Kevin Dennis, M.D., Decision and Order, 52787-52800 [2013-20677]
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[FR Doc. 2013–20688 Filed 8–23–13; 8:45 am]
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Patricia A. Brink,
Director of Civil Enforcement, Antitrust
Division.
[FR Doc. 2013–20687 Filed 8–23–13; 8:45 am]
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[FR Doc. 2013–20689 Filed 8–23–13; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 11–48]
Kevin Dennis, M.D., Decision and
Order
On April 12, 2011, the Deputy
Assistant Administrator, Office of
Diversion Control, issued an Order to
Show Cause to Kevin Dennis, M.D.
(hereinafter, Respondent), of Franklin,
Tennessee. The Show Cause Order
proposed the revocation of
Respondent’s DEA Certification of
Registration and the denial of his
application to renew his registration on
the ground that his ‘‘continued
registration is inconsistent with the
public interest.’’ ALJ Ex. 1, at 1 (citing
21 U.S.C. 823(f)).
More specifically, the Show Cause
Order alleged that from September 2007
through July 2009, Respondent
‘‘prescribed controlled substances to
individuals located in Colorado,
Mississippi, North Carolina, South
Carolina and Tennessee via the Internet
based on online questionnaires,
submissions of unverified medical
records, and/or telephone consultations
without a medical examination.’’ Id.
The Show Cause Order alleged that
Respondent ‘‘failed to establish a valid
physician-patient relationship’’ as
required by various state laws and that
in issuing the prescriptions Respondent
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violated Federal law because he acted
outside of the usual course of
professional practice and lacked a
legitimate medical purpose. Id. at 2
(citing 21 CFR 1306.04(a); other
citations omitted). The Show Cause
Order further alleged that while
Respondent is licensed to practice
medicine in Tennessee, he violated
multiple state laws because he
prescribed controlled substances to
residents of States where he is not
licensed to practice medicine. Id.
(citations omitted). Finally, the Show
Cause Order alleged that Respondent
violated Tennessee law by prescribing
phentermine, a schedule IV controlled
substance, to members of his immediate
family. Id. (citing Tenn. Code Ann.
§§ 63–6–214(b)(1), (4) and (12)).
Respondent requested a hearing on
the allegations and the matter was
placed on the docket of the Office of
Administrative Law Judges. ALJ Ex. 2.
Thereafter, an Administrative Law Judge
(ALJ) conducted a hearing on August 30
and 31, 2011, in Nashville, Tennessee.
ALJ Recommended Decision
(hereinafter, also ALJ), at 4. At the
hearing, the Government elicited
testimony from several witnesses and
submitted various documents into the
record; Respondent testified in his own
´
defense and submitted his resume for
the record. Following the hearing, both
parties filed briefs containing their
proposed findings of fact, conclusions of
law, and argument.
On November 3, 2011, the ALJ issued
his recommended decision. Therein, the
ALJ rejected the Government’s
allegations that Respondent had
prescribed controlled substances over
the internet to numerous persons who
were not Tennessee residents, finding
credible Respondent’s testimony that he
did not issue any of the prescriptions
(and that the prescriptions were forged)
and that the Government’s contrary
evidence was unsubstantiated hearsay.
ALJ at 37–38. While there was also
evidence that Respondent had issued
prescriptions over the internet and
without performing physical
examinations, the ALJ found credible
Respondent’s testimony that he did so
pursuant to an arrangement in which he
was acting ‘‘as an on-call covering
physician’’ for patients who needed a
prescription refill when their doctor was
unavailable. Id. at 39. The ALJ further
found that the Government had failed to
show that Respondent was required to
perform a physical examination to
prescribe to Tennessee residents,
finding credible Respondent’s testimony
that ‘‘he did not give new diagnoses to
the patients’’; that he ‘‘only provided
refills’’ and ‘‘did not prescribe new
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medications’’; and that ‘‘he only issued
prescription refills after he conducted
the telephone consultations with the
patient, reviewed the patient’s medical
file and verified that the patient’s
primary care physician was unavailable
to see the patient.’’ Id.
The ALJ further found that
Respondent had prescribed
phentermine to family members,
including his sister, wife and mother-inlaw. Id. at 41. However, the ALJ also
found credible Respondent’s testimony
that upon being confronted by a
pharmacist that it was unlawful to
prescribe to family members, he stopped
doing so. Id. The ALJ also found that
Respondent had provided a UPS box as
the address of his registered location
even though at the time he was
practicing medicine at several physical
locations and that this was a violation
of 21 U.S.C. 822(e). Id. at 41–42.
Finally, the ALJ found that
Respondent had fully accepted
responsibility for his misconduct and
demonstrated that he will not engage in
future misconduct. The ALJ thus
concluded that while the Government
had established ‘‘a prima facie case that
Respondent has committed acts
inconsistent with the public interest by
unlawfully prescribing controlled
substances to immediate family
members and by failing to maintain a
proper registered practice location,’’ he
had rebutted the Government’s prima
facie case. Id. at 44.
The Government filed exceptions to
the ALJ’s recommended decision.
Thereafter, the record was forwarded to
me for final agency actions.
Having considered the entire record
and the Government’s Exceptions, I
adopt the ALJ’s findings that the
Government proved that Respondent
unlawfully prescribed a controlled
substance to a family member and failed
to update his registered location with
the Agency. I also adopt the ALJ’s
finding that the Government did not
prove that Respondent violated the
CSA’s prescription requirement by
prescribing controlled substances
through the Internet to Tennessee
residents because it did not establish
that his conduct violated the State’s
regulation. However, for reasons
explained below, I reject the ALJ’s
finding that the Government did not
prove that Respondent improperly
prescribed controlled substances
without a valid doctor-patient
relationship to persons who were not
residents of Tennessee. Moreover, even
were I to adopt the ALJ’s finding that
Respondent did not issue or authorize
the issuance of the out-of-state
prescriptions, under agency precedent—
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which was ignored by the ALJ—
Respondent was nonetheless liable for
them because he provided his
registration number to Secure Telemed’s
employees and failed to exercise any
supervision over their use of his
registration. I further reject the ALJ’s
finding that Respondent has rebutted
the Government’s prima facie showing
that his continued registrations would
be inconsistent with the public interest.
Findings of Fact
Respondent is the holder of a DEA
Certificate of Registration, which
authorizes him to dispense controlled
substances in schedules II through V as
a practitioner. GX 1. Respondent’s
registration was due to expire on June
30, 2009. Id. However, on June 16, 2009,
Respondent submitted a renewal
application. GX 2. Accordingly,
Respondent’s registration remains active
pending the issuance of this Decision
and Final Order. 5 U.S.C. 558(c).
The Investigation of Respondent
Respondent came to the attention of
the Agency in the spring of 2008, when
DEA Investigators in Nashville,
Tennessee started receiving complaints
from other DEA offices, as well as
pharmacies throughout the country, that
the pharmacies were receiving
prescriptions issued by Respondent
which appeared to be suspicious. Tr.
115–16. Investigators eventually
determined that the prescriptions were
being issued through an internet scheme
known as Telemed Ventures.1 Id. at 117.
Under the scheme, persons would go
online and fill out a questionnaire,
providing their name, address phone
number, as well as their height, weight,
and estimated blood pressure. Id.
According to an Agency Investigator,
sometimes patients would fax in their
medical records; however, other
patients said they did not do so. Id. at
119. Patients would then be put in
touch with a physician, who would
conduct a phone consultation with the
patient and issue a prescription. Id.
Initially, the prescriptions were
transmitted either electronically or by
fax to a fulfillment pharmacy, which
dispensed the medication. Id. at 119–20.
However, after DEA started cracking
down on fulfillment pharmacies, the
prescriptions were sent directly to the
patients, who took them to their local
pharmacies. Id. at 120.
During the course of the investigation,
DEA Investigators conducted an
1 The scheme was also known as Secure
Telemedicine and Fortune Telemed. Tr. 117.
Throughout the hearing, the parties referred to it as
‘‘Secure,’’ ‘‘Secure Telemed,’’ and ‘‘Secure
Telemedicine,’’ as does this Decision.
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inspection of Contract Pharmacy
Services, a pharmacy located in
Colorado, which filled prescriptions as
part of the Secure Telemed scheme. Id.
at 121. During the inspection, the
pharmacist cooperated with DEA and
identified the names of various
physicians whose prescriptions he had
filled, to include Respondent. Id. The
pharmacist also provided the
Investigators with a spreadsheet of
various prescriptions he had filled
which were attributed to Respondent.
The spreadsheet listed several dozen
controlled substance prescriptions for
drugs (primarily for schedule III
combination drugs of hydrocodone and
acetaminophen), which the pharmacy
dispensed to persons located in
Mississippi and South Carolina between
September 19 and October 30, 2007. See
GX3.
Using the spreadsheets, the Nashvillebased Investigators asked other DEA
offices to interview several of the
persons who were listed as having had
obtained controlled substances in
October 2007, from the pharmacy, based
on prescriptions issued by Respondent.
Tr. 127. Those interviewed included
K.S., a resident of Terry, Mississippi,
and C.T., a resident of Clinton,
Mississippi, to each of whom the
pharmacy dispensed a prescription for
90 tablets of hydrocodone/apap 10/
500mg; as well as A.L., a resident of
Richland, Mississippi, to whom the
pharmacy dispensed a prescription for
90 tablets of hydrocodone/apap 10/
650mg. GX 3, at 1. Each of the
interviews was conducted in the
September/October 2009 timeframe. Tr.
73, 77, 81.
A Mississippi-based Investigator
testified that she interviewed K.S., who
related that she had obtained the
prescription from an online pharmacy
by filling out a form and that she had
faxed her medical records to a Web site.
K.S. further stated that she had
‘‘received a phone call from someone
identifying [him]self as Dr. Dennis,
contacting her about her online form.’’
Tr. 73–74. According to the Investigator,
K.S. further stated that she had never
met Dr. Dennis and had not been
physically examined by him. Id. at 74.
K.S. further stated that she had received
the prescriptions by email and fax and
that she had filled the prescriptions at
a local Walgreens. Id. at 75.
The Investigator also interviewed
A.L., who also told of filling out an
online form through a Web site known
as Fortune Telemed and faxing medical
record to the Web site. Id. at 78–79. A.L.
stated that she had ‘‘received a phone
call from someone stating they were
from Dr. Dennis’ office,’’ id. at 78, and
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that she had no personal contact with
Respondent. Id. at 79. A.L. further stated
that she received six to seven
prescriptions from Respondent, some of
which were filled at a pharmacy in
Miami, and some of which she filled at
a local Wal-Mart. Id. at 80–81.
The Investigator also participated in
an interview of C.T., who also related
that he had filled out a form at a Web
site, faxed his medical records to the
Web site, and ‘‘received a phone call
from someone identifying [himself] as
Dr. Dennis.’’ Id. at 82. C.T. further stated
that he never met Respondent, and that
he had received two to three
prescriptions from him which he filled
at a local Walgreens. Id. at 84.
With respect to each of these three
persons, the Investigator acknowledged
that they did not volunteer
Respondent’s name and that she had
told them that she was investigating a
Dr. Dennis. Id. at 85. She further
acknowledged that none of them would
be able to identify Respondent if they
testified in court. Id. at 87. Moreover,
none of the witnesses identified an
email address or fax number that was
used to send them the prescriptions and
the Investigator acknowledged that the
prescriptions could have been created
by Secure Telemed. Id. at 88.
An Investigator from the Columbia,
South Carolina DEA office testified that
on June 3, 2008, she was contacted by
an Inspector from the South Carolina
Bureau of Drug Control regarding two
prescriptions issued under
Respondent’s registration (for 60 tablets
of Valium and 60 tablets of
hydrocodone/apap 10/325mg and dated
May 30, 2008), which H.B., a resident of
Chapin, South Carolina presented for
filling at a local pharmacy. See Tr. 94–
95; GX 14. According to the DI, the
pharmacy had contacted the state
inspector because the prescriptions had
been issued to a known drug seeker or
doctor shopper and had been written by
an out-of state physician. Tr. 95–96. The
DI testified that she had spoken with
both the pharmacist and a pharmacy
technician regarding the prescriptions,
and that the pharmacist told her that the
pharmacy had a policy of contacting
‘‘every out-of-state physician.’’ Id. at 97.
According to the DI, the pharmacist
had initially attempted to call
Respondent using the phone number
which was listed on the prescription as
Respondent’s but was unable to reach
him because his mailbox was full. Id. at
98. However, the pharmacist looked for
another phone number for Respondent
and was eventually able to speak with
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him and did so on June 2, 2008.2 Id. at
97.
The DI testified that the pharmacist
told her that she asked Respondent if
H.B. was his patient and to verify that
he had written the prescriptions and the
quantities; Respondent told the
pharmacist that H.B. was his patient. Id.
Moreover, the DI further testified that
the pharmacist said that Respondent
verified that he had written the
prescription and the quantity. Id. at 99.
And according to the DI, Respondent
told the pharmacist that he ‘‘had a
record on H.B.’’ but ‘‘had never seen her
in person.’’ Id. at 98–99. Finally, the
pharmacist told the DI that when she
questioned Respondent about this, he
stated that he had been ‘‘assured’’ by his
Medical Director ‘‘that prescribing to
out-of-state patients was legal in all
except two states.’’ Id. at 99. The DI
further testified that the pharmacy had
not filled the prescriptions.3 Id. at 96.
The DI further testified that she had
compiled a spreadsheet based on data
she obtained from the South Carolina
Prescription Monitoring Program (PMP)
of the prescriptions which were issued
by Respondent and filled by South
Carolina pharmacies, and that she had
notated on the document the distance
between the patient’s residence and
Respondent’s location. Id. at 105, 109;
GX 17. The DI verified the data by
contacting all of the pharmacies and
asking whether the prescription had
been presented and whether it had been
filled. Tr. 107–08. She also stated that
she had obtained a faxed copy of all of
2 One of the prescriptions contains a different
handwritten phone number with the same area code
as that listed for Respondent’s phone number. GX
14, at 2. According to the testimony of the DI, the
phone number was on the document at the time she
received it from the pharmacy. Tr. 103. The DI did
not, however, know ‘‘where that number would
call.’’ Tr. 103. However, several other prescriptions
in the record, which Respondent does not dispute
having written, list the same phone number which
was handwritten on the prescription issued to H.B.
Compare GX 13, at 2–5, with GX 14, at 2. See also
Tr. 215 (testimony of Nashville-based Investigator
identifying phone number as Respondent’s phone
number at his Lebanon, Tennessee practice).
The DI further testified that she had received
copies of the two prescriptions from the pharmacy
on June 3, 2008. Tr. 94. Consistent with this
testimony, both prescriptions have a fax header
indicating that they were faxed from the pharmacy
on June 3, 2008. See GX 14, at 1–2.
3 In her testimony, the DI stated that she had
interviewed the pharmacist the week before the
hearing. Tr. 99 & 103. The record does not,
however, clearly establish that the statements
attributed to Respondent were also related by the
pharmacist to the DI in June 2008, after the DI had
received the report from the State and contacted the
pharmacy to obtain the prescriptions. See generally
Tr. 93–103. Nor, with respect to the pharmacist’s
August 2011 statements, did the Government put on
any evidence tending to show that the pharmacist
had an accurate recollection of the 2008 incident
and her phone conversation.
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the prescriptions and that ‘‘[o]n many
of’’ them, ‘‘there is a notation written on
them from the pharmacists that were
working that day that they were verified
with Kevin Dennis.’’ Id. at 111. The
spreadsheet documents more than
seventy controlled-substance
prescriptions, nearly all of which were
for hydrocodone, which were issued
under Respondent’s DEA registration
and which were dispensed between
January 2 and July 18, 2008. Consistent
with the DI’s testimony, the spreadsheet
does not list the two prescriptions for
H.B. as having been filled.
The Government also introduced into
evidence copies of numerous other
prescriptions which it alleged
Respondent had issued through
Telemed, as well as printouts from both
the Tennessee and Mississippi
prescription drug monitoring programs
listing prescriptions which were
dispensed and attributed to Respondent.
GX 5 & 6. These included multiple
prescriptions for 90 tablets of
hydrocodone/apap 10/325 issued to K.P.
of Fort Mill, South Carolina on
December 13, 2007, as well as January
7, February 4, March 3, April 4, April
30, and May 23, 2008. GX 15, at 9–16.
Each of the prescriptions included
Respondent’s cell-phone number, id.,
and the January 7 prescription bears the
handwritten notation: ‘‘these are valid
per Dr. Dennis’’ along with his DEA
number.4 See id. at 10. Regarding this
note, an Agency Intelligence Research
Specialist, who obtained the
prescriptions from the dispensing
pharmacy, testified that she was told
that the note was made ‘‘by the actual
pharmacist after calling and confirming
whether the prescription was valid or
not.’’ Tr. 59. The Research Specialist
testified that she obtained these
prescriptions from a K-Mart Pharmacy
in North Carolina. Tr. 40.
These included multiple prescriptions
for hydrocodone/apap 10/500mg. issued
to patient E.F., who resided in the same
town (Franklin, Tennessee) where
Respondent practiced. GX12. According
to the Government’s lead Investigator, a
local pharmacist had found the
prescriptions to be suspicious 5 and
contacted a state drug task force because
4 This exhibit also includes copies of
prescriptions issued for Naproxen which were
issued on the same dates as the hydrocodone ones
were. See GX 15, at 1–8.
5 According to the DI, the circumstances which
raised the pharmacist’s suspicion included that the
prescriptions contained a reference number, a box
with a bar code, and had been faxed into the
pharmacy. Tr. 166. The DI testified that the
reference number was ‘‘a way for Telemed to keep
track of the prescription [it] sent.’’ Id. at 253.
Numerous prescriptions in the record contain these
hallmarks.
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they contained a reference number and
bar code and had been faxed into the
pharmacy. Tr. 166.
The prescriptions were dated April 4,
May 7, June 11, and July 10, 2008. GX
12. While the first three prescriptions
contain the notation ‘‘filled’’ with a
date, the latter prescription bears the
notation ‘‘refused to fill 7/16 called
Doctor & patient’’ and was marked with
an x across the face of the prescription.
Id. According to the Investigator, this
note was written by the pharmacist. Tr.
167.
In addition, a report from the
Tennessee PMP lists several other
hydrocodone prescriptions which were
dispensed by Tennessee pharmacies to
E.F. pursuant to prescriptions attributed
to Respondent; these include
prescriptions which were dispensed on
November 13 and December 11, 2007;
January 29, and February 28, and
August 4, 2008.6 See GX 6, at 9. Notably,
the PMP report does not list a
dispensing as having occurred in July
2008. See id.
The DI further testified that in August
2008, after obtaining the prescriptions,
he had contacted E.F. seeking to
interview her. Tr. 170. The Investigator
explained to E.F. that he had
determined ‘‘that she was obtaining
medications over the internet.’’ Id.
While E.F. initially offered to call the
Investigator back to arrange for an
interview, she ultimately became ‘‘very
hard to get a hold of.’’ Id. About a year
later, the Investigator went to her house
and found her. Id. at 171. E.F.
eventually agreed to an interview which
was conducted at her house. Id. at 172.
During the interview, E.F. stated that
she had a long history of migraine
headaches and admitted that sometime
in late 2007, she had gone online and
started ordering medications through a
Web site which she referred to as
‘‘Telemed something.’’ Id. She further
stated that she had sent in medical
records from both her primary care
physician and neurologist and that after
calling a 1–800 number for the Web site,
she was told that she would be called
by a physician. Id.
E.F. stated that she then received a
phone call from a person who identified
himself as Kevin Dennis and that she
generally talked with Respondent
whenever she needed a prescription. Id.
at 173. E.F. further stated that she had
asked Respondent if she needed to be
seen by him, and that Respondent stated
that he did not need to see her as long
as he was reviewing her medical records
6 The PMP report shows that E.F. filled her
prescriptions at three different pharmacies.
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and talking to her on the phone. Id. at
174.
The DI also testified that a state
investigator had provided him with a
copy of the medical record E.F.’s
primary care doctor maintained on her.
Id. at 203. Upon reviewing the file, the
Investigator found that there was no
documentation that she was being
prescribed controlled substances by
another physician. Id. at 203–04; see
also GX 22. Nor is there any evidence
in the file of Respondent’s having
contacted E.F.’s primary care doctor.
See GX 22.
The DI further testified that he had
spoken with E.F.’s primary care doctor
(Dr. B.) and asked him whether he had
ever contracted with an organization to
provide cross-coverage for his patients.
Tr. 205. Dr. B. explained that because
there are ‘‘numerous internal medicine
physicians’’ at his practice, there would
be no need to have a physician outside
the practice cover for him. Id. Finally,
Dr. B. said that he had never heard of
Respondent. Id.
The Investigator also interviewed
S.W., a Nashville resident, who
according to the Tennessee PMP report,
obtained prescriptions for hydrocodone
and phentermine which were filled
under Respondent’s DEA registration.
Tr. 135; GX 6, at 27. According to the
PMP report, on December 17, 2007, as
well as January 15 and February 14,
2008, Respondent issued to S.W.
prescriptions for both 90 tablets of
hydrocodone/apap 10/325 and thirty
tablets of phentermine 30mg. GX 6, at
27. According to the Investigator,
although S.W. acknowledged having
ordered hydrocodone through Telemed
she could not remember the name of the
prescribing physician. Tr. 135, 164.
However, the Investigator was
eventually able to identify Respondent
as the prescribing physician. Id. at 164.
During an interview, S.W. stated that
she ordered drugs over the internet and
had been doing so ‘‘for years’’ because
it was ‘‘easier to get’’ some of the
medications she wanted such as ‘‘diet
pills’’ as ‘‘her primary care physician
really didn’t want to prescribe the type
of things she wanted.’’ Id. at 163–65.
S.W. further stated that she never had a
physical exam and never met the
physician. Id. at 164. She also stated
that she filled the prescriptions at a
local Wal-Mart. Id.
S.W. provided the Investigator with
the name of her primary care physician
(Dr. H.). Id. at 165. Subsequently, the
Investigator interviewed Dr. H. and
asked him whether he would contract
with an organization outside of his
practice to provide on-call or crosscoverage for his patients. Id. at 207. Dr.
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H. explained that this would not occur
because there were other physicians in
his practice who covered for him if he
was not available. Id. In addition, Dr. H.
stated that he had never heard of Secure
Telemedicine or any other organizations
with a similar name. Id. at 207–08. Nor
had Dr. H. ever heard of Respondent. Id.
at 208.
During the investigation, the
Government also found evidence that
Respondent was prescribing controlled
substances, specifically phentermine
37.5mg, to family members including
his wife, sister, and mother-in-law. See
GX 19, at 12–13, 17, 19, 21–23 (Rxs
issued to wife); GX 20, at 2–6, 10–13
(Rxs issued to sister); GX 21, at 2, 4–10
(Rxs issued to mother-in-law); Tr. 175–
79, 181–82, 201. The DI further stated
that upon going to a Sam’s Club
Pharmacy in Franklin, Tennessee to
retrieve the prescriptions which
Respondent’s wife and sister had filled
there, the Pharmacy Manager related a
2009 incident in which he had
challenged Respondent’s wife and sister
about the prescriptions. Tr. 185.
According to the Pharmacy Manager,
Respondent’s wife and sister had filled
prescriptions for diet pills at the
pharmacy on several previous occasions
and he had ‘‘always assumed that they
were sisters.’’ Id. However, upon
reviewing the prescriptions, the
Pharmacy Manager had ‘‘put two and
two together’’ and concluded that one of
the women ‘‘might be’’ Respondent’s
wife. Id.
When the women returned to pick up
their prescriptions, the Pharmacy
Manager confronted them, telling them
that it was against state law and Medical
Board policy for a physician to prescribe
to a family member. Id. Respondent’s
wife became agitated and said that she
would just ‘‘go get the doctor and we’ll
clear this up.’’ Id. at 186. The women
left and later returned with Respondent.
The Pharmacy Manager, who declined
to fill the prescriptions, explained the
situation to Respondent, who stated that
‘‘he understood and left without
incident.’’ Id.
On June 26, 2009, Respondent went to
the Nashville DEA office to discuss with
the Investigator and his Supervisor why
the Agency had not renewed his
registration. Id. at 189, 421. After being
advised of his right to remain silent and
that he was not under arrest,
Respondent was informed that DEA was
investigating him for prescribing
controlled substances to persons in
other States and with whom he did not
establish a legitimate doctor-patient
relationship. Id. at 190; see also id. at
422 (testimony of Supervisory
Investigator: ‘‘I advised him that DEA
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was conducting an investigation of
information we had received that he had
been involved in issuing prescriptions
to persons that he had never met, nor
ever examined in other states and that
it appeared that would be without a
legitimate medical purpose, and that
was the reason we were conducting the
investigation. . . .’’).
Respondent stated that he ‘‘kind of
knew what this was about’’ and pulled
out of his pocket, ‘‘some sort of
employment document with Secure
Telemedicine.’’ Id. at 190. However, the
DI did not make a copy of the
document. Id. at 357. According to
Respondent, the document ‘‘was
actually a liability form’’ that had the
‘‘name of [the] company, their
malpractice insurance carrier, along
with the name of seven other doctors,’’
id. at 356, as well as the dates of its
insurance policy. Id. at 358.
Respondent then volunteered that he
quit working for Secure Telemedicine
after receiving a phone call from a
pharmacy in South Carolina questioning
one of his prescriptions and after the
entity’s Medical Director ‘‘could not
provide verification that he could do
this legally in other states.’’ Id. at 194;
see also id. at 197 (testimony that
Respondent ‘‘indicated that he left
Secure Telemedicine because he didn’t
feel like it was the ethical thing to do
and that they couldn’t provide him the
legal documentation to make him feel
comfortable to continue working for
them’’); id. at 425 (Supervisory
Investigator’s testimony to same effect).
Moreover, according to both
Investigators, Respondent stated that he
was surprised to receive the phone call
from the South Carolina pharmacy
because ‘‘it was his understanding that
all these prescriptions went to a
fulfillment [or clearinghouse]
pharmacy.’’ Id. at 198; see also id. at
424. According to the Investigator,
Respondent never denied that he had
issued prescriptions to out-of-state
persons during the interview and said
he had worked for Secure Telemed from
‘‘around November [20]07 through
March 2008.’’ Id. at 195. However, in his
testimony, Respondent denied ever
having told the Investigators that he had
issued prescriptions to out-of-state
persons and asserted that he told them
that he had limited his internet
prescribing to Tennessee residents.
Specifically, Respondent testified that:
I communicated to the investigators at that
time that I was a Tennessee-licensed
physician and that I was not authorized, and
I was only notified by the South Carolina
pharmacist that a prescription arrived in
South Carolina. I did not communicate to the
investigators that I had ‘‘prescribed or
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52791
dispensed medications outside the State of
Tennessee.’’
Id. at 396. According to Respondent,
when he was confronted by an
Investigator as to whether he had issued
internet prescriptions for out-of-state
patients, he stated that he did not
‘‘know of any online pharmacy
activities,’’ and added: ‘‘I don’t know if
it’s an online pharmacy or not, but I’ve
been associated with Secure
Telemedicine. I’ve been an On-Call
Coverage Consultant for that
organization for a period of time.’’ Id. at
397. Respondent again maintained that
he told the Investigator that he ‘‘did not
give Secure Telemedicine authorization
to dispense or prescribe medications
outside the State of Tennessee. I did not
give them that authorization,’’ id. at 398,
and that at the time of the interview, he
was unaware that any other prescription
(beside the one that he was called about
by the South Carolina pharmacist) had
been issued to non-Tennessee residents
using his DEA registration. Id. at 403.
According to the Investigator,
Respondent further stated that ‘‘[i]t was
his understanding that all these
prescriptions went to a fulfillment [or
clearinghouse] pharmacy. So, when he
received a call directly from a pharmacy
in South Carolina, it took him by
surprise.’’ Id. at 198. See also id. at 424
(testimony of Supervisory Investigator
who also attended the interview: ‘‘he
said that he had been contacted by a
pharmacist from South Carolina
concerning one of his prescriptions and
questioning that prescription and that
he was surprised because he thought
that all his prescriptions went through
a clearinghouse pharmacy’’).
Respondent also stated that at the
time he worked for Secure
Telemedicine, he worked in an
emergency room and had a practice in
Lebanon and that he sent out his
resume´ online to ‘‘find some locum
tenens work’’ to supplement his income.
Id. at 195–96; 296. Respondent admitted
that he never saw the patients to whom
he prescribed and did not conduct
physical examinations. Id. at 196.
Rather, he would review a patient’s
record online and conduct a telephonic
consultation with the patients before
issuing a prescription; he further
admitted that he prescribed such
controlled substances as hydrocodone,
Norco (a branded hydrocodone drug),
and Xanax, as well as such noncontrolled drugs as naproxen and
ibuprofen. Id. at 196.
Respondent testified on his own
behalf. Regarding his work for Secure
Telemedicine, Respondent testified that
he became aware of Secure Telemed
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through ‘‘a web search for locum tenens
work’’ and that he did not interview
‘‘face-to-face’’ with them and had never
been to its office, which he understood
to be located in Miami; rather, he
interviewed by phone. Id. at 295–97.
Respondent nonetheless entered into an
agreement with Secure towards the end
of September 2007. Id. at 298.
Respondent maintained that he ‘‘was
to become an on-call covering
physician, considered under [Secure
Telemedicine’s] Consult-A-Doc
program’’ and that he would provide
shift coverage on an eight-hour
basis.7 Id. According to Respondent, he
‘‘would inform the company of the
shifts that [he was] available in advance
such that [he] would be available to
cover on-call for physicians after hours
or when a physician is just unavailable
to be able to manage the care of their
patients.’’ Id.
Respondent further asserted that
under the Consult-A-Doc program,
patients would call into Secure
Telemedicine, and that he would be
notified through what was ‘‘called a
dashboard’’ that a patient was seeking a
consultation, and that he could either
accept or decline the call. Id. at 299.
Respondent maintained that if he
accepted the call, his activities were
limited to triaging a patient call in nonemergency situations and that if a
patient’s situation involved an
emergency, he would direct the patient
to go to the emergency room or an
urgent care center. Id. at 299–300.
Respondent asserted that he would
‘‘never give a new diagnosis’’ to ‘‘any
patient’’ and that upon completion of
the call, he would update the patient’s
record in the electronic medical records
system (EMR). Id. at 300. Respondent
maintained that ‘‘if the patient
requested and they were talking in a
way such that they had a chronic
ailment, such as a pain ailment,’’ the
patient was placed back in the queue
because ‘‘there had to be verification of
their records.’’ Id. at 301. Respondent
then asserted that he would then ‘‘[c]all
the patient’s primary care doctor, the
doctor that’s prescribing the medication,
talk to that office, find out information
about that office and find out about their
unavailability.’’ Id.; see also id. at 303.
Respondent maintained that ‘‘[s]ome
doctors who are in private practice,
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7 In
his letter requesting a hearing, Respondent
asserted that ‘‘Secure contracted with primary care
physicians in Tennessee and other jurisdictions to
provide coverage by other licensed physician in
their respective jurisdictions when the primary care
physician was unavailable to attend to the needs of
their established patients for ongoing conditions.’’
ALJ Ex. 2. However, at the hearing, Respondent
produced no evidence to support the assertion that
Tennessee physicians contracted with Secure.
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mostly private practice, a lot of them
don’t have call coverage or they have
problems finding physicians with call
coverage.’’ Id. Respondent then added
that while working for Secure
Telemedicine, he ‘‘really didn’t have
any contact’’ with any group practice
where ‘‘they communicate to me that
this program was part of them.’’ Id.
Respondent asserted that with respect
to solo practitioners, ‘‘if the office staff
stated that Doctor ABC was actually on
vacation and he will not be back for at
least five days but be back next week,
that extended period of time then
qualified the patient for that particular
medication after reviewing the records
with the staff.’’ Id. at 302. Respondent
stated that he would never initiate a
new medication for a patient and that he
would ‘‘always make sure that the
doctor [was] truly unavailable’’ before
prescribing a controlled substance. Id.
Respondent further testified that he
only accepted on-call coverage for
Tennessee physicians, and that he only
consulted with the patients of
Tennessee physicians. Id. at 303. He
then explained that upon determining
that a hydrocodone prescription needed
to be refilled, he would update the EMR
to note that he had reviewed the
patient’s record, that he had contacted
the office of the patient’s physician and
determined that the ‘‘physician was not
available to this patient’’ and that he
would then push a button on a
computer to send this information to
Telemed, which would prepare the
prescription. Id. at 304. In his
testimony, Respondent emphasized that
he did not actually prepare or sign the
prescriptions. Id.; see also id. at 414. He
also stated that he did not keep any
records of his prescribing activities for
Telemed, id. at 305, because they were
the property of Secure Telemedicine. Id.
at 384.
When asked to square his failure to
retain patient files for those to whom he
prescribed with his obligation as a
physician to maintain a patient record,
Respondent testified that:
I was not the [primary care physician]. I
was only the on-call covering physician;
therefore, it’s not my responsibility at that
time to have or operate in a fashion as though
I am that patient’s primary doctor. I was only
an on-call covering physician.
Id. at 385.
Moreover, he did not forward a copy
of the prescriptions he wrote to the
patient’s primary care physician
claiming that this was the responsibility
of Secure Telemedicine. Id. at 384.
Asked by the Government whether he
ever communicated with the patient’s
primary care physician regarding
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Sfmt 4703
prescriptions he had written
Respondent maintained that the
information was in the electronic
medical record and was sent through
Secure Telemedicine. Id. at 388. And
when asked whether he had ever
verified with someone at Secure
Telemedicine that it had notified a
patient’s primary care physician
regarding his having written a
prescription, Respondent replied: ‘‘I
don’t know of any instance where they
did not. I was not told that information
and I did not question that particular—
I did not pose that question to them.’’
Id. at 389. Strangely, Respondent
acknowledged that he did not remember
having ever been called by the primary
care physician of a patient he had
prescribed to through Secure Telemed,
notwithstanding that his name would
have been on the consult note. Id. at
408–09.
Regarding his decision to terminate
his arrangement with Secure
Telemedicine, Respondent testified that
on about April 4, 2008, he received a
phone call from a South Carolina
pharmacist, who he asserted was ‘‘a
male pharmacist,’’ Tr. 364, questioning
a prescription that had his DEA number
and information on it. Id. at 308.
Respondent asserted that he ‘‘was not
aware that [he] had written
prescriptions for any patients outside
the State of Tennessee’’ and that he
‘‘asked the pharmacist to not fill that
prescription’’ and to send him a copy of
it. Id.; see also id. at 368 (‘‘I
communicated with him [the
pharmacist] that I was unaware that
there was any patient I’ve ever
prescribed any medication for or wrote
a prescription for in the State of South
Carolina.’’). According to Respondent,
the pharmacist agreed not to fill the
prescription. Id. at 308. Respondent did
not, however, recall the name of the
pharmacy or the city it was located in.
Id. at 369. Moreover, Respondent did
not notify DEA that his registration had
been used to issue the prescription. Id.
at 371, 374.
Respondent testified that ‘‘the same
day,’’ he contacted Secure Telemed’s
Medical Director, and asked him ‘‘how
is it that a prescription . . . ‘has gotten
outside the State of Tennessee to a
patient in South Carolina?’ ’’ and said
that he had ‘‘never approved anything
like that.’’ Id. at 308. Continuing,
Respondent testified that he asked
Secure Telemed’s Medical Director:
Can you give me some legalities or
something in writing showing that, you
know, this isn’t happening or how is it
happening? What are the laws concerning a
doctor in Tennessee having the right to have
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a prescription written to a patient in any state
outside of Tennessee?
I was very upset by that conversation, that
this actually occurred, but I said I wanted to
see a copy of it. I really wanted to see one,
because I really hadn’t seen any, because I
hadn’t produced any. I didn’t know what
they looked like.
And he stated he would get back with me,
he would call me, he would investigate and
research this, and he would provide some
documents to me that protected me and
protected the company pertaining to any
Tennessee physician if they were to prescribe
outside the State. I never received those
documents from [him], and I discontinued
providing any service for them probably
within two weeks.
Id. at 308–09.
Respondent further acknowledged
that he had provided Secure
Telemedicine with his DEA registration
number, as well as other documents,
which had his signature on them. Id. at
310. He then expressly denied having
told DEA Investigators that the reason
he quit Secure Telemed was because
they could not justify his continued
prescribing of medications to out-ofstate patients. Id. at 310–11. Rather, he
reiterated that the reasons he quit
Secure Telemed were for the reasons
explained in the block-quote above. Id.
at 311. Respondent did not, however,
create any written correspondence
documenting his decision to terminate
his relationship with Secure
Telemedicine. Id. at 375–77.
Respondent then denied having
prescribed for ‘‘anybody other than
patients that were treated by Tennessee
physicians [that he was] on call for.’’ Id.
at 311. And when questioned by his
counsel if ‘‘the one [prescription] in
South Carolina, that’s the first you heard
about it?,’’ Respondent replied ‘‘[t]hat is
correct,’’ then added: ‘‘And I had never
seen a prescription as well.’’ Id.
Respondent then maintained that he
had never seen any of the prescriptions
until the Government provided them
following the initiation of this
proceeding. Id.
After denying that he ever took a call
from a patient that lived in South
Carolina, Colorado or Washington State,
id. at 305, Respondent then proceeded
to deny having issued all but one all of
the prescriptions for out-of-state
patients.8 Id. at 312–23 (denying
issuance of prescriptions in GXs 3, 5, 8,
9, 10 11); id. at 324–30 (denying
issuance of prescriptions in GXs 12,
14); id. at 336–41 (denying issuance of
prescriptions in GXs 16, 17, and 18).
8 The only exception was for a prescription
contained in GX 7. According to Respondent,
although the patient provided a Colorado address,
she was in the music business and had been a
patient in Respondent’s Tennessee practice. Tr. 314.
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Moreover, he further denied having
authorized Telemed to issue the various
prescriptions. Id.
Regarding the hydrocodone
prescriptions issued to E.F. (GX 12),
who resided in Franklin, Tennessee,
and which included a July 10, 2008
prescription with the notation that the
pharmacist had ‘‘Refused to fill, 7/16,
called doctor and patient,’’ Respondent
acknowledged that ‘‘[i]t’s possible’’ he
received a call about the prescription
and that at the time, he was working in
the ER and was ‘‘quite busy.’’ Tr. 324–
25. Respondent testified that he ‘‘tend[s]
not to answer calls because of the nature
of the hospital’’ and added that ‘‘[i]t’s
always possible that I could have
received a call, and I could have
answered this and spoken to this
pharmacist, and told them not to fill the
prescriptions.’’ Id. at 325. However,
Respondent did not have a ‘‘positive
recollection’’ of the incident. Id.
Respondent then denied having
issued, as well as having authorized
anyone to issue, each of the
prescriptions that E.F. obtained through
Secure Telemed. Id. Respondent added
that during the interview with DEA
Investigators, he had told them that the
only time he received a call regarding a
prescription was for the call that came
from the South Carolina pharmacist. Id.
at 326; see also id. at 363
(acknowledging that it is ‘‘always
possible’’ that he received a phone call
from a pharmacist about E.F. but stating
that he did not ‘‘have any recollection,
and I’ve never seen this patient, I’ve
never talked to this patient.’’); id. at 367.
Later, on redirect examination,
Respondent testified that he would not
have issued prescriptions through the
internet to E.F. because ‘‘[m]y office was
available within a proximity where this
patient can come right to my office so
I can examine them physically, I can see
what’s going on with the medical
conditions’’ and ‘‘I would have no need
to do this.’’ Id. at 404.
Regarding the May 30, 2008
prescriptions for hydrocodone and
valium issued to H.B. of Chapin, South
Carolina, and which were presented to
the Chapin Pharmacy, Respondent
denied writing them or issuing them in
any way. Tr. 330. He also denied
authorizing them ‘‘in any way.’’ Id.
Respondent also denied writing,
authorizing, or otherwise causing the
issuance of the numerous hydrocodone
prescriptions issued to K.P., of Fort
Mill, South Carolina. Id. at 333–34. As
found above, a January 7, 2008
prescription bears the handwritten
notation: ‘‘These are valid per Dr.
Dennis’’ along with his DEA registration
number. GX 15, at 10. Respondent
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nonetheless denied having authorized
or validated the prescription. Tr. 333–
34. Moreover, on cross-examination, he
denied having received any other phone
calls from any pharmacists about
prescriptions other than the phone call
he claimed to have received from a
South Carolina pharmacist in April
2008. Id. at 364. And when asked if he
knew how the notation got on the
prescription, Respondent testified:
I have no idea how the notation arrived
there, but it doesn’t appear to be a
pharmacist. By pharmacy rule of law, any
notation written on a prescription must
contain their initials and it must contain the
date of that communication and/or alteration
of the prescription. By pharmacy law they
must do this. This one does not contain any
initials by a pharmacist, does not contain a
date.
Id. at 334.
Respondent did not, however, cite to
any specific provision of North Carolina
law or the Pharmacy Board regulations
in either his testimony or his brief,
which requires that such a notation that
a prescription has been verified must be
initialed and dated. And even if the
prescription should have been initialed
and/or dated, given that Respondent has
‘‘no idea how the notation arrived’’ on
the prescription, I find that the
testimony of the Agency Intelligence
Research Specialist, who obtained the
prescription, that the note was made by
‘‘the actual pharmacist after calling and
confirming whether the prescription
was valid’’ to constitute substantial
evidence that the note was made by the
pharmacist, and consistent with
pharmacy practice, was likely done so
by the pharmacist in the process of
reviewing the prescription and
determining whether to fill it.9
Respondent further denied having
issued any of the prescriptions listed on
the spreadsheet of prescriptions which
an Agency Investigator had compiled
from the South Carolina PMP report. Tr.
339–40. Moreover, on crossexamination, the Government showed
Respondent the printout from the
Tennessee PMP (GX 6) showing the
controlled substance prescriptions
dispensed pursuant to prescriptions
issued under his DEA registration and
asked him to identify the patients he
had prescribed to through Secure
Telemedicine. Id. at 392. While a recess
was then taken to allow Respondent to
9 Respondent’s counsel also attempted to call into
question the notation by observing that it used ‘‘the
plural ‘these’ ’’ and Respondent testified that he did
no ‘‘know what ‘these’ mean.’’ Tr. 334. However, as
found above, the record also includes a copy of a
Naproxen prescription which was issued on the
same date as the hydrocodone prescriptions which
bears the notation. See GX 15, at 2. Thus, K.P. had
been provided with two prescriptions.
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review the exhibit, upon the
reconvening of the hearing, Respondent
was ‘‘unable to identify any of those
patients.’’ Id. at 394.
Finally, Respondent asserted that the
patients he prescribed to through Secure
Telemedicine were essentially one-time
patients. As he testified, ‘‘The patients
that I saw on this on-call coverage, the
ones that I actually communicated with
from what my recollection is was a onetime call, because the patients had a
doctor and I would not be responsible
and I would not rewrite something for
them. So I didn’t expect to even see that
patient or communicate with that
patient again at any given time.’’ Id. at
406. See also id. at 386 (testifying that
‘‘[t]he patient needed to see their own
doctor and be seen by their primary care
doctor. If I were to take on the
responsibility to prescribe medication
on a monthly basis, then I’m taking over
the patient’s primary care doctor’s
responsibility.’’).
Thus, other than the phentermine
prescription he had issued for his
former patient who had moved to
Colorado, see GX 7, the only
prescriptions in the record which
Respondent admitted to issuing were
the phentermine prescriptions for his
wife, sister, and mother-in-law. Tr. 343–
47. While Respondent questioned
whether his mother-in-law came within
the State’s prohibition on prescribing to
an immediate family member, he
nonetheless ceased prescribing to her
(as well as his wife and sister). Id. 347–
48. He further testified that he
understood the gravity of this situation.
Id. at 348.
As for his internet prescribing,
Respondent testified that he ‘‘will never
get involved with any entity that even
looked similarly as though they were
doing business in any sort on the
internet, ever.’’ Id. at 349. He further
stated that he had made mistakes, that
the mistakes were apparent and clear,
that he has learned from his mistakes
and took responsibility for them. Id.
Continuing, Respondent stated:
I in no way or form intended or willfully,
knowingly participated in any situation that
placed me or placed patients in particular at
risk. I just didn’t do that. I’ve learned today,
throughout this whole process yesterday and
today and throughout this whole
investigation that you can’t do these things.
You have to be more diligent, you have to do
some research, stay with those credible
organizations like I’m currently with now
* * * organizations where you can truly see
how you’re benefitting patients the right way
with your gift of medicine.
*
*
*
*
*
More important than a DEA number is my
name, my name, my credibility. My parents
gave me that name and it’s hard to see myself
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being so stupid to have participated with a
company that misused and used me.
Id. at 349–50.
The Government’s Exceptions
As discussed above, the ALJ found
Respondent fully credible on all of the
material issues including his testimony
that he did not issue or authorize the
issuance of the prescriptions to persons
who resided outside of Tennessee and
that his prescribing activities were
limited to providing on-call services for
Tennessee physicians. ALJ at 32–39.
The Government takes exception to
these findings. More specifically, the
Government argues that the ALJ failed
to give proper weight to the inculpatory
statements Respondent made during the
June 2009 interview with DEA
Investigators. Exceptions at 5–7. The
Government also takes exception to the
ALJ’s finding that the Secure Telemed
prescriptions were issued without his
knowledge or consent and argues that
the ALJ ignored other evidence of
record, including the statements of the
South Carolina pharmacist regarding her
June 2008 phone call to Respondent
regarding the prescriptions issued to
H.B., evidence showing that Respondent
was called about a prescription for K.P.,
who was a South Carolina resident and
verified the prescription, the phone
number evidence, and the fact that
Respondent never reported the misuse
of registration. Id. at 7–19.
Discussion
Section 304(a) of the Controlled
Substances Act (CSA) provides that 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) (emphasis
added). With respect to a practitioner,
the Act requires the consideration of the
following factors in making the public
interest determination:
(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. § 823(f).
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‘‘[T]hese factors are . . . considered
in the disjunctive.’’ Robert A. Leslie,
M.D., 68 FR 15227, 15230 (2003). It is
well settled that 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 MacKay v. DEA, 664 F.3d 808, 816
(10th Cir. 2010); Volkman v. DEA, 567
F.3d 215, 222 (6th Cir. 2009); Hoxie v.
DEA, 419 F.3d 477, 482 (6th Cir. 2005).
Moreover, while I am required to
consider each of the factors, I ‘‘need not
make explicit findings as to each one.’’
MacKay, 664 F.3d at 816 (quoting
Volkman, 567 F.3d at 222 (quoting
Hoxie, 419 F.3d at 482)).10
The Government has the burden of
proving, by a preponderance of the
evidence, that the requirements for
revocation or suspension pursuant to 21
U.S.C. 824(a) are met. 21 CFR
1301.44(e). However, ‘‘once the
[G]overnment establishes a prima facie
case showing a practitioner has
committed acts which render his
registration inconsistent with the public
interest, the burden shifts to the
practitioner to show why his continued
registration would be consistent with
the public interest.’’ MacKay, 664 F.3d
at 817 (citing Medicine ShoppeJonesborough, 73 FR 364, 387 (2008)
(citing cases)).
In this matter, it is undisputed that
Respondent retains an active Tennessee
Medical License (factor one) and that he
has not been convicted of an offense
related to the manufacture, distribution,
or dispensing of a controlled substance
(factor three). However, while I adopt
the ALJ’s findings of fact and legal
conclusions that neither factor one (the
recommendation of the state licensing
board), nor factor three (Respondent’s
conviction record under laws related to
the manufacture, distribution or
dispensing of controlled substances),
supports the revocation of Respondent’s
registration, it has long been settled that
neither factor is dispositive. See
MacKay, 664 F.3d at 817; see also Jayam
Krishna-Iyer, 74 FR 459, 461 (2009);
Edmund Chein, 72 FR 6580, 6593 n.22
(2007), pet. for rev. denied 533 F.3d 828
(DC Cir. 2008); Mortimer B. Levin, 55 FR
8209, 8210 (1990). Rather, the primary
focus of this proceeding is whether, as
10 In short, this is not a contest in which score
is kept; the Agency is not required to mechanically
count up the factors and determine how many favor
the Government and how many favor the registrant.
Rather, it is an inquiry which focuses on protecting
the public interest; what matters is the seriousness
of the registrant’s misconduct. Jayam Krishna-Iyer,
74 FR 459, 462 (2009). Accordingly, as the Tenth
Circuit has recognized, findings under a single
factor can support the revocation of a registration.
MacKay, 664 F.3d at 821.
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alleged by the Government, Respondent
violated the CSA’s prescription
requirement, 21 CFR 1306.04(a), as well
as the laws of several States, by issuing
prescriptions to patients he did not
physically examine and with whom he
did not establish a legitimate doctorpatient relationship, as well as by
engaging in the unauthorized practice of
medicine by prescribing to residents of
States where he was not authorized to
practice medicine. Gov. Br. at 23–24
(citations omitted). In addition, the
Government alleges that Respondent
violated Tennessee law when he issued
phentermine prescriptions to his wife,
sister, and mother-in-law. Id. at 24–25
(citing Tenn. Code Ann. §§ 63–6–
214(b)(1), (4) and (12)).
Factors Two and Four—Respondent’s
Experience in Dispensing Controlled
Substances and Compliance With
Applicable Laws Related to Controlled
Substances
Under a longstanding DEA regulation,
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 ‘‘[a]n
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 recently
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.’’
Gonzalez v. Oregon, 546 U.S. 243, 274
(2006) (citing United States v. Moore,
423 U.S. 122, 135 (1975)).
‘‘Under the CSA, it is fundamental
that a practitioner must establish a
bonafide doctor-patient relationship in
order to act ‘in the usual course of . . .
professional practice’ and to issue a
prescription for a ‘legitimate medical
purpose.’’’ Joseph Gaudio, 74 FR 10083,
10090 (2009) (citing Moore, 423 U.S. at
141–43). Moreover, at the time of the
events at issue here, whether a doctor
and patient have established a bona fide
doctor-patient relationship under the
CSA was generally a question of state
law. Id.; see also Kamir Garces-Mejias,
72 FR 54931, 54935 (2007); United
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Jkt 229001
Prescription Services, Inc., 72 FR 50397,
50407 (2007); Dispensing and
Purchasing Controlled Substances Over
the Internet (DEA Guidance Document),
66 FR 21181, 21182–83 (2001).
‘‘Moreover, ‘[a] physician who
engages in the unauthorized practice of
medicine’ under state laws ‘is not ‘‘a
practitioner acting in the usual course of
. . . professional practice’’’ under the
CSA.’’ Gaudio, 74 FR at 10090 (quoting
United Prescription Services, 72 FR at
50407). As the Supreme Court explained
shortly after the CSA’s enactment, ‘‘[i]n
the case of a physician,’’ the CSA
‘‘contemplates that he is authorized by
the State to practice medicine and to
dispense drugs in connection with his
professional practice.’’ Moore, 423 U.S.
at 140–41. This rule derives from the
plain text of the statute which defines
the term ‘‘practitioner’’ to mean ‘‘a
physician . . . licensed, registered, or
otherwise permitted, by the United
States or the jurisdiction in which he
practices . . . to . . . dispense . . . a
controlled substance,’’ 21 U.S.C.
802(21), and the term ‘‘dispense’’ to
mean ‘‘to deliver a controlled substance
to an ultimate user . . . by, or pursuant
to the lawful order of, a practitioner.’’ 21
U.S.C. 802(10). Thus, a controlledsubstance prescription issued by a
physician who lacks the license or other
authority necessary to practice medicine
within a State is unlawful under the
CSA. See 21 CFR 1306.04(a); cf. 21 CFR
1306.03(a)(1) (‘‘A prescription for a
controlled substance may be issued only
by an individual practitioner who is
. . . [a]uthorized to prescribe controlled
substances by the jurisdiction in which
he is licensed to practice his
profession.’’).
The ALJ rejected all of the
Government’s contentions regarding
Respondent’s prescribing for Secure
Telemed, apparently crediting his
testimony denying having issued, as
well as having authorized the issuance,
of each of the Secure Telemed
prescriptions presented by the
Government. ALJ at 37. While the ALJ
properly discounted some of the hearsay
evidence relied upon by the
Government to refute Respondent’s
denial of having issued the
prescriptions, I find that there is
sufficient other reliable evidence of
record to support the finding that
Respondent issued (or approved the
issuance of) many of the prescriptions.
Indeed, the evidence with respect to
how Secure Telemed operated is
consistent with what DEA has
encountered in numerous other
investigations of unlawful internet
prescribing rings, and given the absence
of any evidence corroborating
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52795
Respondent’s testimony that he acted as
an on-call physician, covering for other
Tennessee physicians after hours or
when they were unavailable to manage
the care of their patients, I conclude that
his testimony is so inherently
implausible that no reasonable
factfinder could find it to be credible.11
As found above, with respect to the
prescriptions issued to the three
Mississippi residents, the Government
elicited the testimony of an Agency
Investigator regarding the statements
they made during interviews to the
effect that, after faxing their medical
records to a Web site, they had received
phone calls from someone identifying
himself as Respondent, and were
subsequently prescribed hydrocodone
without meeting him and undergoing a
physical exam. However, the
Investigators conducted these
interviews approximately two years
after the prescriptions were issued and
the Investigator who testified regarding
the interviews acknowledged that none
of these three persons initially named
Respondent and none could identify an
email address or fax number that was
used to send them the prescriptions. In
addition, the Investigator offered no
testimony that any of these individuals’
statements were reduced to writing and
sworn. Thus, by themselves, these
statements do not bear sufficient indicia
11 I am mindful of the fact that the ALJ observed
the demeanor of the various witnesses and found
Respondent’s testimony credible. However, as the
Supreme Court has explained, ‘‘[t]he findings of the
examiner are to be considered along with the
consistency and inherent probability of [the]
testimony.’’ Universal Camera Corp., v. NLRB, 340
U.S. 474, 496 (1951). As explained below,
Respondent’s testimony was contradicted by other
evidence and contained numerous material
inconsistencies. Cf. Anderson v. City of Bessemer
City, 470 U.S. 564, 575 (1985) (challenge to district
court finding under clearly erroneous standard)
(‘‘This is not to suggest that the trial judge may
insulate his findings from review by denominating
them credibility determinations, for factors other
than demeanor and inflection go into the decision
whether or not to believe a witness. Documents or
objective evidence may contradict the witness’
story; or the story itself may be so internally
inconsistent or implausible on its face that a
reasonable factfinder would not credit it.’’); United
States v. Lathern, 665 F.3d 1351, 1354 (DC Cir.
2012).
Of course, the standard applicable in this matter
is not the clearly erroneous standard, but rather,
whether the Agency’s decision is nonetheless
supported by substantial evidence on the record as
a whole. Universal Camera, 340 U.S. at 492 (‘‘The
responsibility for decision thus placed on the Board
is wholly inconsistent with the notion that it has
the power to reverse an examiner’s findings only
when they are ‘clearly erroneous.’ ’’); see also
Chirino v. NTSB, 849 F.2d 1525, 1530 (DC Cir.
1988) (‘‘In our view, the Board’s determination that
Chirino’s testimony was ‘inherently incredible’
supplied the requisite basis under the NTSB’s
applicable rules to overturn the contrary findings of
the ALJ.’’).
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of reliability to be considered
substantial evidence.
However, this is not the only evidence
that supports a finding that Respondent
did, notwithstanding his denial, issue
prescriptions, through Secure Telemed,
to out-of-state residents. As found
above, the record contains seven
prescriptions for 90 tablets of
hydrocodone/apap 10/325 issued to K.P.
of Fort Mill, South Carolina, each of
which included Respondent’s cellphone number. Most significantly, a
January 7, 2008 prescription bears the
handwritten notation: ‘‘these are valid
per Dr. Dennis’’ along with his DEA
number. The testimony establishes that
the notation was on the prescription
when it was obtained by a DEA
Intelligence Analyst, who was told that
it was made by the actual pharmacist
who called and verified the
prescription.12
While in his findings of fact, the ALJ
found that Respondent ‘‘denied ever
verifying that he issued the
prescriptions to K.P., as indicated by
[the] notation,’’ ALJ at 24 (citing Tr.
333–34; GX 15, at 10), in his legal
conclusions, the ALJ did not even
mention the prescription and its
notation, let alone explain why he
apparently gave it no weight.13
However, I conclude that the notation is
consistent with that which a pharmacist
would make contemporaneously with
having verified a prescription. And I
further hold that the notation supports
the inference that Respondent did not
object to the dispensing of the
prescription and that Respondent was
engaged in issuing prescriptions
through Secure Telemed for persons
who resided outside of Tennessee.
The Government also introduced into
evidence controlled substance
prescriptions for hydrocodone and
Valium issued under Respondent’s DEA
registration to H.B., who was a resident
of South Carolina, which were
presented to the Chapin Pharmacy in
Chapin, South Carolina. Regarding these
prescriptions, the Government also
elicited the testimony of a DEA
Investigator regarding the out-of-court
statements made to her by an Inspector
for the South Carolina Bureau of Drug
12 As found above, K.P. also obtained a Naproxen
prescription which was dated January 7, 2008.
Thus, the notation’s use of the word ‘‘these’’ can be
explained by the fact that pharmacist was verifying
both prescriptions.
13 While at hearing, Respondent contended that
the notation did not comply with law and
regulations because it was not initialed and dated,
he did not cite to any provision of either North
Carolina law or the State’s Pharmacy Board rules
requiring that a pharmacist do this upon verifying
a prescription. Nor does his brief cite to any such
provision.
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Control and the pharmacist. According
to the DI, the State Inspector had
contacted her shortly after he was
contacted by the pharmacist about the
prescriptions, because H.B. was a
known doctor-shopper.
As found above, the DI testified that
the pharmacist had told her that she
attempted to call Respondent because
the pharmacy had a policy of contacting
‘‘every out-of-state physician,’’ and that
when she initially attempted to call him
using the phone number on the
prescription, she received a message
that his mailbox was full. The
pharmacist, however, eventually
reached Respondent on a different
phone number and one of the
prescriptions includes a hand-written
phone number which matches the
phone number listed on several of the
prescriptions Respondent admittedly
issued to family members.
According to the DI, Respondent
verified that H.B. was his patient, that
he had written the prescription and the
quantity. Moreover, Respondent stated
that while he had a record on H.B., he
admitted that he ‘‘had never seen her in
person.’’ Respondent then stated that he
had been assured by his Medical
Director ‘‘that prescribing to out-of-state
patients was legal in all except two
states.’’
The ALJ found these statement did
not constitute substantial evidence,
reasoning that the Government had not
shown a lack of bias on the part of the
pharmacist, that the statements were
neither signed nor sworn to, and that
there was an absence of evidence
‘‘corroborating the substantive content
of the hearsay, namely that [the
pharmacist] actually spoke with
Respondent in or about June 2008.’’ ALJ
at 36. While I ultimately agree with the
ALJ’s conclusion that the statements
cannot constitute substantial evidence, I
disagree with much of his reasoning.
‘‘‘[H]earsay may be substantial
evidence depending on its truthfulness,
reasonableness, and credibility; hearsay
statements are highly probative where
declarants are disinterested witnesses,
statements are essentially consistent,
and counsel had access to the
statements prior to agency hearing’’’)
Bobo v. United States Dep’t of Agric., 52
F.3d 1406, 1414 (6th Cir. 1995) (quoting
Hoska v. United States Dep’t of the
Army, 677 F.2d 131, 138 (DC Cir. 1982));
Johnson v. United States, 628 F.2d 187,
190–191 (DC Cir. 1980). See also
Echostar Comm. Corp. v. FCC, 292 F.3d
749 (DC Cir. 2002) (hearsay can
constitute substantial evidence where
there are ‘‘satisfactory indicia of
reliability’’ of statements).
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Contrary to the ALJ’s finding, the
evidence shows that the pharmacist was
a disinterested witness to the event.
While the ALJ reasoned that the issue of
bias is not entirely speculative because
‘‘[a] pharmacist would generally be
motivated to inform DEA of compliance
with applicable laws and regulations,’’
ALJ at 35 (citing 21 CFR 1306.04(a)), the
ALJ was unconvinced by the
Investigator’s testimony that the
prescriptions were not dispensed. ALJ at
35. As reason for rejecting the
Investigator’s testimony, the ALJ
observed that the prescriptions ‘‘bear no
. . . objective markings consistent with
a rejected prescription’’ and the absence
of a notation on the prescriptions
reflecting the substance of the
pharmacist’s ‘‘conversation with
Respondent, to include such basic
information as time, date, telephone
number and signature of the
pharmacist.’’ Id. at 36.
However, the ALJ ignored the
Investigator’s testimony that as early as
June 3, 2008, she was contacted about
the prescriptions by the State Inspector,
whom the pharmacist had initially
called about the prescriptions. In
addition, the ALJ ignored the
Investigator’s testimony that she
contacted the pharmacy and obtained
the prescriptions that same day, which
is corroborated by the fax header on the
prescriptions.
As related by the Investigator, the
contents of the pharmacist’s
conversation with Respondent clearly
established that Respondent had failed
to perform a physical examination on
H.B. and that the two prescriptions
lacked a legitimate medical purpose and
were issued outside of the usual course
of professional practice. See United
States v. Nelson, 383 F.3d 1227 (10th
Cir. 2004). Thus, by relating the phone
conversation the pharmacist had with
Respondent to the Agency’s
Investigator, the pharmacist would have
exposed herself to criminal (as well as
administrative) liability if she had, in
fact, filled the prescriptions. Beyond
this, unexplained by the ALJ is why a
person who had committed a criminal
act by filling the prescriptions would
then voluntarily (and without
solicitation) report themselves to the
law enforcers.
Here, the Investigator testified that the
prescriptions were not filled. Moreover,
the Investigator obtained from the South
Carolina PMP a list of the prescriptions
which were dispensed by South
Carolina pharmacies which were issued
under Respondent’s registration. The
Investigator testified that she then
verified the data by obtaining the actual
prescriptions from the respective
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pharmacies and prepared a spreadsheet.
The spreadsheet does not, however, list
any dispensings by the Chapin
Pharmacy of prescriptions issued under
Respondent’s registration, let alone
dispensings to this particular person
(H.B.).
The ALJ discounted the clear and
unequivocal testimony of the
Investigator, reasoning that the
prescriptions lacked any markings that
they had been rejected (such as having
been crossed-out), as well as any
notations regarding the phone
conversation. It is true that sometimes a
pharmacist will line-through a
prescription, or otherwise may note on
it, that she has refused to fill it.
However, there is no evidence in this
record establishing that where a
pharmacist declines to fill a
prescription, she is required under
either the South Carolina Board of
Pharmacy’s regulations or the standards
of pharmacy practice to either linethrough the prescription or make a
notation on it. Indeed, given the
undisputed evidence that the
pharmacist reported the incident to the
State authorities contemporaneously
with the incident 14 and provided copies
of the prescriptions to them at the time
of her report, one must wonder why it
would then be necessary to line out the
prescriptions or document the phone
conversation on them.15
The ALJ further surmised that that it
was ‘‘uncertain as to which telephone
number Ms. Owen used to confirm the
prescription, leaving significant doubt
as to whether a call was placed to
Respondent or someone associated with
Telemed.’’ ALJ at 36. In support of this
reasoning, the ALJ noted the testimony
of the Investigator that the pharmacist
was not sure which phone number she
had used to reach Respondent. Id. The
ALJ further explained that he gave
‘‘little to no weight to the telephone
number written on the bottom of’’ one
of H.B.’s prescriptions, because the DI
testified that she did ‘‘‘not know
specifically where that number would
call.’’’ Id. at n.41 (quoting Tr. 103).
The ALJ’s reasoning is simply a
makeweight as only two phone numbers
are listed on the prescriptions and there
is substantial evidence that both phone
numbers were used by Respondent. As
for the number that was printed on the
prescriptions, it was undisputed that
this was either Respondent’s (or his
14 The prescriptions were dated May 30, 2008,
and the testimony indicated that the pharmacist
was not able to speak to Respondent until June 2,
2008. According to a 2008 calendar, May 30th was
a Friday, and June 2nd was a Monday.
15 Indeed, she may have done so after faxing the
prescriptions to the Investigator.
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Jkt 229001
wife’s cell-phone) number. And as for
the number handwritten at the bottom
of one of the prescriptions,
notwithstanding the DI’s testimony that
she did ‘‘not know specifically where
that number would call,’’ Tr. 103, the
record establishes that Respondent used
this number on the prescriptions he
issued to family members. Given the
absence of any other phone numbers on
the prescriptions, I am reasonably
confident that the pharmacist did, in
fact, reach Respondent and not someone
at Secure Telemed.
However, there are other reasons why
the pharmacist’s statements that
Respondent verified writing the
prescription for H.B. and did not
physically examine her cannot be given
weight. While the DI testified that she
had contacted the pharmacy in June
2008 upon receiving the report from the
State Inspector and that she obtained
the prescriptions, she offered no
testimony that she had interviewed the
pharmacist on that occasion, and her
testimony suggests that the pharmacist’s
statements were not made to her until
the interview she conducted one week
before the hearing, more than three
years after the incident. Nor did the DI
offer any testimony to support the
conclusion that the pharmacist
accurately recollected the incident,16
and most importantly, the statements
attributed to Respondent. Thus, the
hearsay statements of the pharmacist
cannot be deemed to be sufficiently
reliable to constitute substantial
evidence.
Nonetheless, there is other substantial
evidence which supports the conclusion
that Respondent, notwithstanding his
denial of having done so, wrote or
authorized the prescriptions issued to
the non-Tennessee residents. The same
DI testified that she had prepared a
spreadsheet of the prescriptions that
were filled by the South Carolina
pharmacies (GX 17).
Moreover, the DI testified that while
she initially obtained a printout from
the South Carolina PMP, she then
proceeded to obtain copies of the
prescriptions from the pharmacies to
verify the information contained in the
PMP report. On cross-examination,
Respondent’s counsel asked the
Investigator whether ‘‘other than
16 It
may be that the pharmacist made a record of
the incident. However, no such evidence was put
forward by the Government. It may also be that the
circumstances of the incident were so unusual, that
the pharmacist accurately recalled Respondent’s
statements. Yet no evidence was put forward to
support such a finding. It may also be that the
pharmacist related Respondent’s statements to the
State Inspector; if so, the Government could have
called the State Inspector or better yet the
pharmacist herself.
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52797
[Respondent’s] name being on those,
you don’t have any information from
any other source that he actually
personally issued those prescriptions?’’
Tr. 111. The Investigator testified that
‘‘[o]n many of the faxed prescriptions
that [were] presented at my South
Carolina pharmacies, there is [a]
notation written on them from the
pharmacists that were working that day
that they were verified with’’
Respondent.17 Id. The ALJ entirely
ignored this testimony.
In addition, according to both Agency
Investigators who interviewed him in
June 2009, Respondent volunteered
information to the effect that following
the receipt of a phone call from a South
Carolina pharmacy questioning a
prescription, he quit Secure
Telemedicine after the entity’s Medical
Director ‘‘could not provide verification
that he could do this legally in other
[S]tates.’’ Tr. 194; see also id. at 425
(testimony that Respondent said that
‘‘he had become concerned that . . . this
wasn’t right, . . . he was not involved in
the right thing to do because Secure
Telemedicine could not provide
documentation to him that it was legal
to operate in . . . the other [S]tates.’’).
Obviously, if Respondent was only
writing prescriptions for Tennessee
residents, there was no need for him to
verify with Secure’s Medical Director
whether it was legal to write
prescriptions for patients in other
States.
Both Investigators also testified that
Respondent was told that he was under
investigation for prescribing controlled
substances to persons in other States
and with whom he did not establish a
legitimate doctor-patient relationship,
and that Respondent replied that he
‘‘kind of knew what this was about.’’ Tr.
190; see also id. at 422 (‘‘‘I thought I
knew why you wanted to talk to me.’’’).
In addition to Respondent’s statement
set forth above, the Investigators
testified that Respondent admitted to
having worked for Secure Telemedicine
and stated that he was surprised to
receive a phone call from a South
Carolina pharmacy because it was his
understanding that all of the
prescriptions were being filled by a
fulfillment pharmacy.18 Moreover,
17 To refute the DI’s testimony, Respondent could
have requested a subpoena requiring the
Government to produce the actual prescriptions and
sought a continuance of the proceeding. He did not.
18 Here again, if Respondent was writing
prescriptions only for Tennessee patients, it begs
the question of why it was his understanding that
the Secure Telemed scheme was using a fulfillment
pharmacy, such as the pharmacy which was located
in Colorado. See Tr. 121. As the Agency’s
Investigator explained, the use of a fulfillment
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according to both Investigators, at no
point during the interview did
Respondent claim that his internet
prescribing activities were limited to
Tennessee residents, id. at 423, or deny
that he had prescribed to out-of-state
patients. Id. at 195.
The ALJ declined to give weight to the
testimony of the Investigators reasoning
that ‘‘the Government presented no
evidence that any of the investigators
specifically asked Respondent whether
he issued out-of-state prescriptions
while he worked at Telemed.’’ ALJ at
38.19 In addition, the ALJ reasoned that
‘‘Respondent was not provided with any
of the prescriptions in question during
his . . . interview.’’ Id.
Yet, the evidence is clear that
Respondent was told that he was being
investigated for prescribing controlled
substances to out-of-state patients with
whom he did not establish a doctorpatient relationship. While this
statement may not have been framed as
a question, it nonetheless was an
accusation, and indeed, Respondent was
under no illusion that it was not such,
as immediately prior to it, he had been
told that he had the right to remain
silent and was not under arrest.20 And
given its serious nature, one would
expect that if it was not true,
Respondent would have ‘‘clearly
challenge[d] the accuracy of the
accusation.’’ McCormick on Evidence
§ 160, at 426 (Edward W. Cleary, ed., 3d
ed. 1984). Yet he did not do so.
Moreover, the two Investigators
further testified that Respondent
volunteered that he quit working for
Secure Telemed after its Medical
Director ‘‘could not provide verification
that he could do this legally in other
states.’’ Tr. 194; see also id. at 425. This
testimony is entirely consistent with
Respondent’s failure to challenge the
Investigators’ accusation. Indeed, given
the vehemence of his denial at the
hearing of having written prescriptions
for out-of state patients or having
authorized their issuance, one must
wonder why a similarly forceful denial
did not occur during the June 2009
pharmacy was a common feature of unlawful
internet prescribing schemes. Id. at 120.
19 The ALJ did not, however, find the testimony
of either Investigator to be incredible. See generally
ALJ at 36.
20 Notably, Respondent did not remain silent in
the face of the accusation. As for the ALJ’s assertion
that Respondent’s failure to deny the accusations is
not entitled to weight because the accusation was
not framed as a question, the ALJ cited no authority
to support this proposition. See United States v.
Ward, 377 F.3d 671, 675 (7th Cir. 2004) (‘‘[A]
statement may be adopted as long as the statement
was made in the defendant’s presence, the
defendant understood the statement, and the
defendant has the opportunity to deny the
statement but did not do so.’’) (emphasis added).
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interview. And because it is clear that
Respondent knew what the nature of the
accusation was, it is of no consequence
that the Investigators did not show him
any specific prescriptions.
The ALJ likewise ignored the inherent
implausibility of Respondent’s
testimony regarding his employment as
‘‘an on-call covering physician’’ under
Secure Telemed’s ‘‘Consult-A-Doc
program.’’ Tr. 298. According to
Respondent, he would inform the
company of when he was available ‘‘to
cover on-call for physicians after hours
or when a physician [was] just
unavailable to manage the care of their
patients.’’ Id.
In his letter requesting a hearing,
Respondent asserted that ‘‘Secure
contracted with primary care physicians
in Tennessee . . . to provided coverage
by other licensed physicians in their
respective jurisdiction when the
primary care physician was unavailable
to attend to the needs of their
established patients.’’ ALJ Ex. 2. Yet, if
Tennessee physicians were entering into
contracts with Secure, it begs the
question of why Respondent was not
informed, at the start of his shift, of the
names of the doctors for whom he was
providing on-call coverage. Notably, in
describing his activities for Secure,
Respondent offered no testimony to the
effect that he was told at the start of his
shifts the names of the physicians for
whom he was providing on-call
coverage, and indeed, Respondent
testified that he would review the
patient’s medical record and then verify
with the office of the patient’s primary
care doctor that the latter was
unavailable.
Respondent also testified that the
patients had already provided their
medical records to Secure Telemedicine
at the time he took their phone call.
Unexplained by Respondent is why the
patients would have known to obtain
their medical records if he was merely
covering for a physician ‘‘after hours.’’
Id. Likewise, Respondent testified that
his activities were limited to ‘‘triag[ing]’’
patients in ‘‘non-emergency situations’’
and that he only issued refills for them.
Id. at 299–300, 302. Yet if he was only
providing coverage ‘‘after hours,’’ it
does not seem likely that he could have
verified at that time with the office of
the patient’s primary care physician that
the latter was unavailable and
Respondent did not explain why, if he
was only triaging patients ‘‘in a nonemergency situation,’’ he did not simply
instruct the patients to contact their
primary care physician the next
morning.
Respondent further asserted that there
would be occasions where a patient’s
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Fmt 4703
Sfmt 4703
primary care physician would be on
vacation and not be back until the ‘‘next
week.’’ Id. at 302. Given his testimony
that he only issued refills for patients
with ‘‘a chronic ailment,’’ id. at 301,
here again, Respondent offered no
explanation as to why the patient’s
primary care doctor would not know in
advance of when he/she would be on
vacation and provide the patient with
either a refill or an additional
prescription to ensure that the patient
had an adequate quantity of medication
and did not run out.
Moreover, when confronted with
evidence that the primary care
physicians of two Tennessee patients to
whom he prescribed had never heard of
him and that they had other physicians
in their group who would take calls for
them, Respondent then denied either
writing the prescriptions or explained
that he ‘‘really didn’t have any contact’’
with any group practice. Id. at 301.
However, Respondent claimed that
‘‘[s]ome doctors who are in private
practice . . . a lot of them don’t have
call coverage or they have problems
finding physicians with call coverage.’’
Id. Were I to credit Respondent’s
testimony, I would have to believe that
the physicians he purportedly took calls
for, had contracted with an entity that
was not even located in Tennessee, and
entrusted it to place the care of their
patients in the hands of physicians they
did not know, let alone had never met.21
And while Respondent maintained that
he had prepared a consult note for each
patient for whom he wrote a
prescription, and asserted that Secure
Telemed forwarded the note on to the
patient’s primary care physician, he did
not recall having ever been called by the
primary care physician of a Secure
Telemed patient. Id. at 408–09. Nor did
he testify that he called the patients’
primary care physicians to inform them
that he had issued a prescription to their
patients.
Notably, Respondent produced no
evidence to corroborate any of his farfetched story. See Chirino v. NTSB, 849
F.2d at 1530. He did not maintain
patient records, see Tenn. Comp. R. &
Regs. R. 0880–02–.14(2)(b)(3), nor even
document any of the phone calls he
claimed to have made to the offices of
the patient’s primary care physicians.
And when asked to review the
Tennessee PMP report and identify any
of the persons who were Secure
Telemed patients, he could not identify
a single one.
21 Also unexplained is why the physicians would
entrust the care of their patients to physicians who
were unlikely to have privileges at the same
hospitals where they had privileges.
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I therefore conclude that
Respondent’s testimony is so inherently
implausible that no reasonable
factfinder could find it to be true.
Anderson, 470 U.S. at 575; Lathern, 665
F.3d at 1354; Chirino, 849 F.2d at 1530.
I thus reject the ALJ’s findings that
Respondent credibly denied either
issuing or authorizing the issuance of
any controlled substance prescriptions
to persons located outside of the State
of Tennessee.22
I therefore hold that because
Respondent failed to perform a physical
examination of the patients located in
Mississippi, North Carolina, and South
Carolina, he did not establish a
legitimate doctor-patient relationship
with them and thus lacked a legitimate
medical purpose and acted outside of
the usual course of professional practice
in prescribing controlled substances to
them.23 See Miss. Code Ann. § 41–29–
137; North Carolina Medical Board,
Contact with patients before prescribing,
at 1 (Nov. 1999); S.C. Code Ann. § 40–
47–113.
Moreover, ‘‘[a] physician who engages
in the unauthorized practice of
medicine is not a ‘practitioner acting in
the usual course of . . . professional
22 The ALJ also found that while Respondent did
not perform physical examinations on the
Tennessee patients, the Government failed to prove
that Respondent had violated Tennessee regulations
because it did not show ‘‘that Respondent was not
exempt under Tenn. Comp. R. & Regs. 0880–2–
.14(7)(b)’’ from the requirements that he perform a
physical examination. ALJ at 39. Under this
provision, ‘‘[a] physician . . . may prescribe or
dispense drugs for a person not in compliance with
[the requirement that he perform a physical
examination] consistent with sound medical
practice . . . [f]or a patient of another physician for
whom the prescriber is taking calls or for whom the
prescriber has verified the appropriateness of the
medication[.]’’ Tenn. Comp. R. & Regs. 0880–2–
.14(7)(b).
The Government offered no expert testimony as
to whether Respondent’s internet prescribing was
‘‘consistent with sound medical practice.’’ Id. Nor
did it cite to any state authority such as a decision
of either the Tennessee Courts or Board of Medicine
explaining what constitutes compliance with the
provision authorizing a prescription where ‘‘the
prescriber has verified the appropriateness of the
medications.’’ Id. I therefore do not find the
allegations of the Show Cause Order proved with
respect to Respondent’s Tennessee patients.
23 The ALJ also noted that some of the signatures
on the Secure Telemed prescriptions differed from
those on the prescriptions Respondent issued to his
family members. See ALJ at 33. Be that as it may,
it provides no comfort to Respondent because he
testified that he did not actually sign any of the
prescriptions he approved for Secure Telemed but
simply pushed a button on his computer approving
the prescriptions, which was then prepared by
someone at Telemed. Tr. at 304 & 414. Indeed,
Respondent’s failure to sign the prescriptions (even
those he admits to issuing) is itself a violation of
the CSA. See 21 CFR 1306.05(a) (‘‘The prescriptions
may be prepared by the secretary or agent for the
signature of a practitioner, but the prescribing
practitioner is responsible in case the prescription
does not conform in all essential respects to the law
and regulations.’’) (emphasis added).
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practice.’ . . . A controlled-substance
prescription issued by a physician who
lacks the license necessary to practice
medicine within a State is therefore
unlawful under the CSA.’’ United
Prescription Services, Inc., 72 FR 50397,
50407 (2007)) (citations omitted). See
also 21 U.S.C. 802(21) (‘‘[t]he term
‘practitioner’ means a physician . . .
licensed, registered, or otherwise
permitted, by the United States or the
jurisdiction in which he practices . . .
to . . . dispense . . . a controlled
substance.’’). As the Supreme Court has
explained: ‘‘In the case of a physician
[the CSA] contemplates that he is
authorized by the State to practice
medicine and to dispense drugs in
connection with his professional
practice.’’ United States v. Moore, 423
U.S. 122, 140–41 (1975) (emphasis
added) (quoted in United Prescription
Services, 72 FR at 50407).
Here, it is undisputed that
Respondent is licensed only in
Tennessee. Accordingly, he engaged in
the unauthorized practice of medicine
by prescribing controlled substances to
patients located in the States of South
Carolina, North Carolina and
Mississippi and therefore acted outside
of the usual course of professional
practice for this reason as well. See S.C.
Code Ann. § 40–47–20(36)(b) & (e)
(defining practice of medicine); id.
§ 40–47–200 (prohibiting practicing
medicine without a license); N.C. Code
Ann. § 90–1.1(5) (defining practice of
medicine); id. § 90–18 (prohibiting
practice of medicine without a license);
Miss. Code Ann. § 73–25–33 (defining
practice of medicine); id. § 73–25–34
(prohibiting practice of telemedicine
without a state license).
Moreover, even were I to adopt the
ALJ’s finding that the Government did
not prove that the ‘‘prescriptions were
issued by Telemed with Respondent’s
knowledge or authorization,’’ ALJ at 32,
that would not be the end of the matter
as far as the Secure Telemed
prescriptions. Contrary to the ALJ’s
understanding, DEA’s authority to
revoke a registration is not limited to
those instances in which ‘‘Respondent
knowingly issued . . . or . . .
authorized Telemed to issue . . .
prescriptions on his behalf.’’ Id.
Rather, this Agency has long held that
a registrant is strictly liable for the
misuse of his registration by any person
to whom he entrusts his registration.
See Scott C. Bickman, 76 FR 17694,
17703 (2011); Harrell E. Robinson, 74
FR 61370, 61376–77 (2009); Paul
Volkman, 73 FR 30630, 30644 & n.42
(2008); Rose Mary Jacinta Lewis, 72 FR
4035, 4040 (2007); Anthony L. Capelli,
59 FR 42288 (1994). Having provided
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52799
his registration number to Secure
Telemedicine, and having no effective
means of supervising its employees to
ensure that his number was not being
misused, Respondent is liable for the
issuance of all of the prescriptions
Secure Telemedicine issued under his
registration as if he had personally
authorized them.24
Moreover, Respondent testified that
he never visited Secure’s office nor
interviewed face-to-face with principals.
He also offered no testimony as to any
due diligence he had performed.
Respondent’s total failure to take any
steps to determine whether Secure was
a legitimate enterprise manifests a level
of irresponsible behavior that is
fundamentally incompatible with
holding a DEA registration.25
The ALJ totally ignored this line of
authority. See ALJ 32. I conclude,
however, that this conduct is
sufficiently egregious to warrant the
revocation of Respondent’s
registration.26
24 Moreover, at the time Respondent entered into
his contract with Secure Telemedicine, this Agency
had already issued several final orders finding that
the prescribing of controlled substances under
similar circumstances (i.e., through the internet
and/or a telephone consultation) violated Federal
law. See, e.g., William R. Lockridge, M.D., 71 FR
77791, 77798 (2006) (discussing expert testimony
regarding steps necessary to establish a doctorpatient relationship, as well as guidelines published
by the Federation of State Medical Boards and the
American Medical Association, and DEA’s 2001
Guidance Document, Dispensing and Purchasing
Controlled Substances Over the Internet, 66 FR
21181). See also Dale L. Taylor, 72 FR 30855 (2007);
Mario Avello, 70 FR 11695, 11697 (2005). So too,
numerous States had issued pronouncements
establishing that such prescribing was unlawful.
25 In Bickman, I noted that ‘‘this is not a case
where a practitioner simply provided his DEA
registration to a health care facility as part of the
credentialing process and a person at the facility
subsequently used his registration for unlawful
purposes.’’ 76 FR at 17703 n.22. Given
Respondent’s total failure to perform due diligence,
so too here.
26 The evidence also showed that Respondent had
prescribed phentermine to family members
including his wife, sister, and mother- in-law.
According to a Policy Statement of the Tennessee
Board, ‘‘[t]reatment of immediate family members
should be reserved only for minor illnesses or
emergency situations,’’ and ‘‘[n]o schedule II, III or
IV controlled substances should be dispensed or
prescribed except in emergency situations.’’
Tennessee State Board of Medical Examiners,
Policy: Prescribing For Oneself And One’s Family 1
(Jan. 1997). The Board’s statement does not,
however, define the term ‘‘immediate family
member,’’ see id., and the Government does not cite
to any decision of either the Board or the Tennessee
courts construing the term. While it would seem
that Respondent’s wife would fall within the
definition, Respondent fully acknowledged his
misconduct in prescribing phentermine to her.
Thus, had this been the only allegation proven in
the case, I would have adopted the ALJ’s
recommended sanction. For similar reasons,
Respondent’s failure to update his registered
location would not warrant anything more than a
reprimand.
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Factor Five—Other Conduct Which May
Threaten Public Health and Safety
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Even were I to adopt the ALJ’s
findings and credit Respondent’s
testimony that he was unaware of the
misuse of his registration until an April
2008 phone call from a South Carolina
pharmacy, see ALJ at 37, the record
supports a further finding that he
engaged in other conduct which
threatened public health and safety.
While Respondent claimed that he
reported the incident to the Tennessee
Medical Board sometime in 2009 and
well after the fact,27 he did not notify
DEA of the incident until the June 2009
interview.28 Tr. 371–72. However, the
record contains evidence establishing
that numerous additional prescriptions
were issued under his registration
through Secure Telemed following the
April 2008 phone call, many of which
were filled. See GX 17, at 1 (spreadsheet
listing multiple prescriptions filled by
South Carolina residents); GX 8, at 5 (Pt.
S.P.H.); GX 12, at 3–4 (Pt. E.F.); GX 14,
at 1–2 (Pt. H.B.); GX 15, at 15 (Pt. K.P.);
GX 6, at 9 (entry for patient for E.F.
showing additional hydrocodone
prescription filled on 8/4/08).
Thus, even crediting his testimony,
Respondent was aware that his
registration was being used for criminal
purposes, and yet did nothing to
prevent this. See 21 U.S.C. 822(a)
(requiring registration to lawfully
dispense a controlled substance) and
§ 841(a)(1) (‘‘Except as authorized by
this subchapter, it shall be unlawful for
any person knowingly or intentionally
. . . to . . . distribute[] or dispense . . .
a controlled substance[.]’’); see also id.
§ 843(a)(2) (‘‘It shall be unlawful for any
person knowingly or intentionally . . .
to use in the course of the . . .
distribution[] or dispensing of a
controlled substance, . . . a registration
number which is . . . issued to another
person.’’). His failure to inform the
Agency of the unlawful use of his
27 Respondent initially testified that he did not
file the report with the State until June 2009 (the
same month that he was interviewed by DEA
Investigators). Tr. 372. Respondent then stated that
he could not recall the exact month although it was
sometime in 2009. Id. Respondent did not,
however, maintain a copy of the report. Id.
28 Contrary to the ALJ’s understanding, see ALJ at
43–44, Respondent’s claim that he reported the
misuse of his DEA registration to the State
authorities (approximately one year after the
incident) neither mitigates his misconduct nor
manifests that he accepts responsibility. State
authorities did not issue his DEA registration and
obviously have no authority to cancel a registration
issued by an Agency of the federal government.
Moreover, the lengthy delay in his reporting of the
incident is consistent with the conduct of someone
who has something to hide.
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17:12 Aug 23, 2013
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registration 29 led to additional acts of
diversion of controlled substances and
constitutes ‘‘other conduct which . . .
threaten[s] the public health and
safety.’’ 21 U.S.C. 823(f)(5).
I thus conclude that this factor also
supports a finding that Respondent has
committed acts which render his
registration inconsistent with the public
interest. 21 U.S.C. 824(a)(4).
Sanction
Under Agency precedent, where, as
here, the Government has made out a
prima facie case that a registrant has
committed acts which render his
registration ‘‘inconsistent with the
public interest,’’ he must ‘‘‘present[]
sufficient mitigating evidence to assure
the Administrator that [he] can be
[en]trusted with the responsibility
carried by such a registration.’’’ Samuel
S. Jackson, 72 FR 23848, 23853 (2007)
(quoting Leo R. Miller, 53 FR 21931,
21932 (1988)). ‘‘Moreover, because ‘past
performance is the best predictor of
future performance,’ ALRA Labs., Inc. v.
DEA, 54 F.3d 450, 452 (7th Cir. 1995),
this Agency has repeatedly held that
where a registrant has committed acts
inconsistent with the public interest, the
registrant must accept responsibility for
[his] actions and demonstrate that [he]
will not engage in future misconduct.’’
Medicine Shoppe-Jonesborough, 73 FR
at 387. As the Sixth Circuit has
recognized, this Agency also ‘‘properly
considers’’ a registrant’s admission of
fault and his candor during the
investigation and hearing to be
‘‘important factors’’ in the public
interest determination. See Hoxie, 419
F.3d at 483.
More recently, the Tenth Circuit
upheld the Agency’s rule, explaining
that:
When faced with evidence that a doctor
has a history of distributing controlled
substances unlawfully, it is reasonable for the
. . . Administrator to consider whether that
doctor will change his behavior in the future.
And that consideration is vital to whether
[his] continued registration is in the public
interest. Without Dr. MacKay’s testimony, the
. . . Administrator had no evidence that Dr.
MacKay recognized the extent of his
misconduct and was prepared to remedy his
prescribing practices.
MacKay, 664 F.3d at 820.
Here, the ALJ found that the
Respondent ‘‘fully accepted
29 Had Respondent reported the misuse of his
registration, the Agency could have—with his
agreement—cancelled his number and posted this
information in the database which the Agency
makes available to other registrants for verifying the
validity of another person’s registration. However,
short of issuing an Immediate Suspension Order,
the Agency could not have indicated in the
database that he did not have a valid registration.
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Frm 00043
Fmt 4703
Sfmt 4703
responsibility’’ for his misconduct. ALJ
at 43. Yet this conclusion was premised
on the ALJ’s finding that Respondent
did not write any of the out-of-state
prescriptions, a finding which I reject.
As explained above, the record as a
whole contains substantial evidence
that Respondent, notwithstanding his
testimony to the contrary, issued
numerous controlled substance
prescriptions to out-of-state patients,
with whom he did not establish a
legitimate doctor-patient relationship,
and that he acted outside of the usual
course of professional practice because
he engaged in the unauthorized practice
of medicine. Because Respondent failed
to accept responsibility for this aspect of
his misconduct, which was the most
egregious of the various types of
misconduct he engaged in, and
continues to deny doing so, I conclude
that he has not rebutted the
Government’s prima facie case.
Accordingly, I will order that
Respondent’s registration be revoked
and that any pending application be
denied.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) & 824(a), as well as
28 CFR 0.100(b), I order that DEA
Certificate of Registration BD8297461,
issued to Kevin Dennis, M.D., be, and it
hereby is, revoked. I further order that
any pending application of Kevin
Dennis, M.D., to renew or modify his
registration, be, and it hereby is denied.
This Order is effective September 25,
2013.
Dated: August 17, 2013.
Michele M. Leonhart,
Administrator.
[FR Doc. 2013–20677 Filed 8–23–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application; Catalent CTS.,
LLC.
Pursuant to Title 21, of the Code of
Federal Regulations 1301.34(a), this is
notice that on March 27, 2013, Catalent
CTS., LLC., 10245 Hickman Mills Drive,
Kansas City, Missouri 64137, made
application to the Drug Enforcement
Administration (DEA) for registration as
an importer of the following basic
classes of controlled substances:
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[Federal Register Volume 78, Number 165 (Monday, August 26, 2013)]
[Notices]
[Pages 52787-52800]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20677]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 11-48]
Kevin Dennis, M.D., Decision and Order
On April 12, 2011, the Deputy Assistant Administrator, Office of
Diversion Control, issued an Order to Show Cause to Kevin Dennis, M.D.
(hereinafter, Respondent), of Franklin, Tennessee. The Show Cause Order
proposed the revocation of Respondent's DEA Certification of
Registration and the denial of his application to renew his
registration on the ground that his ``continued registration is
inconsistent with the public interest.'' ALJ Ex. 1, at 1 (citing 21
U.S.C. 823(f)).
More specifically, the Show Cause Order alleged that from September
2007 through July 2009, Respondent ``prescribed controlled substances
to individuals located in Colorado, Mississippi, North Carolina, South
Carolina and Tennessee via the Internet based on online questionnaires,
submissions of unverified medical records, and/or telephone
consultations without a medical examination.'' Id. The Show Cause Order
alleged that Respondent ``failed to establish a valid physician-patient
relationship'' as required by various state laws and that in issuing
the prescriptions Respondent
[[Page 52788]]
violated Federal law because he acted outside of the usual course of
professional practice and lacked a legitimate medical purpose. Id. at 2
(citing 21 CFR 1306.04(a); other citations omitted). The Show Cause
Order further alleged that while Respondent is licensed to practice
medicine in Tennessee, he violated multiple state laws because he
prescribed controlled substances to residents of States where he is not
licensed to practice medicine. Id. (citations omitted). Finally, the
Show Cause Order alleged that Respondent violated Tennessee law by
prescribing phentermine, a schedule IV controlled substance, to members
of his immediate family. Id. (citing Tenn. Code Ann. Sec. Sec. 63-6-
214(b)(1), (4) and (12)).
Respondent requested a hearing on the allegations and the matter
was placed on the docket of the Office of Administrative Law Judges.
ALJ Ex. 2. Thereafter, an Administrative Law Judge (ALJ) conducted a
hearing on August 30 and 31, 2011, in Nashville, Tennessee. ALJ
Recommended Decision (hereinafter, also ALJ), at 4. At the hearing, the
Government elicited testimony from several witnesses and submitted
various documents into the record; Respondent testified in his own
defense and submitted his resum[eacute] for the record. Following the
hearing, both parties filed briefs containing their proposed findings
of fact, conclusions of law, and argument.
On November 3, 2011, the ALJ issued his recommended decision.
Therein, the ALJ rejected the Government's allegations that Respondent
had prescribed controlled substances over the internet to numerous
persons who were not Tennessee residents, finding credible Respondent's
testimony that he did not issue any of the prescriptions (and that the
prescriptions were forged) and that the Government's contrary evidence
was unsubstantiated hearsay. ALJ at 37-38. While there was also
evidence that Respondent had issued prescriptions over the internet and
without performing physical examinations, the ALJ found credible
Respondent's testimony that he did so pursuant to an arrangement in
which he was acting ``as an on-call covering physician'' for patients
who needed a prescription refill when their doctor was unavailable. Id.
at 39. The ALJ further found that the Government had failed to show
that Respondent was required to perform a physical examination to
prescribe to Tennessee residents, finding credible Respondent's
testimony that ``he did not give new diagnoses to the patients''; that
he ``only provided refills'' and ``did not prescribe new medications'';
and that ``he only issued prescription refills after he conducted the
telephone consultations with the patient, reviewed the patient's
medical file and verified that the patient's primary care physician was
unavailable to see the patient.'' Id.
The ALJ further found that Respondent had prescribed phentermine to
family members, including his sister, wife and mother-in-law. Id. at
41. However, the ALJ also found credible Respondent's testimony that
upon being confronted by a pharmacist that it was unlawful to prescribe
to family members, he stopped doing so. Id. The ALJ also found that
Respondent had provided a UPS box as the address of his registered
location even though at the time he was practicing medicine at several
physical locations and that this was a violation of 21 U.S.C. 822(e).
Id. at 41-42.
Finally, the ALJ found that Respondent had fully accepted
responsibility for his misconduct and demonstrated that he will not
engage in future misconduct. The ALJ thus concluded that while the
Government had established ``a prima facie case that Respondent has
committed acts inconsistent with the public interest by unlawfully
prescribing controlled substances to immediate family members and by
failing to maintain a proper registered practice location,'' he had
rebutted the Government's prima facie case. Id. at 44.
The Government filed exceptions to the ALJ's recommended decision.
Thereafter, the record was forwarded to me for final agency actions.
Having considered the entire record and the Government's
Exceptions, I adopt the ALJ's findings that the Government proved that
Respondent unlawfully prescribed a controlled substance to a family
member and failed to update his registered location with the Agency. I
also adopt the ALJ's finding that the Government did not prove that
Respondent violated the CSA's prescription requirement by prescribing
controlled substances through the Internet to Tennessee residents
because it did not establish that his conduct violated the State's
regulation. However, for reasons explained below, I reject the ALJ's
finding that the Government did not prove that Respondent improperly
prescribed controlled substances without a valid doctor-patient
relationship to persons who were not residents of Tennessee. Moreover,
even were I to adopt the ALJ's finding that Respondent did not issue or
authorize the issuance of the out-of-state prescriptions, under agency
precedent--which was ignored by the ALJ--Respondent was nonetheless
liable for them because he provided his registration number to Secure
Telemed's employees and failed to exercise any supervision over their
use of his registration. I further reject the ALJ's finding that
Respondent has rebutted the Government's prima facie showing that his
continued registrations would be inconsistent with the public interest.
Findings of Fact
Respondent is the holder of a DEA Certificate of Registration,
which authorizes him to dispense controlled substances in schedules II
through V as a practitioner. GX 1. Respondent's registration was due to
expire on June 30, 2009. Id. However, on June 16, 2009, Respondent
submitted a renewal application. GX 2. Accordingly, Respondent's
registration remains active pending the issuance of this Decision and
Final Order. 5 U.S.C. 558(c).
The Investigation of Respondent
Respondent came to the attention of the Agency in the spring of
2008, when DEA Investigators in Nashville, Tennessee started receiving
complaints from other DEA offices, as well as pharmacies throughout the
country, that the pharmacies were receiving prescriptions issued by
Respondent which appeared to be suspicious. Tr. 115-16. Investigators
eventually determined that the prescriptions were being issued through
an internet scheme known as Telemed Ventures.\1\ Id. at 117.
---------------------------------------------------------------------------
\1\ The scheme was also known as Secure Telemedicine and Fortune
Telemed. Tr. 117. Throughout the hearing, the parties referred to it
as ``Secure,'' ``Secure Telemed,'' and ``Secure Telemedicine,'' as
does this Decision.
---------------------------------------------------------------------------
Under the scheme, persons would go online and fill out a
questionnaire, providing their name, address phone number, as well as
their height, weight, and estimated blood pressure. Id. According to an
Agency Investigator, sometimes patients would fax in their medical
records; however, other patients said they did not do so. Id. at 119.
Patients would then be put in touch with a physician, who would conduct
a phone consultation with the patient and issue a prescription. Id.
Initially, the prescriptions were transmitted either electronically or
by fax to a fulfillment pharmacy, which dispensed the medication. Id.
at 119-20. However, after DEA started cracking down on fulfillment
pharmacies, the prescriptions were sent directly to the patients, who
took them to their local pharmacies. Id. at 120.
During the course of the investigation, DEA Investigators conducted
an
[[Page 52789]]
inspection of Contract Pharmacy Services, a pharmacy located in
Colorado, which filled prescriptions as part of the Secure Telemed
scheme. Id. at 121. During the inspection, the pharmacist cooperated
with DEA and identified the names of various physicians whose
prescriptions he had filled, to include Respondent. Id. The pharmacist
also provided the Investigators with a spreadsheet of various
prescriptions he had filled which were attributed to Respondent. The
spreadsheet listed several dozen controlled substance prescriptions for
drugs (primarily for schedule III combination drugs of hydrocodone and
acetaminophen), which the pharmacy dispensed to persons located in
Mississippi and South Carolina between September 19 and October 30,
2007. See GX3.
Using the spreadsheets, the Nashville-based Investigators asked
other DEA offices to interview several of the persons who were listed
as having had obtained controlled substances in October 2007, from the
pharmacy, based on prescriptions issued by Respondent. Tr. 127. Those
interviewed included K.S., a resident of Terry, Mississippi, and C.T.,
a resident of Clinton, Mississippi, to each of whom the pharmacy
dispensed a prescription for 90 tablets of hydrocodone/apap 10/500mg;
as well as A.L., a resident of Richland, Mississippi, to whom the
pharmacy dispensed a prescription for 90 tablets of hydrocodone/apap
10/650mg. GX 3, at 1. Each of the interviews was conducted in the
September/October 2009 timeframe. Tr. 73, 77, 81.
A Mississippi-based Investigator testified that she interviewed
K.S., who related that she had obtained the prescription from an online
pharmacy by filling out a form and that she had faxed her medical
records to a Web site. K.S. further stated that she had ``received a
phone call from someone identifying [him]self as Dr. Dennis, contacting
her about her online form.'' Tr. 73-74. According to the Investigator,
K.S. further stated that she had never met Dr. Dennis and had not been
physically examined by him. Id. at 74. K.S. further stated that she had
received the prescriptions by email and fax and that she had filled the
prescriptions at a local Walgreens. Id. at 75.
The Investigator also interviewed A.L., who also told of filling
out an online form through a Web site known as Fortune Telemed and
faxing medical record to the Web site. Id. at 78-79. A.L. stated that
she had ``received a phone call from someone stating they were from Dr.
Dennis' office,'' id. at 78, and that she had no personal contact with
Respondent. Id. at 79. A.L. further stated that she received six to
seven prescriptions from Respondent, some of which were filled at a
pharmacy in Miami, and some of which she filled at a local Wal-Mart.
Id. at 80-81.
The Investigator also participated in an interview of C.T., who
also related that he had filled out a form at a Web site, faxed his
medical records to the Web site, and ``received a phone call from
someone identifying [himself] as Dr. Dennis.'' Id. at 82. C.T. further
stated that he never met Respondent, and that he had received two to
three prescriptions from him which he filled at a local Walgreens. Id.
at 84.
With respect to each of these three persons, the Investigator
acknowledged that they did not volunteer Respondent's name and that she
had told them that she was investigating a Dr. Dennis. Id. at 85. She
further acknowledged that none of them would be able to identify
Respondent if they testified in court. Id. at 87. Moreover, none of the
witnesses identified an email address or fax number that was used to
send them the prescriptions and the Investigator acknowledged that the
prescriptions could have been created by Secure Telemed. Id. at 88.
An Investigator from the Columbia, South Carolina DEA office
testified that on June 3, 2008, she was contacted by an Inspector from
the South Carolina Bureau of Drug Control regarding two prescriptions
issued under Respondent's registration (for 60 tablets of Valium and 60
tablets of hydrocodone/apap 10/325mg and dated May 30, 2008), which
H.B., a resident of Chapin, South Carolina presented for filling at a
local pharmacy. See Tr. 94-95; GX 14. According to the DI, the pharmacy
had contacted the state inspector because the prescriptions had been
issued to a known drug seeker or doctor shopper and had been written by
an out-of state physician. Tr. 95-96. The DI testified that she had
spoken with both the pharmacist and a pharmacy technician regarding the
prescriptions, and that the pharmacist told her that the pharmacy had a
policy of contacting ``every out-of-state physician.'' Id. at 97.
According to the DI, the pharmacist had initially attempted to call
Respondent using the phone number which was listed on the prescription
as Respondent's but was unable to reach him because his mailbox was
full. Id. at 98. However, the pharmacist looked for another phone
number for Respondent and was eventually able to speak with him and did
so on June 2, 2008.\2\ Id. at 97.
---------------------------------------------------------------------------
\2\ One of the prescriptions contains a different handwritten
phone number with the same area code as that listed for Respondent's
phone number. GX 14, at 2. According to the testimony of the DI, the
phone number was on the document at the time she received it from
the pharmacy. Tr. 103. The DI did not, however, know ``where that
number would call.'' Tr. 103. However, several other prescriptions
in the record, which Respondent does not dispute having written,
list the same phone number which was handwritten on the prescription
issued to H.B. Compare GX 13, at 2-5, with GX 14, at 2. See also Tr.
215 (testimony of Nashville-based Investigator identifying phone
number as Respondent's phone number at his Lebanon, Tennessee
practice).
The DI further testified that she had received copies of the
two prescriptions from the pharmacy on June 3, 2008. Tr. 94.
Consistent with this testimony, both prescriptions have a fax header
indicating that they were faxed from the pharmacy on June 3, 2008.
See GX 14, at 1-2.
---------------------------------------------------------------------------
The DI testified that the pharmacist told her that she asked
Respondent if H.B. was his patient and to verify that he had written
the prescriptions and the quantities; Respondent told the pharmacist
that H.B. was his patient. Id. Moreover, the DI further testified that
the pharmacist said that Respondent verified that he had written the
prescription and the quantity. Id. at 99. And according to the DI,
Respondent told the pharmacist that he ``had a record on H.B.'' but
``had never seen her in person.'' Id. at 98-99. Finally, the pharmacist
told the DI that when she questioned Respondent about this, he stated
that he had been ``assured'' by his Medical Director ``that prescribing
to out-of-state patients was legal in all except two states.'' Id. at
99. The DI further testified that the pharmacy had not filled the
prescriptions.\3\ Id. at 96.
---------------------------------------------------------------------------
\3\ In her testimony, the DI stated that she had interviewed the
pharmacist the week before the hearing. Tr. 99 & 103. The record
does not, however, clearly establish that the statements attributed
to Respondent were also related by the pharmacist to the DI in June
2008, after the DI had received the report from the State and
contacted the pharmacy to obtain the prescriptions. See generally
Tr. 93-103. Nor, with respect to the pharmacist's August 2011
statements, did the Government put on any evidence tending to show
that the pharmacist had an accurate recollection of the 2008
incident and her phone conversation.
---------------------------------------------------------------------------
The DI further testified that she had compiled a spreadsheet based
on data she obtained from the South Carolina Prescription Monitoring
Program (PMP) of the prescriptions which were issued by Respondent and
filled by South Carolina pharmacies, and that she had notated on the
document the distance between the patient's residence and Respondent's
location. Id. at 105, 109; GX 17. The DI verified the data by
contacting all of the pharmacies and asking whether the prescription
had been presented and whether it had been filled. Tr. 107-08. She also
stated that she had obtained a faxed copy of all of
[[Page 52790]]
the prescriptions and that ``[o]n many of'' them, ``there is a notation
written on them from the pharmacists that were working that day that
they were verified with Kevin Dennis.'' Id. at 111. The spreadsheet
documents more than seventy controlled-substance prescriptions, nearly
all of which were for hydrocodone, which were issued under Respondent's
DEA registration and which were dispensed between January 2 and July
18, 2008. Consistent with the DI's testimony, the spreadsheet does not
list the two prescriptions for H.B. as having been filled.
The Government also introduced into evidence copies of numerous
other prescriptions which it alleged Respondent had issued through
Telemed, as well as printouts from both the Tennessee and Mississippi
prescription drug monitoring programs listing prescriptions which were
dispensed and attributed to Respondent. GX 5 & 6. These included
multiple prescriptions for 90 tablets of hydrocodone/apap 10/325 issued
to K.P. of Fort Mill, South Carolina on December 13, 2007, as well as
January 7, February 4, March 3, April 4, April 30, and May 23, 2008. GX
15, at 9-16. Each of the prescriptions included Respondent's cell-phone
number, id., and the January 7 prescription bears the handwritten
notation: ``these are valid per Dr. Dennis'' along with his DEA
number.\4\ See id. at 10. Regarding this note, an Agency Intelligence
Research Specialist, who obtained the prescriptions from the dispensing
pharmacy, testified that she was told that the note was made ``by the
actual pharmacist after calling and confirming whether the prescription
was valid or not.'' Tr. 59. The Research Specialist testified that she
obtained these prescriptions from a K-Mart Pharmacy in North Carolina.
Tr. 40.
---------------------------------------------------------------------------
\4\ This exhibit also includes copies of prescriptions issued
for Naproxen which were issued on the same dates as the hydrocodone
ones were. See GX 15, at 1-8.
---------------------------------------------------------------------------
These included multiple prescriptions for hydrocodone/apap 10/
500mg. issued to patient E.F., who resided in the same town (Franklin,
Tennessee) where Respondent practiced. GX12. According to the
Government's lead Investigator, a local pharmacist had found the
prescriptions to be suspicious \5\ and contacted a state drug task
force because they contained a reference number and bar code and had
been faxed into the pharmacy. Tr. 166.
---------------------------------------------------------------------------
\5\ According to the DI, the circumstances which raised the
pharmacist's suspicion included that the prescriptions contained a
reference number, a box with a bar code, and had been faxed into the
pharmacy. Tr. 166. The DI testified that the reference number was
``a way for Telemed to keep track of the prescription [it] sent.''
Id. at 253. Numerous prescriptions in the record contain these
hallmarks.
---------------------------------------------------------------------------
The prescriptions were dated April 4, May 7, June 11, and July 10,
2008. GX 12. While the first three prescriptions contain the notation
``filled'' with a date, the latter prescription bears the notation
``refused to fill 7/16 called Doctor & patient'' and was marked with an
x across the face of the prescription. Id. According to the
Investigator, this note was written by the pharmacist. Tr. 167.
In addition, a report from the Tennessee PMP lists several other
hydrocodone prescriptions which were dispensed by Tennessee pharmacies
to E.F. pursuant to prescriptions attributed to Respondent; these
include prescriptions which were dispensed on November 13 and December
11, 2007; January 29, and February 28, and August 4, 2008.\6\ See GX 6,
at 9. Notably, the PMP report does not list a dispensing as having
occurred in July 2008. See id.
---------------------------------------------------------------------------
\6\ The PMP report shows that E.F. filled her prescriptions at
three different pharmacies.
---------------------------------------------------------------------------
The DI further testified that in August 2008, after obtaining the
prescriptions, he had contacted E.F. seeking to interview her. Tr. 170.
The Investigator explained to E.F. that he had determined ``that she
was obtaining medications over the internet.'' Id. While E.F. initially
offered to call the Investigator back to arrange for an interview, she
ultimately became ``very hard to get a hold of.'' Id. About a year
later, the Investigator went to her house and found her. Id. at 171.
E.F. eventually agreed to an interview which was conducted at her
house. Id. at 172.
During the interview, E.F. stated that she had a long history of
migraine headaches and admitted that sometime in late 2007, she had
gone online and started ordering medications through a Web site which
she referred to as ``Telemed something.'' Id. She further stated that
she had sent in medical records from both her primary care physician
and neurologist and that after calling a 1-800 number for the Web site,
she was told that she would be called by a physician. Id.
E.F. stated that she then received a phone call from a person who
identified himself as Kevin Dennis and that she generally talked with
Respondent whenever she needed a prescription. Id. at 173. E.F. further
stated that she had asked Respondent if she needed to be seen by him,
and that Respondent stated that he did not need to see her as long as
he was reviewing her medical records and talking to her on the phone.
Id. at 174.
The DI also testified that a state investigator had provided him
with a copy of the medical record E.F.'s primary care doctor maintained
on her. Id. at 203. Upon reviewing the file, the Investigator found
that there was no documentation that she was being prescribed
controlled substances by another physician. Id. at 203-04; see also GX
22. Nor is there any evidence in the file of Respondent's having
contacted E.F.'s primary care doctor. See GX 22.
The DI further testified that he had spoken with E.F.'s primary
care doctor (Dr. B.) and asked him whether he had ever contracted with
an organization to provide cross-coverage for his patients. Tr. 205.
Dr. B. explained that because there are ``numerous internal medicine
physicians'' at his practice, there would be no need to have a
physician outside the practice cover for him. Id. Finally, Dr. B. said
that he had never heard of Respondent. Id.
The Investigator also interviewed S.W., a Nashville resident, who
according to the Tennessee PMP report, obtained prescriptions for
hydrocodone and phentermine which were filled under Respondent's DEA
registration. Tr. 135; GX 6, at 27. According to the PMP report, on
December 17, 2007, as well as January 15 and February 14, 2008,
Respondent issued to S.W. prescriptions for both 90 tablets of
hydrocodone/apap 10/325 and thirty tablets of phentermine 30mg. GX 6,
at 27. According to the Investigator, although S.W. acknowledged having
ordered hydrocodone through Telemed she could not remember the name of
the prescribing physician. Tr. 135, 164. However, the Investigator was
eventually able to identify Respondent as the prescribing physician.
Id. at 164.
During an interview, S.W. stated that she ordered drugs over the
internet and had been doing so ``for years'' because it was ``easier to
get'' some of the medications she wanted such as ``diet pills'' as
``her primary care physician really didn't want to prescribe the type
of things she wanted.'' Id. at 163-65. S.W. further stated that she
never had a physical exam and never met the physician. Id. at 164. She
also stated that she filled the prescriptions at a local Wal-Mart. Id.
S.W. provided the Investigator with the name of her primary care
physician (Dr. H.). Id. at 165. Subsequently, the Investigator
interviewed Dr. H. and asked him whether he would contract with an
organization outside of his practice to provide on-call or cross-
coverage for his patients. Id. at 207. Dr.
[[Page 52791]]
H. explained that this would not occur because there were other
physicians in his practice who covered for him if he was not available.
Id. In addition, Dr. H. stated that he had never heard of Secure
Telemedicine or any other organizations with a similar name. Id. at
207-08. Nor had Dr. H. ever heard of Respondent. Id. at 208.
During the investigation, the Government also found evidence that
Respondent was prescribing controlled substances, specifically
phentermine 37.5mg, to family members including his wife, sister, and
mother-in-law. See GX 19, at 12-13, 17, 19, 21-23 (Rxs issued to wife);
GX 20, at 2-6, 10-13 (Rxs issued to sister); GX 21, at 2, 4-10 (Rxs
issued to mother-in-law); Tr. 175-79, 181-82, 201. The DI further
stated that upon going to a Sam's Club Pharmacy in Franklin, Tennessee
to retrieve the prescriptions which Respondent's wife and sister had
filled there, the Pharmacy Manager related a 2009 incident in which he
had challenged Respondent's wife and sister about the prescriptions.
Tr. 185. According to the Pharmacy Manager, Respondent's wife and
sister had filled prescriptions for diet pills at the pharmacy on
several previous occasions and he had ``always assumed that they were
sisters.'' Id. However, upon reviewing the prescriptions, the Pharmacy
Manager had ``put two and two together'' and concluded that one of the
women ``might be'' Respondent's wife. Id.
When the women returned to pick up their prescriptions, the
Pharmacy Manager confronted them, telling them that it was against
state law and Medical Board policy for a physician to prescribe to a
family member. Id. Respondent's wife became agitated and said that she
would just ``go get the doctor and we'll clear this up.'' Id. at 186.
The women left and later returned with Respondent. The Pharmacy
Manager, who declined to fill the prescriptions, explained the
situation to Respondent, who stated that ``he understood and left
without incident.'' Id.
On June 26, 2009, Respondent went to the Nashville DEA office to
discuss with the Investigator and his Supervisor why the Agency had not
renewed his registration. Id. at 189, 421. After being advised of his
right to remain silent and that he was not under arrest, Respondent was
informed that DEA was investigating him for prescribing controlled
substances to persons in other States and with whom he did not
establish a legitimate doctor-patient relationship. Id. at 190; see
also id. at 422 (testimony of Supervisory Investigator: ``I advised him
that DEA was conducting an investigation of information we had received
that he had been involved in issuing prescriptions to persons that he
had never met, nor ever examined in other states and that it appeared
that would be without a legitimate medical purpose, and that was the
reason we were conducting the investigation. . . .'').
Respondent stated that he ``kind of knew what this was about'' and
pulled out of his pocket, ``some sort of employment document with
Secure Telemedicine.'' Id. at 190. However, the DI did not make a copy
of the document. Id. at 357. According to Respondent, the document
``was actually a liability form'' that had the ``name of [the] company,
their malpractice insurance carrier, along with the name of seven other
doctors,'' id. at 356, as well as the dates of its insurance policy.
Id. at 358.
Respondent then volunteered that he quit working for Secure
Telemedicine after receiving a phone call from a pharmacy in South
Carolina questioning one of his prescriptions and after the entity's
Medical Director ``could not provide verification that he could do this
legally in other states.'' Id. at 194; see also id. at 197 (testimony
that Respondent ``indicated that he left Secure Telemedicine because he
didn't feel like it was the ethical thing to do and that they couldn't
provide him the legal documentation to make him feel comfortable to
continue working for them''); id. at 425 (Supervisory Investigator's
testimony to same effect). Moreover, according to both Investigators,
Respondent stated that he was surprised to receive the phone call from
the South Carolina pharmacy because ``it was his understanding that all
these prescriptions went to a fulfillment [or clearinghouse]
pharmacy.'' Id. at 198; see also id. at 424. According to the
Investigator, Respondent never denied that he had issued prescriptions
to out-of-state persons during the interview and said he had worked for
Secure Telemed from ``around November [20]07 through March 2008.'' Id.
at 195. However, in his testimony, Respondent denied ever having told
the Investigators that he had issued prescriptions to out-of-state
persons and asserted that he told them that he had limited his internet
prescribing to Tennessee residents. Specifically, Respondent testified
that:
I communicated to the investigators at that time that I was a
Tennessee-licensed physician and that I was not authorized, and I
was only notified by the South Carolina pharmacist that a
prescription arrived in South Carolina. I did not communicate to the
investigators that I had ``prescribed or dispensed medications
outside the State of Tennessee.''
Id. at 396. According to Respondent, when he was confronted by an
Investigator as to whether he had issued internet prescriptions for
out-of-state patients, he stated that he did not ``know of any online
pharmacy activities,'' and added: ``I don't know if it's an online
pharmacy or not, but I've been associated with Secure Telemedicine.
I've been an On-Call Coverage Consultant for that organization for a
period of time.'' Id. at 397. Respondent again maintained that he told
the Investigator that he ``did not give Secure Telemedicine
authorization to dispense or prescribe medications outside the State of
Tennessee. I did not give them that authorization,'' id. at 398, and
that at the time of the interview, he was unaware that any other
prescription (beside the one that he was called about by the South
Carolina pharmacist) had been issued to non-Tennessee residents using
his DEA registration. Id. at 403.
According to the Investigator, Respondent further stated that
``[i]t was his understanding that all these prescriptions went to a
fulfillment [or clearinghouse] pharmacy. So, when he received a call
directly from a pharmacy in South Carolina, it took him by surprise.''
Id. at 198. See also id. at 424 (testimony of Supervisory Investigator
who also attended the interview: ``he said that he had been contacted
by a pharmacist from South Carolina concerning one of his prescriptions
and questioning that prescription and that he was surprised because he
thought that all his prescriptions went through a clearinghouse
pharmacy'').
Respondent also stated that at the time he worked for Secure
Telemedicine, he worked in an emergency room and had a practice in
Lebanon and that he sent out his resume[acute] online to ``find some
locum tenens work'' to supplement his income. Id. at 195-96; 296.
Respondent admitted that he never saw the patients to whom he
prescribed and did not conduct physical examinations. Id. at 196.
Rather, he would review a patient's record online and conduct a
telephonic consultation with the patients before issuing a
prescription; he further admitted that he prescribed such controlled
substances as hydrocodone, Norco (a branded hydrocodone drug), and
Xanax, as well as such non-controlled drugs as naproxen and ibuprofen.
Id. at 196.
Respondent testified on his own behalf. Regarding his work for
Secure Telemedicine, Respondent testified that he became aware of
Secure Telemed
[[Page 52792]]
through ``a web search for locum tenens work'' and that he did not
interview ``face-to-face'' with them and had never been to its office,
which he understood to be located in Miami; rather, he interviewed by
phone. Id. at 295-97. Respondent nonetheless entered into an agreement
with Secure towards the end of September 2007. Id. at 298.
Respondent maintained that he ``was to become an on-call covering
physician, considered under [Secure Telemedicine's] Consult-A-Doc
program'' and that he would provide shift coverage on an eight-hour
basis.\7\ Id. According to Respondent, he ``would inform the company of
the shifts that [he was] available in advance such that [he] would be
available to cover on-call for physicians after hours or when a
physician is just unavailable to be able to manage the care of their
patients.'' Id.
---------------------------------------------------------------------------
\7\ In his letter requesting a hearing, Respondent asserted that
``Secure contracted with primary care physicians in Tennessee and
other jurisdictions to provide coverage by other licensed physician
in their respective jurisdictions when the primary care physician
was unavailable to attend to the needs of their established patients
for ongoing conditions.'' ALJ Ex. 2. However, at the hearing,
Respondent produced no evidence to support the assertion that
Tennessee physicians contracted with Secure.
---------------------------------------------------------------------------
Respondent further asserted that under the Consult-A-Doc program,
patients would call into Secure Telemedicine, and that he would be
notified through what was ``called a dashboard'' that a patient was
seeking a consultation, and that he could either accept or decline the
call. Id. at 299. Respondent maintained that if he accepted the call,
his activities were limited to triaging a patient call in non-emergency
situations and that if a patient's situation involved an emergency, he
would direct the patient to go to the emergency room or an urgent care
center. Id. at 299-300.
Respondent asserted that he would ``never give a new diagnosis'' to
``any patient'' and that upon completion of the call, he would update
the patient's record in the electronic medical records system (EMR).
Id. at 300. Respondent maintained that ``if the patient requested and
they were talking in a way such that they had a chronic ailment, such
as a pain ailment,'' the patient was placed back in the queue because
``there had to be verification of their records.'' Id. at 301.
Respondent then asserted that he would then ``[c]all the patient's
primary care doctor, the doctor that's prescribing the medication, talk
to that office, find out information about that office and find out
about their unavailability.'' Id.; see also id. at 303.
Respondent maintained that ``[s]ome doctors who are in private
practice, mostly private practice, a lot of them don't have call
coverage or they have problems finding physicians with call coverage.''
Id. Respondent then added that while working for Secure Telemedicine,
he ``really didn't have any contact'' with any group practice where
``they communicate to me that this program was part of them.'' Id.
Respondent asserted that with respect to solo practitioners, ``if
the office staff stated that Doctor ABC was actually on vacation and he
will not be back for at least five days but be back next week, that
extended period of time then qualified the patient for that particular
medication after reviewing the records with the staff.'' Id. at 302.
Respondent stated that he would never initiate a new medication for a
patient and that he would ``always make sure that the doctor [was]
truly unavailable'' before prescribing a controlled substance. Id.
Respondent further testified that he only accepted on-call coverage
for Tennessee physicians, and that he only consulted with the patients
of Tennessee physicians. Id. at 303. He then explained that upon
determining that a hydrocodone prescription needed to be refilled, he
would update the EMR to note that he had reviewed the patient's record,
that he had contacted the office of the patient's physician and
determined that the ``physician was not available to this patient'' and
that he would then push a button on a computer to send this information
to Telemed, which would prepare the prescription. Id. at 304. In his
testimony, Respondent emphasized that he did not actually prepare or
sign the prescriptions. Id.; see also id. at 414. He also stated that
he did not keep any records of his prescribing activities for Telemed,
id. at 305, because they were the property of Secure Telemedicine. Id.
at 384.
When asked to square his failure to retain patient files for those
to whom he prescribed with his obligation as a physician to maintain a
patient record, Respondent testified that:
I was not the [primary care physician]. I was only the on-call
covering physician; therefore, it's not my responsibility at that
time to have or operate in a fashion as though I am that patient's
primary doctor. I was only an on-call covering physician.
Id. at 385.
Moreover, he did not forward a copy of the prescriptions he wrote
to the patient's primary care physician claiming that this was the
responsibility of Secure Telemedicine. Id. at 384. Asked by the
Government whether he ever communicated with the patient's primary care
physician regarding prescriptions he had written Respondent maintained
that the information was in the electronic medical record and was sent
through Secure Telemedicine. Id. at 388. And when asked whether he had
ever verified with someone at Secure Telemedicine that it had notified
a patient's primary care physician regarding his having written a
prescription, Respondent replied: ``I don't know of any instance where
they did not. I was not told that information and I did not question
that particular--I did not pose that question to them.'' Id. at 389.
Strangely, Respondent acknowledged that he did not remember having ever
been called by the primary care physician of a patient he had
prescribed to through Secure Telemed, notwithstanding that his name
would have been on the consult note. Id. at 408-09.
Regarding his decision to terminate his arrangement with Secure
Telemedicine, Respondent testified that on about April 4, 2008, he
received a phone call from a South Carolina pharmacist, who he asserted
was ``a male pharmacist,'' Tr. 364, questioning a prescription that had
his DEA number and information on it. Id. at 308. Respondent asserted
that he ``was not aware that [he] had written prescriptions for any
patients outside the State of Tennessee'' and that he ``asked the
pharmacist to not fill that prescription'' and to send him a copy of
it. Id.; see also id. at 368 (``I communicated with him [the
pharmacist] that I was unaware that there was any patient I've ever
prescribed any medication for or wrote a prescription for in the State
of South Carolina.''). According to Respondent, the pharmacist agreed
not to fill the prescription. Id. at 308. Respondent did not, however,
recall the name of the pharmacy or the city it was located in. Id. at
369. Moreover, Respondent did not notify DEA that his registration had
been used to issue the prescription. Id. at 371, 374.
Respondent testified that ``the same day,'' he contacted Secure
Telemed's Medical Director, and asked him ``how is it that a
prescription . . . `has gotten outside the State of Tennessee to a
patient in South Carolina?' '' and said that he had ``never approved
anything like that.'' Id. at 308. Continuing, Respondent testified that
he asked Secure Telemed's Medical Director:
Can you give me some legalities or something in writing showing
that, you know, this isn't happening or how is it happening? What
are the laws concerning a doctor in Tennessee having the right to
have
[[Page 52793]]
a prescription written to a patient in any state outside of
Tennessee?
I was very upset by that conversation, that this actually
occurred, but I said I wanted to see a copy of it. I really wanted
to see one, because I really hadn't seen any, because I hadn't
produced any. I didn't know what they looked like.
And he stated he would get back with me, he would call me, he
would investigate and research this, and he would provide some
documents to me that protected me and protected the company
pertaining to any Tennessee physician if they were to prescribe
outside the State. I never received those documents from [him], and
I discontinued providing any service for them probably within two
weeks.
Id. at 308-09.
Respondent further acknowledged that he had provided Secure
Telemedicine with his DEA registration number, as well as other
documents, which had his signature on them. Id. at 310. He then
expressly denied having told DEA Investigators that the reason he quit
Secure Telemed was because they could not justify his continued
prescribing of medications to out-of- state patients. Id. at 310-11.
Rather, he reiterated that the reasons he quit Secure Telemed were for
the reasons explained in the block-quote above. Id. at 311. Respondent
did not, however, create any written correspondence documenting his
decision to terminate his relationship with Secure Telemedicine. Id. at
375-77.
Respondent then denied having prescribed for ``anybody other than
patients that were treated by Tennessee physicians [that he was] on
call for.'' Id. at 311. And when questioned by his counsel if ``the one
[prescription] in South Carolina, that's the first you heard about
it?,'' Respondent replied ``[t]hat is correct,'' then added: ``And I
had never seen a prescription as well.'' Id. Respondent then maintained
that he had never seen any of the prescriptions until the Government
provided them following the initiation of this proceeding. Id.
After denying that he ever took a call from a patient that lived in
South Carolina, Colorado or Washington State, id. at 305, Respondent
then proceeded to deny having issued all but one all of the
prescriptions for out-of-state patients.\8\ Id. at 312-23 (denying
issuance of prescriptions in GXs 3, 5, 8, 9, 10 11); id. at 324-30
(denying issuance of prescriptions in GXs 12, 14); id. at 336-41
(denying issuance of prescriptions in GXs 16, 17, and 18). Moreover, he
further denied having authorized Telemed to issue the various
prescriptions. Id.
---------------------------------------------------------------------------
\8\ The only exception was for a prescription contained in GX 7.
According to Respondent, although the patient provided a Colorado
address, she was in the music business and had been a patient in
Respondent's Tennessee practice. Tr. 314.
---------------------------------------------------------------------------
Regarding the hydrocodone prescriptions issued to E.F. (GX 12), who
resided in Franklin, Tennessee, and which included a July 10, 2008
prescription with the notation that the pharmacist had ``Refused to
fill, 7/16, called doctor and patient,'' Respondent acknowledged that
``[i]t's possible'' he received a call about the prescription and that
at the time, he was working in the ER and was ``quite busy.'' Tr. 324-
25. Respondent testified that he ``tend[s] not to answer calls because
of the nature of the hospital'' and added that ``[i]t's always possible
that I could have received a call, and I could have answered this and
spoken to this pharmacist, and told them not to fill the
prescriptions.'' Id. at 325. However, Respondent did not have a
``positive recollection'' of the incident. Id.
Respondent then denied having issued, as well as having authorized
anyone to issue, each of the prescriptions that E.F. obtained through
Secure Telemed. Id. Respondent added that during the interview with DEA
Investigators, he had told them that the only time he received a call
regarding a prescription was for the call that came from the South
Carolina pharmacist. Id. at 326; see also id. at 363 (acknowledging
that it is ``always possible'' that he received a phone call from a
pharmacist about E.F. but stating that he did not ``have any
recollection, and I've never seen this patient, I've never talked to
this patient.''); id. at 367. Later, on redirect examination,
Respondent testified that he would not have issued prescriptions
through the internet to E.F. because ``[m]y office was available within
a proximity where this patient can come right to my office so I can
examine them physically, I can see what's going on with the medical
conditions'' and ``I would have no need to do this.'' Id. at 404.
Regarding the May 30, 2008 prescriptions for hydrocodone and valium
issued to H.B. of Chapin, South Carolina, and which were presented to
the Chapin Pharmacy, Respondent denied writing them or issuing them in
any way. Tr. 330. He also denied authorizing them ``in any way.'' Id.
Respondent also denied writing, authorizing, or otherwise causing
the issuance of the numerous hydrocodone prescriptions issued to K.P.,
of Fort Mill, South Carolina. Id. at 333-34. As found above, a January
7, 2008 prescription bears the handwritten notation: ``These are valid
per Dr. Dennis'' along with his DEA registration number. GX 15, at 10.
Respondent nonetheless denied having authorized or validated the
prescription. Tr. 333-34. Moreover, on cross-examination, he denied
having received any other phone calls from any pharmacists about
prescriptions other than the phone call he claimed to have received
from a South Carolina pharmacist in April 2008. Id. at 364. And when
asked if he knew how the notation got on the prescription, Respondent
testified:
I have no idea how the notation arrived there, but it doesn't
appear to be a pharmacist. By pharmacy rule of law, any notation
written on a prescription must contain their initials and it must
contain the date of that communication and/or alteration of the
prescription. By pharmacy law they must do this. This one does not
contain any initials by a pharmacist, does not contain a date.
Id. at 334.
Respondent did not, however, cite to any specific provision of
North Carolina law or the Pharmacy Board regulations in either his
testimony or his brief, which requires that such a notation that a
prescription has been verified must be initialed and dated. And even if
the prescription should have been initialed and/or dated, given that
Respondent has ``no idea how the notation arrived'' on the
prescription, I find that the testimony of the Agency Intelligence
Research Specialist, who obtained the prescription, that the note was
made by ``the actual pharmacist after calling and confirming whether
the prescription was valid'' to constitute substantial evidence that
the note was made by the pharmacist, and consistent with pharmacy
practice, was likely done so by the pharmacist in the process of
reviewing the prescription and determining whether to fill it.\9\
---------------------------------------------------------------------------
\9\ Respondent's counsel also attempted to call into question
the notation by observing that it used ``the plural `these' '' and
Respondent testified that he did no ``know what `these' mean.'' Tr.
334. However, as found above, the record also includes a copy of a
Naproxen prescription which was issued on the same date as the
hydrocodone prescriptions which bears the notation. See GX 15, at 2.
Thus, K.P. had been provided with two prescriptions.
---------------------------------------------------------------------------
Respondent further denied having issued any of the prescriptions
listed on the spreadsheet of prescriptions which an Agency Investigator
had compiled from the South Carolina PMP report. Tr. 339-40. Moreover,
on cross-examination, the Government showed Respondent the printout
from the Tennessee PMP (GX 6) showing the controlled substance
prescriptions dispensed pursuant to prescriptions issued under his DEA
registration and asked him to identify the patients he had prescribed
to through Secure Telemedicine. Id. at 392. While a recess was then
taken to allow Respondent to
[[Page 52794]]
review the exhibit, upon the reconvening of the hearing, Respondent was
``unable to identify any of those patients.'' Id. at 394.
Finally, Respondent asserted that the patients he prescribed to
through Secure Telemedicine were essentially one-time patients. As he
testified, ``The patients that I saw on this on-call coverage, the ones
that I actually communicated with from what my recollection is was a
one-time call, because the patients had a doctor and I would not be
responsible and I would not rewrite something for them. So I didn't
expect to even see that patient or communicate with that patient again
at any given time.'' Id. at 406. See also id. at 386 (testifying that
``[t]he patient needed to see their own doctor and be seen by their
primary care doctor. If I were to take on the responsibility to
prescribe medication on a monthly basis, then I'm taking over the
patient's primary care doctor's responsibility.'').
Thus, other than the phentermine prescription he had issued for his
former patient who had moved to Colorado, see GX 7, the only
prescriptions in the record which Respondent admitted to issuing were
the phentermine prescriptions for his wife, sister, and mother-in-law.
Tr. 343-47. While Respondent questioned whether his mother-in-law came
within the State's prohibition on prescribing to an immediate family
member, he nonetheless ceased prescribing to her (as well as his wife
and sister). Id. 347-48. He further testified that he understood the
gravity of this situation. Id. at 348.
As for his internet prescribing, Respondent testified that he
``will never get involved with any entity that even looked similarly as
though they were doing business in any sort on the internet, ever.''
Id. at 349. He further stated that he had made mistakes, that the
mistakes were apparent and clear, that he has learned from his mistakes
and took responsibility for them. Id. Continuing, Respondent stated:
I in no way or form intended or willfully, knowingly
participated in any situation that placed me or placed patients in
particular at risk. I just didn't do that. I've learned today,
throughout this whole process yesterday and today and throughout
this whole investigation that you can't do these things. You have to
be more diligent, you have to do some research, stay with those
credible organizations like I'm currently with now * * *
organizations where you can truly see how you're benefitting
patients the right way with your gift of medicine.
* * * * *
More important than a DEA number is my name, my name, my
credibility. My parents gave me that name and it's hard to see
myself being so stupid to have participated with a company that
misused and used me.
Id. at 349-50.
The Government's Exceptions
As discussed above, the ALJ found Respondent fully credible on all
of the material issues including his testimony that he did not issue or
authorize the issuance of the prescriptions to persons who resided
outside of Tennessee and that his prescribing activities were limited
to providing on-call services for Tennessee physicians. ALJ at 32-39.
The Government takes exception to these findings. More specifically,
the Government argues that the ALJ failed to give proper weight to the
inculpatory statements Respondent made during the June 2009 interview
with DEA Investigators. Exceptions at 5-7. The Government also takes
exception to the ALJ's finding that the Secure Telemed prescriptions
were issued without his knowledge or consent and argues that the ALJ
ignored other evidence of record, including the statements of the South
Carolina pharmacist regarding her June 2008 phone call to Respondent
regarding the prescriptions issued to H.B., evidence showing that
Respondent was called about a prescription for K.P., who was a South
Carolina resident and verified the prescription, the phone number
evidence, and the fact that Respondent never reported the misuse of
registration. Id. at 7-19.
Discussion
Section 304(a) of the Controlled Substances Act (CSA) provides that
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)
(emphasis added). With respect to a practitioner, the Act requires the
consideration of the following factors in making the public interest
determination:
(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).
``[T]hese factors are . . . considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that 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 MacKay v. DEA, 664 F.3d
808, 816 (10th Cir. 2010); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir.
2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while
I am required to consider each of the factors, I ``need not make
explicit findings as to each one.'' MacKay, 664 F.3d at 816 (quoting
Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482)).\10\
---------------------------------------------------------------------------
\10\ In short, this is not a contest in which score is kept; the
Agency is not required to mechanically count up the factors and
determine how many favor the Government and how many favor the
registrant. Rather, it is an inquiry which focuses on protecting the
public interest; what matters is the seriousness of the registrant's
misconduct. Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly,
as the Tenth Circuit has recognized, findings under a single factor
can support the revocation of a registration. MacKay, 664 F.3d at
821.
---------------------------------------------------------------------------
The Government has the burden of proving, by a preponderance of the
evidence, that the requirements for revocation or suspension pursuant
to 21 U.S.C. 824(a) are met. 21 CFR 1301.44(e). However, ``once the
[G]overnment establishes a prima facie case showing a practitioner has
committed acts which render his registration inconsistent with the
public interest, the burden shifts to the practitioner to show why his
continued registration would be consistent with the public interest.''
MacKay, 664 F.3d at 817 (citing Medicine Shoppe-Jonesborough, 73 FR
364, 387 (2008) (citing cases)).
In this matter, it is undisputed that Respondent retains an active
Tennessee Medical License (factor one) and that he has not been
convicted of an offense related to the manufacture, distribution, or
dispensing of a controlled substance (factor three). However, while I
adopt the ALJ's findings of fact and legal conclusions that neither
factor one (the recommendation of the state licensing board), nor
factor three (Respondent's conviction record under laws related to the
manufacture, distribution or dispensing of controlled substances),
supports the revocation of Respondent's registration, it has long been
settled that neither factor is dispositive. See MacKay, 664 F.3d at
817; see also Jayam Krishna-Iyer, 74 FR 459, 461 (2009); Edmund Chein,
72 FR 6580, 6593 n.22 (2007), pet. for rev. denied 533 F.3d 828 (DC
Cir. 2008); Mortimer B. Levin, 55 FR 8209, 8210 (1990). Rather, the
primary focus of this proceeding is whether, as
[[Page 52795]]
alleged by the Government, Respondent violated the CSA's prescription
requirement, 21 CFR 1306.04(a), as well as the laws of several States,
by issuing prescriptions to patients he did not physically examine and
with whom he did not establish a legitimate doctor-patient
relationship, as well as by engaging in the unauthorized practice of
medicine by prescribing to residents of States where he was not
authorized to practice medicine. Gov. Br. at 23-24 (citations omitted).
In addition, the Government alleges that Respondent violated Tennessee
law when he issued phentermine prescriptions to his wife, sister, and
mother-in-law. Id. at 24-25 (citing Tenn. Code Ann. Sec. Sec. 63-6-
214(b)(1), (4) and (12)).
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Compliance With Applicable Laws Related to Controlled
Substances
Under a longstanding DEA regulation, 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 ``[a]n 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 recently 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.'' Gonzalez v. Oregon,
546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122,
135 (1975)).
``Under the CSA, it is fundamental that a practitioner must
establish a bonafide doctor-patient relationship in order to act `in
the usual course of . . . professional practice' and to issue a
prescription for a `legitimate medical purpose.''' Joseph Gaudio, 74 FR
10083, 10090 (2009) (citing Moore, 423 U.S. at 141-43). Moreover, at
the time of the events at issue here, whether a doctor and patient have
established a bona fide doctor-patient relationship under the CSA was
generally a question of state law. Id.; see also Kamir Garces-Mejias,
72 FR 54931, 54935 (2007); United Prescription Services, Inc., 72 FR
50397, 50407 (2007); Dispensing and Purchasing Controlled Substances
Over the Internet (DEA Guidance Document), 66 FR 21181, 21182-83
(2001).
``Moreover, `[a] physician who engages in the unauthorized practice
of medicine' under state laws `is not ``a practitioner acting in the
usual course of . . . professional practice''' under the CSA.'' Gaudio,
74 FR at 10090 (quoting United Prescription Services, 72 FR at 50407).
As the Supreme Court explained shortly after the CSA's enactment,
``[i]n the case of a physician,'' the CSA ``contemplates that he is
authorized by the State to practice medicine and to dispense drugs in
connection with his professional practice.'' Moore, 423 U.S. at 140-41.
This rule derives from the plain text of the statute which defines the
term ``practitioner'' to mean ``a physician . . . licensed, registered,
or otherwise permitted, by the United States or the jurisdiction in
which he practices . . . to . . . dispense . . . a controlled
substance,'' 21 U.S.C. 802(21), and the term ``dispense'' to mean ``to
deliver a controlled substance to an ultimate user . . . by, or
pursuant to the lawful order of, a practitioner.'' 21 U.S.C. 802(10).
Thus, a controlled-substance prescription issued by a physician who
lacks the license or other authority necessary to practice medicine
within a State is unlawful under the CSA. See 21 CFR 1306.04(a); cf. 21
CFR 1306.03(a)(1) (``A prescription for a controlled substance may be
issued only by an individual practitioner who is . . . [a]uthorized to
prescribe controlled substances by the jurisdiction in which he is
licensed to practice his profession.'').
The ALJ rejected all of the Government's contentions regarding
Respondent's prescribing for Secure Telemed, apparently crediting his
testimony denying having issued, as well as having authorized the
issuance, of each of the Secure Telemed prescriptions presented by the
Government. ALJ at 37. While the ALJ properly discounted some of the
hearsay evidence relied upon by the Government to refute Respondent's
denial of having issued the prescriptions, I find that there is
sufficient other reliable evidence of record to support the finding
that Respondent issued (or approved the issuance of) many of the
prescriptions. Indeed, the evidence with respect to how Secure Telemed
operated is consistent with what DEA has encountered in numerous other
investigations of unlawful internet prescribing rings, and given the
absence of any evidence corroborating Respondent's testimony that he
acted as an on-call physician, covering for other Tennessee physicians
after hours or when they were unavailable to manage the care of their
patients, I conclude that his testimony is so inherently implausible
that no reasonable factfinder could find it to be credible.\11\
---------------------------------------------------------------------------
\11\ I am mindful of the fact that the ALJ observed the demeanor
of the various witnesses and found Respondent's testimony credible.
However, as the Supreme Court has explained, ``[t]he findings of the
examiner are to be considered along with the consistency and
inherent probability of [the] testimony.'' Universal Camera Corp.,
v. NLRB, 340 U.S. 474, 496 (1951). As explained below, Respondent's
testimony was contradicted by other evidence and contained numerous
material inconsistencies. Cf. Anderson v. City of Bessemer City, 470
U.S. 564, 575 (1985) (challenge to district court finding under
clearly erroneous standard) (``This is not to suggest that the trial
judge may insulate his findings from review by denominating them
credibility determinations, for factors other than demeanor and
inflection go into the decision whether or not to believe a witness.
Documents or objective evidence may contradict the witness' story;
or the story itself may be so internally inconsistent or implausible
on its face that a reasonable factfinder would not credit it.'');
United States v. Lathern, 665 F.3d 1351, 1354 (DC Cir. 2012).
Of course, the standard applicable in this matter is not the
clearly erroneous standard, but rather, whether the Agency's
decision is nonetheless supported by substantial evidence on the
record as a whole. Universal Camera, 340 U.S. at 492 (``The
responsibility for decision thus placed on the Board is wholly
inconsistent with the notion that it has the power to reverse an
examiner's findings only when they are `clearly erroneous.' ''); see
also Chirino v. NTSB, 849 F.2d 1525, 1530 (DC Cir. 1988) (``In our
view, the Board's determination that Chirino's testimony was
`inherently incredible' supplied the requisite basis under the
NTSB's applicable rules to overturn the contrary findings of the
ALJ.'').
---------------------------------------------------------------------------
As found above, with respect to the prescriptions issued to the
three Mississippi residents, the Government elicited the testimony of
an Agency Investigator regarding the statements they made during
interviews to the effect that, after faxing their medical records to a
Web site, they had received phone calls from someone identifying
himself as Respondent, and were subsequently prescribed hydrocodone
without meeting him and undergoing a physical exam. However, the
Investigators conducted these interviews approximately two years after
the prescriptions were issued and the Investigator who testified
regarding the interviews acknowledged that none of these three persons
initially named Respondent and none could identify an email address or
fax number that was used to send them the prescriptions. In addition,
the Investigator offered no testimony that any of these individuals'
statements were reduced to writing and sworn. Thus, by themselves,
these statements do not bear sufficient indicia
[[Page 52796]]
of reliability to be considered substantial evidence.
However, this is not the only evidence that supports a finding that
Respondent did, notwithstanding his denial, issue prescriptions,
through Secure Telemed, to out-of-state residents. As found above, the
record contains seven prescriptions for 90 tablets of hydrocodone/apap
10/325 issued to K.P. of Fort Mill, South Carolina, each of which
included Respondent's cell-phone number. Most significantly, a January
7, 2008 prescription bears the handwritten notation: ``these are valid
per Dr. Dennis'' along with his DEA number. The testimony establishes
that the notation was on the prescription when it was obtained by a DEA
Intelligence Analyst, who was told that it was made by the actual
pharmacist who called and verified the prescription.\12\
---------------------------------------------------------------------------
\12\ As found above, K.P. also obtained a Naproxen prescription
which was dated January 7, 2008. Thus, the notation's use of the
word ``these'' can be explained by the fact that pharmacist was
verifying both prescriptions.
---------------------------------------------------------------------------
While in his findings of fact, the ALJ found that Respondent
``denied ever verifying that he issued the prescriptions to K.P., as
indicated by [the] notation,'' ALJ at 24 (citing Tr. 333-34; GX 15, at
10), in his legal conclusions, the ALJ did not even mention the
prescription and its notation, let alone explain why he apparently gave
it no weight.\13\ However, I conclude that the notation is consistent
with that which a pharmacist would make contemporaneously with having
verified a prescription. And I further hold that the notation supports
the inference that Respondent did not object to the dispensing of the
prescription and that Respondent was engaged in issuing prescriptions
through Secure Telemed for persons who resided outside of Tennessee.
---------------------------------------------------------------------------
\13\ While at hearing, Respondent contended that the notation
did not comply with law and regulations because it was not initialed
and dated, he did not cite to any provision of either North Carolina
law or the State's Pharmacy Board rules requiring that a pharmacist
do this upon verifying a prescription. Nor does his brief cite to
any such provision.
---------------------------------------------------------------------------
The Government also introduced into evidence controlled substance
prescriptions for hydrocodone and Valium issued under Respondent's DEA
registration to H.B., who was a resident of South Carolina, which were
presented to the Chapin Pharmacy in Chapin, South Carolina. Regarding
these prescriptions, the Government also elicited the testimony of a
DEA Investigator regarding the out-of-court statements made to her by
an Inspector for the South Carolina Bureau of Drug Control and the
pharmacist. According to the DI, the State Inspector had contacted her
shortly after he was contacted by the pharmacist about the
prescriptions, because H.B. was a known doctor-shopper.
As found above, the DI testified that the pharmacist had told her
that she attempted to call Respondent because the pharmacy had a policy
of contacting ``every out-of-state physician,'' and that when she
initially attempted to call him using the phone number on the
prescription, she received a message that his mailbox was full. The
pharmacist, however, eventually reached Respondent on a different phone
number and one of the prescriptions includes a hand-written phone
number which matches the phone number listed on several of the
prescriptions Respondent admittedly issued to family members.
According to the DI, Respondent verified that H.B. was his patient,
that he had written the prescription and the quantity. Moreover,
Respondent stated that while he had a record on H.B., he admitted that
he ``had never seen her in person.'' Respondent then stated that he had
been assured by his Medical Director ``that prescribing to out-of-state
patients was legal in all except two states.''
The ALJ found these statement did not constitute substantial
evidence, reasoning that the Government had not shown a lack of bias on
the part of the pharmacist, that the statements were neither signed nor
sworn to, and that there was an absence of evidence ``corroborating the
substantive content of the hearsay, namely that [the pharmacist]
actually spoke with Respondent in or about June 2008.'' ALJ at 36.
While I ultimately agree with the ALJ's conclusion that the statements
cannot constitute substantial evidence, I disagree with much of his
reasoning.
```[H]earsay may be substantial evidence depending on its
truthfulness, reasonableness, and credibility; hearsay statements are
highly probative where declarants are disinterested witnesses,
statements are essentially consistent, and counsel had access to the
statements prior to agency hearing''') Bobo v. United States Dep't of
Agric., 52 F.3d 1406, 1414 (6th Cir. 1995) (quoting Hoska v. United
States Dep't of the Army, 677 F.2d 131, 138 (DC Cir. 1982)); Johnson v.
United States, 628 F.2d 187, 190-191 (DC Cir. 1980). See also Echostar
Comm. Corp. v. FCC, 292 F.3d 749 (DC Cir. 2002) (hearsay can constitute
substantial evidence where there are ``satisfactory indicia of
reliability'' of statements).
Contrary to the ALJ's finding, the evidence shows that the
pharmacist was a disinterested witness to the event. While the ALJ
reasoned that the issue of bias is not entirely speculative because
``[a] pharmacist would generally be motivated to inform DEA of
compliance with applicable laws and regulations,'' ALJ at 35 (citing 21
CFR 1306.04(a)), the ALJ was unconvinced by the Investigator's
testimony that the prescriptions were not dispensed. ALJ at 35. As
reason for rejecting the Investigator's testimony, the ALJ observed
that the prescriptions ``bear no . . . objective markings consistent
with a rejected prescription'' and the absence of a notation on the
prescriptions reflecting the substance of the pharmacist's
``conversation with Respondent, to include such basic information as
time, date, telephone number and signature of the pharmacist.'' Id. at
36.
However, the ALJ ignored the Investigator's testimony that as early
as June 3, 2008, she was contacted about the prescriptions by the State
Inspector, whom the pharmacist had initially called about the
prescriptions. In addition, the ALJ ignored the Investigator's
testimony that she contacted the pharmacy and obtained the
prescriptions that same day, which is corroborated by the fax header on
the prescriptions.
As related by the Investigator, the contents of the pharmacist's
conversation with Respondent clearly established that Respondent had
failed to perform a physical examination on H.B. and that the two
prescriptions lacked a legitimate medical purpose and were issued
outside of the usual course of professional practice. See United States
v. Nelson, 383 F.3d 1227 (10th Cir. 2004). Thus, by relating the phone
conversation the pharmacist had with Respondent to the Agency's
Investigator, the pharmacist would have exposed herself to criminal (as
well as administrative) liability if she had, in fact, filled the
prescriptions. Beyond this, unexplained by the ALJ is why a person who
had committed a criminal act by filling the prescriptions would then
voluntarily (and without solicitation) report themselves to the law
enforcers.
Here, the Investigator testified that the prescriptions were not
filled. Moreover, the Investigator obtained from the South Carolina PMP
a list of the prescriptions which were dispensed by South Carolina
pharmacies which were issued under Respondent's registration. The
Investigator testified that she then verified the data by obtaining the
actual prescriptions from the respective
[[Page 52797]]
pharmacies and prepared a spreadsheet. The spreadsheet does not,
however, list any dispensings by the Chapin Pharmacy of prescriptions
issued under Respondent's registration, let alone dispensings to this
particular person (H.B.).
The ALJ discounted the clear and unequivocal testimony of the
Investigator, reasoning that the prescriptions lacked any markings that
they had been rejected (such as having been crossed-out), as well as
any notations regarding the phone conversation. It is true that
sometimes a pharmacist will line-through a prescription, or otherwise
may note on it, that she has refused to fill it. However, there is no
evidence in this record establishing that where a pharmacist declines
to fill a prescription, she is required under either the South Carolina
Board of Pharmacy's regulations or the standards of pharmacy practice
to either line-through the prescription or make a notation on it.
Indeed, given the undisputed evidence that the pharmacist reported the
incident to the State authorities contemporaneously with the incident
\14\ and provided copies of the prescriptions to them at the time of
her report, one must wonder why it would then be necessary to line out
the prescriptions or document the phone conversation on them.\15\
---------------------------------------------------------------------------
\14\ The prescriptions were dated May 30, 2008, and the
testimony indicated that the pharmacist was not able to speak to
Respondent until June 2, 2008. According to a 2008 calendar, May
30th was a Friday, and June 2nd was a Monday.
\15\ Indeed, she may have done so after faxing the prescriptions
to the Investigator.
---------------------------------------------------------------------------
The ALJ further surmised that that it was ``uncertain as to which
telephone number Ms. Owen used to confirm the prescription, leaving
significant doubt as to whether a call was placed to Respondent or
someone associated with Telemed.'' ALJ at 36. In support of this
reasoning, the ALJ noted the testimony of the Investigator that the
pharmacist was not sure which phone number she had used to reach
Respondent. Id. The ALJ further explained that he gave ``little to no
weight to the telephone number written on the bottom of'' one of H.B.'s
prescriptions, because the DI testified that she did ```not know
specifically where that number would call.''' Id. at n.41 (quoting Tr.
103).
The ALJ's reasoning is simply a makeweight as only two phone
numbers are listed on the prescriptions and there is substantial
evidence that both phone numbers were used by Respondent. As for the
number that was printed on the prescriptions, it was undisputed that
this was either Respondent's (or his wife's cell-phone) number. And as
for the number handwritten at the bottom of one of the prescriptions,
notwithstanding the DI's testimony that she did ``not know specifically
where that number would call,'' Tr. 103, the record establishes that
Respondent used this number on the prescriptions he issued to family
members. Given the absence of any other phone numbers on the
prescriptions, I am reasonably confident that the pharmacist did, in
fact, reach Respondent and not someone at Secure Telemed.
However, there are other reasons why the pharmacist's statements
that Respondent verified writing the prescription for H.B. and did not
physically examine her cannot be given weight. While the DI testified
that she had contacted the pharmacy in June 2008 upon receiving the
report from the State Inspector and that she obtained the
prescriptions, she offered no testimony that she had interviewed the
pharmacist on that occasion, and her testimony suggests that the
pharmacist's statements were not made to her until the interview she
conducted one week before the hearing, more than three years after the
incident. Nor did the DI offer any testimony to support the conclusion
that the pharmacist accurately recollected the incident,\16\ and most
importantly, the statements attributed to Respondent. Thus, the hearsay
statements of the pharmacist cannot be deemed to be sufficiently
reliable to constitute substantial evidence.
---------------------------------------------------------------------------
\16\ It may be that the pharmacist made a record of the
incident. However, no such evidence was put forward by the
Government. It may also be that the circumstances of the incident
were so unusual, that the pharmacist accurately recalled
Respondent's statements. Yet no evidence was put forward to support
such a finding. It may also be that the pharmacist related
Respondent's statements to the State Inspector; if so, the
Government could have called the State Inspector or better yet the
pharmacist herself.
---------------------------------------------------------------------------
Nonetheless, there is other substantial evidence which supports the
conclusion that Respondent, notwithstanding his denial of having done
so, wrote or authorized the prescriptions issued to the non-Tennessee
residents. The same DI testified that she had prepared a spreadsheet of
the prescriptions that were filled by the South Carolina pharmacies (GX
17).
Moreover, the DI testified that while she initially obtained a
printout from the South Carolina PMP, she then proceeded to obtain
copies of the prescriptions from the pharmacies to verify the
information contained in the PMP report. On cross-examination,
Respondent's counsel asked the Investigator whether ``other than
[Respondent's] name being on those, you don't have any information from
any other source that he actually personally issued those
prescriptions?'' Tr. 111. The Investigator testified that ``[o]n many
of the faxed prescriptions that [were] presented at my South Carolina
pharmacies, there is [a] notation written on them from the pharmacists
that were working that day that they were verified with''
Respondent.\17\ Id. The ALJ entirely ignored this testimony.
---------------------------------------------------------------------------
\17\ To refute the DI's testimony, Respondent could have
requested a subpoena requiring the Government to produce the actual
prescriptions and sought a continuance of the proceeding. He did
not.
---------------------------------------------------------------------------
In addition, according to both Agency Investigators who interviewed
him in June 2009, Respondent volunteered information to the effect that
following the receipt of a phone call from a South Carolina pharmacy
questioning a prescription, he quit Secure Telemedicine after the
entity's Medical Director ``could not provide verification that he
could do this legally in other [S]tates.'' Tr. 194; see also id. at 425
(testimony that Respondent said that ``he had become concerned that . .
. this wasn't right, . . . he was not involved in the right thing to do
because Secure Telemedicine could not provide documentation to him that
it was legal to operate in . . . the other [S]tates.''). Obviously, if
Respondent was only writing prescriptions for Tennessee residents,
there was no need for him to verify with Secure's Medical Director
whether it was legal to write prescriptions for patients in other
States.
Both Investigators also testified that Respondent was told that he
was under investigation for prescribing controlled substances to
persons in other States and with whom he did not establish a legitimate
doctor-patient relationship, and that Respondent replied that he ``kind
of knew what this was about.'' Tr. 190; see also id. at 422 (```I
thought I knew why you wanted to talk to me.'''). In addition to
Respondent's statement set forth above, the Investigators testified
that Respondent admitted to having worked for Secure Telemedicine and
stated that he was surprised to receive a phone call from a South
Carolina pharmacy because it was his understanding that all of the
prescriptions were being filled by a fulfillment pharmacy.\18\
Moreover,
[[Page 52798]]
according to both Investigators, at no point during the interview did
Respondent claim that his internet prescribing activities were limited
to Tennessee residents, id. at 423, or deny that he had prescribed to
out-of-state patients. Id. at 195.
---------------------------------------------------------------------------
\18\ Here again, if Respondent was writing prescriptions only
for Tennessee patients, it begs the question of why it was his
understanding that the Secure Telemed scheme was using a fulfillment
pharmacy, such as the pharmacy which was located in Colorado. See
Tr. 121. As the Agency's Investigator explained, the use of a
fulfillment pharmacy was a common feature of unlawful internet
prescribing schemes. Id. at 120.
---------------------------------------------------------------------------
The ALJ declined to give weight to the testimony of the
Investigators reasoning that ``the Government presented no evidence
that any of the investigators specifically asked Respondent whether he
issued out-of-state prescriptions while he worked at Telemed.'' ALJ at
38.\19\ In addition, the ALJ reasoned that ``Respondent was not
provided with any of the prescriptions in question during his . . .
interview.'' Id.
---------------------------------------------------------------------------
\19\ The ALJ did not, however, find the testimony of either
Investigator to be incredible. See generally ALJ at 36.
---------------------------------------------------------------------------
Yet, the evidence is clear that Respondent was told that he was
being investigated for prescribing controlled substances to out-of-
state patients with whom he did not establish a doctor-patient
relationship. While this statement may not have been framed as a
question, it nonetheless was an accusation, and indeed, Respondent was
under no illusion that it was not such, as immediately prior to it, he
had been told that he had the right to remain silent and was not under
arrest.\20\ And given its serious nature, one would expect that if it
was not true, Respondent would have ``clearly challenge[d] the accuracy
of the accusation.'' McCormick on Evidence Sec. 160, at 426 (Edward W.
Cleary, ed., 3d ed. 1984). Yet he did not do so.
---------------------------------------------------------------------------
\20\ Notably, Respondent did not remain silent in the face of
the accusation. As for the ALJ's assertion that Respondent's failure
to deny the accusations is not entitled to weight because the
accusation was not framed as a question, the ALJ cited no authority
to support this proposition. See United States v. Ward, 377 F.3d
671, 675 (7th Cir. 2004) (``[A] statement may be adopted as long as
the statement was made in the defendant's presence, the defendant
understood the statement, and the defendant has the opportunity to
deny the statement but did not do so.'') (emphasis added).
---------------------------------------------------------------------------
Moreover, the two Investigators further testified that Respondent
volunteered that he quit working for Secure Telemed after its Medical
Director ``could not provide verification that he could do this legally
in other states.'' Tr. 194; see also id. at 425. This testimony is
entirely consistent with Respondent's failure to challenge the
Investigators' accusation. Indeed, given the vehemence of his denial at
the hearing of having written prescriptions for out-of state patients
or having authorized their issuance, one must wonder why a similarly
forceful denial did not occur during the June 2009 interview. And
because it is clear that Respondent knew what the nature of the
accusation was, it is of no consequence that the Investigators did not
show him any specific prescriptions.
The ALJ likewise ignored the inherent implausibility of
Respondent's testimony regarding his employment as ``an on-call
covering physician'' under Secure Telemed's ``Consult-A-Doc program.''
Tr. 298. According to Respondent, he would inform the company of when
he was available ``to cover on-call for physicians after hours or when
a physician [was] just unavailable to manage the care of their
patients.'' Id.
In his letter requesting a hearing, Respondent asserted that
``Secure contracted with primary care physicians in Tennessee . . . to
provided coverage by other licensed physicians in their respective
jurisdiction when the primary care physician was unavailable to attend
to the needs of their established patients.'' ALJ Ex. 2. Yet, if
Tennessee physicians were entering into contracts with Secure, it begs
the question of why Respondent was not informed, at the start of his
shift, of the names of the doctors for whom he was providing on-call
coverage. Notably, in describing his activities for Secure, Respondent
offered no testimony to the effect that he was told at the start of his
shifts the names of the physicians for whom he was providing on-call
coverage, and indeed, Respondent testified that he would review the
patient's medical record and then verify with the office of the
patient's primary care doctor that the latter was unavailable.
Respondent also testified that the patients had already provided
their medical records to Secure Telemedicine at the time he took their
phone call. Unexplained by Respondent is why the patients would have
known to obtain their medical records if he was merely covering for a
physician ``after hours.'' Id. Likewise, Respondent testified that his
activities were limited to ``triag[ing]'' patients in ``non-emergency
situations'' and that he only issued refills for them. Id. at 299-300,
302. Yet if he was only providing coverage ``after hours,'' it does not
seem likely that he could have verified at that time with the office of
the patient's primary care physician that the latter was unavailable
and Respondent did not explain why, if he was only triaging patients
``in a non-emergency situation,'' he did not simply instruct the
patients to contact their primary care physician the next morning.
Respondent further asserted that there would be occasions where a
patient's primary care physician would be on vacation and not be back
until the ``next week.'' Id. at 302. Given his testimony that he only
issued refills for patients with ``a chronic ailment,'' id. at 301,
here again, Respondent offered no explanation as to why the patient's
primary care doctor would not know in advance of when he/she would be
on vacation and provide the patient with either a refill or an
additional prescription to ensure that the patient had an adequate
quantity of medication and did not run out.
Moreover, when confronted with evidence that the primary care
physicians of two Tennessee patients to whom he prescribed had never
heard of him and that they had other physicians in their group who
would take calls for them, Respondent then denied either writing the
prescriptions or explained that he ``really didn't have any contact''
with any group practice. Id. at 301. However, Respondent claimed that
``[s]ome doctors who are in private practice . . . a lot of them don't
have call coverage or they have problems finding physicians with call
coverage.'' Id. Were I to credit Respondent's testimony, I would have
to believe that the physicians he purportedly took calls for, had
contracted with an entity that was not even located in Tennessee, and
entrusted it to place the care of their patients in the hands of
physicians they did not know, let alone had never met.\21\ And while
Respondent maintained that he had prepared a consult note for each
patient for whom he wrote a prescription, and asserted that Secure
Telemed forwarded the note on to the patient's primary care physician,
he did not recall having ever been called by the primary care physician
of a Secure Telemed patient. Id. at 408-09. Nor did he testify that he
called the patients' primary care physicians to inform them that he had
issued a prescription to their patients.
---------------------------------------------------------------------------
\21\ Also unexplained is why the physicians would entrust the
care of their patients to physicians who were unlikely to have
privileges at the same hospitals where they had privileges.
---------------------------------------------------------------------------
Notably, Respondent produced no evidence to corroborate any of his
far-fetched story. See Chirino v. NTSB, 849 F.2d at 1530. He did not
maintain patient records, see Tenn. Comp. R. & Regs. R. 0880-
02-.14(2)(b)(3), nor even document any of the phone calls he claimed to
have made to the offices of the patient's primary care physicians. And
when asked to review the Tennessee PMP report and identify any of the
persons who were Secure Telemed patients, he could not identify a
single one.
[[Page 52799]]
I therefore conclude that Respondent's testimony is so inherently
implausible that no reasonable factfinder could find it to be true.
Anderson, 470 U.S. at 575; Lathern, 665 F.3d at 1354; Chirino, 849 F.2d
at 1530. I thus reject the ALJ's findings that Respondent credibly
denied either issuing or authorizing the issuance of any controlled
substance prescriptions to persons located outside of the State of
Tennessee.\22\
---------------------------------------------------------------------------
\22\ The ALJ also found that while Respondent did not perform
physical examinations on the Tennessee patients, the Government
failed to prove that Respondent had violated Tennessee regulations
because it did not show ``that Respondent was not exempt under Tenn.
Comp. R. & Regs. 0880-2-.14(7)(b)'' from the requirements that he
perform a physical examination. ALJ at 39. Under this provision,
``[a] physician . . . may prescribe or dispense drugs for a person
not in compliance with [the requirement that he perform a physical
examination] consistent with sound medical practice . . . [f]or a
patient of another physician for whom the prescriber is taking calls
or for whom the prescriber has verified the appropriateness of the
medication[.]'' Tenn. Comp. R. & Regs. 0880-2-.14(7)(b).
The Government offered no expert testimony as to whether
Respondent's internet prescribing was ``consistent with sound
medical practice.'' Id. Nor did it cite to any state authority such
as a decision of either the Tennessee Courts or Board of Medicine
explaining what constitutes compliance with the provision
authorizing a prescription where ``the prescriber has verified the
appropriateness of the medications.'' Id. I therefore do not find
the allegations of the Show Cause Order proved with respect to
Respondent's Tennessee patients.
---------------------------------------------------------------------------
I therefore hold that because Respondent failed to perform a
physical examination of the patients located in Mississippi, North
Carolina, and South Carolina, he did not establish a legitimate doctor-
patient relationship with them and thus lacked a legitimate medical
purpose and acted outside of the usual course of professional practice
in prescribing controlled substances to them.\23\ See Miss. Code Ann.
Sec. 41-29-137; North Carolina Medical Board, Contact with patients
before prescribing, at 1 (Nov. 1999); S.C. Code Ann. Sec. 40-47-113.
---------------------------------------------------------------------------
\23\ The ALJ also noted that some of the signatures on the
Secure Telemed prescriptions differed from those on the
prescriptions Respondent issued to his family members. See ALJ at
33. Be that as it may, it provides no comfort to Respondent because
he testified that he did not actually sign any of the prescriptions
he approved for Secure Telemed but simply pushed a button on his
computer approving the prescriptions, which was then prepared by
someone at Telemed. Tr. at 304 & 414. Indeed, Respondent's failure
to sign the prescriptions (even those he admits to issuing) is
itself a violation of the CSA. See 21 CFR 1306.05(a) (``The
prescriptions may be prepared by the secretary or agent for the
signature of a practitioner, but the prescribing practitioner is
responsible in case the prescription does not conform in all
essential respects to the law and regulations.'') (emphasis added).
---------------------------------------------------------------------------
Moreover, ``[a] physician who engages in the unauthorized practice
of medicine is not a `practitioner acting in the usual course of . . .
professional practice.' . . . A controlled-substance prescription
issued by a physician who lacks the license necessary to practice
medicine within a State is therefore unlawful under the CSA.'' United
Prescription Services, Inc., 72 FR 50397, 50407 (2007)) (citations
omitted). See also 21 U.S.C. 802(21) (``[t]he term `practitioner' means
a physician . . . licensed, registered, or otherwise permitted, by the
United States or the jurisdiction in which he practices . . . to . . .
dispense . . . a controlled substance.''). As the Supreme Court has
explained: ``In the case of a physician [the CSA] contemplates that he
is authorized by the State to practice medicine and to dispense drugs
in connection with his professional practice.'' United States v. Moore,
423 U.S. 122, 140-41 (1975) (emphasis added) (quoted in United
Prescription Services, 72 FR at 50407).
Here, it is undisputed that Respondent is licensed only in
Tennessee. Accordingly, he engaged in the unauthorized practice of
medicine by prescribing controlled substances to patients located in
the States of South Carolina, North Carolina and Mississippi and
therefore acted outside of the usual course of professional practice
for this reason as well. See S.C. Code Ann. Sec. 40-47-20(36)(b) & (e)
(defining practice of medicine); id. Sec. 40-47-200 (prohibiting
practicing medicine without a license); N.C. Code Ann. Sec. 90-1.1(5)
(defining practice of medicine); id. Sec. 90-18 (prohibiting practice
of medicine without a license); Miss. Code Ann. Sec. 73-25-33
(defining practice of medicine); id. Sec. 73-25-34 (prohibiting
practice of telemedicine without a state license).
Moreover, even were I to adopt the ALJ's finding that the
Government did not prove that the ``prescriptions were issued by
Telemed with Respondent's knowledge or authorization,'' ALJ at 32, that
would not be the end of the matter as far as the Secure Telemed
prescriptions. Contrary to the ALJ's understanding, DEA's authority to
revoke a registration is not limited to those instances in which
``Respondent knowingly issued . . . or . . . authorized Telemed to
issue . . . prescriptions on his behalf.'' Id.
Rather, this Agency has long held that a registrant is strictly
liable for the misuse of his registration by any person to whom he
entrusts his registration. See Scott C. Bickman, 76 FR 17694, 17703
(2011); Harrell E. Robinson, 74 FR 61370, 61376-77 (2009); Paul
Volkman, 73 FR 30630, 30644 & n.42 (2008); Rose Mary Jacinta Lewis, 72
FR 4035, 4040 (2007); Anthony L. Capelli, 59 FR 42288 (1994). Having
provided his registration number to Secure Telemedicine, and having no
effective means of supervising its employees to ensure that his number
was not being misused, Respondent is liable for the issuance of all of
the prescriptions Secure Telemedicine issued under his registration as
if he had personally authorized them.\24\
---------------------------------------------------------------------------
\24\ Moreover, at the time Respondent entered into his contract
with Secure Telemedicine, this Agency had already issued several
final orders finding that the prescribing of controlled substances
under similar circumstances (i.e., through the internet and/or a
telephone consultation) violated Federal law. See, e.g., William R.
Lockridge, M.D., 71 FR 77791, 77798 (2006) (discussing expert
testimony regarding steps necessary to establish a doctor-patient
relationship, as well as guidelines published by the Federation of
State Medical Boards and the American Medical Association, and DEA's
2001 Guidance Document, Dispensing and Purchasing Controlled
Substances Over the Internet, 66 FR 21181). See also Dale L. Taylor,
72 FR 30855 (2007); Mario Avello, 70 FR 11695, 11697 (2005). So too,
numerous States had issued pronouncements establishing that such
prescribing was unlawful.
---------------------------------------------------------------------------
Moreover, Respondent testified that he never visited Secure's
office nor interviewed face-to-face with principals. He also offered no
testimony as to any due diligence he had performed. Respondent's total
failure to take any steps to determine whether Secure was a legitimate
enterprise manifests a level of irresponsible behavior that is
fundamentally incompatible with holding a DEA registration.\25\
---------------------------------------------------------------------------
\25\ In Bickman, I noted that ``this is not a case where a
practitioner simply provided his DEA registration to a health care
facility as part of the credentialing process and a person at the
facility subsequently used his registration for unlawful purposes.''
76 FR at 17703 n.22. Given Respondent's total failure to perform due
diligence, so too here.
---------------------------------------------------------------------------
The ALJ totally ignored this line of authority. See ALJ 32. I
conclude, however, that this conduct is sufficiently egregious to
warrant the revocation of Respondent's registration.\26\
---------------------------------------------------------------------------
\26\ The evidence also showed that Respondent had prescribed
phentermine to family members including his wife, sister, and
mother- in-law. According to a Policy Statement of the Tennessee
Board, ``[t]reatment of immediate family members should be reserved
only for minor illnesses or emergency situations,'' and ``[n]o
schedule II, III or IV controlled substances should be dispensed or
prescribed except in emergency situations.'' Tennessee State Board
of Medical Examiners, Policy: Prescribing For Oneself And One's
Family 1 (Jan. 1997). The Board's statement does not, however,
define the term ``immediate family member,'' see id., and the
Government does not cite to any decision of either the Board or the
Tennessee courts construing the term. While it would seem that
Respondent's wife would fall within the definition, Respondent fully
acknowledged his misconduct in prescribing phentermine to her. Thus,
had this been the only allegation proven in the case, I would have
adopted the ALJ's recommended sanction. For similar reasons,
Respondent's failure to update his registered location would not
warrant anything more than a reprimand.
---------------------------------------------------------------------------
[[Page 52800]]
Factor Five--Other Conduct Which May Threaten Public Health and Safety
Even were I to adopt the ALJ's findings and credit Respondent's
testimony that he was unaware of the misuse of his registration until
an April 2008 phone call from a South Carolina pharmacy, see ALJ at 37,
the record supports a further finding that he engaged in other conduct
which threatened public health and safety. While Respondent claimed
that he reported the incident to the Tennessee Medical Board sometime
in 2009 and well after the fact,\27\ he did not notify DEA of the
incident until the June 2009 interview.\28\ Tr. 371-72. However, the
record contains evidence establishing that numerous additional
prescriptions were issued under his registration through Secure Telemed
following the April 2008 phone call, many of which were filled. See GX
17, at 1 (spreadsheet listing multiple prescriptions filled by South
Carolina residents); GX 8, at 5 (Pt. S.P.H.); GX 12, at 3-4 (Pt. E.F.);
GX 14, at 1-2 (Pt. H.B.); GX 15, at 15 (Pt. K.P.); GX 6, at 9 (entry
for patient for E.F. showing additional hydrocodone prescription filled
on 8/4/08).
---------------------------------------------------------------------------
\27\ Respondent initially testified that he did not file the
report with the State until June 2009 (the same month that he was
interviewed by DEA Investigators). Tr. 372. Respondent then stated
that he could not recall the exact month although it was sometime in
2009. Id. Respondent did not, however, maintain a copy of the
report. Id.
\28\ Contrary to the ALJ's understanding, see ALJ at 43-44,
Respondent's claim that he reported the misuse of his DEA
registration to the State authorities (approximately one year after
the incident) neither mitigates his misconduct nor manifests that he
accepts responsibility. State authorities did not issue his DEA
registration and obviously have no authority to cancel a
registration issued by an Agency of the federal government.
Moreover, the lengthy delay in his reporting of the incident is
consistent with the conduct of someone who has something to hide.
---------------------------------------------------------------------------
Thus, even crediting his testimony, Respondent was aware that his
registration was being used for criminal purposes, and yet did nothing
to prevent this. See 21 U.S.C. 822(a) (requiring registration to
lawfully dispense a controlled substance) and Sec. 841(a)(1) (``Except
as authorized by this subchapter, it shall be unlawful for any person
knowingly or intentionally . . . to . . . distribute[] or dispense . .
. a controlled substance[.]''); see also id. Sec. 843(a)(2) (``It
shall be unlawful for any person knowingly or intentionally . . . to
use in the course of the . . . distribution[] or dispensing of a
controlled substance, . . . a registration number which is . . . issued
to another person.''). His failure to inform the Agency of the unlawful
use of his registration \29\ led to additional acts of diversion of
controlled substances and constitutes ``other conduct which . . .
threaten[s] the public health and safety.'' 21 U.S.C. 823(f)(5).
---------------------------------------------------------------------------
\29\ Had Respondent reported the misuse of his registration, the
Agency could have--with his agreement--cancelled his number and
posted this information in the database which the Agency makes
available to other registrants for verifying the validity of another
person's registration. However, short of issuing an Immediate
Suspension Order, the Agency could not have indicated in the
database that he did not have a valid registration.
---------------------------------------------------------------------------
I thus conclude that this factor also supports a finding that
Respondent has committed acts which render his registration
inconsistent with the public interest. 21 U.S.C. 824(a)(4).
Sanction
Under Agency precedent, where, as here, the Government has made out
a prima facie case that a registrant has committed acts which render
his registration ``inconsistent with the public interest,'' he must
```present[] sufficient mitigating evidence to assure the Administrator
that [he] can be [en]trusted with the responsibility carried by such a
registration.''' Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting
Leo R. Miller, 53 FR 21931, 21932 (1988)). ``Moreover, because `past
performance is the best predictor of future performance,' ALRA Labs.,
Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), this Agency has
repeatedly held that where a registrant has committed acts inconsistent
with the public interest, the registrant must accept responsibility for
[his] actions and demonstrate that [he] will not engage in future
misconduct.'' Medicine Shoppe-Jonesborough, 73 FR at 387. As the Sixth
Circuit has recognized, this Agency also ``properly considers'' a
registrant's admission of fault and his candor during the investigation
and hearing to be ``important factors'' in the public interest
determination. See Hoxie, 419 F.3d at 483.
More recently, the Tenth Circuit upheld the Agency's rule,
explaining that:
When faced with evidence that a doctor has a history of
distributing controlled substances unlawfully, it is reasonable for
the . . . Administrator to consider whether that doctor will change
his behavior in the future. And that consideration is vital to
whether [his] continued registration is in the public interest.
Without Dr. MacKay's testimony, the . . . Administrator had no
evidence that Dr. MacKay recognized the extent of his misconduct and
was prepared to remedy his prescribing practices.
MacKay, 664 F.3d at 820.
Here, the ALJ found that the Respondent ``fully accepted
responsibility'' for his misconduct. ALJ at 43. Yet this conclusion was
premised on the ALJ's finding that Respondent did not write any of the
out-of-state prescriptions, a finding which I reject. As explained
above, the record as a whole contains substantial evidence that
Respondent, notwithstanding his testimony to the contrary, issued
numerous controlled substance prescriptions to out-of-state patients,
with whom he did not establish a legitimate doctor-patient
relationship, and that he acted outside of the usual course of
professional practice because he engaged in the unauthorized practice
of medicine. Because Respondent failed to accept responsibility for
this aspect of his misconduct, which was the most egregious of the
various types of misconduct he engaged in, and continues to deny doing
so, I conclude that he has not rebutted the Government's prima facie
case. Accordingly, I will order that Respondent's registration be
revoked and that any pending application be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) &
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of
Registration BD8297461, issued to Kevin Dennis, M.D., be, and it hereby
is, revoked. I further order that any pending application of Kevin
Dennis, M.D., to renew or modify his registration, be, and it hereby is
denied. This Order is effective September 25, 2013.
Dated: August 17, 2013.
Michele M. Leonhart,
Administrator.
[FR Doc. 2013-20677 Filed 8-23-13; 8:45 am]
BILLING CODE 4410-09-P