Bobby D. Reynolds, N.P., Tina L. Killebrew, N.P. and David R. Stout, N.P.; Decision and Orders, 28643-28667 [2015-12038]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 80, Number 96 (Tuesday, May 19, 2015)]
[Notices]
[Pages 28643-28667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12038]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Bobby D. Reynolds, N.P., Tina L. Killebrew, N.P. and David R. 
Stout, N.P.; Decision and Orders

    On November 25, 2013, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued Orders to 
Show Cause to Bobby D. Reynolds, N.P. (hereinafter, Reynolds), of 
Limestone, Tennessee; Tina L. Killebrew, N.P. (hereinafter, Killebrew), 
of Kingsport, Tennessee; and David R. Stout, N.P. (hereinafter, Stout), 
of Morristown, Tennessee. GXs A, B, & C.
    With respect to Applicant Reynolds, the Show Cause Order proposed 
the denial of his application for registration as a practitioner, on 
the ground that his registration ``would be inconsistent with the 
public interest'' as evidenced by his repeated violations of state and 
federal law in prescribing controlled substances to seven patients 
while employed as a nurse practitioner at the Appalachian Medical 
Center (AMC), a clinic located in Johnson City, Tennessee. GX A, at 1-2 
(citing 21 U.S.C. 823(f)(2), (4) & (5)). The Show Cause Order alleged 
that he had made unintelligible entries in the medical records of three 
patients (N.S., T.H., and A.W.), that he had violated state law by 
referring N.S. to an unlicensed mental health counselor, that he had 
violated state law by making false entries in N.S.'s chart, that he had 
failed to maintain complete records for T.H., and that he failed to 
properly maintain the patient record of C.S. to accurately reflect 
nursing problems and interventions. GX A, at ]] 5, 6, 7, 11, 12, and 
15.
    With respect to Applicant Killebrew, the Show Cause Order proposed 
the denial of her application for registration as a practitioner, on 
the ground that her registration ``would be inconsistent with the 
public interest'' as evidenced by her repeated violations of state and 
federal law in prescribing controlled substances to three patients 
while employed as a nurse practitioner at the AMC. GX B, at 1-2 (citing 
21 U.S.C. 823(f)(2)(4) & (5)).
    With respect to Registrant Stout, the Show Cause Order proposed the 
revocation of his practitioner's registration and the denial of his 
pending application to renew his registration on two grounds. GX C, at 
1-2. First, the Order alleged that Respondent had materially falsified 
his renewal application when he failed to disclose that on March 10, 
2010, the Tennessee Board of Nursing had summarily suspended his nurse 
practitioner's license and his Certificate of Fitness to prescribe 
legend drugs in Tennessee. GX C, at 13-14; see also 21 U.S.C. 
824(a)(1). The Show Cause Order further alleged that Registrant Stout 
had failed to disclose that on September 3, 2010, he had entered into a 
Consent Order with the State Board, pursuant to which the suspension 
was terminated, but he was placed on probation for two years, his 
multistate privilege to practice in other party states was voided for 
the period of his probation, he was ordered to pay a civil penalty of 
$8,000, and other probationary terms were imposed. GX C, at 14. Second, 
the Show Cause Order alleged that Registrant Stout had ``committed such 
acts as would render his registration inconsistent with the public 
interest,'' in that he had violated state and federal law in 
prescribing controlled substances to five patients while employed as a 
nurse practitioner at the AMC.\1\
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    \1\ Each Show Cause Order made extensive and detailed 
allegations specific to each Applicant's conduct, as well as to 
Registrant Stout's conduct, in prescribing to the various patients. 
See GX A, at 2-26 (Reynolds OTSC); GX B, at 2-9 (Killebrew Order); 
GX C, at 2-14 (Stout Order). In its Request for Final Agency Action, 
the Government pursued only the allegations of unlawful prescribing 
by the three practitioners, as well as the allegations (which were 
raised in its prehearing statements) that Applicant Reynolds had 
made material false statements to a DEA Investigator.
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    Following service of the Show Cause Orders, all three individuals 
timely requested a hearing on the allegations of the respective Order. 
The matters were then placed on the docket of the Agency's Office of 
Administrative Law Judges, and assigned to the Chief Administrative Law 
Judge, who consolidated the matters and proceeded to conduct prehearing 
procedures. However, after extensive prehearing litigation, each of the 
parties filed written notices waiving his/her respective right to a 
hearing, see GXs LL, MM, and PP, and the ALJ terminated the 
proceeding.\2\
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    \2\ On March 27, 2014, NP Stout, through counsel, submitted a 
written request to the Government's counsel seeking to withdraw his 
application to renew his registration. GX RR. Government Counsel 
promptly forwarded the request to the Deputy Assistant 
Administrator. GX SS. According to Government Counsel, no action had 
been taken on the request as of September 16, 2014, the date on 
which the record was forwarded to this Office. Id. Nor has this 
Office been subsequently notified of any action having been taken on 
the request.
     I conclude that granting Stout's request to withdraw would be 
contrary to the public interest and that he has otherwise failed to 
show good cause. Here, the Government has expended extensive 
resources in investigating the allegations, preparing for a hearing, 
and in engaging in pre-hearing litigation; it was also fully 
prepared to go to hearing on the allegations when Stout waived his 
right to a hearing. Moreover, Stout's counsel has made no offer as 
to how long he would wait before reapplying. See GX RR (``This 
proposal is in the public's interest because it saves time and money 
for valuable employees and staff. There will be no need to review 
documents, there will be no need to issue decisions and there will 
be no delay in Mr. Stout being able to show his good faith in hopes 
of someday being able to reapply.''). Finally, having reviewed the 
evidence, I conclude that the public interest would be ill-served by 
allowing him to withdraw his application and thereby avoid the 
findings of fact and conclusions of law which are clearly warranted 
by the evidence.

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[[Page 28644]]

    Thereafter, the Government filed a Request for Final Agency Action 
and forwarded the entire record to my Office for review. Having 
reviewed the entire record, I find that the Government has established 
that Registrant Stout has committed such acts as would render his 
registration ``inconsistent with the public interest.'' 21 U.S.C. 
824(a)(4). Accordingly, I will order that the registration issued to 
Registrant Stout be revoked and that his pending application to renew 
his registration be denied. I further find that the Government has 
established that granting a new registration to Applicants Reynolds and 
Killebrew would be ``inconsistent with the public interest.'' Id. Sec.  
823(f). Therefore, I will also order that their respective applications 
be denied. I make the following findings of fact.

Findings

Jurisdictional Facts

    In 2002, Applicant Bobby D. Reynolds II, FNP, founded the 
Appalachian Medical Center, a clinic located in Johnson City, 
Tennessee; Reynolds owned the clinic until 2010, when it was closed. GX 
42, at 2-3. Reynolds employed both Applicant Killebrew and Registrant 
Stout at AMC. Id.
    Reynolds was previously registered under the Controlled Substances 
Act as a Mid-Level Practitioner, with authority to dispense controlled 
substances in schedules II-V at the registered address of the AMC, 
which was located at 3010 Bristol Highway, Johnson City, Tennessee. GX 
1, at 1. However, this registration expired on April 30, 2011. On May 
19, 2011, Reynolds filed a renewal application; it is this application 
which is the subject of the Show Cause Order issued to him. Id.
    Tina L. Killebrew, F.N.P., was employed as a nurse practitioner at 
AMC from approximately June 2006 through March 11, 2010. GX L, at 13-14 
(Brief in Response to Amended Order December 30, 2013). She was also 
previously registered as a Mid-Level Practitioner with authority to 
dispense controlled substances in schedules II-V at AMC's address. Id. 
at 11. However, this registration expired on December 31, 2010. On or 
about August 30, 2011, Killebrew submitted an application for a new 
registration; it is this application which is the subject of the Show 
Cause Order issued to her. Id.
    David R. Stout, N.P., currently holds DEA Certificate of 
Registration MS0443046, pursuant to which he is authorized to dispense 
controlled substances in schedules II-V as a Mid-Level Practitioner at 
the registered address of the AMC. GX 1, at 6. While his registration 
was due to expire on February 28, 2011, on February 16, 2011, Stout 
filed a renewal application. Accordingly, his registration remains in 
effect pending the final order in this matter. Id.

The Government's Evidence of Misconduct

    In support of the allegations, the Government submitted patient 
files for seven patients, pharmacy records for four patients, along 
with various other documents. The Government also provided these 
materials to Amy Bull, Ph.D., a Board Certified Family Nurse 
Practitioner, who is licensed in Tennessee as both an Advanced Practice 
Nurse and Registered Nurse. GX 40, at 2-3. Dr. Bull is an Assistant 
Professor of Nursing at the Belmont University School of Nursing and 
previously taught at the Vanderbilt University School of Nursing, where 
she served as Director of the Family Nurse Practitioner Program, was 
the coordinator for courses in Advanced Pharmacotherapeutics and Health 
Assessment & Diagnostic Reasoning, and taught various courses. Id. at 
1. Dr. Bull also continues to practice as a Nurse Practitioner at a 
clinic in Dickinson, Tennessee. Id. at 2.
    Dr. Bull reviewed seven patient files. GX 68, at 6-7. Based on her 
review, Dr. Bull concluded that Reynolds, Killebrew, and Stout acted 
outside of the usual course of professional practice and lacked a 
legitimate medical purpose in prescribing controlled substances to the 
patients, see 21 CFR 1306.04(a), and also violated Tennessee Board of 
Nursing Rule 1000-04.08, which sets forth the standards of nursing 
practice for prescribing controlled substances to treat pain. Id. at 7-
8. Dr. Bull specifically found that Reynolds, Killebrew and Stout 
``repeatedly issued prescriptions . . . in the face of red flags that 
should have indicated to him [or her] that these individuals were 
abusing and/or diverting controlled substances and without taking 
appropriate action to prevent further abuse and/or diversion,'' and 
that in doing so, ``their conduct fell far below the standard of care 
in Tennessee and [was] contrary to generally recognized and accepted 
practices of a nurse practitioner in Tennessee.'' Id. at 8. What 
follows below is a discussion of the evidence with respect to patients 
N.S., T.H. and C.S.

N.S.

    N.S.'s first visit to AMC was on June 8, 2004, when she presented 
complaining of neck and back pain. See GX 2, at 102. N.S. apparently 
was seen on this visit by a practitioner other than Mr. Reynolds,\3\ 
Mr. Stout, or Ms. Killebrew. See GX 3, at 129-130. This practitioner 
specifically noted that N.S. had a ``tender neck and low back with 
decreased range of motion, low back tender to light touch'' and 
prescribed a thirty-day supply of thirty tablets of Avinza 60 mg 
(morphine, a schedule II drug), as well as Zanaflex, which is a non-
controlled muscle relaxant. See GX 2, at 102; GX 3, at 129.
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    \3\ According to the Expert, while Mr. Reynolds did not see N.S. 
at her June 8, 2004 visit, he had clearly reviewed the record of 
this visit as at the bottom of the visit note, there is a 
handwritten marking which, based on her review of the patient files, 
the Expert determined was the signature, or abbreviated signature of 
Reynolds. See GX 2 (ID) at 102; GX 68, at 10.
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    According to the Expert, the documentation contained in N.S.'s file 
did not support the prescribing of a thirty-day supply of Avinza 60 mg 
and the prescription was below the standard of care in Tennessee and 
outside the usual course of professional practice. GX 68, at 8. As the 
Expert noted, N.S.'s file contains radiologic reports (CT scans and 
plain radiographs of the neck and lower back) from June 28, 2001 which 
appear to have been generated in connection with N.S.'s prior visit to 
the emergency room (``ER'') due to a motor vehicle collision and which 
described previous surgery to the neck and degenerative changes in the 
lower back. See id. at 8-9; GX 2, at 116-120.
    However, as the Expert then explained, these records were from 
examinations that were performed nearly three years before N.S.'s first 
AMC visit. GX 68, at 9. The Expert then observed that N.S.'s file 
lacked any documentation indicating what, if any, treatment she had 
received since the accident, nor contain any records of any prior 
treating physicians, nor any documentation relating to her substance 
abuse history. Id. Of further note, the Expert observed that N.S. did 
not list any medication she was then taking on the ``New Patient 
Information Sheet'' which she apparently completed at her first visit, 
see GX 2, at 9-10; and the record of her first visit does not document 
the she was taking any medications. Id. at 102; GX 68, at 9.

[[Page 28645]]

    According to the Expert, the absence of this information in the 
file indicates that the AMC practitioner did not know what, if any, 
controlled substances N.S. was then being prescribed, her complete pain 
history, whether she was suffering from any coexisting diseases or 
conditions, who her prior treating physicians were, whether she had 
ever tried non-controlled substances, or whether she had ever received 
other treatment modalities to address her reported pain, such as 
physical rehabilitation. GX 68, at 9. The Expert then concluded that 
absent this information, N.S. should not have been issued a controlled 
substance prescription on her first visit, especially a schedule II 
controlled substance such as Avinza, which is a long-acting formulation 
of morphine. Id. The Expert further explained that if a controlled 
substance such as Avinza had been indicated, the starting adult dose 
would have been only 30mg daily (rather than 60mg which was 
prescribed).\4\ Id.
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    \4\ The Expert acknowledged that as of the date of N.S.'s first 
visit, the Tennessee Board of Nursing had yet to adopt BON Rule 
1000-04-.08, and that the Rule did not go into effect until January 
1, 2005. GX 68, at 10. However, based on her knowledge and 
experience, the Expert explained that advanced nurse practitioners 
(``APNs'') in Tennessee were nevertheless employing the practices 
set forth in the Rule when they prescribed controlled substances for 
the treatment of pain. Id. Thus, the practices articulated in the 
guidelines reflected what, in her opinion, was the standard of care 
in Tennessee for family nurse practitioners as of June 2004. Id. The 
Expert explained that because of the lack of information of N.S.'s 
prior treatment history and substance abuse history, it was below 
the standard of care for a practitioner to issue N.S. a thirty-day 
supply of a schedule II controlled substance such as morphine at her 
first visit. Id.
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    On July 7, 2004, N.S. returned to AMC for a follow-up, but now was 
complaining of a migraine headache. See GX 2, at 101. Again, N.S. was 
seen by a practitioner other than Reynolds, Stout, or Killebrew. See GX 
3, at 130.
    Notably, the record states that N.S. displayed ``Slurred speech + 
Somnolence,'' which, according to the Expert was a potential red flag 
that N.S. was abusing prescription drugs.\5\ GX 68, at 10. The Expert 
noted that the record indicated that N.S. had Tachycardia, as her pulse 
rate was above the normal rate for adults (60-100 beats per minute) and 
was nearly 20 beats higher than at her previous visit. Id. at 11. 
According to the Expert, while Tachycardia occurs for a variety of 
reasons, it can be caused by drug withdrawal. Id.
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    \5\ According to the Expert, these symptoms could represent 
several serious and even life-threatening medical conditions given 
N.S.'s complaint of a migraine headache. Also, N.S.'s slurred speech 
and somnolence could have been an indication that N.S. was having an 
acute neurologic event, such as a hemorrhagic stroke. GX 68, at 10-
11.
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    The Expert noted that the attending practitioner properly ordered a 
Urine Drug Screen (UDS) for N.S. Id. According to the Expert, a UDS is 
a particularly useful tool when the practitioner is presented with a 
red flag indicating that the patient may not be in compliance, such as 
when the patient presents at the office exhibiting the behaviors N.S. 
did on this visit. Id. As the Expert explained, a UDS can assist the 
practitioner in determining whether the patient has been taking the 
drug(s) that the practitioner has prescribed and if the patient was 
ingesting non-prescribed controlled substances, including illicit 
substances. Id. Thus, UDS results help practitioners to determine 
whether a patient is abusing and/or diverting controlled substances. 
Id.
    While this other practitioner appropriately ordered a UDS, 
according to the Expert, he then inappropriately issued to N.S. another 
prescription for thirty tablets of Avinza 60 mg at this visit. Id. at 
11-12. As the Expert found, at this visit, N.S.'s file still lacked any 
information of her prior treatment history and substance abuse history. 
Id. at 12. According to the Expert, in the absence of this information, 
and in light of the fact that N.S. presented at this visit 
demonstrating slurred speech and somnolence, the issuance of the Avinza 
prescription was below the standard of care in Tennessee and outside 
the usual course of professional practice and actually medically 
contraindicated given the mental status changes documented in her 
record. Id. at 12. The Expert further explained that under the 
circumstances presented by N.S., the standard of care and usual course 
of professional practice required that the practitioner refer the 
patient for a comprehensive evaluation (the emergency room) to 
determine the underlying cause of the symptoms of her increased heart 
rate, slurred speech, and somnolence. Id. Moreover, the patient should 
not have received prescriptions (of any type) at this visit until 
medical clearance was provided that she was not experiencing drug 
intoxication or an acute neurologic event. Id. Moreover, because N.S. 
was not referred or transferred for further evaluation, she should not 
have received any controlled medications until the urine drug screen 
results were available to the provider. Id.
    Nearly three months later (on September 29, 2004), N.S. returned to 
AMC for her next visit and was seen by Mr. Reynolds. See GX 2, at 100; 
GX 3, at 71. Prior to this visit, AMC had received the report of the 
results of the UDS that had been administered to N.S. at her July 7, 
2004 visit. Id. at 115. According to the Expert, on the date of the 
UDS, N.S. should have had Avinza left from the prescription issued at 
her first visit and should have still been taking the drug. See GX 2, 
at 102; GX 3, at 129; GX 68, at 12-13. However, the UDS was negative 
for opiates, positive for benzodiazepines, and positive for cocaine. 
Id.; GX 2, at 115.
    According to the Expert, these results should have been a ``huge 
red flag of abuse and diversion'' for Mr. Reynolds because not only did 
N.S. test positive for cocaine, she also tested positive for three 
different benzodiazepines, none of which had been prescribed to her at 
her first visit. GX 68, at 13. The Expert further explained that the 
presence of the three benzodiazepines, in addition to the presence of 
cocaine, were consistent with the somnolence, slurred speech, and 
increased pulse rate that were documented during the July 7, 2004 
visit. Id. The Expert also noted that N.S. tested negative for opiates, 
when she should have tested positive for the Avinza which she should 
have still been taking. Id.
    The Expert also noted that as of this visit, Reynolds still had not 
acquired any information concerning N.S.'s prior treatment history or 
substance abuse history. Id. Also, the file contains no documentation 
that Reynolds had inquired of N.S. where she had been for the nearly 
three months since her July 7, 2004 AMC visit. See generally GX 2. 
According to the Expert, the standard of care required that Reynolds 
inquire about N.S.'s absence and determine what, if anything, she had 
been doing during this time to address her reported pain. GX 68, at 13. 
The Expert further noted that while the note for this visit was for the 
most part illegible, it appeared that Mr. Reynolds did not address 
N.S.'s absence. See id; GX 2, at 100.
    Nonetheless, Reynolds issued N.S. another prescription for thirty 
tablets of Avinza 60 mg. See GX 2, at 100; GX 3, at 71. Based on the 
UDS results and notation in N.S.'s record that she displayed ``slurred 
speech & somnolence,'' the Expert concluded that Reynolds was on notice 
that she was likely diverting the Avinza she obtained at AMC for the 
purpose of obtaining the cocaine and the benzodiazepines. GX 68, at 14. 
The Expert also explained that at the time of these events, it was well 
known in the Tennessee health care community that prescription drug 
abuse and diversion was a problem that was plaguing East Tennessee. Id.
    The Expert explained that the standard of care and usual course of 
practice under these circumstances

[[Page 28646]]

would not have been to issue N.S. an additional thirty-day supply of 
morphine, because ``family nurse practitioners were not then, and are 
now not equipped, through their training and experience, to address the 
complex abuse and diversion issues N.S. was presenting.'' Id. According 
to the Expert, rather than continuing to issue N.S. prescriptions for 
more of the Avinza, the standard of care and usual course of practice 
required that Reynolds ``cease all controlled substances prescriptions 
to her, and instead referred [sic] her for a consultation with a pain 
management specialist who [was] equipped with the knowledge to treat a 
pain patient who has exhibited such aberrant behavior.'' Id. The Expert 
also explained that in the event that a local pain management practice 
did not have all of these specialists, Mr. Reynolds should have, in 
addition to sending her to a pain management specialist, referred her 
to a mental health specialist to address her possible psychological/
drug abuse issues. Id. The Expert thus concluded that Reynolds' 
issuance of this prescription was below the standard of care in 
Tennessee, outside the usual course of professional practice, and for 
other than a legitimate medical purpose. Id.
    N.S.'s file reflects that Reynolds, Stout, and Killebrew each 
continued to issue N.S. controlled substance prescriptions on multiple 
occasions subsequent to September 29, 2004. In fact, N.S. remained an 
AMC patient for over five more years and continued to receive numerous 
controlled substances prescriptions from AMC. See generally GX 2. Based 
on the evidence of N.S.'s abuse and/or diversion of controlled 
substances that was documented in her file, the absence of 
documentation of any prior treatment for pain, and the absence of any 
substance abuse history, the Expert opined that each and every 
controlled substance prescription that these three practitioners issued 
to N.S. from September 29, 2004 forward was below the standard of care, 
not for a legitimate medical purpose, and outside the usual course of 
professional practice. GX 68, at 15. However, ``because each of the 
three practitioners issued additional controlled substance 
prescriptions notwithstanding the existence of more red flags of N.S.'s 
abuse and/or diversion of controlled substances,'' the Expert addressed 
the invalidity of those prescriptions. Id.
    On December 29, 2004, N.S. returned to AMC and saw Mr. Reynolds, 
who issued her a prescription for eight tablets of Avinza 60 mg. See GX 
2, at 97; GX 3, at 76 According to the Expert, in addition to the 
previous evidence of N.S.'s abuse and diversion, Reynolds had received 
an admission report on December 3, 2004 from Johnson City Medical 
Center (``JCMC'') which notified him that N.S. was hospitalized for a 
drug overdose the same day. GX 68, at 15; GX 2, at 126-28. He also 
received notification from JCMC upon N.S.'s discharge on December 7, 
2004. GX 2, at 158-61; GX 68, at 16. Reynolds evidently reviewed the 
report, as his signature marking appears at the bottom of the report's 
first page. GX 2, at 158. Notably, not only did the report state that 
N.S. had been admitted for a drug overdose, it also stated that N.S. 
had a history of multiple prior drug overdoses, the last one being in 
May 2004, one month before her first AMC visit, and a history of 
multiple suicide attempts. Id. at 126-27; 158-59.
    Of further significance, the report listed two different primary 
care physicians for N.S., one of whom, Dr. Michael Dube, was not an AMC 
practitioner. Id. at 159. Also, the report stated that she was taking 
Lortab, a combination drug containing hydrocodone (which was then a 
schedule III controlled substance); Xanax, a schedule IV controlled 
substance; and Soma (carisoprodol), which was not federally scheduled 
at that time. Id. at 158. However, Reynolds had not previously 
prescribed any of these three drugs to N.S. See generally GX 2.
    The report also stated that a urine toxicology test was performed 
on N.S. and that she tested positive for opiates and benzodiazepines. 
Id. at 159. However, as before, AMC had not prescribed any 
benzodiazepines to N.S. As the Expert explained, the report should have 
been another enormous red flag to Reynolds that N.S. was continuing to 
abuse and divert controlled substances and was engaging in doctor-
shopping by obtaining controlled substances from multiple sources (AMC 
and Dr. Dube), another red flag of drug-seeking behavior. GX 68, at 16.
    As of the December 29 visit, Reynolds also was aware that the 
physician who treated N.S. at JCMC had, three weeks earlier, discharged 
N.S. to Indian Path Pavilion (``IPP''), a local, in-patient mental 
health facility. See GX 2, at 160. In addition, on December 23, AMC 
received a fax showing that on December 21, N.S. had been admitted 
again to IPP for ``polysubstance abuse.'' See GX 2, at 153-56. Thus, as 
of N.S.'s December 29 visit, Reynolds was on notice that she may have 
suffered two overdoses in an approximately three-week period, that 
these would have been the latest of several overdoses she had suffered, 
and that she had been sent for mental health treatment on each of those 
two occasions. GX 68, at 17.
    However, on reviewing N.S.'s patient file, the Expert found (as do 
I) that Reynolds did not contact: (1) The JCMC to obtain its records of 
N.S.'s multiple previous overdoses; (2) Dr. Dube to obtain records of 
the nature and extent of the treatment he had provided N.S., including 
the controlled substances he had prescribed her, (3) the IPP to obtain 
records regarding N.S.'s December 21, 2004 admission to that facility 
for polysubstance abuse; and/or (4) the pharmacy N.S. was using to fill 
her prescriptions to determine if she was obtaining controlled 
substances prescriptions from other practitioners. Id. According to the 
Expert, the standard of care and usual course of professional practice 
for a family nurse practitioner required that Reynolds obtain all of 
this information about N.S.'s history of overdoses, her suicide 
attempts, and her current hospitalizations, as well as information 
about other practitioners from whom she may have been obtaining 
controlled substance prescriptions, in order to determine the proper 
course to take in her care. Id.
    As the Expert previously explained, a family practice nurse 
practitioner is not qualified to treat the complex issues presented by 
this type of patient. Thus, the Expert also explained that in light of 
the information contained in the December 3, 2004 JCMC and the December 
21, 2004 IPP admission reports, the standard of care in Tennessee 
required that Reynolds cease all further controlled substance 
prescriptions (which he already should have), send N.S. to an out-
patient or in-patient detoxification program and refer her to a pain 
management specialist. Id. at 18. Thus, the Expert concluded that the 
issuance of the December 29, 2004 Avinza prescription was outside the 
usual course of professional practice and lacked a legitimate medical 
purpose. Id.
    Nevertheless, from January 2005 through June 2005, Reynolds 
continued to see N.S. at AMC on a monthly basis and continued to issue 
her monthly prescriptions for Avinza 60 mg. See GX 2, at 86-96; GX 3, 
at 76-79. According to the Expert, the issuance of each of these 
prescriptions was below the standard of care and outside the usual 
course of professional practice as well. GX 68, at 18. As the Expert 
explained, N.S. should not have been treated and prescribed controlled 
substances at a family practice in light of the drug abuse and 
diversion issues she presented, and

[[Page 28647]]

should have been referred to a specialist. Id.
    According to the Expert, on January 1, 2005, the Board of Nursing's 
Rule 1000-04-.08 went into effect. Id. As a result, Reynolds was 
required to comply with the controlled substance prescribing guidelines 
contained in that Rule. However, as of January 6, 2005, Reynolds still 
had not obtained any information about her treatment history for the 
three years immediately preceding her first AMC visit on June 8, 2004. 
See TN BON Rule 1000-04-.08(4)(C)1; see also generally GX 2; GX 68, at 
18. Moreover, Reynolds did not create a written treatment plan for 
N.S.; nor did he document that he had considered the need for further 
testing, consultations, referrals, or the use of other treatment 
modalities. GX 2; GX 68, at 18.
    As the Expert explained, under the new Rule, Reynolds was required 
to create and maintain a ``written treatment plan tailored for the 
individual needs of the patient'' that ``include[d] objectives such as 
pain and/or improved physical and psychological function'' and was 
required to ``consider the need for further testing, consultations, 
referrals, or use of other treatment modalities dependent on patient 
response[.]'' GX 68, at 18 (quoting TN BON Rule 1000-04-.08(4)(c)2). As 
found above, in December 2004, the JCMC and IPP had forwarded to 
Reynolds information establishing that N.S. had a substantial history 
of substance abuse which had resulted in multiple drug overdoses and 
suicide attempts. Based on the results of the July 2004 UDS, he also 
had information that N.S. may not have been taking the Avinza and 
possibly was diverting the drug and that she was taking cocaine and 
benzodiazepines which had not been prescribed by his clinic. GX 68, at 
19. The Expert thus concluded that Reynolds did not comply with the 
Rule and acted outside of the usual course of professional practice 
when he issued the Avinza prescription to N.S. Id.
    The evidence further shows that beginning on February 8, 2005, 
Reynolds added Xanax 1 mg. to N.S.'s controlled substance regimen. See 
GX 2, at 94; GX 3, at 77-79. Reynolds issued this prescription after 
diagnosing N.S. with ``Major Depressive Disorder'' and ``GAD,'' the 
latter being an abbreviation for ``Generalized Anxiety Disorder.'' The 
Xanax prescription issued on February 8, 2005 was the first of numerous 
Xanax prescriptions N.S. received from Reynolds, Stout, and Killebrew 
over the course of the next five years. See GX 2.
    According to the Expert, the decision of the nurse practitioners to 
address N.S.'s mental health issues by prescribing Xanax, was below the 
standard of care and outside the usual course of professional practice. 
GX 68, at 19. As support for her opinion, the Expert cited a treatise 
which she stated was generally recognized and accepted as authoritative 
by Tennessee family practitioners. Id. at 19-20 (citing Constance R. 
Uphold & Mary Virginia Graham, Clinical Guidelines in Family Practice, 
4th Ed. (2003) (hereinafter, ``Uphold & Graham'')). This treatise was 
submitted as part of the record. See GX 41.
    The Expert explained that ``according to Uphold & Graham, 
benzodiazepines, such as Xanax, are effective only for the short-course 
treatment of generalized anxiety disorder, or GAD, and family 
practitioners were cautioned against the use of this class of drugs for 
greater than a two week period because they carry `the risk of 
dependence and withdrawal syndrome.' '' Id. at 20 (quoting GX 41, at 
8). The Expert then noted that ``Uphold & Graham further instructs that 
if the patient's `anxiety [is] associated with another psychiatric 
condition, most often depression,' the patient `should be treated for 
the primary problem,' and `most patients in this category should be 
referred to a specialist if possible.' '' GX 68, at 20 (quoting GX 41, 
at 9). Additionally, ``Uphold & Graham instructs that for `patients 
with anxiety that is substance-induced' whether by licit or illicit 
drugs, family nurse practitioners are to `provide the patient with 
counseling/referral to a drug detoxification program.' '' Id. According 
to the Expert, ``Uphold & Graham emphasizes that two of the `categories 
of patients [who] should be referred to specialists for treatment' are 
`[t]hose with high suicide risk' and `[p]atients with comorbid 
conditions (primary anxiety disorder, substance abuse, dementia).' '' 
Id. (quoting GX 41, at 14).
    Thus, based on Uphold & Graham, the Expert concluded that ``even 
assuming N.S. could have been treated for her purported major 
depressive order in a primary care setting, which she could not, she 
should not have been started on a benzodiazepine such as Xanax.'' Id. 
(citing GX 41, at 15). The Expert further noted that AMC asserted that 
its protocols were based on the Uphold & Graham Guidelines. Id. at 19-
20 (citing GX 39).
    According to the Expert, Reynolds, Stout, and Killebrew were 
required under Tennessee law to evaluate N.S. for a continuation or 
change of her medications at each periodic interval at which they 
evaluated her. GX 68, at 21; BON Rule 1000-04-.08(4)(c)4. However, 
while Xanax is a highly abused and diverted drug in Tennessee, 
Reynolds, Stout and Killebrew prescribed Xanax to N.S., ``at numerous 
periodic intervals over the course of the next several years and in the 
face of mounting evidence of her abuse of controlled substances, and 
without referring her for treatment by a specialist.'' GX 68, at 21. 
The Expert thus concluded that the prescriptions issued by the three 
nurse practitioners fell well below the standard of care and outside 
the usual course of their professional practice. Id.
    On July 1, 2005, Reynolds issued N.S. prescriptions for 30 capsules 
of Avinza 60 mg and 60 tablets of Xanax 1 mg. See GX 2, at 86; GX 3, at 
79. Reynolds issued these prescriptions even though he had not obtained 
the results of the UDS he ordered for N.S. during her June 1, 2005 AMC 
visit (and apparently never did based on a review of N.S.'s patient 
file). See GX 2, at 87. In fact, N.S.'s patient file does not contain 
any record of her even having been administered the UDS. GX 68, at 21; 
see also GX 2.
    In the Expert's opinion, Reynolds' issuance of these prescriptions 
was below the standard of care and outside the usual course of 
professional practice. GX 68, at 21. Based on the evidence of N.S.'s 
abuse and diversion of controlled substances set forth above, and the 
fact that Reynolds had not obtained the results for the UDS he ordered 
at N.S.'s previous visit, the standard of care and usual course of 
professional practice under these circumstances would not have been to 
issue N.S. further controlled substances prescriptions. Id. at 22. 
Instead, it would have been to locate the results, and if she had not 
taken the UDS, which would be a red flag based on her history, require 
her to provide one and cease all further controlled substances 
prescribing until the results could be reviewed. Id. (citing Board Rule 
1008-04-08(2) & (4) (c)(2)).
    Likewise, on August 2, 2005, Mr. Reynolds issued N.S. prescriptions 
for 30 capsules of Avinza 60 mg and 60 tablets of Xanax 1 mg, each of 
which was for a thirty-day supply. See GX 2, at 85; GX 3, at 79. A note 
in the record of her August 2, 2005 visit states, ``Pt. called to 
request refill on Xanax. Stated she had taken all she had before due 
date. Script written for Xanax.'' GX 2, at 85 (emphasis added). Yet 
notwithstanding the extensive evidence that N.S. was abusing and 
diverting controlled substances, Reynolds issued her the prescription 
and did not refer her to an outside specialist to address her aberrant 
behavior. See, e.g., GX 41, at 8-9, 14 (Uphold & Graham). The

[[Page 28648]]

Expert thus concluded that Reynolds' issuance of the prescription was 
below the standard of care and outside the usual course of professional 
practice. GX 68, at 22-23.
    Twenty days later, on August 22, 2005, Mr. Reynolds issued N.S. a 
prescription for 20 tablets of Xanax 0.5 mg. See GX 2, at 84; GX 3, at 
80. According to the Expert, this prescription was an extremely early 
refill, specifically, ten days early, in light of the fact that he had 
just issued N.S. a thirty-day supply of 60 tablets of Xanax 1 mg on 
August 2, 2005, and was further evidence that N.S. was either abusing 
the Xanax by taking extra pills in contravention of his directions, or 
was diverting the drugs he was prescribing to her. GX 68, at 23.
    Moreover, on September 2, 2005, Mr. Reynolds issued N.S. 
prescriptions for 30 capsules of Avinza 60 mg and 60 tablets of Xanax 1 
mg. See GX 2, at 82; GX 3, at 81. According to the Expert, Reynolds was 
then aware that N.S. had apparently not complied with his August 24, 
2005 request for her to come into AMC for a pill count. See GX 68, at 
24; GX 2, at 83. The Expert then explained that the failure of a 
patient to comply with a practitioner's request for a pill count, which 
is another tool utilized to monitor the patient's compliance with a 
controlled substances regimen, is another red flag of possible abuse 
and/or diversion. GX 28, at 24.
    On October 3, 2005, Mr. Reynolds issued N.S. a prescription for 75 
tablets of Xanax 1mg and 60 capsules of Kadian (a brand name for 
morphine) 30 mg. See GX 2, at 80; GX 3, at 81. N.S.'s file contains a 
handwritten note dated September 13, 2005, which was just eleven days 
after Reynolds had prescribed to her a thirty-day supply of 60 tablets 
of Xanax 1 mg, stating, ``Pt requested Xanax 1 mg TID for anxiety 
attacks.'' GX 68, at 25; GX 2, at 81. As of this date, Reynolds was 
aware that N.S. should have had 19 days of Xanax tablets remaining from 
the September 2nd prescription, and thus, she was requesting additional 
Xanax well before she should have consumed the prior prescriptions and 
was also requesting an increase from two (i.e., ``BID'') to three 
tablets a day (i.e., ``TID''). GX 68, at 25.
    On November 1, 2005, Registrant Stout issued his first controlled 
substance prescriptions to N.S.; the prescriptions were for 75 tablets 
of Xanax 1 mg and 60 capsules of Kadian 30 mg. See GX 2, at 79; GX 3, 
at 82. According to the Expert, because this was N.S.'s. first visit 
with Stout, it was incumbent on him to review N.S.'s file before he 
issued her controlled substances prescriptions, so that he could 
determine the appropriate course of treatment. GX 68, at 26. Noting 
that under Board Rule 1000-04-.08, Stout was required to ``evaluate[ ] 
the patient for continuation or change of medications'' and to include 
in the patient record ``progress toward reaching treatment objectives, 
any new information about the etiology of the pain, and an update on 
the treatment plan,'' the Expert explained that an Advanced Practice 
Nurse cannot evaluate a patient for the continuation or change of 
medications, or determine the progress the patient is making towards 
reaching treatment objectives, or even know what the patient's 
treatment objectives are, without knowing the patient's treatment 
history. Id.
    The Expert thus concluded that when Stout issued N.S. the Xanax and 
Kadian prescriptions, he should have been aware of N.S.'s prior abuse 
and diversion of controlled substances which was documented in her 
patient file. Id. Based on N.S.'s history, the Expert further concluded 
that the standard of care and usual course of professional practice 
under these circumstances would not have been for Mr. Stout to issue 
her further controlled substances prescriptions but to cease further 
prescribing and refer her to an outside specialist to address her 
aberrant behavior. Id. at 26-27 (citing GX 41, at 8-9, 14) (Uphold & 
Graham).
    On July 20, 2006, Applicant Killebrew issued her first controlled 
substances prescriptions to N.S.; the prescriptions were for 75 tablets 
of Percocet 7.5/325 mg (oxycodone/acetaminophen, a schedule II 
controlled substance), and 60 tablets of Xanax 0.5 mg. See GX 2, at 76; 
GX 3, at 84. For the same reasons she identified in her discussion of 
the validity of Stout's initial prescriptions to N.S., the Expert found 
that Killebrew's prescriptions were below the standard of care and 
outside the usual course of professional practice. GX 68, at 27.
    The Expert further noted that this was N.S.'s first visit to AMC in 
nearly eight months, (her last visit having been a Dec. 1, 2005 visit 
with Reynolds), and that Killebrew had noted in the record of this 
visit that N.S. was ``[j]ust released from jail 7/6/06 . . . requesting 
to be put back on pain meds she was on for back and neck pain.'' Id. at 
27-28 (citing GX 2, at 76). The Expert noted, however, that Killebrew 
did not document having asked N.S. about the reason for her 
incarceration, specifically, whether it was drug-related, whether she 
was on probation, and, if so, whether her probationary status may have 
prohibited her from possessing controlled substances. GX 68, at 28. Nor 
did Killebrew document having asked N.S. about how she had addressed 
her alleged pain during her incarceration when she had told Killebrew 
that she was not receiving any pain medications. Id. According to the 
Expert, given N.S.'s history, the standard of care and usual course of 
professional practice under these circumstances, would not have been to 
issue her additional controlled substances prescriptions but to refer 
her to a pain management practice to address her purported back and 
neck pain and possible continuing substance abuse. Id. (citing GX 41, 
at 8-9, 14) (Uphold & Graham).
    On August 17, 2006, Stout prescribed N.S. 75 tablets of Percocet 
7.5/325 mg and 60 tablets of Xanax 0.5 mg. See GX 2, at 75; GX 3, at 
87. According to the medical record, on July 19, 2006, less than a 
month before he issued N.S. these prescriptions, Stout had treated N.S. 
while he was working in the North Side Hospital emergency room 
(``ER''). See GX 16, at 2-3. According to North Side's records, N.S. 
presented to the ER on that date complaining of neck pain from a fall. 
Stout noted in the record for the ER visit that N.S. ``[r]efused meds . 
. . Wants stronger narcotics. Admits to having long history of drug 
abuse. . . .'' In the ``Impressions'' section of this report, Stout had 
also noted that N.S. displayed ``[d]rug seeking behavior.'' Id.
    Moreover, N.S.'s AMC record included the note for her July 20 visit 
(the day after Stout saw her in the ER). Thus, the Expert found that 
Stout should also have been aware that N.S.'s previous visit was her 
first visit to AMC in seven months and that she had just been released 
from jail and had requested to be put back on pain medications. GX 68, 
at 29; GX 2, at 76. The Expert further explained that ``[a]s was the 
case with N.S.'s visit with Killebrew, Stout did not question N.S. as 
why she had been incarcerated . . . whether it was drug-related, 
whether she was on probation, and, if so, whether her probationary 
status may have prohibited her from possessing controlled substances. 
He also did not question N.S. about how she had been addressing her 
alleged pain during her incarceration when she, based on her own report 
to Killebrew, had not received pain medications.'' GX 68, at 29. Based 
on these circumstances (including the amply documented history of 
N.S.'s abuse and/or diversion), the Expert found that Stout's issuance 
of these prescriptions was below the standard of care and outside

[[Page 28649]]

the usual course of professional practice. Id.
    On October 11, 2006, Stout again saw N.S. and issued her additional 
prescriptions for 75 tablets of Percocet 7.5 mg and 60 tablets of Xanax 
0.5 mg. See GX 2, at 71, 73; GX 3, at 88. In addition to the previous 
documented incidents of N.S.'s abuse and/or diversion, N.S.'s file 
contained a note dated September 13, 2006, stating, ``[N.S.] selling 
perocet's (sic.).'' See GX 2, at 74. Moreover, in the record of the 
visit, Stout wrote, ``Confronted PT about ? selling meds. PT denies. 
States meds were stolen. Will do UDS today. Advised PT if UDS (-) 
drugs/abuse found would d/c. Has been taking meds for past week per 
pt.'' See GX 2, at 71, 73. Also, Stout had N.S. sign a Pain Management 
Agreement (``PMA''), which he and another AMC employee witnessed, and 
then issued her the controlled substance prescriptions. See GX 2, at 
11-12.
    According to the Expert, the fact that N.S. denied selling her 
drugs should not have overcome the evidence in her file, including the 
recent note of the report that she was selling her drugs and the 
extensive evidence of her history of abuse and/or diversion of 
controlled substances. GX 68, at 30. The Expert thus concluded that 
Stout's issuance of these prescriptions was below the standard of care 
and outside the usual course of professional practice. Id.at 29-30 
(citing GX 41, at 8-9, 14 (Uphold & Graham)).
    The UDS results showed that N.S. tested negative for oxycodone/
oxymorphone, despite the fact that she had been receiving oxycodone 
(Percocet) prescriptions from AMC on a monthly basis since July 20, 
2006. See GX 2, at 71-75, 105-107; see also GX 3, at 4-5. The results 
also showed that N.S. tested positive for hydrocodone/hydromorphone, 
even though no one at AMC had prescribed those drugs to her since she 
had returned to the practice. GX 2, at 107.
    On November 10, 2006, Reynolds saw N.S. and issued her additional 
prescriptions for 75 tablets of Percocet 7.5 mg and 60 tablets of Xanax 
0.5 mg. See GX 2, at 70; GX 3, at 91. In addition to the various recent 
notes in her file, Reynolds should have been aware of the October 18, 
2006 results of the UDS administered to N.S. at the October 11, 2006 
visit. As the Expert explained, based on the UDS results, Reynolds was 
aware that N.S. had lied to Stout during her October 11, 2006 visit 
when she told him that she was taking her pain medications, and that 
she was likely selling her Percocet because she tested negative for 
this drug. GX 68, at 31. In addition, Reynolds was aware of Stout's 
warning to N.S. during her October 11, 2006, visit that she would be 
discharged (``d/c'') if the results were negative (which they were for 
oxycodone), or if she was found to be abusing drugs, which was 
established by her testing positive for hydrocodone, a drug that she 
had not been prescribed at AMC. Id. at 32.
    The Expert thus found that the UDS results were further evidence of 
N.S.'s continued abuse and/or diversion of controlled substances. Id. 
at 31. The Expert further opined that the standard of care and usual 
course of professional practice under these circumstances would not 
have been to issue N.S. further controlled substance prescriptions, but 
to discharge her from the practice and to refer her to a pain 
management practice to address her purported pain issues or a substance 
abuse/addiction specialist to address her likely substance abuse 
issues. Id. at 32. Thus, the Expert concluded that Reynolds' issuance 
of these prescriptions was below the standard of care and outside the 
usual course of professional practice. Id. at 31 (citing GX 41, at 8-9, 
14) (Uphold & Graham)).
    On December 11, 2006, Stout issued N.S. prescriptions for 75 
tablets of Percocet 7.5 mg and 60 tablets of Valium 5 mg. See GX 2, at 
69; GX 3, at 91. At the time of the visit, Stout had received the 
results of the UDS and was aware that N.S. had lied to him during her 
October 11, 2006 visit, when she told him she was taking her pain 
medications. N.S.'s patient record shows that Stout attempted to refer 
N.S. to two different pain management practices at this visit--
``Appalachian Pain Rehab'' (Dr. Tchou) and ``Pain med associates.'' See 
GX 2, at 67. However, N.S. had apparently already been seen at those 
two practices and neither practice was willing to again accept her as a 
patient.\6\ Id.
---------------------------------------------------------------------------

    \6\ Notes in the file state that N.S. ``has been double dotted'' 
at Appalachian Pain Rehab, which ``means won't see,'' and that N.S. 
``already has been to Pain med associates + can't be seen there 
either!!'' GX 2, at 67.
---------------------------------------------------------------------------

    According to the Expert, this additional information should have 
been another red flag that N.S. was abusing and or diverting controlled 
substances. GX 68, at 33. The Expert thus concluded that under the 
circumstances, the standard of care and usual course of professional 
practice would not have been to issue N.S. more prescriptions, but to 
enforce the terms of the Pain Management Agreement and to follow 
through on the warning Stout had given N.S. during her October 11 visit 
that she would be discharged from AMC if she failed the UDS. Id. 
Additionally, the standard of care and usual course of professional 
practice would have been to attempt to refer N.S. to a mental health or 
an addiction specialist to address her purported pain issues and her 
likely substance abuse issues. Id. at 33-34 (citing GX 41, at 8-9, 14 
(Uphold & Graham excerpts)). Yet Stout failed to either discharge her 
or refer her to a specialist.
    On February 27, 2007, Reynolds issued N.S. prescriptions for 75 
tablets of Percocet 7.5 mg and 60 tablets of Xanax .5 mg. See GX 2, at 
66; GX 3, at 93. At the time of the visit, Reynolds was aware of the 
December 11, 2006 notes stating that neither Appalachian Pain Rehab nor 
Pain Med Associates would see N.S. See GX 2, at 67. For the same 
reasons discussed above, the Expert concluded that Reynolds' issuance 
of the prescriptions was well below the standard of care and outside of 
the usual course of professional practice. GX 68, at 32.
    On June 1, 2007, Reynolds issued N.S. additional controlled 
substances prescriptions for 90 tablets of MS Contin 30 mg and 90 
tablets of Xanax 0.5 mg. See GX 3, at 96. Notwithstanding that the 
quantity of both prescriptions had been increased by fifty percent from 
N.S.'s previous visit, her patient file does not contain a record of 
Reynolds having seen her on this date, nor any information as to why 
N.S. was not seen on this occasion. See GX 2, at 63-64. Based on the 
other documented evidence of N.S.'s abuse and/or diversion, the Expert 
concluded that Reynolds' issuance of these prescriptions was below the 
standard of care and outside the usual course of professional practice. 
GX 68, at 34-35 (citing Rule 1000-04-.08(4)(c) (requiring periodic re-
evaluation for continuing or changing control substance 
prescriptions)).
    On July 2, 2007, after N.S. called in and said she had run out of 
prescriptions the day before, Killebrew directed that prescriptions be 
called in for 40 tablets of Lortab 10 mg (hydrocodone/acetaminophen) 
and 30 tablets of Xanax 0.5 mg. See GX 2, at 63; GX 3, at 96. While 
Killebrew should have been aware of N.S.'s extensive history of abuse 
and diversion, according to N.S.'s patient file, she issued these 
prescriptions without requiring that N.S. come in for an office visit 
and after being notified that N.S. had called AMC and requested new 
prescriptions because she was out of her medications. See GX 2, at 63. 
The Expert further noted that N.S. evidently had not been seen at AMC 
since her May 3, 2007 office visit and that this

[[Page 28650]]

was a further red flag given N.S.'s history. GX 68, at 35. Moreover, 
once again, there is no information in the file documenting why N.S. 
could not have been seen. Id. The Expert thus concluded that the 
issuance of the prescriptions was below the standard of care and 
outside of the usual course of professional practice. Id.
    On November 16, 2007, Reynolds issued N.S. prescriptions for 30 
tablets of Lortab 10 mg and 30 tablets of Xanax 0.5 mg. See GX 2, at 
52; GX 3, at 102. The Expert found that N.S. was seeking an early 
refill of her controlled substances, because fifteen days earlier, 
Reynolds had prescribed her thirty-day supplies of 90 tablets each of 
Xanax 0.5 mg, MS Contin 30 mg, and Percocet 7.5/500 mg, each of which 
had a dosing of ``one po tid,'' or one tablet three times per day. See 
GX 68, at 36; GX 2, at 53-54; GX 3, at 102. N.S.'s early refill request 
presented another red flag of her potential abuse and/or diversion of 
controlled substances, which Reynolds ignored. GX 68, at 36. Moreover, 
N.S.'s Pain Management Agreement stated that ``medications taken early 
due to reasons not discussed with your provider [will not] be replaced 
early.'' GX 2, at 5. Yet Reynolds did not enforce the Pain Management 
Agreement. GX 68, at 36.
    The Expert also concluded that given N.S.'s numerous prior red 
flags of drug abuse and diversion, Reynolds should have taken steps to 
determine if she was in fact taking the drugs he had been prescribing, 
or if she was diverting them. Id. at 37. The Expert explained that 
Reynolds should have required her to submit to a UDS, and that he also 
should have checked the Tennessee Controlled Substances Monitoring 
Database (``CSMD''), which became available on January 1, 2007, in 
order to determine if she possibly was doctor-shopping. Id. The Expert 
also noted that Reynolds did not ask why she was seeking an early 
refill. Id. The Expert thus concluded that Reynolds' issuance of these 
prescriptions was below the standard of care and outside the usual 
course of professional practice. Id. at 36-37 (citing Board Rule 1000-
04-.08(4)(c) (2) & (4) and GX 41, at 8-9, 14 (Uphold & Graham)).
    On January 3, 2008, Reynolds issued N.S. a prescription for 90 
tablets of MS Contin 30 mg, 90 tablets of Xanax 0.5 mg, and 30 tablets 
of Percocet 7.5 mg. See GX 2, at 47-48; GX 3, at 103. According to her 
file, on November 30, 2007, N.S. had called and sought an early refill. 
Moreover, documentation in her file establishes that Reynolds should 
have known (having received reports on both December 22 and 26), that 
on December 22, N.S. had been admitted to JCMC and diagnosed with, 
among other conditions, ``polysubstance abuse.'' See GX 2, at 139-140. 
Here again, the Expert found that Reynolds' issuance of these 
prescriptions was below the standard of care and outside the usual 
course of professional practice and that she should not have been 
issued any further controlled substance prescriptions. GX 68, at 37 
(citing GX 41, at 8-9, 14 (Uphold & Graham)).
    On December 22, 2008, Killebrew issued N.S. prescriptions for 60 
tablets of Lortab 7.5 mg and 30 tablets of Xanax 0.5 mg. See GX 2, at 
40-41; GX 3, at 106. Notably, the chart indicates that this was N.S.'s 
first visit to AMC since February 2008 because she was pregnant, see GX 
2, at 42-44, and that during the intervening ten months N.S had 
reportedly been receiving Suboxone/Subutex treatment from another 
practitioner and apparently had been able to function during the 
previous ten months without the need for Lortab and Xanax. Id. at 40.
    According to the Expert, based on N.S.'s representations, Killebrew 
should have taken steps to determine whether N.S. had a legitimate 
medical need for these drugs prior to prescribing them. GX 68, at 38-
39. The Expert explained that the usual course of professional practice 
would have been for Killebrew to determine the name of the practitioner 
who had provided Suboxone treatment to N.S. and contact that 
practitioner to determine the nature and extent of the treatment and to 
obtain a copy of the records. Id. at 39. The Expert also opined that 
given N.S.'s history of red flags, Killebrew should have run a check of 
the Tennessee CSMD to determine if her representations were accurate 
and to ensure that N.S. was not doctor-shopping. Id. However, according 
to N.S.'s file, Killebrew did not do so. GX 2. The Expert also found 
that Killebrew did not document any new illness or injury to N.S. as of 
this visit. GX 68, at 39. Also, on review of N.S.'s record, the Expert 
concluded that Killebrew had performed a cursory physical exam and that 
the lack of additional diagnostics or further evaluation by Killebrew 
further demonstrates that she failed to establish N.S.'s need for 
controlled substances at this visit. Id. Thus, the Expert concluded 
that Killebrew's issuance of these prescriptions was below the standard 
of care and outside the usual course of professional practice. Id. at 
38-39 (citing TN BON Rule 1000-04-.08(4)(c)1, 2, and 4).
    On June 4, 2009, Reynolds prescribed N.S. 60 tablets of MS Contin 
30 mg, 30 tablets of Percocet 7.5 mg, and 90 tablets of Xanax 0.5 mg. 
See GX 2, at 38-39; GX 3, at 107. Significantly, Reynolds issued the 
prescriptions notwithstanding that N.S. had not been seen at AMC since 
her December 22, 2008 visit with Killebrew. See GX 2, at 40-41. 
Moreover, the record of the June 4, 2009 visit does not contain any 
documentation of what N.S. had been doing to treat her purported pain 
over the course of the previous five plus months. Id. at 38-39. The 
Expert also found that Reynolds should have been aware that N.S.'s 
December 22, 2008 visit had been her first visit to AMC since February 
2008, after she had called AMC and informed staff that she was two 
months pregnant and had destroyed her medications. GX 68, at 39-40.
    As with the previous visit, the Expert explained that the usual 
course of practice would have been for Reynolds take steps to determine 
whether N.S. had a legitimate medical need for the drugs prior to 
prescribing them. Id. at 40. These steps included asking N.S. what she 
had been doing over the past six months to address her purported pain 
and, given her history of abuse and diversion, running a check of the 
Tennessee CSMD to determine if she had been obtaining controlled 
substances from any other practitioners over the past six months. Id. 
However, according to N.S.'s file, Reynolds did not conduct such a 
check. GX 2. The Expert thus concluded that Reynolds' issuance of these 
prescriptions was below the standard of care and outside the usual 
course of professional practice. GX 68, at 39-40 (citing TN BON Rule 
1000-04-.08(4)(c)(1, 2, 4)).\7\
---------------------------------------------------------------------------

    \7\ The Expert also explained that Reynolds' decision to issue 
N.S. controlled substances prescriptions on June 4, 2009 was 
contrary to the additional guidelines AMC was employing at that time 
as part of its practice protocols. GX 68, at 40. According to the 
Expert, she reviewed a February 23, 2010 letter Reynolds had sent to 
a Tennessee Department of Health Investigator, as well as several 
documents that were enclosed with the letter, including copies of 
AMC's practice protocols. Id.; see also GX 39. The Expert noted that 
Reynolds stated in his letter that one of the attached documents was 
``a copy of the current treatment recommendations for chronic pain 
in the primary care setting as outlined by the American Family 
Physician in their [sic] November 2008 article `Chronic Nonmalignant 
Pain in Primary Care' '' which was authored by R. Jackman, J.M. 
Purvis, and B.S. Mallett (hereinafter, ``Jackman article''). GX 68, 
at 40-41. According to Reynolds, AMC ``currently [is] referencing 
this article in our charting notes and intend to add these 
guidelines as an Addendum to our protocols when they are renewed in 
July 2010.'' GX 39, at 1. In his record of N.S.'s June 4, 2009 
visit, Reynolds wrote: ``[t]his patient's pain has been approached 
with specific attention to the American Family Physician's November 
2008 analysis that indicates nonmalignant pain should be addressed 
in the primary care setting.'' GX 2, at 38.
    The Expert noted that her review of N.S.'s file found that 
Reynolds overlooked several recommendations contained within that 
article. GX 68, at 41. These included the article's statement that 
``[o]pioids pose challenges with abuse, addiction, diversion, lack 
of knowledge, concerns about adverse effects, and fears of 
regulatory scrutiny. These challenges may be overcome by adherence 
to the Federation of State Medical Board's guidelines, use of random 
urine drug screening, monitoring for aberrant behaviors, and 
anticipating adverse effects.'' See id. (quoting GX 39, at 5). The 
Expert further noted that the article also states that ``[w]hen 
psychiatric comorbidities are present, risk of substance abuse is 
high and pain management may require specialized treatment or 
consultation. Referral to a pain management specialist can be 
helpful,'' and that the evaluation of the patient must include ``[a] 
thorough social and psychiatric history [that] may alert the 
physician to issues, such as current and past substance abuse, 
development history, depression, anxiety, or other factors that may 
interfere with achieving treatment goals.'' Id.
    The Expert also noted the article's statement that ``[f]or 
patients at high risk of diversion and abuse, consider the routine 
use of random urine drug screens to assess for presence of 
prescribed medications and the absence of illicit substances.'' GX 
68, at 42 (quoting GX 39, at 9 of 22) (emphasis added). Finally, the 
Expert noted the article's statement that ``[a]berrant behavior that 
may suggest medication misuse includes use of pain medications other 
than for pain treatment, impaired control (of self or of medication 
use), compulsive use of medication . . . selling or altering 
medications, calls for early refills, losing prescriptions, drug-
seeking behavior (e.g. doctor-shopping), or reluctance to try 
nonpharmacologic intervention.'' Id. (quoting GX 39, at 11) 
(emphasis added).

---------------------------------------------------------------------------

[[Page 28651]]

    On November 11, 2009, Reynolds issued another prescription to N.S. 
for 14 tablets of Xanax 0.25 mg. See GX 2, at 25; GX 3, at 108. 
According to N.S.'s file, N.S. sought a refill claiming that the Xanax 
Reynolds had prescribed to her on October 29, 2009 had been stolen. GX 
2, at 25. According to the Expert, a patient reporting that her 
controlled substances were stolen is another classic red flag of a 
patient's potential abuse and/or diversion of controlled substances. GX 
68, at 43 (citing GX 39, at 11 (Jackman article's examples of aberrant 
behavior)).
    According to the Expert, the standard of care and the usual course 
of professional practice would have been for Reynolds to enforce the 
terms of N.S.'s Pain Management Agreement, and refuse to provide her 
additional controlled substances. GX 68, at 43-44 (quoting GX 2, at 5; 
``Lost or stolen medicines will not be replaced''). Also, according to 
the Expert, Reynolds should have required N.S. to submit to a UDS, and 
to run a check of the CSMD to determine if N.S. was engaged in 
diversion. GX 68, at 44. According to N.S.'s file, Reynolds did not 
take either action and simply issued her an additional Xanax 
prescription for 36 tablets of .25 mg. GX 2, at 25; GX 3, at 70. The 
Expert thus concluded that Reynolds' issuance of the prescription was 
below the standard of care and outside the usual course of professional 
practice. GX 68, at 43-44.
    According to N.S.'s file, her visits to AMC ended in February 2010 
after a nearly six-year relationship with the practice. GX 2. 
Summarizing her findings, the Expert noted that while during that time, 
N.S. presented numerous red flags of abuse and diversion, the 
monitoring of her controlled substances use by Reynolds, Stout, and 
Killebrew was woefully inadequate, and far below the standard of care 
in Tennessee. GX 68, at 44. The Expert also observed that over the 
course of nearly six years, N.S. was only asked to provide two UDSs, 
both of which she failed by testing positive for a drug she had not 
been prescribed at AMC (including cocaine on one of the tests), and 
testing negative for the drug which she had been prescribed. Id.
    The Expert also noted that N.S. was required to come into AMC for 
but a single pill count, and there was no documentation showing that 
she even complied with the request. Id. The Expert then noted that even 
though the CSMD had been available since January 1, 2007, the only time 
N.S.'s prescription history had been checked was on the date of her 
last visit in February 2010. Id.; see also GX 2, at 129-131. The Expert 
also observed that there was no documentation that prior to the 
implementation of the CSMD, the practitioners had ever checked with 
N.S.'s pharmacy to ascertain whether she was engaged in drug-seeking or 
diversionary behavior. GX 68, at 44.
    The Expert concluded by observing that none of these steps were 
taken, notwithstanding that: (1) N.S. showed up at her second visit 
exhibiting somnolence and slurred speech; (2) failed the UDS that was 
administered at that visit, and (3) several months later, suffered a 
drug overdose that the practitioners learned was the latest of several 
prior drug overdoses, in addition to multiple prior suicide attempts. 
Id. at 44-45. As the Expert found, Reynolds, Stout, and Killebrew 
ignored numerous warning signs that N.S. was abusing and/or diverting 
controlled substances that continued throughout her nearly six-year 
association with AMC, and they continued to provide her with controlled 
substances when they knew or should have known that she was acquiring 
the controlled substances for other than legitimate medical purposes. 
Id. at 45.
    In a letter to a DEA Diversion Investigator, Reynolds addressed 
AMC's treatment of N.S. He asserted that N.S. was kept on the same 
medication that she had been prescribed by a neurosurgeon who had 
referred her to AMC. GX 42, at 7. Yet as the Expert noted, no such 
documentation exists in N.S.'s file.
    Reynolds did acknowledge that on December 3, 2004, N.S. was 
admitted to a local hospital by a Dr. James for a drug overdose; he 
also stated that she was subsequently ``transferred to Indian Path 
Pavilion and continued on her then prescribed medications'' and that 
``Dr. James added Soma and Lortab to the AMC regimen.'' GX 42, at 7. 
However, Reynolds also asserted that after this incident, N.S. ``never 
had another overdose incident while being treated at AMC'' and ``[s]he 
never again displayed signs of addiction to include requesting 
increases in medication without cause, going to numerous providers, 
aberrant behavior, contacting provider for medication after hours or on 
weekends, early refills, or refusal to follow plans of care.'' Id. 
Finally, Reynolds further asserted that ``[i]n October of 2006, she 
passed drug screens and observation by AMC providers.'' Id.

T.H.

    T.H.'s initial visit was on October 3, 2005. See GX 17, at 4, 47. 
According to the record of this visit, T.H. was seen by an AMC 
practitioner other than Reynolds, Stout, or Killebrew. He reported that 
he was suffering from back pain, but said that it was not due to trauma 
or injury. Id. at 47; see also id at 4 (report of ``Back Pain''). 
T.H.'s record does not, however, quantify the extent of the pain he 
reported, nor document how long he had been suffering from back pain. 
Id. at 47. T.H. also reported a history of anxiety with panic attacks. 
Id. According to the intake paperwork that T.H. completed, he reported 
that he was not currently seeing any other provider, id. at 3, and also 
reported that he was not taking any drugs other than asthma 
medications. Id. at 4.
    According to the Expert, the record of T.H.'s first visit is 
noteworthy for the absence of any information about his history and 
potential for substance abuse. GX 68, at 45; GX 17, at 47. Also, the 
record does not contain a written treatment plan that documents 
objectives for evaluating progress from the use of controlled 
substances. GX 68, at 45; GX 17, at 47. As the Expert explained, all of 
these issues were required to be, but were not addressed before T.H. 
was prescribed controlled substances. GX 68, at 46 (citing TN BON Rule 
1000-04-.08(4)(c)1 and 2).
    The Expert further found that the record of T.H.'s first visit 
revealed the first of several red flags of his potential abuse and/or 
diversion of controlled substances. Id. These included that on the 
initial intake form he completed,

[[Page 28652]]

T.H. reported that he had ``frequent or recurring problems'' with 
alcohol. GX 17, at 4. He also reported that either he or a close family 
member had suffered from ``Alcoholism'' and ``Mental Illness.'' Id.
    According to the Expert, T.H.'s disclosure of issues with alcohol 
abuse and mental illness were red flags of his potential drug abuse; 
she also noted that the Pain Management Agreements which T.H. was 
required to sign provided that ``[t]he use of alcohol and opioid 
medications is contraindicated.'' GX 68, at 46 (citing GX 17, at 5). 
According to the Expert, T.H.'s disclosures should have been explored 
further by the nurse practitioner who saw him, but according to the 
record were not assessed. Id. The Expert further opined that without a 
further evaluation of these issues, the practitioner should not have 
issued T.H. a prescription for controlled substances. Id.
    The Expert also explained that if T.H. was in recovery from 
alcoholism, he should have been referred to a comprehensive pain 
specialist program, and should not have been treated by a primary care 
nurse practitioner. Id. As the Expert explained: `` `[p]atients who are 
alcohol dependent and who also have a psychiatric disorder should be 
referred for treatment for the underlying disorder as these patients 
are usually complex.' '' Id. (quoting GX 41, at 23 (Uphold & Graham)). 
Thus, according to the Expert, the decision to issue him any controlled 
substance prescriptions at this initial visit was contrary to the 
guidelines set forth in TN BON Rule 1000-04-.08(4)(c)1 & 2, and 
accordingly, below the standard of care in Tennessee and outside the 
usual course of professional practice. Id. at 46-47. Nonetheless, T.H. 
was issued prescriptions for 30 Lortab 7.5 mg and 30 Xanax .25 mg. GX 
17, at 47.
    During his second visit on October 25, 2005, T.H. reported that he 
had recently lost his job and was looking for a new one. He also 
reported increased stress, that he was not sleeping, and that he was 
having ``roller coaster feelings.'' Id. at 46. According to the Expert, 
``the reported loss of income by a patient who is receiving opioids, 
such as hydrocodone (Lortab), is also a red flag of potential 
diversion. The practitioner must consider the risk that the patient may 
try to sell those drugs to generate the income he no longer is 
obtaining from his job.'' GX 68, at 47. The Expert noted, however, that 
there is no documentation in the visit note that the issue of how he 
was going to pay for his treatments and medications was discussed, nor 
is there any evidence that T.H. was asked to submit to a UDS to see if 
he was taking the drugs he had been prescribed. Id.
    The practitioner also diagnosed T.H. as suffering from anxiety and 
depression. GX 17, at 46. According to the Expert, diagnosing the 
potential source of a patient's stress is critical in determining the 
appropriate course of treatment. GX 68, at 47. Thus, the decision to 
issue T.H. any controlled substance prescriptions at this visit based 
on the information he reported was contrary to the guidelines set forth 
in TN BON Rule 1000-04-.08(4)(c)1,2,4, and accordingly, below the 
standard of care and outside the usual course of professional practice. 
Id. (citing GX 41 (Uphold & Graham)). However, here again T.H. was 
issued prescriptions for 45 Lortab 7.5 mg and 30 Xanax .5 mg. GX 17, at 
46.
    At T.H.'s third visit on November 28, 2005, the practitioner noted 
that he discussed marriage counseling, thus indicating that he was 
having marital problems. Id. at 45; GX 68, at 47. According to the 
Expert, this was another potential red flag with respect to the 
prescribing of opioids given T.H.'s reports of anxiety and depression, 
as well as his prior report that he had lost his job. GX 68, at 47-48. 
T.H. was referred to another provider (Dr. Williams), and directed to 
return for a follow-up visit in ``2 months.'' GX 17, at 45. He was also 
issued prescriptions 60 Lortab 7.5 mg and 30 Xanax .5 mg. Id.
    Nearly three months later on February 21, 2006, T.H. returned to 
AMC and saw Reynolds. See GX 17, at 43. In the interim, on December 5, 
2005, T.H. was seen at Dr. T. Williams' pain clinic, Pain Medicine 
Associates. See GX 17, at 57-58; 45-46. John Powell, a Physician 
Assistant in Dr. Williams' clinic, identified a possible source of the 
``mechanical low back pain'' that T.H. was reporting. GX 17, at 57. 
Notably, the pain clinic recommended that ``facet blocks should be 
undertaken as a diagnostic procedure followed by radiofrequency 
denervation if positive.'' GX 17, at 58. Also, the pain clinic 
recommended that T.H. be prescribed 90 tablets of Lortab 10 mg, one 
tablet three times a day, ``until we can get the above accomplished.'' 
Id. (emphasis added).
    Based on her review of the pain clinic's letter, the Expert 
concluded that the clinic had issued T.H. a prescription for a thirty-
day supply of Lortab 10 mg to hold him over until he received the facet 
blocks. GX 68, at 48. In addition, and significantly, Mr. Powell 
documented that T.H. had again disclosed that he ``had an alcohol 
problem in the past'' and ``still drinks occasionally.'' GX 17, at 57. 
Furthermore, Mr. Powell noted that T.H.'s ``chronic low back pain'' had 
been going on for ``two years.'' Id.
    According to the record of his Feb. 21, 2006 visit, T.H. 
specifically ``Requested Bob.'' GX 17, at 43. The Expert found that the 
record of this visit is largely unintelligible due to Reynolds' 
incomprehensible handwriting. GX 68, at 48. However, there is no 
evidence in T.H.'s file that the facet blocks had been performed in the 
two and one-half months since he had seen Mr. Powell. Id.; see also GX 
17. In fact, there is no evidence in the file that the facet blocks 
were ever done. GX 17. Also, there is no documentation of what, if 
anything, T.H. had been doing to address his pain for the past month 
when he would have been out of the drugs prescribed by Mr. Powell.\8\ 
See GX 68, at 48-49; GX 17, at 43.
---------------------------------------------------------------------------

    \8\ In his letter to the DI, Reynolds asserted that TH 
``returned to AMC on February 21, 2006 from pain management on long-
term medication, Oxy[C]ontin, 40 milligrams, twice daily, and 
Lortab, 10 milligrams, #30. This medication was continued until the 
patient's death.'' GX 42, at 4. There is, however, no evidence in 
T.H.'s file (such as a discharge summary form Pain Medicine 
Associates) which supports this assertion.
---------------------------------------------------------------------------

    Nonetheless, at the visit, Reynolds issued T.H. prescriptions for 
60 tablets of OxyContin 40 mg, 30 tablets of Lortab 10 mg, and 90 Xanax 
1 mg. See GX 17, at 43; GX 5, at 13. According to the Expert, Reynolds' 
issuance of these prescriptions was contrary to the guidelines set 
forth in TN BON Rule 1000-04-.08 and, accordingly, below the standard 
of care in Tennessee and outside the usual course of professional 
practice. GX 68, at 49.
    According to the Expert, Reynolds lacked ``an appropriate medical 
justification for adding a prescription for a schedule II controlled 
substance such as OxyContin 40 mg to treat [T.H.'s] purported pain,'' 
given that the pain specialist (Mr. Powell) was of the opinion that 
``T.H. did not require anything more than a short-term prescription for 
Lortab [then a schedule III controlled substance], and for only as long 
as it took to get the facet blocks completed.'' Id. Also, even though 
Reynolds was now aware (based on Mr. Powell's report) that T.H. had 
been having back problems for two years, there was still no 
documentation or records of any prior treatments he had received before 
he started at AMC in October 2005. See GX 68, at 49-50 (citing TN BON 
Rule 1000-04-.08(4)(c)1 (requiring documentation of historical data 
that includes ``pertinent evaluations by another provider'')).

[[Page 28653]]

    The Expert also found that up to this point, neither Reynolds nor 
the AMC practitioner who had treated T.H. at his previous visits had 
adequately documented and evaluated his prior alcohol problems and the 
extent of his current consumption of alcohol. Id. at 49 (citing TN BON 
Rule 1000-04-.08(4)(c)1 (requiring documentation of historical data 
that includes ``history of and potential for substance abuse'')). The 
Expert also found it significant that neither Reynolds nor his 
colleague had sufficiently explored T.H.'s psychological problems, 
specifically, the anxiety and increased stress that T.H. previously had 
reported despite circling ``anxious'' and ``depressed'' in the 
examination section of the record of this visit. Id. at 49-50 (citing 
TN BON Rule 1000-04-.08(4)(c)1 (requiring documentation of historical 
data that includes ``pertinent coexisting diseases and conditions'' and 
``psychological functions'')). And the Expert noted that Reynolds did 
not inquire about T.H.'s current employment status, which, in her view, 
could be significant if he was still unemployed. Id. at 49.
    The Expert observed that Reynolds' failure to evaluate these issues 
prior to issuing the Xanax prescription was contrary to AMC's own 
practice guidelines. Id. at 50. Specifically, the Expert explained that 
according to Uphold & Graham, `` `[s]ubstance abuse can also produce 
anxiety. . . . Anxiety can also occur as part of the withdrawal from 
the following: alcohol, cocaine, sedatives, hypnotics, anxiolytics.' '' 
Id. (quoting GX 41, at 5). Continuing, the Expert explained that 
according to Uphold & Graham, `` `[a]nxiety associated with other 
psychiatric disorders (depression and alcohol dependence) is common. 
Discriminating between an anxiety disorder and a depressive illness is 
quite difficult because of the overlap in symptoms.' '' Id. at 50 
(quoting GX 41, at 6.) The Expert thus concluded that ``without a 
detailed evaluation of T.H.'s anxiety and psychosocial history and 
substance abuse history (including a drug toxicology screen, or UDS), 
it was inappropriate for Mr. Reynolds to prescribe Xanax for the 
treatment for anxiety. He lacked any understanding of the etiology of 
that reported condition at that juncture.'' Id.
    The Expert also explained that the combination and quantity of 
prescriptions Reynolds issued at the visit was further evidence that 
these prescriptions were not issued in the usual course of professional 
practice or for a legitimate medical purpose. Id. According to the 
Expert, ``the combination of OxyContin and Lortab together would not be 
the next step for a patient with uncontrolled pain. In this situation, 
the patient's medication [was] escalated to a long-acting opioid, such 
as OxyContin 10 mg twice daily, which is done when pain management is 
expected to be for a prolonged period of time.'' Id. at 50-51. The 
Expert then noted that Reynolds had prescribed a starting dose of 40mg 
twice daily, which is four times the normal starting dose, and that 
``when starting a patient on a long-acting opioid, a short-acting 
opioid may be used for break-through pain, but not typically at the 
initial prescribing of the long-acting medication.'' Id. at 51.
    The Expert also explained that Lortab and OxyContin given in 
combination ``may increase the risk of CNS and respiratory depression, 
profound sedation and hypotension,'' and that Lortab and Xanax in 
combination ``may increase risk of CNS depression and cause psychomotor 
impairment'' due to additive effects. Id. Also, according to the 
Expert, OxyContin given in combination with Xanax may result in 
``vasodilation, severe hypotension, CNS and respiratory depression, 
[and] psychomotor impairment due'' to additive effects. Id. Finally, 
the Expert noted that the dose and the amount of Xanax prescribed was 
excessive as it was six times the total daily dosage of T.H.'s previous 
prescriptions and could be lethal, especially if taken in combination 
with two opioids. Id.
    Citing Reynolds' failure to perform a proper evaluation of T.H., 
the illogical and potentially dangerous escalation of opioid and 
benzodiazepine dosages in the prescriptions he issued, and the red 
flags of potential drug abuse and diversion that T.H. presented, the 
Expert concluded that the prescriptions he issued to T.H. at this visit 
were below the standard of care for a primary care provider and outside 
the usual course of professional practice. Id.
    On March 22, 2006, T.H. returned for a follow-up visit and saw 
Stout. See GX 17, at 42. The Expert found that the record of this visit 
was sparse, as ``Stout simply noted that T.H. was ``[h]ere for a 
follow-up. Denies recent trauma or illness. No fever, chills, nvd,'' 
and then circled entries on the record indicating that T.H. was 
anxious, depressed, and had lower back pain and cervical pain. GX 68, 
at 51.
    Stout issued T.H. additional prescriptions for 60 tablets of 
OxyContin 40 mg, 30 tablets of Lortab 10 mg, and 60 tablets of Xanax 1 
mg. See GX 17, at 42; GX 5, at 13. However, the Expert found that Stout 
did not document any evidence of the appropriateness of therapy by 
failing to quantify or evaluate T.H.'s pain and that there was also no 
information provided about the efficacy of the medications or the 
functionality of the patient. GX 68, at 52 (citing TN BON Rule 1000-
04.08(4)(c)). The Expert also noted that while Stout acknowledged that 
T.H. was anxious and depressed, the visit notes had no additional 
information about the psychosocial situation of the patient. Id.
    The Expert also observed that Stout did not generate a written 
treatment plan for T.H. and, as such, there was still no written 
treatment plan for T.H. Id. (citing TN BON Rule 1000-04.08(4)(c)2). Nor 
did Stout evaluate or assess T.H.'s history of, or potential for, 
substance abuse. Id. (citing TN BON Rule 1000-04.08(4)(c)1). The Expert 
thus concluded that these prescriptions were issued contrary to the 
guidelines set forth in TN BON Rule 1000-04-.08(4)(c) and, accordingly, 
below the standard of care and outside the usual course of professional 
practice. Id.
    On April 21, 2006, T.H. returned to AMC and saw Reynolds, who 
issued him more prescriptions for 60 tablets of OxyContin 40 mg, 30 
tablets of Lortab 10 mg, and 60 tablets of Xanax 1 mg. See GX 17, at 
41; GX 5, at 13. Once again, the Expert found that the record for the 
visit was largely unintelligible. GX 68, at 52. She also observed that 
while Reynolds documented that T.H. was complaining of right upper 
quadrant pain and referred him for possible ventral hernia, there did 
not appear to be any documentation in the file that the prior 
deficiencies in complying with the guidelines of TN BON Rule 1000-
04-.08 had been corrected. Id. at 51-52. Also, no AMC practitioner, 
including Mr. Reynolds and Mr. Stout, had created a written treatment 
plan for T.H, id. at 53 (citing TN BON Rule 1000-04.08(4)(c)2); and 
Reynolds still had not evaluated or assessed T.H.'s history of, or 
potential for, substance abuse. Id. (citing TN BON Rule 1000-
04.08(4)(c)1).
    According to the Expert, ``opioids typically would not be indicated 
in a case of new onset of abdominal pain, or even contraindicated 
pending an evaluation of the cause of the pain.'' Id. Given that T.H. 
had reported losing his job, the Expert also found it significant that 
the visit noted stated that he had a ``$310 balance; ins no pay.'' Id. 
(quoting GX 17, at 41). According to the Expert, this was a red flag 
for potential diversion which should have been explored because ``it 
indicates that T.H. [wa]s likely uninsured with increasing medical 
bills [and] [a] practitioner would have to be concerned about how T.H. 
was going to pay for not only the balance he owed to AMC, but also the 
drugs he was being prescribed in the

[[Page 28654]]

absence of insurance and possibly (still) a job.'' Id.
    The Expert also found that T.H. presented another red flag in that, 
according to the visit note, he did not complain ``of constipation.'' 
Id. According to the Expert, ``[i]f T.H. actually was taking the amount 
of narcotics he had been prescribed, Mr. Reynolds should have expected 
T.H. to complain of constipation and need a prescription to treat this 
condition. Absence of a constipation complaint may be a signal [that] 
T.H. was NOT taking the drugs and instead was diverting them.'' Id.
    The Expert then explained that under these circumstances, the 
standard of care and usual course of professional practice required 
that T.H. undergo a UDS to determine if he was taking the drugs that 
were prescribed and not diverting them. Id. However, the Expert found 
that there was no documentation in the visit note, or anywhere else in 
T.H.'s file, that he was asked to submit to a UDS at this visit. Id.; 
see also GX 17. The Expert thus concluded that Reynolds' issuance of 
the April 21, 2006 prescriptions was contrary to the guidelines set 
forth in TN BON Rule 1000-04-.08(4)(c) and, accordingly, below the 
standard of care and outside the usual course of professional practice. 
GX 68, at 53-54.
    On May 22, 2006, T.H. returned to AMC and was seen by both Reynolds 
and Stout. See GX 17, at 40.\9\ According to the Expert, the 
handwriting of both Stout and Reynolds appears on the record of this 
visit, even though the visit noted was signed by Mr. Stout. GX 68, at 
54.
---------------------------------------------------------------------------

    \9\ The Expert based her conclusion on the fact that in course 
of reviewing the records, she had become familiar with the 
respective handwriting of Reynolds, Stout, and Killebrew. GX 68, at 
54.
---------------------------------------------------------------------------

    During the visit, Stout noted that T.H. reported that he had been 
seeing another practitioner at the same time that he was obtaining 
controlled substances from AMC. GX 17, at 40. Specifically, Stout 
wrote: ``[Patient] has spoken with Bob Reynolds about seeing Dr. Doobie 
[(sic)]. [Patient] states has not seen since 4/2006.'' Id.
    As the Expert explained, this was another red flag for diversion 
and abuse, ``which is commonly referred to as `doctor-shopping.' '' GX 
68, at 54. Moreover, ``T.H.'s disclosure established that he had 
violated the Pain Management Agreement,'' which included the provision 
that he would `` `use only one physician to prescribe and monitor all 
opioid medications and adjunctive analgesics,' '' and that `` `[a]ny 
evidence of . . . acquisition of any opioid medication or adjunctive 
analgesia from other physicians . . . may result in termination of the 
doctor-patient relationship.' '' GX 68, at 54-55 (quoting GX 17, at 5). 
Indeed, in his letter to a DEA Diversion Investigator, Reynolds 
acknowledged that T.H. had signed the Pain Management Agreement at his 
first visit to AMC. GX 42, at 4.
    Notwithstanding T.H.'s clear violation of the Agreement, Reynolds 
issued him more prescriptions for 60 tablets of OxyContin 40 mg, 30 
tablets of Lortab 10 mg, and 60 tablets of Xanax 1 mg. See GX 17, at 
40; GX 18, at 30. As the Expert explained, when Reynolds issued these 
prescriptions, T.H. presented with multiple red flags in addition to 
that of doctor shopping. These included his financial, mental health, 
and alcohol issues. GX 68, at 55. However, ``T.H.'s file contains no 
indication that either Reynolds or Stout took the measures that a 
reasonable and prudent practitioner would have taken, such as to 
contact the other doctor [Dr. Dube] to confirm that he was no longer 
seeing T.H. and to ascertain the nature and extent of his treatment of 
T.H.'' Id. Also, neither Reynolds nor Stout took ``any other steps to 
ascertain the scope of T.H.'s abuse and/or diversion of controlled 
substances,'' such as by requiring him to provide a UDS. Id.; see also 
GX 17, at 5 & 40. Moreover, while in the Pain Management Agreement, 
T.H. had agreed to use only one pharmacy (the Hillcrest pharmacy), GX 
17, at 5; neither Reynolds nor Stout checked with the pharmacy to 
determine if he was, in fact, presenting all of his AMC prescriptions 
there and if he was also presenting controlled substances prescriptions 
from other practitioners. See generally GX 17.
    According to the Expert, ``each of these steps was an action that a 
reasonable and prudent family nurse practitioner would have taken when 
presented with this information, and was required by the standard of 
care in Tennessee.'' GX 68, at 55-56. The Expert thus explained that 
under the circumstances, the standard of care and the usual course of 
professional practice required the enforcement of the terms of the Pain 
Management Agreement, see GX 17, at 5 (pars. 1, 3, and 9); the 
cessation of the issuance of more controlled substances prescriptions; 
the taking of measures to ascertain whether T.H. was diverting the 
drugs he had been prescribed by requiring a UDS and contacting his 
pharmacy; and the referral of T.H to either a pain management 
specialist and/or a psychological/addiction specialist. GX 68, at 56.
    On June 20, 2006, T.H. returned to AMC and was again seen by 
Reynolds. GX 17, at 39. Once again, Reynolds issued T.H. more 
prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of Lortab 
10 mg, and 60 tablets of Xanax 1 mg. See id.; GX 18, at 30. Moreover, 
at this visit, T.H. presented a further red flag--specifically, 
Reynolds learned that T.H. was being treated with Suboxone, a schedule 
III controlled substance used to treat narcotic dependency, at the same 
time he had been receiving narcotics from AMC. GX 17, at 39. As the 
Expert found, the record of this visit contains an entry apparently 
made by A.N., a Registered Nurse, stating: `` `observed note regarding 
Medicine Shoppe in Jonesboro TN & Suboxone 8 mg (Knoxville region) & 
Oxycodone 40 mg from Appalachian Med Center & will consult proprietor 
of Appalachian Med Center Bob Reynolds FNP regarding urine screen 
possibly needed & how to proceed in care of this pt. Contact person at 
Medicine Shoppe is Jeff Street.' '' GX 68, at 56-57 (quoting GX 17, at 
39).
    In reviewing T.H.'s file, the Expert observed that the note 
referenced by A.N. was not in the file. Id. at 57. The Expert also 
observed that T.H.'s file did not contain any documentation indicating 
that Reynolds had investigated the information documented by the RN, 
such as documentation that Reynolds had contacted the pharmacy about 
T.H.'s Suboxone treatment or obtained a record of the prescriptions 
T.H. had presented and filled at the pharmacy. Id. And the Expert 
further explained that the fact that the Medicine Shoppe had 
prescription information for T.H. was also a red flag because T.H. had 
agreed to use only the Hillcrest pharmacy to fill his prescriptions. 
See id. The Expert thus concluded that Reynolds' issuance of the 
prescriptions was outside of the usual course of professional 
practice.\10\ Id. at 56-57.
---------------------------------------------------------------------------

    \10\ The Expert further explained that the usual course of 
professional practice required that the Pain Agreement be enforced, 
the cessation of controlled substance prescriptions, that the 
Medicine Shoppe be contacted to follow-up on the items noted, that 
T.H. be required to submit a UDS, and that T.H. be referred to 
either a pain management specialist, and/or a psychological/
addiction specialist. GX 68, at 57.
---------------------------------------------------------------------------

    On July 19, 2006, T.H. returned to AMC. Reynolds again issued him 
more prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of 
Lortab 10 mg, and 60 tablets of Xanax 1 mg. See GX 17, at 38; GX 18, at 
29. And once again, Reynolds had received additional information 
indicating that T.H. was likely engaged in abuse. GX 68, at 58.

[[Page 28655]]

    More specifically, T.H.'s file contains four documents that 
apparently were faxed to AMC from ``Northside Admin,'' and appear to 
have been faxed on the same date.\11\ See GX 17, at 59-62. However, the 
date on the fax banner at the top of each page is cut-off. See id.
---------------------------------------------------------------------------

    \11\ The Expert acknowledged that the fax banner on the copies 
in T.H.'s file was cut off. However, the Expert explained that she 
had reviewed copies of the same four documents that were sent to 
another provider (see GX 22), which were provided by DEA, and that 
the date appearing on the fax banner was July 5, 2006. It is clear, 
however that these documents were faxed and received by AMC because 
the next day, one William Clever, another Advance Nurse Practitioner 
at AMC, wrote a letter to T.H. on AMC's letterhead that he was 
``withdrawing from further professional attendance with you,'' 
suggested that T.H. find ``another provider without delay,'' and 
that ``after receipt of this letter, we will no longer be able to 
prescribe narcotics to you.'' GX 21, at 1.
---------------------------------------------------------------------------

    Notably, one of the documents was an April 21, 2006, letter from 
Dr. Michael Dube informing T.H. that he ``will no longer be treated as 
a patient at Medical Care Clinic and/or Watauga Walk-in Clinic.'' See 
GX 17, at 61. A second document showed that as of March 31, 2006, T.H. 
owed $230 to Medical Care Clinic. Id. at 59. A third document showed 
that as of June 6, 2006, T.H. owed $2,976 to Pain Medicine Associates 
(Dr. Williams' clinic), where T.H. was seen on December 5, 2005, having 
been referred by AMC. Id. at 60. The fourth document showed that on 
June 12, 2006, T.H. had received a prescription for Zoloft, a non-
controlled drug used to treat depression, from a medical doctor in 
Knoxville, Tennessee. Id. at 62.
    As the Expert explained, the letter from Dr. Dube confirmed the 
information that Reynolds and Stout received at T.H.'s April 20, 2006 
visit, namely, that he was seeing another provider at the same time he 
was receiving controlled substances from AMC, and thus likely doctor-
shopping. GX 68, at 58. The billing statements from Medical Care Clinic 
(Dr. Dube's practice) and Pain Medicine Associates (Dr. Williams' 
practice), ``provide[d] further evidence that T.H. was having 
significant financial difficulties.'' Id. at 58-59. According to the 
Expert, the fact that T.H. was approximately $3000 in debt to two 
medical practices should have been viewed as another red flag of his 
possible diversion of controlled substances. Id. at 59.
    As for the Zoloft prescription, the Expert observed that this was 
evidence that T.H. was having his mental health issues addressed by 
another provider. Id. As such, it was also a red flag that T.H. was 
possibly obtaining controlled substances from another practitioner 
after he was discharged by Dr. Dube. Id. The Expert further explained 
that Reynolds should have been interested in knowing if the Zoloft 
prescriber was the same Knoxville-based practitioner who reportedly was 
providing T.H. with Suboxone as mentioned in the RN's note for T.H.'s 
previous visit. Id.
    Noting that there was no evidence that Reynolds had contacted Dr. 
Dube, the Zoloft prescriber, the Hillcrest Pharmacy, or the Medicine 
Shoppe Pharmacy; nor evidence that he had required that T.H. provide a 
UDS; the Expert concluded that Reynolds' issuance of the prescriptions 
was below the standard of care and outside of the usual course of 
professional practice. Id. at 58-59. The Expert further opined that 
under the circumstances, the standard of care and usual course of 
professional practice would not be to issue T.H. additional controlled 
substances prescriptions but to enforce the terms of the Pain 
Management Agreement and cease further prescribing of controlled 
substances to T.H. Id. at 59.
    On August 10, 2006, T.H. returned to AMC, even though this was just 
twenty-two days since his last visit. GX 17, at 37. Reynolds again saw 
T.H. and issued him prescriptions for 10 tablets of Lortab 10 mg and 15 
tablets of Xanax 1 mg, which he authorized T.H. to fill on that date, 
as well as prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets 
of Lortab 10 mg, and 60 tablets of Xanax 1 mg, which could not be 
filled until August 15, 2006. See GX 17, at 37; GX 5, at 13. Reynolds 
issued these prescriptions notwithstanding the evidence that T.H. was 
abusing and/or diverting controlled substances discussed above, and 
even though T.H. was seeking an early refill of his Lortab and Xanax 
prescriptions on this visit. GX 68, at 60. As the Expert explained, 
T.H. should have had eight days of Xanax tablets remaining on the 
prescription Reynolds issued him on July 19, 2006. Id. (citing GX 18, 
at 29).
    Here again, T.H.'s early refill request was another red flag that 
T.H. was abusing and/or diverting the controlled substances that 
Reynolds was prescribing to him. Id. For the same reason as stated 
above, the Expert concluded that ``the standard of care and usual 
course of professional practice under these circumstances would not be 
to issue T.H. additional controlled substances prescriptions.'' Id. 
Rather, the standard of care and usual course of professional practice 
required that Reynolds ``enforce the terms of the'' Pain Contract, see 
GX 17, at 5 (par. 9), ``cease issuing further controlled substances to 
T.H., contact Hillcrest Pharmacy and Medicine Shoppe pharmacy to 
determine the prescriptions T.H. had filled, and order T.H. to take a 
UDS to determine if he was taking or diverting the controlled 
substances he had been issued or was taking controlled substances he 
had not been prescribed at AMC.'' GX 68, at 60.
    On September 7, 2006, T.H. returned to AMC and was seen by Stout, 
who issued him prescriptions for 60 tablets of OxyContin 40 mg, 45 
tablets of Lortab 10 mg, and 75 tablets of Xanax 1 mg. See GX 17, at 
36; GX 18, at 8. According to the Expert, Stout noted in the record of 
this visit that ``[T.H.] got meds filled early on 08/10/06--Rx dated 
08/15/06.'' GX 68, at 61. As the Expert explained, Stout was clearly 
aware of this red flag and should have questioned if T.H. was taking 
more than the prescribed amount or if he was selling the drugs. Id. 
Notwithstanding this, as well as the extensive other evidence in T.H.'s 
record that he was either abusing and/or diverting controlled 
substances, Stout issued the prescription. GX 18, at 8. For the same 
reasons set forth with respect to T.H.'s previous visit, the Expert 
concluded that Stout's issuance of the prescriptions was below the 
standard of care and outside of the usual course of professional 
practice. GX 68, at 61.
    On September 29, 2006, T.H. returned to AMC and was seen by 
Reynolds, who issued him prescriptions for 60 tablets of OxyContin 40 
mg, 75 tablets of Xanax 1 mg, and 45 Lortab 10 mg. GX 17, at 35; GX 18, 
at 8. Once again, T.H. presented a red flag in that he was seeking an 
early refill of both his OxyContin and Xanax prescriptions. GX 68, at 
62. According to the Expert, T.H. should have had eight days left on 
the previous OxyContin prescription (which was for a thirty-day supply) 
and at least three days left on the previous Xanax prescription (which 
provided 75 tablets with a dosing of one tablet every 8-12 hours). See 
GX 68, at 62; GX 17, at 36; GX 18, at 8.
    The Expert also noted that while T.H. had been receiving narcotics 
from AMC for nearly one year and had yet to be subjected to a UDS, and 
T.H.'s file documents that Reynolds sent him for blood work after this 
visit to check his blood counts, thyroid, and metabolic panel, see GX 
16, at 50; Reynolds did not require that T.H. provide a UDS. GX 68, at 
62. ``Based on this new red flag and the prior information indicating 
T.H.'s abuse and/or diversion of controlled substances,'' the Expert 
concluded that ``it was below the standard of care and outside the 
usual course of professional practice for Reynolds to issue these 
prescriptions without taking any steps to monitor his controlled 
substances use, including conducting a UDS and checking with

[[Page 28656]]

his pharmacy for controlled substances prescriptions he was 
filling.''\12\ Id.
---------------------------------------------------------------------------

    \12\ Reynolds also saw T.H. on November 6 and December 4, 2006; 
at each visit, Reynolds issued him prescriptions for 60 OxyContin 40 
mg, 30 Percocet 10/325 mg, and 75 Xanax 1 mg. GX 17, at 33-34; GX 
18, at 9-10.
---------------------------------------------------------------------------

    On January 3, 2007, T.H. went to AMC and saw Killebrew, who issued 
him prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of 
Percocet 10/325 mg, and 75 tablets of Xanax 1 mg. See GX 17, at 32; GX 
18, at 28. Killebrew noted in the record of this visit that T.H. was 
``[g]etting [d]ivorced,'' complaining of increased anxiety due to his 
divorce, and was crying. See GX 17, at 32. The visit note also 
documents that T.H. had lost six pounds since his last visit. Id.
    According to the Expert, this may indicate that T.H. had depression 
given the information T.H. shared about his divorce and Killebrew wrote 
him a prescription for an antidepressant (Celexa) at this visit. GX 68, 
at 63 (citing GX 17, at 32). T.H. also reported that his pain was a 
seven out of ten, which indicates that the drug regimen he had been 
prescribed previously at AMC was not controlling his pain. Id. 
Killebrew also had T.H. sign a new Pain Management Agreement, which she 
witnessed. GX 17, at 2.
    The Expert explained that based on the information T.H. reported at 
this visit, as well as the information in his file from prior visits, 
T.H. should have been considered a ``high-risk patient for managing 
chronic pain'' and whose ``care extend[ed] beyond the scope of'' a 
nurse practitioner engaged in family practice ``at this point.'' GX 68, 
at 63. The Expert further noted that a prudent practitioner would have 
considered T.H. to be ``a risk for suicide and diversion'' and would 
have referred him ``to a mental health specialist and a comprehensive 
pain management program.'' Id. Yet, the Expert found no evidence in the 
file that Killebrew did so. Id.
    The Expert also noted that there was no documentation in T.H.'s 
file indicating that Killebrew had checked with the pharmacy T.H. had 
identified on his pain contracts as the sole pharmacy he would use to 
fill his prescriptions to determine if he still was engaging in doctor-
shopping. Id. The Expert also found no evidence that Killebrew required 
him to submit to a UDS. Id. at 63-64. Based on the red flags T.H. 
presented and Killebrew's failure to take these steps to monitor T.H.'s 
use of controlled substances, the Expert opined that the issuance of 
the prescriptions was contrary to the Board's Rule 1000-04-.08(4)(c), 
and, accordingly, below the standard of care and outside the usual 
course of professional practice. Id. at 64.
    On March 2, 2007, T.H. visited AMC and saw Stout, who issued him 
prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of Lortab 
10 mg, and 75 tablets of Xanax 1 mg. See GX 17, at 29; GX 18, at 27. 
The Expert opined that Stout's notes for this visit were ``sparse, at 
best'' as they state only that T.H. was ``[h]ere for follow-up. Denies 
recent trauma or illness. Patient states pain medication is controlling 
his pain. Describes pain as 4/10 while on pain medication. Denies 
fever, chills, nvd.'' GX 68, at 64 (quoting GX 17, at 29). The Expert 
also observed that the visit notes contained no discussion of T.H.'s 
anxiety issues which Killebrew had documented during the January 3, 
2007 visit. Id. The Expert also found that there was ``no documentation 
of any evaluation or assessment of the alcohol and financial red flags 
that were presented at several prior visits,'' that Stout ``neglected 
to inquire about whether T.H. was now employed or whether he was 
currently drinking alcohol'' even though the form contained a section 
for alcohol use (``ETOH''), nor elaborated on his purported finding 
that T.H. was ``anxious.'' Id.
    The Expert also found that there was still no evidence that a 
written treatment plan was created for T.H. identifying objectives of 
treatment, or an update on the treatment plan as required by TN BON 
Rule 1000-04-.08(4)(c)2 & 4. Id. Moreover, the Expert found that while 
on January 1, 2007, the Tennessee prescription monitoring program 
(CSMD) had become available to practitioners to assist them in 
determining whether their patients were seeing other providers, there 
was no evidence in the file that Stout conducted a check on T.H. at 
this visit, even though T.H.'s record documented multiple instances in 
which AMC obtained information that T.H. was engaged in doctor-
shopping. Id. at 64-65. Nor did the Expert find any evidence in the 
file that Stout had checked with the pharmacy T.H. identified on his 
pain contracts as the sole pharmacy he would use to fill his 
prescriptions to determine if he was doctor shopping. Id. at 65. The 
Expert thus opined that Stout's issuance of these prescriptions was 
contrary to the guidelines set forth in Tennessee BON Rule 1000-
04-.08(4)(c), and, accordingly, below the standard of care in Tennessee 
and outside the usual course of professional practice. Id.
    On May 1, 2007, T.H. visited AMC and saw Stout, who again issued 
him prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of 
Lortab 10 mg, and 75 tablets of Xanax 1 mg. See GX 17, at 27; GX 18, at 
25-26. Once again, the Expert found that Stout's record of the visit 
was ``very sparse,'' as it stated only: ``Here for follow-up. PT denies 
trauma. Patient states back pain is controlled by pain medication. 
Denies radiation of pain or urinary incontinence. Denies chest pain or 
sob. Denies fever, chills, nvd.'' GX 68, at 65. Once again, the Expert 
observed that the visit note did not document that Stout had discussed 
with T.H. his use of alcohol (the ETOH portion of the form being 
blank), his anxiety,\13\ and his employment and financial situation. 
Id.
---------------------------------------------------------------------------

    \13\ While the note stated that T.H. was ``anxious,'' the Expert 
explained that Stout ``failed to elaborate on his finding.'' GX 68, 
at 65.
---------------------------------------------------------------------------

    The Expert also found that there was still no evidence of a written 
treatment plan for T.H. identifying treatment objectives, or an update 
on the treatment plan as required by TN BON Rule 1000-04-.08(4)(c)2, 4; 
she also found that Stout failed to quantify T.H.'s pain on this visit. 
Id. at 66. And once again, the Expert found that Stout did not take any 
steps to monitor whether T.H. was currently doctor-shopping and seeing 
other practitioners. Id. The Expert thus opined that Stout's issuance 
of these prescriptions was contrary to the guidelines set forth in 
Tennessee BON Rule 1000-04-.08(4)(c), and accordingly, below the 
standard of care in Tennessee and outside the usual course of 
professional practice. Id.
    On June 26, 2007, T.H. visited AMC and saw Stout, who again issued 
him prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of 
Lortab 10 mg, and 75 tablets of Xanax 1 mg. See GX 17, at 23-24; GX 5, 
at 14-17. While the Expert noted that AMC had started using electronic 
medical records and that Stout had noted that T.H. ``is satisfied with 
the current treatment plan,'' she still found that there was no 
documentation in the record of a written treatment plan. GX 68, at 66 
(citing TN BON Rule 1000-04-.08(4)(c)2). The Expert further noted that 
while Stout documented that T.H. reported he was having ``some 
increases [sic] problems situationally lately with their [sic] anxiety 
and depression,'' Stout again neglected to inquire about T.H.'s use of 
alcohol, which could have been the source of his anxiety and depression 
problems. Id. (quoting GX 17, at 23); also citing GX 41, at 6 (Uphold & 
Graham).
    According to the Expert, Stout's failure to address this issue was 
contrary to the requirements of TN BON

[[Page 28657]]

Rule 1000-04-.08(4)(c)2 because ``[w]ithout knowing about the status of 
his alcohol issues, Mr. Stout was unable, and in fact did not `consider 
[the] need for further testing, consultations, referrals, or use of 
other treatment modalities.' '' Id. at 67. Also, while Stout noted that 
T.H. was having ``work issues'' and ``financial problems,'' he failed 
to document whether T.H. was in fact now employed and capable of paying 
for his continued treatment (including medications). Id. Moreover, the 
Expert found no evidence that Stout took any steps to monitor whether 
T.H. was currently doctor-shopping and seeing other practitioners. Id. 
The Expert thus opined that Stout's issuance of these prescriptions was 
contrary to the guidelines set forth in Tennessee BON Rule 1000-
04-.08(4)(c), and accordingly, below the standard of care in Tennessee 
and outside the usual course of professional practice. Id.
    On July 24, 2007, T.H. returned to AMC and saw Killebrew, who 
issued him prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets 
of Lortab 10 mg, and 90 tablets of Valium 10 mg. See GX 17, at 21-22; 
GX 18, at 24. T.H. reported that his pain was a 4 out of 10, that he 
was having problems with anxiety (which, according to the Expert 
indicated that the Xanax was not controlling his anxiety), and that he 
was trying to quit alcohol. GX 17, at 21. T.H. also reported that he 
had made an appointment with a local mental health facility. Killebrew 
noted that T.H. presented with ``Hand tremors, anxious today'' and that 
he had an elevated blood pressure. Id. According to the Expert, these 
findings may have been signs of anxiety or alcohol/drug withdrawal. GX 
68, at 68.
    According to the Expert, alcohol abuse was a red flag and Killebrew 
should have considered that if T.H. was abusing alcohol, he may also 
have been abusing opioids and/or illicit substances. Id. (citing GX 41, 
at 20-21 (Uphold & Graham)). Relying on Uphold & Graham, the Expert 
further noted that `` `[p]atients who are alcohol dependent and who 
also have a psychiatric disorder should be referred for treatment for 
the underlying disorders as these patients are usually complex.' '' Id. 
(quoting GX 41, at 23); see also GX 41, at 15 (stating that 
``[p]atients with comorbid conditions (primary anxiety disorder, 
substance abuse, dementia)'' should be referred to a specialist). 
According to the Expert, ``Killebrew's findings on this visit are 
further evidence that T.H. required care that was beyond the scope of 
family practice nurse practitioners.'' GX 68, at 68.
    While the Expert noted that Killebrew had documented in T.H.'s 
record that she had provided him with information on Alcoholics 
Anonymous and other recovery groups, id. (citing GX 17, at 21); the 
Expert then explained that ``a patient who is trying to quit alcohol is 
not an appropriate patient for [a] primary care nurse practitioner to 
attempt to manage his chronic pain'' Id. The Expert thus found that 
``Killebrew should have ceased issuing T.H. further controlled 
substance prescriptions and sent him for evaluation by a mental health 
specialist,'' and further concluded that Killebrew's issuance of the 
prescriptions was ``contrary to the guidelines set forth in Tennessee 
BON Rule 1000-04-.08(4)(c), and accordingly, not consistent with the 
standard of care and outside the usual course of professional 
practice.'' Id.
    On August 23, 2007, Killebrew again saw T.H. and issued him 
prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of Lortab 
10 mg, and 90 tablets of Valium 10 mg. See GX 17, at 19-20; GX. 18, at 
23. Killebrew noted in the visit record that T.H. had recently gone to 
the JCMC emergency room after injuring his left leg. See GX 17, at 19.
    According to the Expert, this information was also a red flag 
suggestive of either abuse or an injury caused by over sedation, as the 
latter could have resulted from T.H.'s combined ingestion of Valium 
(which she had previously prescribed to him) and alcohol, or Valium 
alone, given the high dosage (10 mg three times per day) she had 
prescribed. GX 68, at 69 (citing GX 17, at 21-22; GX 18, at 24).
    The Expert further noted that Killebrew neither asked T.H. if he 
had obtained any pain medications at his JCMC ER visit, nor obtained 
any records from the JCMC to determine whether T.H. had been given any 
prescriptions. Id. at 69. The Expert also found that Killebrew neither 
contacted T.H.'s pharmacy to obtain a recent dispensing history, nor 
conducted a check of the CSMD to see if he had been receiving 
controlled substances from other practitioners. Id.
    While Killebrew again noted in the record that T.H. was ``trying to 
quit [alcohol]'' and ``[h]as made an appt. with Frontier Health,'' she 
did not document that she discussed with T.H. his efforts to quit 
alcohol since his previous visit or that she had discussed with T.H. 
whether he had been seen by the mental health clinic. GX 17, at 19. As 
the Expert found, Killebrew simply issued T.H. ``additional controlled 
substance prescriptions in the face of all of the red flags of T.H.'s 
abuse and diversion of controlled substances set forth in the 
paragraphs above.'' GX 68, at 69-70. The Expert thus concluded that 
Killebrew's issuance of the additional controlled substance 
prescriptions was contrary to the guidelines set forth in Tennessee BON 
Rule 1000-04-.08(4)(c), and accordingly, below the standard of care and 
outside the usual course of professional practice. Id. at 70 (citing 
Uphold & Graham, GX 41, at 14, 23).
    On September 19, 2007, T.H. returned to AMC and saw Reynolds, who 
issued him prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets 
of Percocet 10/650 mg, and 90 tablets of Valium 10 mg. See GX 17, at 
17-18; GX 18, at 23. According to the Expert, Reynolds issued these 
prescriptions without discussing with T.H. his visit at the mental 
health facility and did not obtain any records from the facility, even 
though the two previous visit notes mentioned that T.H. had made such 
an appointment. GX 68, at 70. Reynolds also did not acquire any 
information from T.H. about his efforts to quit alcohol, even though 
this was also mentioned in the two previous visit notes, and Reynolds 
did not document that he even addressed with T.H. his alcohol issues. 
Id.; GX 17, at 17-18. Nor is there any documentation that Reynolds 
discussed with T.H. his recent visit to the Emergency Room and T.H.'s 
file contains no record of his visit to the ER. GX 17, at 17-18.
    The Expert further noted that Reynolds ``failed to take any other 
steps to monitor T.H.'s controlled substances use, despite the numerous 
red flags of potential drug abuse and diversion that T.H. had presented 
on prior visits.'' GX 68, at 70. The Expert thus concluded that 
``Reynolds' issuance of the additional controlled substance 
prescriptions was contrary to the guidelines set forth in Tennessee BON 
Rule 1000-04-.08(4)(c), and accordingly, below the standard of care and 
outside the usual course of professional practice.'' Id.
    On October 17, 2007, T.H. returned to AMC and again saw Reynolds, 
who issued him more prescriptions for 60 tablets of OxyContin 40 mg, 30 
tablets of Percocet 10 mg, 90 tablets of Xanax 1 mg, and Celexa 20 mg 
(a non-controlled anti-depressant). See GX 17, at 13-15; GX 19, at 2-6. 
In the visit note, Reynolds documented that T.H. ``has had increased 
problems with depression and had ran out of his Prozac, he is going to 
seek counseling at wmh and we will restart antidepressant today.'' GX 
17, at 13.
    Notably, T.H. had not previously been prescribed Prozac by anyone 
at AMC. See generally GX 17, at 17-47.

[[Page 28658]]

According to the Expert, this information should have placed Reynolds 
``on notice that T.H. was seeing another practitioner, in particular a 
mental health specialist.'' GX 68, at 71. The Expert further explained 
that:

[i]f a mental health specialist had taken over care for T.H. and his 
depression was worsening, as . . . Reynolds' notes of this visit 
reflect, then the usual course of practice would have been for the 
primary care nurse practitioner to contact the specialist and have 
the specialist manage T.H.'s care. Under these circumstances, Mr. 
Reynolds, as the primary care nurse practitioner, should not have 
changed T.H.'s antidepressant from Prozac to Celexa, and he should 
not have prescribed him Xanax and opioids, especially in the 
quantities he did, which have lethal potential in someone with 
increasing depression and history of alcohol use/abuse.

Id. at 71-72.
    According to the Expert, Reynolds should also have asked T.H. about 
his use of Prozac, run a CSMD check, and required T.H. to submit to a 
UDS before issuing him more prescriptions. Id. at 71. However, 
according to T.H.'s record, Reynolds did none of these. See GX 17, at 
13-15; GX 68, at 71. Moreover, according to the Expert, while T.H. 
would still have had several days left on his Valium 10 mg 
prescription, ``Reynolds should have, but according to the record did 
not'' instruct T.H. to stop taking the drug even though Reynolds had 
prescribed Xanax 1 mg along with the opioids (OxyContin and Percocet). 
GX 68, at 72 (citing GX 17, at 17-18; GX 18, at 23). According to the 
Expert, ``[a]dding 10 mg Valium to a drug regimen of OxyContin 40 mg, 
Percocet 10 mg, and Xanax 1 mg had the potential to be a lethal 
combination because of the respiratory depressing effects of these 
drugs.'' Id. The Expert thus concluded that Reynolds' issuance of the 
controlled substances prescriptions at this visit ``was contrary to the 
guidelines set forth in Tennessee BON Rule 1000-04-.08(4)(c), and 
accordingly, below the standard of care and outside the usual course of 
professional practice.'' Id.
    T.H. died the following day. GX 24, at 2. According to the Medical 
Examiner's report, ``[p]ostmortem blood toxicology showed oxycodone 
(and its metabolite) in a supratherapeutic to potentially lethal 
concentration, alprazolam in a therapeutic to toxic concentration and 
diazepam (and its metabolite) in a therapeutic concentration.'' Id. at 
1. The Medical Examiner thus concluded that ``[a]lthough the drugs may 
be present in therapeutic to potentially lethal concentrations, the 
combined/synergistic effects of the drugs caused death by central 
nervous system depression.'' Id.
    Summarizing her findings, the Expert explained that during the two-
year period in which T.H. went to AMC, he presented ``numerous red 
flags of abuse and diversion'' and yet he ``was never asked to take a 
UDS, nor was he ever asked to come into AMC for a pill count.'' GX 68, 
at 72. The Expert also explained that while ``the CSMD was available 
for the last ten months of his AMC visits, none of the practitioners 
ever conducted a CSMD check for him.'' Id. The Expert thus opined that 
``the monitoring of [T.H.'s] controlled substances use by Mr. Reynolds, 
Mr. Stout, and Ms. Killebrew was woefully inadequate, and far below the 
standard of care in Tennessee.'' Id.

C.S.

    On December 12, 2008, C.S. made her first visit to AMC and was seen 
by Reynolds. GX 26, at 45-46. C.S. completed a patient intake form 
stating that she had shoulder, knee, and back pain; she wrote that she 
had suffered injuries from a car accident which resulted in a metal rod 
in her femur and a plate and screw in her ankle. Id. at 10-11. Notably, 
on this form, C.S. stated that she did not have a current healthcare 
provider and did not list any medications that she was currently 
taking. Id. at 10, 11. C.S. also signed a Pain Management Agreement at 
this visit, which Reynolds also signed. Id. at 9. Reynolds prescribed a 
thirty-day supply of 90 tablets of Percocet 7.5/500 mg (oxycodone/
acetaminophen, a schedule II drug) and 60 tablets of Valium 5 mg. See 
GX 26, at 45-46; GX 29, at 3.
    The Expert observed that while Reynolds noted in the record that 
C.S. had ``a longstanding [history] of back pain,'' ``he did not have 
any information regarding treatment C.S. had been receiving for the 
fourteen months immediately preceding her first visit to AMC.'' GX 68, 
at 76 (citing GX 26, at 45). The Expert further observed that the only 
documentation of prior treatments in C.S.'s file were records Reynolds 
obtained from a physician who treated her between June 2007 and October 
25, 2007.\14\ Id. Significantly, that physician had noted that C.S. 
``takes extra Rx pain pills in contrast to my recommendations'' and 
that he did ``not think she can self-medicate. . . .'' GX 26, at 58-61.
---------------------------------------------------------------------------

    \14\ The file does include records indicating that from June-
October 2007 C.S. was taking Percocet and Ativan, as well as 
Effexor, a non-controlled drug prescribed to treat major depressive 
disorder, anxiety and panic disorder. GX 26, at 58-61.
---------------------------------------------------------------------------

    According to the Expert, this information ``should have been a red 
flag to Reynolds that C.S. misused and abused previous medications she 
had been prescribed.'' GX 68, at 76. Yet the Expert found that ``C.S's 
file indicates that Reynolds did not take any steps to follow-up on 
this information, such as contacting the previous physician about these 
entries and the nature, extent and duration of his treatment of C.S.'' 
Id. Nor, according to the Expert, did Reynolds ``obtain any other 
information related to C.S.'s history of[,] and potential for[,] 
substance abuse, despite being placed on clear notice of such issues.'' 
Id. The Expert also found that Reynolds ``failed to conduct a CSMD 
check, which would have provided him information about previous 
treatments with controlled substances and her substance use and abuse 
history.'' Id at 76-77.
    The Expert further found that Reynolds ``failed to create a patient 
record that appropriately documented C.S.'s medical history and 
pertinent historical data, such as pain history, pertinent evaluations 
by other providers, history of and potential for substance abuse, and 
pertinent coexisting diseases and conditions. He also did not create a 
written treatment plan tailored for C.S.'s individual needs, nor did he 
consider the need for further testing, consultations, or referrals, or 
the use of other treatment modalities.'' Id. at 77 (citing Tenn. BON 
Rule 1000-.04-.08(4)(c)1 & 2. The Expert thus concluded that Reynolds' 
decision to immediately start C.S. on a controlled substances regimen 
contravened the guidelines of TN BON Rule 1000-04-.08. Id.
    The Expert also noted that Reynolds had written in C.S.'s record 
that her pain was being treated in accordance with the guidelines in 
the Jackman article, which AMC had purportedly adopted for its 
treatment protocols.\15\ Id. at 73. Consistent with her analysis and 
conclusions regarding N.S. and T.H., the Expert concluded that Reynolds 
ignored several recommendations contained within that article in his 
treatment of C.S. Id.
---------------------------------------------------------------------------

    \15\ See Robert P. Jackman, M.D., et al., ``Chronic Nonmalignant 
Pain in Primary Care,'' American Family Physician (Nov. 2008) (GX 
39, at 5-12).
---------------------------------------------------------------------------

    These included that ``[w]hen psychiatric comorbidities are present, 
risk of substance abuse is high and pain management may require 
specialized treatment or consultation. Referral to a pain management 
specialist can be helpful.'' Id. (quoting GX 39, at 5) As the Expert 
explained, the article then instructed that the evaluation of the

[[Page 28659]]

patient must include ``[a] thorough social and psychiatric history 
[that] may alert the physician to issues, such as current and past 
substance abuse, development history, depression, anxiety, or other 
factors that may interfere with achieving treatment goals.'' Id. at 74.
    According to the article, ``[b]y identifying patients at risk of 
possible opioid misuse (e.g. persons with past or current substance 
abuse, persons with psychiatric issues), physicians can choose to 
modify the monitoring plan or to refer the patient to a pain 
specialist.'' GX 39, at 5. The article further stated that ``[f]or 
patients at high risk of diversion and abuse, consider the routine use 
of random urine drug screens to assess for presence of prescribed 
medications and the absence of illicit substances.'' Id. at 9 (emphasis 
added). The article also advised that ``[a]berrant behavior that may 
suggest medication misuse includes use of pain medications other than 
for pain treatment, impaired control (of self or of medication use), 
compulsive use of medication . . . selling or altering medications, 
calls for early refills, losing prescriptions, drug-seeking behavior 
(e.g. doctor-shopping), or reluctance to try nonpharmacologic 
intervention.'' Id. at 11 (emphasis added).\16\
---------------------------------------------------------------------------

    \16\ The Jackman article was supplemented in the same edition of 
American Family Physician by an Editorial, which provided additional 
guidance on the ``risk of drug misuse, abuse, and addiction'' that 
exists when treating patient with long-term opioids, a topic that 
was not fully explored in the Jackman article. See GX 49. The 
Editorial discussed the steps physicians should take to ``monitor'' 
these risks, including focusing on the patient's medical history, 
obtaining information from family members, focusing on physical 
signs of possible aberrant drug-taking behavior, such as slurred 
speech, small pupils, and unusual affect, and the use of urine drug 
screening that ``should be positive for prescribed medications, 
negative for medications that have not been prescribed, and negative 
for illicit drugs.'' Id. at 1-2. The Editorial, moreover, emphasized 
that ``[t]he current standard of care used by pain management 
specialists to treat patients with chronic pain and aberrant drug-
taking behavior is an abstinence-oriented approach.'' Id. at 2. 
According to the Editorial, ``[i]n this approach, patients initially 
discontinue their opioid use for a `drug holiday.' Formal inpatient 
or outpatient detoxification is sometimes required to stabilize 
opioid withdrawal syndrome. Following this, patients are given 
multidisciplinary treatment for opioid dependency and chronic pain, 
including cognitive behavior therapy (i.e. for chronic pain and a 
substance abuse disorder) that is concurrent with nonopioid pain 
management.'' Id.
---------------------------------------------------------------------------

    Based on the guidance contained in the Jackman article, the 
Editorial, and the requirements set forth in TN BON Rule 1000-
04-.08(4)(c), the Expert concluded that ``Reynolds['] issuance of the 
controlled substances prescriptions to C.S. at her first visit was 
below the standard of care and outside the usual course of professional 
practice.'' GX 68, at 75. Moreover, based on her review ``of C.S.'s 
patient file through her last visit on November 30, 2009,'' the Expert 
concluded that both Reynolds and Stout ``failed to comply with the 
Rule's guidelines on subsequent visits by C.S.'' Id. at 77. More 
specifically, the Expert found that Reynolds and Stout ``never acquired 
the information that was lacking at C.S.'s initial visit and, 
therefore, the controlled substances prescriptions they issued at 
subsequent visits were contrary to the Rule's guidelines for the same 
reasons as the prescriptions issued on the initial visit.'' Id.
    The Expert also found that ``at each periodic interval, Reynolds 
and Stout failed to appropriately evaluate C.S. for continuation or 
change of medication, and include in the patient record her progress 
towards reaching treatment objectives, any new information about the 
etiology of the pain, and an update on the treatment plan.'' Id. at 77-
78 (citing TN BON Rule 1000-04-.08(4)(c)4). The Expert thus concluded 
that on C.S.'s subsequent visits, such as those of March 12, 2009 and 
April 10, 2009, when Stout prescribed 90 tablets of Percocet 7.5/500 
mg, 60 tablets of Valium 5 mg, and 30 tablets of Fastin 30 mg 
(phentermine, a schedule IV drug) to her, he acted in contravention of 
the Rule's guidelines, as well as the standard of care. Id. at 78 
(citing GX 26, 28-37, 40; GX 27, at 2, 4, 5; GX 29, at 4).
    The Expert also found that both Reynolds and Stout ignored red 
flags of abuse and diversion that were presented to them at C.S.'s 
subsequent visits, and did so even though C.S. had violated the terms 
of her Pain Management Agreement. Id. For example, on July 9, 2009, 
Reynolds issued C.S. prescriptions for 45 tablets of Roxicodone 15 mg 
(oxycodone), 60 tablets of Valium 5 mg and 30 tablets of Fastin 37.5 
mg. See GX 26, at 29-30; GX 28, at 2. Reynolds issued these 
prescriptions even though on June 12, 2009, Reynolds documented that he 
had received a phone call from a person at ``Genesis Healthcare,'' 
which was a ``new practice in Boones Creek''; according to the note, 
Reynolds was informed that C.S. had told Genesis Healthcare that ``she 
did not have a family practice [and] was seeking to establish new 
[patient] care.'' GX 26, at 31. Reynolds was further informed that C.S. 
also used another name (``goes by [C.M.]).'' Id. Reynolds received this 
call three days after he had seen C.S. at AMC (on June 9, 2009), and 
had prescribed to her 45 tablets of Roxicodone 15 mg and 60 tablets of 
Valium 5 mg. See GX 26, at 33-34; GX 28, at 2. Of further note, the 
call from Genesis occurred two days after C.S. had called AMC seeking a 
refill of Fastin, which Reynolds refused to issue. GX 26, at 32.
    According to the Expert, the telephone call from Genesis Healthcare 
was ``a huge red flag.'' GX 68, at 79. The Expert explained that it 
``should have been alarming'' to Reynolds ``that C.S. told another 
practice that she did not have a family practice when she had been 
going to AMC monthly for the past seven months'' and that she was also 
using a second name. Id. As the Expert explained, after the phone call, 
Reynolds was aware that C.S. had misled both AMC and the other 
practitioner, and likely was doctor-shopping. Id. This was a violation 
of the terms of her Pain Management Agreement, which included the 
provision that: ``I will not attempt to obtain any controlled 
medicines, including opioid pain medicines, controlled stimulants, or 
anti-anxiety medicines from any other doctors.'' Id. (quoting GX 26, at 
9).
    Yet, at her July 9, 2009 visit, Reynolds did not discuss or 
otherwise confront C.S. about the information he had received from 
Genesis. Id. (citing GX 26, at 29-30). Moreover, C.S.'s patient record 
contains no documentation that Reynolds addressed C.S.'s violation of 
her PMA, even though its terms provided that if she broke the 
agreement, ``my provider will stop prescribing controlled substances 
immediately and only provide care for life threatening and chronic 
medical conditions'' and that she would ``either be discharged from 
th[e] practice or [o]ffered only alternative treatments such as non-
narcotic medications and treatment center options.'' Id. at 79-80 
(quoting GX 26, at 9); see also GX 26, at 29-30.
    Moreover, the medical record contains no evidence that Reynolds 
took steps to monitor C.S.'s controlled substances use, such as by 
conducting a check of the CSMD before issuing the prescriptions. Id. at 
79-80; see also GX 26. He also did not require her to submit to a UDS 
to determine if she was taking the drugs she had been prescribed at AMC 
and if there were any non-AMC prescribed drugs in her system. Id. at 
80; GX 26.
    ``For all of these reasons,'' the Expert concluded that ``Reynolds' 
decision to continue issuing [C.S.] controlled substance prescriptions 
on July 9, 2009 was contrary to [the] guidelines set forth in Tenn. BON 
Rule 1000-.04-.08, and accordingly, below the standard of care and 
outside the usual course of professional practice.'' GX 68, at 80. 
Relying on the Jackman article and

[[Page 28660]]

accompanying Editorial, the Expert further concluded that ``the 
standard of care and usual course of professional practice . . . would 
have been to enforce the terms of C.S.'s [Pain Mgmt. Contract], cease 
prescribing her controlled substances, and refer her to a pain 
management specialist and/or addiction specialist to address her drug-
seeking behavior.'' Id.
    On August 4, 2009, C.S. returned to AMC and saw Stout, who issued 
her prescriptions for 45 tablets of Roxicodone 15 mg, 60 tablets of 
Valium 5 mg, and 30 tablets of Fastin 37.5 mg. See GX 26, at 27-28; GX 
27, at 2; GX 28, at 2 & 14. Stout issued these prescriptions even 
though he had since received further evidence unequivocally showing 
that C.S. had engaged in doctor-shopping at both Genesis Healthcare and 
a third practitioner, as well as pharmacy-shopping. GX 68, at 80. 
Notably, on the date of this visit, AMC ran two CSMD queries to 
determine what controlled substances had been dispensed to C.S. during 
the period August 1, 2008, through August 4, 2009; the report was 
placed in C.S.'s AMC patient file. Id. (citing GX 26, at 54-57). The 
query was run using both of the names C.S. was known to have used when 
she sought controlled substances. Id. As the Expert explained, this 
demonstrates that AMC and Stout were aware of the fact that C.S. used 
multiple names. Id. at 80-81.
    According to the Expert, the two CSMD reports revealed the 
following information:

    (a) On June 3, 2009, C.M. received prescriptions for 56 
oxycodone 7.5 mg and 15 Alprazolam 1 mg from the above-referenced 
practitioner in Boones Creek, Tennessee, which was six days before 
she visited AMC on June 9, 2009 and obtained prescriptions for 45 
tablets of Roxicodone 15 mg and 60 tablets of Valium 5 mg from 
Reynolds.
    (b) On June 15, 2009, C.S. received a prescription for 
phentermine 37.5 mg, another schedule IV controlled substance for 
weight loss, from a third different practitioner just six days after 
her June 9, 2009 visit to AMC, and five days after Reynolds refused 
her request to refill her prescription for Fastin.
    (c) C.S. had been treated for narcotic dependence during the 
several months preceding her first visit to AMC. Specifically, the 
CSMP report shows that C.S. was treated with Suboxone throughout 
2008. Significantly, the CSMP report showed that on October 10, 
2008, just two months before C.S. began as a patient at AMC, she was 
issued a Suboxone prescription by Dr. Vance Shaw, AMC's Medical 
Director.
    (d) C.S. was pharmacy shopping, in addition to doctor-shopping. 
On May 11, 2009, C.S. presented to Church Hill Drugs prescriptions 
for a thirty-day supply of oxycodone and alprazolam that she had 
obtained from AMC (Reynolds). Twenty-four days later, on June 3, 
2009, C.S. presented to a different pharmacy, Wilson Pharmacy, the 
oxycodone and alprazolam prescriptions she obtained from the Boones 
Creek practitioner. Then, six days later, on June 9, 2009, which 
would have been the thirty-day expiration date of the May 11, 2009 
prescriptions, C.S. returned to Church Hill Drugs to present the 
oxycodone and diazepam prescriptions she obtained from AMC 
(Reynolds). Thus, the CSMP report alerted Stout to the fact that 
C.S. was consciously selecting different pharmacies at which to 
present prescriptions for the same types of controlled substances so 
as to avoid being detected for doctor-shopping and to obtain early 
refills.

Id. at 81-82 (citing GX 26, at 49-57).
    Thus, the CSMD reports clearly showed that C.S. had violated the 
terms of her Pain Management Agreement by both doctor shopping and 
pharmacy shopping (i.e., filling her controlled substance prescriptions 
at multiple pharmacies).\17\ Id. at 82. Notwithstanding the 
``information showing that C.S. was seeing three different practices at 
the same time, was pharmacy-shopping, was in violation of her PMA, and 
was being treated for narcotics dependence for the several months 
leading up to her first AMC visit, which she had not disclosed to AMC, 
Stout issued her the above-referenced controlled substances 
prescriptions.'' Id.
---------------------------------------------------------------------------

    \17\ In her Pain Management Agreement, C.S. had agreed to use 
only Church Hill Drugs to fill her controlled substance 
prescriptions. See GX 26, at 9.
---------------------------------------------------------------------------

    Indeed, according to C.S.'s file, during the visit, Stout did not 
even discuss the CSMD reports with C.S. GX 26, at 27-28. Nor did he 
require her to provide a UDS or subject her to a pill count, which, 
according to the Expert, would have been reasonable responses to the 
red flag information he possessed. Id. The Expert thus found that 
Stout's decision to issue her more controlled substance prescriptions 
on August 4, 2009 was ``contrary to guidelines set forth in Tenn. BON 
Rule 1000-.04-.08, and accordingly, below the standard of care and 
outside the usual course of professional practice.'' GX 68, at 83.
    Reynolds and Stout issued additional controlled substances 
prescriptions for oxycodone and benzodiazepines (Valium and Xanax) to 
C.S. on September 3, 2009, September 30, 2009, October 29, 2009, and 
November 30, 2009. See GX 26, at 19-26. For the reasons previously 
stated, the Expert found that Reynolds' and Stout's decisions to 
issuance C.S. more controlled substance prescription on these dates was 
contrary to AMC's professed protocols and the Board's Rule 1000-
04.-.08(4)(c), and was therefore ``below the standard of care and 
outside the usual course of professional practice.'' GX 68, at 84.
    Moreover, the Expert found that on September 30, 2009, another CSMD 
report was obtained on C.S., presumably by Stout who saw her on this 
date. GX 68, at 84; GX 26, at 49-52. Significantly, the report showed 
that on August 4-5, 2009, C.S. presented the prescriptions she received 
from Mr. Stout on August 4, 2005, see id. at 23-24; to two more 
pharmacies, Cave's Drugs and P&S Pharmacy. See id. at 49, 51. Stout, 
however, also ignored this additional violation of the Pain Management 
Agreement and issued C.S. prescriptions for 45 Roxicodone 15 mg and 60 
Valium 5 mg. GX 68, at 84.
    On October 29, 2009, Reynolds saw C.S. and actually increased her 
Roxicodone prescription from 45 to 60 tablets; he also issued her a 
prescription for 60 tablets of Valium 5 mg. GX 26, at 22. Not only did 
he ignore the information regarding C.S.'s doctor and pharmacy 
shopping, he also did so while noting in the visit record: ``No recent 
accidents or injuries and no significant changes in current medical 
condition. . . . Pt has no interest in further intervention and is 
satisfied with current treatment plan. . . .'' Id. at 21.
    On November 30, 2009, C.S. made her last visit to AMC and saw 
Reynolds, who again prescribed to her 60 tablets of Roxicodone 15 mg. 
Id. at 20. Moreover, while the note contains the same statement that 
there were ``no significant changes in current medical condition'' and 
that the C.S. was ``satisfied with current treatment plan,'' Reynolds 
changed her prescription from Valium to 90 dosage units of Xanax .5 mg. 
Id. at 19-20.
    To be sure, the visit note states her psychiatric condition as 
follows: ``Patient states that they [sic] have had some increases [sic] 
problems situationally lately with anxiety and depression. This seems 
to be related to social stressors such as family problems, work issues, 
financial stressors and sometimes for no reason to mention.'' Id. at 
19. Yet this was the exact same statement that Reynolds provided in his 
documentation of C.S.'s psychiatric condition at her previous visit. 
See id. at 21. The record thus contains no explanation as to why 
Reynolds changed her prescription.
    C.S. died the next day. Her death certificate lists the cause of 
death as ``multiple drug toxicity--oxycocodone, benzodiazepines, 
carbamates.'' \18\ Id. at 5.
---------------------------------------------------------------------------

    \18\ While not discussed above because it was not a controlled 
substance during the period in which C.S. was obtaining the 
prescriptions from AMC's practitioners, the evidence shows that she 
had also received Soma (carisoprodol) prescriptions at AMC on 
multiple occasions in the months prior to her death. See GX 26, at 
20, 22-23, 26-27, 30. Carisoprodol is a derivative of carbamate. It 
has since been placed in schedule IV of the Controlled Substance Act 
because of substantial evidence of its abuse, particularly when 
taken in conjunction with narcotics and benzodiazepines. See 
Placement of Carisoprodol Into Schedule IV, 76 FR 77330 (2011).

---------------------------------------------------------------------------

[[Page 28661]]

    Summing up her conclusion with respect to the latter prescriptions, 
the Expert found that Reynolds and Stout acted below the standard of 
care and outside the usual course of professional practice. GX 68, at 
84. Consistent with her conclusions regarding the previous 
prescriptions, the Expert concluded that Reynolds and Stout should have 
``enforced the terms of the [Pain Management Agreement], ceased issuing 
her further controlled substances prescriptions, and immediately 
referred her to a pain management specialist and/or addiction 
specialist for treatment.'' \19\ Id. at 85.
---------------------------------------------------------------------------

    \19\ In reviewing C.S.'s medical record, the Expert also found 
that on the nine occasions on which Reynolds saw C.S. between 
December 12, 2008 and November 30, 2009, he created identical, 
verbatim records for each visit which included the following 
entries:
    ``Pt reports having increased pain with movement and decreased 
pain with rest'';
    ``Pt states their pain is a 4 out of 10 and that they have a 
better quality of life and are able to `do more''';
    ``Patient states that they have had a headache for the last 1-2 
days, radiating from their neck and around their temples. They 
relate it to increases in stressors such as home, work, financial, 
or problems with their family. They note some nause (sic), 
photophobia, and increased intensity with noise'';
    ``Anxiety and depression noted in patients (sic) mannerisms and 
actions during interview.''
    GX 68, at 85 (quoting GX 26, at 19-46). Moreover, Reynolds and 
Stout documented the exact same physical exam findings at each of 
her visits. See id.
---------------------------------------------------------------------------

Discussion

    As found above, each of the NPs has an application currently 
pending before the Agency, and by virtue of his having filed a timely 
renewal application, Mr. Stout also holds a registration. Pursuant to 
Section 304(a) of the Controlled Substances Act (CSA), a registration 
to ``dispense a controlled substance . . . may be suspended or revoked 
by the Attorney General upon a finding that the registrant . . . has 
committed such acts as would render his registration under section 823 
of this title inconsistent with the public interest as determined under 
such section.'' 21 U.S.C. 824(a)(4). Thus, in determining whether the 
revocation of an existing registration is necessary to protect the 
public interest, the CSA directs that I consider the same five factors 
as I do in determining whether the granting of an application would be 
consistent with the public interest. These factors are:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing . . . controlled 
substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

Id. Sec.  823(f).
    ``These factors are . . . considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or 
a combination of factors, and may give each factor the weight [I] deem[ 
] appropriate in determining whether a registration should be 
revoked.'' Id.; see also Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 
2009). While I must consider each factor, I am ``not required to make 
findings as to all of the factors.'' Volkman, 567 F.3d at 222; see also 
Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); Morall v. DEA, 412 
F.3d 165, 173-74 (D.C. Cir. 2005). However, even where an Applicant or 
Registrant ultimately waives his right to a hearing on the allegations, 
the Government has the burden of proving, by substantial evidence, that 
the requirements are met for both the denial of an application and the 
revocation or suspension of an existing registration. 21 CFR 
1301.44(d)-(e).
    In this matter, I have considered all of the factors. Based on the 
Government's evidence with respect to factors two and four, I conclude 
that each practitioner has engaged in misconduct which establishes that 
granting his or her application, and in the case of Stout, continuing 
his registration, would be ``inconsistent with the public interest.'' 
\20\ 21 U.S.C. 823(f) & 824(a)(4).
---------------------------------------------------------------------------

    \20\ As for factor one, the recommendation of the state 
licensing authority, while each of the practitioners apparently 
retains his/her Advanced Practice Nurse license, the Tennessee Board 
of Nursing has not made a recommendation to the Agency as to whether 
he/she should be granted a new DEA registration. Moreover, although 
each practitioner is currently licensed by the State and thus 
satisfies an essential condition for obtaining (and maintaining) a 
registration, see 21 U.S.C. 802(21) & 823(f), DEA has held 
repeatedly that the possession of state licensure `` `is not 
dispositive of the public interest inquiry.' '' George Mathew, 75 FR 
66138, 66145 (2010), pet. for rev. denied Mathew v. DEA, No. 10-
73480, 472 Fed Appx. 453 (9th Cir. 2012); see also Patrick W. 
Stodola, 74 FR 20727, 20730 n.16 (2009); Robert A. Leslie, 68 FR 
15227, 15230 (2003). As the Agency has long held, ``the Controlled 
Substances Act requires that the Administrator . . . make an 
independent determination [from that made by state officials] as to 
whether the granting of controlled substance privileges would be in 
the public interest.'' Mortimer Levin, 57 FR 8680, 8681 (1992). 
Thus, this factor is not dispositive either for, or against, the 
granting of Respondent's application. Paul Weir Battershell, 76 FR 
44359, 44366 (2009) (citing Edmund Chein, 74 FR 6580, 6590 (2007), 
pet. for rev. denied Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008)).
     Regarding factor three, there is no evidence that Reynolds, 
Stout, or Killebrew has been convicted of an offense related to the 
manufacture, distribution or dispensing of controlled substances. 21 
U.S.C. 823(f)(3). However, as there are a number of reasons why a 
person may never be convicted of an offense falling under this 
factor, let alone be prosecuted for one, ``the absence of such a 
conviction is of considerably less consequence in the public 
interest inquiry'' and thus, it is not dispositive. David A. Ruben, 
78 FR 38363, 38379 n.35 (2013) (citing Dewey C. MacKay, 75 FR 49956, 
49973 (2010), pet. for rev. denied MacKay v. DEA, 664 F.3d 808 (10th 
Cir. 2011)).
---------------------------------------------------------------------------

Factors II and IV--The Applicant's Experience in Dispensing Controlled 
Substances and Compliance with Applicable Laws Related to Controlled 
Substances

    To effectuate the dual goals of conquering drug abuse and 
controlling both the legitimate and illegitimate traffic in controlled 
substances, ``Congress devised a closed regulatory system making it 
unlawful to manufacture, distribute, dispense, or possess any 
controlled substance except in a manner authorized by the CSA.'' 
Gonzales v. Raich, 545 U.S. 1, 13 (2005). Consistent with the 
maintenance of the closed regulatory system, a controlled substance may 
only be dispensed upon a lawful prescription issued by a practitioner. 
Carlos Gonzalez, M.D., 76 FR 63118, 63141 (2011).
    Fundamental to the CSA's scheme is the Agency's longstanding 
regulation, which states that ``[a] prescription for a controlled 
substance [is not] effective [unless it is] issued for a legitimate 
medical purpose by an individual practitioner acting in the usual 
course of his professional practice.'' 21 CFR 1306.04(a). This 
regulation further provides that ``an order purporting to be a 
prescription issued not in the usual course of professional treatment . 
. . is not a prescription within the meaning and intent of [21 U.S.C. 
829] and . . . the person issuing it, shall be subject to the penalties 
provided for violations of the provisions of law relating to controlled 
substances.'' Id.
    As the Supreme Court has explained, ``the prescription requirement 
. . . ensures patients use controlled substances under the supervision 
of a doctor so as to prevent addiction and recreational abuse. As a 
corollary, [it] also bars doctors from peddling to patients who crave 
the drugs for those prohibited uses.'' Gonzales v. Oregon, 546 U.S. 
243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143 
(1975)); United States v. Alerre, 430

[[Page 28662]]

F.3d 681, 691 (4th Cir. 2005), cert. denied, 574 U.S. 1113 (2006) 
(stating that the prescription requirement likewise stands as a 
proscription against doctors acting not ``as a healer[,] but as a 
seller of wares.'').
    Under the CSA, it is fundamental that a practitioner must establish 
and maintain a legitimate doctor-patient relationship in order to act 
``in the usual course of . . . professional practice'' and to issue a 
prescription for a ``legitimate medical purpose.'' Paul H. Volkman, 73 
FR 30629, 30642 (2008), pet. for rev. denied, 567 F.3d 215, 223-24 (6th 
Cir. 2009); see also Moore, 423 U.S. at 142-43 (noting that evidence 
established that the physician exceeded the bounds of professional 
practice, when ``he gave inadequate physical examinations or none at 
all,'' ``ignored the results of the tests he did make,'' and ``took no 
precautions against . . . misuse and diversion''). The CSA, however, 
generally looks to state law and standards of practice to determine 
whether a doctor and patient have established a legitimate doctor-
patient relationship. Volkman, 73 FR at 30642.
    Moreover, while a finding that a practitioner has violated 21 CFR 
1306.04(a) establishes that the practitioner knowing and intentionally 
distributed a controlled substance in violation of 21 U.S.C. 841(a)(1), 
``the Agency's authority to deny an application [and] to revoke an 
existing registration . . . is not limited to those instances in which 
a practitioner intentionally diverts a controlled substance.'' 
Bienvenido Tan, 76 FR 17673, 17689 (2011) (citing Paul J. Caragine, 
Jr., 63 FR 51592, 51601 (1998)); see also Dewey C. MacKay, 75 FR at 
49974. As Caragine explained: ``[j]ust because misconduct is 
unintentional, innocent, or devoid of improper motive, [it] does not 
preclude revocation or denial. Careless or negligent handling of 
controlled substances creates the opportunity for diversion and [can] 
justify'' the revocation of an existing registration or the denial of 
an application for a registration. 63 FR at 51601.
    ``Accordingly, under the public interest standard, DEA has 
authority to consider those prescribing practices of a physician, 
which, while not rising to the level of intentional or knowing 
misconduct, nonetheless create a substantial risk of diversion.'' 
MacKay, 75 FR at 49974; see also Patrick K. Chau, 77 FR 36003, 36007 
(2012). Likewise, ``[a] practitioner who ignores the warning signs that 
[his] patients are either personally abusing or diverting controlled 
substances commits `acts inconsistent with the public interest,' 21 
U.S.C. 824(a)(4), even if [he] is merely gullible or na[iuml]ve.'' 
Jayam Krishna-Iyer, 74 FR 459, 460 n.3 (2009); see also Chau, 77 FR at 
36007 (holding that even if physician ``did not intentionally divert 
controlled substances,'' State Board Order ``identified numerous 
instances in which [physician] recklessly prescribed controlled 
substances to persons who were likely engaged in either self-abuse or 
diversion'' and that physician's ``repeated failure to obtain medical 
records for his patients, as well as to otherwise verify their 
treatment histories and other claims, created a substantial risk of 
diversion and abuse'') (citing MacKay, 75 FR at 49974).
    As explained by the Government's Expert, in 2004, the Tennessee 
Board of Nursing promulgated Rule 1000-04-.08, setting forth guidelines 
for determining whether the prescribing practices of Advance Practice 
Nurses are within ``the usual course of professional practice for a 
legitimate purpose in compliance with applicable state and federal 
law''; this rule became effective on January 1, 2005.\21\ Board Rule 
1000-04-.08(4); GX 68, at 10. This rule provided that the patient's 
medical record ``shall include a documented medical history and 
physical examination by the Advance Practice Nurse . . . providing the 
medication.'' Board Rule 1000-04-.08 (4)(c)(1). It further stated that 
the ``[h]istorical data shall include pain history, any pertinent 
evaluations by another provider, history of and potential for substance 
abuse, pertinent coexisting diseases and conditions, psychological 
functions and the presence of a recognized medical indication for the 
use of a controlled substance.'' Id.
---------------------------------------------------------------------------

    \21\ See also Board Rule 1000-04-.08(1)(d) (defining 
``[p]rescribing pharmaceuticals or practicing consistent with the 
public health and welfare'' as ``[p]rescribing pharmaceuticals and 
practicing Advanced Practice Nursing for a legitimate purpose in the 
usual course of professional practice'').
---------------------------------------------------------------------------

    The Rule also provided that ``[a] written treatment plan tailored 
for individual needs of the patient shall include objectives such as 
pain relief and/or improved physical and psychosocial function, and 
shall consider need for further testing, consultations, referrals or 
use of other treatment modalities dependent on patient response.'' Id. 
at 4(c)(2). Also, the rule provided that ``[a]t each periodic 
interval'' at which the patient is evaluated ``for continuation or 
change of medications, the patient record shall include progress toward 
reaching treatment objectives, any new information about the etiology 
of the pain, and an update on the treatment plan.'' Id. at (4)(c)(4). 
And the Expert also testified that Advanced Nurse Practitioners were 
employing the practices set forth in the guidelines in prescribing 
controlled substance before the Rule became effective on January 1, 
2005.
    As found above, the Government's Expert reviewed the medical 
records maintained by AMC on patients N.S., T.H., and C.S. and 
concluded that in issuing the prescriptions, Messrs. Reynolds and 
Stout, as well as Ms. Killebrew, failed to comply with the Board's Rule 
and the standard of care as set forth in various practice guidelines 
which the clinic asserted it followed. Most importantly, the 
Government's Expert concluded that Reynolds, Stout, and Killebrew had 
issued multiple controlled substance prescriptions without a legitimate 
medical purpose and outside of the usual course of professional 
practice and thus also violated 21 CFR 1306.04(a).

N.S.

    N.S. was initially seen at AMC by providers other than Reynolds, 
Stout, and Killebrew. However, at the time of her first visit with 
Reynolds, the latter knew that N.S. has previously been subjected to a 
UDS and tested positive for several benzodiazepines, even though these 
drugs had not been prescribed to her by the other NPs at AMC, as well 
as cocaine. She also tested negative for opiates even though she had 
been prescribed Avinza (morphine) at AMC, and on the date of the test, 
she should still have been taking the drug. Reynolds also knew that at 
N.S's previous visit, she had shown signs of somnolence, slurred 
speech, and rapid heart rate. Finally, N.S.'s file still lacked 
information concerning her prior treatment history and substance abuse 
history, and given that three months had passed since N.S.'s previous 
visit, Reynolds should have asked N.S. where she had been, but failed 
to do so. Reynolds failed to refer her to a specialist who could have 
addressed her aberrant behavior, and instead, issued her another Avinza 
prescription.
    As found above, throughout the lengthy course of her visits to AMC, 
N.S. continued to engage in aberrant behavior, which was largely 
ignored by Reynolds, Stout, and Killebrew, who continued to prescribe 
controlled substances to her. These episodes included overdoses 
resulting in multiple hospitalizations including for mental health 
treatment. Moreover, the discharge summary for the first of these, 
which occurred while N.S. was obtaining drugs at AMC, referenced her

[[Page 28663]]

history of multiple overdoses and suicide attempts; listed two 
physicians as her primacy care providers (one of whom was not 
affiliated with AMC); stated that N.S. was taking hydrocodone, Xanax, 
and carisoprodol, none of which had been prescribed to her at AMC; and 
reported the results of a UDS, which again showed she was positive for 
benzodiazepines.
    Yet, notwithstanding these multiple red flags, Reynolds continued 
to prescribe Avinza to N.S. and did so without having obtained 
information about her treatment before coming to AMC, did not create a 
written treatment plan, and did not document that he had considered the 
need to refer her for further testing or consultations.
    Thereafter, Reynolds added Xanax for N.S.'s anxiety, 
notwithstanding that because of her obvious psychiatric issues, she 
should have been referred to a specialist. As the Expert explained, 
this was contrary to the Uphold & Graham Guidelines, which Reynolds 
claimed were the protocols that AMC followed.
    Following this, N.S. sought multiple early refills for Xanax; 
Reynolds also had directed her to come in for a pill count, but N.S. 
failed to comply. Yet Reynolds continued to issue her more Xanax, and 
even did so on an occasion when she should have had 19 days left on a 
prescription.
    As for Stout, while he did not prescribe to N.S. until seventeen 
months into her visits to AMC, the Expert explained that because it was 
her first visit with him, he was obligated to review her patient file 
before prescribing controlled substances to determine whether it was 
appropriate to continue or change her medications. The Expert thus 
concluded that Stout should have been aware of N.S.'s history of 
substance abuse and diversion, which was documented in her file, and 
that Stout breached the standard of care and acted outside of the usual 
course of professional practice when he issued her Xanax and Kadian 
prescriptions, rather than cease further prescribing and refer her to a 
specialist who could address her aberrant behavior.
    While Killebrew did not see N.S. until July 2006, when she had been 
going to AMC for more than twenty-five months, the Expert found that 
she too acted outside of the usual course of professional practice 
because she was obligated to review N.S.'s patient file and should not 
have prescribed controlled substances to her given her history of drug 
abuse and diversion. Moreover, this was N.S.'s first visit to AMC in 
seven months, and Killebrew noted that N.S. had recently been released 
from jail. However, Killebrew failed to ask why she had been 
incarcerated and how she had addressed her pain issues during that 
period. Killebrew nonetheless issued N.S. prescriptions for Percocet 
and Xanax.
    Thereafter, N.S. continued to see Reynolds and Stout (and 
occasionally Killebrew) and repeatedly obtained more controlled 
substance prescriptions while the practitioners ignored additional red 
flags. For example, in August 2006, Stout prescribed Percocet and Xanax 
to N.S., even though the day before N.S.'s July 20 visit with 
Killebrew, he had treated her while working in a local emergency room 
and documented that N.S. had admitted ``to having a long history of 
drug abuse'' and displayed ``drug seeking behavior.'' Stout also failed 
to address with N.S. why she had been jailed and how she addressed her 
pain issues while she was incarcerated.
    Two months later, Stout issued N.S. more Percocet and Xanax 
prescriptions, even though her file contained a note (dated one month) 
earlier stating that she had been selling Percocet. N.S. denied this, 
claiming her medications had been stolen, but then said she had been 
taking her medications for the past week. While Stout required that 
N.S. take a UDS, she tested negative for oxycodone (which she claimed 
she was taking) but positive for hydrocodone/hydromorphone, even though 
no one at AMC had prescribed those drugs to her. And notwithstanding 
these results, which showed that she was abusing and/or diverting, and 
demonstrated that N.S. had lied to him, Stout issued her more Percocet 
and Xanax prescriptions.
    Several months later, Stout attempted to refer her to two different 
pain management practices. However, N.S. had already been seen at these 
practices and neither would accept her as a patient. Once again, Stout 
issued her more prescriptions for Percocet and Xanax, and several 
months later, Reynolds issued more of the same prescriptions, ignoring 
the evidence that N.S. was abusing and diverting, and acted outside of 
the usual course of professional practice in doing so.
    Several months later, Reynolds increased the quantity of N.S.'s 
prescriptions (she had been switched from Percocet to morphine), by 
fifty percent from those issued at the previous visit, and yet there is 
no evidence that Reynolds saw her on this occasion and no explanation 
in her record as to why she was not seen. And the following month, N.S. 
called AMC and stated that she had run out of her prescriptions and 
Killebrew directed that prescriptions for Lortab and Xanax be called in 
for her; however, N.S. had not been seen at AMC in two months, which 
according to the Expert, also raised a red flag.
    Thereafter, N.S's behavior continued to present red flags, such as 
in November 2007, when she twice sought refills of controlled 
substances, including refills which were fifteen days early; yet 
Reynolds issued her more prescriptions. And the following month, N.S. 
was admitted to a local hospital which sent AMC both admission and 
discharge summaries; notably, the summaries listed ``polysubstance 
abuse'' as one of her diagnoses. Yet, even after receiving this 
information, Reynolds prescribed more MS Contin, Xanax, and Percocet to 
her.
    Thereafter, N.S. became pregnant and did not visit AMC between 
February and late December 2008, and apparently had received Suboxone 
or Subutex treatment from a physician (who was not affiliated with AMC) 
during her pregnancy. Yet, on N.S.'s return, Killebrew prescribed to 
her both 60 Lortab 7.5 mg and 30 Xanax .5 mg. However, Killebrew did 
not even obtain the name of the physician who had provided the 
Suboxone/Subutex treatment, let alone contact him/her. She also did not 
conduct a check of the State's prescription monitoring database, even 
though in the Expert's view, N.S's history of doctor shopping warranted 
this. Moreover, Killebrew did not document that N.S. had incurred a new 
illness or injury, and according to the Expert, performed a cursory 
physical exam. I thus adopt the Expert's conclusion that Killebrew 
acted outside of the usual course of professional practice and lacked a 
legitimate medical purpose in issuing the prescriptions. 21 CFR 
1306.04(a).
    Following this visit, N.S. did not return to AMC for more than five 
months. Yet on her return, Reynolds issued her prescriptions for even 
more potent controlled substances and in even greater quantities (60 MS 
Contin 30 mg, 30 Percocet 7.5 mg, 90 Xanax .5 mg). However, Reynolds 
did not document how N.S. had managed her purported pain since her last 
visit, failed to run a check on her with the CSMD, and failed to 
conduct a UDS on her. Once again, the Expert concluded that these 
prescription were issued in violation of 21 CFR 1306.04(a).
    As the Expert explained, over the course of the nearly six-year 
period in which N.S. obtained controlled substances at AMC, she 
presented numerous red flags (including overdoses) and yet was 
subjected to only two UDSs, both of which she failed, and but a single 
pill count.

[[Page 28664]]

Moreover, the only time her prescription history was obtained from the 
CSMD was on the date of her last visit. Also, there were several 
episodes in which N.S. had not appeared at AMC for months on end, and 
yet was given more prescriptions without the treating practitioner even 
attempting to verify her explanation for her absence, asking her how 
she addressed her pain during her absence, contacting her purported 
treating physicians, or performing an adequate physical examination. I 
therefore conclude that all three practitioners acted outside of the 
usual course of professional practice and lacked a legitimate medical 
purpose when they issued controlled substance prescriptions to N.S. 21 
CFR 1306.04(a).
    I also conclude that all three practitioners acted outside of the 
usual course of professional practice and lacked a legitimate medical 
purpose in issuing multiple controlled substance prescriptions to T.H. 
As explained by the Expert, from T.H.'s initial visit, the 
practitioners knew that T.H. had problems with alcohol as well as 
mental health issues, and yet they failed to adequately evaluate his 
alcohol-related issues and refer him to a specialist who could properly 
address his mental health issues.
    Moreover, while T.H. was referred to a pain management clinic, 
which recommended that he undergo facet blocks and that he take only 
three Lortab 10 mg per day and do so only for as long as it took to 
have the procedures performed, T.H. returned to AMC where he saw 
Reynolds, who failed to determine whether T.H. had ever undergone the 
procedures. Also, while T.H. should have been out of the controlled 
substance prescribed by the pain management clinic for a month, 
Reynolds made no inquiry as to how T.H. had managed his pain. Yet 
Reynolds then proceeded to escalate T.H.'s prescriptions to 60 
OxyContin 40 mg, 30 Lortab 10 mg, and 90 Xanax 1 mg. As the Expert 
explained, there was no medical justification for adding OxyContin 40 
mg to T.H.'s medications, which she explained was four times the normal 
starting dose. The Expert also explained that the amount of Xanax 
Reynolds prescribed was excessive as it was six times the daily dosage 
T.H. had previously received and could be lethal when taken with the 
narcotics that Reynolds prescribed. The Expert further noted that 
Reynolds did not properly evaluate T.H.'s alcohol-related problems or 
his anxiety. I agree with the Expert that Reynolds lacked a legitimate 
medical purpose and acted outside of the usual course of professional 
practice in issuing the prescriptions. 21 CFR 1306.04(a).
    At the next visit, T.H. saw Stout, who issued him more 
prescriptions for the same three drugs. Yet as the Expert explained, 
Stout did not properly evaluate T.H.'s pain and psychosocial situation, 
the efficacy of the drugs on his ability to function, did not develop a 
written treatment plan, and did not evaluate T.H.'s history or 
potential for abuse. I agree with the Expert's conclusion that Stout 
lacked a legitimate medical purpose and acted outside of the usual 
course of professional practice in issuing the prescriptions. Id.
    During the course of the two years in which T.H. visited AMC, he 
presented multiple red flags. These included that: (1) He was receiving 
high doses of narcotics and yet never complained of opioid-induced 
constipation; (2) he admitted that he was simultaneously seeing another 
physician, yet neither Reynolds nor Stout contacted the physician to 
determine the nature of the treatment T.H. was receiving; (3) a 
pharmacy reported that T.H. was receiving Suboxone treatment from still 
another physician (again, neither Reynolds nor Stout contacted the 
physician); (4) T.H. was clearly using multiple pharmacies 
notwithstanding that he had agreed to use only a single pharmacy; (5) 
AMC had received a fax which included various documents establishing 
that T.H. had been treated at three other clinics; (6) T.H. was being 
treated for depression by a physician; (7) T.H. owed approximately 
$3,000 to two medical practices; (8) T.H. sought multiple early 
refills; (9) and T.H. was trying to stop abusing alcohol.
    However, T.H. was never required to provide a UDS, was never 
subjected to a pill count, and a CSMD report was never obtained on him. 
Moreover, according to the Expert, at no point did any of the three 
practitioners (including Killebrew, who saw T.H. and prescribed to him 
on several occasions) create a written treatment plan and properly 
evaluate his use of alcohol. Yet all three practitioners continued to 
prescribe both OxyContin and either Percocet or Lortab, as well as 
Xanax, to T.H., up until the day before he overdosed and died. Based on 
the Expert's extensive findings, I conclude that each of the 
practitioners acted outside of the usual course of professional 
practice and lacked a legitimate medical purpose when they issued T.H. 
the prescriptions for multiple narcotics and benzodiazepines.\22\ 21 
CFR 1306.04(a).
---------------------------------------------------------------------------

    \22\ It is noted that Ms. Killebrew's involvement with T.H. was 
limited to only three visits and that the prescriptions she issued 
were generally the same as those issued by Reynolds and Stout. With 
respect to T.H.'s first visit with Killebrew, the Expert opined that 
the information he reported regarding his impending divorce and 
increased anxiety rendered him a ``high-risk patient for managing 
chronic pain and whose care extended beyond the scope of a nurse 
practitioner engaged in family practice,'' and that a ``prudent 
practitioner would have considered T.H. to be a risk for suicide and 
diversion and would have referred him to a mental health specialist 
and a comprehensive pain management program,'' which Killebrew 
failed to do. GX 68, at 63.
     While the Expert's discussion sounds in malpractice, the Expert 
further noted that as of the date of his first visit with Killebrew, 
T.H.'s file contained extensive evidence that he was abusing and/or 
diverting controlled substances yet Killebrew failed to take steps 
to monitor his use of controlled substances. I thus agree with the 
Expert's conclusion that Killebrew acted outside of the usual course 
of professional practice when she prescribed to T.H. 60 OxyContin 40 
mg, 30 Percocet 10 mg, and 75 Xanax 1 mg. Id. at 63-64.
     Similarly, at T.H.'s second visit with her, he reported that he 
was having problems with anxiety, that he trying quit alcohol, that 
he had made an appointment at a mental health facility and had hand 
tremors; according to the Expert, the latter was a sign of anxiety 
or alcohol/drug withdrawal. Killebrew did not, however, refer T.H. 
for treatment by specialists as was called for in the Uphold & 
Graham practice guidelines which AMC had previously adopted as its 
practice protocols. GX 39, at 15. Instead, she issued him more 
prescriptions, these being for 60 OxyContin 40 mg, 30 Lortab 10 mg, 
while changing his prescription for Xanax to 90 Valium 10 mg. She 
also ignored other red flags which were documented in T.H.'s patient 
file. At T.H.'s next visit, Killebrew issued T. H. these same 
prescriptions, again ignoring the red flags he presented and AMC's 
practice protocols. Consistent with the Expert's testimony, I 
conclude that Killebrew acted outside of the usual course of 
professional practice and lacked a legitimate medical purpose in 
prescribing controlled substances to T.H. 21 CFR 1306.04(a).
---------------------------------------------------------------------------

    I also agree with the Expert's conclusions that both Reynolds and 
Stout acted outside of the usual course of professional practice and 
lacked a legitimate medical purpose when they issued various controlled 
substance prescriptions to C.S. As the Expert noted, C.S. claimed that 
she had suffered injuries in a car accident and suffered from back pain 
(at a level of 4 out of 10) as well as neck pain, although the records 
also state: ``Pt has no interest in further intervention and is 
satisfied with current treatment plan.'' The note for her first visit 
further stated that C.S. reported that she had ``increase[d] problems 
situationally lately with their anxiety and depression.''
    According to the Expert, at C.S.'s first visit, Reynolds failed to 
create a patient record that appropriately documented her medical 
history, including her pain history, pertinent evaluations by other 
practitioners, her history of, and potential for, substance abuse, and 
pertinent coexisting diseases and treatments. The Expert also found 
that he did not create a treatment plan which was tailored for her 
individual needs.

[[Page 28665]]

While Reynolds made an entry in the medical record that he had 
performed a physical exam, notably, with the exception of her vital 
signs, the physical exam notes for each of her visits are repeated 
verbatim.
    Notwithstanding that C.S. had reported increased problems with 
anxiety and depression, and according to the clinic's protocols, 
presented a higher risk of substance abuse, Reynolds did not refer her 
to a specialist and did not document that he had even considered doing 
so. Moreover, while C.S. had reported injuries, she also wrote on her 
intake form that she did not have a current health care provider. As 
the Expert explained, there is no evidence that Reynolds inquired as to 
how she had addressed her pain if she had no current provider. 
Moreover, while Reynolds could have run a CSMD check to verify if C.S. 
had, in fact, recently seen another provider, as well as obtain 
information as to her substance abuse history, he did not do so. Of 
note, that report would have shown that in the period preceding her 
visit, she had obtained Suboxone from three different physicians. 
Reynolds started her on Percocet and Valium. I agree with the Expert's 
conclusion that the prescriptions lacked a legitimate medical purpose 
and were issued outside of the usual course of professional practice. 
21 CFR 1306.04(a).
    At some point, Reynolds did obtain C.S's medical records from a 
physician who treated her over a five-month period, which had ended 
more than thirteen months before her first visit to AMC. Most 
significantly, the physician had documented that C.S. was taking more 
pain medications than he recommended and explained that he did not 
think that she could ``self-medicate.'' Yet both Reynolds and Stout 
continued to prescribe multiple controlled substances including 
Percocet, Valium, and phentermine to C.S. Moreover, there is no 
evidence that either Reynolds or Stout ever contacted that physician.
    The Expert further found that neither Reynolds nor Stout properly 
evaluated C.S. at her follow-up visits to determine whether her 
medications should be continued or changed. Moreover, both Reynolds and 
Stout repeatedly ignored red flags that C.S. was engaged in both doctor 
and pharmacy shopping and thus violating her pain contract. These 
incidents included one in which Reynolds received a phone call from 
another clinic reporting that C.S. had sought to become a patient, 
claiming that she did not have a family practice, and that she also 
used two names at various practices. Neither Reynolds nor Stout 
documented having addressed this incident with her. Instead, they 
continued to issue her more prescriptions and never ran a UDS on her.
    Moreover, while AMC eventually obtained CSMD reports on her (two 
months after the above report), they again ignored multiple items of 
information in those reports which showed that C.S. had been treated 
for narcotic dependency prior to her first visit at AMC (and had 
obtained Suboxone from three physicians), that she had recently 
obtained controlled substances from two other physicians, and that she 
had also filled prescriptions at multiple pharmacies in violation of 
her pain agreement. Yet Reynolds and Stout continued to issue her 
prescriptions for both oxycodone and benzodiazepines up until her 
death. I therefore agree with the Expert's conclusion that both 
Reynolds and Stout acted outside of the usual course of professional 
practice and lacked a legitimate medical purpose when they issued the 
prescriptions to C.S. 21 CFR 1306.04(a).
    In summary, I find that the Government's evidence with respect to 
factors two and four establishes that each of the three practitioners 
issued prescriptions in violation of the CSA's prescription requirement 
and engaged in the knowing diversion of controlled substances. I 
further hold that the Government has established by substantial 
evidence that the misconduct of each practitioner is sufficiently 
egregious to conclude that he/she has committed acts which render his/
her ``registration inconsistent with the public interest.'' 21 U.S.C. 
823(f) & 824(a)(4). With respect to each of the three practitioners, 
these findings are sufficient to support the denial of their 
applications, and in the case of Stout, to revoke his registration.

Factor Five--Such Other Conduct Which May Threaten Public Health and 
Safety

    The Government also contends that practitioner Reynolds engaged in 
actionable misconduct under this factor when he wrote a letter to a DEA 
Diversion Investigator which contained various material false 
statements regarding AMC's treatment of N.S. I agree with the 
Government.
    As recognized by the Sixth Circuit, ``[c]andor during DEA 
investigations, regardless of the severity of the violations alleged, 
is considered by the DEA to be an important factor when assessing 
whether a [practitioner's] registration is consistent with the public 
interest.'' Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005). To be 
actionable, the Government is required to show that the statement was 
false and material to the investigation. See Roy S. Schwartz, 79 FR 
34360, 34363 n.6 (2014); Belinda R. Mori, 78 FR 36582, 36589 (2013). As 
the Supreme Court has explained, a false statement is material if it `` 
`has a natural tendency to influence, or was capable of influencing the 
decision of the decisionmaking body to which it was addressed.' '' 
Kungys v. United States, 485 U.S. 755, 770 (1988) (quoting Weinstock v. 
United States, 231 F.2d 699, 701 (D.C. Cir. 1956)). The Court has 
further explained that:

it has never been the test of materiality that the misrepresentation 
. . . would more likely than not have produced an erroneous 
decision, or even that it would more likely than not have triggered 
an investigation. Rather, the test is whether the misrepresentation 
. . . was predictably capable of affecting, i.e., had a natural 
tendency to affect, the official decision.

485 U.S. at 770-71. ``It makes no difference that a specific 
falsification did not exert influence so long as it had the capacity to 
do so.'' United States v. Alemany Rivera, 781 F.2d 229, 234 (1st Cir. 
1985).
    The Government first argues that Reynolds made a materially false 
statement when he wrote that N.S. ``was admitted to JCMC on December 3, 
2004 by Dr. . . . James with drug overdose. She was transferred to 
[IPP] . . . and continued on her then prescribed medications.'' Req. 
for Final Agency Action, at 42 (quoting GX 42, at 7). Based on an 
affidavit it obtained from Dr. James, the Government argues that 
Reynolds' statement was false because Dr. James ``did not continue N.S. 
on her then prescribed medications'' but ``ceased prescribing'' all 
controlled substances to her because she had ``been admitted [to JCMC] 
for a drug overdose, had a history of multiple overdoses and suicide 
attempts, and was [being transferred] to IPP for inpatient psychiatric 
treatment.'' Id. at 43.
    Notwithstanding Dr. James' statement (which may well have reflected 
her instructions), the discharge summary for N.S.'s hospitalization 
(which was part of her patient file), lists Soma, Xanax, MSCN 
(morphine), and Lortab as ``medications to continue'' and is blank in 
the space for listing ``medications to discontinue.'' GX 2, at 160. 
While the form was apparently completed by a nurse and not Dr. James, 
absent proof that Reynolds had otherwise obtained knowledge that Dr. 
James had instructed that N.S.'s medications were to be discontinued, 
it was not unreasonable for him to conclude that the nurse had

[[Page 28666]]

accurately reflected Dr. James' instructions on the discharge summary. 
I thus reject the contention that Reynolds knowingly made a material 
false statement when he wrote that N.S. had been continued on her then-
prescribed medications.\23\
---------------------------------------------------------------------------

    \23\ Even were I to hold that a negligently made false statement 
is actionable under factor five, no argument has been made as to why 
Reynolds was negligent when he relied on the discharge summary.
---------------------------------------------------------------------------

    Reynolds, however, also claimed that N.S. ``never had another 
overdose incident while being treated at AMC'' after a December 3, 2004 
hospitalization at Johnson City Medical Center. GX 42, at 7. The 
Government, however, produced a copy of a report created upon N.S.'s 
admission to the Johnson City Medical Center on August 19, 2005, which 
clearly stated that ``[t]he patient was transferred from Northside 
Hospital because of unresponsiveness secondary to drug overdose.'' GX 
14, at 29.
    The report further stated that N.S. had told her mother that she 
had taken five Soma tablets, that her mother found her unresponsive on 
the floor, that she was taken to Northside Hospital where ``she was 
found unresponsive to painful stimuli . . . with pinpoint pupils,'' and 
that Narcan, a drug used to counter the effects of opioids, ``was not 
helpful.'' Id. The report also listed ``[d]rug overdose'' under the 
attending physician's impressions, and noted that she was to be 
admitted to the ICU. Id. at 30. Finally, the attending physician listed 
Reynolds as N.S.'s primary care provider and listed him as a recipient 
of a copy of the report. Id.
    Based on the above, I conclude that Reynolds knew that N.S. had 
been hospitalized for a second overdose incident after the December 3, 
2004 hospitalization and that his statement was false. I further 
conclude that the statement was material because it was clearly made by 
Reynolds to the DI in an attempt to excuse the misconduct he and his 
fellow practitioners engaged in when they continued to prescribe 
controlled substances to N.S. even when faced with knowledge that she 
was drug abuser. See GX 42, at 2 (Reynolds' letter to DI; ``I am 
including in this letter the documents that I have developed to explain 
my actions and the rationale behind the decisions that have been called 
into question by the Office of General Counsel of Tennessee and I 
assume the DEA.'') As explained above, that misconduct is clearly 
within the Agency's jurisdiction and his statement was clearly capable 
of influencing the decision of the Agency to pursue this matter.
    In his letter, Reynolds also stated that Dr. James (the physician 
who admitted N.S. to the JCMC for her December 2004) ``took the medical 
and social history from [N.S.'s] family [and] not the patient.'' GX 42, 
at 7. The Government notes that in the Admission Report, Dr. James 
documented that N.S. ``has had multiple episode of over dose in the 
past, the last one was in May 2004, when she was admitted to the 
Intensive Care Unit with drug overdose'' and that N.S.'s ``[h]istory 
[wa]s obtained mainly from the emergency room records and the patient's 
parents.'' Req. for Final Agency Action, at 45.
    The Government argues that taken within the context of the letter, 
Reynolds' statement was materially false and was made ``for the purpose 
of demonstrating that the history noted by Dr. James . . . of `multiple 
over dose in the past' was somehow inaccurate because'' it had not been 
obtained ``directly from N.S.'' Id. Notably, in his letter, Reynolds 
further asserted that when, after the overdose incident, N.S returned 
to AMC, ``[s]he argued with [him] that her overdose was a one-time 
mistake she had made'' which was caused by ``domestic issues at home'' 
and that he ``gave her the benefit of the doubt'' and prescribed more 
controlled substances to her. GX 42, at 7.
    Here again, I agree with the Government that the statement was made 
to justify Reynolds' decision to ignore the clear evidence that N.S. 
was a substance abuser and to excuse his misconduct (as well as that of 
his fellow practitioners) in continuing to prescribing controlled 
substances to her. I further conclude that the statement was false and 
was capable of influencing the Agency's investigation and was therefore 
material.
    Next, the Government argues that Reynolds made a material false 
statement when he wrote that after the December 3, 2004 
hospitalization, N.S. `` `never again displayed signs of addiction to 
include . . . aberrant behavior . . . [and] early refills.' '' Req. for 
Final Agency Action, at 44 (quoting GX 42, at 7). As found above, the 
record contains substantial evidence that N.S. displayed numerous signs 
of addiction and aberrant behavior. These included: (1) Her nearly 
eight-month absence from the practice (between Dec. 1, 2005 and July 
20, 2006) and her reappearance at AMC during which she told Killebrew 
that she had been in jail; (2) Stout's having treated her the day 
before her reappearance at AMC at a local hospital's ER and noting that 
she wanted ``stronger narcotics'' and had ``displayed drug seeking 
behavior''; (3) a Sept. 13, 2006 report that N.S. was selling Percocet; 
(4) an Oct. 11, 2006 UDS which was positive for narcotics she had not 
been prescribed but negative for narcotics which she had been 
prescribed; (5) her false statement at that visit that she was taking 
the prescribed medications; (6) the December 2006 refusal of two 
different pain management practices, both of which had previously seen 
her, to accept her as a patient; (7) her having sought (in November 
2007) a refill fifteen days early; (8) her admission to a local 
hospital in late December 2007, which diagnosed her with various 
conditions including poly-substance abuse; (9) the more than five-month 
gap between her December 22, 2008 and June 4, 2009 visit; and (10) her 
November 2009 claim that her drugs had been stolen and she needed a 
refill.
    Here again, Reynolds clearly knew of these various incidents and 
his statement was clearly made to excuse the misconduct he and his 
fellow practitioners engaged in by continuing to prescribe controlled 
substances to N.S. in the face of her aberrant behavior. I therefore 
find that the statement was materially false.
    Reynolds further stated that ``[i]n October of 2006, [N.S.] passed 
drug screens and observations by MC providers.'' GX 42, at 7. As found 
above, this statement was clearly false as N.S. tested positive for 
hydrocodone/hydromorphone, even though no one at AMC had prescribed 
these drugs to her, and tested negative for oxycodone/oxymorphone, even 
though she had received a Percocet prescription at her previous visit 
to AMC. Here again, Reynolds' statement was false and clearly made to 
excuse the misconduct that he and his fellow practitioners engaged in 
by continuing to prescribe controlled substances to N.S.
    Based on the multiple materially false statements Reynolds made in 
his letter to a DEA Investigator, I further find that Reynolds has 
engaged in additional conduct which may threaten public health or 
safety. This finding provides a further reason to deny Reynolds' 
application.

Sanction

    Under agency precedent, ``where a registrant [or applicant] has 
committed acts inconsistent with the public interest, [he or] she must 
accept responsibility for his [or her] . . . actions and demonstrate 
that he [or she] . . . will not engage in future misconduct.'' Jayam 
Krishna-Iyer, 74 FR 459, 463 (2009); see also Medicine Shoppe-
Jonesborough, 73 FR 364, 387 (2008). Here, each practitioner has waived 
his/her right to a hearing and

[[Page 28667]]

therefore the opportunity to present evidence to refute the 
Government's showing that he/she has committed acts which render his/
her registration ``inconsistent with the public interest,'' 21 U.S.C. 
823(f), and the only evidence in the record relevant to these issues is 
Reynolds' letter to the DI.
    Therein, Reynolds stated that he has closed his practice and would 
not re-open it; that he has taken 55 hours of continuing education in 
ethics, boundaries, pharmacology and pain; and offered to take ``other 
training'' to ensure the public safety and his ``compliance with DEA 
standards.'' GX 42, at 2. Even were I to give weight to Reynolds's 
unsworn statement regarding the remedial measures he has undertaken, I 
would still deny his application because he has presented no evidence 
that he acknowledges his misconduct. To the contrary, the multiple 
material false statements Reynolds made in his letter establish that he 
does not accept responsibility for his misconduct in prescribing to 
N.S. and others. Thus, I conclude that Reynolds has not refuted the 
Government's prima facie showing that granting his application would be 
``inconsistent with the public interest.'' 21 U.S.C. 823(f). So too, 
because there is no evidence that either Stout or Killebrew has 
accepted responsibility for his/her misconduct, nor any evidence that 
either Stout or Killebrew has undertaken remedial measures to ensure 
that he/she will not re-offend in the future, I also conclude that 
neither one has refuted the Government's prima facie showing. 
Accordingly, I will order that the registration issued to Stout be 
revoked, and that the applications of Reynolds, Stout, and Killebrew 
\24\ be denied.
---------------------------------------------------------------------------

    \24\ While compared to Reynolds and Stout, Killebrew issued 
substantially fewer illegal prescriptions, her misconduct still 
involved the knowing diversion of controlled substances, and as 
such, is sufficiently egregious to support the denial of her 
application. See Jayam Krishna-Iyer, 74 FR at 464 (``[E]ven where 
the Agency's proof establishes that a practitioner has committed 
only a few acts of diversion, this Agency will not grant [an 
application for] registration unless [she] accepts responsibility 
for [her] misconduct.''); see also MacKay v. DEA, 664 F.3d 808, 822 
(10th Cir. 2011) (sustaining agency order revoking practitioner's 
registration based on proof physician knowingly diverted drugs to 
two patients).
---------------------------------------------------------------------------

Orders

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a)(4), as well as 28 CFR 0.100(b), I order that DEA Certificate of 
Registration MS0443046 issued to David R. Stout, N.P., be, and it 
hereby is, revoked. I further order that the application of David R. 
Stout, N.P., to renew his registration, be, and it hereby is, denied. 
This Order is effective June 18, 2015.
    Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well 
as 28 CFR 0.100(b), I order that the application of Bobby D. Reynolds 
II, F.N.P., for a DEA Certificate of Registration as an MLP--Nurse 
Practitioner, be, and it hereby is, denied. This Order is effective 
June 18, 2015.
    Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well 
as 28 CFR 0.100(b), I order that the application of Tina L. Killebrew, 
F.N.P., for a DEA Certificate of Registration as an MLP--Nurse 
Practitioner, be, and it hereby is, denied. This Order is effective 
June 18, 2015.

    Dated: April 30, 2015.
Michele M. Leonhart,
Administrator.
[FR Doc. 2015-12038 Filed 5-18-15; 8:45 am]
 BILLING CODE 4410-09-P