Mireille Lalanne, M.D.; Denial of Application

Federal RegisterAug 6, 2013

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 11-30]

Mireille Lalanne, M.D.; Denial of Application

On August 18, 2011, Chief Administrative Law Judge (ALJ) John J. Mulrooney, II, issued the attached decision, recommending that I deny the Respondent's application for a Certificate of Registration as a practitioner. Thereafter, the Government, but not Respondent, filed Exceptions to the decision.

All citations to the ALJ's Decision are to the slip opinion as originally issued by him.

Having reviewed the entire record and the Government's Exceptions, I have decided to adopt the ALJ's recommended rulings, findings of fact, conclusions of law, and recommended order except as discussed below.

I will

therefore order that Respondent's application be denied.

I do not adopt the ALJ's discussion of Factor 2 (the applicant's experience in dispensing controlled substances) contained in the third paragraph of page 52 of his decision. Nor do I adopt the ALJ's reasoning that there is “an arguable lack of at least readily- apparent ambiguity” in the language of factor two. ALJ at 53 (citing

Chevron U.S.A., Inc.

NRDC, Inc.,

467 U.S. 837 (1984)). In short, Congress only directed that the Agency “consider” evidence regarding an applicant's experience in dispensing controlled substances; nothing in the statute tells the Agency how much weight to give a practitioner's evidence of, in the ALJ's words, “hav[ing] conducted a significant level of sustained activity within the scope of [her] registration for a sustained period.” ALJ at 52.

As set forth in multiple cases, DEA can revoke based on a single act of intentional or knowing diversion, and an applicant's/registrant's evidence that she has otherwise complied with the CSA for a sustained period, does not, by itself, refute the Government's

prima facie

case.

See Dewey C. MacKay,

75 FR 49956, 49977 (2010) (citing

Jayam

Krishna-Iyer,

74 FR 459,463 (2009)),

pet. for rev. >denied

664 F.3d 808 (10th Cir. 2011). Indeed, in

MacKay,

the Tenth Circuit expressly rejected the contention that a practitioner's so-called “positive experience” negates a

prima facie

showing of intentional diversion.

See

664 F.3d at 819 (“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 [two patients] is sufficient to support her determination that his continued registration is inconsistent with the public interest.”). So too, where, as here, the evidence supports a finding that an applicant/registrant acted with deliberate ignorance in prescribing controlled substances. As the ALJ correctly noted, in such cases, “Agency precedent has firmly placed acknowledgment of [wrongdoing] and acceptance of responsibility as conditions precedent to merit the granting or continuation” of a registration. ALJ at 44 (citing cases).

This is not to say that such evidence is never entitled to weight. Such evidence may persuade the Agency that an applicant/registrant has offered credible testimony that she accepts responsibility and will not engage in future misconduct. So too, where the Government's proof does not establish egregious violations, such evidence is given due consideration in setting the appropriate sanction.

See Gregg & Sons, Distributors,

74 FR 17517, 17524 (2009).

The Government's Exception

The Government takes exception to the ALJ's conclusion that the unsworn hearsay statement of TG, purportedly one of Respondent's former patients, was entitled to no weight, because the Government did not establish that the statements contained therein are sufficiently reliable to constitute substantial evidence of a material fact.

Exceptions at 1 (citing ALJ at 7-9). Specifically, the Government elicited the testimony of a former Assistant Commonwealth's Attorney (hereinafter, prosecutor) regarding his interview of TG to show that Respondent had doubled TG's dose of Xanax for no medical reason. Exceptions at 2. Significantly, TG's unsworn statement comprised the entirety of the Government's proof of the allegation.

The Government agrees with the ALJ's ultimate conclusion that Respondent “`has committed acts that render [her] registration inconsistent with the public interest'” and his recommendation that her application be denied. Exceptions at 1.

In declining to give weight to TG's statement, the ALJ applied the four factors for assessing the reliability of hearsay evidence set forth in

J.A. M. Builders, Inc.,

Herman,

233 F.3d 1350 (11th Cir. 2000). More specifically, the ALJ explained that:

No foundation was laid by the Government regarding the absence of bias from . . . TG. The information provided in the interview[] could not be tested for consistency because such testimony was not corroborated by other evidence of record. Furthermore, there is no case law or other authority recognizing this variety of evidence as inherently reliable. Simply put, the Government, as a proponent of the evidence, did not lay a foundation sufficient to permit consideration of [TG's] interview[] to support [a finding that it constitutes] substantial evidence . . . .

ALJ at 8.

Notably, the Government does not take issue with the ALJ's reliance on

J.A. M. Builders,

even though that case is not binding on the Agency outside of a matter which falls within the jurisdiction of the Eleventh Circuit.

Instead, the Government argues that the ALJ improperly “placed the burden on the Government to prove a stream of negatives as a prerequisite to giving the testimony any weight.” Exceptions at 3.

It is noted that the Government does not cite to any case law of either the Sixth Circuit or DC Circuit, the two courts of appeals which would have jurisdiction were Respondent to file a petition for review.

The Government notes that “there was no objection to [the former prosecutor's] testimony regarding TG's out of court statement.” Exceptions at 3 & n.1. While Respondent's failure to object “`is a waiver upon appeal of any ground of complaint against its admission,'” TG's statement became “`part of the evidence in the case, and is usable as proof to the extent of whatever rational persuasive power it may have.'”

Passaic Daily News

NLRB,

736 F.2d 1543, 1554 (DC Cir. 1984) (quoting C. McCormick,

Handbook of the Law of Evidence

113 (2d ed. 1972)). However, because as explained in this decision, I agree with the ALJ that TG's statement lacks sufficient indicia of reliability, it has no rational persuasive power. Accordingly, Respondent's failure to object to the testimony is of no consequence.

Regarding the first

J.A. M. Builders

factor—the issue of TG's potential bias—the Government argues that the former prosecutor testified about his interview and “based on the testimony and cross-examination, no bias or inconsistencies were detected on TG's part.” Exceptions at 4. As to the second factor—whether the statement was made known to Respondent prior to the hearing and whether the declarant could have been subpoenaed—the Government argues that TG's name and the details of his interview were “disclosed to Respondent prior to the hearing, but Respondent declined to have [him] subpoenaed or take any steps to determine the veracity of [his] statement.”

Id.

With respect to the third factor—whether the information was inconsistent on its face—the Government argues that “there was nothing inconsistent on its face” in the testimony of the former prosecutor regarding the interview, and that the ALJ improperly relied on inconsistencies in a transcript of the interview which the Government did not offer into evidence.

Id.

Finally, addressing the fourth factor—whether the information has been recognized by the courts as inherently reliable—the Government contends that “the truth of the facts alleged by TG could have been corroborated (or refuted) by an examination of TG's medical record,” and that “[p]resuming that Respondent made medical notes reflecting changes in TG's condition, she would have had access to the type of evidence needed to verify TG's statement that he received an amount of Xanax in excess of what was medically necessary.”

Id.

Thus, the Government contends that TG's statement “was not unlike hearsay testimony from a laboratory report or laboratory technician which has been found to be inherently reliable because it can be verified with other scientific data,

i.e.,

TG's medical file.”

Id.

at 4-5 (citing

United States

Minnitt,

617 F. 3d 327, 334-35 (5th Cir. 2010)).

Contrary to the Government's statement, it is obvious that Respondent would have no interest in verifying TG's statements that he received Xanax in an amount that exceeded what was medical necessary.

Notwithstanding that the ALJ should have looked to the case law of the Sixth and DC Circuits in determining whether TG's statement constituted substantial evidence of the material fact for which it was offered, the Government's exception is still not well taken. As for its contention that the ALJ improperly “placed the burden on the Government to prove a stream of negatives as a prerequisite to giving the testimony any weight,” Exceptions at 3, apparently, in the Government's view, the mere admission of the evidence was sufficient to place on Respondent the burden of showing that the statement is not reliable.

The Government cites no authority for its position. Moreover, while it may be that the burden of producing evidence showing that some of the factors which counsel against giving weight to a hearsay statement is properly placed on the party against whom the statement is offered, the Government acknowledges no obligation to establish even a threshold level of reliability.

However, under the Administrative Procedure Act, “the proponent of a rule or order has the burden of proof,” 5 U.S.C. 556(d), and given the manner in which courts generally treat the admission of hearsay, it seems most unlikely that any

court of appeals would sustain the Government's view.

For example, had TG given his statement under oath or provided an affidavit, some threshold level of reliability would have been established. Under such circumstances, the Government might have a point in arguing that Respondent should then have to show that TG was not disinterested. However, unsworn statements are notoriously unreliable and the Government put forward no evidence of corroborating circumstances which would support the conclusion that the statement was trustworthy.

For example, under the Federal Rules of Evidence, the proponent offering a hearsay statement “bears the burden of showing the requirements are satisfied.” Christopher B. Mueller & Laird C. Kirkpatrick,

Federal Evidence

§ 8:140, at 271 (3d ed. 2007). Analogous to the statement at issue here, a hearsay statement, which is not otherwise admissible under one of the various exceptions contained in Rules 803 and 804 of the Federal Rules of Evidence, may nonetheless be admissible if “the statement has equivalent circumstantial guarantees of trustworthiness”; in other words, if it is deemed to be sufficiently reliable. F.R. Evid. R. 807. Yet the courts have uniformly held that the proponent of the statement has the burden of establishing that it is trustworthy and admissible.

See United States

Kim,

595 F.2d 755, 766 (DC Cir. 1979) (“the burden is on the proponent to produce evidence of trustworthiness”);

see also

Stipulations B-C, E-G.

This sum represented, at least in the state's theory, ill-gotten gains (85% of which went to the Harlan County Sheriff's Department, 15% of which went to the Harlan County Commonwealth Attorney's Office).

The circumstances surrounding the Respondent's Harlan County guilty plea, including the Respondent's discomfiture regarding the propriety of the forfeitures, are well beyond the jurisdiction of this forum, have played no part in this recommended decision, and can play no part in the Agency decision in this matter.

Not unlike its presentation of Deputy Teagle's testimony, the Government elicited information from former ACA Guindi relative to interviews that he

conducted of AW

and TG,

who, like TE, were purportedly former patients of TPA while the Respondent was a partner there. An affidavit executed by AW was offered by the Government and received into evidence.

Gov't Ex. 17; Tr. 364-67. The Respondent, through counsel, registered timely, cogent (ultimately well-founded) objections to the Government's approach in this regard. Tr. 347, 360, 362-64, 367.

In the transcript prepared in connection with her statements to Mr. Guindi, it was clear that at the time she made her statements to him, AW was incarcerated based on charges related to the investigation of TPA. Gov't Ex. 19 at 1. AW admitted that she was addicted to drugs during the time she was being seen at TPA and “was under the influence most of the time [she] was in [at the practice].”

Id.

at 6. AW's interview provided information that, if credited, could arguably have established that the Respondent knew or should have known that AW always had fresh needle marks on her arms from intravenously injecting her pain medications before office visits, had prior scarring from same, and wore sleeveless shirts during warm weather so that these obvious signs of drug abuse were clearly displayed. Furthermore, her interview also could have supported the proposition that AW was not physically examined by the Respondent prior to receiving controlled substance prescriptions, and that she was never questioned by the Respondent about selling her controlled prescriptions or her reasons for travelling such a long distance each month for medical care. Additionally, the interview results would have arguably shown that AW recognized other patients at TPA as residents of her home town in Harlan County, and that some of her neighbors/fellow patients exhibited signs and behaviors of intoxication that also should have been apparent to the Respondent and other TPA staff. Tr. 358-60, 364, 385; Gov't Ex. 19.

If credited, TG's interview could have provided evidence that he and other Harlan County residents travelled a long distance together to obtain controlled substances from the Respondent to abuse or sell back in Harlan, that the Respondent prescribed controlled substances to TG for three years, that she increased his dosage at least once for no reason, and that the practice habits at TPA allowed TG to abuse the controlled substances that he obtained there. Tr. 368-71.

The affidavit was generated by the prosecution in the state criminal case in opposition to a defense motion to dismiss. Tr. 378-83

An application of the

J.A.M. Builders

factors to the interviews of AW and TG militate against affording it weight. Although the Respondent's counsel conceded that he neither made an attempt to subpoena AW, nor expended efforts to discover whether she still remained in jail, Tr. 347-48, (and while not on the record, the same circumstance may be assumed as true with regard to TG), each of the remaining factors favor exclusion of the evidence regarding Guindi's interviews. Regarding AW's possible bias, the transcript reveals that at the time of the interview AW was serving prison time after flunking a drug diversion rehabilitation program. Tr. 351-52. On the issue of whether AW could have been influenced by a desire to reduce her criminal liability based on her cooperation, Mr. Guindi was not particularly helpful. Guindi testified that he did not think AW was in a position to be placed back into the (rehab) program that she had washed out of, but that he did not know whether cooperation was a condition of the pretrial agreement that resulted in her diversion to Drug Court.

Tr. 353-54, 356. It is, likewise, not insignificant that during her interview, AW volunteered that she was inflicted with a back issue that conceivably could have justified the proper utilization of pain medications. Tr. 357.

Although Mr. Guindi represented that this sort of information was easily obtainable at the time through his mobile smart phone or by quick telephone request made to the Harlan County Clerk's Office to fax over AW's plea sheet, neither the Government nor the Respondent entreated him to make such an inquiry. Tr. 354, 356-57.

No foundation was laid by the Government regarding the absence of bias from AW or TG. The information provided in the interviews could not be tested for consistency because such testimony was not corroborated by other evidence of record. Furthermore, there is no case law or other authority recognizing this variety of evidence as inherently reliable. Simply put, the Government, as the proponent of the evidence, did not lay a foundation sufficient to permit consideration of the AW/TG interviews to support substantial evidence, or even sufficient for this tribunal to make findings relevant to the issue that could be defended at any level of appeal. AW acknowledged her intoxication during the events that were the subject of the interview, and presented in this third-hand fashion, there is no way that her recollection could be meaningfully explored. TG, who at the tail end of his interview acknowledged that he saw the Respondent ninety percent of the time, overwhelmingly used the pronoun “he” throughout the transcript to describe the physician who treated him at TPA, referring to the Respondent's partner, Dr. Vilvarajah. Gov't Ex. 21 at 17. Regarding his state of mind during the events that he was recounting, TG revealed that “[a]ll you think about is the medicine, you know, where your next little bit's going to come from.” Gov't Ex. 21 at 17-18. As discussed,

supra,

the Government opted to elicit this information in this fashion rather than to produce the witnesses at the hearing or at least lay an adequate foundation for the meaningful reception of their testimony, and made this election at its own peril. Without more of a foundation, such as a way to gauge their degree of bias, potential interest, or the consistency of their recollections,

the reliability of the testimony regarding the AW/TG interviews falls short of a level where they can be considered gainfully, or contribute to a determination supported by substantial evidence.

Further confounding the usefulness of AW's statements, Guindi testified that AW told him that she was impaired by the effects of the narcotic pain drugs most of the time that she visited the Respondent's practice and that the drugs interfered with her recollection abilities. Tr. 384-85. The same was reflected in the transcript of AW's interview. Gov't Ex. 19 at 6.

Consistent with Mr. Guindi's testimony (as well as mutually-stipulated facts), the Government submitted into evidence documents reflecting the transactions of the Respondent's conviction and sentencing in Harlan County, Kentucky. Among the documents was the Commonwealth's Offer on a Plea of Guilty, which indicated that Count I of the indictment for engaging in organized crime, a felony, was amended to facilitation to trafficking in a controlled substance, a misdemeanor. Gov't Ex. 7 at 1;

see

Stipulation B. The state's offer of a reduced charge was conditioned on the Respondent's agreement to refrain from prescribing any medications to residents of Harlan County, and was based, at least in part, on the Respondent's having excluded at least 251 patients from her pain management practice for “misusing prescription drugs,” and the state's conclusion that the Respondent was “instrumental” in prosecuting 16 patients for “misusing printed prescription pads and forging signatures.” Gov't Ex. 7 at 2. The recommended sentence part of the plea offer, which was ultimately ratified by the state district court,

proposed that the court dismiss Counts II through V; that the court dismiss the subsequent indictment for wanton murder,

see

Stipulation E;

that the Respondent receive eleven months imprisonment in the county jail, probated to four months; and that the Respondent forfeit $500,000

to the state. Gov't Ex. 7 at 2. The Government also introduced into evidence the Order of Probation, dated January 11, 2010, pursuant to the plea agreement and conviction, that ordered,

inter alia,

the unsupervised probation of the Respondent and the proscription from prescribing controlled substances

to residents of Harlan County. Gov't Ex. 11 at 2.

Gov't Ex. 10 (Judgment and Sentence on Plea of Guilty);

see

Gov't Ex. 9 (Guilty Plea).

The indictment was ordered dismissed by the Harlan Circuit Court on February 2, 2010. Gov't Ex. 12.

Half of the $500,000 sum was forfeited to the state as illegal drug trafficking proceeds, and the remaining half was donated to the Harlan Fiscal Court for use in youth activities and facilities aimed at preventing drug abuse. Gov't Ex. 10 at 5.

During her testimony at her DEA administrative hearing, the Respondent made it clear that even though she entered a guilty plea on the criminal charge, she has always maintained, and still does unwaveringly maintain, her innocence on the charges, and believes her acts were “unintentional.” Tr. 922-24, 1038;

see also

Stipulation F.

State Medical Board Proceedings

The evidence of record unequivocally establishes that the Tennessee Medical Board adjudicated a disciplinary case based on the Respondent's Kentucky state court criminal conviction. Following an initial summary suspension effected on January 29, 2010, a hearing was conducted by the Board. A final order issued by the Board on March 22, 2010, acknowledged the Respondent's state court misdemeanor conviction for facilitation to trafficking in a controlled substance in the first degree, but afforded her the benefit of retaining her medical privileges, subject to several conditions.

Gov't Exs. 14, 15;

Stipulations I, J.

The specified probation conditions include: (1) undergoing an evaluation by the Center for Personalized Education; (2) completing a two-day course on medical ethics and a three-day course of medical recordkeeping; and (3) obtaining practice monitoring for five years. During the practice monitoring, at least ten percent of all Respondent's patient medical files must be reviewed each month and Respondent must receive training in the treatment of chronic or intractable pain. The practice monitor must also provide the Medical Board with reports every three months that include the Respondent's: (1) compliance with the practice monitor's recommendations; (2) completion of education programs; (3) prescribing practices; (4) medical recordkeeping; and (5) treatment of chronic or intractable pain. Stipulation J.

The Respondent's Prescribing Practices

The Government's investigation regarding the COR application

at the center of these administrative proceedings was presented primarily through the testimony of Rhonda Phillips and James Stevens, DEA Diversion Investigators (DIs) stationed in Nashville, Tennessee.

A copy of the current application, which was submitted online, was received into evidence.

See

Gov't Ex. 2.

The Diversion Investigators

Notwithstanding the parties' stipulations regarding the procedural milestones associated with the Respondent's state criminal case, DI Phillips, a veteran of over twenty-three years as a DI, outlined numerous court-related documents associated with the misdemeanor conviction. Gov't Exs. 3-7, 9-12; Resp't Ex. 31. DI Phillips also testified that the Respondent surrendered a previous COR

through the execution of a Form DEA-104 (Form 104) signed by the Respondent and conveyed to Phillips by facsimile through her counsel. Tr. 672-74; Gov't Ex. 13. DI Phillips recalled that she prepared the surrender form upon telephonic consultation with the Respondent's counsel, explained that the surrender would be designated as “for cause,” and received an executed facsimile copy the same day. Tr. 672-74. Above the Respondent's signature, the Form 104 has a checked box adjacent to boilerplate language in the form reading, in pertinent part:

A copy of the Respondent's prior COR was received into the record.

See

Gov't Ex. 1.

In view of my alleged failure to comply with the Federal requirements pertaining to controlled substances, and as an indication of my good faith in desiring to remedy any incorrect or unlawful practices on my part[,] I hereby voluntarily surrender my [COR], unused order forms, and all my controlled substances . . . as evidence of my agreement to relinquish my privilege to handle controlled substances . . . . Further, I agree and consent that this document shall be authority for the Administrator of the Drug Enforcement Administration to terminate and revoke my registration without an order to show cause, a hearing, or any other proceedings . . . .

Gov't Ex. 13. Immediately above the afore-quoted standard surrender language appear the words: “I am surrendering this privilege only as a condition of bond, and I am not making any admissions as to any wrongdoing.”

Id.

The Respondent's counsel and Phillips had discussions surrounding the execution of the Form 104 wherein the former explained to the latter that the Respondent needed to effect a COR surrender as a condition of her bond release on the state criminal court matter. Tr. 810-11. Phillips explained unequivocally that a new application and administrative show cause process must precede the Respondent's reacquisition of her registration privileges. Tr. 811-12

DI Phillips also testified that, as part of her investigation into the current application, she obtained

and reviewed some charts from TPA

that were identified to her as relating to the Respondent's patients from the custody of the Tennessee Medical Board's Office of General Counsel (OGC),

and three additional charts

from the Harlan County, Kentucky Commonwealth's Attorney's Office (KCA). Tr. 688-94, 700. Ten files from the universe of files retrieved from OGC

and KCA were selected at random and provided to a medical consultant, Dr. Stephen Loyd, M.D., for analysis. Tr. 825.

Phillips utilized an administrative subpoena to acquire the patient charts. Tr. 424.

Phillips credibly testified that, through differences in handwriting, she was able to distinguish the Respondent's notes from those of her partner at TPA, Dr. Vilvarajah. Tr. 704-05. The Respondent, who heard DI Phillips' testimony in which she distinguished the Respondent's hand from Dr. Vilvarajah's, testified that Phillips' interpretations were accurate. Tr. 982-83.

According to DI Phillips, all but two of the charts selected bore a certification of accuracy from the Respondent. Tr. 690-92, 826-28.

Gov't Exs. 26, 45, 51.

DI Stevens testified that while two boxes of charts were retrieved from OGC, the two DIs reviewed only one box of charts, and that one box was chosen at whim. Tr. 514-15.

Additionally, over a well-reasoned, timely objection interposed by the Respondent's counsel, Tr. 793-99, DI Phillips testified concerning her interview of CM,

a former patient of TPA that was treated by the Respondent,

Tr. 799-808. Applying the

J.A.M. Builders

factors to this evidence, CM's hearsay statements, conveyed through DI Phillips, cannot be considered for any purpose in these proceedings. While the Respondent's counsel arguably could have subpoenaed the witness, the Government has tendered no information as to how lack of bias could be assessed or how to gauge the consistency of the information, and this is not the type of information that has been recognized by the courts as inherently reliable. Thus, DI Phillips' account of CM's statements have not been considered for any purpose in this recommended decision and should not be used in support of any finding in the adjudication of the present application.

DI Phillips testified that the interview was not recorded by video or audiotape. Tr. 831. However, Phillips testified that she did prepare written notes regarding the interview, and at the hearing the Government acquiesced to a request made by Respondent's counsel for access to those notes. Tr. 833.

Had CM's statements to Phillips been deemed sufficiently reliable to have been considered, they would have indicated that she was treated by TPA for four years, and that the Respondent and Dr. Vilvarajah did not take her off controlled substances even after she informed them that she was pregnant. Tr. 802-07. Ironically, in light of the fact that neither of the two experts who testified at the hearing was asked to render an opinion on the relative merits of prescribing controlled substances to pregnant patients (or continuing to do so), on the present record, the usefulness of CM's statements to Phillips regarding this issue (even if they had been sufficiently reliable to be considered) would have been dubious.

233 F.3d 1350, 1354 (2000).

DI Stevens testified that while he has been a DI for approximately three years, he is also a retired police lieutenant with over thirty years of experience, twenty-four of which were spent assigned to cases involving narcotics, pharmaceutical drugs, and illegal

controlled substances. Tr. 418-19. Like DI Phillips, Stevens testified to reviewing patient charts in connection with the Respondent's case to detect indicators of abuse or diversion.

Tr. 421. The testimonies presented by DI Stevens and DI Phillips were sufficiently detailed, consistent, and plausible to be deemed credible in these proceedings.

Stevens credibly testified that, through differences in handwriting, he was able to distinguish the Respondent's notes from those of her partner at TPA, Dr. Vilvarajah. Tr. 428. The Respondent confirmed that DI Stevens' interpretations were able. Tr. 982-83.

The Government's Expert

The Government presented testimony from, and a written report

prepared by, Dr. Stephen Loyd, M.D.

Dr. Loyd testified that: (1) he holds a board certification in general internal medicine; (2) he serves as the Associate Chief of Staff for Education at the Veterans Affairs Medical Center (VAMC) in Johnson City, Tennessee; and (3) he is an associate professor of internal medicine at the James H. Quillen College of Medicine at East Tennessee State University.

Tr. 11, 13. Dr. Loyd testified that he practices medicine at VAMC in both in-patient and out-patient capacities, teaches medical school courses at all levels, trains medical residents, and has been recognized as an expert in other litigation forums. Tr. 14-16, 231-32. He testified that although he handles chronic pain patients, those cases comprise less than ten percent of his patient-base.

Tr. 16. Without objection, Dr. Loyd was received as an expert in the field of internal medicine with an emphasis on proper controlled substance prescribing practices.

Tr. 14-16.

Dr. Loyd's written report was received into evidence.

See

Gov't Ex. 57.

Dr. Loyd testified that the Government was compensating him at a rate of $300.00 per hour for his expertise and testimony. Tr. 232.

Dr. Loyd testified that his duties include both direct patient care and teaching responsibilities. Tr. 218-19, 223-24.

Interestingly, although Dr. Loyd testified that while he treats chronic pain patients, his practice group also refers patients requiring more specialized care out to a medical group that specializes in pain management. Tr. 220-23. In response to a question seeking clarification about his qualifications, Dr. Loyd stated “If you're talking about the medical specialty of pain management, no, I did not practice that. Did I take care of pain patients? Absolutely.” Tr. 221.

Dr. Loyd's CV was received into evidence.

See

Gov't Ex. 55.

Dr. Loyd testified that, when treating patients afflicted with chronic pain, physicians follow a protocol, the first step of which is to identify the chief complaint, or in other words, the patient's own understanding of why they are seeking medical intervention. Tr. 17-19. The second step of the protocol is to ascertain the patient's history regarding the genesis of the chief complaint. Tr. 19-20. A differential diagnosis, that is a list of possible etiologies for the pain symptom(s), comes next, with a review of bodily systems and physical examination, followed by an assessment and treatment plan prepared based on the information acquired by the foregoing process. Tr. 20-24. According to Dr. Loyd, the nature and extent of the physical exam can be affected by the nature of the chief complaint and can be of a more limited nature on subsequent visits. Tr. 23-24.

According to Dr. Loyd, in treating chronic pain, consistent with the guidance set forth in the Pain Control Ladder (PCL) developed by the World Health Organization (WHO), he commences chronic pain treatment with the least addictive medication, which is generally a non-controlled, non-steroidal, anti-inflammatory drug (NSAID). Tr. 25-28. If that level of medication has not proven effective, Dr. Loyd testified that he would “take it up a notch” to the second rung of the PCL, a low-potency opioid analgesic, reserving “the very powerful narcotics, such as oxycodone, OxyContin, [or] Duragesic” for “severe chronic pain.” Tr. 27.

Dr. Loyd also testified that a physician prescribing controlled substances has an obligation to probe for signs of patient addiction, and that this is a process that normally commences with questions deployed while eliciting the patient's history and are designed to flesh out areas of potential concern. Tr. 28-31. Dr. Loyd opined that the questioning becomes more in depth when he is treating a chronic pain case where the utilization of controlled-substance medication may be of longer duration, and that there are identifiable “red flags” of diversion risk that a treating physician should look for. Tr. 31.

A “crescendo pattern of drug use,” defined in his testimony as an increase “in the frequency and strength of the drug over time,” is a phenomenon that Loyd identified as a diversion red flag. Tr. 31-32. Dramatic, overstated, but vague pain complaints, as well as a patient seeking a specific medication by name

are other red flags described by Dr. Loyd. Tr. 33-34. Likewise, patient reports of lost or stolen prescriptions and early requests for refills were also characterized by Loyd as red flags, Tr. 49, as was evidence that a patient has declined to avail himself of treatment recommendations that are not related to controlled substances (e.g., a patient who ignores a recommendation to obtain an MRI or participate in physical therapy), Tr. 59-60. In Dr. Loyd's opinion, monitoring to ensure that patients are not procuring controlled substances from multiple physicians and/or pharmacies, or as Dr. Loyd characterized it, “doctor shopping” and “pharmacy shopping,” is also an important feature of controlled substance prescribing. Tr. 35-36. In that regard, Dr. Loyd testified that Tennessee has had an online prescription monitoring program available for practitioner query since 2008. Tr. 49.

Dr. Loyd acknowledged that his utilization of this phenomenon as a red flag is tempered by the reality that some patients, through experience, can legitimately apprise a treating physician regarding the success of particular medications used in the past in a way that can appropriately inform the doctor's prescribing decisions. Tr. 253.

Dr. Loyd testified that the practice of directing random urine drug screens (UDS) is a tool that should be utilized when prescribing controlled substances. Tr. 34-35. According to Loyd, through the use of UDSs, practitioners can evaluate whether pain patients are taking the medication that has been prescribed to them, which serves the dual purposes of assisting the physician in determining how effective a given drug regimen is in addressing pain symptoms and monitoring for diversion. Tr. 35. Patients who screen positive for illicit substances were described by Dr. Loyd as “very much at risk for suffering from addiction” and need careful monitoring. Tr. 36. Dr. Loyd testified that although a physician could prescribe to a patient who initially presents with positive UDS results for illicit substances (e.g., marijuana or cocaine), evidence of continued use would be grounds to discontinue controlled substance pain medication.

Id.

Dr. Loyd testified that he would be reluctant to prescribe a controlled substance before receiving results from an initial UDS administered to a patient upon intake, but that he would possibly go ahead and issue controlled substances in a case where a patient presented with a cancer diagnosis. Tr. 37.

Loyd testified that, in his opinion, the accepted medical practice is always to address a UDS anomaly with what he characterized as a “confrontation” with the patient to investigate the basis. Tr. 42-44. While Dr. Loyd agreed that a single UDS anomaly was not universally a reason to summarily discharge a patient from his practice, even a single

inconsistent UDS requires exploration of the issue. Tr. 251. In describing the standards at his own practice, Dr. Loyd stated that “at the very least, when you had [a UDS] that was inconsistent, you would investigate.”

Id.

Thus, a suspicious UDS requires a patient confrontation. Furthermore, such a confrontation and its results must be documented in the patient chart. Dr. Loyd put it this way:

If you didn't document it, you didn't do it. That's the standard.

So I may have had a long discussion with my patient and [he] may have told me [he] didn't take [his] medication because [he was] hospitalized and [he] didn't take it for two weeks while [he was] on a ventilator. Very well may have been the case.

If I didn't document it in my chart, then it didn't happen. That is the standard.

Tr. 44 (emphasis supplied);

see also id.

at 50.

Interestingly, Dr. Loyd testified that he is unaware of any recognized standard regarding the frequency with which UDSs should be administered, but in his practice, he directs one at intake, and another upon his perception of a red flag that emerges during the course of treatment. Tr. 48-49.

Dr. Loyd's presentation regarding the accepted standard set within the state of Tennessee for controlled substance prescribing was not without rough spots. The witness initially indicated that there was no acceptable medical practice within the state that he knew of that would provide guidance on how to handle a UDS anomaly. Tr. 39-40. He then retreated from this (otherwise seemingly unequivocal) position by indicating that there was an “[a]ccepted medical practice,” for that issue and others, as described above. Tr. 42. Loyd also acknowledged that he was not aware of any state standard for the definition of chronic pain, Tr. 17, 319-20, and conceded that he was unaware that any standards for prescribing within the state were memorialized in any formal way, Tr. 28. As discussed in some detail,

infra,

there is guidance in Tennessee regarding the utilization and monitoring of pain medication that the Government's expert was unaware of and woefully unprepared to address. In a similar vein, Dr. Loyd conceded that he had no familiarity with the Federation of State Medical Boards'

Model Policy for the Use of Controlled Substances for the Treatment of Pain,

2004 (

Model Policy

), a widely recognized guidance tool utilized by physicians and legislatures nationwide. Tr. 137.

It was also interesting that Dr. Loyd did not outline pain management standards existent within the state of Tennessee, but instead styled the parameters of his critical analysis as “accepted medical practice” that he learned “in [his] training.” Tr. 42. While undoubtedly true that there is an established requirement in legal precedent to tailor analysis of medical practice to standards existent within a state law,

Volkman v. DEA,

567 F.3d 215, 223 (6th Cir. 2009) (citing

Gonzales v. Oregon,

546 U.S. 243, 272, 274 (2006)), the Agency has recently accepted the propriety of “measur[ing] the usual course of professional practice under [the CSA and the regulations] with reference to generally recognized and accepted medical practices.”

Jacobo Dreszer, M.D.,

76 Fed. Reg. 19386 (2011) (quoting

United States v. Smith,

573 F.3d 639, 647-48 (8th Cir. 2009) (internal quotation marks omitted) (citing

United States v. Merrill,

513 F.3d 1293, 1306 (11th Cir. 2008)).

A written report of sorts that was prepared by Dr. Loyd in connection with his review of selected patient charts from the Respondent's practice was also received into evidence. Gov't Ex. 57. As a preliminary matter, it is worthy of note that the format of Dr. Loyd's report was confusing and singularly unhelpful. While a critical objective of securing expert assistance is to aid the trier of fact in analyzing and processing material beyond the ken of the ordinary citizen, Dr. Loyd's report is untitled, unsigned, disorganized, unfocused, and written in a manner that bespeaks a free association narration of documents and other items provided to him by the Government in no particular order. A principal reason for the difficulty in the structure (or lack of it) employed by the report undoubtedly comes from the manner of its genesis. During his testimony, Dr. Loyd explained that the document that was characterized as his “report” was actually a collection of patient chart review summaries that he provided to the lead diversion investigator (DI) on the case “to see what [DEA] thought of my work.” Tr. 53-54. Loyd acknowledged that clerical mistakes are present in the report, owing in his estimation, to his own limited typing skills and misunderstanding of the purpose to which the pages he provided to DEA would be utilized.

Id.

Although undoubtedly true that enhanced communication between expert and proponent could likely have yielded a more refined written product, the submitted pages demonstrated a significant level of analysis regarding the reviewed patient charts.

Its weaknesses notwithstanding, Dr. Loyd's overall presentation as an expert was sufficiently clear, cogent, and well-reasoned to be relied upon in this recommended decision.

The Respondent's Expert

The Respondent presented the testimony of Dr. Thomas Miller, M.D.,

a board-certified anesthesiologist who is also a diplomate of the American Academy of Pain Management.

Tr. 541-41. Dr. Miller, who specializes in pain management and has practiced in that area since 1978, was accepted without objection as an expert in the fields of anesthesiology and pain management. Tr. 543.

Dr. Miller testified that he was being compensated by the Respondent at a rate of $500 per hour for his expertise and testimony. Tr. 544.

Dr. Miller's CV was received in evidence.

See

Resp't Ex. 30.

While, in contrast to Dr. Loyd, Dr. Miller expressed some level of awareness that the Federation of State Medical Boards had adopted a

Model Policy,

he like Dr. Loyd, had no awareness of any pain medication guidance set forth in state statutes. Tr. 591. In some contrast to Dr. Loyd, however, Dr. Miller testified that pain management is the principal focus of his practice. Tr. 544-46. In the course of his testimony, Dr. Miller outlined the steps ordinarily taken regarding chronic pain patient care at intake. During the intake process, Dr. Miller, who does not accept walk-in patients, has each new patient complete pain symptom forms, directs that the patient bring in any current medication(s), explains the parameters and significance of the pain medication contract between doctor and patient, takes vital signs, directs a UDS, conducts a full physical examination, and outlines a treatment plan. Tr. 545-48. Regarding the appropriate use of an intake UDS report that reflects the presence of illicit drugs, Dr. Miller indicated that while he would not automatically refuse to treat every patient who registers positive for illegal drugs, there would be much discussion with such a patient on the issue and that he would schedule an additional urinalysis and explain to the prospective patient that he or she must be clean from illicit drugs prior to treatment. Tr. 549-52. According to Miller, “[T]here's a lot of interaction going on with that patient, but

I simply don't write controlled substances for somebody who has an illicit substance in their urine.”

Tr. 552 (emphasis supplied). When pressed on the issue later in his testimony, Dr. Miller was emphatic that he would not continue to treat a patient who demonstrated illicit drug use on more than one occasion, and indicated that doing so would be

problematic. Tr. 613-14. Dr. Miller testified that he believes that he tests for drugs more often than other pain management specialists because, in his words, “I'm very, very keyed in on trying to identify diverters.” Tr. 556. It is Dr. Miller's practice to inquire of the last time the patient took a dose of his or her prescribed medication prior to the administration of a UDS. Tr. 563. Inasmuch as Dr. Miller is aware of the expected length of time medications will remain in the body and the patient has advised him of the most recent dose taken, there is little room for ambiguity in this evolution regarding the implications of his patients' UDS results. Tr. 563. When a UDS report in Dr. Miller's practice reflects the absence of a controlled substance that his pre-test conversation reveals should have been in the patient's system, his reaction is unequivocal; he stated: “[T]hat's a drug diverter, and I will then alert law enforcement.”

Id.

Miller also explained that where a patient takes medicine in a way that is inconsistent with the terms of the pain medication contract (even with an excuse), that patient is directly told that such a deviation will not be tolerated in the future. Tr. 566. Dr. Miller also endorsed the importance of documenting UDS results, stating as unequivocally as Dr. Loyd, that “

if there's no documentation, then I assume it wasn't done.”

Tr. 593 (emphasis supplied). Furthermore, according to Dr. Miller, “[i]gnoring [UDS] results would be a problem.” Tr. 616. Much as the two experts agreed on the issue of the importance of documentation, Miller's testimony concerning the handling of a UDS anomaly revealed a consonant viewpoint with that of Dr. Loyd. While not referring to the evolution as a “confrontation,” Dr. Miller indicated that upon a UDS irregularity, he would invariably discuss the discrepancy with the patient and document the results of that discussion. Tr. 623-25.

Dr. Miller also testified that, in his practice, reviewing a new patient's prior medical records is a condition precedent to rendering opioid pain management treatment, and that he has insisted on the expeditious acquisition of such records even where the patient's former doctor is hundreds of miles away. Tr. 587-88. Miller observed that, although the charts he reviewed for the Respondent reflected that while the pain management contracts employed at TPA included a provision requiring that past medical records be obtained, “they just didn't follow through with it all the time.” Tr. 588. Miller was clear in stating that he would not rely only on the word of his patient regarding the pain medications and dosages prescribed by former physicians. Tr. 604.

Dr. Miller testified that, at the Respondent's request, he reviewed and evaluated thirty-two of her patient files that were provided to DEA through the Tennessee Medical Board and the Commonwealth's Attorney's Office.

Tr. 567-70. In that regard, Miller testified that in his expert opinion there were both positive and negative features about the Respondent's patient files. Tr. 570. On the positive side, the records reflected histories and physical examinations on intake, as well as indicators that UDS testing was being performed at the practice. Tr. 571. On the negative side, when asked about the presence of prior medical records and imaging reports, Miller could say only that these were “sometimes” present in the charts.

Id.

Dr. Miller indicated that the type of UDS that TPA employed to test for opiates did not measure the presence of oxycodone. Tr. 575-76. Additionally, Miller faulted the Respondent's practice for unevenness in obtaining referral information from the patients, and for “poor documentation” on follow up visits regarding areas such as activities of daily living and aberrant behavior with respect to medication compliance. Tr. 576-78. Furthermore, Dr. Miller criticized the Respondent's practice regarding how well the doctors and staff followed up on diversion red flags once they were enountered. Miller put it this way:

The patient charts that were offered and received into evidence represent a subset of this group.

Sometimes they had a problem that they recognized some substance abuser or that a person had a substance abuse problem, and they recognized that they needed to send [the patient] to rehab, but there's no evidence that the patient actually went to rehab, and they continued prescribing.

Tr. 578.

Based upon his review of the Respondent's patient charts, Dr. Miller also concluded that that one or two patients among those he analyzed were prescribed methadone and OxyContin together, a combination of medications that in Miller's view is unwise. Tr. 584-85, 610-11.

However, Dr. Miller was also of the view that the deficiencies that the Respondent demonstrated regarding her pain management practice were correctable with proper training. Tr. 579-80. Although Dr. Miller testified that the Respondent advised him that she no longer intended to practice pain management,

he also testified that the Respondent visited him for two days at his office and they spent that time reviewing correct controlled medication prescribing practices and monitoring. Tr. 581-83. Miller indicated his willingness to serve as a “practice monitor” for the Respondent in the same manner as he has performed this function in the past for nurse practitioners. Tr. 590-91.

Tr. 615. However, this view is in some conflict with the Respondent's own testimony, wherein she seemed to convey a potential interest to resume practice in the field of pain management when explaining reasons why she wished that DEA would grant her COR application. Tr. 993-94.

Dr. Miller's testimony, while not without its weaknesses, was sufficiently consistent, comprehensive, and founded on material in the evidence of record to be relied upon in the adjudication of this application. Although there were no dramatic differences of significant consequence between his expert opinions and those of Dr. Loyd that impact on consequential issues here, to the extent that conflicts exist, Dr. Miller's depth and breadth of experience in the area of pain management were clearly more comprehensive than that of Dr. Loyd.

The Respondent's Testimony

The Respondent testified that she graduated medical school in Haiti in 1977, acquired subspecialties of pain medicine and anesthesiology, and amassed what can fairly be characterized as an impressive level of experience in those fields. The Respondent apparently practiced medicine for twenty-seven (presumably uneventful)

years prior to her regrettable foray into the Kentucky criminal justice system. Tr. 862, 867. A year after graduation she began residing regularly in the United States and moved to the District of Columbia where she completed her first year of residency at a hospital concentrating in surgery. Tr. 862-63. In 1979, she embarked on three additional years of medical training at Howard University Hospital, the first two of which were focused in the area of anesthesia satisfying her second and third year residency requirements, and the last year which was a fellowship in the dual areas of anesthesiology and obstetrics. Tr. 873. The Respondent testified that she accepted a job offer following her formal

medical training at the formerly-known Meharry-Hubbard Hospital in Nashville, Tennessee, serving a thirteen-year post as the head of the anesthesia department within the division of surgery, from 1982 until 1995. Tr. 863-64. She also had the additional responsibility of teaching classes to medical and dental students as an assistant professor in surgery. Tr. 864. The Respondent explained that she was laid off due to a hospital merger in 1995.

Id.

Brief stints practicing bariatric medicine and anesthesiology at the Orofacial Institute followed, until 1997 when she and Dr. V. Vilvarajah formed TPA,

a practice focused primarily in pain management and secondarily in bariatrics. Tr. 864-65; 882. The Respondent testified to holding medical licenses in three states: an inactive license in Kentucky,

a probated license in Tennessee, and an active license in Florida. Tr. 866-67. She also testified that throughout the time that she practiced pain management, she kept current and abreast of the specialty's progress and evolution by investing considerable time each year into continuing medical education (CME) courses and networking, and that she incorporated the improvements and advances to the field that she learned about into her own practice. Tr. 892-93. By the Respondent's own reckoning, she accumulated twice the minimum CME credits required to maintain her license every three years. Tr. 893.

The Respondent testified that although the Kentucky Medical Board had asked to review patient charts in 2003, no charges resulted from that inquiry. Tr. 929-32. In fact, she stated that she has never been disciplined by any medical board prior to the evolution by the Tennessee Medical Board that caused her license there to be placed on probation. Tr. 866-67.

While the Respondent and Dr. Vilvarajah were married for a brief period, their marriage had dissolved prior to the formation of their business relationship. Tr. 1041-42.

According to the Respondent's testimony, she let her license lapse without renewing it, and it has not been the subject of any disciplinary action. Tr. 866.

As discussed in more detail elsewhere in this recommended decision, her plea of guilty notwithstanding, the Respondent is now and has consistently been resolute in her conviction that she has committed no crime. Tr. 922-24, 1038.

Regarding her medical practice, the Respondent testified that each prospective patient who penetrated the doors of TPA, whether by referral or as a walk-in,

was subjected to a screening process by which their appropriateness for pain management was evaluated and their medical complaint was verified. Tr. 876-80. The medical assistant who scheduled the initial appointment was tasked with notifying the prospective patient that he or she must bring identification to their first visit (

e.g.,

a driver's license), a medical record, past imaging reports, pharmacy profiles, and bottles that held previously-prescribed medications (if any) to their first visit. Tr. 877. The Respondent stated that patients were not automatically accepted into the practice, even with the required documentation, and medical assistants were directed to inform the patients of that policy when arranging the first appointment.

Id.

The Respondent also stated that once the patient arrived at the office for an initial visit, the medical assistant would ensure that he or she was in compliance with the documentation production policy, to wit: “[T]he medical assistant verifie[d] that they ha[d] whatever she asked them to bring.” Tr. 879. It was the Respondent's recollection (at least initially) that seventy percent of all patients coming into TPA were based on referrals from other doctors. Tr. 898-90. The Respondent testified that some patients were screened by the TPA staff and rejected as patients for various reasons,

and sometimes patients were discharged with reports made to law enforcement authorities. Tr. 905-06, 913-14. According to the Respondent, TPA stopped accepting medical insurance and became a cash-only practice in 2006. Tr. 890.

The Respondent testified that while TPA used to advertise in the telephone directory and accepted walk-in patients (who arranged for an appointment by their own devices beforehand) starting in 1997, this was a practice that ceased in 2006. Tr. 876-78.

The Respondent testified that TPA maintained a log book with photocopies of the driver's licenses of prospective patients who were rejected in the course of the intake process. Tr. 905-06. An exhibit that was purported to be photocopies of the contents of the log book was excluded based on foundational and relevance grounds. Tr. 906-13; Resp't Ex. 1 (ID). The evidence does not contradict the Respondent's assertion that some patients were rejected from TPA at intake, and the Government has not contested this premise.

As assertive as her testimony began, the Respondent progressively became more equivocal in how she continued to describe the office's new patient evaluation procedure. The next phase of the protocol that she explained included a face-to-face conversation between the patient and either Dr. Vilvarajah or herself, to allow the physician to observe, among other things, dress, demeanor, and manner of speech.

Id.

The Respondent's portrayal of the protocol shifted from the doctor routinely verifying the authentication of the patient-supplied documents, to “

we see a report of an x-ray, we

may

call that x-ray lab and verify that this x-ray lab is correct.”

Id.

(emphasis added). The Respondent later stated that if she or her partner decided to accept the person as a patient, and caused the initial workup procedures to commence (including taking vital signs, blood work, and a urine screen), that she would “go again over their medical record and

if they [brought] a medical record,

we [would] take from that medical record whatever is pertinent to the patient's problem and have the medical assistant make a copy of [these] document reports.” Tr. 885. (emphasis supplied). When pressed on the issue of why she would ever prescribe controlled substances at an initial visit in a case where the patient declined to furnish his or her prior medical records, the Respondent's equivocation diminished and she asserted that such a practice was “[n]ot [done] without prior medical records [and that] [t]hey ha[d] to have some type of problem, some medical reason why [she] would prescribe to them.” Tr. 898. Such medical justification might be established to the satisfaction of the Respondent with just an MRI (in addition to the patient's complaint and her exam).

Id.

When pressed on the issue of why she did not forbear prescribing until a full medical record was obtained rather than just an x-ray or pharmacy report, the Respondent stated that “some [of her patients did] not have a medical record[, s]o, all they bring is that x-ray,” and testified that she believed that there was not a patient chart in evidence reflecting that the patient lacked a prior medical record or x-ray but yet still received prescriptions for opiates on the first visit. Tr. 899;

see

Tr. 1004 (confirming her policy of not prescribing controlled substances without some form of prior medical record). However, even a perfunctory glance at the charts received into the record reflects that the Respondent's statements in this regard are inaccurate.

See, e.g.,

Gov't Ex. 22 (controlled substance prescriptions issued first visit, MRI report dated same as initial visit and initialed by TPA the

day after

initial visit, no prior medical record); Gov't Ex. 23 (controlled substance prescriptions issued at first visit, two MRI reports for knee and lumbar spine, no prior medical chart); Gov't Ex. 24 (controlled substance prescription issued at first visit, only MRI submitted with sole impression of “[n]o acute osseous abnormality,” no prior medical chart); Gov't Ex. 28 (controlled substance prescriptions issued at first visit, only MRI report dated four years prior, no prior medical chart); Gov't Ex. 31 (controlled substance prescriptions issued at first visit, only prescription label for OxyContin 40 mg and MRI with “[m]ild degenerative changes” as sole impression submitted at first visit, no prior patient chart); Gov't Ex. 32 (controlled substance prescriptions issued at first visit, MRI report dated almost five years prior, single progress

note by former physician over nine months prior, no prior patient chart); Gov't Ex. 33 (controlled substance prescriptions first visit, incomplete record of an initial evaluation by former physician four and a half years prior, no prior patient chart); Gov't Ex. 34 (controlled substance prescriptions issued by Respondent at first visit, chief complaint regarding ribs and knees, one follow up chart note regarding elbow x-ray by previous physician less than two years prior, no prior medical chart); Gov't Ex. 38 (controlled substance prescriptions issued at first visit, no prior medical records); Gov't Ex. 43 (controlled substance prescriptions issued by Respondent at first visit, prior MRI report dated over eight years prior and office visit note by a prior neurosurgeon over eight years prior, no prior medical chart); Gov't Ex. 48 (controlled substance prescriptions issued by Respondent at first visit, no prior medical records); Gov't Ex. 49 (controlled substance prescriptions issued by Respondent at first visit, no prior medical records). Even the Respondent's own expert, Dr. Miller, indicated that past medical records and imaging reports were only “sometimes” in the patient charts. Tr. 571.

This area saw some additional level of exploration during the Respondent's cross-examination. Regarding Patient FH (Gov't Ex. 39), the Respondent recounted that the patient's chief compliant was pain emanating from a broken rib and his knees, and that she prescribed him Lortab, OxyContin, and Xanax at his first visit. Tr. 1004-06.

When confronted that the only prior objective medical evidence furnished by the patient was a record pertaining to an elbow fracture, the Respondent was moved to concede on reflection that “looking at it back, I

probably

gave it to him, this prescription, based on my findings from his broken ribs and his knees.” Tr. 1006 (emphasis supplied). She then further admitted that she failed to follow up, and prescribed controlled substances to FH for four years, grounded almost exclusively based upon a subjective patient complaint. The chart reflects no x-ray or MRI that could have confirmed, refuted, or explained the patient's alleged conditions. The Respondent agreed that upon reflection, her controlled substance prescribing lacked a medical justification. Tr. 1006-07.

The chart reflects that the Respondent failed to take down a patient history reflective of what opioid drugs Patient FH had received in the past, if any, when she prescribed Lortab and OxyContin for the first time.

See

Gov't Ex. 39 at 23, 85-86, 89. This was apparently in spite of FH reporting on his intake form that while he was not currently on any pain medications,

see id.

at 89 (blank line under prompt regarding treatments and medications presently received for pain);

see also id.

at 86 (new patient notes filled in by Respondent), he experienced ninety percent relief in the last day from the pain medications or treatments he was experiencing,

id.

at 89.

During her testimony, the Respondent addressed the manner in which she reacted to UDS anomalies, including how she responded to new patients whose UDS failed to reflect medications they attested to being on, or who subsequently tested negative for drugs prescribed at TPA. According to the Respondent's testimony, it was not uncommon for patients to test negative for substances prescribed, but in those cases she would speak to the patient and document the reason why that was the case. Tr. 894-95. The Respondent recounted numerous justifications she encountered that were connected with UDS result irregularities. Examples included TPA's determination to commence opioid treatment on a new patient at a lesser dose than the patient's former practice, a phenomenon that sometimes resulted in the patient consuming the medications prescribed at TPA at a more rapid pace; another patient who experienced vomiting before providing a urine sample, an event that could result in a reduction of the drug in the system; a patient who was prescribed antibiotics by his or her primary care physician, and was therefore directed by that physican to suspend the taking of TPA's pain medications; a patient who suspended taking controlled prescriptions temporarily on his or her own judgment out of safety concerns associated with impaired driving ability. Tr. 894-96. The Respondent recollected that the TPA's tolerance for prescribing to patients who demonstrated potential drug addiction became more restrictive near the end of 2007. Tr. 1013. However, unlike the more stringent policy of her expert witness, Dr. Miller, the Respondent indicated that TPA would tolerate two UDS stumbles which reflected illicit drug hits. Tr. 1013-15.

The Respondent's assertions to the contrary notwithstanding, the record is replete with instances where the Respondent remained willing to continue to prescribe controlled substances in the face of negative UDS results that should have been positive, with associated charts that were devoid of documentation that might explain the discrepancies.

See, e.g.,

Gov't Ex. 27 (Patient CE); Gov't Ex. 28 (Patient DF); Gov't Ex. 33 (Patient TH); Gov't Ex. 34 (Patient FH); Gov't Ex. 38 (Patient MM); Gov't Ex. 48 (Patient HGW).

The Respondent's handling of this issue during the course of her testimony was not altogether consistent. Upon a representation made by Government counsel that Patient HGW's chart (Gov't Ex. 48) contained twenty instances of individual substances found in drug screen reports that reflected results inconsistent with what was legal or prescribed by TPA (at which point the Respondent admitted that there were at least some inconsistent drug results that she noticed), the Respondent initially disclaimed that her care and prescribing did not fall below the standard of care in Tennessee by responding this way, “For that particular patient, it depends on how you see it.” Tr. 1002-03. But when directed to a page reflecting that she prescribed four separate controlled substances at HGW's next to last visit of four years of treatment, the Respondent agreed that issuing that set of controlled prescriptions after so many red flags did fall below the state standard of care. Tr. 1003.

The Respondent provided detail about additional policies she employed to stem diversion. She testified that when she suspected a patient was engaged in doctor shopping, she would confront the patient, where appropriate verify the treatment with the another treating physician, and in cases where the patient's explanation for a discrepancy panned out, the Respondent testified that it was her custom to offer the patient the option of continuing treatment with her partner. Tr. 1010-11. However, the Respondent later admitted that although Patient RN's chart

reflected exactly this scenario, no such notes were to be found in the file. Tr. 1011-12. The Respondent explained that prospective patients who were unable to produce a pharmacy profile were afforded the option providing prescription bottles, the labels of which would be removed and affixed to the TPA patient chart. Tr. 1009-10. When asked if the patient charts produced at the hearing contained such indicia, she clarified that those patients who lacked profiles in reality only sometimes brought in their bottles. According to the Respondent, she knew that it occurred at least on occasion, inasmuch as she observed bottle labels affixed in several “other charts” not submitted into evidence (of the thirty that were).

Id.

Gov't Ex. 39.

The Respondent stated that TPA switched drug screen analysis methods from immunoassay (IA) to gas chromatography (GC) midway through 2007, because the GC has a more sensitive cutoff and is able to discriminate among naturally-occurring or synthetically-engineered opioid

substances.

See

Tr. 899-902. However, in light of TPA's history of chronic inaction in the face of problematic testing results, enhancements regarding UDS testing bear little relevance on the Respondent's suitability for a registration. Put another way, unreliable results are as easily ignored as reliable ones.

During the course of her testimony, the Respondent conceded that the recordkeeping entries she employed in her patient charts “were not completely adequate,” but ascribed at least some of the blame to the nature of her early training during the 70's and 80's. Tr. 903. The Respondent testified that she now understood how the field had changed over time.

Id.

There was no direct link made by the Respondent between recent developments in examination protocol and her history of seeming indifference to diversion red flags (principally the unresolved UDS result anomalies) that appear throughout the examined patient charts. In the Respondent's estimation, she may have been “duped” by some of her patients in the midst of her endeavors “to take care of these patients with all [her] heart.” Tr. 993-94, 1041.

The Respondent, through her own testimony, submitted into evidence numerous certificates demonstrating the successful participation in CME seminars. Some courses were completed pursuant to the probation status imposed on her by the Medical Board as obligatory terms, while others were undertaken over-and-above the probationary conditions. Tr. 986-87;

see

Tr. 987-92; Resp't Ex. 3 (“Intensive Course in Medical Record Keeping,” June 3-4, 2010) (certificate of attendance only, no credit value indicated); Resp't Ex. 4 (“Prescribing Controlled Drugs,” July 21-23, 2010) (20.75 credits);

Resp't Ex. 7 (“Intensive course in Medical Ethics, Boundaries & Professionalism,” Sept. 2-3, 2010) (22.50 credits); Resp't Ex. 8 (“Topics in Pain Management, Volume 26, Issue 1,” Sept. 20, 2010) (1.50 credits); Resp't Ex. 9 (“Topics in Pain Management, Volume 26, Issue 2,” Sept. 20, 2010) (1.50 credits); Resp't Ex. 10 (“Risk Management Essentials for Physicians, Second Edition, Part I,” October 15, 2010) (5.0 credits); Resp't Ex. 12 (“Controversies in Pain Management, Pain, Dependency, and Addiction,” Nov. 12, 2010) (7.00 credits); Resp't Ex. 13 (“Topics in Pain Management, Volume 26, Issue 3,” Nov. 24, 2010) (1.50 credits); Resp't Ex. 14 (“CME.COM Principles and Practice of Pain Medicine,” Dec. 30, 2010) (27.00 credits).

She also provided a letter, dated August 23, 2010, from Winston C.V. Parris, M.D., a professor of anesthesiology and the Division Chief of Pain Management at Duke Medicine. Resp't Ex. 5. Dr. Parris certified that the Respondent was with him for two weeks in August of 2010, at the Pain and Palliative Care Clinic at Duke University Medical Center.

Id.

During that time, the Respondent observed Dr. Parris's new patient interactions and evaluations, follow-up patient assessments, and performance of interventional procedures.

Id.

In addition to her observations, Dr. Parris verified that the Respondent also “attended all Grand Round lectures and Journal Club” and participated in discussions regarding chronic pain management patients.

Id.; see

Tr. 988-89.

Where indicated, all credits submitted reflect that they are awarded as something counting toward “American Medical Association (AMA) PRA Category 1,” a term that regrettably does not have the benefit of further explanation in the record.

Although unclear as to any relevant purpose it has toward the disposition of her COR application, the Respondent also provided proof as to her attendance in a course on “Domestic Violence: Care and Intervention,” completed as mandatory CME credit for her continued licensure on November 1, 2010. Resp't Ex. 11; Tr. 990.

During the Respondent's testimony, there was no acknowledgement of her own culpability. Consistent with her guilty plea and the surrender of her COR, the Respondent maintained a relatively calm demeanor that lent itself more to one patiently enduring a required procedural evolution than one who has truly acknowledged any measure of wrongdoing or desired to signal acceptance of any measure of responsibility. On the issue of credibility, the Respondent repeatedly acknowledged clear conflicts with admitted documentary evidence of record, and was forced, on multiple occasions, to withdraw from positions she had previously presented without discernible ambiguity. Her position that much of the deficiencies outlined in discharging her obligations were explainable by the time period during which she attended medical residency

flies directly in the face of her extensive and impressive training and experience in the fields of pain management and anesthesiology, and simply stated, is patently implausible. She was also frequently ambiguous in outlining details associated with her patient care. In short, beyond some biographical data and a handful of uncontested topics, the Respondent's testimony was not sufficiently detailed, consistent, or plausible to be deemed fully credible on contested issues in these proceedings.

Tr. 903.

Patient Chart Reviews

DIs Phillips and Stevens both reviewed patient charts that the former had procured from the Tennessee Medical Board and the Commonwealth's Attorney's Office. A subset of ten of the acquired charts were provided to and reviewed by the Government's medical consultant, Dr. Loyd, and the entire group was eventually provided to and reviewed by the Respondent's medical expert, Dr. Miller. By a preponderance, the evidence of record supports the following observations and findings relative to the reviewed patient records.

Patient LC

The LC patient chart

was reviewed by DI Stevens, was received in evidence for review by this tribunal, and was analyzed by Dr. Loyd. Dr. Loyd testified that although his review of LC's chart revealed numerous urinalysis anomalies, there was no evidence of any of the sort of patient confrontations about those anomalies that he indicated were required by his understanding of accepted medical practice.

Tr. 60-61. Loyd also testified that there were other red flags of diversion in the chart, including requests for specific drugs, signs of doctor shopping (to the tune of “eight different providers, utilizing five different pharmacies in a three-month period”),

and a crescendo pattern of controlled substance use that was unsupported by history, physical examination, or imaging. Tr. 63, 65-66. According to Dr. Loyd, these red flags, that were present in the chart, did not receive the required patient confrontation.

Id.

Additionally, a chart note references a possible addiction issue, recommends a formal addiction treatment regimen at an identified facility, but sets forth no measure of documented follow up on the issue. Tr. 66-67. Significantly, Dr. Loyd found that the Respondent continued to prescribe controlled substances to LC even after the UDS anomalies became apparent. Tr. 72. Loyd testified he concluded that the controlled substances prescribed by the

Respondent to LC “were outside the scope of accepted medical practice and not for legitimate medical reasons.”

Id.

In his report, Dr. Loyd summarized his conclusions regarding the Respondent's controlled substance prescribing practices relative to LC as follows:

See

Gov't Ex. 24.

Although Dr. Loyd initially testified that he perceived that the patient's failure to follow up on a physical therapy recommendation also constituted a red flag that did not benefit from a required confrontation, his subsequent acknowledgement that he was unable to ascertain the mechanics of how the recommendation was made or followed up on, sufficiently eviscerated the strength of this observation to deprive it of any appreciable weight. Tr. 58-62.

Tr. 66.

[LC] was prescribed scheduled drugs in quantities and frequency [sic] inappropriate for his complaint or illness. He had dramatic and compelling but vague complaint (10/10 pain) not substantiated by physical exam findings or imaging. He was clearly “doctor shopping.” He had five inconsistent drug screens, several of which were suspicious for diversion. He had a crescendo pattern of drug use with progression to multiple drugs. He requested drugs by name. . . . The controlled substances prescribed in [LC's] case were outside the scope of accepted medical practice and not for a legitimate medical purpose.

Gov't Ex. 57 at 2.

Through his testimony, DI Stevens identified what he believed to be six red flags

of abuse or diversion, five of which were purportedly inconsistent UDS results and one that was a letter reporting suspicion of doctor shopping by a health insurance company. DI Stevens addressed these areas in the LC patient chart chronologically.

A single anomalous UDS may contain multiple anomalies.

The first UDS addressed by DI Stevens' testimony was conducted on August 20, 2003. Tr. 425-26; Gov't Ex. 24 at 64. The results of this UDS reflected values below the cutoff thresholds (negative results) for each of the controlled substance classes tested, including amphetamines, barbiturates, benzodiazepines, cocaine, marijuana, methadone, methaqualone, opiates, phencyclidine (PCP), and propoxyphene. Gov't Ex. 24 at 64; see Tr. 425-26. DI Stevens, who is not a medical professional, testified that he found a prescription in the chart issued by the Respondent on July 23, 2003 (less than a month prior to the UDS) for Percocet, a Schedule II controlled substance that contains oxycodone. Tr. 426; Gov't Ex. 24 at 50 (script photocopy);

see

21 C.F.R. § 1308.12(b)(1)(xiii) (2011). Percocet is a drug that DI Stevens expected to cause a positive result on Patient LC's UDS for opiates.

Notwithstanding this alleged anomaly, which would have been received by the Respondent's clinic some days after the screen, DI Stevens pointed out that Patient LC continued to receive controlled substances in ascending quantities and additional varieties at subsequent office visits, including the first visit after the UDS on October 15, 2003, Gov't Ex. 49 (script photocopy for #84 Percocet 10/325 mg), and another visit on January 6, 2004 by the Respondent,

id.

at 47 (script photocopies for #112 Percocet 10/325 mg and the benzodiazepine #30 Valium 5 mg), without any notation regarding the anomaly to the patient chart, Tr. 427-31;

see also

Gov't Ex. 24 at 17-18 (chart entries dated October 15, 2003 and January 6, 2004 reflecting issuance of same prescriptions as the script photocopies).

DI Stevens testified that the chart note for the October visit, rather than expressing concern over the anomaly, instead observed (counter intuitively) that “patient has no side effects or evidence of addiction.” Tr. 430; Gov't Ex. 24 at 18 (chart entry dated October 15, 2003, “Patient has no side effects or evidence of addiction”);

see also id.

at 17 (chart entry dated January 6, 2004, “No side effects or evidence of addiction”).

During the course of DI Stevens' testimony, it quickly became apparent that he was operating under the assumption that a substance containing oxycodone, like Percocet, should cause a positive on the UDS for opiates if taken as prescribed the month preceding it.

See, e.g.,

Tr. 434-38 (noting the significance that Patient LC tested positive in a later UDS for opiates even though he was not issued a prescription for Percocet a month immediately prior), 460 (commenting the significance of Patient HGW's UDS negative result for opiates even though he obtained prescriptions for Percocet and OxyContin a month prior).

Both parties to this proceeding submitted proposed evidence in the form of photocopies contained in exhibits in advance of hearing that, due presumably to poor or multi-generational photocopying, were found profoundly unintelligible. Prior to hearing, this tribunal issued an advisal to the parties taking notice of this issue, ALJ Ex. 19, and the parties were further advised on the record before the first witness was sworn that these pages would be returned to its respective proponent at the time the balance of the exhibit was offered into evidence, Tr. 5-6, as these pages could not constitute substantial evidence in any shape or form. Throughout the course of the hearing, to cure this problem, the parties identified some problematic portions of their respective proposed exhibits and were afforded the relief of substituting better-quality reproductions. Insofar as proving that prescriptions for controlled substances emanated from the Respondent, the Government also employed the alternative method of relying solely on progress and treatment plan notes entered in the patient chart appearing to have been written by the Respondent's hand when the photocopies of scripts were indiscernible or only partially depicted. This alternative process proceeded without objection by the Respondent, and the Respondent confirmed, through her own testimony, the reliability of prescription notes that Government witnesses claimed were made by her, Tr. 982-83.

DI Stevens testified that a drug screen collected March 3, 2004 indicated Patient LC was negative for all controlled substances including opiates and benzodiazepines, notwithstanding a chart entry reflecting prescriptions issued on February 3, 2004 for Percocet and Valium signed by the Respondent. Tr. 431-33; Gov't Ex. 24 at 17. Again, this information inspired the Respondent to enter a note that there were “[n]o side effects or evidence of addiction.” Tr. 433; Gov't Ex. 24 at 17. However, DI Stevens testified to finding photocopies of additional scripts issued and signed by the Respondent following the March 2004 UDS results. Tr. 433-34; Gov't Ex. 24 at 44;

see also id.

at 16 (chart entry with Respondent's signature dated May 26, 2004 documenting “No side effects or evidence of addiction” and prescriptions for Percocet and Valium).

DI Stevens also noted a September 15, 2004 discrepant UDS report that signaled positive results for the presence of opiates, benzodiazepines, and methadone. Tr. 434; Gov't Ex. 24 at 60. Stevens review of the chart revealed controlled prescriptions only for Percocet and Valium (no methadone) at documented visits occurring before the test, Tr. 435-36; Gov't Ex. 24 at 16 (chart entry dated May 26, 2004 signed by Respondent), and that Patient LC received his first prescription for methadone from the Respondent's practice on the same visit that he first tested positive for the drug, Tr. 436; Gov't Ex. 24 at 15 (chart note), 43 (script photocopy). The chart also shows no controlled substance prescription for the month before the September UDS, and no explanation as to why the patient was not coming in, or whether during his absence from the practice he was receiving controlled prescriptions elsewhere.

See

Tr. 438. According to DI Stevens, this is another example of a drug screen anomaly.

See

Tr. 437-38. A progress note dated September 15, 2004 (a time concurrent with the UDS but before methadone was prescribed) and signed by the Respondent reads, “[Patient] feels that the methadone gives him more profound relief. No side effects or evidence of addiction.” Gov't Ex. 24 at 15. The chart sets forth neither a basis for the patient's knowledge of the advantages of methadone, nor a comment regarding whether and under what conditions (legal or otherwise) LC obtained and tried methadone, nor is any detail provided as to what dosages of methadone were taken by LC and how often. Despite these possible causes for concern (or at the very least grounds for further documentation), DI Stevens testified that he observed evidence within LC's patient chart of controlled substances being prescribed by the Respondent at his next two office visits, on October 13, 2004, for Valium and Percocet, and on November 10, 2004, for Valium and methadone. Tr. 436-37; Gov't Ex. 24 at 15 (chart notes).

The next red flag that DI Stevens identified in his testimony was a report generated by, and accompanied with a

cover letter dated November 19, 2004, from, the insurance company United Health Care, which was found in the LC patient chart and addressed to the Respondent.

Tr. 438-39; Gov't Ex. 24 at 70-71. The report advised that during the third quarter of 2004, eight prescribers individually prescribed an assortment of controlled substances to Patient LC that he filled at five different pharmacies.

Id.

at 70. In its letter, the insurance company “encourage[d]” Respondent to, “if appropriate, use [the report] to modify [Patient LC's] use of narcotic analgesics.”

Id.

at 71. Based upon his experience as a diversion investigator, Stevens believed this information to be demonstrative of doctor shopping on the part of Patient LC. Tr. 439. A chart note reflective of this information was identified by DI Stevens to have been made by Dr. Vilvarajah on December 7, 2004, to wit: “According to UHC [Patient LC] visited 8 MD's, 5 Pharmacies [sic] and obtained 215 days [sic] supply during 7/9/04 through 9/30/04.”

Tr. 439; Gov't Ex. 24 at 13. A hand-scrawled annotation was also identified as the phrase “Correct immediately!” with an arrow pointing to the total number of unique pharmacies reported. Gov't Ex. 24 at 82. Still, DI Stevens identified prescriptions issued by the Respondent approximately one month later on January 5, 2005, for methadone and Valium, notwithstanding the presence of the entries and insurance letter in the chart. Tr. 440; Gov't Ex. 24 at 40. A chart note reflecting these prescriptions was entered by the Respondent immediately below (on the same page as) Dr. Vilvarajah's chart note documenting his doctor shopping reservations. Gov't Ex. 24 at 40.

For reasons non-apparent, the report was dated after the cover letter, November 30, 2004.

Therefore, Patient LC was able to fill enough prescriptions to supply him with 215 days worth of controlled substances in only an 83-day period.

Another anomalous UDS, taken May 25, 2005, was also addressed by DI Stevens' testimony.

See

Tr. 440-42; Gov't Ex. 24 at 59. The results, reminiscent of others discussed

supra,

were negative for all controlled substances tested. Tr. 441-42; Gov't Ex. 24 at 59. Because Patient LC received prescriptions for Valium and methadone at an office visit the month before the test on April 27, 2005, a UDS report that was devoid of these substances would presumably come as a surprise to the treating physician confronting such results. Tr. 441; Gov't Ex. 24 at 12 (chart note). DI Stevens testified that because he expected, based on the controlled substances prescribed the month before the UDS, to see positive showings for benzodiazepines and methadone, this was another example of a red flag of diversion that earned no mention in the progress notes written into the patient chart by the Respondent. Tr. 442-43. Nevertheless, Patient LC received controlled substances issued by the Respondent at the next two office visits for Valium and methadone on June 22 and July 22, 2005, respectively. Tr. 443-45; Gov't Ex. 24 at 11 (chart note), 37 (June 22, 2005 script photocopy for methadone), 36 (July 20, 2005 script photocopies for methadone and Valium).

An UDS that was collected on March 1, 2005 reflected a positive response only for methadone should have raised some level of concern, in view of the fact that the Respondent has prescribed methadone plus Percocet and Valium to LC twenty-eight days prior (February 1, 2006) to the date the urine sample was provided. Tr. 445-46; Gov't Ex. 24 at 56, 32 (script photocopies);

id.

at 12 (chart note). As perceived by DI Stevens, not even passing concern over the apparent inconsistency appears anywhere in the patient chart. Tr. 446-47; Gov't Ex. 24 at 8-9. In spite of the drug screen, the Respondent blithely continued to provide Patient LC with a steady flow of Percocet, methadone, and Valium prescriptions during the course of the next three office visits that followed the UDS results. Tr. 447-48; Gov't Ex. 24 at 30 (script photocopies dated April 26, 2006), 29 (script photocopies dated May 24, 2006), 28 (script photocopies dated June 21, 2006);

see id.

at 7-8 (chart entries reflecting same prescriptions issued by Respondent).

Patient RN

The patient chart

maintained on Patient RN was reviewed by DI Phillips, was received in evidence for review by this tribunal, and was evaluated by Dr. Loyd. Dr. Loyd's report and testimony discussed the controlled substance prescribing practices evident in the patient chart maintained on RN. Loyd noted that although this chart reflected an effective pain assessment history, no alcohol or substance abuse history was taken, and although controlled substances were ostensibly prescribed to address complaints of chronic knee pain, the chart failed to show any physical examination of the knee during the patient's monthly office visits. Gov't Ex. 57 at 7. It was Loyd's view that the upward titrations of controlled pain drugs were implemented “without a history, physical exam or imaging to support the increase in medications.”

Id.

In fact, Loyd testified that he “didn't feel like there was enough [in the chart] to indicate the use of opiate narcotics.” Tr. 163.

See

Gov't Ex. 39.

More fundamentally, Loyd observed that three UDS reports recorded in the chart reflect the absence of controlled substances that had been prescribed to RN and should have been in his system.

Gov't Ex. 57 at 7. The chart reflects that RN eventually was expelled from the practice upon a fourth UDS which showed the presence of cocaine. Gov't Ex. 39 at 4; Gov't Ex. 57 at 7.

Yet Dr. Loyd felt that regarding a positive methadone UDS result, the chart reflected a sufficient inquiry. Tr. 300.

At the conclusion of his assessment regarding the RN patient chart, Dr. Loyd summarized his conclusions as follows:

[RN] was prescribed scheduled drugs in quantities and frequency [sic] inappropriate for his complaint(s)—left knee and low back pain. These complaints were not supported with physical exam findings or imaging. He had no substance abuse history taken. He requested medication by name—Percocet. He had a total of four failed drug tests. He had findings that were consistent with drug diversion that were not followed up on. He had a crescendo pattern of drug use with progression to multiple drugs. . . . The controlled substances prescribed for left knee pain and low back pain in [RN's] case were outside the scope of accepted medical practice and not for a legitimate medical purpose.

Id.

at 7-8.

The Government also elicited some testimony regarding Dr. Loyd's estimation of the relative distance between RN's home and the Respondent's practice, Tr. 159-61, but the issue was not sufficiently developed to merit consideration on any issue to be decided in this case, and like other testimony relative to such distances, played no part in this recommended decision.

In her testimony, DI Phillips presented what she believed to have been five anomalous UDS results evident in RN's patient chart. Among them was a drug screen reporting negative results for all controlled substances a month after opiates and benzodiazepines were prescribed to RN, Tr. 703-06; Gov't Ex. 39 at 14 (chart entry dated August 27, 2005 noting prescriptions for Percocet, OxyContin, and Xanax), 37 (photocopies of same), 50 (UDS report dated September 6, 2005 negative for all substances), and another reflected a positive result for cocaine, Tr. 715-16; Gov't Ex. 39 at 44 (UDS report dated March 24, 2007);

see

Gov't Ex. 39 at 4 (March 31, 2007 chart note by Dr. Vilvarajah reflecting RN positive for cocaine).

Regarding a UDS that popped positive for methadone and opiates, neither of which were ever prescribed by Dr. Vilvarajah, and had not been prescribed for the month prior to the screen by the Respondent, the presence of methadone was addressed by the Respondent as reflected in

a chart note. Tr. 707-08, 710-11, 845-49. The handwritten entry by the Respondent indicated that Patient RN had been admitted to the VA hospital and that the VA administered methadone to RN. Tr. 846-47; Gov't Ex. 39 at 11-12;

see

710-11. Records within Patient RN's file to verify the veracity of her account, or documented efforts to procure them, were absent from the chart. During her testimony, the Respondent acknowledged that RN's chart did not reflect any efforts by anyone at TPA to reach out to the VA hospital to inquire about the alleged methadone prescription. Tr. 1012.

The patient record shows that Dr. Vilvarajah terminated Patient RN from the practice as a consequence for testing positive for cocaine. Gov't Ex. 39 at 3-4.

DI Phillips also pointed to chart indications that Patient RN tested negative for opiates despite prescriptions for oxycodone 40 mg and oxycodone 15 mg a month before the test. Tr. 711-12; Gov't Ex. 39 at 10 (chart entry of prescriptions issued August 12, 2006), 47 (UDS dated September 9, 2006 negative for opiates). DI Phillips' testimony demonstrated that the Respondent's seemingly inexorable response to each anomaly was to provide Patient RN with additional prescriptions for controlled substances.

See, e.g.,

Tr. 707-09, 713-15.

One purported UDS irregularity suggested by DI Phillips relative to the RN chart does not withstand objective analysis. A UDS conducted in connection with RN's initial visit on March 11, 2005 reflects the presence of opiates in RN's system on that date. Tr. 717; Gov't Ex. 39 at 52. DI Phillips concluded that this was problematic based upon the form for new patient notes wherein it signified that RN was not currently on any medications. Tr. 716; Gov't Ex. 39 at 67. While, after it was brought to her attention, DI Phillips conceded that on the same form under “History of Present Illness” prescriptions for OxyContin and Lortab were written, it was her theory that these drugs were presumably taken by Patient RN at some point, but not necessarily contemporary with the initial visit. Tr. 851-53. It was further revealed on cross-examination that Patient RN indicated on one of his intake forms that he was currently receiving oxycodone and Lortab for his pain. Tr. 853-54, Gov't Ex. 39 at 74. Thus, on the current record, the March 11, 2005 UDS report cannot be conclusively found to support a true anomaly requiring additional investigation or confrontation.

Patient BR

The BR patient chart

was reviewed by DI Phillips, was received in evidence for review by this tribunal,

and was evaluated by Dr. Loyd. In his report and testimony, Dr. Loyd noted that pain medications trended upwards, and that the chart contained indications of three UDS reports where BR failed to test positive for controlled substance pain medications that should have been in his system, with no indication that the matter was raised between doctor and patient. Gov't Ex. 57 at 10; Tr. 186-87. The chart also contained a remark that BR was visibly drowsy while standing by for his appointment in the office waiting room, as well as a phone call notation that a pharmacy employee had telephoned to report that on the same day he was nodding off in the waiting room, he had fallen down at the pharmacy. Gov't Ex. 57 at 10; Tr. 188-89. Loyd testified that respiratory suppression is a potential side effect of the controlled substance medications prescribed to BR, Tr. 187, 190, and that, in his expert opinion, simply jotting a note that memorialized these events and conducting no confrontation or follow up is not within the usual course of professional practice, Tr. at 189-91.

See

Gov't Ex. 42.

Compare

Gov't 42 at 54 (Patient BR denies on patient history intake form “nervous breakdown/depression/anxiety”),

with id.

at 52 (patient anxiety documented on new patient notes);

compare id.

at 44 (UDS anomalies positive for marijuana and non-prescribed opiates,

and id.

at 43 (UDS anomalies negative for prescribed opioids and benzodiazepines),

with id.

at 11, 30 (prescriptions afterward by Respondent for OxyContin, Percocet, and Xanax),

and id.

at 11, 29 (same);

compare id.

at 42 (UDS anomaly negative for prescribed opioids),

with id.

at 10, 28 (prescriptions afterward by Respondent for OxyContin, Percocet, and Xanax),

and id.

at 10, 27 (same but substituting methadone for Percocet),

and id.

at 9, 26 (same),

and id.

at 8-9, 25 (same),

and id.

at 8, 24 (same);

compare id.

at 39 (UDS anomalies negative for prescribed methadone and opioids),

and id.

at 7 (chart note by Dr. Vilvarajah that BR tripped and fell in pharmacy day of UDS and that BR was negative for opiates and methadone),

and id.

(chart entry at next visit by Dr. Vilvarajah that BR was notified about the pharmacist call),

with id.

at 6, 21 (prescriptions afterward by Respondent for methadone and Xanax),

and id.

at 6, 20 (same),

and id.

at 5, 18 (same),

and id.

at 4, 17 (same),

and id.

at 3, 16 (same). For reasons discussed elsewhere in this decision, DI Phillips' observations regarding the possible commuting distance for Patient BR that she apparently gleaned from the Internet, Tr. 792-93, has not been sufficiently developed on the present record to be utilized for any purpose in this recommended decision.

Loyd also found a red flag that, although BR's intake paperwork indicated that he was currently taking no medication,

a UDS

performed registered positive for marijuana metabolite and opiates. Tr. 191-93. There was no chart indication that an appropriate confrontation about this issue between physician and patient ever occurred.

Gov't Ex. 42 at 55.

Gov't Ex. 42 at 44.

Dr. Loyd's report set forth the essence of his analysis as follows:

[BR] was prescribed narcotics inappropriately. He had a trauma injury that may have required a controlled substance. However, his urine drug screens were negative for medication that he was being prescribed for his pain. He had a crescendo pattern of drug use with a progression to multiple drugs. . . .

Although Dr. Loyd also mentioned that he attached some level of significance to his observation that BR did not participate in recommended physical therapy, Tr. 185-86, as discussed elsewhere in this decision,

see supra

note 42, this aspect of his review is critically diminished by Loyd's acknowledgement that he is unfamiliar with the office protocol regarding referrals and follow-up. Tr. 58-62. Similarly, although in his report and initial testimony Dr. Loyd felt that the patient's continued ability to pursue physically arduous employment while simultaneously registering complaints of significant pain constituted a red flag, he subsequently retreated from that position. Tr. 195-97.

Gov't Ex. 57 at 10.

Patient MC

The MC chart

was reviewed by DI Phillips, was received in evidence for review by this tribunal,

and was evaluated by Dr. Loyd. Dr. Loyd testified that although chart indicators supported the utilization of controlled substance pain agents, Tr. 83-85, the Respondent incorrectly continued to prescribe controlled substances to MC, even after encountering multiple UDS anomalies with no documentation supporting any evidence that an appropriate patient confrontation took place.

Tr. 78-80. Even though MC's patient chart shows three UDS reports which were negative for opiates that were prescribed, according to Loyd's report, “[t]here were no questions raised as to why the screens were negative and the possibility of diversion was not mentioned.” Gov't Ex. 57 at 3. Based on the uninterrupted controlled substance prescribing without probing confrontation, Dr. Loyd opined that the Respondent's controlled substance prescribing regarding Patient MC was not within the usual course of a professional practice. Tr. 86.

See

Gov't Ex. 25.

Compare

Gov't Ex. 25 at 50 (UDS anomaly negative for prescribed opioids),

with id.

at 13, 37 (prescriptions afterward by Respondent for OxyContin and Percocet with note authored by her “no evidence of addiction”),

and id.

13 (same);

compare id.

at 48 (UDS anomalies positive for PCP and negative for prescribed opioids),

with id.

at 9, 28 (prescriptions afterward by Respondent for OxyContin and Percocet),

and id.

at 9, 27 (same),

and id.

at 8, 26 (same),

and id.

at 7-8 (same);

compare id.

at 47 (UDS anomaly negative for prescribed opioids and note on report by Dr. Vilvarajah remarking same),

with id.

at 6, 22 (prescriptions afterward by Respondent for OxyContin and Percocet and chart entry to “[c]ontinue present pain regime”),

and id.

at 4, 18 (prescriptions same).

While Dr. Loyd testified that he would have preferred to see additional evidence of development of a potential psychological issue stemming from a traumatic event raised by MC's history, Tr. 82-83, 85-86, there was insufficient development of this issue to put it to useful purpose in a disposition of the issues relevant to this case.

Patient MF

The MF patient chart

was reviewed by DI Phillips, was received in evidence for review by this tribunal,

and was evaluated by Dr. Loyd. Dr. Loyd testified that the chart maintained on Patient MF demonstrated both a crescendo pattern

of controlled substance use and multiple UDS anomalies, neither of which received the benefit of an appropriate confrontation conference with the patient.

Tr. 89-94. According to Dr. Loyd's report, the chart showed three UDS reports that were negative for prescribed controlled substances that had been prescribed to [MF] and should have registered positive, and that “[n]o questioning took place as to why these screens didn't show the drugs [MF] was supposed to be taking[,] and the possibility of diversion was not raised.” Gov't Ex. 57 at 4. Regarding a subsequent UDS that reflected a positive result for methadone, a drug that had not been prescribed to Patient MF, the report noted that the patient's explanation that she had fallen out of bed and taken her husband's medication was an unacceptable explanation which only showed a violation of the law and her medication pain agreement.

Id.

See

Gov't Ex. 29.

Compare

Gov't Ex. 29 at 48 (UDS anomalies negative for prescribed opioids and benzodiazepines),

with id.

at 9, 29 (prescriptions afterward by Respondent for OxyContin 20mg, OxyContin 40mg, and Xanax);

compare id.

at 46 (UDS anomaly negative for prescribed benzodiazepines),

with id.

at 5 (chart entry by Respondent “Lab results discussed with patient and copy given. P[atien]t's mother died a w[ee]k ago and the next day after the funeral, her father fell and got a head concussion [illegible] was released yesterday. P[atien]t feel (sic) overwhelmed [with] all these problems.”),

and id.

at 4-5, 21 (prescriptions by Respondent after UDS and concurrent with chart entry for OxyContin, Percocet, and Xanax),

and id.

at 4, 19 (same prescriptions),

and id.

at 3, 17 (same prescriptions).

Dr. Loyd also discussed a letter in the patient chart from MF's attorney detailing an interaction with police wherein her medication was seized, and asking that her medication be replaced. Tr. 95-99; Gov't Ex. 57 at 4. There was some level of confusion regarding the date of the letter, Tr. 280-82, 314-15, and insufficient development of the issue to reliably divine an appropriate utilization of this incident for a relevant issue in the case.

Regarding the Respondent's controlled substance prescribing to MF, Dr. Loyd acknowledged that narcotics were appropriate for this patient based on the chart,

but opined that “[t]he controlled substances prescribed in th[is] case were inappropriate in strength and frequency while obvious signs of misuse of controlled substances were ignored,” Tr. 101.

Tr. 102.

DI Phillips' testimony identified a drug screen report that reflected positive results for methadone and propoxyphene, two substances that were not prescribed to Patient MF by either the Respondent or Dr. Vilvarajah, and a negative result for benzodiazepines, which had been prescribed to MF in the form of Xanax a month prior to the test. Tr. 756-57; Gov't Ex. 29 at 14 (chart entry noting prescriptions issued September 14, 2005), 51 (UDS report dated October 12, 2005). As acknowledged by DI Phillips, in a chart note, the Respondent recorded that she confronted and admonished MF about her unauthorized methadone use. Tr. 841;

see

Gov't Ex. 29 at 13. It was also DI Phillips' testimony that other than reading on to check for patient compliance with the Respondent's warning, she declined to make a judgment call on the sufficiency of the Respondent's actions here,

Tr. 845-46, but did note that there was nothing to indicate that the positive propoxyphene elicited any documented reaction from the Respondent. Tr. 841. Regarding MF's explanation that she took her husband's methadone after a spill out of bed, Phillips opined that beyond Dr. Loyd's estimation that the excuse was wanting, the scenario was not merely indicative of a red flag, but constituted an admission of actual diversion. Tr. 89-90. What is more, as highlighted in the Government's brief and similar to the unexplained presence of propoxyphene, no effort was documented to confront Patient MF regarding the absence of Xanax (which had been prescribed) from her system.

See

Gov't Br. at 17. Later drug screens in the record support the continued practice of the Respondent to prescribe controlled substances to Patient MF in the face of red flags and without raising them with the patient.

Undoubtedly a prudent course in view of her lack of medical training.

Patient TH

The TH chart

was reviewed by DI Phillips, was received in evidence for review by this tribunal,

and was evaluated by Dr. Loyd. In his testimony and in his report, Dr. Loyd observed that the chart maintained on Patient TH reflected several red flags. A UDS administered at the time of intake showed positive for cocaine. Gov't Ex. 57 at 5; Gov't Ex. 33 at 13, 49. The chart does record a confrontation of sorts on this issue, wherein TH apparently explained his use as a method to “deal with the pain.” Gov't Ex. 33 at 13. However, during his testimony, Dr. Loyd explained that while direct application of cocaine could cause some level of local, topical numbing, the ingestion of cocaine has no pain relieving feature. Tr. 289-90. Inasmuch as the offered explanation (that the patient was using cocaine to ameliorate pain symptoms) has no medically reasonable basis, the note documenting the patient's statement in the chart can hardly be reasonably perceived as a valid explanation of a UDS anomaly produced by the investigation of a serious registrant.

See

Gov't Ex. 33.

Compare

Gov't Ex. 33 at 49-50 (UDS anomaly positive for cocaine),

and id.

at 48 (UDS anomalies negative for prescribed opioids and benzodiazepines),

with id.

at 13 (prescriptions afterward by Respondent for OxyContin 20 mg, OxyContin 40 mg, Tylox, and Xanax and chart note by Respondent noting Patient TH took cocaine to try to “deal” with the pain but absence of explanation for negative prescribed opioids and benzodiazepines result),

and id.

at 12 (same),

and id.

at 12, 40 (same),

and id.

at 11, 39 (same);

compare id.

at 45 (UDS anomaly positive for marijuana),

with id.

at 7, 42 (chart entry by Dr. Vilvarajah to repeat UDS because of possible false positive due to TH's denial of marijuana use and claim of taking several antacids, but no verification of claim and drug test not repeated until eight months later; entry also notes that TH should attend substance abuse classes and proof of attendance and completion is expected, but no follow up indicated in chart),

and id.

at 5, 20 (prescriptions afterward by Respondent for OxyContin, Tylox, and Xanax),

and id.

at 4, 19 (same),

and id.

at 3-4, 18 (same),

and id.

at 15 (same).

Dr. Loyd also described a subsequent positive marijuana UDS result, Gov't Ex. 33 at 45, as well as negative drug screens that failed to show the presence of controlled substances the patient had been prescribed, Gov't Ex. 57 at 5; Tr. 104-06. Loyd opined that the chart reflected inadequate follow up measures,

that there was no sign of the required patient confrontation on the issues, and that the prescribing of controlled substances should have been abated upon the second UDS that reflected an illicit substance. Tr. 107. In his report, Dr. Loyd noted a two-year period of treatment that was devoid of physical exams and imaging reports, and noted that

Although a chart entry concerning the positive marijuana result reads, “Takes several antacids possible false (+) will repeat [drug screen],” Gov't Ex. 33 at 7, Dr. Loyd testified that TH's chart did not reflect any prescription for the antacids that could cause false results for the marijuana metabolite. Tr. 107-08. Furthermore, although Dr. Loyd testified that a UDS should have been conducted a month after the positive UDS was discussed with TH, the patient was not retested for marijuana for another seven months. Tr. 110-12; Gov't Ex. 33 at 42.

[d]uring this same two[-]year period [TH] had two other [UDSs] that were inappropriate for the medications that he was being prescribed [one that was]

negative for [benzodiazepines] and opiates—he was supposed to be taking both and [another that was] negative for opiates [that] he was supposed to be taking. No questioning took place as to why these were negative and about the possibility of diversion.

Dr. Loyd corrected a UDS date in his testimony. Tr. 113.

Gov't Ex. 57 at 5.

Dr. Loyd testified that while he takes no professional issue with the decision to prescribe controlled substances based on the chart findings, the prescriptions were not within the usual course of a professional practice in that “[t]he strengths and frequency were inappropriate given the history, physical examination and imaging findings and the [UDSs] being inconsistent [was] ignored. Tr. 102. In his report, Dr. Loyd stated that TH

was prescribed scheduled drugs in quantities and frequency [sic] inappropriate for his complaint or illness. He lacked physical exam findings or imaging results to support the use of chronic narcotics. [TH] had a crescendo pattern of drug use with progression to multiple drugs. He had a history of active illicit drug use—cocaine and marijuana. He had multiple, inconsistent drug screens that were not questioned. The controlled substances prescribed in [TH's] case were outside the scope of accepted

medical practice and not for a legitimate medical purpose.

Gov't Ex. 57 at 5.

Patient RW

The RW chart

was reviewed by DI Phillips, was placed in evidence for review by this tribunal,

and was evaluated by Dr. Loyd. Dr. Loyd's report and testimony addressed his analysis of the chart maintained on Patient RW. Dr. Loyd observed that the intake processes for this patient contained an insufficient history and physical examination and that there was no indication that a substance abuse history was elicited. Gov't Ex. 57 at 12. Loyd noted three UDS results that failed to reflect the presence of controlled substances that had been prescribed and should have been in RW's system.

Id.;

Tr. 210-12.

See Gov't

Ex. 50.

Compare

Gov't Ex. 50 at 34 (UDS anomaly negative for prescribed opioids),

and id.

at 9 (note by Dr. Vilvarajah following that Patient RW tested negative for prescribed medications),

with id.

at 9 (note immediately underneath by Respondent that RW has “[n]o side effects or evidence of addiction [and that RW] takes her medications regularly [and] feels better”),

and id.

at 8, 23 (prescription afterward by Respondent for Percocet),

and id.

at 7, 21 (same with increased dosage units).

The report written by Dr. Loyd summarized his review of RW's chart as follows:

[RW] was prescribed scheduled drugs in quantities and frequency [sic] inappropriate for her complaint or illness. She was prescribed narcotics on the first office visit without alternatives being tried and without a physical exam or imaging to support her complaint. No alcohol or drug history was taken. She requested drugs by name—Oxycodone, Hydrocodone. She had urine drug screens that were inconsistent with the medication that she was being prescribed multiple times per day. The controlled substances prescribed in [RW's] case were outside the scope of accepted medical practice and not for a legitimate purpose.

Govt' Ex. 57 at 12;

see also

Tr. 212-13.

Patient LS

The chart

maintained on Patient LS was also reviewed by DI Stevens, was received in evidence for review by this tribunal,

and was analyzed by Dr. Loyd in his report and in his testimony. Dr. Loyd noted that the LS patient chart evidenced three UDS reports reflecting negative results for controlled substance medications that had been prescribed, which should have been in the patient's system, and which did not inspire any manner of confrontation or inquiry. Gov't Ex. 57 at 11; Tr. 202-05. Loyd also found it significant that the level of controlled substance medication remained stagnant for three years without benefit of further physical examination or imaging.

Id.

See

Gov't Ex. 44.

Compare

Gov't Ex. 44 at 69 (UDS anomaly negative for prescribed opioids),

with id.

at 13, 39 (prescriptions afterward by Respondent for OxyContin, Percocet, and Xanax),

and id.

at 12 (same);

compare id.

at 66 (UDS anomaly negative for prescribed opioids),

with id.

at 11, 36 (prescriptions afterward by Respondent for OxyContin, Percocet, and Xanax and chart entry documenting that drug screen results were discussed and a copy of the report was given to LS),

and id.

at 9, 31 (prescriptions same),

and id.

at 8, 30 (same),

and id.

at 7-8, 29 (same);

compare id.

at 65 (UDS anomaly negative for prescribed opioids),

with id.

at 7, 28 (prescriptions afterward by Respondent for OxyContin, Percocet, and Xanax),

and id.

at 5, 26 (same),

and id.

at 5, 25 (same),

and id.

at 4, 23-24 (same),

and id.

at 3-4, 22 (same).

Although Dr. Loyd testified that in his view the level of the patient's complaints seemed inconsistent with his perceived severity of the MRI results, Tr. 199-200, it would be difficult (and in this case unnecessary) to tease out where his testimony in this regard constitutes a potential good-faith professional difference of medical opinions, from a departure from a registrant-related duty to minimilegitimate prescriptions. The latter concern is a proper focus of ze diversion by issuing only these proceedings, while the former presents an issue for a different venue. 21 C.F.R. § 1306.04(a);

see Gonzales v. Oregon,

546 U.S. 243, 270 (2006) (explaining that the CSA grants the Attorney General authority to regulate the practice of medicine “insofar as it bars doctors from using their prescription-writing powers as a means to engage in illicit drug dealing and trafficking as conventionally understood [not the power] to regulate the practice of medicine generally”). Dr. Loyd's testimony that he would have commenced treatment of LS with an NSAID, Tr. 201-02, warrants like consideration.

In his report, Dr. Loyd set forth his view on the controlled substance prescribing as follows:

[LS] was prescribed scheduled drugs in quantities and frequency [sic] inappropriate for her illness. She had no physical exam findings or imaging to support the use of chronic narcotics. She was started on controlled substances, multiple, [sic] on the first office visit without alternatives being tried. . . Her complaint was dramatic and compelling, 9/10 pain, and was not supported with history, physical exam findings or imaging. She had three separate urine drug screens that were inappropriate for the medications that she was being prescribed indicating that she was not taking them as prescribed and raising the possibility of diversion. The controlled substances prescribed in this case were outside the scope of accepted medical practice and were not for a legitimate medical purpose.

Gov't Ex. 57 at 11;

see

Tr. 207.

Patient FH

The patient chart

maintained on Patient FH was reviewed by DI Stevens, was placed in evidence for review by this tribunal,

and was analyzed by Dr. Loyd. In his report and testimony, Dr. Loyd noted that FH's chart reflects seven UDS reports that did not contain the controlled substance opioids and benzodiazepines that the patient had been prescribed, and no sign of the appropriate doctor-patient confrontation that should have occurred based on those incidents. Gov't Ex. 57 at 6; Tr. 134-37. Although a potentially painful rib fracture was among the possible etiologies of the pain symptoms, FH declined to obtain the chest x-ray directed by the Respondent. Tr. 129. Furthermore, Dr. Loyd testified that his review of the chart did not reveal “anything from the history, the physical examination or imaging to support . . . a narcotic analgesic at any dose.” Tr. 129.

See

Gov't Ex. 34.

Compare

Gov't Ex. 34 at 78 (UDS anomalies negative for prescribed opioids and benzodiazepines and positive for non-prescribed propoxyphene),

and id.

at 76 (UDS anomalies negative for prescribed opioids and benzodiazepines,

and id.

at 75 (UDS anomalies negative for prescribed opioids and benzodiazepines),

with id.

at 14, 47 (prescriptions afterward by Respondent for OxyContin, Lortab, and Xanax),

and id.

at 14, 46 (same);

compare id.

at 73 (UDS anomalies negative for prescribed opioids and benzodiazepines),

and id.

at 72 (UDS anomalies negative for prescribed opioids and benzodiazepines),

with id.

at 10, 38 (prescriptions after by Respondent for OxyContin, Lortab, and Xanax),

and id.

at 10 (same),

and id.

at 9 (same),

and id.

at 9, 36 (same);

compare id.

at 70 (UDS anomalies negative for prescribed opioids and benzodiazepines),

with id.

at 8, 34 (prescriptions afterward by Respondent for OxyContin, Lortab, Xanax),

and id.

at 32 (same),

and id.

at 30 (same),

and id.

at 6 (same with chart entry by Respondent “Lab results discussed [with patient] and copy given. [Patient] states that he takes [

sic

] “runs out” his medications every [month]. . . . No side effects. [Patient] aware that he must take his medication of to [

sic

] his visit to TPA. Will reject random [drug screen].”),

and id.

at 6, 29 (same prescriptions),

and id.

at 5, 28 (same),

and id.

at 5, 27 (same),

and id.

at 4, 25 (same).

In his report, Dr. Loyd provides the following summary regarding his chart analysis:

[FH] was prescribed controlled substances in quantities and frequency [sic] inappropriate for his illness. He was prescribed narcotics on the first office visit. He lacked physical exam findings or imaging to support the indication of controlled substances.

He had a crescendo pattern of

drug use with progression to multiple drugs. He seemed to have no interest in his diagnosis as he didn't follow up and obtain a chest x-ray. He had seven inconsistent urine drug screens. The controlled substances prescribed in [FH's] case were outside the scope of accepted medical practice and not for a legitimate medical purpose.

Although Dr. Loyd testified that, consistent with the guidance provided in the WHO Ladder, he would have initiated a course of NSAIDs, Tr. 118-21, there is no basis on the current record upon which this apparent difference of medical opinion can be construed to reflect positively or negatively on whether the Respondent failed in some way to discharge her duties as a DEA registrant to minimize the risk of diversion and issue controlled substance prescriptions for a legitimate medical purpose and within the course of a professional practice.

See

21 C.F.R. § 1306.04(a);

Gonzales v. Oregon,

546 U.S. 243, 270 (2006) (explaining that the CSA grants the Attorney General authority to regulate the practice of medicine “insofar as it bars doctors from using their prescription-writing powers as a means to engage in illicit drug dealing and trafficking as conventionally understood [not the power] to regulate the practice of medicine generally”). This is a difference, albeit a nuanced one, from Dr. Loyd's conclusion that the objective imaging, information, and documented observations

in the chart do not support the utilization of controlled substances.

Gov't Ex. 57 at 6. During his testimony, Dr. Loyd affirmed his view that the controlled substance prescribing practices demonstrated in LC's chart were outside the scope of accepted medical practice, were not for a legitimate medical purpose, and were not within the usual course of a professional practice. Tr. 141-42.

Patient DP

Dr. Loyd's report and testimony also outlined his review of the patient chart

maintained on DP. Loyd's assessment was that DP's medical history, which included a right-leg crush injury (from a 500-pound boulder), multiple resultant surgeries, and reflex sympathetic dystrophy (described by Loyd as “very painful and debilitating”), Tr. 171, justified the utilization of controlled pain medication. In fact, Dr. Loyd's report contains his conclusion that “[t]he narcotics prescribed in [DP's] case were for a legitimate medical condition and [] were used within the scope of accepted medical practice.” Gov't Ex. 57 at 9.

See

Gov't Ex. 41.

That said, Dr. Loyd also noted that the chart contained three UDS reports which reflected that prescribed controlled pain medications that should have been present in DP's system were not, and that the chart is devoid of any indication that the patient was confronted about a single one.

Id.;

Tr. 172-73, 176.

The Government also elicited some testimony regarding Dr. Loyd's estimation of the relative distance between DP's home and the Respondent's practice, Tr. 181-82, but the issue was not sufficiently developed to merit consideration on any issue to be decided in this case, and like other testimony relative to such distances, played no part in this recommended decision.

Patient ES

DI Phillips also presented testimony regarding her review of the patient chart

maintained on Patient ES. Phillips testified that she identified six anomalies connected to UDSs reports in the ES chart. Among those anomalies were testing positive for marijuana while testing negative for all other substances, including benzodiazepines and opiates following prescriptions for Xanax and two strengths of OxyContin, Tr. 722-23; testing negative for all substances, including those prescribed (twice), Tr. 725, 733-34;

testing positive for methadone without a prescription from the Respondent's practice, Tr. 728-29; testing negative for benzodiazepines following a prescription for Xanax, Tr. 731-33; and testing negative for opiates after being prescribed two forms of oxycodone, Tr. 739-40.

Consistent with the aforementioned anomalies, Patient ES was supplied with prescriptions for controlled substances following them.

See

Tr. 724-30, 733, 735-45.

See

Gov't Ex. 43.

At the visit following an all-negative drug screen on July 21, 2004, the Respondent entered the following concurrent observations in the patient chart, dated August 18, 2004, that Patient ES is “very anxious” due to a divorce evolution and “‘runs out' of [medication] 3-4 days before visit,” but that he also evidences “[n]o side effects or evidence of addiction.” Gov't Ex. 43 at 23. These assertions along with the negative drug screen, coexisting in somewhat of a tension with the Respondent's duties as a registrant charged with detecting addiction to those she prescribes controlled substances and verifying red flags, was noticed by the Government in its brief.

See

Gov't Br. at 11 n.13.

Patient ES's medical chart reflects numerous prescriptions for the drug Adipex, which is a brand of phentermine, a Schedule IV controlled substance, prescribed to ES for weight loss. 21 C.F.R. § 1308.14(e)(9) (2011);

see, e.g.,

Gov't Ex. 43 at 20. For reasons that were not established at hearing or otherwise, the Government did not address these prescriptions in its case. Accordingly, they will play no role in the determination that must be made through this recommended decision.

Patient HGW

DI Stevens reviewed the patient chart

100

of HGW. DI Stevens identified nine UDS that contained anomalies, Gov't Ex. 48 at 161 (dated February 14, 2003), 160 (dated March 14, 2003), 159 (dated April 11, 2003), 157 (dated October 28, 2003), 148 (dated May 19, 2004), 147 (dated March 29, 2005), 146 (dated May 24, 2005), 145 (dated November 10, 2005), 142 (dated May 25, 2006), and one phone message dated December 21, 2005 from another pain management clinic seeking verification of information pertaining to Patient HGW as a new patient (indicating that HGW was doctor shopping on the Respondent's practice),

101

id.

at 15;

see generally

Tr. 449-75. Anomalies were identified by DI Stevens within each drug screen, yet the Respondent, undeterred, continued to supply the patient with increasing quantities and varieties of controlled substances. For instance, at the first visit, Patient HGW represented that he was not on any medications at all, Tr. 452; Gov't Ex. 48 at 181, yet his drug test came back with positive results for cocaine, marijuana, opiates, and benzodiazepines, Tr. 450; Gov't Ex. 48 at 161-62. HGW was tested again the next month (March 14, 2003) and a second positive marijuana result appeared on the drug screen report. Tr. 453; Gov't Ex. 48 at 160. The Respondent, despite both of these red flags, prescribed Percocet and Xanax on July 31, 2003. Tr. 458; Gov't Ex. 48 at 130. In all, Patient HGW tested positive for marijuana four times while at the Respondent's practice.

See

Tr. 461; Gov't Ex. 48 at 148 (May 19, 2004 UDS), 147 (March 29, 2005 UDS). There were even times identified in the HGW patient chart by DI Stevens that the Respondent continued to prescribe controlled substances following UDS results that were negative for all substances tested.

See, e.g.,

Tr. 467, 469-70.

Compare,

Gov't Ex. 48 at 100-01 (prescriptions dated October 8, 2004 for OxyContin, Xanax, and Percocet),

and

145 (UDS dated November 10, 2005 reporting negative results for all substances examined),

with

71 (controlled prescriptions issued December 8, 2005 by Respondent for OxyContin, Percocet, Xanax, and Halcion),

and

15 (chart note dated December 8, 2005 reflecting issuance of controlled prescriptions, but silent regarding UDS anomaly). Even though each of these anomalous drug screens were noted in the patient chart, the Respondent doled out prescriptions for controlled substances to HGW after almost every one.

100

See

Gov't Ex. 48.

101

Receiving prescriptions for controlled substances from other physicians was a violation of HGW's pain management contract with the Respondent. Gov't Ex. 48 at 178, para. 9.

Additional Patient Charts

Other medical files were addressed by DI Phillips' testimony in an expedited fashion and were subjected to this tribunal's examination. According to Phillips, her review of each of these charts revealed that the Respondent continued to prescribe controlled substances without resolving UDS irregularities that presented red flags in need of further investigation or inquiry. This list of additional charts reviewed incorporated patients CE (Gov't Ex. 27),

102

DF (Gov't Ex. 28),

103

EJ (Gov't Ex.

35),

104

TK (Gov't Ex. 36),

105

TP (Gov't Ex. 40),

106

DP (Gov't Ex. 41),

107

and SY (Gov't Ex. 52).

108

102

Compare

Gov't Ex. 27 at 24 (UDS anomalies negative for prescribed opioids and benzodiazepines and initialed by Respondent),

and id.

at 7 (chart entry by Respondent noting CE tested negative for her prescribed medications),

with id.

at 6, 14 (prescriptions afterward by Respondent for Lortab and Xanax),

and id.

at 6 (same),

and id.

at 5, 13 (same),

and id.

at 5, 12 (same),

and id.

at 4 (same),

and id.

at 4 (same).

103

Compare

Gov't Ex. 28 at 37 (UDS anomaly negative for prescribed opioids),

with id.

at 8, 26 (prescriptions afterward by Respondent for OxyContin, Percocet, and Xanax and chart entry by Respondent “no evidence of addiction”),

and id.

9, 25 (same),

and id.

at 10, 21 (same),

and id.

at 11, 20 (same).

104

Compare

Gov't Ex. 35 at 54 (pharmacy report supplied by Patient EJ, OxyContin 80 mg absent),

with id.

at 57 (new patient notes documenting purported prescription by prior practitioner for OxyContin 80 mg);

compare id.

at 59 (patient history intake form indicating Patient EJ denied “nervous breakdown/depression/anxiety”),

with id.

at 57 (new patient notes documenting complaints of anxiety and insomnia);

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