Syed Jawed Akhtar-Zaidi, M.D.; Decision and Order

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 14-2]

Syed Jawed Akhtar-Zaidi, M.D.; Decision and Order

On February 10, 2014, Administrative Law Judge (ALJ) Christopher B. McNeil issued the attached Recommended Decision.

1

Both parties filed Exceptions to the ALJ's Recommended Decision.

1

All citations to the Recommended Decision are to the slip opinion as issued by the ALJ.

Having reviewed the entire record, including the parties' Exceptions, I have decided to adopt the ALJ's findings of fact except as discussed below. I further adopt the ALJ's conclusions of law that:

(1) Respondent issued prescriptions for controlled substances to three undercover officers outside the usual course of professional practice and which lacked a legitimate medical purpose;

(2) Respondent violated Federal law when he issued controlled substance prescriptions which did not include the patient's address;

(3) Respondent violated Ohio law requiring that he “complete and maintain accurate medical records reflecting the physician's examination, evaluation, and treatment of [his] patients,” when, with respect to the three undercover officers, he “falsely reported the extent and nature of his examination of [them] and falsely reported the patients' reports of pain”;

(4) Respondent “failed to comply with the requirements of Ohio law applicable to the treatment of chronic pain.”

R.D. 81-86. Finally, I adopt the ALJ's ultimate conclusions of law that the Government has met its

prima facie

burden of showing that “Respondent's continued . . . registration is inconsistent with the public interest” and that “Respondent has failed to rebut the Government's

prima facie

case.”

Id.

at 87.

According to the ALJ's Recommended Decision, Respondent's registration was due to expire on June 30, 2014, and according to the registration records of the Agency, of which I take official notice,

see 5

U.S.C. 556(e), Respondent has not filed either a renewal or new application. While ordinarily, these findings would render a case moot,

see Ronald J. Riegel,

63 FR 67132, 67133 (1998), this Agency has recognized that where a registrant is served with an Immediate Suspension Order, there may be collateral consequences which preclude a finding of mootness. Here for example, the Immediate Suspension Order authorized the Government to seize any controlled substances it found at Respondent's registered location,

see

ALJ Ex. 1, at 4 (citation omitted); and pursuant to 21 U.S.C. 824(f), “[u]pon a revocation order becoming final, all such controlled substances . . . shall be forfeited to the United States” and “[a]ll right, title, and interest in such controlled substances . . . shall vest in the United States upon a revocation order becoming final.”

See also

21 CFR 1301.36(f)). Moreover, the Agency has held that a registrant, who has been issued an Immediate Suspension Order, cannot defeat the effect of this provision by allowing his registration to expire.

Meetinghouse Community Pharmacy, Inc.,

74 FR 10073, 10074 n.5 (2009).

Accordingly, on May 8, 2015, the former Administrator issued an Order directing the parties to address whether the case was moot. Thereafter, both parties filed responses asserting that the case remains a live controversy, with the Government specifically noting that various controlled substances including Demerol, morphine sulfate, hydrocodone, and midazolam were seized from Respondent's office during service of the Immediate Suspension Order. Gov't Response to Order, at 2. The Government further represents that there are no other proceedings pending to determine title to the drugs and therefore requests that I issue a final order to resolve this issue.

Accordingly, I conclude that this proceeding presents the collateral consequence of who has title to the controlled substances seized by the Government. While I do not adopt the ALJ's recommended order that I revoke Respondent's registration and deny any pending application to renew or modify his registration, I will affirm the issuance of the Immediate Suspension Order and declare that all right, title, and interest in the seized drugs is forfeited to the United States. A discussion of Respondent's Exceptions follows.

2

2

The Government takes exception to the ALJ's discussion of factor two and whether the Agency has properly applied it in revocation proceedings because the factor refers only to “the applicant's” experience in dispensing controlled substances.

See

R.D. at 54-58. The Government's exception is well taken.

Pursuant to Congress's direction in 21 U.S.C. 824(a)(4) that the Agency may revoke a registration “upon a finding that the registrant . . . has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest

as determined under such section,”

every Administrator and Deputy Administrator who has exercised the authority granted by section 824 has rejected the ALJ's view. Moreover, in

Clair L. Pettinger, M.D.,

78 FR 61592 (2013), the Administrator thoroughly addressed and rejected the ALJ's reasoning. Indeed, no court has ever questioned the Agency's interpretation that it is required to consider (although not necessarily make findings with respect to) each of the public interest factors in a revocation proceeding.

See Dewey C. MacKay,

664 F.3d 808, 816 (10th Cir. 2011) (noting, in revocation proceeding, that “[t]he agency is required to consider five factors `[i]n determining the public interest' ”);

id.

at 819 (upholding agency's determination that evidence that physician diverted controlled substances was relevant under both factors two and four);

Morall v DEA,

412 F.3d 165, 173 (D.C. Cir. 2005) (noting, in revocation proceeding, that “[s]ection 823(f) provides the factors to be considered `[i]n determining the public interest' ” and listing all five factors).

Thus, the issue has been conclusively decided. Because the ALJ's decision is only a recommendation, the Agency has no obligation to publish any portion of it, let alone that which persists in re-arguing that which has been long decided.

See Iran Air

v.

Kugelman,

996 F.2d 1253, 1260 (D.C. Cir. 1993) (quoting Joseph Zwerdling,

Reflections on the Role of an Administrative Law Judge,

25 Admin. L. Rev. 9, 12-13 (1973) (an ALJ “ `is governed, as is the case of any trial court, by the applicable and controlling precedents. These precedents include . . . the agency's policies as laid down in its published decisions. . . . Once the agency has ruled on a given matter . . . it is not open to reargument by the administrative law judge' ”)). Accordingly, I decline to publish the ALJ's discussion regarding the applicability of factor two in revocation proceedings.

Exception One—The ALJ Arbitrarily and Capriciously Barred Respondent From Presenting the Testimony of His Expert Witness, His Employees, and His Patients

Respondent argues that the ALJ's refusal to allow him to present testimony from his expert, Dr. Richard Stieg, three of his employees, and his patients, “was arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with law.” Resp. Exceptions, at 1-2. While I find the ALJ's ruling denying Respondent the right to call Dr. Stieg to be problematic, for reasons explained below, I hold that Respondent has not demonstrated that the ALJ committed prejudicial error. I further find that Respondent has failed to demonstrate that the ALJ erred when he barred the employees and the patients from testifying, let alone that the error was prejudicial.

The ALJ's Ruling Barring Dr. Stieg's Testimony

Respondent argues that even before the proceeding was initiated, “the Government had several months in which to . . . obtain an expert witness” and have the expert review the evidence against him. Resp. Exceptions, at 2. By contrast, Respondent argues he “had a very limited period of time in which to . . . retain an expert and have the expert review the documents and files” and form his opinion.

Id.

Noting that the ALJ “placed near complete reliance on the testimony of the Government's expert,”

id.

at 3,

Respondent contends

that “expert testimony [was] critical to establishing [his] defense,”

id.

at 2,

and that Dr. Stieg (his expert), “was prepared to testify that contrary to the Government's position, he did not fail to meet the standard of care in pain medicine.”

Id.

at 3.

Respondent further contends that he “was placed in a perilous position by the” ALJ, apparently because after Respondent identified Dr. Stieg and disclosed “his expected testimony,” he “also discovered that Dr. Stieg” had a serious medical condition and was to undergo treatment on the dates set for the hearing (December 16-17, 2013) and “would be unable to testify.”

Id.

Respondent then notes that “[u]pon discovering this information,” he immediately moved for a continuance of the proceeding, but that the ALJ denied his motion.

Respondent further argues that the ALJ's basis for denying his motion was inconsistent with agency precedent. In his Recommended Decision, the ALJ explained that he found Dr. Stieg's testimony “would likely have little probative value, as the witness did not appear to be familiar with Ohio medical practice standards.” R.D. at 4. Respondent argues that the ALJ's reason is “arbitrary, capricious, an abuse of discretion, and not in accord with DEA precedent,” noting that in

Mireille Lalanne,

78 FR 47750, 47759 (2013), the Agency held that evidence as to “generally recognized and accepted medical practices” may be admitted to show “the usual course of professional practice” under the CSA and the Agency's regulations. R.D. at 4 (other citation omitted). He then notes that several of the factors which the Agency is required to consider under the public interest standard are “not set by state law.” Resp. Exceptions, at 5.

Moreover, Respondent suggests that the ALJ made inconsistent findings when he held that Respondent had not demonstrated that the exclusion of Dr. Stieg's testimony would cause him “substantial prejudice,” while at the same time he held that the Government would be prejudiced by the testimony.

Id.

at 4.

Finally, Respondent notes that while the ALJ had initially considered allowing Dr. Stieg to testify through video teleconference (and be taken out of order), he reversed his position after Respondent invoked his Fifth Amendment privilege and refused to testify when called as a witness by the Government.

Id.

at 5 (citing Tr. 248). According to Respondent, the ALJ's ruling was an “attempt to punish Respondent for exercising his constitutional right.”

Id.

While some of Respondent's arguments are well taken, I hold that Respondent has failed to demonstrate prejudicial error.

See

5 U.S.C. 706. As several federal courts have explained, an ALJ's discretion “includes the power to make reasonable, nonarbitrary decisions regarding the admission or exclusion of evidence.”

Gunderson

v.

Department of Labor,

601 F.3d 1013, 1021 (10th Cir. 2010). However, even where it is shown that an ALJ erred in excluding evidence, that error must “ `prejudicially affect a substantial right of a party.' ”

Id.

(quoting

Sanjuan

v.

IBP, Inc.,

160 F.3d 1291, 1296 (10th Cir. 1998)).

See also Air Canada

v.

Department of Trans.,

148 F.3d 1142, 1156 (D.C. Cir. 1998) (“As incorporated into the APA, the harmless error rule requires the party asserting error to demonstrate prejudice from the error.”) (citing 5 U.S.C. 706).

Moreover, “[a]n error is prejudicial only `if it can be reasonably concluded that with . . . such evidence, there would have been a contrary result.’ ”

Gunderson,

601 F.3d at 1021 (quoting

Sanjuan,

160 F.3d at 1296). Applying this standard, Respondent cannot prevail.

According to Respondent's proffer, “Dr. Stieg would have testified that there is no `gold standard' or one defined standard which defines with certainty the accepted and prevailing standards of care for pain medicine medical services” and that “whether a physician has met the accepted and prevailing standards of care for pain medicine service is a case by case analysis, taking into account the individual circumstances of each patient and the relevant medical decisions in connection with the treatment of that patient.” Resp. Offer of Proof, at 3.

Moreover, Dr. Stieg “would have testified that a physician in [Respondent's] position has an ethical duty to believe what his patient tells him regarding his or her medical condition, and has a duty to attempt to provide appropriate treatment which he believes helps his patient with the condition the patient represents to him,” and that it is “reasonable and ethically imperative to believe” the patient until a “physician is presented with objective evidence that the patient is lying . . . or is otherwise non-compliant.”

Id.

at 3-4. Dr. Stieg would have further testified that various actions Respondent took in prescribing to the undercover officers were “appropriate and . . . within the accepted and prevailing standard of care,” as well as being “appropriate to protect against addiction, diversion, and misuse.”

Id.

at 4.

Respondent further proffered that Dr. Stieg would testify “that the physician/patient relationship for pain medicine must evolve over time,”

id.,

and that the “approximately three to four month[ ]” periods in which Respondent treated the undercover officers “is an extremely short period which provided additional difficulties [in] discover[ing] the lies told to him by the undercover agents.”

Id.

at 4-5.

On the issue of the adequacy of the physical exams, Respondent proffered that “Dr. Stieg would testify that there is no single standard to determine exactly what an adequate physical examination requires in every circumstance” and that “there is a consensus standard that a physical examination should focus on the cause of the pain.”

Id.

at 5. Moreover, Dr. Stieg would have testified “that a full physical examination is usually not required for every pain medicine encounter.”

Id.

Respondent also proffered that “Dr. Stieg would have testified that the diagnosis made by Dr. Zaidi for each undercover agent were [sic] within the accepted and prevailing standards of care,” that the initial “diagnosis often becomes clearer as the physician/patient relationship yields more information over time,” and while an “MRI and further testing may have revealed [a] more specific pathological diagnosis . . . the diagnosis of lumbago and lumbar radiculosis can be justified, pending further analysis.”

Id.

at 6. Finally, Respondent proffered that Dr. Stieg would have testified that given “the short treatment period, the standard of care” did not require that Respondent demand that the undercover officers undergo “additional expensive treatment at that time, such as physical therapy,” and that Respondent acted within the standard of care by considering the undercover officers' representations that they were unable “to pay for the” MRIs and alternative treatments.

Id.

Thus, Dr. Stieg would have testified that Respondent's “treatment of the undercover agents was for legitimate medical purposes.”

Id.

at 3.

I agree with Respondent that it was not reasonable to require him to identify his expert witness, have the expert review the Government's evidence against him, and prepare an adequate summary of the expert's testimony within the time period provided for in the ALJ's pre-hearing ruling. Indeed, it is not clear on this record how Respondent could have provided an adequate summary of his expert's

testimony in his prehearing statement when, under the ALJ's Order for Prehearing Statements, he was required to file the statement one week before the parties were even required to exchange their proposed exhibits.

See

ALJ Exs. 3 & 4. I also agree with Respondent that it was not reasonable for the ALJ to deny his request for a continuance after he determined that his expert was unable to attend the hearing because he needed to undergo treatment for a serious medical condition. Finally, I agree with Respondent that under agency precedent, evidence as to “generally recognized and accepted medical practices” remains admissible to show whether a physician acted within “the usual course of professional practice” under federal law.

See Mireille Lalanne,

78 FR 47750, 47759 (2013). While Dr. Stieg's apparent lack of familiarity with the State of Ohio's medical practice standards might properly lead to giving his testimony less weight, especially when it was weighed against that of an expert who is knowledgeable in the Ohio standards and who has served as an expert reviewer for the State's medical board, it was not a

per se

bar to its admission.

This aside, much of the proffered testimony is consistent with that given by the Government's expert. But most significantly, this is not a case in which the evidence is limited to the testimony of dueling experts. Rather, the Government presented substantial evidence beyond the testimony of its expert to support the conclusion that Respondent acted outside the usual course of professional practice and lacked a legitimate medical purpose in issuing the prescriptions to the undercover officers. Thus, even if Dr. Stieg had testified that Respondent acted within the accepted standard of care in making the diagnoses and prescribing controlled substances to the undercover patients, as ultimate factfinder, I would not find this sufficient to reject the ALJ's findings.

Gunderson,

601 F.3d at 1021 (quoting

Sanjuan,

160 F.3d at 1296).

Here, with respect to each of the undercover officers, the record is replete with evidence that Respondent falsified each officer's medical record at every visit to document both: (1) The performance of physical exam tests which he never conducted, and (2) pain levels which were higher than the officers actually reported. Nothing in the proffered testimony of Dr. Stieg refutes the fair inference which arises from the falsifications—that Respondent falsified the records in order to justify the prescribing of controlled substances, and that in prescribing the controlled substances, Respondent acted outside the usual course of professional practice and lacked a legitimate medical purpose.

See

21 CFR 1306.04(a) (“A prescription for a controlled substance . . . must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.”).

This conclusion is buttressed by Respondent's invocation of his Fifth Amendment privilege when called to testify by the Government. As the Supreme Court has explained, “the Fifth Amendment does not forbid adverse inference against parties to civil actions when they refuse to testify in response

to probative evidence

offered against them.”

Baxter

v.

Palmigiano,

425 U.S. 308, 318 (1976) (emphasis added);

see also MacKay

v.

DEA,

664 F.3d 808,

820 (10th Cir. 2011) (quoting

Keating

v.

Office of Thrift Supervision,

45 F.3d 322, 326 (9th Cir. 1995) (“Not only is it permissible to conduct a civil [administrative] proceeding at the same time as a related criminal proceeding, even if that necessitates invocation of the Fifth Amendment privilege, but it is even permissible for the trier of fact to draw adverse inferences from the invocation of the Fifth Amendment in a civil [administrative] proceeding.”));

Hoxie

v.

DEA,

419 F.3d 477, 483 (6th Cir. 2005).

In its prehearing statement, the Government provided notice that it intended to call Respondent to testify “that his treatment of the undercover officers fell below accepted medical standards and that the controlled drugs [were not] prescribed in the usual course of professional practice or for a legitimate medical purposes,” as well as “that his documentation of his examinations of [each undercover officer] was inaccurate and not based on objective data that he gathered during the exams.” ALJ Ex. 8. Respondent's invocation of his Fifth Amendment privilege, considered in light of the probative evidence weighed by the ALJ, thus supports the inference that he acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed controlled substances to the undercover officers.

3

See T.J. McNichol,

77 FR 57133, 57150 (2012) (drawing adverse inference that physician knowingly diverted controlled substances when he failed to testify “notwithstanding the substantial probative evidence of irregularities in his prescribing practices”).

4

3

The ALJ also found credible the testimony of a DEA Diversion Investigator that during an interview, Respondent was asked why the pain levels documented in the medical record of one the undercover officers were different than what the undercover officer had said during the visits. R.D. 27 (citing Tr. 620). While Respondent was allowed to look at the undercover chart, Tr. 621, he “did not have a response” to the question.

Id.

at 620. This testimony, which was unrefuted, also supports an inference that Respondent falsified the undercover officers' medical records.

4

I further find that Respondent has not demonstrated that the ALJ committed prejudicial error when he barred Dr. Stieg's testimony. As noted above, Respondent also contended that the ALJ's ruling barring Dr. Stieg's testimony was an attempt to punish him for exercising his Fifth Amendment privilege. For purposes of resolving his contention, I assume, without deciding, that the ALJ violated Respondent's rights under the Fifth Amendment when he relied on Respondent's failure to testify as a ground for his ruling.

See

Tr. 248.

However, even in criminal cases, the Supreme Court has held that a violation of a defendant's Fifth Amendment privilege is subject to harmless-error analysis.

Neder

v.

United States,

527 U.S. 1, 18 (1999) (“The erroneous admission of evidence in violation of the Fifth Amendment's guarantee against self-incrimination . . . and the erroneous exclusion of evidence in violation of the right to confront witnesses guaranteed by the Sixth Amendment . . . are both subject to harmless-error analysis under our cases.”). In this proceeding, the standard for assessing whether an error is prejudicial is whether “`it can be reasonably concluded that with . . . such evidence, there would have been a contrary result.’ ”

Gunderson,

601 F.3d at 1021 (quoting

Sanjuan,

160 F.3d at 1296). As explained above, Respondent has not made such a showing.

See United States

v.

Local 560, Int'l Bhd. of Teamsters,

780 F.2d 267, 292 n.32 (3d Cir. 1985) (holding that “while the district court erred in drawing an [adverse inference from a litigant's invocation of the Fifth Amendment], that error was harmless in light of the independent evidence supporting the district court's conclusion”) (citation omitted).

In justifying his refusal to grant a continuance to Respondent, the ALJ also explained that he was “guided by the expectation that where doing so is not inconsistent with a litigant's rights under the Due Process Clause or the Administrative Procedure Act, I should endeavor to submit the certified record of these proceedings to the Administrator . . . not later than the 150th day after the issuance of an immediate suspension (excepting any days caused by Respondent's own actions).” R.D. at 4-5. However, even where an immediate suspension order has been issued, the Administrator has clearly instructed the Agency's ALJs that they may grant a continuance upon a registrant's request. Here, but for the fact that Respondent cannot show prejudicial error, I would have remanded this matter.

The ALJ's Ruling Barring Testimony From Respondent's Employees

Respondent further argues that the ALJ acted arbitrarily and capriciously when he barred the testimony of three employees (C.B., J.B., and R.Z.). Exceptions, at 5-6. Respondent maintains that the employees “were directly involved in the patient care of the undercover [officers] and were also interviewed by the . . . Agents when they raided [his] office.”

Id.

at 5.

In his proffer, Respondent stated that C.B. is a certified medical assistant who took each undercover officer's history and that she “did extensive histories on

them” as well as other patients. Resp. Offer of Proof, at 9-10. C.B. would also have testified to the procedures used by Respondent in obtaining urine drug screens and reports from the Ohio prescription monitoring program (OARRS).

Id.

at 10. Moreover, C.B. would have testified regarding Respondent's procedures for using “random urine drug screening and access to the OARRS database with regard to the patients whose charts were offered as Respondent's exhibits, as well as her explanation to patients regarding the [pain] contract.”

Id.

C.B. would have also testified as to various patients Respondent discharged because they “engaged in the use of illegal drugs and/or the misuse of controlled substances prescribed by” Respondent, and finally, C.B. would have testified to Respondent's treatment of various patients and “how [he] has helped these patients regain functionality and control over their debilitating pain.”

Id.

According to his proffer, R.O. would have largely duplicated C.B.'s testimony regarding Respondent's treatment of the patients, whom he helped to regain functionality and control of their pain, as well as those patients who were discharged for using either illegal drugs or for misusing drugs he had prescribed.

Id.

at 11.

R.O. would also have “testified regarding the contract signed by the undercover agents and her explanation to those agents of the contents of the contract.”

Id.

Finally, J.B. “would have testified regarding her observations concerning [Respondent's] interaction with and treatment of patients including the undercover agents and those patients” identified in Respondent's Exhibits A through R, as well as regarding the patients that Respondent discharged.

Id.

at 12. J.B. would also have testified that she is the record custodian for Respondent's practice and that these records were authentic.

Id.

The ALJ barred Respondent from presenting the testimony of these three witnesses because the substance of their testimony was not timely disclosed and did not sufficiently establish relevance. Here, in contrast to the ALJ's rulings on Respondent's proposed expert, I conclude that the ALJ did not err in barring the testimony on the ground that it was not timely disclosed. Respondent had more than one month from the date of the ALJ's prehearing order to determine whether his employees could offer relevant evidence in the matter and a week from the time the Government provided a detailed summary of the testimony of each of its witnesses to disclose their anticipated testimony. Moreover, Respondent's proffer (which was filed even after the testimonial phase of the hearing was concluded) does not identify any material fact which any of the employees would have refuted. Accordingly, I conclude that Respondent has also failed to establish prejudice.

5

5

While the proffered testimony was arguably relevant to an assessment of Respondent's experience in dispensing controlled substances (factor two) and his compliance with applicable laws related to controlled substances (factor four), the fact that a physician engaged in the legitimate practice of medicine with respect to other patients does not refute a

prima facie

showing that a physician knowingly diverted controlled substances.

See MacKay

v.

DEA,

664 F.3d at 808, 819 (10th Cir. 2011) (“Although Dr. MacKay may have engaged in the legitimate practice of pain medicine for many of his patients, the conduct found by the Deputy Administrator with respect to [the two patients] is sufficient to support her determination that his continued registration is inconsistent with the public interest.”);

see also Jayam Krishna-Iyer,

74 FR 459, 463 (2009) (holding that, even assuming that physician has treated thousands of other patients in compliance with the CSA, these prescribings did not “render her prescribings to the undercover officers any less unlawful . . . [b]ecause under law, registration is limited to those who have authority to dispense controlled substances in the course of professional practice, and patients with legitimate medical conditions routinely seek treatment from licensed medical professionals[;] [ thus] every registrant can undoubtedly point to an extensive body of legitimate prescribing over the course of her professional career”).

The ALJ's Rulings Barring Evidence Regarding Respondent's Treatment of Other Patients

Respondent also sought to elicit testimony from ten patients regarding the care they received from Respondent and how his treatment of them “dramatically improved their lives, functionality, and ability to tolerate their ongoing pain.” Resp. Proffer, at 13;

see also

Resp. Exceptions, at 1 & 6.

6

Because DEA is not a state medical board, whether Respondent improved the lives and functionality of these patients is not relevant under any of the public interest factors. While evidence of Respondent's lawful prescribing and compliance with federal and state controlled substances rules with respect to these patients would be relevant under the public interest standard, no such proffer was made. Accordingly, the ALJ did not err in barring this testimony.

7

6

Respondent also proffered that Dr. Stieg would have testified regarding the patients whose records were offered in Respondent's Exhibits A through R, as well as those patients Respondent discharged for noncompliance, and that Respondent met the standard of care in treating both categories of patients. Resp. Offer of Proof, at 7-9. While the ALJ also barred this testimony, Respondent does not raise the issue in his Exceptions. Therefore, I deem it waived.

7

Respondent's proffered exhibits also includes his curriculum vitae showing his professional experience, as well as certificates showing that he is a diplomate of the American Board of Physical Medicine and Rehabilitation, with a subspecialty of pain medicine; a diplomate of the American Board of Pain Medicine; a Diplomate of the American Board of Electrodiagnostic Medicine; and a Fellow of Interventional Pain Practice. To be sure, this evidence may have had some probative value in assessing his experience as a dispenser of controlled substances. However, in his Exceptions, Respondent makes no argument that the ALJ improperly excluded these exhibits.

Exception Two—The ALJ Erred in Applying Ohio Revised Code § 4731.052 and Ohio Admin. Code § 4731-21-02 as the Standard for Determining Whether Respondent Violated 21 CFR 1306.04(a)

Respondent argues that “the Government's expert failed to establish with any degree of medical certainty the standard of care which Respondent . . . failed to meet” and that the ALJ erred in applying Ohio Revised Code § 4731.052 and Ohio Admin. Code § 4731-21-02 “as the sole standard” when he held that Respondent violated 21 CFR 1306.04(a) when he prescribed to the undercover officers. Resp. Exceptions, at 6. Respondent argues that the ALJ's reliance on these provisions was misplaced because they apply only to the treatment of chronic or intractable pain and not acute pain, which was the condition presented by the undercover officers.

Id.

at 7.

I reject Respondent's exception. Contrary to his contention, the ALJ specifically acknowledged (as did the Government's expert) that the Ohio provisions did “not apply during that phase of treatment where the diagnosis is of acute pain, but appl[ied] only after the treatment extend[ed] past twelve weeks.” R.D. at 69. However, as the ALJ explained, Ohio law defines “chronic pain” as “pain that has persisted after reasonable medical efforts have been made to relieve the pain or cure its cause and that has continued, either continuously or episodically, for longer than three continuous months.”

Id.

at 70. Here, each of three undercover officers received controlled substances from Respondent for more than three months after they initially saw Respondent and received a controlled-substance prescription.

8

Yet, as the

Government's expert testified, Respondent did not comply with the heightened standards imposed on prescribing controlled substances to treat chronic pain.

8

I agree with Respondent that the undercover agents did not present as suffering from “intractable pain,” as that term is defined by Ohio's regulation. Resp. Exceptions, at 7. The regulation defines “intractable pain” as “a state of pain that is determined, after reasonable medical efforts have been made to relieve the pain or cure its cause, to have a cause for which no treatment or cure is possible or for which none has been found.” Ohio Admin. Code § 4731-21-01(G). Here, Respondent did not make a diagnosis of intractable pain with respect to any of the undercover officers. Nor is it clear how any such diagnosis could have been made given that Respondent did not perform anything more than a cursory physical exam at the

initial visit and generally no exam at subsequent visits, and never recommended that his patients even modify their daily activities, let alone undergo physical therapy. Tr. 118, 125. I therefore reject the ALJ's conclusion of law Number 11. R.D. at 84-85 (concluding “that Respondent failed to comply with the requirements of Ohio law for the treatment of intractable pain”).

However, based on the length of the prescribings, I agree with the ALJ's conclusion that Respondent failed to comply with Ohio's chronic pain statute.

See

Ohio Rev. Code § 4731.052. This provision defines “chronic pain” as “pain that has persisted after reasonable medical efforts have been made to relieve the pain or cure its cause and that has continued, either continuously or episodically, for longer than three continuous months.”

Id.

at § (A)(1). Thus, this provision does not appear to require that the pain be incapable of being cured.

Moreover, notwithstanding that neither of the Ohio provisions applied in the initial three-month period of the undercover officers' treatment, the record contains substantial evidence to support the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed to each of the undercover officers during this period. For example, with respect to Patient Tyler Williams, Respondent diagnosed him as having “thoracic and lumbar radiculitis, lumbago.” GX 12, at 8. However, the Government's expert testified that he had reviewed the video recording of the UC's first visit and found that while Respondent documented that he had performed numerous tests during the physical examination, many of the tests were actually not performed. Tr. 71-76. The expert thus explained that his “impression of the physical examination is that it is falsified, it is embellished, and it is inaccurate, to the point that much of it, though documented here, was not performed.”

Id.

at 76.

The Government's expert then explained that Respondent's diagnosis was not justified by the patient's history and the physical examination and that the diagnosis of radiculitis was “blatantly inaccurate.”

Id.

at 78. The expert further opined that Respondent's issuance of a prescription for Percocet was “not justified by the presentation of the patient.”

Id.

at 79.

The progress note for the UC's second visit states that he had “moderate tenderness and spasm in paralumbar muscles with guarding in forward flexion” and that the “lower extremity examination is normal to sensory and motor testing.” GX 12, at 12. Here again, the Government's expert reviewed the recording and transcript of the visit and found that Respondent did not perform a physical examination (while documenting that he did) and that the findings were falsified. Tr. 80-81. He further noted that while the progress note stated that the treatment plan included a home exercise program (in addition to controlled substances), there was no evidence of “any educational endeavor that would allow someone to conduct a home exercise program.”

Id.

at 81;

see also id.

at 83-85. As for Respondent's prescription for Percocet, the expert opined that it was “not justified” and was “prescribed outside the usual course of professional practice.”

Id.

at 86.

With respect to the third visit, the Government's expert similarly observed that there was no evidence that Respondent had examined the UC's lumbar spine or performed sensory or motor testing of his lower extremities,

id.

at 88,

although Respondent documented having done so. GX 12, at 11. The expert also noted that the progress note documented a pain level of “5,” which was higher than what the UC reported. Tr. 88.

Indeed, the UC reported that his present pain level was a “2,” and that the worst it had been in the past week was a “3.” GX 12, at 18. Once again, the expert testified that Respondent's diagnosis of lumbar radiculitis could not be justified based on the “the entirety of the history and the physical examination.” Tr. 89.

With respect to the UC's fourth and fifth visits, the expert again found that there was no justification for the lumbar radiculitis diagnosis and that Respondent did not physically examine the UC's lumbar region and lower extremities while documenting that he did. Tr. 97-99. Moreover, at the fourth visit, Respondent again documented that the UC had a pain level of 5, although the transcript contains no indication that the UC was asked about his pain level by Respondent.

9

GX 9, at 20-22.

10

9

Nor does the medical record contain an entry for this visit in the Nursing Progress Record (as it does for the other visits). GX 12, at 18. Respondent's signed progress note for the UC's fifth and final visit does not contain a numerical entry for his pain level; however, the Nursing Progress Record documents both the present level of his pain, and its worst level during the week as a “2.”

Id.

10

The record also contains substantial evidence to support findings that Respondent failed to perform physical examinations of the two other undercover officers while documenting that he had done so, as well as that he documented that the undercover officers reported higher pain levels than they actually had.

See

R.D. at 79 (FoF #7).

Respondent further contends that the ALJ erred in concluding that he “failed to fully document his periodic assessment and documentation of the patient's functional status, including the ability to engage in work or other purposeful activities, the interference with activities of daily living, quality of family life and social activities.” Exceptions, at 7 (quoting R.D. 79, Conclusion of Law #8). Respondent asserts that Ohio law does not require “a prescribing physician to perform these measures for acute pain patients.”

Id.

Apparently, Respondent's view is that notwithstanding that he treated each of the UCs for pain with controlled substances for “longer than three continuous months,” Ohio Rev. Code § 4731.052(A)(1), he cannot be held to have violated the Ohio statute because he never actually diagnosed the patients as having chronic pain.

See

Resp. Post-Hrng. Br., at 7-9. (“The express language of . . . § 4731.052 requires a physician diagnosis of `chronic pain.' The statute does not mandate a diagnosis of chronic pain, but rather is instructive as to what is required after such a diagnosis. In the present case, none of the undercover . . . Agents was diagnosed by Dr. Zaidi as having chronic pain.”).

Notably, the Government's expert (who has been an expert reviewer for the state medical board) explained that at twelve weeks, Ohio law considers this to be “protracted prescribing,” which requires “a much higher level of intensity of service.” Tr. 100;

see also id.

at 285-87.

11

But even if it is the case that a physician can avoid having to comply with the requirements section 4731.052 imposes after three months by simply failing to make a diagnosis of chronic pain, I would still conclude that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in prescribing to the undercover officers.

11

As the expert testified:

That 90 days is a pause, and it is a method of communicating very forcefully to the physician, that if this is going on for that time, there better be quite a bit of substantiation behind it, and intensity of service needs to justify the continued uses of that medication. . . . It's not reasonable, especially when a patient is being seen acutely, that even we see from the emergency department with several weeks of pain, it's really not reasonable to know how long that prediction is. But what the law is saying is that if somebody needs controlled substances that long, this is the level of intensity of service that somewhere along the line, needs to have been accomplished.

Id.

at 286-87.

As the Government's expert explained, the prescriptions “were not for a legitimate medical purpose,” Tr. 103, because the diagnosis of lumbar radiculitis “is not justified or substantiated by either the history or the physical examination.”

Id.

at 107;

see also id.

at 268 (expert finding “no

supporting evidence” for a diagnosis of lumbar radiculitis). The expert also observed that if he had “reviewed only the medical record . . . [he] would have arrived at a different opinion” than what he did having been able “to see a transcript and watch an audio/visual recording of what actually occurred during that encounter,” and that the medical record “makes it appear that the severity of the patient['s] condition is much more severe than what I'm seeing when I actually am watching and listening to the recording of the events.”

Id.

at 108. Given what the video recordings of the UC's visits with Respondent show, I agree.

12

12

For example, at the UC's first visit, Respondent's physical examination was limited to asking the UC to stand up, turn around and show him where the pain was; having the UC bend forward and come back up; and then having the UC walk on his heels, turn, and walk on his toes. GX 3a. The entire encounter between Respondent and the UC lasted four minutes and resulted in Respondent writing a prescription for Percocet.

Id.

During the UC's subsequent four visits, Respondent never performed a physical exam, while documenting having done so.

See

GX3b, c, d, and e. Moreover, the UC's encounters with Respondent lasted between three minutes and thirty seconds (3′30″) at the second visit and one minute and twenty seconds (1′20″) at the fifth visit.

See id.

Also, the expert explained that the treatment plan “focuse[d] only on controlled substances and not on other alternative approaches to care,”

id.

at 103, such as “physical therapy” and “non-controlled” medications such as non-steroidal anti-inflammatories, neuro-modulators, and tricyclic medications.

Id.

at 107. And while the progress notes after the undercover officer's first visit list a “home exercise program” as part of the treatment plan, as the expert explained, there was no evidence that Respondent provided such a program to the undercover officer.

Id.

at 108;

see also

Tr. 82.

Respondent also asserts that the Government's expert applied “his own subjective interpretation of how he believed a physical examination should be conducted and diagnosis determined” and that “[t]here is no evidence in the record to establish what a physical exam or diagnosis requires.” Resp. Post-Hrng. Br., at 11. It is noted, however, that the Government's expert is board certified in anesthesiology, internal medicine, and pain medicine; that he is the Director of Pain Medicine Services and the Pain Medicine Fellowship at the Ohio State University Medical Center; that he has taught courses in Acute Pain, Chronic Pain, and Chronic Back Pain; and that he has served as an expert reviewer in pain medicine for the State Medical Board of Ohio. GX 2.

Moreover, in his testimony, the Government's expert acknowledged the “concept described as [the] minimal standard of care,” which he explained as “those actions and decisions that would be made by a reasonable physician under similar circumstances.” Tr. 204. The expert then testified that in the “environment under which we discuss this case, that standard of care and the minimal standard of care can be considered one [and] the same,” and that if a physician meets the minimal standard of care, he meets the standard of care.

Id.

at 204-05.

Thus, I reject Respondent's contention that the expert applied his own subjective standard rather than the standard of a reasonable physician in concluding that Respondent acted outside the usual course of professional practice in prescribing to the undercover officers.

So too, while the expert was not asked what tests are necessary to conduct a physical examination which meets the standard of care with respect to the specific diagnoses made by Respondent, on cross-examination, the expert explained that “[r]adiculopathy and radiculitis are very similar diagnoses and [have] very similar causes, but the diagnosis of radiculopathy is a nerve injury that is a permanent loss of nerve function and that the distribution of the change in permanent function is that which corresponds to those muscles or portions of . . . the body that that particular nerve serves.”

Id.

at 203-04. When then asked whether he saw “any evidence of that type of diagnosis in any of the undercover agents,” the expert answered that he “did not see any evidence . . . of them displaying the physical findings or the complaints of a permanent nerve injury.”

Id.

at 204. Thus, I am satisfied that substantial evidence supports a finding that Respondent's diagnosis of lumbar radiculitis with respect to two of the undercover officers was not justified by their histories and physicals.

13

13

While I have discussed the expert's testimony in addressing Respondent's Exceptions, as stated above, the recordings which show that Respondent falsified the medical records with respect to both the scope of the examinations he performed and the UCs' reported pain levels, the briefness of the encounters, and his refusal to testify, provide sufficient evidence, apart from the expert's testimony, to support a finding that he acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed to the UCs.

See United States

v.

Pellman,

668 F.3d 918, 924 (7th Cir. 2012) (quoting

United States

v.

Armstrong,

550 F.3d 382, 389 (5th Cir. 2008) (“While expert testimony may be both permissible and useful, a jury can reasonably find that a doctor prescribed controlled substances not in the usual course of professional practice or for other than a legitimate medical purpose from adequate lay witness evidence surrounding the facts and circumstances of the prescriptions.”));

Armstrong,

550 F.3d at 389 (“Jurors have had a wide variety of their own experiences in doctors' care over their lives, thus . . . expert testimony is not necessarily required for jurors to rationally conclude that seeing patients for as little as two or three minutes before prescribing powerful narcotics is not in the usual course of professional practice.”)).

See also T.J. McNichol,

77 FR 57133, 57147 (2012) (discussing both judicial and administrative cases);

Jack A. Danton,

76 FR 60900, 60901 (2011).

I therefore reject Respondent's exception to the ALJ's legal conclusion that the prescriptions were not issued for a legitimate medical purpose in the usual course of professional practice.

See

R.D. at 82-83 (Conclusion of Law #8); Resp. Exceptions, at 6-9.

Exception Three—The ALJ Erred In Evaluating the Public Interest Factors

Respondent further argues that the ALJ “incorrectly determined that Factors 2, 4, and 5 support revocation” of his registration. Resp. Exceptions, at 10. While I find that some of Respondent's contentions are well taken, I conclude that the record as a whole supports the ALJ's ultimate conclusions that Respondent has committed such acts as to render his registration inconsistent with the public interest (had he submitted an application), and that Respondent failed to rebut this conclusion. R.D. at 87.

As this Agency has long held, I am not required to make findings under each of the factors and findings under a single factor are sufficient to support the revocation or suspension of a registration.

See Hoxie

v.

DEA,

419 F.3d, 477 482 (6th Cir. 2005);

Morall

v.

DEA,

412 F.3d 165, 173-74 (D.C. Cir. 2005).

In short, this is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest.

With respect to factor two—Respondent's experience in dispensing controlled substances—Respondent argues that the Government seized more than 400 patient files from his office “and failed to present any evidence . . . that the treatment of those patients failed to meet the standard of care.” Resp. Exceptions, at 10. He also argues that “there were over 400 additional patients' charts which were not seized and [that] no evidence was presented to question their treatment.”

Id.

Respondent thus contends that in this matter, “there was no attempt at `fair adjudication.' ”

Id.

The Agency has repeatedly rejected Respondent's contention.

See, e.g.,

Jayam Krishna-Iyer,

74 FR 459, 463

(2009). In

Krishna-Iyer,

a case in which the Government relied solely on evidence of the physician's unlawful prescribing to several confidential sources, the Agency assumed that the physician's prescribing to 12 patients whose files were seized but were not relied on by the Government in presenting its case, as well as thousands of other patients (other than the undercover operatives), constituted evidence of dispensing controlled substances in circumstances which did not constitute diversion.

Id.

However, as the Agency explained, the physician's “prescribings to thousands of other patients do not . . . render her prescribings to the undercover officers any less unlawful, or any less acts which are `inconsistent with the public interest.' ”

Id.

The Agency further explained that:

under the CSA, a practitioner is not entitled to a registration unless she “is authorized to dispense . . . controlled substances under the laws of the State in which [she] practices.” 21 U.S.C. 823(f). Because under law, registration is limited to those who have authority to dispense controlled substances in the course of professional practice, and patients with legitimate medical conditions routinely seek treatment from licensed medical professionals, every registrant can undoubtedly point to an extensive body of legitimate prescribing over the course of her professional career. Thus, in past cases, this Agency has given no more than nominal weight to a practitioner's evidence that he has dispensed controlled substances to thousands of patients in circumstances which did not involve diversion.

Id.

(citations omitted);

see also Medicine Shoppe-Jonesborough,

73 FR 364, 386 & n.56 (2008) (even though pharmacy “had 17,000 patients,” “[n]o amount of legitimate dispensings” could render the pharmacy's “flagrant violations [acts which are] `consistent with the public interest' ”),

aff'd, Medicine Shoppe-Jonesborough

v.

DEA,

300 Fed. Appx. 409 (6th Cir. 2008).

Accordingly, in

Krishna-Iyer,

the Agency held that “evidence that a practitioner has treated thousands of patients [without violating the CSA] does not negate a

prima facie

showing that a practitioner has committed acts inconsistent with the public interest.” 74 FR at 463. The Agency thus explained that “[w]hile such evidence may be of some weight in assessing whether a practitioner has credibly shown that she has reformed her practices, where a practitioner commits intentional acts of diversion and insists she did nothing wrong, such evidence is entitled to no weight.”

Id.

Subsequent to

Krishna-Iyer,

the Agency adhered to this rule in

Dewey C. MacKay,

75 FR 49956 (2010),

pet. for rev.

denied, MacKay

v.

DEA,

664 F.3d 808 (10th Cir. 2011). Based on the substantial evidence that the physician had knowingly diverted controlled substances to two patients who acted in an undercover capacity, the Agency held that the Government had satisfied its

prima facie

burden of showing that Respondent had committed acts which rendered his registration inconsistent with the public interest. 75 FR 49977.

The Agency also addressed and rejected the physician's contention that “[a] better assessment of [his] medical practice and habits can be ascertained from [his] numerous positive experiences in prescribing controlled substances, some of which were recounted by the patients themselves . . . at the hearing.”

Id.

(quoting Resp. Br. at 3). As the Agency explained: “even assuming, without deciding, that Respondent's prescribing practices to all of his other patients (including those whose medical records were reviewed by the Government's expert but who did not perform undercover visits

14

) fully complied with the CSA and Utah law, these prescribings do not refute the evidence showing that he intentionally diverted to [the two undercovers] in violation of both the CSA and Utah law.” 75 FR at 49977. Noting that the physician had failed to testify and offer evidence that he recognized the extent of his misconduct and was prepared to remedy his unlawful practices, the Agency revoked his registration.

14

In light of the evidence provided by the undercover visits of the two patients, the Agency found it unnecessary to make any findings based on the expert's chart review. 75 FR 49972.

The Tenth Circuit denied the physician's petition for review.

MacKay

v.

DEA,

664 F.3d 808 (10th Cir. 2011). Of relevance here, the Tenth Circuit specifically addressed and rejected the physician's argument that the Agency had failed to consider his “positive experience” in dispensing controlled substances to other patients. As the Court of Appeals explained:

Despite Dr. MacKay's claim to the contrary, the Deputy Administrator considered the entire record, including the evidence in Dr. MacKay's favor. She determined, however, that none of Dr. MacKay's evidence negated the DEA's prima facie showing that Dr. MacKay had intentionally diverted drugs to K.D. and M.R. Indeed, she found that even if Dr. MacKay had provided proper medical care to all of his other patients, that fact would not overcome the government's evidence with regard to M.R. and K.D.

None of the evidence presented by Dr. MacKay undermines the evidence relating to M.R. and K.D. Although numerous patients and colleagues of Dr. MacKay related their positive experiences with him, none had any personal knowledge regarding his treatment of M.R. and K.R. Notably, Dr. MacKay's medical expert, Dr. Fine, failed to specifically discuss and justify Dr. MacKay's treatment of M.R. and K.D. As a result, none of Dr. MacKay's evidence contradicts the testimony and evidence presented by the DEA relating to the knowing diversion of drugs to these two patients.

664 F.3d at 819.

The Court of Appeals thus concluded that “[a]lthough Dr. MacKay may have engaged in the legitimate practice of pain medicine for many of his patients, the conduct found by the Deputy Administrator with respect to K.D. and M.R. is sufficient to support her determination that his continued registration is inconsistent with the public interest.”

Id.

In this matter, I have assumed that Respondent lawfully complied with the CSA whenever he prescribed controlled substances to all of his patients (including the 800 patients with respect to whom no evidence was offered) other than the undercover officers.

15

But even assuming that Respondent lawfully prescribed controlled substances to all of these other patients, the evidence still supports a finding that he knowingly and intentionally diverted controlled substances to the undercover officers.

16

This finding is relevant in assessing both his experience in dispensing controlled substances (factor two) and his compliance with applicable laws related to controlled substances (factor

four), and by itself, it is sufficient to satisfy the Government's

prima facie

burden of showing that Respondent “has committed such acts as would render his registration . . . inconsistent with the public interest.”

17

15

This is not a case in which there is any ambiguity as to Respondent's intent when he prescribed controlled substances to the undercover officers. Thus, evidence of his lawful prescribings to others would not lead any reasonable factfinder to conclude that he acted within the usual course of professional practice when he prescribed to the undercover officers.

16

In his decision, the ALJ also observed that Respondent's “decision to manage a pain clinic using a protocol that permitted the issuance of prescriptions for controlled substances without conducting physical examinations threatens the public safety. Either through ignorance or deliberate indifference, [his] decision to establish such operations indicates he lacks sufficient insight and experience to be trusted to participate in the controlled substances distribution process.” R.D. at 50-51.

Given that Respondent was the only doctor at the clinic, there is no need to decide whether the evidence establishes the existence of such a protocol (whether written or not) or whether such “operations” were established. As the evidence shows, Respondent repeatedly failed to perform physical examinations (or performed inadequate exams) and then falsified the undercover officers' medical records to reflect his having performed such exams; he also falsified the medical records by documenting higher pain levels than those reported by the undercover officers. As explained above, this evidence establishes that Respondent

knowingly

diverted controlled substances. Indeed, the ALJ specifically found that Respondent violated 21 CFR 1306.04(a) when he issued prescriptions that lacked “a legitimate medical . . . purpose and were not written in the ordinary course of [his] professional practice.” R.D. 83. I therefore reject it.

17

Respondent also takes exception to the ALJ's finding that he did not adequately address various red flags presented by the undercover officers. Resp. Exceptions, at 11-12. Among the red flags cited by the ALJ were the UCs requesting specific drugs such as OxyContin, Percocet, and Opana, which are highly diverted; the UCs seeking increases in the quantities of the prescriptions; a UC being unable to produce his driver's license; a UC's report of having obtained medication from his wife; and the UCs' non-compliance with Respondent's recommendations that they obtain MRIs or receive cortisone injections. R.D. at 79-80.

Respondent notes that when the undercover officer posing as Patrick Tock requested that he be prescribed Opana (because a friend had said it worked for him), Respondent warned him about the dangers of the drug and did not prescribe the drug. Resp. Exceptions, at 11. Respondent further notes the testimony of the Government's expert that Respondent's decision not to prescribe the medication was appropriate.

Id.

(citing Tr. 200). Moreover, in other instances, the Government's expert conceded that Respondent could properly take into consideration a patient's ability to pay for a test or procedure. Respondent thus contends that the ALJ's finding “ignores the undisputed evidence” and was arbitrary and capricious.

Id.

While I agree with the ALJ's reasoning that “[a] practitioner's failure to resolve red flags strongly suggests that the practitioner's subsequent dispensation of controlled substances to that patient is not for a legitimate medical purpose,” R.D. at 60, this is so because such evidence is probative of the physician's knowledge or intent. However, in this matter, there is no need to resolve the issue of whether Respondent adequately addressed various red flags. This is so because the evidence that: 1) Respondent failed to performed physical exams (as well as various tests as part of the physical exams) yet falsified the medical records by documenting that he did, 2) falsified the medical records to reflect higher pain levels than those actually reported by the undercover officers, as well as 3) the adverse inference to be drawn from his refusal to testify, conclusively prove that Respondent acted outside the usual course of professional practice and lacked a legitimate medical purpose when he prescribed controlled substances to the undercover officers and thus knowingly diverted controlled substances.

Thus, to the extent Respondent failed to address any red flags, this is simply additional evidence probative of the illegality of the prescriptions.

See United States

v.

Moore,

423 U.S. 122, 142-43 (1975). Proof that a physician knowingly diverted controlled substances is the best evidence for assessing his experience in dispensing controlled substances, although it is also relevant in assessing his compliance with applicable laws related to controlled substances. However, while such evidence is relevant under both factors two and four, in making the public interest determination, the Agency does not adjudicate the case by mechanically counting up the number of factors that favor each party and declare a winner. Rather, consistent with the statute, the Agency's inquiry focuses on whether the registrant “has committed such acts as would render his registration . . . inconsistent with the public interest.” 21 U.S.C. 824(a)(4). Thus, what matters is the egregiousness of the proven misconduct, the need to deter future noncompliance by both the specific registrant and the community of registrants, and the registrant's evidence of remediation and acceptance of responsibility.

With respect to factor four, Respondent contends that the ALJ took a “quantum leap” when he found “that Respondent intentionally kept inconsistent medical records on [the UC's] pain levels in order to protect himself from an audit.” Resp. Exceptions, at 13 (citing R.D. 66). According to Respondent, “[i]t defies logic to believe that [he] would attempt to intentionally create a false medical record by increasing a pain level from 3 to 4 or 5 on a 1-10 scale, especially knowing the chart accurately contains references to [the] pain levels communicated by the DEA agent,” which are still “in the same moderate range.”

Id.

It is true that the undercover officers' charts contain a nursing progress record which accurately reflects what they reported to Respondent's medical assistant. That being said, Respondent does not challenge the ALJ's findings that he falsified the medical records by documenting having performed various tests as part of a physical examination which he failed to do. Based on this evidence, as well as Respondent's refusal to testify and explain the disparity in the pain levels, I draw the same inference that the ALJ did—that the pain levels were falsified (along with the results of physical examinations he did not perform) to provide documentation to support the prescriptions.

18

I therefore reject Respondent's exception.

18

Contrary to Respondent, it does not necessarily defy logic to conclude that he intentionally falsified the record by listing a higher pain level than that documented by his medical assistant in the nursing progress record. Respondent may not have even bothered to read the nursing progress record.

Respondent's diversion of controlled substances is properly considered as evidence of his lack of compliance with applicable laws related to controlled substances. So too, his failure to comply with Ohio's regulation which requires that “[a] physician shall complete and maintain accurate medical records reflecting the physician's examination, evaluation, and treatment of all the physician's patients,” Ohio Admin. Code § 4731-11-02(D), is also relevant in assessing his compliance with applicable laws related to controlled substances.

19

19

With respect to factor five, the Government argued that Respondent “maintained policies [that] were contrary to Federal law,” in that his “employees were forbidden from contacting law enforcement in the event they suspected patients were obtaining multiple prescriptions for controlled substances from multiple doctors.” Gov. Post-Hrng. Br., at 26. While the ALJ found that the evidence did not support the existence of such a policy, he then noted that one of Respondent's employees testified that she “felt that laws regarding patient privacy prohibited her from reporting patient activities to law enforcement authorities” and that she and Respondent “never talked about it.” R.D. at 74. The ALJ then opined that:

a strong argument can be made for the proposition that [Respondent's] failure to correctly understand the law enforcement exceptions to HIPAA and to discuss with his staff the role law enforcement plays in preventing abuse and diversion is important. If pain management staff members observe evidence of doctor shopping or diversion of prescribed narcotics, those staff members should be familiar with steps they can and must take to alert the relevant authorities of possible illicit action. [Respondent] is responsible for ensuring that his staff understands the practitioner's role in preventing abuse and diversion of controlled substances.

Id.

at 75-76. The ALJ then found that Respondent's “office practice generally created a risk to the public safety in failing to properly train his staff regarding the role of law enforcement officers in detecting abuse and diversion of controlled substances.”

Id.

Respondent takes exception to the ALJ's findings and legal conclusions, noting that while the “HIPAA provides certain law enforcement exceptions to the confidentiality of protected health information, there is no provision in HIPAA that requires an office practice to report `doctor shopping' to law enforcement.” Resp. Exceptions, at 15. Respondent further notes that “[i]n this case, there is not even any evidence of `doctor shopping.' ”

Id.

I agree with Respondent that the HIPAA does not require such reporting (as well as that there is no evidence of doctor shopping in this case). Moreover, in this case, there is no evidence that either Ohio law or the standards of professional practice require a doctor to report a doctor shopper to law enforcement, and there may be valid reasons why a physician, who acts entirely within the bounds of both the law and the standards of professional practice, would take issue with the notion that his/her employees should report instances of doctor shopping to the authorities rather than to him or herself.

Accordingly, I reject the ALJ's reasoning. I also reject his finding of fact number twelve, to the extent it states that Respondent “did not provide training to his staff regarding exceptions to patient privacy laws that apply when the staff members observe behavior relating to controlled substance abuse, misuse, or diversion,” R.D. at 80, as well as his conclusion of law number thirteen.

Id.

at 86 (concluding that Respondent's “actions or omissions” constitute “other conduct which may threaten public health and safety” because he “failed to provide training to his staff regarding exceptions to patient privacy laws that apply when staff members observe behavior relating to controlled substance abuse, misuse, or diversion”).

While I reject the ALJ's finding and conclusion of law on this issue, I agree with the ALJ's finding that the pre-signing of prescriptions, even if there is no proof that the prescriptions were issued on a subsequent day, constitutes conduct which may threaten public health and safety.

Exception Four—The ALJ's Recommended Order of Revocation is not Warranted

While merged with his exception to the ALJ's factor five analysis, Respondent also takes exception to the ALJ's recommended order of revocation, arguing that this sanction “is unwarranted in law and without justification in fact.” Resp. Exceptions, at 16. He further asserts—notwithstanding his refusal to testify—that he “has accepted responsibility for

his recordkeeping issues” and that “[t]hrough his counsel, [he] states that he is willing, if given the opportunity, to remediate these issues in order to avoid future misconduct.”

Id.

This issue, however, is rendered moot by Respondent's failure to file a renewal application.

See Darryl J. Mohr,

77 FR 34998, 34999 (2012) (“While this Agency has recognized that because an immediate suspension order involves the exercise of summary process, it is reviewable in a proceeding under 21 U.S.C. 824, even where collateral consequences exist, review of the order is limited to challenging its factual and legal basis. Whether a former registrant has accepted responsibility for his misconduct has no bearing on the validity of the suspension order.”).

Order

Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a)(4), as well as 28 CFR 0.100(b), I affirm the Order of Immediate Suspension of DEA Certificate of Registration BA3842259, issued to Syed Jawed Akhtar-Zaidi, M.D. Also, pursuant to the authority vested in me by 21 U.S.C. 824(f), I further order that all right, title, and interest in the controlled substances seized by the Government during the execution of the Order of Immediate Suspension be, and hereby is, vested in the United States.

20

20

For the same reasons that led me to immediately suspend Respondent's registration, I conclude that this Order should be effective immediately. 21 CFR 1316.67.

Dated: July 13, 2015.

Chuck Rosenberg,

Acting Administrator.

Frank W. Mann, Esq.,

for the Government

Walter F. Ehrnfelt, Esq.,

for the Respondent

RECOMMENDED RULINGS, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION OF THE ADMINISTRATIVE LAW JUDGE

Nature of the Case

Administrative Law Judge Christopher B. McNeil. These are proceedings before the Drug Enforcement Administration and the United States Department of Justice, under docket number 14-2, captioned In the Matter of Syed Akhtar-Zaidi, M.D. The proceedings are being held pursuant to sections 303 and 304 of the Controlled Substances Act, Title 21 United States Code sections 823 and 824.

On October 8, 2013, the Drug Enforcement Administrator through her Deputy Administrator issued an order to show cause why the Administrator should not revoke DEA Certificate of Registration number BA3842259, issued to Syed Jawed Akhtar-Zaidi, M.D., and should not deny any application for renewal or modification of the same.

1

That certificate authorizes distribution of controlled substances out of an office located at 34055 Solon Road, Suite 201, Solon, Ohio 44139.

2

The order also immediately suspended this DEA registration, under the authority found in 21 CFR 1301.36(e) and 1301.37(c).

1

ALJ Ex. One at 1.

2

Gov't Ex. One.

In the order, the Deputy Administrator alleged that Dr. Zaidi's continued registration is inconsistent with the public interest, in that between September 2012 and May 2013, Dr. Zaidi distributed controlled substances by issuing prescriptions under conditions that fell outside the usual course of professional practice or were for other than legitimate medical purposes.

3

Further, the Administrator determined that based on reports presented to her, Dr. Zaidi's continued DEA registration constitutes an imminent danger to the public health and safety, warranting the immediate suspension of Dr. Zaidi's registration, which is to remain in effect until a final determination is reached in these proceedings.

4

3

ALJ Ex. One at 1-3.

4

Id.

at 4.

On October 23, 2013, the Office of Administrative Law Judges for the DEA received Respondent's Request for a Hearing to determine whether Dr. Zaidi's continued registration would be consistent with the public interest.

5

5

ALJ Ex. Two at 1.

I granted Respondent's request for a hearing, and in advance of the hearing I asked the parties to offer prehearing statements that included summaries of proposed testimony along with proposed stipulations of fact, with the Government being directed to file their proposal by November 19, 2013, and Respondent by November 26, 2013. I also set the matter for hearing to commence on December 10, 2013, with non-testimonial presentations to be held at the DEA's hearing facility in Arlington, Virginia, and with testimony to be taken during the week beginning January 6, 2014, in Cleveland, Ohio.

6

6

ALJ Ex. Three.

On November 6, 2013 I received the parties' consent motion to accelerate the hearing.

7

Upon this motion on November 6, 2013, I ordered the testimonial hearing to begin on December 16, 2013, in Cleveland, and retained all other procedural deadlines.

8

7

ALJ Ex. Five

8

ALJ Ex. Six.

On December 10, 2013, the initial day of the hearing, federal offices were closed due to winter weather, and I ordered the cancelation of the initial day of hearing.

9

Upon Respondent's request, a prehearing telephone conference was held on December 12, 2013, in order to address pending procedural issues.

10

9

ALJ Ex. 21.

10

ALJ Ex. 24.

At that time I had before me the Government's motion for an order

in limine

and Respondent's motion to delay the evidentiary hearing scheduled to begin four days later.

11

The core premise relied upon by the Government in support of its motion was Respondent's failure to timely comply with the procedural orders set forth in my prehearing order of October 24, 2013, particularly with respect to the failure to timely identify Respondent's expert witness and the substance of his testimony, and Respondent's failure to provide sufficient descriptions of expected testimony.

12

Further, the Government argued that witness descriptions provided by Respondent's prehearing statement indicate the proposed testimony would be irrelevant or otherwise inadmissible.

13

11

See ALJ Exs. 22 & 20.

12

ALJ Ex. 20.

13

Id.

Respondent, on the other hand, sought to delay the hearing in order to accommodate his expert witness, whom he described as having medical problems that prevented his appearance on December 16 or 17, 2013.

14

14

ALJ Ex. 22.

During the prehearing teleconference on December 12, 2013, I denied Respondent's renewed motion to delay the hearing, finding cause had not been shown to require a delay in the testimonial segment of this proceeding. Respondent first sought to delay the hearing on November 25, 2013, the day before prehearing statements were due, in order to have “adequate time to prepare,” citing the difficulties in doing so occasioned by the Government's “prehearing seizure of effectively all of Respondent's liquid assets.”

15

I considered the balancing of convenience to the litigants, witnesses, counsel, and the Office of Administrative Law Judges, the complexity of the case, and whether denial of the request would result in

identifiable prejudice to Respondent.

16

Upon considering these factors I found cause had not been shown to delay either the scheduled hearing or the pre-hearing deadlines.

15

ALJ Ex. Nine.

16

See

Fitzhugh

v.

Drug Enforcement Administration,

813 F.2d 1248, 1252 (D.C. Cir. 1987).

I received Respondent's second request to delay the hearing on December 6, 2013.

17

This was based on the representation that an expert witness, Richard Stieg, M.D., would be unavailable on the dates set for hearing.

18

I considered the factors set forth above, and found cause had not been shown to delay the hearing in an order dated December 6, 2013.

19

On December 12, 2013, I received Respondent's motion for reconsideration of the order denying Respondent's second requested continuance.

20

In denying the motion during the prehearing teleconference, I considered the premises presented in support of the motion, including the premise that the continuance was needed to permit Respondent's medical expert to testify.

17

ALJ Ex. Seventeen.

18

Id.

19

ALJ Ex. Eighteen.

20

ALJ Ex. 22.

In reviewing Respondent's prehearing statement and each supplement thereto, I found that the proposed expert witness's testimony as summarized by Respondent did not need to be presented at the same time as the rest of the testimony being offered, and could be taken out of order without prejudice to Respondent. I further found that the evidence would likely have little probative value, as the witness did not appear to be familiar with Ohio medical practice standards. I also considered the uncertain nature of the length of the delay that would be needed to accommodate Dr. Stieg.

Additionally, I considered the potential adverse effects of such an uncertain delay in resolving this matter. In this regard I am guided by the expectation that where doing so is not inconsistent with a litigant's rights under the Due Process Clause or the Administrative Procedure Act, I should endeavor to submit the certified record of these proceedings to the Administrator in accordance with 21 CFR 1316.65 not later than the 150th day after the issuance of an immediate suspension (excepting any days caused by Respondent's own actions).

21

I also considered the possible prejudice to either party were the hearing to proceed as scheduled, and found no substantial prejudice had been demonstrated. I also considered the potential importance of the testimony being sought, should a delay be granted. Upon weighing these factors and exercising the discretion delegated to me,

22

I found cause had not been shown to delay the testimonial portion of this proceeding. I also permitted Respondent to proffer the medical expert's report for the Administrator's review, so that the hearing could proceed expeditiously while allowing Respondent to present the substance of that report to the Administrator, for her consideration.

21

See Memorandum re: Immediate Suspension of DEA Registration; Hearing Process DFN: 301-01, October 4, 2006 at 1 (copy attached as Appendix).

22

See

Richard A. Herbert, M.D.,

76 FR 53942-02, 53942 (DEA Aug. 30, 2011).

Further, I granted the Government's motion for an order

in limine,

finding the proffer of testimony presented with respect to witnesses Elizabeth and Larry Bloch, Patricia Gray, Carolyn Hamilton, Beverly and Virgil Humphreys, James Justice, Greg Ratesic, Lorinda Rose, and Carl Shortridge was insufficient to establish that their testimony would be relevant to the issues before me. I found Respondent's proffer of testimony from his employees Christi Barrett, Julie Brzozwski, and Ricki Zotto was untimely and was insufficient to establish that their testimony would be relevant, and for those reasons I sustained the motion with respect to those three witnesses. I noted that Respondent's employee, Kim Maniglia, was identified as a Government witness and determined that there was no reason to bar her from testifying on behalf of Respondent.

With respect to testimony from Respondent's expert, I found sufficient prejudice had been shown by the Government to sustain its motion and bar the testimony of Dr. Stieg, due to the untimely disclosure of the identity of the expert and the nature of his testimony, and due to the lack of detail in the description of the proposed testimony, including the description presented in Respondent's December 12, 2013 supplemental prehearing statement.

Regarding the lack of specificity and detail provided regarding Respondent's own testimony, I found Respondent's prehearing statement did not comply with my prehearing order in that it did not indicate clearly each and every matter as to which he intended to testify. While cause had been shown to bar Respondent's testimony, the Government did not seek to bar Respondent from testifying but instead sought to have Respondent supply the required summary prior to the conclusion of the first day of hearing, which had been scheduled for December 10, 2013.

23

Although I found sufficient cause including clear prejudice to the Government due to Respondent's failure to comply with my prehearing order, Respondent was not barred from testifying but his testimony was limited to responding to the areas of inquiry presented in the Government's prehearing statement along with any areas set forth in a more complete summary which I allowed to be filed by not later than 2 p.m. on Friday, December 13, 2013. Although Respondent filed a “Brief in Opposition to the Government's Motion

in Limine”

describing testimony he would elicit from other witnesses,

24

he provided no supplemental statement describing the scope of his own testimony.

23

ALJ Ex. 20 at 7.

24

ALJ Ex. 25.

When the parties convened in Cleveland for the testimonial portion of the hearing, acting on the advice of his attorney, Dr. Zaidi exercised his constitutional right against compulsory self-incrimination and, after being sworn and identifying himself, declined to answer questions presented to him on direct examination by the Government.

25

The Government presented the testimony of its medical expert, four investigative witnesses, and Dr. Zaidi's billing clerk. Dr. Zaidi presented no testimony, but offered documents which have been identified as proffers and have been included in the record for the Administrator's review. I did not, however, consider Respondent's proffered exhibits in reaching my Recommended Decision.

25

Tr. at 50.

Summary of the Evidence

The Government's case was presented through testimony of three undercover agents who posed as patients; Dr. Zaidi's billing clerk, Kim Maniglia; Diversion Investigator Scott A. Brinks; and Steven Severyn, M.D., who testified as the Government's medical expert.

26

26

Id.

at 51.

Testimony of the Government's Medical Expert

Dr. Severyn practices medicine at the Comprehensive Spine Center located at The Ohio State University Wexner Medical Center, in Columbus, Ohio.

27

He is licensed to practice medicine in Ohio, and serves as the Director of the Pain Medicine Services office of the Medical Center's Department of Anesthesiology, the Director of the Medical Center's Pain Medicine Fellowship, and the Director of the Pain

Services section of the Spine Center.

28

He is an assistant professor of clinical anesthesiology, teaching on almost a daily basis in clinical and educational capacities, and practices in the Spine Center and throughout the hospitals of The Ohio State University.

29

He estimated that 50 percent to two-thirds of the patients he treats for pain are prescribed controlled substances for that pain.

30

27

Id.

at 52.

28

Id.

at 52-53.

29

Id.

at 53-54, 58-59.

30

Id.

at 166.

Dr. Severyn holds a baccalaureate degree from Johns Hopkins University, a medical degree from The Ohio State University, a master's degree in business administration from Ohio University, and a master's degree in strategic studies at the United States Army War College.

31

He completed an internal medicine residency at Riverside Methodist Hospital, as well as a residency in anesthesiology at The Ohio State University.

32

He holds board certifications with the American Board of Internal Medicine, the American Board of Anesthesiology, and that Board's pain medicine subspecialty.

33

31

Id.

at 54.

32

Id.

33

Id.

at 56.

In his current medical practice, Dr. Severyn works full time in the sub-specialty of pain medicine.

34

He stated that on a typical clinical day he will encounter approximately 30 patients, and on a typical surgical day he will perform between three and six operative procedures.

35

He explained that his patients predominantly are persons without cancer-related diagnoses who are seen on an out-patient basis and are experiencing acute and chronic intractable pain, although some are treated on an in-patient basis for post-operative pain.

36

34

Id.

at 55.

35

Id.

at 58.

36

Id.

at 55.

Dr. Severyn stated that he has been qualified in the past as an expert witness in matters concerning the evaluation and treatment of patients using controlled substances, for both the DEA and the United States Department of Justice.

37

Without objection, Dr. Severyn was recognized as an expert in the field of pain management in these proceedings.

38

37

Id.

at 60.

38

Id.

at 61.

In preparing to testify in this matter, Dr. Severyn reviewed video recordings of interactions between undercover agents Parkison, Leonard, and Moses, and Dr. Zaidi.

39

He also read the transcripts from those interactions, and the medical records maintained by Dr. Zaidi regarding the treatment of these three patients.

40

In his review, Dr. Severyn applied his understanding of provisions in Ohio law, including section 4731-21-02 of the Ohio Administrative Code, regarding the treatment of intractable chronic pain.

41

Based on this review and applying his understanding of the requirements for the treatment of pain using controlled substances applicable in Ohio, Dr. Severyn concluded that Dr. Zaidi prescribed controlled substances to each of these patients outside the usual course of professional practice

42

and for other than a legitimate medical purpose.

43

39

Id.

40

Id.

at 61-62.

41

Id.

at 167.

42

Id.

at 104, 130, 153.

43

Id.

at 103, 130, 153.

In reaching these conclusions, Dr. Severyn noted the requirements found in the Ohio Administrative Code regarding the use of controlled substances for the treatment of pain.

44

According to Dr. Severyn,

44

Id.

at 62.

When selecting a treatment for a patient, the first principle is evaluation, establishing of a diagnosis, the considering of alternative treatments in making a recommendation to a patient [in] regard to treatment, a provision of the risk of each of those alternatives, and then the treating of the patients in a way that conforms with current professional standards of care.

45

45

Id.

Further, he stated that one part of the professional standard of care for such providers is that when prescribing controlled substances for the treatment of pain, a provider must take into account the medication's potential for diversion and abuse.

46

In addition, in those cases where controlled substances are being considered as part of the treatment plan, “the standard of care, and the prevailing practice of physicians, is to perform a diligent and a very sophisticated and intense evaluation.”

47

In this context, Dr. Severyn stated that the minimal standard of care would be “those actions and decisions that would be made by a reasonable physician under similar circumstances.”

48

“It establishes,” according to Dr. Severyn, “what would be the least degree of response or establishes the least degree of care in the provision of treatment, when a physician is faced with a clinical decision, resulting in action or inaction” and equals the minimal standard of care.

49

46

Id.

at 63.

47

Id.

at 65.

48

Id.

at 204.

49

Id.

at 204-05.

Dr. Severyn noted that when referring to the minimal standard of care throughout his testimony, he regards this as describing the standard of care for pain medicine physicians.

50

He noted further that his own practice differs from many pain medicine practices because his patients all have been referred to his clinic by other medical providers in the OSU health care system.

51

In this respect, Dr. Severyn distinguished what a reasonable physician would do at the initial appointment from what he does in his own practice, because in the initial appointment stage of his own practice all of his patients are either referred by other OSU medical offices or have recently undergone emergency treatment.

52

50

Id.

at 205.

51

Id.

at 263.

52

Id.

Beyond this, however, Dr. Severyn stated that in a pain medicine practice, there are “additional requirements for the specificity and the degree of detail in keeping medical records when prescribing controlled substances on a protracted basis, greater than twelve weeks,” calculated from the initial prescribing encounter.

53

He said, however, that there is no federal or state law that defines the types or amounts of drugs that should be prescribed in any particular situation—that this is a decision to be made by the doctor.

54

That decision, according to Dr. Severyn, is to be based on “[e]xpertise, experience, intensity of service, diligence of work, assessment of the situation, integration of all available information, previous red flags [and] current events.”

55

53

Id.

at 64, 256.

54

Id.

at 206.

55

Id.

at 207.

Dr. Severyn explained that before a physician may prescribe controlled substances for pain, he or she must reach a medical diagnosis and determine the appropriate treatment plan.

56

In the treatment plan, the physician and patient interact, “availing themselves of alternative approaches for care, and will go about certain actions” regarding both procedures and medication, which may then “be re-evaluated at a later time, so as to determine the efficacy of the original plan.”

57

56

Id.

at 65.

57

Id.

at 65-66.

Such a treatment plan would need to include “regular follow up and monitoring, not only of the patient

condition, but also of the response to treatment.”

58

Monitoring in this context is performed through “medical encounters, history, physical, imaging studies, social history, family history, response to medications, and it takes time to develop that, and also, attention to other details, accuracies, and any unusual events that are occurring,” along with reviewing the OARRS report.

59

The resulting plan “needs to include the thought processes of the physician” in order to fulfill “the physician's fiduciary responsibility to the patient.”

60

58

Id.

at 66.

59

Id.

at 223. OARRS is the Ohio Automated Rx Reporting System. Tr. at 471, 602.

60

Tr. at 233.

In those cases where a physician in Ohio prescribes controlled substances for pain on a protracted basis, which in this case means for greater than twelve weeks, Dr. Severyn said that the physician must obtain the patient's consent and inform the patient of the risks and benefits associated with such a treatment plan.

61

Dr. Severyn said the consent needs to be in writing and needs to reflect that the physician has educated the patient “as to the nature of the condition, makes a recommendation about the approach for care, describes the risks of each of those alternatives, describes the benefits of each[,] and . . . explores alternative approaches.”

62

Also in cases where treatment is on a protracted basis, the physician needs to assess the patient's functional status, which includes determining how the pain is interfering with the patient's ability to work, with activities of daily living, with social activities, and with the quality of family life.

63

61

Id.

at 67.

62

Id.

63

Id.

at 68.

Dr. Severyn agreed with the proposition, presented during cross examination, that it will sometimes take a period of time and a number of visits for a physician to observe and evaluate a patient with respect to red flags associated with controlled substance diversion, misuse, or addiction.

64

When asked about the length of time Dr. Zaidi spent monitoring the progress of the cases of the three undercover agents, Dr. Severyn opined that the five or six months spent was a “moderate” amount of time.

65

He also explained that while the DEA maintains on its Web site a list of relevant red flags, he personally was “not familiar enough with that Web site and each and every flag, for me to say that I'm going to use that as my only standard.”

66

He added, however, that the “Web site does contain a number of causes for a physician to be suspic[ious] that the seeking of the medication may not be strictly for the treatment of the condition for which the physician intends to prescribe.”

67

64

Id.

at 173.

65

Id.

at 224-25.

66

Id.

at 172.

67

Id.

When asked whether he believes community-based pain management clinics (

i.e.,

clinics not in an academic setting) have a place in medicine and serve a legitimate purpose, Dr. Severyn said they certainly do have a role.

68

He also agreed with the proposition, asked during cross examination, that the patient's ability to pay “does have more relevance now than it did in the past few years, in the informing of a physician's recommendation or offer of care to the patient.”

69

When asked, however, whether he would dismiss a patient who elected (on the basis of cost) to forgo a recommended MRI, Dr. Severyn said he would dismiss the patient “[i]f I felt strongly enough about it.”

70

Elaborating, he said that if a patient was presenting signs and symptoms “of a worsening nerve injury” and if he felt the patient's health “would be permanently impaired because of a nerve injury and if the patient continued to insist that they were not going to or be able to obtain an MRI, I would seriously consider withdrawing care from that [patient].”

71

68

Id.

at 182.

69

Id.

at 184-85.

70

Id.

at 185.

71

Id.

Another resource available to physicians in Ohio, according to Dr. Severyn, is the Ohio Automated Rx Reporting System, or OARRS.

72

Asked during cross examination whether consulting this reporting system constitutes an attempt by a physician to address a red flag, Dr. Severyn said yes, “OARRS reports are tremendously helpful and the requirement to check them, as a standard of care, is valid.”

73

Dr. Severyn was asked if he knew Dr. Zaidi conducted such a check on each patient.

74

Dr. Severyn indicated that he was not aware that this was a part of Dr. Zaidi's prescription practice.

75

There is, however, some evidence from Ms. Maniglia that she would print out an OARRS report for every new patient.

76

72

Id.

at 178.

73

Id.

74

Id.

75

Id.

76

Id.

at 414.

Dr. Severyn also was asked whether transitioning from an immediate-release form of Oxycodone to a time-released form is another means of responding to red flags.

77

After noting that time-released OxyContin “can be converted to immediate release Oxycodone by crushing or chewing or otherwise altering it,” Dr. Severyn stated that while there is some protection against abuse, “the choice of a time release medication is less driven by red flags and the issue of abuse than it is driven by the intent to follow a medical treatment plan that provides a more steady state of medication.”

78

He said time-release OxyContin is “less likely, to a degree, to lead to diversion or to lead to addiction, but . . . [i]t's only to a degree that makes it a little more difficult for the patient who seeks to be abusing the medication or seeks to divert the medication, to do so successfully.”

79

77

Id.

at 180.

78

Id.

79

Id.

at 213-14.

Two of the undercover agents represented to Dr. Zaidi they suffered from pain or stiffness in the lower back.

80

When asked what he does when a patient presents with a complaint of back pain, Dr. Severyn gave this response:

80

Gov't Ex. Nine at 3; Gov't Ex. Ten at 6.

I want to find out some basic information about the patient. Where is your pain? Does it radiate into the legs? For how long have you had it? What makes it better? What makes it worse? Have any procedures or surgeries been done to make a difference in this, in the past, and zero to ten, what is your severity of pain? Have you had physical therapy? Has that been helpful for you in the past? Might it be something to consider again? Then I look at the OARRS report, because I want to know how accurate is my patient's reported history in comparison to what has already been documented as being dispensed. Next, I look through the medical record to see if at Ohio State, during any of the time that the patient has been seen, there is a urine drug screen present. If so, I copy it into the medical record and make a decision, then and there, if I'm going to be obtaining another one.

81

81

Tr. at 216-17.

Dr. Severyn explained that because his practice at The Ohio State University is a referral practice, the patients he sees usually are being cared for by other members of OSU's medical staff.

82

He said if he is prescribing controlled substances he will order a urine drug screen, and “go through all of the areas of the portion of the administrative rule that pertains to the initial prescribing” of controlled substances.

83

After that, he will review “the past medical history, which, of course, is medical history, surgical history, medication history, [and] social

history. After that, it's going to be a review of symptoms, which is about 50 specific symptoms to do, and then I'm going to go through my physical examination.”

84

He would then check for imaging, if any is available, and following that he would make his assessment and diagnosis, which he will discuss with the patient.

85

From there, the patient must decide the course of action based on Dr. Severyn's recommended course of action, after which prescriptions can be written along with any other orders, and arrangements are made for follow up visits.

86

82

Tr. at 220.

83

Id.

84

Id.

85

Id.

at 221.

86

Id.

Dr. Zaidi's Treatment of Officer Tyler Parkison (Under the Name Tyler Williams)

Tyler Parkison is a DEA Special Agent, a position he has held since 2008.

87

Between 2005 and 2008 he was a DEA Diversion Investigator, having graduated from the DEA's twelve-week training academy at Quantico, Virginia.

88

As a diversion investigator, Agent Parkison was trained in the investigation of criminal and regulatory cases, including those involving drug audits and identification and the execution of warrants.

89

Agent Parkison has been trained in the use of firearms, undercover operations, surveillance, physical fitness, financial investigations, and drug identification.

90

87

Id.

at 296.

88

Id.

89

Id.

at 297.

90

Id.

at 299.

Agent Parkison stated that the investigation into Dr. Zaidi's prescription practice began after an agent in his office received a complaint indicating “suspicious prescribing involving controlled substances” along with a complaint alleging a family member of the complainant “was addicted to Dilaudid” and an allegation that “there were drug transactions taking place in the parking lot” of Dr. Zaidi's practice.

91

Included in the report by the complainant was the assertion that “patients were going in and out very quickly, that they were seeing up to ten to fifteen people in an hour.”

92

Acting on this information, Agent Parkison obtained a report from OARRS setting forth the prescription history for Dr. Zaidi, revealing that “the amounts of Schedule II drugs that he was prescribing was very high.”

93

When asked to elaborate on this during cross examination, Agent Parkison said that based on his experience, Dr. Zaidi's prescriptions for Schedule II drugs seemed high when compared with “a couple” of other physicians he had been investigating.

94

Given this information, Agent Parkison “decided to schedule an office visit at Pain Management of Northern Ohio.”

95

91

Id.

at 320.

92

Id.

93

Id.

at 320-21.

94

Id.

at 436.

95

Id.

at 321.

In his investigation of Dr. Zaidi, Agent Parkison acted in an undercover capacity under the name Tyler Williams,

96

and also was part of the team that executed a search warrant and retrieved records from Dr. Zaidi's office.

97

He acknowledged, during cross examination, that he approached Dr. Zaidi as an undercover agent intending to falsely report that he had pain, but he denied attempting to fool Dr. Zaidi.

98

96

Id.

at 309.

97

Id.

at 299.

98

Id.

at 445.

Agent Parkison's first of five visits to Dr. Zaidi's office was recorded in audio and audio/video recordings, the transcripts of which are in our record.

99

Agent Parkison explained that the first visit took place on September 11, 2012, and confirmed that Government Exhibit 3a contains a video recording of that visit.

100

I viewed this video, and found that Dr. Zaidi's medical office appears to be furnished and staffed in a manner similar to many office practices: The office is located in an office complex, and upon passing through a hallway, Agent Parkison opened the door to find a reception area in which a receptionist took his name and driver's license, while a billing clerk (later identified as Kim Maniglia) spoke on the telephone regarding authorization for an imaging procedure and another staff member in clinical garb entered and left the receptionist's office.

101

99

Gov't Exs. 3a through 3e; Gov't Ex. Nine.

100

Tr. at 300-01.

101

Gov't Ex. 3a, folder AudioVideo Recordings—09-11-12, file 105605 at 10:57:05-10:59:43.

Ms. Maniglia explained that she has been employed at Pain Management of Northern Ohio for twelve and a half years.

102

She said Dr. Zaidi owns the business, and that she does all of the billing for the business, and also works at the front desk.

103

She explained that while she has no medical training and does not participate in patient treatment, she does have a role in filling out prescriptions for the office.

104

She stated that for every new patient, Dr. Zaidi runs an OARRS report—she prints out the report and puts them in the new patient's file for Dr. Zaidi to review.

105

The reports indicate what prescriptions the patient is getting and what doctors the patient has seen.

106

According to Ms. Maniglia, after Dr. Zaidi sees a patient, the patient's medical chart comes to her, at which point she reads what Dr. Zaidi has written and logs prescription information into the back of the chart.

107

After the patient is seen, she shreds the OARRS report.

108

102

Tr. at 406.

103

Id.

104

Id.

at 407.

105

Id.

at 414.

106

Id.

at 415.

107

Id.

at 407.

108

Id.

According to Ms. Maniglia, Dr. Zaidi requires urine drug screening for all new patients, and uses such screens periodically throughout the patient's treatment.

109

She added that if a patient does not “have good urine Dr. Zaidi usually writes on the bottom not to fill any scripts for them” or may indicate “NPUS” on the chart, to direct “no prescriptions until seen.”

110

Based on what Dr. Zaidi has written, Ms. Maniglia will write the prescription information on a blank prescription form.

111

She said that Dr. Zaidi would sign blank prescriptions in the morning, and after they were signed she would fill out the prescriptions throughout the day, using the signed forms.

112

109

Id.

110

Id.

111

Id.

112

Id.

Ms. Maniglia explained that there may be days when prescriptions that Dr. Zaidi has signed are not actually needed that day, so “[t]here might have been a few left over,” but when that happens the signed prescriptions are stored “triple-locked up in the drug cart” and are used the next day.

113

Ms. Maniglia acknowledged that some of these prescriptions have been for controlled substances.

114

She said Dr. Zaidi trained her in this aspect of her job, and she has performed these tasks for more than twelve years.

115

When asked whether Dr. Zaidi ever mentioned the need to have a patient's address on the prescription, Ms. Maniglia said no, even with prescriptions for controlled substances, “we just need two identities, just the birth date and the name.”

116

113

Id.

at 408-09.

114

Id.

at 410.

115

Id.

at 428-29.

116

Id.

at 429.

Affixed to the window separating the waiting area from the receptionists office are stickers indicating payment could be made using Visa, Diners Club, MasterCard and Discover, along with a sign that states the staff is not permitted

to accept any homemade food, and another that states co-payments are to be paid at the time of the office visit.

117

The waiting area is appropriate in size, judging from the eight to ten office chairs that were visible in the video, and was sufficient for the three or four patients waiting in the room.

118

117

Gov't Ex. 3a, folder AudioVideo Recordings—09-11-12, file 105605 at 10:59:08-09.

118

Id.

at 11:00:37-11:01:27.

The receptionist area appeared to be equipped with telephones, computers, fax, copy, or multifunction machines, and file cabinets that typically are found in offices of this size.

119

The overall impression was that this was a fully functional small medical practice. According to Agent Parkison, Dr. Zaidi was the only doctor at the office of Pain Management of Northern Ohio.

120

There was no evidence that the office accepted only cash, or that it refused to treat persons covered by insurance. In fact, Ms. Maniglia can be heard on the phone confirming approval for a “three-level lumbar discogram,” which suggests she was confirming this service would be paid for by the patient's health insurance.

121

During the hearing, Ms. Maniglia explained that on average, the office will deposit about $3,000 per week in cash, but that most of the office gross receipts, roughly 80 percent, come from insurance providers.

122

119

Id.

at 10:57:44-10:57:46.

120

Tr. at 339.

121

Gov't Ex. 3a, folder AudioVideo Recordings—09-11-12, file 105605 at 10:57:51-10:58:13.

122

Tr. at 426.

Ms. Maniglia was asked to recall what she was asked when DEA agents came to Dr. Zaidi's office to search the premises.

123

She said the agent, whom she referred to only as Damien, asked about Dr. Zaidi's children, the car he drives, and his religion.

124

She said they also asked if Dr. Zaidi kept controlled substances in the office, and she responded that he does not, not even samples.

125

123

Id.

at 420-21.

124

Id.

at 421.

125

Id.

Ms. Maniglia also testified about what she told DEA investigators with respect to doctor shopping. She said she understood doctor shopping involved patients going to different doctors in order to get multiple prescriptions for controlled substances.

126

She was asked whether she was aware of any instances where Dr. Zaidi's patients may have been accused of doctor shopping, and responded that she has “nothing to do with the patients” when they are in the back being examined by Dr. Zaidi.

127

She did, however, recall being asked by law enforcement officers during the search of Dr. Zaidi's office, about patients who might be involved in doctor shopping.

128

She said the officer who claims she told him she was not allowed to report such patients to law enforcement misunderstood her—that under HIPAA “we weren't allowed to discuss anything” regarding such patients.

129

Apparently Ms. Maniglia understood that under HIPAA, staff members were not permitted to contact law enforcement due to “patient confidentiality,” but she added that her understanding was not the result of instructions from Dr. Zaidi.

130

Rather, her understanding of this restriction was based on her work “in the field for 20 years and we're not allowed to talk about any patient confidentiality stuff.”

131

She denied, however, being instructed not to call authorities if there were dirty urine screens or if an OARRS report showed multiple doctor encounters, adding, “We've never talked about it.”

132

126

Id.

at 410.

127

Id.

128

Id.

at 411.

129

Id.

130

Id.

at 412.

131

Id.

132

Id.

at 416.

At the time search warrants were being executed, DEA Diversion Investigator Scott Brinks questioned Dr. Zaidi regarding his office practice.

133

Investigator Brinks said Dr. Zaidi consented to the interview, and when asked about pre-signed prescriptions found in the office, responded by telling Investigator Brinks that he did pre-sign them, and agreed that they were presently blank but for the signature.

134

Investigator Brinks also stated Dr. Zaidi confirmed writing a prescription for Vicodin to his daughter.

135

He added, however, that he did not know whether the prescription was for emergency treatment, nor whether the prescription was ever filled.

136

133

Id.

at 618.

134

Id.

at 618-19.

135

Id.

at 619.

136

Id.

at 620.

In addition to providing insight into the operations of Dr. Zaidi's medical office at the time of the execution of the DEA's search warrant, the Government also included in the record transcripts and recording showing how Dr. Zaidi's office staff handled patient visits. Generally, a staff assistant would conduct an initial intake interview with the patient, and then Dr. Zaidi would review the intake forms and meet with the patient.

137

At subsequent office visits, the staff member would continue to conduct an initial review of current symptoms with the patient, and thereafter Dr. Zaidi would briefly meet with the patient and determine whether to continue to prescribe controlled substances.

138

137

See,

e.g.,

Gov't Ex. 3a folder AudioVideo Recordings 09-11-12, file 114021.

138

See,

e.g.,

Gov't Ex. 3a, folder AudioVideo Recordings 09-11-12, file 115238.

Christy Barrett, a member of Dr. Zaidi's office staff, conducted an intake interview with Agent Parkison, lasting approximately nine minutes.

139

During this interview, Ms. Barrett took Agent Parkison's blood pressure; pulse; and pulse oxygen levels; asked his height and weight; inquired about his level of pain and location of pain; use of tobacco, alcohol, and caffeine; past surgeries and physical therapy; past MRIs; use of blood thinners; and could be seen filling out the medical intake form.

140

She then went through the contents of a pain management contract, which Agent Parkison had signed prior to this interview.

141

At the end of the intake interview, she directed Agent Parkison to provide a urine sample for a drug screen.

142

139

Gov't Ex. 3a, folder AudioVideo Recordings 09-11-12, file 114021.

140

Id.

at 11:40 to 11:47; Gov't Ex. Twelve at 19.

141

Gov't Ex. 3a, folder AudioVideo Recordings 09-11-12, file 114021 at 11:47 to 11:49; Gov't Ex. Twelve at 25.

142

Gov't Ex. 3a, folder AudioVideo Recordings 09-11-12, file 114021 at 11:49 to 11:51.

The doctor's examination took place in a room that appeared to be well-equipped with modern, functional furnishings, including a full-size examination table.

143

Dr. Zaidi greeted Agent Parkison as “Mr. Tyler,” reviewed papers contained in a folder, and asked questions regarding his medical history for approximately one minute.

144

Although Agent Parkison told Dr. Zaidi he did concrete work, there was never any discussion about whether the work involved heavy lifting or any other physical activity.

145

Also, although Agent Parkison wrote in his history that he had a work-related injury, during the interview with Dr. Zaidi he denied being injured; yet, according to Agent Parkison, this inconsistency was never addressed by Dr. Zaidi.

146

143

Gov't Ex. 3a, folder AudioVideo Recordings 09-11-12, file 115238.

144

Id.

at 11:54 to 11:55.

145

Tr. at 331.

146

Id.

Dr. Zaidi discussed Agent Parkison's hypertension, and then had Agent Parkison stand, bend from the waist forward then back, walk on his toes and heels, and thereafter told Agent Parkison he had slight scoliosis, ending the examination after approximately 60

seconds.

147

After confirming he had no medical insurance, Dr. Zaidi told Agent Parkison that he would order an MRI, but it would be acceptable if Agent Parkison elected to wait for two weeks before getting the imaging, and added that there was a source for MRIs that would provide the service for $350 to uninsured patients of the office, if that was what Agent Parkison decided to do.

148

147

Gov't Ex. 3a, folder AudioVideo Recordings 09-11-12, file 115238 at 11:55:17 to 11:56:15.

148

Id.

at 11:56:16 to 11:57:300.

Without discussing the possibility of physical therapy or home exercises,

149

Dr. Zaidi wrote a prescription for 20 tablets of Percocet five mg,

150

charged a $300 fee for the office visit,

151

and directed that Agent Parkison return in two weeks.

152

Dr. Zaidi added that they could discuss whether epidural injections might help, asked additional questions regarding Agent Parkison's medical history and ended the visit (although at this time Dr. Zaidi took no further notes while on camera).

153 154

149

Tr. at 333.

150

Percocet is the brand name of a combination of Oxycodone and Acetaminophen. Tr. at 254.

151

Tr. at 309.

152

Gov't Ex. Nine at 8.

153

Gov't Ex. 3a, folder AudioVideo Recordings 09-11-12, file 115238 at 11:56:38 to 11:58:16.

154

Gov't Ex. 3a also included files 111619, 112129, and 112930. After I watched and listened to each of these, I found no information relevant to this proceeding in these files. The exhibit also includes an audio-only file identified as CCR_0001, which neither party referred to during the hearing and which did not appear to have any information relevant to this proceeding.

After confirming that he reviewed the undercover recordings and the entire medical record maintained by Dr. Zaidi regarding treatment of Agent Parkison (under the name Tyler Williams), Dr. Severyn expressed opinions regarding both Dr. Zaidi's physical examination of Agent Parkison and the medical history that supported Dr. Zaidi's decision to prescribe controlled substances to this patient.

155

As noted above, prior to meeting with Dr. Zaidi, Agent Parkison met with and was interviewed by Christy Barrett.

156

Dr. Severyn opined that when Ms. Barrett took Agent Parkison's blood pressure and pulse oximetry readings, inquired of his medical history, and inquired of his pain level and functional capacities,

157

“that encounter and the collection of information satisfies the requirement of a minimum standard of care” for taking the history of a patient, but not “for initially prescribing a controlled substance to a patient who will ultimately be receiving it for longer than twelve weeks.”

158

155

Tr. at 69-70.

156

Gov't Ex. Nine at 1-6.

157

Id.

158

Tr. at 237-39.

Dr. Severyn noted that the patient “is acknowledging no past medical history, no past surgical history, and having been completely healthy all of his life” until two weeks prior to the visit, when he experienced lower back pain.

159

Rating his pain at a four (on a ten-point scale), the patient did not acknowledge having any pain radiating to his legs, nor any weakness or numbness; and indicated he was employed as a concrete worker at a construction company at the time of the office visit.

160

159

Id.

at 70-71.

160

Id.

at 71; Gov't Ex. Twelve at 19.

When Dr. Severyn compared what was in the written medical chart

161

with what he observed while watching the audio/video recording of the initial office visit, he noted the following. First, he noted that the written medical chart indicates that the patient's pupils were equal when reacting to light, and explained that to make this determination, “[the] physician needs to shine a light into one pupil and then into the other pupil. And I didn't find any evidence in the video recording or in the transcript that that was occurring” during this office visit.

162

Similarly, he found the written entry indicating that the oral mucosa (

i.e.,

the inside of the mouth) was moist and pink, but saw no evidence that the patient was ever asked to open his mouth while Dr. Zaidi examined its interior.

163

161

Gov't Ex. Twelve at 7.

162

Gov't Ex. Twelve at 7; Tr. at 72.

163

Gov't Ex. Twelve at 7; Tr. at 72-73.

Next, Dr. Severyn noted that a cranial nerve examination was indicated in the written notes.

164

He explained that an examination of the cranial nerve is conducted by touching the neck to determine the size of the thyroid gland, and by touching the armpits to determine whether the axillary lymph nodes were enlarged—neither of which were performed during this examination.

165

Also included in such an examination is a range of motion test for the neck, which Dr. Severyn said he did not find in the recording or the transcript.

166

164

Gov't Ex. Twelve at 7; Tr. at 73.

165

Gov't Ex. Twelve at 7; Tr. at 73.

166

Tr. at 73.

Similarly, although the medical record indicates normal sensory and motor testing, “[t]here was no testing that went on with sensation of the arms, the hands, or the range of motion or strength of the fingers, the wrists, the biceps, and triceps.”

167

Further, there is an entry indicating normal range of motion in all the joints of the upper extremities, but such an examination did not occur, according to Dr. Severyn.

168

167

Gov't Ex. Twelve at 7; Tr. at 73-74.

168

Gov't Ex. Twelve at 7; Tr. at 74.

Dr. Severyn noted that Dr. Zaidi reported mild scoliosis without deformity, but also that the lower extremities were normal with respect to sensation and strength, and that the “[a]bdomen is soft and nontender.”

169

Dr. Severyn said that Dr. Zaidi certainly would have seen the patient walk as part of the office visit, and would thereby be able to report that the patient's balance and coordination were normal, and confirmed that Dr. Zaidi had the patient perform heel and toe walking (which were described as normal).

170

He did not, however, see Dr. Zaidi touch the patient's abdomen to test it for softness and for the presence of tenderness.

171

169

Gov't Ex. Twelve at 7; Tr. at 74.

170

Gov't Ex. Twelve at 7; Tr. at 75.

171

Gov't Ex. Twelve at 7; Tr. at 75.

Next, Dr. Severyn said that while the medical records indicate a chest examination was performed, “to do that requires the use of a stethoscope, and a stethoscope was nothing that I could observe during any of the recording of this encounter.”

172

He said the same was true regarding the notation of normal heart sounds—heart sound examinations require a stethoscope, but none was observed during the video recording of this examination.

173

172

Gov't Ex. Twelve at 7; Tr. at 75.

173

Gov't Ex. Twelve at 7; Tr. at 75.

Dr. Severyn opined that the report of this patient's examination was falsified in that “it is embellished, and it is inaccurate, to the point that much of it, though documented here, was not performed.”

174

Moreover, in his opinion, the medical history described a patient with “an acute condition of mild severity and of a generally benign nature” that would not “justify prescribing a controlled substance or relying upon a controlled substance as the predominant approach to treatment.”

175

174

Id.

at 76.

175

Id.

Also of concern, according to Dr. Severyn, was Dr. Zaidi's diagnosis indicating thoracic and lumbar radiculitis. Dr. Severyn stated:

Radiculitis is a diagnosis of nerve root dysfunction at the level of the spine, at the level where the nerve roots exit the spine. If it is lumbar radiculitis, then it is a nerve root that's exiting in the lumbar area, and so for the thoracic area, radiculitis is a condition

that will then affect the entire nerve root to some degree or another, but it is not pain that is limited to just the portion of the back. We call that instead axial pain. It has other causes. That is the use of the word lumbago, which is lumbar pain.

But, putting a diagnosis of radiculitis as opposed to other causes, that, based on this history and the lumbar portion of the examination are much more reasonable, brings to my mind the question as to the accuracy of that diagnosis, because I think that an experienced physician, especially one in the field of pain medicine, would recognize that this is not the presentation and the examination that's compatible with a diagnosis of radiculitis. This diagnosis is blatantly inaccurate.

176

176

Id.

at 77-78.

Accordingly, Dr. Severyn opined that both the treatment plan and the recommendation for this patient were “not justified by the presentation of this patient.”

177

177

Id.

at 79.

Dr. Severyn expressed the same opinion regarding Dr. Zaidi's diagnosis of lumbar radiculitis during the follow-up visit on October 4, 2012, based on what he observed from the recordings of the follow-up visit and what appears in Dr. Zaidi's written notes of that encounter.

178

He said Dr. Zaidi's notation that he conducted a physical examination during that visit allowing him to find moderate tenderness and spasm in the paralumbar muscles (with guarding and forward flexing) was falsified, as was his description of a lower extremity examination establishing normal sensory and motor testing.

179

178

Id.

at 80.

179

Gov't Ex. Twelve at 12; Tr. at 81.

The October 4, 2012 visit began with Ms. Barrett

180

taking Agent Parkison's blood pressure and pulse oximetry,

181

and recording her findings while seated and using the examination table as her desk.

182

Ms. Barrett inquired of Agent Parkison's current pain level, which he stated was three or four, with the best level around two and worst pain at four.

183

Those pain levels are recorded in notes apparently written by Ms. Barrett, indicating current pain as a four, with worst pain at four and best pain at two.

184

At no time did Agent Parkison indicate a pain level as high as five.

180

Gov't Ex. Nine at 11.

181

Tr. at 232.

182

Gov't Ex. 3b, folder Tyler UC visit, subfolder AudioVideo Recordings—10-04-12, file 102359 at 10:24:38 to 10:26:40.

183

Id.;

Gov't Ex. Nine at 11.

184

Gov't Ex. Twelve at 18.

As Ms. Barrett finished her notes in the file, Dr. Zaidi entered and Ms. Barrett stood up from behind the examination table, at which point Dr. Zaidi took the seat and briefly turned his back to Agent Parkison and consulted his computer monitor.

185

Dr. Zaidi then turned to face Agent Parkison, and began his interview, asking about whether the Percocet had been effective and discussing his concerns about Agent Parkison's blood pressure, which he said was high and created the risk of stroke.

186

When Dr. Zaidi asked how the Percocet was working, Agent Parkison stated “it worked pretty good, it worked alright; I just felt like I didn't quite have enough of it.”

187

They did not, however, discuss whether Agent Parkison had taken all of the prescribed Percocet.

188

185

Gov't Ex. 3b, folder Tyler UC visit, subfolder AudioVideo Recordings—10-04-12, file 102359 at 10:26:31-10:27:05.

186

Gov't Ex. 3b, folder Tyler UC visit, subfolder AudioVideo Recordings—10-04 12, file 102359 at 10:27:05 to 10:28:11.

187

Id.;

Gov't. Ex. Nine at 13.

188

Tr. at 336.

Agent Parkison then asked Dr. Zaidi “if I could get a little bit more” and hoped “to try two in the morning and two in the evening.”

189

Without more, Dr. Zaidi stated “Okay. So I'll give you four a day.”

190

Based on this examination, Dr. Zaidi gave Agent Parkison a prescription for 56 Percocet five mg tablets.

191

189

Gov't Ex. Nine at 13.

190

Id.

191

Tr. at 310; Gov't Ex. Fifteen at 2.

In his transcribed notes for the subjective examination, Dr. Zaidi wrote:

[Agent Parkison] is stable with his lower back pain at 5 on a scale of 0-10. No change in his personal, family, or social history. No focal weakness or numbness. No abdominal or chest pain. His blood pressure is again very elevated. We again discuss the potential complications from such high blood pressure and he is to go and see his PCP today or ER to have that addressed. Otherwise, no abdominal or chest pain at present. No headaches. No visual disturbances.

192

192

Gov't Ex. Twelve at 12.

In his report of objective findings, Dr. Zaidi wrote that Agent Parkison's “vital signs are stable though blood pressure is elevated. Moderate tenderness and spasm in paralumbar muscles with guarding in forward flexion. Lower extremity examination is normal to sensory and motor testing. His gait is normal.”

193

Having seen the audio-video recording of this encounter, I find no evidence that Dr. Zaidi has accurately described the scope of his physical examination, and consistent with Dr. Severyn's findings, I find this to be a falsified examination report.

193

Id.

By this point in the visit, Dr. Zaidi had spent approximately two minutes in the room with Agent Parkison, all of it seated, with the examination table between himself and Agent Parkison.

194

As Dr. Severyn noted, there is no evidence that Dr. Zaidi performed any physical examination either before or after agreeing to increase the Percocet prescription.

195

Indeed, the discussion predominating this visit addressed Agent Parkison's high blood pressure, not his pain or his treatment for pain. There was no discussion about exercise, physical therapy, injections, alternatives to the use of controlled substances, or Agent Parkison's functional capacity.

194

Gov't Ex. 3b, folder Tyler UC visit, subfolder AudioVideo Recordings—10-04 12, file 102359 at 10:26:31 to 10:28:40.

195

Tr. at 80.

Dr. Severyn remarked that there was a notation regarding home exercise as part of the plan of treatment.

196

He added, however, that he found nothing in the material that “contained any educational endeavor that would allow someone to conduct a home exercise program.”

197

He explained that in order to provide a home exercise program to a patient, “there would need to be either verbal or oral communication. It would include instructions as to what are the physical maneuvers to be performed, the frequency, the timing, and the expected response and instructions as to how to avoid exacerbating the condition.”

198

While this could be accomplished by handing the patient various brochures that might explain a home exercise program for this kind of pain, there is nothing in the record to indicate such education took place.

199

Agent Parkison confirmed this, testifying that at no time during any of his office visits did Dr. Zaidi provide him with examples of exercises he could perform to treat his back pain, nor was there any discussion about a home exercise program.

200

196

Id.

at 81.

197

Id.

198

Id.

at 84-85.

199

Id.

at 85.

200

Id.

at 350.

Despite the paucity of information gathered during this second visit, Dr. Zaidi increased by one hundred percent the number of Percocet tablets he prescribed to Agent Parkison.

201

According to Dr. Severyn, there was no justification presented in the medical record for doubling the amount of Percocet to Agent Parkison.

202

Dr. Severyn explained that while Agent Parkison's continued complaint of pain should be considered, Dr. Zaidi should have considered alternatives to

controlled substances as treatment.

203

Dr. Severyn opined that when Dr. Zaidi prescribed 56 Percocet tablets for Agent Parkison during this visit, he did so outside the usual course of professional practice.

204

201

Id.

at 85.

202

Id.

203

Id.

at 86.

204

Id.

According to Dr. Severyn, Agent Parkison's next visit, on November 14, 2012, did not include an examination of the lumbar spine, nor any testing for guarding in forward flexion, nor was there any sensory or motor testing of the lower extremities.

205

205

Id.

at 88.

Having reviewed the audio-video recording of the November 14, 2012 office visit, I concur with Dr. Severyn's assessment and find there was no examination of Agent Parkison's lumbar spine during this visit, nor was there any testing for guarding in forward flexion, nor was there any sensory or motor testing of the lower extremities.

206

206

Gov't Ex. 3c, folder Tyler UC Visit 3, subfolder AudioVideo—11-14 12, file 094453. Note that Government Exhibit 3c also includes an audio-only recording, which was not discussed by the parties and which contains no information relevant to this matter that is not also available in the audio-video recording.

Agent Parkison stated that for this visit, he reported a current pain level of two and the worst level had been a three.

207

In taking his history for this visit, Ms. Barrett accurately recorded in his patient medical chart that Agent Parkison reported a maximum pain level of three, a minimum of two, and a present level of two.

208

After Ms. Barrett obtained Agent Parkison's blood pressure and oximetry readings and recorded his responses to her questions about current and recent pain levels, Ms. Barrett left the room and Dr. Zaidi entered shortly thereafter.

209

Dr. Zaidi remained standing near the office door and reviewed the chart provided to him by Ms. Barrett, and for approximately two minutes discussed with Agent Parkison his high blood pressure and the steps he should be taking to address that problem.

210

At no time did Dr. Zaidi place his hands on Agent Parkison or approach him—instead, he stood by the chart until he determined that the pain medication was working and completed his discussion regarding the seriousness of Agent Parkison's elevated blood pressure.

211

207

Tr. at 341.

208

Gov't Ex. 3c, folder Tyler UC Visit 3, subfolder AudioVideo—11-14 12, file 094453 at 10:00:26 to 10:02:25; Gov't Ex. Twelve at 18.

209

Id.

at 10:00:37 to 10:04:56.

210

Id.

at 10:04:56 to 10:06:57.

211

Id.

Based on this encounter, Dr. Zaidi made written subjective findings, stating that Agent Parkison's “lumbar pain is at 5 on a scale of 0-10” despite the notations to the contrary in the chart prepared by Ms. Barrett and despite the absence of any evidence indicating Agent Parkison was reporting pain at that level.

212

Despite the lack of questions (by either Ms. Barrett or Dr. Zaidi) addressing these subjects, Dr. Zaidi wrote there was “[n]o change in his personal, family, or social history.”

213

Despite the absence of any physical examination or questions presented to Agent Parkison regarding these areas, Dr. Zaidi wrote in his subjective findings that there were no abdominal or chest pains, and no focal weakness or numbness.

214

212

Gov't Ex. Twelve at 11; cf.

Id.

at 18.

213

Id.

at 11.

214

Id.

Consistent with what Agent Parkison told Dr. Zaidi, in the Objective findings section Dr. Zaidi noted Agent Parkison's continued high blood pressure, adding, “He has seen his PCP and has been asked to monitor it at home, and I asked him to make a follow-up again very soon.”

215

Dr. Zaidi accurately reported that they again discussed the potential complications of hypertension.

216

He continued, however, to report “[m]oderate tenderness and spasm in paralumbar muscles with guarding in forward flexion. Lower extremity examination is normal to sensory and motor testing.”

217

Also, despite the fact that Agent Parkison was seated throughout his encounter with Dr. Zaidi during this visit, Dr. Zaidi wrote that Agent Parkison's “gait is normal.”

218

Based on these subjective and objective findings, Dr. Zaidi wrote that the impression is that of lumbar radiculitis, and issued a prescription for 56 tablets of Percocet five mg.

219

215

Id.

216

Id.

217

Id.

218

Id.

219

Id.;

Tr. at 341.

Dr. Severyn opined that Dr. Zaidi's diagnosis of lumbar radiculitis “is a more severe condition than what this patient is voicing complaints [] of,” and “is not justified on the basis of the entirety of the history and the physical examination.”

220

He explained that the objective findings that appear in Dr. Zaidi's written report of the November 14, 2012 visit—including spasms in paralumbar muscles and guarding in forward flexion—could not be reached without a physical examination, but that there was no evidence that such an examination occurred.

221

I too saw no evidence of an examination during this visit.

220

Tr. at 88-89.

221

Id.

at 90-91.

Dr. Severyn also noted that while the written record of treatment for November 14, 2012, reports Agent Parkison reported pain at level five (on a scale of ten), the recording and transcript show that Agent Parkison reported pain at level two to three—and there is no explanation to account for this difference.

222

222

Id.

at 92.

The Government also presented testimony from DEA Diversion Investigator Brinks, who was present when Agent Parkison interviewed Dr. Zaidi at the time the DEA's search warrant was executed.

223

Investigator Brinks testified that Agent Parkison had the medical chart reflecting pain levels higher than Agent Parkison reported to either Dr. Zaidi or Ms. Barrett, and asked Dr. Zaidi if he could explain this difference.

224

According to Investigator Brinks, Dr. Zaidi had no response when presented with Agent Parkison's treatment chart.

225

223

Id.

at 618, 620.

224

Id.

at 619-20.

225

Id.

at 620.

Dr. Severyn was asked to interpret the exchange between Dr. Zaidi and Agent Parkison, where the latter, during his visit of December 12, 2012, told Dr. Zaidi that his current medication has “been helping some at the end of the day,” but that he had “a little bit of nagging stiffness,” adding that one of his “buddies said something that [OxyContin] kind of helps him.”

226

Without more, according to Dr. Severyn, this would not be a sufficient justification for changing a medication to OxyContin, but that is what Dr. Zaidi did.

227

226

Id.

at 95; Gov't Ex. Nine at 20.

227

Tr. at 95.

The audio-video recording of the December 12, 2012 visit confirms Dr. Severyn's description of the sequence leading to this change in medication. For this visit, Ms. Barrett does not appear to have taken a history or recorded Agent Parkison's blood pressure, and Dr. Zaidi met with Agent Parkison for slightly less than three minutes.

228

For the first minute or so, Dr. Zaidi did not actually look at Agent Parkison, but instead was apparently reviewing his medical chart.

229

While still studying the chart, Dr. Zaidi inquired how Agent Parkison was doing, and Agent Parkison responded

that he had been experiencing some “nagging stiffness” and remarked that one of his “buddies” had suggested “Oxy kind of helps him.”

230

Without a pause (other than to observe that such a change would be “a lot more dose” and would be more expensive), Dr. Zaidi wrote a prescription for 42 ten mg tablets of OxyContin.

231

228

Gov't Ex. 3d, folder Tyler UC Visit, subfolder AudioVideo—12-12-12, file 132123 at 13:48:56—13:51:17.

229

Id.

at 13:48:56—13:50:18.

230

Id.

at 13:49:10—13:50:00; Gov't Ex. Nine at 20.

231

Id.

at 13:49:00—13:50:00; Gov't Ex. Nine at 20; Tr. at 313.

Dr. Zaidi then engaged Agent Parkison with questions and advice about his blood pressure (although it appears no one recorded Agent Parkison's blood pressure for this visit).

232

In his treatment notes under the “Subjective” section for the visit on December 12, 2012, Dr. Zaidi wrote that Agent Parkison's pain level is “5 on a scale of 0-10,” although there is nothing in the medical chart nor the recording that supports this finding.

233

Further, Dr. Zaidi wrote that Agent Parkison “is not tolerating Percocet, which is lasting only a couple of hours and we are going to change that to OxyContin 10 mg three times a day.”

234

There was, however, nothing in either the recording or the patient medical records that indicates the Percocet was lasting only a couple of hours nor that Agent Parkison was not tolerating Percocet—only that he had some “nagging stiffness” and a “buddy” said OxyContin helped.

235

232

Gov't Ex. 3d, folder Tyler UC Visit, subfolder AudioVideo—12-12-12, file 132123 at 13:50:00-13:50:46; see also Gov't Ex. Twelve at 18 (chart notations indicating blood pressure readings during office visits on October 4, 2012, November 14, 2012, and January 9, 2013, but not for December 12, 2012).

233

Gov't Ex. Twelve at 10.

234

Id.

235

Gov't Ex. Nine at 20.

Dr. Severyn said that requesting OxyContin under these circumstances “raises in my mind, as it does in that of my associates and colleagues, a question of why is this patient asking for a specific medication by name, instead of relying on my expertise to introduce a specific medication. . . .”

236

He said that “these are red flags that I've heard in . . . national medical conferences for a decade or more.”

237

236

Tr. at 96.

237

Id.

Dr. Severyn next explained there are more rigorous standards that apply in Ohio when using controlled substances to treat pain that no longer can be described as acute but is instead chronic or intractable.

238

After reviewing patient treatment records for treatment during the first twelve weeks, Dr. Severyn stated that by January 2013, “the medical care is entering into that portion that the statutes in Ohio consider as protracted prescribing.”

239

According to Dr. Severyn,

238

Id.

at 100-01.

239

Id.

at 100.

At that point, there is a much higher level of service reflected by documentation that needs to take place. Some of those [include an] evaluation of what is the current employment history, what is the activity of daily living. . . . Is the treatment plan justified? [W]hat is the effectiveness of the treatment plan? That is not recorded here.

240

240

Id.

Dr. Severyn explained that by the time the protracted prescribing of controlled substances has begun, “the diagnosis needs to be substantiated by the physical findings and my opinion is that they are not, and it needs to be substantiated by the history, and my opinion is that it is not.”

241

241

Id.

at 100-01.

Because Dr. Zaidi had been treating Agent Parkison for more than twelve weeks by January 2013, “[a]n entirely elevated level of service is called for,” which was not evidenced in either the medical chart or the recordings of the office visits from January 2013 forward.

242

242

Id.

at 101.

In reviewing the audio-video recording of the January 9, 2013 visit, I found no examination took place other than the taking of Agent Parkison's blood pressure and oxygen levels by Ms. Barrett.

243

Dr. Zaidi's report of Agent Parkison's subjective symptoms indicates “[h]e is doing better with OxyContin, but it is not strong enough and I am going to increase OxyContin to 15 mg three times a day.”

244

Apparently this was based entirely on Agent Parkison stating, “I was wondering if I could get maybe just a little bit stronger” notwithstanding that he reported to Ms. Barrett reductions in his pain level—that at its worst the pain was at level two.

245

Further, despite there being no discussion of Agent Parkison's personal, family, or social history, Dr. Zaidi reported no changes in those histories.

246

Similarly, notwithstanding the absence of any physical examination, Dr. Zaidi wrote that for the subjective examination there were no abdominal or chest pains, no shortness of breath or dizziness.

247

Further, without actually conducting an examination to support these findings, Dr. Zaidi wrote in his objective findings:

243

Gov't Ex. 3e at 14:01:29 to 14:02:21. Note that in Government Exhibit 3e at folder labeled Audio 01-09-13 contains a file named 01-09-13, appears to contain an audio-only recording of Agent Parkison's January 13, 2013 office visit. As neither party referred to this recording it has not been reviewed here. Similarly, Government Exhibit 3e in folder AudioVideo 01-09-13 contains a file named Thumbs, which was not referred to by either party and which I was not able to access. Accordingly, it has not been reviewed here.

244

Gov't Ex. Twelve at 9.

245

Gov't Ex. 3e at 14:05:22 to 14:05:57; Gov't Ex. Nine at 23-24.

246

Gov't Ex. Twelve at 9.

247

Id.

Pupils are equal and reacting to light. Skin is warm and dry. Moderate diffuse tenderness and spasm in paralumbar muscles with minimal guarding in forward flexion and extension. Lower extremity examination is normal to sensory and motor testing. His gait is normal.

248

248

Id.

During cross examination, Agent Parkison stated that after this visit, he determined no additional visits were warranted.

249

He said he had worked cases like these in the past, and in those cases the DEA stopped after the third visit.

250

By the fifth visit with Dr. Zaidi, Agent Parkison “felt it was pretty clear that I had been issued prescriptions other than for a legitimate medical purpose and didn't feel that I needed to continue to go” back for additional treatment.

251

He said by this fifth visit, he had seen that Dr. Zaidi would not question him when he asked for more medication and would not check to see if there was something that was causing him to be in more pain.

252

249

Tr. at 465-66.

250

Id.

at 466.

251

Id.

252

Id.

According to Dr. Severyn, Dr. Zaidi to this point had failed to make an adequate assessment of Agent Parkison' functional status, or of his activities of daily living.

253

Further, and as was the case in the three prior office visits, while Dr. Zaidi indicates a plan of treatment that includes a “home exercise program,”

254

there was no discussion of any home exercises during the office visit, nor is there any evidence that written details of such a program were ever provided to Agent Parkison at any visit.

253

Id.

at 102-03.

254

Gov't Ex. Twelve at 9-12.

Dr. Severyn also noted that when a patient reports “stiffness” in the mid-back, as Agent Parkison did during the visit on January 9, 2013,

255

this is significant “because if a patient is describing stiffness as opposed to pain, then whatever treatment plan has brought that patient to that stiffness . . . [is] a medical success. That's quite good. That sounds like improvement over time. . . . [I]t's an indication that this patient may be getting better, and probably is.”

256

Stiffness and pain are, in Dr. Severyn's view, dissimilar, in that “a patient who is complaining of

stiffness is a patient for whom pain has been well-controlled. The etiology and cause appears to be in regression or remission and their response to treatment is quite good.”

257

When presented with a patient who complains of stiffness but also indicates pain at a level four on a ten point scale, Dr. Severyn stated that a physician can reconcile this by “just asking the patient to be a little more clear” in response to the physician's questions.

258

255

Id.

256

Tr. at 108-09.

257

Id.

at 259.

258

Id.

at 261.

Such a complaint would not justify prescribing controlled substances in the manner shown in the records for Agent Parkison, according to Dr. Severyn, “because there are so many less risky alternatives that can be offered, including muscle relaxants that can be very helpful here, and other approaches to care.”

259

Dr. Severyn found, however, no evidence that these alternatives were considered.

260

259

Id.

at 109.

260

Id.

at 109-10.

In Dr. Severyn's opinion, Dr. Zaidi's controlled substance prescriptions for Agent Parkison were based on a diagnosis that is “completely inaccurate” and “focuses only on controlled substances and not on the several other alternative approaches to care [including] physical therapy, non-controlled substance medication, [and] the medications in several different classes.”

261

He also noted that by January 2013, there was no proper informed consent obtained by Dr. Zaidi for this patient.

262

Dr. Severyn acknowledged the form Agent Parkison signed on September 11, 2012 (at the start of his treatment) states, “I consent at this time for treatment with medications and therapeutic procedures.”

263

According to Dr. Severyn, however, this does not constitute informed consent, as it “does not sufficiently describe the risks that can go along with using a controlled substance on a regular basis,” including “delayed breathing, slowed breathing, risk of overdose, risk of drug withdrawal, risk of diversion of medications, risk of becoming addicted, risk of being a victim of theft and home break-in, and the risk actually for the worsening of pain over time . . . .”

264

261

Id.

at 103.

262

Id.

at 104-05.

263

Id.

at 104-05; Gov't Ex. Twelve at 25.

264

Tr. at 105-06.

Dr. Severyn noted that by his fourth visit, Agent Parkison asked for OxyContin by name, something Dr. Severyn regarded as a red flag.

265

He explained that “OxyContin has been a largely diverted and abused medication, and a patient asking for that medicine . . . by name . . . should and would arise suspicion in the mind of a prescribing physician.”

266

Further, during the fifth visit, when Agent Parkison asked for an increase in OxyContin, this too would be considered a red flag, given that there was no physical examination conducted at that visit, and given that it appeared the existing treatment plan was “achieving what it had meant to achieve.”

267

Dr. Severyn found no evidence, however, that Dr. Zaidi tried to resolve any of these red flags.

268

265

Id.

at 113.

266

Id.

267

Id.

268

Id.

at 114.

When asked how a physician should respond to a patient who sees an advertisement for a particular drug, Dr. Severyn stated that if the drug was a controlled substance, he would “incorporate that into the remainder of the medical decision-making process” although this did not mean the incident would necessarily be noted in the patient's medical record.

269

He added, however, that in none of the three undercover cases did it appear that the patient told Dr. Zaidi he wanted a particular drug because he had seen the drug advertised.

270

269

Id.

at 199.

270

Id.

at 280.

When asked on cross examination about things a physician must do to resolve red flags associated with potential diversion, misuse, or addiction, Dr. Severyn stated that first the physician must observe the patient over time, note the “maturation” of what is observed, and when encountering more than one “element of discontinuity” more than just observation is called for.

271

“The ultimate `to-do' always is to say, `You know, this is not a treatment that I am going to continue for this patient.' That's one approach. Another alternative is other medication, physical therapy, [and] referrals, those are important.”

272

271

Id.

at 173-74.

272

Id.

at 174-75.

Dr. Severyn agreed, on cross examination, that there may have been instances where patients have deceived him without his knowledge.

273

He recalled one such instance where he discovered the deception only after evaluating the results of a urine screen—a test he requires at the initial encounter (as does Dr. Zaidi

274

), and thereafter at “every encounter” for patients receiving controlled substances on a protracted basis.

275

He added, however, that Ohio law does not require testing at every encounter, so he would not opine that Dr. Zaidi should have conducted a urine screen each time these patients visited the office.

276

Further, Dr. Severyn noted that by seeing his patients at least once a month, Dr. Zaidi complied with the standard of care in frequency of patient visits, agreeing during cross examination that this practice is another way to help protect against misuse, diversion, or addiction.

277

273

Id.

at 191.

274

Id.

at 193.

275

Id.

at 191-92.

276

Id.

at 194.

277

Id.

at 196.

Regarding a patient's decision not to seek treatment (such as a recommended epidural injection) or diagnostic measures (such as an MRI), Dr. Severyn was asked if he recalled whether the patient attributed the decision to cost or an inability to pay.

278

He said he did recall discussions about patients wishing to await the availability of insurance.

279

He noted, however, that “I also see in the record before me, receipts for medical encounters of $300 cash on a frequent basis.”

280

When he stated he thought these were on a monthly basis, he initially indicated that there were at least two such payments made by Agent Parkison.

281

The record, however, does not support this, and instead indicates the $300 cash payment was made only at the initial visit, and $95 was charged for all subsequent visits.

282

After this discrepancy was brought to his attention, Dr. Severyn was asked whether he believed these patients could afford MRIs or injections if these were indicated, and he stated he did not agree that the patients could have afforded those procedures.

283

278

Id.

at 187.

279

Id.

280

Id.

281

Id.

282

Id.

at 187-88; Gov't Ex. Sixteen.

283

Tr. at 188.

Dr. Severyn stated that an MRI is helpful in the context of pain medicine, “when it answers, in the mind of the physician . . . what is the cause of this patient's complaints, the etiology of the physical findings and the implication and impact of learning that information upon the recommendation to be made to the patient and the treatment plan to be put into effect.”

284

When asked on cross examination whether it was appropriate for Dr. Zaidi to advise Agent Parkison to have an MRI “because of the vague symptom that he has in his lower back,”

285

Dr. Severyn said no, and agreed that the fact that no MRI was

ever performed did not breach the standard of care.

286

284

Id.

at 240.

285

Gov't Ex. 12 at 8.

286

Tr. at 234.

On cross examination, Dr. Severyn agreed that one appropriate means of responding to red flags in the context of prescribing pain medication is to use urine drug screens, and he acknowledged that Dr. Zaidi used these screens as part of his prescription practice.

287

287

Id.

at 175.

Dr. Severyn next explained why the inaccuracies found in Dr. Zaidi's medical records of Agent Parkison's treatment are important in the review of Dr. Zaidi's prescription practice:

There is inaccuracy and a listing of a more severe level of pain than what the patient is actually voicing during the encounter with staff or with the physician. The diagnosis, the impression that is listed here, the most impressive and important of them, with regards to guiding the patient through treatment, would be the lumbar radiculitis, and that is not justified or substantiated by either the history or the physical examination. Finally, the approach to treatment that relies on only a controlled substance and does not include many of the other approaches, such as non-steroidal anti-inflammatory, neuromodulator, tricyclic medications [and] physical therapy. Those are absent. The home exercise program, I found no evidence that that is being provided.

I found, to a large degree, that if I were to have reviewed only the medical record, as it was presented here, I would have arrived at a different opinion than I am able to, having now had the ability to see a transcript and watch an audio/visual recording of what actually occurred during that encounter.

288

288

Id.

at 107-08.

For these reasons, Dr. Severyn opined that Dr. Zaidi's prescriptions of controlled substances for Agent Parkison “were well outside the usual course of professional practice . . . .”

289

289

Id.

at 104.

Dr. Zaidi's Treatment of Officer Patrick Leonard (Under the Name Patrick Tock)

Patrick James Leonard has been employed at the Akron (Ohio) Police Department for about 20 years, the last sixteen of which he has been a detective in the narcotics diversion department.

290

In addition, for the past two years Detective Leonard has been assigned to the DEA as a task force officer, serving in an undercover capacity in the investigation of physicians and others suspected of illicit drug transactions.

291

He was trained as a military police officer in the United States Army, has completed training at the Ohio Police Officer Training Academy, and received training in pharmaceutical diversion through the Ohio Board of Pharmacy.

292

290

Id.

at 553.

291

Id.

at 554-55.

292

Id.

at 555.

Detective Leonard participated in the surveillance of Dr. Zaidi's medical office and was a patient in an undercover capacity, under the name Patrick J. Tock.

293

In his role as a patient, Detective Leonard attended six office visits with Dr. Zaidi, and in each visit received prescriptions for controlled substances.

294

Each of these visits were surreptitiously recorded, and both the recordings and the transcriptions of the relevant portions of those recordings are included in our record.

295

He agreed on cross examination that in his undercover capacity, he was engaged in misleading Dr. Zaidi and his staff during these visits.

296

He denied, however, that there was “any trickery involved. We presented a certain set of facts and waited to see if Dr. Zaidi would write prescriptions.”

297

293

Id.

at 555-56.

294

Id.

at 556-64.

295

Id.

296

Id.

at 588.

297

Id.

at 588-89.

In his role as Patrick Tock, Detective Leonard reported that he had stiffness in his lower back.

298

In his initial interview with Christy Barrett, Detective Leonard reported pain levels of between three and four on a ten-point scale, denying any pain in his legs.

299

He also denied ever being treated for this condition, and denied ever having an MRI or x-ray with respect to the condition.

300

At the conclusion of the initial office visit, he obtained from Dr. Zaidi a prescription for 42 tablets of Percocet five mg.

301

According to Detective Leonard, at no time did Dr. Zaidi suggest any treatment for his condition other than controlled substances, nor did Dr. Zaidi suggest physical therapy, exercise, or any other non-medication treatment.

302

He said Dr. Zaidi did recommend that he obtain an MRI, providing to Detective Leonard the name of a provider whose charges for this service were reduced for persons, like Detective Leonard, who lacked health insurance.

303

Despite this recommendation, Detective Leonard returned to Dr. Zaidi's office five more times without obtaining an MRI, and on each occasion Dr. Zaidi prescribed him controlled substances.

304

According to Detective Leonard, while Dr. Zaidi did conduct a physical examination during the first office visit, he conducted no physical examinations during any of the subsequent visits.

305

298

Id.

at 567.

299

Id.

at 568-69.

300

Id.

at 571.

301

Id.

302

Id.

at 572.

303

Id.

at 572-73.

304

Id.

at 573; Gov't Ex. Thirteen.

305

Tr. at 576-83.

As was the case with his review of Agent Parkison's treatment, Dr. Severyn reviewed the medical charts, transcripts, and recordings

306

relating to Dr. Zaidi's treatment of Officer Leonard during six visits to that office.

307

And as was the case with the records of treatment of Agent Parkison, Dr. Severyn noted material differences between what appears in Officer Leonard's written medical chart and what actually occurred during Dr. Zaidi's treatment of the patient.

306

The recordings in ev

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