Id.

at 3. The Board thus found that Respondent deviated from the standard of care in that he did not perform an adequate psychiatric evaluation of AL, he did not perform tests to confirm his diagnosis and the necessity of medication, and he did not monitor AL's use of the medication.

Id.

The Board further found that there was no collateral information in AL's record to support prescribing Adderall, which created a potential for misdiagnosis, addiction, abuse, misuse, overdose and diversion.

Id.

The Board also found that because no urine drug tests were performed, it was unknown whether AL was taking the medication as prescribed and/or whether she was utilizing illicit substances.

Id.

Finally, the Board found that Respondent's records did not comply with Ariz. Rev. Stat. § 32-1401(2), because there was no documentation of the initial Adderall prescription, no documented initial treatment plan, the psychiatric evaluation was inadequate, there was no documented rationale for his prescribing of several medications, and several of his progress notes were illegible, including his use of non-standard abbreviations.

Id.

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

The Board found that on March 25, 2008, Respondent began treating KF, a twenty-one year old female patient, who complained that she had “difficulty finishing tasks and focusing.”

Id.

at 4. Respondent prescribed Adderall to KF, yet “[t]here was no documentation that [he] obtained her past medical records or ordered any laboratory tests that would qualify KF for a diagnosis to support the use of Adderall.”

Id.

Respondent prescribed frequent early refills at several subsequent office visits without documenting any rationale for the refills.

Id.

Moreover, on November 4, 2008, Respondent increased KF's dose of Adderall from 20 mg to 30 mg, without any rationale for the prescription.

Id.

There was no documentation that Respondent ordered any laboratory studies to support his continued prescribing of the drug, or any urine drug screens to determine whether KF was taking the medications as prescribed and/or any illicit substances; also, “several of Respondent's progress notes were illegible.”

Id.

The Board found that the standard of care requires a psychiatrist to perform adequate psychiatric evaluations, and that Respondent deviated from the standard of care because he did not perform an adequate psychiatric evaluation.

Id.

The Board also found that the standard of care requires a physician who prescribes Adderall “to obtain prior medical records, perform tests to confirm the diagnosis and the necessity of the medication[,] and to monitor the patient's use of the medication.”

Id.

The Board thus found that “Respondent deviated from the standard of care because he did not obtain prior medical records, perform tests to confirm the diagnosis and the necessity of the medication[,] and he

did not monitor KF's use of the medication.”

Id.

The Board also found that “[t]here was no collateral information to support prescribing Adderall, creating a potential for misdiagnosis, addiction, abuse, misuse, overdose and diversion. Since no urine drug tests were performed it is unknown whether KF was taking the medication as prescribed and/or whether she was utilizing illicit substances.”

Id.

at 4-5.

Finally, the Board found that Respondent's records were inadequate because he did not obtain KF's past medical records, did not document a physical examination prior to prescribing medications, did not document any rationale for the prescriptions, dosage escalations, additions of medication, that several of Respondent's progress notes were illegible, and that he used non-standard abbreviations.

Id.

at 5 (citing Ariz. Rev. Stat. § 32-1401(2)).

Here again, Respondent's Expert did not dispute the Board's finding that Respondent provided AL with “frequent early refills of Adderall.” Tr. 669. She also did not “take issue with the fact that this dose was increased.”

Id.

at 670.

The Board found that Respondent began treating patient JF, a nineteen-year old female patient in August 2007 for chronic pain, Attention Deficit Disorder and Obsessive Compulsive Disorder.

Id.

JF reported current prescriptions of OxyContin 40 mg and oxycodone 30 mg.

Id.

There was neither a documented physical examination nor laboratory studies, and Respondent did not obtain past medical records.

Id.

Respondent, however, prescribed 90 tablets of OxyContin 40 mg, 45 tablets of oxycodone 30 mg, and Requip to her.

Id.

The Board found that Respondent added Adderall to JF's medication regime in October 2007, without documenting any rationale for the medication.

Id.

It also noted that during the course of JF's treatment, she reported on multiple occasions damaged or stolen prescriptions, running out of medication, and that the pharmacy had refused to fill a prescription because of different handwriting.

Id.

However, Respondent continued to prescribe to her and escalated the doses of oxycodone and Adderall.

Id.

The Board further found that there was no documentation that Respondent ordered laboratory studies to support his continued prescribing of OxyContin, oxycodone, and Adderall, or that he did any urine drug screens to determine whether JF was taking the medications as prescribed and/or illicit substances.

Id.

at 5-6. In addition, there was no documentation that Respondent referred JF to a specialist for consultation.

Id.

at 6.

The Board found that that the standard of care requires a psychiatrist to perform adequate psychiatric evaluations, and that Respondent deviated from the standard of care because he did not perform an adequate psychiatric evaluation for JF.

Id.

In addition, the Board found that when a physician prescribes Adderall, the standard of care requires that he perform tests to confirm the diagnosis and the necessity of the medication and to monitor the patient's use of the medication, and that Respondent deviated from this standard because he prescribed the drug without performing tests to confirm the diagnosis and the necessity of the medication and did not monitor JF's use of the medication.

Id.

Next, the Board found that when prescribing opioids for the treatment of chronic pain, the standard of care requires a physician to review previous diagnostic studies and interventions, assess the chronic pain complaint prior to initiating an opioid trial, appropriately monitor the patient's use of the medication, and obtain appropriate therapeutic and laboratory test results that support the diagnosis.

Id.

The Board found that Respondent deviated from the standard of care because he did not review past medical records and he did not order appropriate tests or consultations for JF.

Id.

The Board further found that there was no collateral information to support prescribing Adderall, which created a potential for misdiagnosis, addiction, abuse, misuse, overdose and diversion, and that no urine drug tests were performed to determine whether JF was taking the medication as prescribed.

Id.

The Board also found that Respondent's medical records for JF were inadequate because he did not obtain JF's past medical records, did not document a physical examination prior to prescribing medications, did not document any rationale for prescriptions, dosage escalations, and additions of medication.

Id.

at 7. Further, it found that Respondent used non-standard abbreviations in his records.

Id.

(citing Ariz. Rev. Stat. § 32-1401(2)).

DD, SS, AM & MF

The Board found that in 2008, Respondent treated patients DD, SS, AM and MF for chronic pain.

Id.

He prescribed medications that included OxyContin and oxycodone based on the patients' reported history and complaints of chronic pain.

Id.

Yet the Board found that there was no documentation that Respondent obtained past medical records to confirm the patients' diagnoses.

Id.

Moreover, the Board found that during the course of his treatment, Respondent provided early refills and escalated the patients' doses of OxyContin and oxycodone, without documenting any rationale to support his diagnosis or prescribing.

Id.

The Board further found that Respondent “did not perform adequate physical examinations, obtain past medical records, or order diagnostic and laboratory studies.”

Id.

Also, there was no documentation that Respondent referred the patients to a specialist to confirm his continued prescribing of opioids, or that he performed any urine drug screens to determine whether the patients were taking the medications as prescribed and/or illicit substances.

Id.

The Board found that when prescribing opioids for the treatment of chronic pain, the standard of care “requires a physician to review past diagnostic studies and interventions, assess and confirm the chronic pain complaint prior to initiating an opioid trial, appropriately monitor the patient's use of the medication, and obtain appropriate therapeutic and laboratory results that support the diagnosis.

Id.

at 8.

The Board found that Respondent deviated from the standard of care because he did not review DD's, SS's, AM's and MF's past diagnostic studies and interventions, assess and confirm their chronic pain complaints prior to initiating an opioid trial, appropriately monitor their use of the medication, and obtain appropriate therapeutic and laboratory test results that supported his diagnoses of chronic pain.

Id.

The Board further found that there was no collateral information to support prescribing opioids to DD, SS, AM and MF, thus creating the potential for misdiagnosis, addiction, abuse, misuse, overdose and diversion, and that because no urine drug tests were performed, it was unknown whether they were taking the medication as prescribed and/or whether they were utilizing illicit substances.

Id.

Finally, the Board found that Respondent's records for patients, DD, SS, AM, and MF were inadequate because he did not obtain past medical records, did not document adequate physical examinations or laboratory and diagnostic studies prior to prescribing medications, did not obtain any diagnostic studies to support his continued prescribing of medications,

and did not document any rationale for prescriptions and dosage escalations.

Id.

at 8-9 (citing Ariz. Rev. Stat. § 32-1401(2)).

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

The Board investigated a complaint regarding Respondent's care and treatment of patient WO, a fifty-two year old male, for chronic pain syndrome.

Id.

at 11. Respondent assumed WO's care in January 2008, at which time “WO was on [o]xycodone, [m]orphine [s]ulfate immediate release (MSIR) and Soma, which had been prescribed by his previous physician.”

Id.

The Board found that Respondent reviewed previous imaging studies, including a computed tomography scan of WO's pelvis and abdomen that showed healed lower right lateral rib fractures, but no other abnormalities, and a cervical spine film that showed mild hypertrophic degenerative changes in the mid-cervical spine, but no other abnormalities.

Id.

The Board found that from WO's initial visit until July 2009, Respondent continued to see WO and refill the prescriptions.

Id.

The Board found, however, that there was no documentation that he performed a neurological or musculoskeletal exam or ordered any imaging studies of WO's lumbar spine or laboratory studies, prior to continuing the treatment of WO's previous physician.

Id.

The Board also found that from March 2008 through December 2008, Respondent increased WO's dosage of oxycodone 30 mg to six tablets per day.

Id.

at 12. Moreover, on May 30, 2008, Respondent added Morphine Sulfate (MS) Contin 30 mg for poor sleep, but subsequently increased the dose without documenting a rationale for the increase.

Id.

Yet there was no documentation that Respondent performed any physical examinations or obtained any radiologic studies to support his increased opioid prescribing.

Id.

Next, the Board found that in February 2009, Respondent discontinued prescribing MS Contin to WO and instead prescribed six tablets per day of morphine sulfate 30 mg to him.

Id.

The Board found that Respondent simultaneously increased WO's oxycodone dose to eight tablets per day, yet did not document a rationale for the increase.

Id.

In March 2009, Respondent performed a urine drug screen on WO; the screen was negative for oxycodone, but positive for methadone and codeine, which were not among his prescribed medications, as well as heroin.

Id.

At WO's next visit, Respondent documented that he was aware of the positive drug screens.

Id.

The Board found however, that Respondent did not adequately investigate or address the abnormal results by either referring him to an addiction medicine specialist or discontinuing the opioid prescriptions.

Id.

The Board found that the standard of care requires a physician to perform an adequate work up of a patient prior to continuing treatment of the patient's prior treating physician, to perform an adequate physical examination, and to obtain radiologic data to support the amount of opioid medications prescribed to the patient.

Id.

The Board found that Respondent deviated from the standard of care because he did not perform an adequate work-up and that the physical examination and radiologic data did not support the amount of opioid medications he prescribed to WO.

Id.

at 12-13.

The Board also found that the standard of care requires a physician to adequately investigate or address a patient's abnormal urine drug screen.

Id.

at 13. The Board found that Respondent deviated from the standard because he did not adequately investigate or address WO's abnormal urine drug screen.

Id.

The Board further found that Respondent allowed WO to continue a pattern of illicit substance use and opioid misuse.

Id.

The Board found that that Respondent's prescribing of 240 tablets of oxycodone per month also created a potential for misuse and diversion.

Id.

Finally, the Board found that Respondent's records were inadequate because there was no documentation that he performed a neurological or musculoskeletal examination, ordered any imaging or lab studies prior to continuing the treatment, and there was no documented rational for his excessive prescribing of opioids.

Id.

(citing Ariz. Rev. Stat. § 32-1401(2)).

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

Summary of the 2010 Order

Based on its findings with respect to all of the patients, the Board found that Respondent committed unprofessional conduct by “failing or refusing to maintain adequate records on a patient,” Ariz. Rev. Stat. § 32-1401(27)(e), as well as by engaging in “[a]ny conduct or practice that is or might be harmful or dangerous to the health of the patient or the public,” Ariz. Rev. Stat. § 32-1401(27)(q). GX 18, at 17. The Board issued Respondent a Decree of Censure and prohibited him “from prescribing, administering or dispensing any opioids for a period of one year.”

Id.

at 18. It also placed him on probation for two years; among the terms of the probation, Respondent was required “to complete the PACE prescribing course within 6 months of the effective date of this Order” and enter into a contract providing for quarterly chart reviews by a monitor.

Id.

Regarding the 2010 AMB Order, Respondent testified that the Board had reviewed 45 of his patient records and had not criticized his recordkeeping other than with respect to the thirteen that were the subject of the Order. Tr. 856-58. He asserted that the reason his recordkeeping was inadequate was because his “early training and practice was primarily in psychiatry” where “[t]he confidentiality of the patient is paramount,” such that his “[n]otes were often brief” and hit just “the main points” of the patient's “main complaint, perhaps a mental status examination, the diagnosis and the plan.”

Id.

at 859-60. He then testified that “the main purpose of the record was to refresh your own memory and wasn't necessarily always focused on outside review,”

id.

at 860, but that he was now “making every effort to make the record transparent to outside individuals, which was really not the standard of care or the practice for psychiatry.”

Id.

at 861.

Respondent further testified that during the period in which the AMB was investigating his prescribing to D.K., he sought out assistance from other pain management physicians, studied for and took the board in Pain Medicine, read multiple textbooks and took online courses.

Id.

at 864. He also testified that he had complied with the 2010 Order's practice restriction, which prohibited him from prescribing opioids, and that the restriction had been lifted.

Id.

at 870.

As far as other measures he has undertaken since 2007, Respondent stated that his practice was now able to use the Arizona Controlled Substance Prescription Monitoring Program, that the office was now certified to do in-office urine testing and that it was doing random urine screening, that the office was using the fax alert system, and that he was now placing “[a] very high priority” on calls from pharmacies.

Id.

at 870-72. Respondent also stated that he had imposed an “internal kind of ceiling on opiate dosing,” and that “[w]e're not a prescribing mill.”

Id.

874, 877.

Regarding the second AMB Order, Respondent testified that “there was a Board statement that no actual harm was found in any patient” and “no patients . . . were found to have been diverting substances.”

Id.

at 883. He then asserted that “[t]here was no potential addiction, which was perpetuated by my behavior, which is one of the claims.”

Id.

When asked whether he accepted the AMB's criticism of his recordkeeping and care of his patients, Respondent testified: “Yes. I realize this is a difficult area and that I need to keep working to improve and I have and I will.”

Id.

at 884. Respondent then testified that “I accept the general criticism that there needs to be improvement of my care as I can do so” but that he did not agree with some of the specifics of the Order, as his Expert had testified.

Id.

The Undercover Visits

The Government also introduced evidence that it sent two confidential sources (CS) into Respondent's office to obtain controlled substances; each source performed two visits and obtained controlled substances at each visit. With respect to these visits, the Government introduced the recordings (and transcripts) of each visit, and the medical record for each CS. In addition, the Government elicited testimony from a Special Agent (S/A) who was involved in conducting the visits and debriefing the CSs after the visits.

The Government did not, however, elicit testimony from an expert witness regarding whether Respondent had acted within the usual course of professional practice and with a legitimate medical purpose when he prescribed to the two CSs. Instead, it argues that the evidence shows that “on four occasions,” Respondent prescribed controlled substances to the CSs “without ever conducting a physical examination,” and that the prescriptions violated an Arizona Statute, which provides that it is “ `[u]nprofessional conduct' ” to “ `[p]rescrib[e], dispens[e], or furnish[] a prescription medication . . . to a person unless the licensee first conducts a

physical examination

of that person or has previously established a doctor-patient relationship,' ” and therefore, the prescriptions violated 21 CFR 1306.04(a). Gov. Exceptions at 3 (quoting Ariz. Rev. Stat. §§ 32-1401(27)(ss)).

With respect to RL, the evidence showed that she visited Respondent on April 9 and May 7, 2008, obtaining a prescription for 120 oxycodone 5 mg at the first visit and a prescription for 60 OxyContin 20 mg. at the second visit.

See

GXs 3 and 5. In addition, the S/A testified that during the debriefing of RL following her visit, RL said that “she told [Respondent] where she had pain” and that Respondent “asked a series of questions regarding exercise, sleep, family history, basically general medical questions as to how her life is, what her occupation is, what she does, is she stressed out, does she have anxiety, things of that nature.” Tr. 358. The S/A further testified that RL did not provide any medical records to Respondent and that RL “said there was no physical examination.”

Id.

at 359.

According to the transcript of the visit, RL complained of having hip pain which was caused by a fall. GX 11, at 2. Respondent asked RL a series of questions, including when she had fallen; whether her hips had been ok prior to the fall; whether she had had an x-ray or MRI, and whether the x-ray showed arthritis; whether the pain bothered her when she did various body movements and whether it went down her leg; how often she had the pain; whether it was a sharp or dull pain; whether she had any numbness; whether it impaired her ability to walk; whether it affected her ability to sleep, her appetite, her energy, and her mood; whether she had anxiety attacks; whether she drank alcohol; whether she had taken any medication for the pain and whether it had helped; whether her health was otherwise good; and whether her family had certain medical conditions.

Id.

at 3-8; 13-15; 18-22. Respondent also discussed various forms RL needed to complete, including one to describe her pain, his controlled substance contract, and a form regarding which pharmacy she was using.

Id.

at 25. Respondent then told RL that oxycodone and Percocet were “not refillable” and that the long-term effect of taking oxycodone could include constipation and affect her level of hormones.

Id.

at 29.

Although the transcript corroborates some of RL's hearsay statements (as related by the S/A), significantly, the transcript shows that early on in the visit, the following colloquy occurred:

Respondent: Do you have any tenderness if, if you push on it like this?

RL: Yeah.

Respondent: Where does it hurt? Just when you push on it here?

RL: Directly on it, yes.

Id.

at 6.

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

While the transcript for RL's second visit contains no indication that Respondent physically examined her, and the S/A testified that RL stated that she was not physically examined on that occasion,

see

Tr. 367, the Arizona statute does not require that a physician physically examine his patient on each occasion that he prescribes a controlled substance to her.

See

Ariz. Rev. Stat. §§ 32-1401(27)(ss)). Nor did the Government offer any evidence that under the standard of care, a physician is required to perform a physical exam on each occasion that he prescribes.

With respect to the second CS (ML), the evidence showed that she saw Respondent on May 2, 2008 and June 6, 2008. GX 6, at 1; GX 8, at 1. At the first visit, Respondent prescribed 30 oxycodone 5 mg to ML, GX 6, at 1; at the second visit, Respondent prescribed both 30 oxycodone 5 mg and 30 morphine sulfate ER 15 mg. GX 8, at 1.

According to the S/A, during the debriefing following her first visit, ML stated “that an evaluation was done with questions based on anxiety, sleep, her family history, [and] what her pain was. She said she had a pain in her shoulder due to her occupation.” Tr. 373. ML also told Respondent that she had undergone gastric bypass surgery and “how much weight she had lost.”

Id.

The S/A further testified that ML did not provide Respondent with any medical records on this visit, and when asked what type of physical examination Respondent had performed on her during the visit, ML answered: “[n]one.”

Id.

The transcript for the visit shows that after discussing her dental pain, ML complained of pain, stated that the pain was “right here” and that it was “really hurting . . . a lot!” GX 15, at 4. Respondent then asked if the pain was in the bone or “the joint here?”

Id.

ML stated that “it's like a muscle type tissue or something.”

Id.

Respondent then asked ML to “point right there,” ML said, “[i]t, it hurts.”

Id.

at 4-5. Respondent suggested that ML should “maybe . . . get that injected” and asked “[w]hen did that start?”

Id.

at 5. ML stated that she didn't remember when, or what she was doing when she started feeling the pain, and that she had to alter the position of her bra strap.

Id.

After discussing that Respondent was also a psychiatrist, Respondent suggested that ML see his colleague, Dr. Skinner, who “might be able to adjust that,” and asked if the pain went down

her arm.

Id.

at 5-6. ML replied in the affirmative and said it was “hard for” her because “what I do is on the phone.”

Id.

at 6. Respondent then suggested that ML use a headset so she could keep her “head up straight,” and asked, “how often does that hurt you?”

Id.

ML said the pain “comes and goes,” but that “it's been about a month now that . . . it pulls.”

Id.

Respondent then said he would see if Dr. Skinner would be available to help ML and asked “what else is going on?”

Id.

ML then complained that “I get emotional” and “just stress out because I think people are looking at me”; ML and Respondent then discussed ML's efforts to lose weight and her having undergone a gastric bypass procedure.

Id.

at 7-9.

Next, Respondent asked ML if she was “sleeping okay”; ML replied that she had “a sleeping disorder” for which she took “some sleeping pills.”

Id.

at 9. Thereafter, Respondent asked ML “about [her] energy” (with ML stating that she fatigued easily), if she was “irritable or grouchy” (with ML answering in the affirmative), and whether ML had anxiety or panic attacks, (with ML saying just when she hurt).

Id.

at 10. Respondent again asked ML, “what hurts? It's, it's this area in your shoulder?” and ML replied “it's the shoulder, my back.”

Id.

Respondent then asked ML if she had depression (with ML saying she did not think so), whether she drank alcohol (ML answering “no”), what ML took to sleep (with ML saying she had “no idea”), whether she took any other medications (with ML apparently answering that she took a drug for blood pressure), and whether she had “any other health problems” (with ML answering “no.”).

Id.

at 11-12. Following this, Respondent asked ML a series of questions about her family, including whether her parents were still alive, whether she had siblings, whether she was married and had children, as well as where she was living, and the circumstances surrounding the death of her mother.

Id.

at 12-17. Respondent then asked ML if she had ever taken medication for anxiety or depression; ML replied that she had taken Lexapro for a while and that it had helped but that she didn't have insurance and the drug was expensive.

Id.

at 17-18. ML added that the only drug she was presently taking were her “pain pills” and that they made her “feel better.”

Id.

at 18. When Respondent asked ML what she had taken in the past, the latter said that she had tried hydrocodone but was allergic to it, and that the only drug she thought she could take was oxycodone.

Id.

Respondent then asked how much oxycodone she could take; ML said she could take one a day and that the drug “calm[ed her] down a lot,” but that she did not know how many milligrams the pills were.

Id.

at 18-19. ML then said she was just really nervous and explained that she worked as a phone sex operator and that she had previously worked as a financial counselor at a hospital.

Id.

at 20-22.

Respondent asked ML who had previously given her pain medication; ML identified the name of a doctor and his practice.

Id.

at 22. Respondent then said he would see if Dr. Skinner was available and suggested that she might be able to “fix” ML's injured area and added that he would get ML some prescriptions.

Id.

at 24. Respondent then found Dr. Skinner and brought her to see ML.

Id.

at 26.

Respondent explained to Dr. Skinner that ML “ha[d] a crook on her neck,” which was “like a . . . [a] little rock in there.”

Id.

Notably, before Respondent completed this sentence, ML stated: “That right there!”

Id.

ML then complained that she could not move her arm very well and again said that she had to alter where she wore her bra strap.

Id.

Dr. Skinner then observed that ML's shoulders were straight but that her “neck [wa]s out,” and after an unintelligible comment by Respondent, replied “I know.” Dr. Skinner then said that she would “rotate it to the right . . . and then to the left.”

Id.

at 27. ML asked if that was “from a muscle spasm?”

Id.

Dr. Skinner asked ML if she was “on the phone,” and after ML said that it was her “job,” Skinner stated: “Okay, listen to me. Don't do that!”

Id.

Respondent and Dr. Skinner then discussed with ML that she needed to get a headset or some other device so that ML could keep her head upright while she was on the phone.

Id.

at 27-28. ML then asked Dr. Skinner if she could “feel that?”

Id.

Dr. Skinner said “[y]eah,” and Respondent asked if there was something such as acupuncture” that could be useful.

Id.

at 28-29.

Dr. Skinner then told ML not to “resist [her] pain” and explained that “it's stuck because you keep your head in the wrong position” and that ML was “not going to be able to fix it, if [she] ke[pt] using [her] head, putting [her] head . . . that way.”

Id.

at 29. ML said “[a]h,” and Dr. Skinner stated: “Don't resist it please.”

Id.

ML said “[o]kay,” and Dr. Skinner replied: “Just accept it, until I say move. You might need to come back . . . I think it's going to take some time.”

Id.

ML said “now it's starting to feel a little better”; Skinner replied: “Yeah, it does,” and added “but if you resist it[,] it's going to feel worse.”

Id.

at 30.

ML then asked if “it's more[ ] like a mental thing?”

Id.

Dr. Skinner replied “[e]xactly,” and Respondent interjected: “[w]ell, your muscles are attached to your brain[,] [y]ou know?”

Id.

ML said “[o]h,” and Respondent added: “So your . . . brain has to let it . . . .”

Id.

Dr. Skinner then stated: “We got to release all that, so we can—and your neck is out of alignment. And I don't know if anything—yeah, push your head against my hand and relax.”

Id.

After ML said “Ah,” Skinner said “[o]kay,” and added that “we're going to have to work on it with acupuncture.”

Id.

ML said “okay,” and Respondent told ML that if she made an appointment with Dr. Skinner, she would “have it adjusted.”

Id.

at 30-31. Respondent then asked Skinner if acupuncture would be of any use, and Skinner said that “it helps it release it so.”

Id.

at 31. After Respondent, Skinner, and ML discussed her weight loss, Skinner left.

Id.

at 31-32.

Respondent then told ML that he had various paperwork which had to be completed when he prescribed controlled substances, including his pain contract, a form that was sent to the patient's pharmacy, and a form on which ML was to show the location of her pain and describe it.

Id.

at 32-33. He also told ML that she was expected to participate in the meetings of a monthly support group for his pain management patients.

Id.

at 34-37.

Respondent then discussed with ML that all he was going to prescribe to her was oxycodone and asked if she had ever taken Percocet, a drug which combines oxycodone with Tylenol (acetaminophen).

Id.

at 38. ML said that she had taken Tylenol but it “ha[d] done nothing” for her, and after Respondent said that Percocet was a combination of the drugs, added that he would be giving ML oxycodone.

Id.

Respondent then explained that oxycodone had to be written every month.

Id.

at 39. After some small talk, the visit ended.

Id.

at 39-41.

Here again, the evidence shows that Respondent did more than simply observe ML during the course of her first visit. Rather, the evidence shows that ML was palpated during the visit.

In its Exceptions, the Government argues that “Respondent's own expert (Dr. Schneider) testified that Respondent failed to conduct a physical examination of either [RL or ML] prior to issuing them prescriptions for controlled substances.” Exceptions at 3. As support for the contention, the Government cites various portions of Dr. Schneider's testimony during cross-examination regarding both her review of RL's and ML's patient files and the

transcripts of the visits, as well as a May 27, 2011 letter she had written regarding Respondent's treatment of RL and ML.

Id.

In the letter, Dr. Schneider noted that she had reviewed the charts of both RL and ML, as well as the transcripts of their visits.

RX 23, at 1.

In the letter, Dr. Schneider wrote with respect to RL that Respondent “asked her about the quality of the pain, effect of exercise, what helps, diurnal course. He asked what she had tried and what medication worked. He asked about a history of alcohol or drug abuse. He obtained a social history.

He did a physical and mental exam.”

RX 23, at 1 (emphasis added). After discussing RL's second visit, Dr. Schneider asserted that “[t]he transcripts were consistent with his chart notes,” and that Respondent “did a lot of things correctly, including excellent documentation, discussion with patient, asking about her past treatments for the pain problem, getting addiction history on first visit, dealing with her mental status, doing a physical exam on first visit, assessing and treating her smoking . . . , and talking with her about physical medicine options.”

Id.

So too with respect to M.L., Dr. Schneider wrote that Respondent “did a lot of things correctly, including excellent documentation, discussion with the patient, asking about her alcohol use, dealing with her mental status,

doing a focused physical on first visit,

referring her for physical medicine and psychotherapy group, and documenting his thinking and his plan.”

Id.

at 2 (emphasis added).

On cross-examination, the Government questioned Dr. Schneider about various findings that Respondent had documented in RL's record, including that her pulse was 70, that her respiration was 16, meaning that she was “breathing at 16 times per minute,” her hip flexion was 1 over 4 for her right hip and 3 over 4 for her left hip, and that her range of motion was fair. Tr. 635-36.

The Government then asked Dr. Schneider to point to where in the transcript Respondent had measured RL's pulse.

Id.

at 638. Dr. Schneider testified: “I don't believe it is in there.”

Id.

Next, the Government asked Dr. Schneider where in the transcript Respondent had measured RL's respiration.

Id.

Dr. Schneider replied: “I believe it's not in the transcript.”

Id.

Regarding whether a physician is required to take a patient's vital signs during a physical examination which is performed at a patient's initial visit, Dr. Schneider testified:

That's usually done. Again, listening to heart and lungs in someone with low back pain is not really going to be all that helpful. It's just sort of a tradition to do it, let's say. So, yeah I would imagine you would get normal vital signs. And a lot of times the nurse does it, not the doctor so it doesn't even come up in the discussion on the transcript because it was done even before the doctor comes into the office. And that's actually the usual thing. That's [the] rule rather than the exception, that the medical assistant does the vital signs.

Tr. 664-65. Notably, in his testimony, Respondent did not maintain that an assistant or nurse took vital signs for him.

Moreover, while Dr. Schneider testified that observing the patient was “part of the physical exam,” she then acknowledged that “[t]here are some things you need to do more directly; for example, you have to put your stethoscope on their chest and listen to their lungs and heart. You can't just look at them across the room and assess their heart function.”

Id.

at 713. While Dr. Schneider testified that taking a pulse does not necessarily require a conversation, to do so she “would take the patient's hand and with my fingers on their radial artery and count up how many times I feel it over a 15 second period” and then multiply by four.

Id.

at 696.

The Government then asked Dr. Schneider to point to where in the transcript Respondent had measure RL's hip flexion; Dr. Schneider acknowledged: “It is not in there.”

Id.

Likewise, when asked in reference to Respondent's documentation that RL was able to do a partial squat and bend at the waist, where in the transcript this had occurred, Dr. Schneider answered that “I probably won't be able to find it.”

Id.

at 639.

Turning to Dr. Schneider's letter, in which she wrote that “[o]n April 9, 2008 Dr. Ruben conducted a physical and mental exam,” Dr. Schneider interrupted the Government counsel before the latter even asked a question, testifying:

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

Id.

at 640. Likewise, when asked about her having noted in her letter, that Respondent's plan included obtaining an x-ray followed by a referral to an orthopedic surgeon, Dr. Schneider could not recall where in the transcript Respondent had told RL that she would need to get an x-ray.

Id.

at 641.

Regarding his treatment of RL, Respondent testified that she was able to do a partial squat, which he determined by watching her sit down in a chair.

Id.

at 920. With regard to how he had determined RL's pulse rate, Respondent testified:

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

Now if I'm concerned about their pulse being something that I can't really think is within the normal range, I may sit down and take their pulse for 15 seconds and sit there formally with them. Or if I can't find their pulse easily. But most people you can—with some practice, you can pretty much find it. You can pretty much hold their hand and you have the pulse.

Id.

at 924-25.

See also id.

at 984 (testifying in response to Government's question: “[h]ow long would a handshake last?,” that “[i]f you're holding their hand it often can last the three or four second[s] needed to kind of evaluate the pulse”);

id.

at 985-86 (testifying in response to Government's question “what's a normal pulse range for your three second handshake?,” that “[a]ll you need to assess, if you're experienced at assessing, is a couple of beats” and then maintaining that “[i]t's more the rhythm. You don't have to actually count it. You can feel. If you feel two or three beats, you can really tell what—basically within ten—we're only interested in seeing . . . if somebody is within normal range.”).

However, on further questioning as to whether he had determined R.L.'s pulse using his three-second handshake technique, Respondent testified:

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

Id.

at 987.

As for how he determined RL's rate of respiration, Respondent testified that “[y]ou can look at you or me, particularly if they don't have covering on their upper chest as in summer. This was in May. And you can watch the respirations. You can tell the respirations again, with an observation of a very short time. You can look and watch.”

Id.

at 926. Respondent then stated that the “normal range for resting respirations is probably 14 to 17 or something like that,” and that “[i]f it's not within a normal range, then you can do more definitive testing,” including “count[ing] them more clearly” and “listen[ing] to see if their lungs are clear.”

Id.

at 927.

See also id.

at 987-88 (“I can tell a respiratory rate just from watching a person at any point in an interview where you're in the same room with them. Just by watching if their chest is moving.”).

As for his findings that RL was “[a]ble to do partial squat and bend at waist,” Respondent testified that this was essentially the chair test and that when “ladies put down their purse[,] [t]hey reach over for that[,] [t]hey reach for things[,] [a]ll that is information about their movement.”

Id.

at 928. On cross-

examination, Respondent testified that he “may not have” asked RL to do a partial squat and “probably would not have” asked her to bend at her waist.

Id.

at 990. Respondent then testified that “[a]nd if it's not here, I must have not asked it. But I gained the information through observation.”

Id.

And as for his finding that RL's hip flexor was “R

1/4

, L

3/4

,” Respondent testified that “[f]our is a norm” and that “[i]t's more of an average of what was going on.”

Id.

at 928. Continuing, Respondent explained: “You know, I might of [sic] observed as she sat down she favored—she flexed one side more than—sat one way rath[er]—and guarded on [one] side. So that would be an estimation of that.”

Id.

at 928-29. And regarding his finding RL's “R hip tender with ROM [f]air,” Respondent testified:

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

Id.

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

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

Id.

at 991.

On cross-examination, Respondent further testified that he did not do “a more formal physical exam” on RL, because he “felt [he] gathered sufficient information to meet the needs for her first visit to begin to treat her and make a diagnosis and to make a basis for prescribing the limited amounts of medication that she was receiving.”

Id.

at 982-83. Respondent then stated that he “didn't perform more than what I did. But I told you—that's true.”

Id.

at 983.

Likewise, with respect to M.L., the Government established that Respondent made findings in her patient record that she had a pulse of 80 beats per minute, a respiration rate of 18 breaths a minute, that she “[h]a[s] decreased flexion and extension” in her head, that her cranial nerves were intact, that her grip for both hands was a

2/4

, and that she moved “both arms in abduction and adduction.” Tr. 650-52; RX 2, at 2. The Government then asked Dr. Schneider where in the transcript there was evidence that Respondent had performed these various tests. Tr. 653-56.

Dr. Schneider admitted that she did not see in the transcript where Respondent had taken M.L.'s pulse or measured her respiration.

Id.

at 653, 655. As for where Respondent had measured the extension and flexion of M.L.'s head, Dr. Schneider acknowledged that “[i]t's not in there.”

Id.

at 653. However, Dr. Schneider then testified “that [it] is possible to tell from—sometimes from looking at a person.”

Id.

Dr. Schneider also acknowledged that the transcript contained no indication that Respondent had done “a formal” cranial nerve examination, nor measured M.L.'s grip.

Id.

at 653-54. As for where in the transcript there was evidence that Respondent had ML move her arms, Dr. Schneider answered: “[T]hat again, he may have seen just watching her.”

Id.

at 654.

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

Q. Okay. And in your experience, is it acceptable to replace your own physical examination of the patient with the examination of someone else in your office?

A. That's a good question and I don't have an exact answer because that doesn't often come up. I suppose if it's someone else who's skilled who is doing the physical exam that might be appropriate. I don't know.

Id.

at 654-55.

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

Next, the Government noted that in her letter, Dr. Schneider had stated that Respondent “did a focused physical exam on the first visit of” ML and asked Dr. Schneider “where in the transcript does [Respondent] conduct a focused physical of [ML] on this occasion?”

Id.

at 655-56. Dr. Schneider answered: “I don't see it.”

Id.

at 656. And with regard to Dr. Schneider's statement in her letter that Respondent “had excellent documentation of his treatment of” ML, Dr. Schneider acknowledged that her definition of excellent documentation does not include documenting findings “that were not actually discerned during the course of a visit.”

Id.

Regarding what constitutes “a focused physical exam,” Dr. Schneider testified:

It's when you concentrate on one particular part of the body. So for example, if someone has back pain, you watch how they get up, you watch how they sit down, you watch how they move, you watch how they pick up something and you can get some conclusions without doing a formal one. Ideally, you'd want to do a formal one, but it is possible to gather information from observing the patient.

Tr. 664.

In its Exceptions, the Government also cites to its cross-examination of Dr. Schneider regarding the statements in her letter that, at ML's second visit, Respondent performed “a focused physical exam” and that ML had “said her pain had decreased to 3/10 on [the] current dose.” Exceptions at 3-4 (citing Tr. 662-64);