Registrant Actions - 2011
[Federal Register Volume 76, Number 191 (Monday, October 3, 2011)]
[Notices]
[Pages 61154-61181]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25229]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 09-50]
Robert Raymond Reppy, D.O.; Decision and Order
On March 31, 2011, Administrative Law Judge (ALJ) Timothy D. Wing
issued the attached recommended decision. Neither party filed
exceptions to the decision.
Having reviewed the entire record including the parties' briefs, I
have decided to adopt the ALJ's recommended ruling, findings of fact,
conclusions of law, and recommended order. Accordingly, I will order
that Respondent's DEA Certificate of Registration be revoked and that
any pending applications be denied.
As the ALJ found, between 2002 and 2006, Respondent wrote thousands
of controlled- substance prescriptions (approximately 5000 each year)
to patients who sought such drugs as hydrocodone and alprazolam through
the internet, most of whom (at least 90 percent) he never physically
examined, let alone met. ALJ at 12, 20-21.\1\ Respondent wrote the
prescriptions based on medical records which were sent to him not by
the patients' doctors, but by the patients themselves, and a telephone
consultation with the patients. Id. at 20-21. As the ALJ found,
"Respondent rarely contacted a patient's primary care physician whose
records he was reviewing" and had no way of verifying whether the
person he prescribed to was the actual person whose record he was
reviewing. Id. at 21.
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\1\ All citations to the ALJ's decision are to the slip opinion
as originally issued.
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Respondent maintains that in 2002, when he agreed to write the
prescriptions, the legality of prescribing controlled substances via
the internet was "a gray area" and that the standards were not the
same "as are agreed upon now." Tr. 64. Respondent further claims that
he did his "due diligence," which included doing "a little research
on [his] own," with the result being that he "couldn't find anybody
saying * * * for definite that you cannot do this" and that he was
even shown a letter from "DEA giving permission to do it." Id. at 60.
Respondent was shown this letter by an attorney, Mr. Robert Carr, who
happened to be the founder and President of United Prescription
Services, a Tampa, Florida-based pharmacy which was to fill most of the
prescriptions Respondent issued; Respondent knew that Carr had a
financial interest in United Prescription Services. Id. at 60-61, 151.
As for Respondent's assertion that he was unable to find
"anybody" definitely saying that it was illegal to prescribe
controlled substances over the internet to persons he never examined,
this may be consistent with his claim that he did "little research."
However, it clearly was not the case, as even by 2002, multiple States
had enacted statutes, promulgated rules, or published policy statements
to the effect that prescribing drugs in this manner was illegal.
Moreover, as explained below, it was clearly unreasonable for
Respondent to rely on Carr's purported advice.
In 2000, California enacted a provision which prohibits the
prescribing or dispensing of a dangerous drug "on the Internet for
delivery to any person in this state, without an appropriate prior
examination and medical indication therefore." Cal. Bus. & Prof. Code
Sec. 2242.1. Moreover, as early as November 2001, the Medical Board of
California (MBC) issued a citation order to an out-of-state physician
for prescribing over the Internet to California residents. See Citation
Order, Carlos Gustav Levy (Nov. 30, 2001). The MBC cited both the
physician's failure to conduct "a good faith prior examination," as
well as his lack of "a valid California Physician and Surgeon's
License to practice medicine in California." Id. at 1. The Board
further ordered Doctor Levy "to cease and desist from Internet
prescribing to individuals in California without first performing a
good faith prior examination, without having medical indication to
prescribe such medication and without having a California Physician and
Surgeon's License," and fined him $25,000. Id. at 1-2. See also
Citation Order, Martin P. Feldman (Aug. 15, 2003); see also Citation
Order, Harry Hoff (June 17, 2003); Citation Order, Carlos Gustavo Levy
(Jan. 28, 2003).
In addition, in January 2003 (and prior to much of Respondent's
prescribing activity which continued until October 2006), the MBC
revoked a physician's medical license when he engaged in practices
similar to those of Respondent. See In re Steven Opsahl, M.D., Decision
and Order, at 3 (Med. Bd. Cal. 2003) (available by query at http://publicdocs.mbc.ca.gov/pdl/mbc.aspx).
In Opsahl, the MBC held that "[b]efore prescribing a dangerous
drug, a physical examination must be performed" and that a physician
"cannot do a good faith prior examination based on a history, a review
of medical records, responses to a questionnaire, and a telephone
consultation with the patient, without a physical examination of the
patient." Id. The MBC also held that a "medical indication" is
determined only after the taking of a history, the conducting of a
physical examination, and an assessment of "the patient's condition."
Id. The MBC further explained that "[a] physician cannot determine
whether there is a medical indication for prescription of a dangerous
drug without performing a physical examination." Id.
In April 2001, Ohio enacted a statute which defines
"telemedicine" as "the practice of medicine in this state through
the use of any communication, including oral, written, or electronic
communication, by a physician outside th[e] state" and also requires
that a physician obtain a "telemedicine certificate" to lawfully
prescribe within the State, id. Sec. 4731.296 (effective 4-10-01), and
a "special activity certificate." Id. Sec. 4731.294 (effective 4-10-
01). Moreover, in 2002, Ohio adopted a regulation which, except for in
circumstances not at issue here, prohibits the dispensing of controlled
substances "to a person who the physician has never personally
examined and diagnosed." Ohio Admin. Code Sec. 4731-11-09(A).
In 2002, Tennessee law prohibited (as it still does) the practice
of medicine within the State without a license issued by the State.
Tenn. Code Ann. Sec. 63-6-201(a) (2002); see also id. Sec. 63-6-204
(2002) (defining "a person [who is] regarded as practicing medicine"
as one "who treats, or professes to diagnose, treat, operate[] on or
prescribes for any physical ailment or any physical injury to or
deformity of another"). Like Ohio, Tennessee also provides for
"restricted licenses and special licenses based upon licensure to
another state for the limited purpose of authorizing the practice of
telemedicine." Id. Sec. 63-6-209(b) (1996). See also Tennessee Board
of Medical Examiners, Position Statement: Prerequisites to Prescribing
or Dispensing Drugs-In Person, Electronically or Over the Internet
(Sept. 2000) ("[I]t shall be a prima facie violation of [State law]
for a physician to prescribe or dispense any drug to any individual,
whether in person or by electronic means or over the Internet or over
telephone lines, unless the physician has first done and appropriately
documents, for the person to whom a prescription is to be issued or
drugs dispensed, all of the following: (a) Performed an appropriate
history and physical examination * * * ").\2\
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\2\ This statement likewise recognizes three situations in which
a drug may be prescribed without the physician having performed a
physical examination of the patient: (1) In admission orders for new
admitted hospital patients, (2) when covering for another physician,
and (3) on a short-term basis for a new patients prior to the
patient's first appointment. None of these applied to Respondent's
internet practice.
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[[Page 61155]]
Prior to Respondent's prescribing activity, Tennessee had also
promulgated a regulation which provided clear notice that, before
issuing a prescription for a controlled substance "by electronic means
or over the Internet or over telephone lines," a physician must
"[p]erform[] an appropriate history and medical examination,"
"[m]a[k]e a diagnosis based upon the examinations and all diagnostic
and laboratory tests consistent with good medical care,"
"[f]ormulate[] a therapeutic plan," and "[i]nsure[] availability of
the physician or coverage for the patient for appropriate follow-up
care." Tenn. Comp. R. & Regs. 0880-2-14.(7)(a) (2002).
In April 2000, the Alabama State Board of Medical Examiners
promulgated its "Contact with Patients before Prescribing" rule. The
rule states the Board's position:
that prescribing drugs to an individual the prescriber has not
personally examined is usually inappropriate. Before prescribing a
drug, the physician should make an informed medical judgment based
on the circumstances of the situation and on his or her training and
experience. Ordinarily, this will require that the physician perform
an appropriate history and physical examination, make a diagnosis,
and formulate a therapeutic plan, a part of which might be a
prescription.
Ala. Admin Code r.540-X-9.11(1). While the Alabama rule also recognizes
that in certain situations a prescribing physician is not required to
have performed a physical exam of the patient (such as admission orders
for a newly admitted patient, where the prescriber is taking call for
another physician, and where the prescriber continues medication "on a
short-term basis for a new patient prior to the patient's first
appointment"), none of these exceptions applied to Respondent's
internet prescribing. Id. r.540-X-9.11(2).
In February 2002, the Georgia Composite State Board of Medical
Examiners amended its regulation defining "Unprofessional Conduct" to
include "[p]roviding treatment and/or consultation recommendations via
electronic or other means unless the licensee has performed a history
and physical examination of the patient adequate to establish
differential diagnoses and identify underlying conditions and/or
contra-indications to the treatment recommended." Ga. Comp. R. & Regs.
360-3-.02 (2002). While the regulation provided an exception in the
case of a licensee who is on call or covering for another doctor, the
exception did not apply to Respondent's internet prescribing. See also
S.C. Code Reg. 81-28(A) (effective May 25, 2001) (requiring prescribing
physician to "[p]ersonally perform an appropriate history and physical
examination").
In addition, prior to Respondent's commencement of internet
prescribing, numerous state boards had issued policy statements which
made clear that this activity was unprofessional conduct and illegal.
For example, in November 1999, the North Carolina Medical Board issued
a position statement entitled "Contact With Patients Before
Prescribing" (available at http://www.ncmedboard.org/position_statements/detail/contact_with_patients_before_prescribing/).
Therein, the Board stated "that prescribing drugs to an individual the
prescriber has not personally examined is inappropriate" except in the
case of admission orders for newly hospitalized patients, taking call
for another physician, and on short-term basis prior to a patient's
first appointment. The Board further explained that "[o]rdinarily,
this will require that the physician perform an appropriate history and
physical examination, make a diagnosis, and formulate a therapeutic
plan, part of which might be a prescription."
In December 1999, the Texas State Board of Medical Examiners issued
its Internet Prescribing Policy. This Policy stated that "[i]t is
unprofessional conduct for a physician to initially prescribe any
dangerous drugs or controlled substances without first establishing a
proper physician-patient relationship." Texas State Board of Medical
Examiners, Internet Prescribing Policy (available at http://www.tmb.state.tx.us/rules/guidelines/ipp.php). The Policy further
explained that "at a minimum," this requires, inter alia, "verifying
that the person requesting the medication is in fact who they claim to
be," and "establishing a diagnosis through the use of accepted
medical practices such as a patient history, mental status exam,
physical examination and appropriate diagnostic and laboratory
testing." Id.
In May 2000, the Louisiana State Board of Medical Examiners issued
a Statement of Position on Internet/Telephonic Prescribing, which
stated "the Board's view, [that] it is unlawful for a physician to
prescribe medication, treatment or a plan of care generally if the
physician has not examined the patient and established a diagnostic
basis for such therapy." Louisiana State Board of Medical Examiners,
Statement of Position on Internet/Telephonic Prescribing, at 2
(available at http://www.lsbme.la.gov/Statements%20of%20position.html).
The Board further explained that:
A physician establishes a physician-patient relationship by:
- Verifying that the person requesting the medication is in
fact who they claim to be;
- Conducting an appropriate examination of the patient;
- Establishing a diagnosis through the use of accepted
medical practices, i.e., a patient history, mental status, examination,
physical examination and appropriate diagnostic and laboratory testing;
- Discussing with the patient the diagnosis, risks and
benefits of various treatment options; and
- Insuring the availability for appropriate follow-up care.
Id. at 2. The Louisiana Board further stated that "[a]s a matter of
law, to be valid, effective and lawful, each prescription or order for
medication must be issued or given by an authorized practitioner (i.e.,
a Louisiana licensed physician) with respect to an individually
identified patient, based on the practitioner's examination and
diagnosis of the patient." Id. at 3. Finally, the Board explained
that:
because the [State's] Medical Practice Act restricts the practice of
medicine to persons possessing a license issued by [it,] [a]n
individual who issues a prescription or orders medication for an
individual who is a resident of or located in Louisiana, who does
not possess a Louisiana medical license or other authorization to
practice medicine in this state, is necessarily engaged in the
unauthorized practice of medicine in contravention of the Medical
Practice Act.
Id.
Moreover, in November 2000, the Oklahoma State Board of Medical
Licensure and Supervision adopted its Policy on Internet Prescribing.
The Oklahoma Board adopted most of the same standards as the Louisiana
statement, including that "at a minimum," a physician must verify the
identity of a patient requesting medication and "establish[] a
diagnosis through the use of accepted medical practices such as a
patient history, mental status exam, physical examinations and
appropriate diagnostic and laboratory testing by the prescribing
physician." Oklahoma State Board of Medical Licensure and Supervision,
Policy on Internet Prescribing (available at http://www.
[[Page 61156]]
okmedicalboard.org/download/308/precribing+on+the+Internet.htm). The
Oklahoma Board also stated that "[c]omplete management of a patient by
Internet, e-mail, or other forms of electronic communications is
inappropriate." Id.; see also Washington Medical Quality Assurance
Commission, Position on Internet Prescribing (Winter 2001) (available
at http://www.doh.wa.gov/hsqa/mqac/policies.htm) ("The standard of
medical practice in the state of Washington requires a physician, when
prescribing medication to [inter alia,] verify that the person
requesting the medication is in fact who he or she claims to be," and
"establish a diagnosis through the use of accepted medical practices
such as a patient interview, physical examination, and appropriate
ancillary testing.").
To similar effect, in May 2000, the Mississippi State Board of
Medical Licensure issued a policy statement on Internet Prescribing.
The Mississippi policy stated that the "[e]ssential components of
proper prescribing and legitimate medical practice require that the
physician obtains a thorough medical history and conducts an
appropriate physical examination before prescribing any medication for
the first time." Mississippi State Board of Medical Licensure,
Internet Prescribing (available at http://www.msbml.state.ms.us/regulations/2004%20policy%20book.pdf). While the Mississippi Board
recognized exceptions for admission orders for newly hospitalized
patients, cross-coverage situations, and for short-term prescribing
prior to a new patient's first appointment, as noted previously, none
of these situations applied to Respondent's internet prescribing.
In December 2001, the Massachusetts State Board of Registration in
Medicine amended its Prescribing Practices Policy and Guidelines to
address the subject of Internet Prescriptions. The Board stated that
"a prescription to be legally valid must be issued within the context
of a physician-patient relationship under circumstances in which the
physician has conformed to certain minimum norms and standards for the
care of patients, such as taking an adequate medical history and
conducting an appropriate physical examination." Massachusetts State
Board of Registration in Medicine, Prescribing Practices Policy and
Guidelines, Internet Prescriptions (available at http://www.mass.gov/Eeohhs2/docs/borim/policies_guidelines/policy_03_06.pdf).\3\ The
Board further advised that "[p]rescribing over the internet while
deviating from these requirements is therefore unlawful." \4\
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\3\ The Board subsequently amended its policy on December 17,
2003; the amended policy did not change the requirement that the
prescribing physician must "conduct[] an appropriate physical"
examination. It further stated that "[i]ssuance of a prescription,
by any means, including the Internet or other electronic process,
that does not meet these requirements is therefore unlawful."
\4\ Other States adopted similar statutes, rules and/or policy
statements on Internet prescribing within the next several years and
well before Respondent ceased his internet prescribing. See Colorado
Board of Medical Examiners, Policy 40-9: Guidelines Regarding
Prescribing for Unknown Patients (Nov. 16, 2003) (available at
http://www.dora.state.co.us/medical/policies/40-09.pdf) ; Ind. Admin
Code 5-41 (Oct. 2003) ("Except in institutional settings, on-call
situations, cross-coverage situations, and situations involving
advanced practice nurses with prescriptive authority * * * a
physician shall not prescribe, dispense, or otherwise provide, or
cause to be provided, any controlled substance to a person who the
physician has never personally physically examined and
diagnosed."); New York State Board for Professional Medical
Conduct, Statements on Telemedicine (Dec. 24, 2003) (available at
http://www.health.ny.gov/professionals/doctors/conduct/telemedicine.htm.) ("All the current standards of care regarding
the practice of medicine apply. The fact that an electronic medium
is utilized for contact between parties or as a substitute for face-
to-face consultation does not change the standards of care.").
While these provisions were adopted after Respondent commenced his
Internet prescribing, Respondent had a continuing obligation to keep
track of the law as it changed.
In addition, as early as June 2001, DEA had revoked the
registration of a physician whose state controlled substance
registration and medical licenses had been suspended for prescribing
over the Internet. See Rick Joe Nelson, 66 FR 30752 (2001). This
same physician was ultimately indicted for conspiracy to distribute
controlled substances outside of the usual course of professional
practice, 21 U.S.C. 846, and convicted. See United States v. Nelson,
383 F.3d 1227 (10th Cir. 2004). Of note, his conviction was affirmed
(in a published decision) on September 20, 2004, more than two years
before Respondent left the clinic. See also Mark Wade, 69 FR 7018,
7021 (Feb. 12, 2004) (revoking registration of Internet prescriber
and noting physician had pled guilty to violation of 21 U.S.C. 846).
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At the instant hearing, Respondent did not testify as to any state
laws or Board positions (with the exception of Florida) he found which
authorized prescribing to patients he would not meet, based on a review
of records and a telephone consultation. Instead, he maintained that
"as part of [his] due diligence" in deciding whether to engage in
Internet prescribing, he reviewed the Model Guidelines for the
Appropriate Use of the Internet in Medical Practice (RX 9), a policy
document issued by the Federation of State Medical Boards of the United
States (FSMB). Tr. 76-77. Respondent testified that this document gave
him the impression that Attorney Carr's advice that Internet
prescribing was legal was accurate "because it specifically says the
physician/patient relationships exists whether or not there has been a
personal encounter between the physician and the patient," and that
this was "[b]lack and white."
The fact that a physician-relationship "is clearly established
when a physician agrees to undertake diagnosis and treatment," RX 9,
at 7, however, does not mean that a physician has established an
adequate physician-patient relationship sufficient to support the
diagnosis of a patient and the issuance of a prescription. Indeed, the
Guidelines further state that "[t]reatment and consultation
recommendations made in an online setting, including issuing a
prescription via electronic means, will be held to the same standards
of appropriate practice as those in traditional (face-to-face)
settings." Id. at 8. At the hearing, Respondent offered no explanation
as to what he thought this statement meant.
Just one page later, the Guidelines further state that
"[p]hysicians who treat or prescribe through Internet Web sites are
practicing medicine and must possess appropriate licensure in all
jurisdictions where patients reside." Id. at 9. Respondent admitted
that during the period of his internet prescribing, he was licensed
only in the State of Florida. Respondent thus engaged in the
unauthorized practice of medicine in numerous States. As the California
Court of Appeals has explained, the "proscription of the unlicensed
practice of medicine is neither an obscure nor an unusual state
prohibition of which ignorance can reasonably be claimed, and certainly
not by persons * * * who are licensed health care providers. Nor can
such persons reasonably claim ignorance of the fact that authorization
of a prescription pharmaceutical constitutes the practice of
medicine." Hageseth v. Superior Court, 59 Cal. Rptr.3d 385, 403 (Ct.
App. 2007).
Respondent's assertion that he relied on the FSMB Guidelines and
yet "couldn't find anybody saying * * * for definite that you cannot
do this," Tr. 60, is especially remarkable given that the Guidelines
included a list of References. RX 9, at 11. Among the authorities cited
therein are the position/policy statements of the Boards of Louisiana,
New York, North Carolina, Oklahoma, South Carolina, Texas and
Washington State, each of which--as discussed above--provided ample
notice that each of these Board's considered internet prescribing to
violate the accepted standards of professional practice.\5\ In
[[Page 61157]]
short, Respondent's assertion that he did "a little research" is an
accurate statement only to the extent that emphasis is placed on the
word "little."
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\5\ In April 2001, DEA published a Guidance Document entitled
Dispensing and Purchasing Controlled Substances over the Internet,
66 FR 21181 (2001). The Guidance explained that "[o]nly
practitioners acting in the usual course of their professional
practice may prescribe controlled substances. These practitioners
must be registered with DEA and licensed to prescribe controlled
substances by the State(s) in which they operate." Id. at 21181
(emphasis added).
In addition, the Guidance Document specifically stated that
"Federal law requires that '[a] prescription for a controlled
substance to be effective must be issued for a legitimate medical
purpose by an individual practitioner acting in the usual course of
his professional practice.' " Id. at 21182 (quoting 21 CFR
1306.04(a)). The Guidance explained that "[e]very state separately
imposes the same requirement under its laws" and that "[u]nder
Federal and state law, for a doctor to be acting in the usual course
of professional practice, there must be a bona fide doctor/patient
relationship." Id.
Continuing, the Guidance explained that "[f]or purposes of
state law, many state authorities, with the endorsement of medical
societies, consider the existence of the following four elements as
an indication that a legitimate doctor/patient relationship has been
established:
A patient has a medical complaint;
A medical history has been taken;
A physical examination has been performed; and
Some logical connection exists between the medical complaint,
the medical history, the physical examination, and the drug
prescribed.
Id. at 21182-83.
The Guidance further stated that "[c]ompleting a questionnaire
that is then reviewed by a doctor hired by the internet pharmacy
could not be considered the basis for a doctor/patient
relationship." Id. at 21183.
While the DEA Guidance Document does not have the force and
effect of law, it nonetheless provided an additional source of
information as to the potential illegality of Respondent's Internet
prescribing.
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Respondent also asserts that a February 27, 2002 letter from the
Chief of the DEA's Office of Diversion Control's Liaison and Policy
Section to Carr, "g[ave] permission to do it." Tr. 60; see also RX 4.
According to Respondent, Carr showed him the letter which "seemed very
convincing" and that the letter "basically said they [DEA] were okay
with it." Tr. 90-91.
While the letter stated "[i]t appears that the submitted policies
and procedures meet the federal requirements regarding controlled
substances prescriptions," it further noted that the pharmacy had
represented that under its policies, it "plans to verify the
authenticity and legal authority to prescribe of each prescriber." RX
4, at 1. More specifically, the letter noted that "[m]anagement
personnel will verify several elements including, but not limited to *
* * [p]rofessional licensure, DEA registration, [l]egitimate patient/
prescriber relationship, [p]rescriptions are issued in the usual course
of professional practice, and [p]rescriptions are issued for a
legitimate medical purpose." Id. (emphasis added). Continuing, the
letter noted "valid controlled substance prescriptions must be issued
for a legitimate medical purpose," and that "this is usually defined
and interpreted by the prescriber's respective state professional
licensing board." \6\ Id.
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\6\ As explained above, this was not an entirely accurate
statement of the law with regards a physician's prescribing to
patients who reside in a different State. As the Model Guidelines
explained, most (if not all) States deem prescribing to a resident
to be practicing medicine within the State, and thus, a physician
doing so is subject to both the licensing and medical practice
standards of the patient's State and the physician's State. See RX
9, at 9; see also discussion above.
However, Respondent produced no evidence showing that Carr, in
requesting DEA's review of its policies, disclosed to the Agency
that the doctors whose prescriptions it filled would be practicing
medicine across state lines. See RX 3. Moreover, even if Respondent
relied on the Florida Telemedicine Regulation, and even conceding
that the regulation did not clearly state on its face that the
prescriber (as opposed to another doctor) must perform a physical
exam, see Fla. Admin. Code r.64B15-14.008(2), having claimed to have
reviewed the Model Guidelines (and having previously been licensed
in other States), Respondent cannot credibly claim ignorance of the
fact that the regulation of the practice of medicine is a state
function and that each State has its own Board and set of rules with
which he was required to comply. See, e.g., Hageseth, 59
Cal.Rptr.3d, at 403.
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Thus, contrary to Respondent's claim, the DEA letter did nothing
more than address the lawfulness of the pharmacy's dispensing of
prescriptions and did so based on Carr's representation that the
underlying prescriptions would be lawfully issued. The letter thus
provides no comfort to Respondent.
As for his reliance on Carr's purported legal advice, Respondent
stated that he "assumed the lawyer would give me his honest opinion
and expertise and I wouldn't have to go around consulting three or four
of them to get the same thing." Tr. 60-61. Yet Respondent acknowledged
that he knew Carr had a financial interest in the pharmacy. Id. at 61.
Given Carr's financial interest, and even assuming (without deciding)
that Carr and Respondent entered into an attorney-client relationship,
Respondent had ample reason to question whether Carr was capable of
providing disinterested legal advice. Id. at 60-61. Moreover, Carr's
advice was fundamentally at odds with various statements contained in
the Model Guidelines, a document which Respondent purportedly read,
including the statements that: (1) "[t]reatment and consultation
recommendations made in an online setting, including issuing a
prescription via electronic means, will be held to the same standards
of appropriate practice as those in traditional (face-to-face)
settings"; and (2) "[p]hysicians who treat or prescribe through
Internet Web sites are practicing medicine and must possess appropriate
licensure in all jurisdictions where patients reside." RX 9, at 8-9.
Thus, because it is clear that Respondent did not reasonably rely on
Carr's advice, this is not a mitigating factor.
Finally, Respondent asserts that his cooperation in the proceeding
involving United Prescription Services, Inc., 72 FR 50397 (2007),
should be considered as a factor in mitigation. Resp. Br. 25. The
Government did not dispute that Respondent provided testimony and an
affidavit in that matter that was of some benefit to the Government.
Tr. 78.
That being said, I conclude that Respondent's cooperation is
substantially outweighed by the extensive and egregious misconduct he
committed. As the ALJ found, with the exception of a period of several
months during which he was on a leave of absence, see GX 10, at 85; for
more than four years, Respondent wrote thousands of controlled
substances prescriptions outside of the usual course of professional
practice and which lacked a legitimate medical purpose. ALJ at 54, 60;
see also 21 CFR 1306.04(a).
While this is reason alone to reject's Respondent cooperation as a
mitigating factor, in addition, the ALJ also found that Respondent
flagrantly failed to supervise a Physician Assistant, who wrote
thousands of controlled substance prescriptions under his registration.
ALJ at 65. As the ALJ found, the PA wrote 14,000 prescriptions, many of
which were for controlled substances, during the period in which
Respondent was on leave of absence. Id. Upon his return in March 2004,
Respondent discovered that the PA had written some controlled substance
prescriptions in his name, Tr. 38, 139; a violation of both state and
federal law. See Fla. Sta. Ann. Sec. 459.022(4)(e) (prohibiting PAs
from prescribing controlled substances); 21 U.S.C. 843(a)(2)
(prohibiting dispensing of a controlled substance by use of a
registration number "issued to another person"); id. Sec. 822(a)(2)
(requiring "[e]very person who dispenses" to obtain a registration).
The evidence showed that Respondent was upset that the PA was
writing prescriptions under his registration without complying with his
instructions and could not be controlled. Tr. 139. Respondent
complained to the clinic's owner "about [the PA's] prescribing
patterns using [his] DEA registration," RX 12, at 4; and asked him to
fire the PA several times; however, the clinic's owner refused to
[[Page 61158]]
do so.\7\ Tr. 37-38; see GX 10, at 106. Nonetheless, Respondent
continued to work for the clinic and did so for more than another year.
Notwithstanding Respondent's professed concern that the PA "was being
pretty arrogant [and] doing a lot of things on his own," Tr. 121, and
his awareness of the PA's prescribing irregularities, RX 12, at 4;
Respondent offered no evidence that he had reported the PA to either
law enforcement or regulatory authorities. This provides an additional
reason to reject Respondent's cooperation as a ground for mitigating
the sanction.
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\7\ In an affidavit given in the United Prescription Services
proceeding, Respondent stated that the clinic owner removed the PA
from the clinic. RX 12, at 4. However, in both the united and
instant proceedings, Respondent testified that the clinic owner
"would never fire [the PA], no matter how many times I requested
it." GX 10, at 106; Tr. 37. Respondent also testified the PA "was
kept away from me," TR.101, and that the PA would frequently work
from home.
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In conclusion, the record here establishes that over the course of
more than four years, Respondent was responsible for the issuance of
thousands of illegal controlled-substance prescriptions. Respondent's
misconduct was egregious, and the Agency's interest in deterring
similar misconduct on the part of others provides ample justification
to support the ALJ's recommended order. See Joseph Gaudio, 74 FR 10083,
10094 (2009); Southwood Pharmaceuticals, Inc., 72 FR 36487, 36504
(2007) (citing Butz v. Glover Livestock Commission Co., Inc., 411 U.S.
182, 187-88 (1973)).
Moreover, as the ALJ explained, while at the hearing, Respondent
occasionally acknowledged some wrongdoing, most of his testimony was
then spent on blaming others or offering absurd or disingenuous
justifications for his egregious misconduct. See ALJ at 65 (discussing
verification of internet customers' identities--"I'm relying on the
state that issued their driver's license attesting their identity. If
the state did not adequately check their identity before issuing them a
driver's license, then * * * I had no way of determining that. * * * I
used the same method of checking their identity' as I would if they
were present in front of me."). See also id. at 66-67 (finding that
"rather than admit that * * * his telemedicine practices were in clear
violation of contemporaneous standards * * * Respondent * * * attempted
to cast doubt on the clarity of the rules."); id. at 68 (comparing
Respondent's testimony that he was "sorry" for the prescriptions but
then stating that "if I thought I was doing anything wrong, I wouldn't
have done it"); id. (stating that he was remorseful, but adding "I
sincerely wish I had never been duped into being any part of their
operation at all").
In sum, as the ALJ found, Respondent "fail[ed] to sustain his
burden to credibly accept responsibility for his misconduct and
demonstrate that he will not engage in future misconduct." ALJ at 71.
Accordingly, I will adopt the ALJ's recommended sanction.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) &
824(a)(4), as well as by 28 CFR 0.100(b), I order that DEA Certificate
of Registration BR5287342, issued to Robert Raymond Reppy, D.O., be,
and it hereby is, revoked. I further order that any application for
renewal or modification of such registration be, and it hereby is,
denied. This Order is effective November 2, 2011.
Dated: September 19, 2011.
Michele M. Leonhart,
Administrator.
D. Linden Barber, Esq., for the Government.
A.S. Weekley, Jr., M.D., Esq., for Respondent.
Recommended Ruling, Findings of Fact, Conclusions of Law and Decision
of the Administrative Law Judge
I. Introduction
Timothy D. Wing, Administrative Law Judge. This proceeding is an
adjudication pursuant to the Administrative Procedure Act (APA), 5
U.S.C. 551 et seq., to determine whether the drug enforcement
administration (DEA) should revoke a physician's certificate of
registration (COR) as a practitioner and deny any pending applications
for renewal or modification of that registration. Without this
registration the practitioner Robert Raymond Reppy, D.O. (Respondent or
Dr. Reppy), of Tampa, Florida, will be unable to lawfully prescribe,
dispense or otherwise handle controlled substances in the course of his
practice.
On April 28, 2009, the DEA Deputy Assistant Administrator, Office
of Diversion Control, issued an Order to Show Cause (OSC) to
Respondent, giving Respondent notice of an opportunity to show cause
why the DEA should not revoke Respondent's DEA COR BR5287342 pursuant
to 21 U.S.C. 824(a)(4), and deny any pending applications for renewal
or modification pursuant to 21 U.S.C. 823(f), on the grounds that
Respondent's continued registration would be inconsistent with the
public interest as that term is used in 21 U.S.C. 824(a)(4) and 823(f).
In substance, the OSC alleges as follows:
1. Respondent has a DEA COR scheduled to expire by its own terms on
April 30, 2009;
2. Respondent issued prescriptions to Internet customers from early
2004 until October 2006;
3. Respondent allowed a physician's assistant (PA) to use
Respondent's COR to issue purported prescriptions to Internet
customers, in violation of 21 U.S.C. 846 and Fla. Stat. Ann. Sec.
458.347 (2008);
4. The above-referenced prescriptions were issued without a
legitimate medical purpose and outside the usual course of professional
practice, in violation of 21 CFR 1306.04(a) and 21 U.S.C. 841(a)(1);
5. Respondent issued purported prescriptions of controlled
substances to customers throughout the United States even though
Respondent is licensed to practice medicine only in Florida;
6. The above-referenced prescriptions violated state laws
prohibiting the unauthorized practice of medicine, including
unlicensed, out-of-state physicians issuing controlled substance
prescriptions to state residents. See e.g., Miss. Code Ann. Sec. 73-
25-34; Cal. Bus. & Prof. Code Sec. 2052; Ala. Code Sec. 34-24-51; and
7. Respondent violated Florida law and regulations prohibiting
licensed physicians from issuing controlled substance prescriptions in
excessive or inappropriate quantities, from issuing prescriptions via
the Internet without documented patient evaluation and without
discussing treatment options with patients. Fla. Stat. Ann. Sec.
458.331(q); Fla. Admin. Code Ann. r. 64B8-9.014.
On May 26, 2009, Respondent, through counsel, requested a hearing
on the allegations in the OSC.\8\ Following prehearing procedures,\9\ a
hearing was held on November 16, 2010, in Bradenton, Florida, with both
the Government and Respondent represented by counsel. Both parties
called witnesses to testify and introduced documentary evidence. After
the hearing, both parties filed proposed findings of fact, conclusions
of law and argument. All of the evidence and post-hearing submissions
have been considered, and to the extent the parties' proposed findings
of fact have
[[Page 61159]]
been adopted, they are substantively incorporated into those set forth
below.
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\8\ Respondent submitted an application to renew his COR on
April 6, 2009. (ALJ Ex. 3 at 1.)
\9\ This case was originally assigned to Administrative Law
Judge Mary Ellen Bittner. (See, e.g., OPHS May 27, 2009.) On January
15, 2010, Administrative Law Judge Gail A. Randall was assigned to
the case. (Mem. Jan. 15, 2010.) Judge Randall reassigned the case to
me on July 19, 2010. (Mem. Jul. 19, 2010.)
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II. Preliminary Evidentiary Issues
Prior to discussing the evidence and reaching the substantive
issues in this case, a threshold evidentiary issue is the weight to be
given, if any, to (1) the Deputy Administrator's conclusions of law
regarding Dr. Reppy's compliance with state law contained in United
Prescription Services, Inc., 72 FR 50,397 (DEA 2007), a separate
proceeding in which Dr. Reppy was a witness but not a party; (2) a
transcript of Dr. Reppy's sworn testimony in that case, admitted
without objection as Government Exhibit 10 in the present proceeding;
and (3) affidavits of Respondent's current employees and patients
offered as Respondent's Exhibit 19, and an affidavit of Respondent
offered as Respondent's Exhibit 13.
A. The 2007 Final Order in United Prescription Services, Inc.
On August 23, 2007, the Federal Register published a final order in
United Prescription Services, Inc., 72 FR 50,397 (DEA 2007). Therein,
the then-Deputy Administrator made legal conclusions touching upon the
conduct of Dr. Reppy, who testified in that case but was not named as a
party. The Deputy Administrator found that "Dr. Reppy violated the
laws of California, Tennessee, Indiana, and Louisiana" because
"[e]ven if Dr. Reppy's * * * conduct established a valid doctor-
patient relationship under Florida law (a dubious proposition at that),
[he] violated the laws of other States which clearly require that the
prescriber personally perform the physical exam except in limited
situations not applicable here." United Prescription Servs., 72 FR at
50,408 (internal citations omitted). The Deputy Administrator also
concluded that Dr. Reppy's PA, Mr. Protheroe, "used Dr. Reppy's DEA
registration while Reppy was on leave of absence and not supervising
him * * *. These prescriptions violated the State of Florida's
regulations" regarding Dr. Reppy's delegation of authority to a
PA.\10\ Id. at 50,409.
---------------------------------------------------------------------------
\10\ Specifically, United Prescription Services cites Fla.
Admin. Code Ann. r. 64B8-30.008(2). See 72 FR at 50,409. As
discussed below, that rule is inapplicable to Dr. Reppy because he
is an osteopathic physician; the applicable rule (which is textually
identical) is r. 64B15-6.0038. Infra text following note 63.
---------------------------------------------------------------------------
In the "proposed conclusions of law" section of the Government's
post-hearing brief in the present case, the Government cites a number
of such conclusions by the Deputy Administrator, apparently arguing
that I should give weight to those conclusions here. (See Gov't Br. 5-6
(discussing Factors Two and Four of 21 U.S.C. 823(f)).)
At issue, therefore, is whether legal conclusions from a prior
proceeding relating to the conduct of a non-party witness should be
given weight or controlling effect in a subsequent proceeding against
the witness. I note at the outset that Dr. Reppy was not named as a
party in United Prescription Services, had not yet had any adverse
action taken against him by the DEA with respect to his COR (see Gov't
Ex. 10 at 61), and was apparently unrepresented by counsel at the time.
The APA provides that "[t]he transcript of testimony and exhibits,
together with all papers and requests filed in the proceeding,
constitutes the exclusive record for decision" in this administrative
proceeding. 5 U.S.C. 556(e). The APA further defines "party" to
include a person or agency named or admitted as a party, or properly
seeking and entitled as of right to be admitted as a party * * *." 5
U.S.C. 551(3), amended by Public Law 111-350, Jan. 4, 2011, 124 Stat.
3677 (no relevant changes) ("party[] in an agency proceeding"). In
the instant case, the final Agency decision in United Prescription
Services cannot serve as substantial evidence because it is not part of
the "exclusive record for decision" to which Dr. Reppy was a
party.\11\ I therefore find that the APA precludes me from considering
the individualized legal conclusions on the ultimate issues\12\
regarding Dr. Reppy contained in United Prescription Services as a
potential basis for imposing a sanction in this case.\13\ See id. Sec.
556(e).
---------------------------------------------------------------------------
\11\ Although the Government offered the United Prescription
Services decision as an exhibit in its January 19, 2010 supplemental
prehearing statement (Gov't Supp. PHS at 5), it withdrew the exhibit
at hearing (see Tr. 6-7).
\12\ As used herein, "ultimate issues," also called "mixed
questions of law and fact" and "deep issues," are distinguishable
from precedential holdings of general applicability.
\13\ I do not suggest that United Prescription Services is
without binding effect as Agency precedent with respect to its
holdings of general applicability. See, e.g., supra Section VI(C)(c)
(citing United Prescription Services for the proposition that state
law controls the question of whether a doctor-patient relationship
exists).
---------------------------------------------------------------------------
I further find that the doctrine of res judicata, or collateral
estoppel, provides no basis for adopting without analysis the Deputy
Administrator's findings in United Prescription Services that Dr. Reppy
violated state law. Under the doctrine of res judicata, (1) a final
judgment (2) on the merits (3) between the parties is binding on the
parties in subsequent litigation. See, e.g., Restatement (Second) of
Judgments Sec. 24; Black's Law Dictionary (9th Ed.) (res
judicata).\14\ Agency precedent has acknowledged the Supreme Court's
recognition of the applicability of the res judicata doctrine in DEA
administrative proceedings. Christopher Henry Lister, P.A., 75 FR
28,068, 28,069 (DEA 2010) (citing Univ. of Tenn. v. Elliot, 478 U.S.
788, 797-98 (1986) ("When an administrative agency is acting in a
judicial capacity and resolves disputed issues of fact properly before
it which the parties have had an adequate opportunity to litigate, the
courts have not hesitated to apply res judicata * * *")).
---------------------------------------------------------------------------
\14\ Accord, e.g., Ritch v. State, 14 So.3d 1104, 1107 n.5 (Fla.
App. 1 Dist. 2009) ("Collateral estoppel bars relitigation of an
issue only when (1) an identical issue was presented in the prior
proceeding; (2) the issue was a critical and necessary part of the
prior determination; (3) there was a full and fair opportunity to
litigate that issue; (4) the parties in the two proceedings are
identical; and (5) the issue was actually litigated.").
---------------------------------------------------------------------------
It is conceded that the Deputy Administrator's conclusions in
United Prescription Services concerning Dr. Reppy's compliance with
state law, including the extent of his supervision of his PA, went to
the merits of that decision, and that the decision constituted the
Agency's final order. However, Dr. Reppy was not a party to that
proceeding. See 5 U.S.C. 551(3), amended by Public Law 111-350, Jan. 4,
2011, 124 Stat. 3677 (no relevant changes) (the term "'party' includes
a person or agency named or admitted as a party, or properly seeking
and entitled as of right to be admitted as a party"). Indeed, as the
United States Court of Appeals for the Fifth Circuit found before that
Circuit split into the Fifth and Eleventh Circuits, "the offensive use
of collateral estoppel calls for the courts to use special care in
examining the circumstances to ascertain that the defendant has in fact
had a full and fair opportunity to litigate and that preclusion will
not lead to unjust results." \15\ Johnson v. United States, 576 F.2d
606, 614 (5th Cir. 1978). After carefully examining the circumstances,
I conclude that when the Agency issued the final order in United
Prescription Services, Dr. Reppy had not been afforded a full and fair
opportunity to litigate whether he violated the laws of California,
Tennessee, Indiana, Louisiana and Florida. Res judicata is therefore
inapplicable. See East Main Street Pharmacy, 75 FR 66,149, 66,154
[[Page 61160]]
n.24 (DEA 2010) ("While I previously found [in a prior decision that a
patient] had died of multiple drug intoxication and had both oxycodone
and alprazolam in her system, Respondent was not a party to that
proceeding. The Government was thus required to prove this fact anew *
* *." (internal citations omitted)).
---------------------------------------------------------------------------
\15\ In Bonner v. City of Prichard, 661 F.2d 1206, 1209 (11th
Cir. 1981) (en banc), the United States Court of Appeals for the
Eleventh Circuit adopted as binding precedent all decisions of the
former Fifth Circuit handed down prior to October 1, 1981.
---------------------------------------------------------------------------
For the foregoing reasons, I find that the Deputy Administrator's
finding in a prior case to which Dr. Reppy was not a party that "Dr.
Reppy violated the laws of California, Tennessee, Indiana, Louisiana"
and Florida, 72 FR at 50,408-09 (internal citations omitted), does not
constitute substantial evidence in the above-captioned proceeding, and
I give that finding no weight in this Recommended Decision.\16\
---------------------------------------------------------------------------
\16\ Compare supra note 13.
---------------------------------------------------------------------------
B. Respondent's Prior Testimony
In its January 19, 2010 supplemental prehearing statement (Gov't
Supp. PHS at 5), the Government noticed its intention to offer into
evidence a transcript of Dr. Reppy's testimony in United Prescription
Services, Inc., 72 FR 50,397 (DEA 2007). Dr. Reppy was not a named
party in that proceeding, had not yet had any adverse action taken
against him by the DEA with respect to his COR (see Gov't Ex. 10 at 61)
and at the time was apparently unrepresented by counsel. In the present
case, on consent of the parties,\17\ I admitted the transcript of Dr.
Reppy's former testimony. (Tr. 126-27.) A preliminary issue in this
Recommended Decision is what weight, if any, to give to that testimony.
---------------------------------------------------------------------------
\17\ Counsel for Respondent asked Respondent a series of
questions regarding whether his former testimony included various
topics and was accurate; Respondent answered in the affirmative.
(Tr. 78-80.)
---------------------------------------------------------------------------
The APA provides that final determinations in Agency administrative
proceedings must be based upon "reliable, probative and substantial
evidence." 5 U.S.C. 556(d). In addition, I may consider "evidence
that is competent, relevant, material and not unduly repetitious." 21
CFR 1316.59(a) (2010). Where prior testimony from a previous proceeding
is reliable, probative, material and not unduly repetitious, Agency
precedent supports the admission of such testimony. See United
Prescription Servs., Inc., 72 FR 50,397, 50,403 (DEA 2007) (crediting
documentary evidence containing substance of witness's prior testimony
"[i]n another proceeding"); see also Nestor A. Garcia, M.D., 61 FR
30,099, 30,100 (DEA 1996) (giving weight to witness's testimony at
hearing that recounted witness's former testimony before state medical
board).
Here, the transcript of Respondent's previous testimony in United
Prescription Services is reliable insomuch as it contains Respondent's
sworn testimony at a formal administrative hearing (see Tr.127
(referring to what Respondent said "under oath")) and Respondent
testified at the present proceeding that his former testimony was
accurate, true and correct.\18\ (Tr. 80.) Moreover, Respondent gave the
prior testimony in 2007, closer in time to the events at issue in the
present case, presenting an increased chance that his memory accurately
reflected the events.\19\ The transcript of Respondent's prior
testimony is probative and material to the extent it addresses matters
at issue in the present proceeding, to include without limitation the
state(s) in which Respondent held a medical license from 2004 to 2006
(Gov't Ex. 10 at 69); the relationship between witnesses and between
the clinic and pharmacy at which Respondent allegedly worked and had
prescriptions filled, respectively (Gov't Ex. 10 at 10, 42, 55, 65, 74-
77, 82, 89); the evolving ownership and name of the clinic at which
Respondent allegedly worked (Gov't Ex. 10 at 6, 9, 46); the extent of
Respondent's supervision of a PA (Gov't Ex. 10 at 84-85, 95-97, 101,
106); the practices of Respondent with respect to patient evaluation
and treatment (Gov't Ex. 10 at 12, 25-26, 30, 73-74, 77, 78-80, 93-94);
and other topics. Finally, although the transcript of Respondent's
prior testimony covers many of the topics he addressed in his testimony
at hearing, I find that it is not unduly repetitious and that any
repetition is offset by its probative value.
---------------------------------------------------------------------------
\18\ I draw a distinction between reliability, on the one hand,
and accuracy, on the other. Although I find that Respondent's prior
testimony in United Prescription Services is reliable, only a
balancing of the transcript against other evidence in this case can
shed light on whether it is accurate.
\19\ As noted throughout this Recommended Decision, I also find
that statements contained in the transcript of Respondent's prior
testimony are generally consistent with Respondent's testimony at
hearing.
---------------------------------------------------------------------------
For the foregoing reasons, I find it proper to give weight to
relevant portions of the transcript of Respondent's prior testimony in
University Prescription Services. (See Gov't Ex. 10.)
C. Affidavits of Respondent's Employees, Respondent's Patients and
Respondent
The parties stipulated at hearing to the admission of affidavits of
Respondent's employees Adele Durina and Janice Viscio and his patients
"[C.K.]" \20\ and "[D.C.]," who did not testify in person. (Tr.
166.) In addition, Respondent testified at hearing that, pursuant to
his prior testimony in United Prescription Services, he provided an
affidavit beneficial to the Government, which he signed. (Tr. 78.)
Respondent further testified that Respondent's Exhibit 12 is an
unsigned copy of that affidavit. (Tr. 78.) By stipulation of the
parties, I admitted Respondent's affidavit. (Tr. 7-9; see Resp't Ex.
12.)
---------------------------------------------------------------------------
\20\ To protect the privacy of Respondent's patients, only
initials are used.
---------------------------------------------------------------------------
An issue is what weight, if any, to give these affidavits.
Because the patient and employee affidavits address Respondent's
professional conduct since the conduct alleged in the OSC, they are
relevant to the issue of whether Respondent is currently in compliance
with state and federal standards for the prescribing and practice of
controlled substances. Moreover, the contents of Respondent's affidavit
also bear on matters directly relevant to this case, to include his
employment and the extent of his supervision of his PA, John Protheroe,
among other topics. Finally, the Government stipulates and does not
object to the admission of any of the affidavits. I therefore find it
proper to give weight to relevant portions of affidavits of Respondent
and Respondent's employees and patients. See 5 U.S.C. 556(d); 21 CFR
1316.59(a) (2010).
III. Substantive Issue
Whether a preponderance of the evidence establishes that, pursuant
to 21 U.S.C. 824(a)(4), Respondent's DEA COR BR5287342 should be
revoked and any pending applications for renewal or modification
denied, because Respondent's continued registration would be
inconsistent with the public interest as that term is used in 21 U.S.C.
823(f).
IV. Evidence and Incorporated Findings of Fact
I find, by a preponderance of the evidence, the following facts:
A. The Clinic and the Pharmacy
Significant testimony at hearing related to Respondent's connection
with two entities: University Physicians Resources (UPR), a medical
clinic, and United Prescription Services (UPS), a pharmacy. (See, e.g.,
Tr. 23.)
[[Page 61161]]
B. The Witnesses and Affiants \21\
Respondent Robert Raymond Reppy, D.O., is licensed as an
osteopathic physician in the State of Florida pursuant to license
number OS7246. (Tr. 20; Gov't Ex. 15 at 1.) His licensure status is
Obligation/Active.\22\ (ALJ Ex. 3 at 1.) Although Respondent was
previously licensed to practice medicine in Georgia, California and
Hawaii, since 2000 he has only been licensed in Florida. (Tr. 20-21;
Gov't Ex. 10 at 69.) Respondent is registered with the DEA as a
practitioner in Schedules II through V pursuant to DEA COR BR5287342.
(ALJ Ex. 3 at 1.) Respondent's COR was scheduled to expire by its terms
on April 30, 2009. On April 6, 2009, DEA received Respondent's
application for renewal.\23\ (ALJ Ex. 3 at 1.)
---------------------------------------------------------------------------
\21\ In its prehearing statement and supplements thereto, the
Government identified Diversion Investigator Peter W. Flagg, Special
Agent Daniel A. Forde, Diversion Investigator Deborah Y. Butcher,
and Respondent as witnesses. At hearing, however, the Government
rested upon the testimony of Respondent alone, along with the
exhibits it introduced into evidence. Moreover, Respondent's counsel
did not conduct a separate direct examination of Respondent during
Respondent's case-in-chief. Instead, I permitted counsel to expand
the scope of cross examination.
\22\ Respondent's Curriculum Vitae (CV) facially contradicts
this stipulation, stating that Respondent's Florida medical license
expired on March 31, 2008. The CV, however, appears to be outdated,
notwithstanding Respondent's representation in his post-hearing
brief that it is "accurate" (Resp't Br. at 2) and his argument
that I accept evidence that is uncontroverted (Resp't Br. at 26-27).
For instance, the CV indicates that Respondent is presently employed
at UPR (Resp't Ex. 10 at 4), despite the otherwise uncontroverted
testimony at hearing that Respondent stopped working at UPR in 2006.
(Tr. 21-23, 51.) In light of this and other evidence concerning the
status of Respondent's state medical license, I find that the weight
of the evidence contradicts any inference that Respondent lacks
state authority to handle controlled substances in Florida.
\23\ Pursuant to 5 U.S.C. 558(c), Respondent's COR continues in
effect until DEA takes final action on the renewal application.
(See, e.g., ALJ Ex. 3.)
---------------------------------------------------------------------------
Respondent's witness Robert Arthur Carr, Esq. (Mr. Carr) is an
attorney who has worked in the area of medical malpractice for twenty
years. (Tr. 143.) He is not a physician and has no medical training.
(Tr. 156-57; see also Tr. 61.) Mr. Carr testified that he knew
Respondent when he worked at UPS. (Tr. 142.) Mr. Carr stated that he
had no ownership interest in UPR, but at one point he did have a
financial interest in UPS.\24\ (Tr. 151-52; see Resp't Ex. 5.) Every
prescription filled by UPS represented revenue for Mr. Carr. (Tr. 152.)
---------------------------------------------------------------------------
\24\ In his testimony at a prior proceeding, Respondent
testified that a Mr. Jerome Carr and a Mr. Rob Carr were listed as
president of UPS in 2003. (Gov't Ex. 10 at 76, 89.) The
inconsistency was never explained.
---------------------------------------------------------------------------
Respondent's witness Melissa Messick, also known as Missy Messick
(see Tr. 67-68) (Ms. Messick), was employed by UPS from 2001 to 2005.
(Tr. 129, 132.) She testified that she was in a position to observe
Respondent's work. (Tr. 129.) Ms. Messick is not a medical practitioner
and lacks legal or medical training. (Tr. 135.) In a prior proceeding,
Respondent testified that a "Ms. Messich" presently owns UPR. (Gov't
Ex. 10 at 10; see also id. at 76-77.)
Respondent's affiant Janice Vischio (Ms. Vischio) has been a LPN
\25\ for twenty years, of which she has spent fifteen years in Florida.
Her license is in good standing with the Florida Department of Health.
As of July 15, 2010, she had worked with Respondent for at least
eighteen months. (See Resp't Ex. 19 at 2.) Ms. Vischio handles
administrative work for Respondent and does not see patients. (Id. at ]
3.)
---------------------------------------------------------------------------
\25\ Although the record in this case is silent, various
provisions of federal law define the term "LPN" as "licensed
practical nurse." See, e.g., 32 CFR 199.2; 42 CFR 482.51(a)(2).
---------------------------------------------------------------------------
Respondent's affiant Adele Durina (Ms. Durina) has over twenty
years of medical office experience and presently works as Respondent's
Office Manager and Medical Assistant. (Resp't Ex. 19 at 6 ] 2.) As of
as late as July 15, 2010, Ms. Durina had worked with Respondent since
he began working at Cosmopolitan Clinic. (Id. at ] 3; see also Tr.
167.)
As of July 15, 2010, [C.K.] has been a patient of Respondent since
Respondent began practicing in the local area and [D.C.] had been a
patient of Respondent for approximately thirteen to fourteen months for
the treatment of degenerative spondylosis. (Resp't Ex. 19 at 12 ] 2;
id. at 9 ]] 1-2.)
C. Respondent, the Clinic and the Pharmacy
Although he did not remember the precise dates, Respondent
testified that he was employed at UPR, a medical clinic, for four years
beginning in 2002 until approximately 2006. (Tr. 21-23, 51.)
Respondent's salary at UPR was the same as his salary at his previous
employer; he was paid by the hour or the day rather than by the number
of prescriptions he wrote.\26\ (Tr. 61, 79.)
---------------------------------------------------------------------------
\26\ Respondent also testified that he did not have any
ownership affiliation with UPS. (Gov't Ex. 10 at 46.)
---------------------------------------------------------------------------
When Respondent was first approached about working at UPR, he
understood that customers would interact with UPR via the Internet.
(Tr. 59-60.) Respondent testified that he was the only physician who
worked at UPR. (Tr. 23.) This statement is somewhat inconsistent with
testimony by Mr. Carr that the company worked in the mail-order
pharmacy realm and acquired licenses to ship pain relievers to anywhere
in the country by working with a number of physicians.\27\ (Tr. 143;
see also Resp't Ex. 5 ] 4.)
---------------------------------------------------------------------------
\27\ The contradiction is perhaps explained by Respondent's
testimony in a prior proceeding that another physician worked at UPR
before Respondent began working there. (See Gov't Ex. 10 at 65.)
Moreover, the record contains no evidence that UPR was the sole
clinic with which UPS worked.
---------------------------------------------------------------------------
Before joining UPR, Respondent worked at Home Harbor Urgent Care
Center. (Tr. 61.) After leaving UPR, Respondent worked at a clinic
called Gulf Shore from 2007-2009; between 2009 and the present, he has
worked at Cosmopolitan Clinic in Brooksville, presumably in Florida.
(Tr. 56, 68, 107; Resp't Ex. 17.) Gulf Shore was a pain management
practice run by an anesthesiologist. (Tr. 57.) Cosmopolitan is a
combination family practice and pain management clinic. (Tr. 57.)
In his testimony in a prior proceeding, Respondent testified that
UPR changed its name to MediHealth, which evolved into a general family
practice. (Gov't Ex. 10 at 6, 9; see generally Tr. 107-08.) This
testimony is consistent with Respondent's testimony in the present case
that from 2007 to 2009 Respondent worked part-time at MediHealth, a
clinic owned by Ms. Messick. (Tr. 67-68.)
(a) The Connection between UPR and UPS
Respondent testified that UPS is a pharmacy. (Tr. 23.) UPR, by
contrast, is a medical clinic. (Tr. 23.) The two organizations had
close connections.
For instance, Respondent learned in 2006 that UPS owned UPR and
that a Sam Bollinger \28\ (Mr. Bollinger) was the owner of both UPR and
UPS.\29\ (Tr. 22-23.) Respondent stated, however, that Mr. Bollinger
"had always represented to me that no financial link was there." \30\
(Tr. 23.) In addition, Mr. Carr testified that he formed UPS in 2001
(Tr. 143; see Tr. 61; see also Resp't Ex. 5) and that UPS worked in the
mail-order pharmacy realm and acquired licenses to ship pain relievers
to anywhere in the
[[Page 61162]]
country by "working with a number of physicians." \31\ (Tr. 143.)
---------------------------------------------------------------------------
\28\ The transcript of hearing in the above-captioned case
spells the name "Bollinger," (e.g., Tr. 23) and that is the
convention adopted here. But see Gov't Ex. 10 at 9 ("Ballinger");
Resp't Ex. 12 (same); Resp't Ex. 5 (same).
\29\ Mr. Bollinger is not a medical professional. (Tr. 24.)
\30\ In his testimony in a prior proceeding, however, Respondent
testified that Mr. Bollinger required Respondent to send his
patients' prescriptions to UPS, that the vast majority of his
prescriptions from 2005 and 2006 were filled at UPS, that most of
the clerks and staff at UPR had at one time worked at UPS and that
Mr. Bollinger "pretty much ran the show." (Gov't Ex. 10 at 42, 55,
74-76, 82.)
\31\ In light of Respondent's testimony that he was the only
physician employed by UPR between 2002 and 2006 (Tr. 21-23, 51), Mr.
Carr's statement that UPS worked with "a number of physicians"
(Tr. 143) may be explained by Respondent's testimony that a Dr. Long
and a Dr. Ibanez previously worked at UPR (See, e.g., Gov't Ex. 10
at 80-81). See note 27, supra.
---------------------------------------------------------------------------
In addition, Respondent testified that the UPS pharmacy filled the
vast majority of the prescriptions Respondent wrote while at UPR. (Tr.
61.) Respondent testified that although he thought he was working for
the clinic UPR, he inadvertently was working for UPS. (Tr. 94.) He then
contradicted himself, stating that he wasn't working for UPS. (Tr. 94.)
Mr. Carr stated that Respondent was not employed by UPS. (Tr. 151-52.)
He denied supervising Respondent, and further denied having any say
over Respondent's medical practice. (Tr. 152.) Ms. Messick testified
that she was employed simultaneously by UPS and UPR from 2001 to 2005.
(Tr. 129, 132, 133.) She described it as a "back and forth," and she
observed what went on at UPS and UPR. (Tr. 133.) She confirmed that she
observed Respondent's work at UPR, and stated that Respondent didn't
work at UPS. (Tr. 133.) She had seen Respondent in the pharmacy at UPS
only once. (Tr. 134.) She testified that she was in a position to
observe Respondent's work, and that Respondent followed guidelines set
by Mr. Carr. (Tr. 129.)
(b) Respondent's and Mr. Carr's Telemedicine Research
Respondent stated that when he began prescribing controlled
substances to individuals who contacted him at UPR primarily via the
Internet, telemedicine was a new practice; "the legal community was
struggling in a gray area to determine what those [legal standards]
would be * * *." (Tr. 64.) Consequently, Respondent viewed his work at
UPR as an experiment involving new ways to use the Internet. (Tr. 31.)
He had some concerns about the legitimacy of the practice, "[s]o I did
my due diligence." (Tr. 60). He "did a little research on my own,"
consulted with the attorney Mr. Carr and relied on "a letter shown me
from the DEA giving permission to do it." (Tr. 60; see also Tr. 89-
92.)
The letter to which Respondent referred was preceded by a letter
dated January 28, 2002, and signed by "Robert Carr/President/United
Prescription Services, Inc." (Resp't Ex. 3.) Addressed to Patricia M.
Good, Chief, Liaison and Policy Section, Office of Diversion Control,
DEA, Mr. Carr's letter describes the "Community Pharmacy" UPS and
solicits Ms. Good's "views on whether any requirements or changes are
warranted in our policy." (Resp't Ex. 3; Tr. 90.) Although the letter
recites that a copy of UPS's policies is attached (Resp't Ex. 3), no
policy pages are attached to the record copy (see Resp't Ex. 3) and
Respondent testified that he never saw the policy pages.\32\ (Tr. 96.)
Mr. Carr confirmed that he contacted the DEA on January 28, 2002, to
inquire whether the policies of UPS were in conformity with the law.
(Tr. 144-45.)
---------------------------------------------------------------------------
\32\ Mr. Carr's description of the policies that he sent to DEA
for review (see Tr. 145-46, 158-59) accordingly have little bearing,
if any, on the question of what Respondent believed at the time he
read the letter.
---------------------------------------------------------------------------
Slightly less than one month later, Mr. Carr received a response.
(Tr. 146.) A February 27, 2002 letter by Ms. Good, addressed to "Mr.
Robert Carr/President/United Prescription Services, Incorporated"
opined that "the submitted policies and procedures meet the federal
requirements regarding controlled substance prescriptions." \33\
(Resp't Ex. 4 at 1; see Tr. 91.) Mr. Carr testified that the DEA
advised him that "there was no further things [sic] we had to be
concerned with our physicians that were practicing telemedicine." (Tr.
146.) Respondent and Mr. Carr agreed that Mr. Carr advised Respondent
that by following Mr. Carr's guidance, Respondent would be in
compliance with state and federal law. (Compare Tr. 91, with Tr. 147.)
---------------------------------------------------------------------------
\33\ Mr. Carr testified that he no longer has a copy of the
policy documents he submitted to the DEA with his June 28, 2002
letter, explaining that he left them with UPS when he sold the
company. (Tr. 158.)
---------------------------------------------------------------------------
Respondent testified that Mr. Carr showed him Ms. Good's February
27, 2002 letter (Tr. 91) and that Respondent believed the letter gave
Respondent permission to prescribe to patients in multiple
jurisdictions who contacted him via an Internet web site but did not
necessarily meet with him face to face. (See Tr. 59-60, 110.)
Respondent conceded, however, that Mr. Carr's letter asks about the
dispensing practices of the pharmacy, not the prescribing practices of
physicians. (Tr. 97.) Respondent further conceded that he lacked
specific knowledge of what policies Ms. Good approved for the pharmacy.
(Tr. 96.) And in any event, the record reflects that Ms. Good's general
expression of approval of the pharmacy came with a number of caveats:
"Management personnel will verify several elements including * * *
professional licensure[,] DEA registration[, l]egitimate patient/
prescriber relationship[, p]rescriptions are issued in the usual course
of professional practice, and [p]rescriptions are issued for a
legitimate medical purpose." (Resp't Ex. 4 at 1.)
Although Respondent now concedes that Mr. Carr's assurances that
Respondent was complying with the law were inaccurate (Tr. 110-11), he
devoted significant testimony to defending his reliance on Mr. Carr's
advice. (See Tr. 64, 67, 98, 100-01.)
Mr. Carr also testified as to the legal status of Internet
prescribing practices as well as his own role in establishing UPS. Mr.
Carr stated that he researched the law regarding telemedicine and
related prescribing practices, surveying the laws of all fifty states
addressing the regulation of pharmacies, general medicine and pain
medication. (Tr. 144.) He said he searched for anything in the
telemedicine realm, compiling a file "well over a foot high of
documents that I reviewed extensively from various states, various
regulatory authorities." (Tr. 150.) He stated that in 2001 the
statutes and regulations were very minimal on telemedicine. Mr. Carr
testified that the only reference was a statute from an unidentified
jurisdiction addressing neural radiology in telemedicine. (Tr. 144.)
Mr. Carr stated that "California is one of the states that we were
prescribing to, or shipping drugs to." (Tr. 158.) He could not,
however, identify the effective date of the California law requiring
that a physician hold a California medical license before prescribing
to people in California over the Internet. (Tr. 150, 157.) He moreover
could not confirm whether he specifically researched California's law,
stating only that "yes, there would have been a review of all
California licenses * * * in 2002 * * * ." (Tr. 158.)
Mr. Carr also testified regarding the Model Guidelines for the
Appropriate Use of the Internet in Medical Practice (Model
Guidelines).\34\ He did not recall seeing that document in particular
during the course of his research of telemedicine. He stated, however,
that if it was published in 2002, he would have reviewed it
extensively. (Tr. 149-50.) He also stated that he was generally
familiar with the document. (Tr. 155.)
---------------------------------------------------------------------------
\34\ See Resp't Ex. 9.
---------------------------------------------------------------------------
Page nine of the Model Guidelines contains the following provision:
"Physicians who treat or prescribe through Internet Web sites are
practicing medicine and must possess appropriate licensure in all
jurisdictions where patients reside." (Resp't Ex. 9 at 9; See Tr.
156.) Mr. Carr testified that he did not previously see that sentence.
[[Page 61163]]
(Tr. 156.) "I would not have advised [Respondent] of that" because
"there wasn't to my knowledge any specific requirement in Florida as
to determine the nexus of where physician/patient relationship was in
fact occurring and where the medical practice was occurring." (Tr.
156.)
Mr. Carr further testified that he relied on statements, such as
the one appearing in the Model Guidelines, that "the [physician-
patient] relationship is clearly established when the physician agrees
to undertake diagnosis and treatment of the patient * * * whether or
not there has been a personal encounter between the physician * * * and
patient." (Tr. 163; Resp't Ex. 9 at 7.) He did not recall, however,
seeing that statement in particular during the course of his research
of telemedicine. He could confirm only that "[s]omething like this was
something I'd probably even send down to the doctors to give them * * *
assurances." (Tr. 163.)
Ms. Messick's testimony in this regard was consistent, if equally
vague: Ms. Messick explained that Mr. Carr had provided statutes and
regulations on practicing telemedicine and the physician-patient
relationship to physicians at UPR.\35\ (Tr. 134-35.) Ms. Messick
testified that the guidance Mr. Carr provided to Respondent was legal,
not medical, and dealt with telemedicine and how to maintain a
physician-patient relationship. (Tr. 135.) Ms. Messick elaborated that
this question was a controversial subject of much discussion in the
office.\36\ (Tr. 136.)
---------------------------------------------------------------------------
\35\ He did not provide them to Ms. Messick, however. (Tr. 135.)
\36\ For instance, Ms. Messick cited the question of whether
"the patient actually had to be seen by the physician or the
physician's office [or] another physician." (Tr. 137.)
---------------------------------------------------------------------------
Mr. Carr testified that he relied on a Federal Register Notice
entitled "Dispensing and Purchasing Controlled Substances Over the
Internet." (Tr. 153; see generally Resp't Ex. 8.) That document
provides that "practitioners must be registered with DEA and licensed
to prescribe controlled substances by the state(s) in which they
operate." (Tr. 154; see Resp't Ex. 8 at 3.) Yet, while UPS filled
prescriptions written by Respondent and shipped them all over the
United States, Respondent was not licensed to practice medicine in any
state other than Florida. (Tr. 154.) Many of Respondent's patients did
not come to Florida, but interacted with Respondent electronically.
(See Tr. 25, 154.) Mr. Carr explained that he interpreted Respondent's
Internet prescribing practices as operating in the state of Florida.
(Tr. 160-61.)
D. Respondent's Physician's Assistant (PA)
Significant testimony at hearing concerned actions allegedly taken
by John Protheroe (Mr. Protheroe), a PA, and the extent, if any, of
Respondent's supervision of Mr. Protheroe.
Mr. Protheroe began working for UPR a few months after Respondent
started working there in 2002. (Tr. 37, 38, 120.) Respondent did not
hire him, but he worked under Respondent's license. (Tr. 37, 131.)
Respondent testified that "[Mr. Protheroe] was hired because * * * I
was not making Mr. Bollinger happy with the amount of restrictions that
I was placing on the patients and thus slowing everything down * * * he
hired Mr. Protheroe to go behind my back and speed things up. He never
discussed with me 'do you need one?' " (Tr. 120.)
Mr. Protheroe was not often present while Respondent was in the
office, and frequently worked from home. (Tr. 37, 38, 41; Gov't Ex. 10
at 85 ("He was purportedly * * * supposed to work under my license,
submit himself to my review * * * And yet he was allowed to review
patients' charts from his own home, away from the office where no one
could see him.").) Mr. Protheroe was a PA only to Respondent, and not
to any other doctor. (Tr. 120.)
Respondent testified to having an antagonistic relationship with
Mr. Protheroe (Tr. 37) and developing a number of concerns before
November 2003. (Tr. 121.) Respondent accused Mr. Protheroe of
exploiting Respondent's license "behind my back without my
permission" (Tr. 37, 42), and failing to adhere to the criteria by
which Respondent rejected patients (Tr. 122).
Mr. Protheroe's compensation was connected to the number of
prescriptions Mr. Protheroe wrote, most of which were for controlled
substances. (Tr. 79; Gov't Ex. 10 at 96-97; Resp't Ex. 12 at 2.) Ms.
Messick testified that Mr. Protheroe was compensated at a rate of
fifteen dollars per prescription. (Tr. 132.) According to Respondent,
Mr. Protheroe "wrote so many prescriptions without my authorization
using a stamp of my signature" that Respondent was uncertain whether
Respondent had completed the conduct charged in an administrative
complaint by the Florida Department of Health,\37\ or whether Mr.
Protheroe had written the prescriptions in question. (Tr. 41.)
Respondent testified that the number of prescriptions that Mr.
Protheroe wrote without Respondent's authorization was at least 14,000.
(Tr. 80; see generally Tr. 132; Gov't Ex. 10 at 84-85.) Respondent did,
however, acknowledge occasions in which Respondent approved
prescriptions written by Mr. Protheroe. (Tr. 38.) Respondent estimated
the quantity as "only a few a day." (Tr. 42.) The vast majority of
Mr. Protheroe's prescriptions, however, Respondent was unaware of. (Tr.
38.)
---------------------------------------------------------------------------
\37\ As detailed below, the Florida Department of Health accused
Respondent of prescribing controlled substances to a patient
without: conducting a face-to-face meeting, performing an adequate
physical exam, taking an adequate medical history, documenting a
treatment plan or making referrals, inter alia. (Gov't Ex. 14 at 4.)
---------------------------------------------------------------------------
Respondent testified that Mr. Protheroe wrote the majority of the
objectionable prescriptions while Respondent was away from the office
from November 2004 to March 2005 after his wife was diagnosed with a
serious health issue. (Tr. 121-22, 132; Gov't Ex. 10 at 85, 96, 101.)
Mr. Protheroe's misconduct continued the entire time Mr. Protheroe
worked there, until Mr. Protheroe left in 2005, shortly after
Respondent returned from medical leave. (Tr. 138.) It was only after
returning that Respondent complained about Mr. Protheroe to Ms.
Messick, who recalled Respondent's complaint that Mr. Protheroe wrote
prescriptions without accurately reading the diagnoses or medical
records. (Tr. 131, 138-39.)
Respondent approached Mr. Bollinger several times and requested
that Mr. Protheroe be fired. (Tr. 37; see also Tr. 131; Gov't Ex. 10 at
106.) Respondent said he did not need Mr. Protheroe, and that Mr.
Protheroe "was put there by someone else and I had no power to remove
him because I did not pay his salary. I could not tell him to leave."
(Tr. 37; see Tr. 122.) In July 2005, Mr. Bollinger removed Mr.
Protheroe from UPR. (Resp't Ex. 12 at 4.)
Respondent testified that he was precluded from a full right to
supervise Mr. Protheroe, which he now regrets so much that "it's so
soured me on the experience that I've never hired any physician's
assistants since and I don't think I ever will." (Tr. 108-09.) But
Respondent's testimony that he lacked the full authority to supervise
Mr. Protheroe, including the right to fire him if necessary, is
substantially undercut both by the relationship (Mr. Protheroe was the
physician's assistant and Respondent was the physician), as well as by
Respondent's affidavit, affirming that Respondent was medical director
of UPR and its sole corporate officer beginning in 2004. (See Resp't
Ex. 12 at 2.)
[[Page 61164]]
Negligibly mitigating this contradiction is a statement by
Respondent that he did not realize he was UPR's sole corporate officer
until 2006, even though as early as 2004, he understood he was medical
director:
In 2004, Mr. Bollinger asked me to sign some corporate documents
for [UPR]. I understood that these documents would list me as the
medical director of [UPR]. I learned in late 2006, that Mr.
Bollinger made me the sole corporate officer and removed himself as
a corporate officer of [UPR] by having me sign these documents. When
Mr. Bollinger did this, Mr. Bollinger listed my address as 2304 East
Fletcher Avenue, Tampa, Florida. That is not the address of [UPR],
nor is it the address at which I worked. The address Mr. Bollinger
listed for me on the corporate filings is the address for [UPS].
(Resp't Ex. 12 at 2.)
After carefully evaluating Respondent's testimony, other record
evidence and Respondent's demeanor while testifying, I find that
Respondent's testimony regarding the scope of his authority over Mr.
Protheroe is not fully credible. For instance, to the extent that
Respondent testified that he lacked the authority to supervise or fire
Mr. Protheroe after 2004, this testimony stands in stark contrast with
Respondent's own evidence that Respondent understood Respondent was
medical director of UPR in 2004. Additionally, the evidence includes
Respondent's concession that he had an obligation to properly supervise
Mr. Protheroe (Tr. 101; see Resp't Ex. 9 at 5 ("physicians should * *
* [p]roperly supervise physician extenders")), and his assertion that
he did, in fact supervise Mr. Protheroe "when he was in the office * *
*." (Gov't Ex. 10 at 105.) For the foregoing reasons, I find that
Respondent possessed both the obligation and the authority to supervise
Mr. Protheroe.\38\
---------------------------------------------------------------------------
\38\ A later section of this Recommended Decision addresses
whether Respondent had any legal obligation or authority in this
regard, and if so, whether Respondent discharged it.
---------------------------------------------------------------------------
E. Respondent's Prescriptions to Internet Customers, 2004 Through
October 2006
(a) Respondent's Service to Internet Customers at UPR, Generally
Respondent testified as to how he handled prescription requests
from customers when he worked at UPR. Respondent conducted a telephonic
or in-person consultation with every person to whom he prescribed
controlled substances. (Tr. 29.) Respondent would interview most
patients over the phone and then determine whether to issue a
prescription or order any "tests on further verifications that were
necessary." (See Tr. 25.) Approximately ninety percent of the
consultations occurred exclusively by telephone, without an in-person
meeting. (See Tr. 26; see also Gov't Ex. 10 at 77 (ten percent or
"[m]aybe less than five percent").) In approximately 2005, Respondent
began encouraging more patients to come to the clinic in Florida. (See,
e.g., Gov't Ex. 10 at 93-94.)
Before phone consultations took place, patient records "were
compiled by the customer and sent to me." \39\ (Tr. 34.) Other doctors
did not send patient records to Respondent; patients sent them.\40\
(Tr. 34, 79-80.) Respondent testified that "Patients did not make them
up on their own." (Tr. 34.) Respondent's staff at UPR would initially
"screen" patients and compile charts containing patients' contact
information, diagnoses and medical documentation verifying their
conditions. (Tr. 24-25, 37.) The staff would provide a chart "whenever
I requested it." \41\ (Tr. 70.)
---------------------------------------------------------------------------
\39\ See also Gov't Ex. 10 at 73 ("Usually it was the patient's
job to gather the records and forward them to me.").
\40\ There is also evidence that an entity called FedexMeds.com
was an occasional referral source of patients, which occasionally
transmitted medical records to Respondent. (Gov't Ex. 10 at 73-74;
see generally Resp't Ex. 12 at 3.)
\41\ This testimony is consistent with Ms. Messick's testimony
that she or her staff provided medical records to Respondent before
he conducted telephone interviews with Internet patients or
prescribed medication to them. (Tr. 130.)
---------------------------------------------------------------------------
During the four years that Respondent worked at UPR (Tr. 35-36,
51), other doctors referred approximately 300 patients to Respondent.
(Tr. 35-36.) As for the rest of Respondent's thousands of patients
(e.g., Tr. 43), the physicians whose records Respondent relied on to
justify prescribing controlled substances were not affiliated with
Respondent and did not provide any medical services, testing or
evaluation at Respondent's request. (Tr. 36.)
Respondent testified that to have a valid doctor-patient
relationship, a servicing medical professional must have conducted a
physical examination of the patient. (Gov't Ex. 10 at 79-80 ("Someone
must have done [a physical examination]).") For follow-up
consultations, Respondent did not require "a new physical exam with
every consult. When it became, in my opinion, too dated, then I would
demand another physical exam." (Gov't Ex. 10 at 79.) But Respondent
performed physical examinations on only two percent of his patients in
his first year of employment with UPR, a percentage which rose to no
more than seven percent of patients in later years. (Tr. 25-26.)
Moreover, in a given week, Respondent rarely contacted a patient's
primary care physician whose records he was reviewing. (Tr. 32, 34-35,
80; Gov't Ex. 10 at 30, 78.)
Although he sometimes would do so, Respondent did not always find
it appropriate to tell customers that online communication cannot take
the place of face-to-face communication. (Tr. 102-03.)
(b) Extent of Respondent's Verification of Patient Identities at UPR
Respondent had no face-to-face interactions with as many as ninety
percent of his patients. (Tr. 26, 55.) When ascertaining a patient's
identity before issuing a controlled substance prescription, therefore,
Respondent relied on representations made by the radiologist who read
the patient's CAT scan or MRI, or the office notes of the physician who
first saw the patient. (Tr. 54.)
As for how he verified the identity of patients with whom he never
physically interacted, Respondent testified that "I used the same
method of checking their identity as I would if they were present in
front of me." (Tr. 54.) Yet Respondent conceded that he never looked
at the face of the vast majority of people to whom he issued
prescriptions. (Tr. 55.) He conceded that it was possible, therefore,
that a family member could take the medical records and identification
of a deceased person, and Respondent would have no way of knowing
whether the person on the phone was actually the person whose medical
records and identification Respondent was reviewing. (Tr. 55-56.)
Respondent explained that "I was rather good at detecting fraud"
by comparing font and language in different parts of patient medical
records. (Tr. 56.) Respondent added: "If the state did not adequately
check their identity before issuing them a driver's license * * * I had
no way of determining that." (Tr. 54.)
(c) Extent of Respondent's Patient Evaluation and Documentation
Practices at UPR
When he worked at UPR, Respondent conducted physical examinations
on some of the individuals who contacted him through Internet Web
sites. (Tr. 25.) The percentage was very small. (Tr. 25.) "It went
from about two percent in the beginning to six or seven percent towards
the end." (Tr. 26.) Respondent did not conduct physical examinations
on more than ninety percent of his patients. (Tr. 26.) Nor did other
physicians perform examinations of those patients at Respondent's
[[Page 61165]]
direction.\42\ (Tr. 36.) Respondent elaborated that other physicians
had already performed examinations or tests before the patient came
into contact with Respondent, explaining "That's the whole point."
(Tr. 36.) Respondent had no affiliation with the physicians whose
records he relied on. (Tr. 36.) He admitted to prescribing hydrocodone
to thousands of individuals without a face-to-face examination. (Tr.
43; see Tr. 53.)
---------------------------------------------------------------------------
\42\ As Respondent explained, "the physical examination has to
be done by someone else in the case of telemedicine. [Patients] have
to have seen a local doctor that actually saw them and performed the
physical examination, and gotten those notes to me, so that I know
what was seen and have the information available." (Gov't Ex. 10 at
25-26.)
---------------------------------------------------------------------------
Each day Respondent consulted with approximately thirty customers.
(Tr. 26, 51.) He worked five days per week. (Tr. 35; 51-52.) On
average, he issued controlled substances prescriptions to 150 patients
per week. (Tr. 52.) Respondent worked at least forty weeks per year,
usually more. (Tr. 52.) Thus, on approximately 5000 occasions per year
or more, Respondent issued controlled substance prescriptions to new or
repeat customers. (Tr. 53.)
Many patients came to him pre-diagnosed, and Respondent stated that
they had to prove what the diagnosis was. (Tr. 29.) Although Respondent
testified that he contacted a patient's primary physician whose medical
records he was reviewing "on occasion" (Tr. 80) and "whenever it was
necessary" (Tr. 32), he also testified that he only consulted one or
two physicians out of the 150 patients he serviced in a given week,
(Tr. 34, 35; see generally Gov't Ex. 10 at 30, 78 ("I generally did
not have to do that on a regular basis. That was less than once a day.
It was when I had specific questions.")). Respondent testified that it
is not a common practice to speak with the medical professional who
prepares medical records such as MRIs and radiology reports. (Tr. 32.)
Respondent stated that it would be inappropriate and "not smart
medicine" (Gov't Ex. 10 at 26) to complete a first-time diagnosis over
the phone, but not necessarily a subsequent diagnosis.\43\ (Tr. 29-30,
104.) Later, however, he stated that "I have enough expertise to know
whether someone has a respiratory problem at the moment by how they're
talking to me over the phone." (Tr. 115.)
---------------------------------------------------------------------------
\43\ See also Gov't Ex. 10 at 12 ("it's certainly not
considered appropriate to make new diagnoses in a telemedicine
format").
---------------------------------------------------------------------------
Respondent conceded that it would be inappropriate to prescribe
controlled substances to an individual who had not been diagnosed with
having a legitimate medical need for the drugs. (Tr. 30.)
The record also reflects allegations by the Florida Department of
Health that Respondent failed to adequately discuss and document
treatment options with patients (see, e.g., Gov't Ex. 14 at 3-4),
although these allegations were resolved by settlement agreement (Gov't
Exs. 15 & 16).
At hearing, Respondent confessed that his evaluation of patients
and documentation at UPR "is not considered adequate," and that "I
have a different standard now because I've been educated about it."
(Tr. 45-46.) "[T]he happy medium [in fighting controlled substance
abuse] is to insist on proper documentation--and try to wean people off
it when you can." (Tr. 66.) Reflecting on his current practice at
Cosmopolitan, Respondent stated that he has been lowering patient
dosages and "getting rid of the people who had abuse potential." (Tr.
66.) "I think I've done a good job where I am of * * * cleaning up the
practice." (Tr. 66.)
(d) Respondent's Internet Consulting and Prescribing Policies at UPR
Respondent testified to his belief that his patients' primary care
physicians had undertaken personal encounters with patients, and
therefore patients "were not placing their whole care in my hands."
(Tr. 110.) He further testified that in 2002, the Federation of State
Medical Boards stated that a face-to-face encounter was not necessary
as long as the patient expected that the doctor would take over the
treatment plan and review medical documentation. (Tr. 43-44.)
The Federation of State Medical Boards, however, is "a collection
of licensing bodies from all the states." (Tr. 44.) Respondent
testified that he did not initially know whether it is itself a
licensing authority. (Tr. 45.) But he then conceded that "I realize
now that it was a mistake after people with more legal expertise than I
have told me" that statements by the Federation of State Medical
Boards do not carry "legal weight." \44\ (Tr. 45; see also Tr. 164.)
---------------------------------------------------------------------------
\44\ In any event, Respondent conceded that he personally has
not received a license from the Federation of State Medical Boards.
(Tr. 45.)
---------------------------------------------------------------------------
Respondent disputed the suggestion that he failed to adequately
perform patient evaluations at UPR, testifying that his interaction
with patients was adequate according to his understanding of what was
required by the Federation of State Medical Boards. (Tr. 43.) He
further stated that none of his patients for whom he prescribed over
the Internet came to any harm: "there were no mortalities, no
morbidity." \45\ (Tr. 116.) Asked whether any patient suffered an
overdose death, Respondent answered that "I know none of them did
while I was prescribing. If it happened since that time, then it
happened because someone else was prescribing it. I can't be
responsible for what some other doctor did." (Tr. 117.) "I'm sure
there would have been a lawsuit if there was one and I never received
any." (Tr. 123.) He conceded, however, that he has not stayed in touch
with all of his UPR Patients since leaving UPR. (Tr. 117.)
---------------------------------------------------------------------------
\45\ This testimony is consistent with testimony of Ms. Messick,
who stated that she was not aware of any injuries or complaints by
patients as a result of Respondent's prescribing practices. (Tr.
130.) She conceded, however, that she had not stayed in touch with
the thousands of Internet patients with whom Respondent consulted.
(Tr. 137.)
---------------------------------------------------------------------------
(e) Location of Respondent's Customers
Respondent testified that most of the individuals to whom
Respondent prescribed controlled substances became Respondent's
customers through Internet Web sites. (Tr. 25.) Respondent testified
that he issued prescriptions for controlled substances to people
located all across the United States. (Tr. 27, 39.) Although he did not
remember precisely how many different states, he said the list was
"long." (Tr. 39; see Resp't Ex. 12 at 3 ("hundreds of patients who
lived outside of Florida").) For instance, in response to questioning
by counsel for the Government, Respondent conceded issuing
prescriptions for controlled substances to people in Tennessee,
California, Illinois and North Carolina. (Tr. 38.) Respondent said that
Kentucky and Mississippi were "off limits," but did not actually deny
prescribing to individuals in those states. (Tr. 28.)
Respondent admitted that he was not licensed to practice medicine
in all fifty states while he worked at UPR. (Tr. 28.) He presently
understands that he has an obligation to prescribe or dispense
controlled substances in accordance with all applicable state laws, and
that prescribing across state lines sometimes includes the application
of laws other than the laws of the State of Florida. (Tr. 63.) He
concedes that, in hindsight, the prescriptions he issued at UPR to
Internet customers "did not meet the highest standard * * * and I'm
sorry." (Tr. 63-64.) In his post-hearing brief, Respondent states that
he "now realizes that the prescriptions he issued at [UPR] to Internet
patients were not issued in the usual course of professional practice *
* * ." (Resp't Br. at 17.) When asked whether he now knows that his
Internet prescribing at UPR was not consistent with the law as it was
at that time, Respondent answered "Absolutely." (Tr. 91-92.)
Contradicting himself somewhat, Respondent also stated that
[[Page 61166]]
at the time he engaged in the prescribing practices that are the
subject of the OSC, he wasn't doing anything wrong (Tr. 64-65),
explaining that "if I thought I was doing anything wrong, I wouldn't
have done it." (Tr. 65.)
Significant testimony addressed the extent of Respondent's reliance
on and understanding of the Model Guidelines. Respondent admitted that
before accepting employment with UPR, he does not recall whether he
read the provision from "Section Five[:] Guidelines for the
Appropriate Use of the Internet in Medical Practice," entitled
"Compliance with State and Federal Laws and Web Standards." (Tr.
105.) In pertinent part, that provision reads: "Physicians who treat
or prescribe through Internet Web sites are practicing medicine and
must possess appropriate licensure in all jurisdictions where patients
reside." (Resp't Ex. 9 at 9.) Respondent admitted that he failed to
comply with that provision. (Tr. 105.)
Asked if he was regretful and remorseful for the role he played at
UPR in prescribing controlled substances, Respondent stated: "Yes,
very much. I sincerely wish I had never been duped into being any part
of their operation at all." (Tr. 92.) Respondent testified that in the
future, he would not prescribe for patients in jurisdictions in which
he lacks a medical license. (Tr. 111.) Asked by counsel whether he felt
remorse for having done so, he said "Yes. Not only am I remorseful
about it, but I feel rather foolish and stupid for doing so in
retrospect." (Tr. 111.) He also deemphasized his own responsibility,
stating "I was just an hourly employee. I was just a pawn in the
machine." (Tr. 119.)
(f) Quantity of Prescriptions and Extent of Diversion Avoidance at UPR
On approximately 5000 occasions per year or more during his tenure
at UPR, Respondent issued controlled substance prescriptions to new or
repeat customers. (Tr. 53; see also Tr. 25, 32, 43.)
Most or many of the individuals who contacted Respondent at UPR
sought and ultimately received a specific controlled substance. (Tr.
28, 36.) The most common request was for hydrocodone, a Schedule III
narcotic. (Tr. 28.) Respondent testified that some patients also sought
alprazolam, which he identified as a Schedule IV benzodiazepine trading
under the brand name Xanax or Valium.\46\ (Tr. 29.) Patients requested
these drugs before Respondent consulted with them. (Tr. 29.) Respondent
explained that patients "were just reiterating what their own
physician had put them on." (Tr. 70.) Respondent testified that on
many occasions, he reduced the amount of medications for some patients
and suggested alternate treatment methods. (Tr. 79-80.)
---------------------------------------------------------------------------
\46\ Respondent's testimony that alprazolam is sold under the
trade name Valium is incorrect. I take official notice that
alprazolam sells under the trade name Xanax and that diazepam sells
under the trade name Valium. Under the APA, an agency "may take
official notice of facts at any stage in a proceeding--even in the
final decision." U.S. Dept. of Justice, Attorney General's Manual
on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons,
Inc., Reprint 1979). In accordance with the APA and DEA's
regulations, Respondent is "entitled on timely request, to an
opportunity to show to the contrary." 5 U.S.C. 556(e); 21 CFR
1316.59(e) (2010); see, e.g., R & M Sales Co., 75 FR 78,734, 78,736
n.7 (DEA 2010). Respondent can dispute the facts of which I take
official notice by filing a properly supported motion for
reconsideration within twenty days of service of this Recommended
Decision, which shall begin on the date it is mailed. See, e.g.,
Joseph Gaudio, M.D., 74 FR 10,083, 10,088 (DEA 2009) (granting
respondent opportunity to dispute officially noticed facts within
fifteen days of service).
---------------------------------------------------------------------------
In Respondent's professional medical opinion, the abuse of
controlled substances is a significant problem. (Tr. 65.) Respondent
testified that some people misuse and abuse the kinds of controlled
substances that Respondent prescribed at UPR, particularly hydrocodone,
alprazolam, oxycodone and methadone. (Tr. 65.) From time to time
Respondent encountered patients who abused controlled substances and
immediately dismissed them. (Tr. 65.) "I ferreted it out where I
could." (Tr. 65.) Respondent, however, could not state how many of his
patients were addicted to narcotics while he was prescribing to them.
(Tr. 118.) Respondent is familiar with the rising rate of oxycodone
overdose deaths, calls it a big problem and "I do best to make sure
that doesn't happen." (Tr. 59.) Respondent stated that when physicians
prescribe correctly, doctors who prescribe controlled substances to
drug abusers do not themselves contribute to the pharmaceutical abuse
problem. (Tr. 66.)
(g) The Florida Department of Health Administrative Complaint
Respondent testified that Florida instituted an administrative
complaint (Complaint) against him arising out of his Internet
prescribing practices at UPR.\47\ (Tr. 40; Gov't Ex. 14.) The Complaint
alleged, inter alia, that in 2004 Respondent repeatedly prescribed
hydrocodone to patient [D.P.], a resident of Wyoming who had never had
a face-to-face meeting with Respondent. (Gov't Ex. 14 at 2, 3.) It
further alleged that Respondent failed to perform an adequate
evaluation of [D.P.], including an adequate medical history and an
adequate physical examination to justify prescribing controlled
substances; that Respondent failed to document discussing the risks and
benefits with [D.P.]; that Respondent failed to prepare and document an
adequate treatment plan or keep adequate medical records of his
treatment of [D.P.]; and that Respondent failed to refer [D.P.] for
additional consultations or diagnostic testing. (Gov't Ex. 14 at 4.)
---------------------------------------------------------------------------
\47\ Respondent stated that he never received correspondence
from licensing boards in other states complaining of his practice.
(Tr. 39.) He did, however, become aware of some such complaints in
the context of a previous proceeding against UPS. (Tr. 40.)
---------------------------------------------------------------------------
Respondent could not confirm or deny whether he completed the
conduct alleged in the Complaint because "this PA John Protheroe wrote
so many prescriptions without my authorization using a stamp of my
signature that it may well have been done under--under that process."
(Tr. 41.) Respondent explained that when he received the Complaint, he
had no way of looking into the patient records to determine whether it
was Respondent or Mr. Protheroe who wrote the prescriptions in
question. (Tr. 41-42.)
Respondent further testified that he did not know the identity of
"[J.N.]," another patient. (Tr. 42.) The Complaint alleged that
[J.N.] was Respondent's patient, located in Idaho, to whom Respondent
allegedly prescribed hydrocodone, without conducting a face-to-face
meeting or physical examination, discussing the risks and benefits of
controlled substances, preparing and documenting an adequate treatment
plan, keeping adequate medical records of treatment, or referring
[J.N.] for additional consultations or diagnostic testing. (Tr. 42; see
Gov't Ex. 14 at 4-6.) Respondent explained that when he received the
Complaint, he did not have access to the records of patient [J.N.].
(Tr. 73-74.) Nor did Respondent have the opportunity to review the
records of [S.J.], another patient listed in the Complaint, because
Respondent lacked access to those records, as well. (Tr. 74.)
In short, Respondent does not know whether he issued any of the
prescriptions alleged in the Complaint. (Tr. 42, 43.) Respondent
conceded, however, that even if he did not personally issue the
prescriptions, he did prescribe hydrocodone to thousands of individuals
without conducting face-to-face examinations. (Tr. 43.) Respondent
explained his belief that the patients for whom he was prescribing
already had had a face-to-face meeting with their primary care
physicians; Respondent believed he was merely renewing existent
prescriptions,
[[Page 61167]]
continuing the course of care and not initiating the first treatment
plan. (Tr. 109.) He conceded, however, that he had treated some
patients who had been dropped by their providers, whether for lack of
funds or another reason. (Tr. 113, 116.) "I was continuing the
treatment plan that was first set up by their doctor who might no
longer have been willing to continue that plan * * * So the patient had
nowhere else to go." (Tr. 113.)
The Complaint resulted in a settlement agreement, dated October 2,
2007, implemented through a final order dated December 26, 2007. (Tr.
46-48; Gov't Exs. 15 & 16.) Respondent agreed to pay a fine of $12,500,
complete continuing medical education courses about prescribing
controlled substances ("drug course"), maintaining medical records
("records course") and laws and rules ("laws and rules course"),
perform 100 hours of community service and prepare a paper suitable for
publishing in the Journal of the American Osteopathic Association. (Tr.
46; Gov't Ex. 15; see also Gov't Ex. 16.)
Respondent's community service was to be completed by December 30,
2009, but Respondent did not complete it until February 9, 2010.
(Resp't Ex. 18 at 2; see also Tr. 72.) For instance, a February 2, 2010
letter from the Florida Department of Health states that "Dr. Reppy
has not completed any term imposed by the final order and is considered
out of compliance at this time." (Gov't Exs. 20 & 22.) At hearing,
Respondent testified that he had since submitted the paper he was
assigned. (Tr. 72.) The paper warns practitioners against the dangers
of Internet prescribing, gives case histories and reflects on what
happened to Respondent. (Tr. 93.)
Respondent's drug course was to be completed within one year of
December 26, 2007, the date of the final order. (Tr. 48; Gov't Ex. 15.)
Respondent did not complete the drug course until December 9 through
December 11, 2009. (Tr. 48.) He did not complete the records course or
the laws and rules course until after September 2010. (Tr. 48.) As of
the date of the hearing, however, Respondent had complied with all of
his continuing education requirements. (Tr. 71; Resp't Ex. 18 at 2.)
Explaining his failure to meet all the deadlines set by the
settlement agreement, Respondent asserted that in 2006 DEA placed on
the Internet information related to his reprimand. (Tr. 50.)
Thereafter, Respondent "became essentially unemployable" at any
hospital or large clinic. (Tr. 50.) Consequently, Respondent had no
income and was unable to pay the $3000 and $5000 cost of the courses he
agreed to take. (Tr. 51.)
Per the settlement agreement, Respondent agreed to pay his $12,500
fine within two years of December 26, 2007. (Gov't Ex. 15; Tr. 49.)
Respondent acknowledged that the settlement agreement and final order
provided that Respondent would cease professional practice if he did
not comply with the two-year deadline for paying the fine set therein.
(Tr. 50; see Gov't Ex. 15 at 4.) Respondent testified that he has not
yet paid the fine in full, but has practiced medicine continuously
since the December 26, 2007 final order was issued, in part because he
was unable to secure other employment, a problem he attributes
partially to the DEA. (Tr. 49, 51.) Respondent testified that "unless
I was ordered by the Department of Health I wasn't going to" cease
practicing medicine, although he had agreed to do so in the October 2,
2007 settlement agreement. (Tr. 50.) The Florida Department of Health
"agreed to the schedule that I'm paying it back on." \48\ (Tr. 49.)
In mitigation, Respondent stated that he reported to a compliance
officer who was aware of Respondent's continued practice. (Tr. 70.)
---------------------------------------------------------------------------
\48\ Respondent's Exhibit 18, dated October 20, 2010, indicates
that Respondent made four periodic payments in February, May, July
and September 2010, amounting to a total of $1500 paid out of
$12,500 owed. (See Resp't Ex. 18 at 2.)
---------------------------------------------------------------------------
F. Respondent's Family Practice at Cosmopolitan
(a) Generally
In July or August of 2010, after leaving UPR, Respondent placed an
ad in the local newspaper advertising his new family practice at his
current employer, Cosmopolitan Clinic. (Tr. 88; Resp't Ex. 17.) The ad
resulted in Respondent acquiring new, non-pain management patients.
(Tr. 88.) Respondent has acted to change his practice from a pain
management practice to a family practice. (Tr. 88-89.)
Respondent testified as to his documentation practices at
Cosmopolitan. (See Tr. 80-87; Resp't Ex. 15.) In pertinent part, he
testified to using a Consent for Chronic Opioid Therapy, and later
using a Controlled Substances Narcotic Agreement. These documents
enable Respondent to summarily dismiss any patient who seeks controlled
substances from other physicians (Tr. 84), or who fails to notify the
clinic in writing upon switching pharmacies, (Tr. 86; Resp't Ex. 15.)
Respondent testified that as of the date of the hearing, he understood
that he is required to dispense or prescribe controlled substances only
for a legitimate medical purpose in the usual course of his
professional practice. (Tr. 62.)
At his current practice at Cosmopolitan, Respondent's most
frequently prescribed controlled substances are methadone and
oxycodone. (Tr. 57.) Respondent prescribes methadone to treat chronic
pain conditions unlikely to improve without surgery, and oxycodone for
conditions where a short-acting medication is more appropriate. (Tr.
58-59.)
(b) Respondent's Current Patients at Cosmopolitan
[D.C.] has been a patient of Respondent for approximately thirteen
to fourteen months for the treatment of degenerative spondylosis.
(Resp't Ex. 19 at 9 ]] 1-2.) During this time, Respondent met with
[D.C.] approximately ten times. (Id. at ] 6.) Respondent physically
examined [D.C.] at most visits and inquired whether [D.C.] was
experiencing any new pain. (Id. at ] 7.) Respondent always took time
with [D.C.] to discuss treatment options and [D.C.] never felt like the
visit was rushed. (Id. at ] 9 & 10.)
[D.C.] believed [D.C.]'s former pain doctor was overmedicating
[D.C.]. Respondent happily agreed to reduce the dosage of pain
medication that [D.C.]'s former pain doctor was prescribing. (Resp't
Ex. 19 at 9 ]] 3-4.) Respondent gradually lowered the dosage over a
period of months, ensuring that [D.C.] did not experience any new pain.
(Id. at ] 5.) In fact, the reduction in [D.C.]'s pain has been
dramatic. (Id. at ] 8.) Prior to treatment by Respondent, [D.C.] was
taking 30 mg oxycodone five times per day, 10 mg methadone six times
per day; and 2 mg Xanax two times per day. (Id. at ] 11.) Presently,
however, [D.C.] considers [D.C.]'s pain to be under control and is
taking 5 mg methadone once a day and one teaspoon of liquid oxycodone
once a day. (Id. at ]] 11 & 12.) The Xanax prescription is no longer
needed. (Id. at ] 12.)
Another patient of Respondent, [C.K.], likes Respondent because he
is a "straight up" sort of person; [C.K.] feels very comfortable with
him. (Resp't Ex. 19 at 12 ] 3.) Respondent treats [C.K.] for back and
neck pain stemming from an automobile accident, and also pain from a
"bad knee," for which surgery has been recommended. (Id. at ]] 4, 5 &
6.) Respondent examines [C.K.] on each visit and discusses treatment
options. (Id. at ] 7.) Respondent has worked with [C.K.] to reduce the
[[Page 61168]]
amount of [C.K.]'s pain medication. (Id. at ] 6.)
(c) Respondent's Current Employees at Cosmopolitan
Respondent's administrative employee Janice Vischio also submitted
an affidavit. Although Ms. Vischio is not generally present when
Respondent consults with patients, she does witness parts of some
conversations. (Resp't Ex. 19. at 2 ] 4.) She states that Respondent
personally sees patients, takes or reviews patient history and reviews
patient office forms. (Id. at ]] 5-7.) Moreover, Ms. Vischio has seen
Respondent's handwritten notes in patient files. (Id. at ] 7.)
Conceding that she has not personally seen Respondent examine
patients, Ms. Vischio states that she has witnessed him performing
exams on occasion and that Respondent documents exams in his files.
(Id. at ] 8.) Respondent takes twenty minutes or more with each new
patient, and ten minutes for a follow-up visit, and sometimes exceeds
the allotted time limit. (Id. at ] 9.) Respondent discusses treatment
plans with patients, returns their phone calls and discusses their
options with them. (Id. at ] 10.) Ms. Vischio has worked with many
physicians in a variety of medical settings, and calls Respondent
thorough in his documentation and diligent in his examinations and
follow-up. (Id. at ] 13.)
Ms. Vischio also addressed the new patient intake process. New
patients must either obtain a referral for pain management or have a
prescription history or list from six months to one year before seeing
Respondent. (Resp't Ex. 19 at 3 ] 11.) New patients must fill out new
patient packet forms, including medical history and treatment. They
must also undergo an MRI or have had one within two years. (Id. at ]
11.) All MRIs are verified by the MRI facility before Respondent sees
them. (Id. at ] 11.)
Ms. Vischio stated that when appropriate, Respondent has reduced
the amount of pain medication prescribed; has instructed Ms. Vischio to
advise patients of the same; and has heard patients complain that
Respondent reduced their pain medication levels. (Id. at ] 12.)
Ms. Adele Durina, Respondent's office manager and medical
assistant, submitted an affidavit stating she enjoys working with
Respondent and has worked with him since he began working at
Cosmopolitan Clinic because Respondent is considerate of his patients
and office staff. (Resp't Ex. 19 at 6 ] 3; see also Tr. 167.)
When Respondent sees a new patient, he takes twenty to thirty
minutes or longer and is very thorough. (Resp't Ex. 19 at 6 ] 4.) He
conducts a physical examination and records the findings in the
patient's chart. (Id. at ] 5.) Follow-up visits are usually fifteen
minutes but can be more. (Id. at ] 6.) Patients commonly comment that
Respondent has taken an exceptional amount of time with them and
answered questions and provided information that patients were unable
to get from other doctors. (Id. at ] 7.) Respondent returns patient
phone calls with unusual speed, which patients appreciate. (Id. at ]
8.)
Cosmopolitan Clinic often tests patients to ensure they are not
taking medications that Respondent has not prescribed. (Resp't Ex. 19
at 7 ] 9; see also Tr. 167.) Patients who fail the screen are often
dismissed immediately; others are given one, but only one, chance. (Id.
at ] 9.)
V. The Parties' Contentions
A. The Government
The Government argues that Respondent prescribed controlled
substances to thousands of individuals across the United States when he
was only licensed to practice medicine in the state of Florida, thereby
violating the laws of numerous states,\49\ in contravention of 21 CFR
1306.04 (2010). (Gov't Br. at 5; see Tr. 11.) Respondent often based
his decision to prescribe solely on a review of medical records
submitted by individuals who were seeking a controlled substance,
usually hydrocodone, a Schedule III narcotic. (Tr. 11-12.) Respondent
did not conduct physical examinations on the majority of these
individuals. (Tr. 12.)
---------------------------------------------------------------------------
\49\ The Government argues in part that I should give weight to
findings in United Prescription Services, Inc., in which "the
Deputy Administrator found that Dr. Reppy violated the laws of
California, Tennessee, Indiana and Louisiana * * * ." (Gov't Br. at
5-6.)
---------------------------------------------------------------------------
In addition, the Government argues that Respondent completed the
conduct described above while employed by an Internet pharmacy "whose
sole business was to allow people to visit a Web site, ask for a
certain drug, get referred to a physician who would consult with them
by telephone, look at medical records that had been submitted and then
issue the prescribed drug to be filled by that pharmacy." (Tr. 12.)
The Government urges that Respondent had a legal duty to supervise his
PA, Mr. Protheroe, and as a last resort, Respondent should have
withdrawn from his employment if Mr. Protheroe failed to comply with
Respondent's instructions. (Gov't Br. at 6.) The Government argues that
Respondent's failure to do so "indicates Respondent is willing to
permit the misuse of his DEA registration in order to maintain his
employment," rendering Respondent's registration contrary to the
public interest. (Id.)
Finally, the Government argues that Respondent's testimony and
demeanor at hearing evinced a lack of remorse and an attempt to blame
others for his misconduct. "Had Respondent accepted responsibility and
demonstrated remorse for his conduct, his claims that he reformed his
prescribing practices might portend a change in conduct." (Id. at 7.)
Instead, the Government argues, registration is improper where
"Respondent blames the legal community, a lawyer who had a financial
interest in the pharmacy where Respondent's prescriptions were filled,
a physician's assistant, the owner of [UPS], and even DEA for his
failure to abide by the law." (Id.)
B. Respondent
Respondent disputes the quantity of controlled substances that
Respondent prescribed. (Tr. 12-13.) Pointing to the practitioner manual
distributed by the DEA (see Resp't Ex. 6 at 15), Respondent also argues
that of the five grounds stated therein upon which a COR may be
revoked, the only allegation that the Government has made is that
Respondent committed an act that would render the DEA COR inconsistent
with the public interest. (Tr. 14.) Noting that 21 U.S.C. Sec. 823 and
824 set forth factors for determining the public interest, Respondent
argues that the Florida Board of Osteopathic Medicine has not made a
recommendation regarding the issuance of a DEA registration. (Tr. 14;
Resp't Br. at 21-22.) Moreover, Respondent argues that Respondent's
experience in dispensing controlled substances has not been challenged,
and in any event, Respondent has such experience. (Tr. 14; Resp't Br.
at 22.) Additionally, Respondent has not been convicted under federal
or state laws relating to the manufacture, distribution or dispensing
of controlled substances. (Tr. 14; Resp't Br. at 22.)
As for the final factor, "such other conduct which may threaten
the public safety," Respondent argues that he is no threat to the
public safety. (Tr. 19.) As an initial matter, Respondent argues that
he is remorseful, has been rehabilitated and that since discontinuing
his Internet prescribing practices, "no conduct which might threaten
the public health and safety has been charged and proved." (Resp't Br.
at 22.) Respondent also notes that attorney Robert Carr assured
Respondent that Respondent's
[[Page 61169]]
prescribing practices at UPR were within the scope of permitted
practice. (Tr. 16; Resp't Exs. 3 & 4.) Additionally, Respondent argues
that many of the prescriptions attributed to him were either forged or
written by a PA. (Tr. 16; Resp't Br. at 24.) Moreover, Respondent
argues that he was acting as a consultant to primary care physicians
and was merely extending prescriptions for drugs that had already been
prescribed by other physicians. (Tr. 17.)
Respondent further contends that he acquired adequate medical
history documentation from Ms. Messick, and that Respondent, "when
necessary, would speak by telephone with either the patient or the
patient's primary care physician." (Tr. 17-18.)
Respondent also notes that he was compensated on an hourly basis,
so the number of prescriptions he wrote was not a factor in his
prescribing habits. (Tr. 18.)
In addition, Respondent immediately terminated his Internet
prescribing upon being notified that his actions were not in conformity
with regulations. (Tr. 16.) He discontinued his prescribing habits far
before any notice of these administrative proceedings. (Tr. 18.) He
regrets his mistakes and apologizes for them. (Tr. 16, 18.)
In the nearly four years since Respondent engaged in Internet
prescribing practices at UPR, Respondent argues that he has conformed
his practice to meet all state and federal requirements, including
requirements of the Florida Department of Health, Board of Osteopathic
Medicine (Tr. 18, 19), and is converting his pain management practice
to a family practice treating indigent and low-income patients. (Tr.
18.)
VI. Discussion and Conclusions
A. The Applicable Statutory and Regulatory Provisions
The Controlled Substances Act (CSA) provides that any person who
dispenses (including prescribing) a controlled substance must obtain a
registration issued by the DEA in accordance with applicable rules and
regulations.\50\ "A prescription for a controlled substance to be
effective must be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional
practice. The responsibility for the proper prescribing and dispensing
of controlled substances is upon the prescribing practitioner" with a
corresponding responsibility on the pharmacist who fills the
prescription.\51\ It is unlawful for any person to possess a controlled
substance unless that substance was obtained pursuant to a valid
prescription from a practitioner acting in the course of his
professional practice.\52\ In addition, I conclude that the reference
in 21 U.S.C. 823(f)(5) to "other conduct which may threaten the public
health and safety" would as a matter of statutory interpretation
logically encompass the factors listed in Sec. 824(a).\53\
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\50\ 21 U.S.C. 822(a)(2); 21 U.S.C. 802(10).
\51\ 21 CFR 1306.04(a).
\52\ 21 U.S.C. 844(a).
\53\ See Kuen H. Chen, M.D., 58 FR 65,401, 65,402 (DEA 1993).
---------------------------------------------------------------------------
B. The Public Interest Standard
The CSA, at 21 U.S.C. 824(a)(4), provides, insofar as pertinent to
this proceeding, that the Deputy Administrator may revoke a COR if she
finds that the registrant's continued registration would be
inconsistent with the public interest as that term is used in 21 U.S.C.
823(f). In determining the public interest, the Deputy Administrator is
required to consider the following factors:
(1) The recommendation of the appropriate state licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing or conducting research
with respect to 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.
As a threshold matter, the factors specified in Section 823(f) are
to be considered in the disjunctive: the Deputy Administrator may
properly rely on any one or a combination of those factors, and give
each factor the weight she deems appropriate, in determining whether a
registration should be revoked or an application for registration
denied. See David H. Gillis, M.D., 58 FR 37,507, 37,508 (DEA 1993); see
also D & S Sales, 71 FR 37,607, 37,610 (DEA 2006); Joy's Ideas, 70 FR
33,195, 33,197 (DEA 2005); Henry J. Schwarz, Jr., M.D., 54 FR 16,422,
16,424 (DEA 1989). Additionally, in an action to revoke a registrant's
COR, the DEA has the burden of proving that the requirements for
revocation are satisfied.\54\ The burden of proof shifts to the
registrant once the Government has made its prima facie case.\55\
---------------------------------------------------------------------------
\54\ 21 CFR 1301.44(e) (2010).
\55\ Medicine Shoppe--Jonesborough, 73 FR 364, 380 (DEA 2008);
see also Thomas E. Johnston, 45 FR 72,311, 72,311 (DEA 1980).
---------------------------------------------------------------------------
C. The Factors To Be Considered
Factors 1 and 3: The Recommendation of the Appropriate State Licensing
Board or Professional Disciplinary Authority and Conviction Record
Under Federal or State Laws Relating to the Manufacture, Distribution
or Dispensing of Controlled Substances
In this case, regarding Factor One, it is undisputed that
Respondent currently holds a valid medical license in Florida, but
Respondent's medical license has been the subject of state disciplinary
action in the past. As discussed in the Evidence and Incorporated
Findings of Fact section of this Recommended Decision, the Florida
Department of Health instituted an Administrative Complaint against
Respondent in May 2007. (Tr. 40; Gov't Ex. 14.) The Complaint alleged,
in sum and in substance, that Respondent repeatedly prescribed
controlled substances without having face-to-face meetings with
patients; without performing adequate patient evaluations, taking
adequate medical histories, conducting adequate medical examinations,
discussing the risks and benefits of the course of treatment,
documenting treatment plans or making appropriate referrals. (E.g.,
Gov't Ex. 14 at 2-3, 14.)
The Complaint resulted in a settlement agreement, dated October 2,
2007, implemented through a final order dated December 26, 2007. (Tr.
46-48; Gov't Exs. 15 & 16.) Respondent agreed to pay a fine of $12,500,
complete continuing medical education courses, perform 100 hours of
community service and prepare a paper suitable for publication. (Tr.
46; Gov't Ex. 15; see also Gov't Ex. 16.)
Respondent failed to timely complete the deadlines set by the
settlement agreement, but as of hearing had completed most of his
requirements and was in the process of paying the assessed fine. (See,
e.g., Resp't Ex. 18 at 2 & Tr. 72 (community service); Tr. 48 & Gov't
Ex. 15 (drug course); Gov't Ex. 15 & Tr. 49, 51 ($12,500 fine).)
The most recent action by the Florida Department of Health reflects
a determination that Respondent, notwithstanding findings of
unprofessional conduct, can be entrusted with a medical license subject
to probationary terms and conditions. While not dispositive,\56\ this
action by the Florida Department of Health does weigh against a finding
that Respondent's continued registration
[[Page 61170]]
would be inconsistent with the public interest under Factor One. Cf.
Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (DEA 2003) (under Factor
One, prior suspension of respondent's state medical license held not
dispositive where state license currently under no restrictions).
---------------------------------------------------------------------------
\56\ Mortimer B. Levin, D.O., 55 FR 8209, 8210 (DEA 1990)
(finding DEA maintains separate oversight responsibility and
statutory obligation to make independent determination whether to
grant registration).
---------------------------------------------------------------------------
Regarding Factor Three, there is no evidence that Respondent has
ever been convicted under any federal or state law relating to the
manufacture, distribution or dispensing of controlled substances. I
therefore find that this factor, although not dispositive, see Leslie,
68 FR at 15,230, weighs against a finding that Respondent's continued
registration would be inconsistent with the public interest.
Factors 2 and 4: Respondent's Experience in Handling Controlled
Substances; and Compliance With Applicable State, Federal or Local Laws
Relating to Controlled Substances
Respondent argues that his experience in dispensing controlled
substances has not been challenged. (Tr. 14; see Resp't Br. at 22.)
It has. As summarized above and discussed below, the Government
challenges Respondent's supervision of his PA, his unauthorized
practice of medicine, the legitimacy of his prescribing practices and
his compliance with telemedicine standards, all applied to the
dispensing \57\ of controlled substances.
---------------------------------------------------------------------------
\57\ Under the CSA, prescribing is included in the definition of
"dispensing." 21 U.S.C. 802(10).
---------------------------------------------------------------------------
(a) Adequacy of Notice of PA Supervision Issue
A threshold matter concerns whether the Government adequately
noticed its contention that Respondent violated Florida law relating to
the supervision of his PA, Mr. Protheroe.\58\ Before the Agency may
properly impose a sanction on the basis of a given allegation, Agency
precedent requires that a registrant be provided a "'full and fair
opportunity' to litigate both the factual and legal bases of the
Government's theory." CBS Wholesale Distribs., 74 FR 36,746, 36,750
(DEA 2009). As for the factual basis of the Government's theory, I find
that the issue of Respondent's relationship with his PA was adequately
noticed by the Government's supplemental prehearing statement.\59\
---------------------------------------------------------------------------
\58\ The OSC alleges that Respondent violated Fla. Stat. Ann.
Sec. 458.347 (2008) ("Physician assistants"). (ALJ Ex. 1.)
\59\ The Government noticed Respondent's testimony: "regarding
his relationship with Physician's Assistant John Protheroe * * * He
will testify generally to the manner in which he supervised Mr.
Protheroe as well as Mr. Protheroe's responsibilities * * * Mr.
Protheroe issued prescriptions for controlled substances using
Respondent's DEA registration number * * * with Respondent's consent
and under his supervision." (Gov't Supp. PHS at 4.)
---------------------------------------------------------------------------
More complicated is whether the Government adequately noticed
provisions of Florida law relevant to the supervision of PAs. The OSC
alleges in pertinent part that Respondent violated Fla. Stat. Ann.
Sec. 458.347 (2008) ("Physician assistants"), which sets forth a
regulatory framework for the training, conduct and supervision of
PAs.\60\ (See ALJ 1.) That provision is codified in Chapter 458,
entitled "Medical Practice." But Respondent is an osteopathic doctor
(Tr. 20; Gov't Ex. 15 at 1), and not an allopathic doctor, so the
standards of his practice are governed by Chapter 459 ("Osteopathic
Medicine") and not Chapter 458 ("Medical Practice"). See Fla. Stat.
Ann. Sec. 458.303 ("The provisions of * * * [the Florida statute
noticed in the OSC, Section] 458.347 shall have no application to * * *
[o]ther duly licensed health care practitioners * * * ."). As codified
in Section 459.022, Chapter 459 contains a PA provision applicable to
osteopathic doctors that substantially mirrors the PA provision
applicable to allopathic doctors actually noticed by the Government. In
fact, a word-by-word comparison of Sec. 458.347 (allopathic doctors)
and Sec. 459.022 (osteopathic doctors), as codified during the
relevant time period,\61\ reveals that the language from each provision
governing a physician's duty of care with respect to supervising a PA
is textually identical,\62\ and the remaining provisions contain no
differences relevant to this proceeding.\63\
---------------------------------------------------------------------------
\60\ The version Fla. Stat. Ann. Sec. 458.347 alleged in the
OSC is from 2008, but the relevant time period of Respondent's
conduct was from 2004 until approximately 2006. (ALJ Ex. 1.)
Consequently, the following analysis concerns the 2004 through 2006
versions of that statute.
\61\ See Gov't Ex. 5 (collecting versions of Fla. Stat. Ann.
Sec. 459.022 from 2004-2006); see also supra note 60.
\62\ Compare Fla. Stat. Ann. Sec. 459.022(3) ("Each physician
* * * shall be * * * responsible and liable for the performance and
the acts and omissions of the physician assistant."), with Fla.
Stat. Ann. Sec. 458.347(3) (same). Compare also Fla. Stat. Ann.
Sec. 459.022(4)(e) ("A supervisory physician may delegate to a
fully licensed physician assistant the authority to prescribe or
dispense any medication used in the supervisory physician's practice
unless such medication is listed on the formulary created pursuant
to Sec. 458.347 * * * A physician assistant must clearly identify
to the patient that she or he is a physician assistant [and] inform
the patient that the patient has the right to see the physician * *
*."), with Fla. Stat. Ann. Sec. 458.347(4)(e) (same). The
reference in Section 459.022(4)(e) to the location of the formulary
of drugs a PA may not prescribe is consistent with the reference in
Section 458.347(4)(e) to "the formulary created pursuant to
paragraph (f)" because the formularies are identical. See Fla.
Admin. Code Ann. rr. 64B15-6.0038 & 64B8-30.008.
\63\ For instance, the addition of the word "osteopathic" in
the legislative intent headings of Fla. Stat. Ann. Sec. 459.022(1)
cannot be considered a material difference from the text found in
Section 458.347(1).
---------------------------------------------------------------------------
The OSC also alleges violations of Fla. Admin. Code Ann. r. 64B8-
30.008(1)(a) (formulary requirements for PAs). That provision, which
falls under the subtitle of regulations applicable to allopathic
physicians, provides in pertinent part that PAs are not authorized to
prescribe controlled substances. Fla. Admin. Code Ann. r. 64B8-
30.008(1)(a). But because subtitle 64B8 of the Florida Administrative
Code Annotated governs matters pertinent to the Board of [allopathic]
Medicine, and Respondent is a doctor of osteopathy, the relevant
Florida administrative provisions governing Respondent's conduct are
located under subtitle 64B15 ("Board of Osteopathic Medicine"). As
codified in Rule 64B15-6.0038, subtitle 64B15 contains a formulary
provision that mirrors the formulary provision applicable to allopathic
doctors actually noticed by the Government. A word-by-word comparison
of Rule 64B8-30.008(1)(a) (applicable to PAs under allopathic doctors)
and Rule 64B15-6.0038 (applicable to PAs under osteopathic doctors) as
codified during the relevant time period \64\ reveals that the two
provisions are textually identical.
---------------------------------------------------------------------------
\64\ See Gov't Ex. 3 (collecting Fla. Admin. Code Ann. rr.
64B15-6.0038 (2004), 64B8-30.008 (2005) and 64B15-6.0038 (2006));
see also supra note 60.
---------------------------------------------------------------------------
As summarized thus far, the OSC in this case notices the
Government's intention to litigate issues embracing supervision of
Respondent's PA and related formulary provisions of Florida law.
Although the provisions actually noticed by the Government pertain to
allopathic doctors and not osteopathic doctors, two reasons compel the
conclusion that the notice provided in this instance is sufficient to
apprise Respondent "that this allegation would be litigated." See
CBS, 74 FR at 36,749.
First, as discussed above, the pertinent operative sections of the
provisions actually noticed in the OSC are literally identical to the
duty-of-care provisions applicable to osteopathic doctors. Respondent
therefore had not just substantial notice, but truly actual notice of
the exact legal standards that the Government alleges that Respondent
violated.
Second, DEA, to a certain extent, adopts a "notice pleading"
model with respect to certain matters of law. Cf. 21 U.S.C. 823(f)(4)
(requiring the DEA to assess a registrant's "[c]ompliance with
[[Page 61171]]
applicable state, federal or local laws relating to controlled
substances"). I find that an otherwise adequate provision of notice of
the substantive legal issues to be addressed is not undercut by an
erroneous citation, when the text that should have been cited is
literally identical to the erroneously cited text and is contained
within a neighboring chapter of the same code of state law.
Therefore, although the Government's inaccurate noticing of the
provisions of law upon which it intends to seek revocation of a COR
could be misleading in some circumstances, I find that under the
circumstances of this case Respondent received adequate and timely
notice of the legal and factual issues surrounding Respondent's
interaction with and supervision of his PA. I therefore conclude that
Respondent's interaction with and supervision of his PA may properly be
considered as a potential basis for revoking Respondent's COR and
denying any pending applications for registration or renewal.
(b) Respondent's Supervision of His PA
An issue under Factors Two and Four of 21 U.S.C. 823(f) is whether
Respondent adequately discharged his duty under Florida and federal law
to supervise his PA, Mr. Protheroe. I find insofar as is pertinent to
this proceeding that Florida law sets forth the duties and obligations
of osteopathic physicians vis-[agrave]-vis PAs, as set forth below. See
generally Fla. Stat. Ann. Sec. 459.022; Fla. Admin. Code Ann. r.
64B15-6.0038.
A "physician assistant" is "a person who is a graduate of an
approved program or its equivalent or meets standards approved by the
boards and is licensed to perform medical services delegated by the
supervising physician." Fla. Stat. Ann. Sec. 459.022(2)(e).
"Supervision" means "responsible supervision and control. Except in
cases of emergency, supervision requires the easy availability or
physical presence of the licensed physician for consultation and
direction of the actions of the physician assistant * * * 'easy
availability' includes the ability to communicate by way of
telecommunication." Id. Sec. 459.022(2)(f). A physician "supervising
a licensed physician assistant * * * shall be * * * responsible and
liable for the performance and the acts and omissions of the physician
assistant." Id. Sec. 459.022(3). Failing to adequately supervise a PA
constitutes grounds for discipline. Id. Sec. 459.015(1)(hh). Subject
to certain limitations, "[a] supervisory physician may delegate to a
fully licensed physician assistant the authority to prescribe or
dispense any medication used in the supervisory physician's practice. *
* *" id. Sec. 459.022(4)(e), but, as emphatically stated in the
Florida Administrative Code:
PHYSICIAN ASSISTANTS APPROVED TO PRESCRIBE MEDICINAL DRUGS UNDER
THE PROVISIONS OF * * * 459.022(4)(E), F.S., ARE NOT AUTHORIZED TO
PRESCRIBE THE FOLLOWING MEDICINAL DRUGS, IN PURE FORM OR
COMBINATION: (a) Controlled substances.* * *"
Fla. Admin. Code Ann. r. 64B15-6.0038. In addition, a PA must
"clearly identify to the patient that he or she is a physician
assistant * * * [and] must inform the patient that the patient has the
right to see the physician prior to any prescription being prescribed
or dispensed by the physician assistant." Id. Sec. 459.022(4)(e)(1).
Federal law also bears upon a physician's supervision of a PA. As
an initial matter, 21 U.S.C. 846, a provision noticed by the OSC in the
above-captioned case, imposes liability for attempt and conspiracy to
violate certain provisions of the CSA.\65\ In pertinent part, the
following statutory provisions are susceptible to the sweep of Sec.
846. "Except as authorized by this title, it shall be unlawful for any
person knowingly or intentionally * * * to * * * dispense[] a
controlled substance." 21 U.S.C. 841(a). Moreover, "[e]very person
who dispenses * * * any controlled substance, shall obtain from the
Attorney General a registration," \66\ 21 U.S.C. 822(a)(2), with the
exception of "[a]n agent or employee of any registered * * * dispenser
of any controlled substance if such agent or employee is acting in the
usual course of his business or employment," Sec. 822(c)(1). It is
illegal "to use in the course of * * * dispensing of a controlled
substance * * * a registration number * * * issued to another person."
Sec. 843(a)(2).
---------------------------------------------------------------------------
\65\ Under 21 U.S.C. 846, "[a]ny person who attempts or
conspires to commit any offense defined in this title shall be
subject to the same penalties as those prescribed for the offense,
the commission of which was the object of the attempt or
conspiracy."
\66\ See also 21 CFR 1301.11 (2010).
---------------------------------------------------------------------------
Read together, I find as a matter of statutory construction that 21
U.S.C. 822, 841, 843 and 846 impose on a practitioner an affirmative
duty to supervise his or her PA to ensure that the PA dispenses \67\
medication only in accordance with the law, and to prevent the
unauthorized use of the practitioner's COR.\68\ See 21 CFR 1301.22 (2010) ("The requirement of registration is waived for any agent or
employee of a person who is registered to engage in any group of
independent activities, if such agent or employee is acting in the
usual course of his/her business or employment."). This conclusion is
consistent with Agency precedent holding that a registrant must
adequately supervise his or her PA to prevent the unlawful issuance of
prescriptions for controlled substances. As the Administrator recently
explained, "a registrant is strictly liable for the misconduct of
those persons who he authorizes to act under his registration." Scott
C. Bickman, M.D., 76 FR 17,694, 17,703 (DEA 2011); see Robert G.
Hallermeier, M.D., 62 FR 26,818, 26,820 (DEA 1997) (failure to
supervise PA "permitted the prescribing of controlled substances by an
unauthorized individual in violation of numerous provisions of Federal
and state laws and regulations, including 21 U.S.C. 829(b) and 841 and
21 CFR 1306.03 and 1306.04(a) (1997) . * * *"); Jay Wheeler Cranston,
M.D., 59 FR 36,786, 36,789 (DEA 1994) ("Respondent authorized
physician assistants to issue and sign controlled substance
prescriptions to patients without direct supervision of a physician in
violation of 21 CFR 1306.03 and 1306.05(a) (1994)."). See generally
Dan E. Hale, D.O., 69 FR 69,402, 69,406 (DEA 2004) (respondent's grant
of permission to PA to "provide controlled substances to patients
prior to the effective date of legislation permitting such activity * *
* and unauthorized utilization of a physician assistant to provide
controlled substances * * * to drug abusing patients so they would
submit to unnecessary medical tests, violated laws relating to
controlled substances * * * [and] weighs against registration").
---------------------------------------------------------------------------
\67\ Dispensing includes, inter alia, prescribing. 21 U.S.C.
802(10).
\68\ See, e.g., 21 U.S.C. 820(3) (defining "agent" as "an
authorized person who acts on behalf of or at the direction of a * *
* dispenser").
---------------------------------------------------------------------------
Turning to the facts of the case at bar, the record reveals that
Respondent's supervision of his PA, Mr. Protheroe, was virtually non-
existent. Respondent testified that Mr. Protheroe worked under
Respondent's license (Tr. 37, 131), giving rise to Respondent's legal
duty to supervise him. See Fla. Stat. Ann. Sec. 459.022(2)(e). Yet
Respondent's testimony shows that Respondent did not supervise Mr.
Protheroe. Respondent did not hire him (see Tr. 37 ("he was put there
by someone else"), did not need him (Tr. 37), complained about him
repeatedly to Mr. Bollinger
[[Page 61172]]
and Ms. Messick (see, e.g., Resp't Ex. 12 at 4; Tr. 131, 138-39), did
not control Mr. Protheroe's hours (see Tr. 37 ("he was not even
present most of the time I was there")), did not control Mr.
Protheroe's work product (see Tr. 37 ("He ended up basically
exploiting my license behind my back without my permission."); Tr. 122
(Mr. Protheroe failed to adhere to the criteria by which Respondent
rejected patients); see also Tr. 131, 138-39) and did not believe he
could fire him (Tr. 37 ("I had no power to remove him because I did
not pay his salary. I could not tell him to leave.")).
I find that Respondent failed to exercise "responsible supervision
and control" over Mr. Protheroe, in violation of Fla. Stat. Ann. Sec.
459.022(2)(f), based in part on the uncontroverted evidence that Mr.
Protheroe wrote at least 14,000 unauthorized prescriptions in
Respondent's name (Tr. 80; see generally Tr. 132; Gov't Ex. 10 at 84-
85), many of which while Respondent was away from the office for an
extended period of time (Tr. 121-22, 132; Gov't Ex. 10 at 85, 96, 101).
Because Respondent testified that he developed concerns regarding Mr.
Protheroe's performance before November 2003 (Tr. 121), which was
before Respondent went on leave in 2005 (see Tr. 121-22, 132), it
cannot reasonably be questioned that Respondent is "responsible and
liable for the performance and the acts and omissions of the physician
assistant." Id. Sec. 459.022(3).
Respondent's testimony that Respondent approved a few of Mr.
Protheroe's prescriptions each day (Tr. 42) and supervised Mr.
Protheroe during the limited times that the latter was in the office
(see Gov't Ex. 10 at 105) does not satisfy Respondent's duty to
supervise Mr. Protheroe, nor is there any evidence that Respondent
adequately supervised Mr. Protheroe telephonically as would have been
permissible under Fla. Stat. Ann. Sec. 459.022(2)(f). Respondent's
failure to adequately supervise Mr. Protheroe constitutes grounds for
discipline under Florida law. Id. Sec. 459.015(1)(hh).
The evidence further reflects that the majority of prescriptions
Mr. Protheroe wrote were for controlled substances. (E.g., Resp't Ex.
12 at 2.) This evidence constitutes a flagrant violation of Florida law
that unambiguously prohibits PAs from prescribing controlled substances
under any circumstances. Under the Florida Administrative Code,
"physician assistants * * * are not authorized to prescribe * * *
[c]ontrolled substances. * * *" \69\ Fla. Admin. Code Ann. r. 64B15-
6.0038 (internal formatting omitted). Mr. Protheroe's illegal conduct
is chargeable to Respondent because Respondent is "responsible and
liable for the performance and the acts and omissions of the physician
assistant." Fla. Stat. Ann. Sec. 459.022(3). Accord cf. Scott C.
Bickman, M.D., 76 FR at 17,703 (holding registrant strictly liable for
misconduct of "those persons who he authorizes to act under his
registration").
---------------------------------------------------------------------------
\69\ In this context the term "controlled substances" is
defined by Fla. Stat. Ann. Sec. Sec. 893.02 (2004) and 893.03
(2004) and includes hydrocodone and oxycodone, among other drugs.
See Fla. Stat. Ann. Sec. 893.03(2)(a) (2004).
---------------------------------------------------------------------------
Respondent's testimony that he approved a few of Mr. Protheroe's
prescriptions each day (Tr. 42), read together with Respondent's
admission that "[m]ost of the prescriptions written by Mr. Protheroe
were for controlled substances" (Resp't Ex. 12 at 2), suggests
Respondent attempted to confer upon Mr. Protheroe in some instances the
authority to prescribe controlled substances. But Respondent lacked
authority under Florida law to make such an authorization. "A
supervising physician may delegate to a prescribing physician assistant
only such authorized medicinal drugs as are * * * not" controlled
substances. Fla. Admin. Code Ann. r. 64B15-6.0038.
To summarize, substantial evidence supports the conclusion that
Respondent allowed a PA to use Respondent's COR to issue purported
prescriptions of controlled substances to Internet customers, and that
Respondent otherwise failed to adequately supervise his PA.
Respondent's conduct in this regard violated Fla. Stat. Ann. Sec.
459.022; Fla. Stat. Ann. Sec. 459.015(1)(hh) and Fla. Admin. Code Ann.
r. 64B15-6.0038, as well as Respondent's duty under federal law to
supervise his PA to ensure that the PA dispenses medication only in
accordance with the law, and to prevent the unauthorized or unlawful
use of Respondent's COR, e.g., Robert G. Hallermeier, M.D., 62 FR
26,818, 26,820 (DEA 1997); Jay Wheeler Cranston, M.D., 59 FR 36,786,
36,789 (DEA 1994).\70\ This finding weighs strongly in favor of a
finding under Factors Two and Four of 21 U.S.C. 823(f) that
Respondent's continued registration would be inconsistent with the
public interest.
---------------------------------------------------------------------------
\70\ See also supra text at notes 65 to 68.
---------------------------------------------------------------------------
(c) Unauthorized Practice of Medicine
Pursuant to 21 CFR 1306.03 (2010), "[a] prescription for a
controlled substance may be issued only by an individual practitioner
who is * * * authorized to prescribe controlled substances by the
jurisdiction in which he is licensed to practice his profession." The
OSC in the above-captioned case alleges violations of the laws of
Mississippi, California and Alabama relating to the unlicensed or long-
distance practice of medicine. (See ALJ Ex. 1 at 2.)
First at issue is the law of Mississippi. As codified at Miss. Code
Ann. Sec. 73-25-34(2), Mississippi has provided without amendment
since 1997 that
no person shall engage in the practice of medicine across state
lines (telemedicine) in this state, hold himself out as qualified to
do the same, or use any title, word or abbreviation to indicate to
or induce others to believe that he is duly licensed to practice
medicine across state lines in this state unless he has first
obtained a license to do so from the State Board of Medical
Licensure. * * *
See 1997 Miss. Laws 436.\71\
---------------------------------------------------------------------------
\71\ See 1997 MS ALS 436 (on LexisNexis) (historical versions)
and MS LEGIS 436 (1997) (Westlaw) (same).
---------------------------------------------------------------------------
In this case, the record reflects that Respondent currently holds a
medical license from the state of Florida. (Tr. 20.) Respondent was
previously licensed in Georgia, California and Hawaii, but has not held
medical licenses in any of those states since 1999. (Tr. 21.) Since
2000, Respondent has been licensed to practice medicine solely in
Florida. (See, e.g., Tr. 21.)
The record further reflects that during the relevant time period of
2004 to 2006 (ALJ Ex. 1 at 1), most of the individuals to whom
Respondent prescribed controlled substances became Respondent's
customers through Internet Web sites. (Tr. 25.) Respondent testified
that he recalled issuing prescriptions for controlled substances to
people located all across the United States. (Tr. 27, 39; see Resp't
Ex. 12 at 3.) Although he did not remember precisely how many different
states his client base represented, he said the list was long. (Tr.
39.) I therefore find that substantial evidence supports the OSC
allegation that Respondent issued controlled substances to customers
throughout the United States while licensed to practice medicine only
in Florida.
This finding, however, does not end the inquiry. Respondent's
testimony suggests that he did not issue prescriptions for controlled
substances to individuals in Mississippi because that state was "off
limits" in terms of what his telemedicine contract would permit. (Tr.
28.) The hearing transcript reads:
[[Page 61173]]
Q: Dr. Reppy, the people that you provided service to when you
worked at University, these were people from all over the United
States, is that correct?
A: Yes.
Q: And in fact you serviced people in all 50 states, didn't you,
during that time?
A: There were some states that were off limits because--like--
like Kentucky was one of them and Mississippi was the other one.
Those two states had stated that they would--were against any
telemedicine-type of contract at all. Now, I was--I was represented
by their legal counsel, by--by Mr. Carr that the--that the
prescribing pharmacy was licensed in all 50 states and therefore
that covered any legal issues with it. That--that wasn't true, but
that's what I was told.
(Tr. 27-28.) The record reveals no other information specifically
relating to Respondent's Mississippi prescribing practices,\72\ and the
Government called no witnesses other than Respondent, even though DEA
Diversion Investigator Peter Flagg, identified in the Government's
supplemental prehearing statement as a witness, was present in the
courtroom.\73\ (Tr. 2; Gov't Supp. PHS at 1.) Although the second half
of Respondent's testimony quoted above lends some support to the
Government's allegation that Respondent prescribed to Mississippi
residents, the first part of his statement, that Mississippi was off
limits, cuts evenly in the other direction, leaving the evidence in
equipoise.
---------------------------------------------------------------------------
\72\ Even the decision in United Prescription Servs., Inc., 72
FR 50,397 (DEA 2007), which the Government withdrew as an exhibit,
does not once mention the word "Mississippi."
\73\ See supra note 21 (recounting the Government's withdrawal
of its other witnesses).
---------------------------------------------------------------------------
"Under the preponderance of the evidence test, the [party with the
burden of proof] loses when the evidence is in equipoise because he did
not present that slight quantum of evidence necessary to tip the
balance from equipoise to his favor." United States v. Rodriguez, 406
F.3d 1261, 1300 (11th Cir. 2005) (Barkett, C.J., dissenting) (citing
Nat'l Lime Ass'n v. EPA, 627 F.2d 416, 453 n.139 (D.C. Cir. 1980)
("The standard of ordinary civil litigation, a preponderance of the
evidence, demands only 51% certainty.") and Black's Law Dictionary
1201 (7th ed. 1999)). I therefore conclude that substantial evidence
does not support the conclusion that Respondent violated Miss. Code
Ann. Sec. 73-25-34.\74\
---------------------------------------------------------------------------
\74\ To summarize: the OSC alleges that Respondent violated
Miss. Code Ann. Sec. 73-25-34 (ALJ Ex. 1 at 2), but the Government
offered no evidence to support this allegation other than the
testimony of Respondent. See supra note 21.
---------------------------------------------------------------------------
Turning to California, the law of that state has provided in
pertinent part without amendment since 2002 that
any person who practices or attempts to practice, or who advertises
or holds himself or herself out as practicing, any system or mode of
treating the sick or afflicted in this state, or who diagnoses,
treats, operates for, or prescribes for any * * * physical or mental
condition of any person, without having at the time of so doing a
valid, unrevoked, or unsuspended [California medical license] is
guilty of a public offense, punishable by fine, imprisonment or
both. Cal. Bus. & Prof. Code Sec. 2052(a).
As is true in most contexts, ignorance of the law is no defense.
The California Court of Appeal has noted that the "proscription of the
unlicensed practice of medicine is neither an obscure nor an unusual
state prohibition of which ignorance can reasonably be claimed, and
certainly not by persons * * * who are licensed health care providers.
Nor can such persons reasonably claim ignorance of the fact that
authorization of a prescription pharmaceutical constitutes the practice
of medicine." Hageseth v. Superior Court, 59 Cal. Rptr. 3d 385, 403
(Ct. App. 2007).
Here, Respondent's unrebutted testimony confirms that he issued
prescriptions for controlled substances to people in California while
he was licensed to practice medicine solely in Florida. (Tr. 21, 28.)
Respondent's witness Mr. Carr also testified that "I know California
is one of the states that we were prescribing to--or shipping drugs
to." (Tr. 158.) I therefore conclude that substantial evidence
supports a finding that Respondent violated Cal. Bus. & Prof. Code
Sec. 2052(a) (prohibiting the unlicensed practice of medicine).
In addition, Mr. Carr testified that in 2001 or 2002 he researched
the law of all fifty states regarding telemedicine (Tr. 144-45) and
"left no stone unturned," compiling a file "well over a foot high of
documents I reviewed extensively. * * *" (Tr. 150), finding that "the
telemedicine * * * realm * * * in 2001 was almost non-existent in any
kind of regulations, statutes or anything." (Tr. 144.) He concluded
that "the only reference you could really find back--back at that time
was neural radiology in pain medicine." (Tr. 144.) He could not
identify the effective date of California's statute related to Internet
prescribing. (Tr. 150, 157.)
Although neither the Government nor Respondent addressed the matter
in argument, in light of Mr. Carr's testimony, I find it notable that
California in fact adopted an Internet prescribing statute at least as
early as 2000. See Cal. Bus. & Prof. Code Sec. 2242.1. Pertinent parts
of that provision, with 2006 amendments noted,\75\ reads:
---------------------------------------------------------------------------
\75\ Added text is marked by underlining and deleted text is
marked by [brackets].
---------------------------------------------------------------------------
No person or entity may prescribe, dispense, or furnish, or
cause to be prescribed, dispensed, or furnished, dangerous drugs * *
* on the Internet for delivery to any person in this state, without
[a good faith] an appropriate prior examination and medical indication [therefor], except as authorized by Section 2242.
Id. Violators are subject to fines or civil penalties of up to
$25,000 per occurrence, id. Sec. 2242.1(b) or, "[i]f the person * * *
is not a resident of this state, a violation of this section shall, if
applicable, be reported to the person's * * * appropriate professional
licensing authority," id. Sec. 2242.1(e).
In light of the existence of this statute prior to and during the
relevant time period (see ALJ Ex. 1 (2004 to 2006)), and Mr. Carr's
testimony that he shared his research on standards for Internet
prescribing practices with Respondent before Respondent began working
for UPR, Respondent's testimony that in 2003 "the legal community was
struggling in a gray area to determine what [those standards] would
be" (Tr. 64), at least with respect to California, is not credible.
(Compare Tr. 60; see also Tr. 89-92.) When Respondent issued the
prescriptions at issue here, numerous states had already adopted laws
or regulations, or had issued policy statements making clear, that
Respondent's Internet prescribing practices were illegal.\76\ In
addition, a 2001 Federal Register notice, offered as Respondent's own
exhibit, makes clear that practitioners "must be licensed to prescribe
controlled substances by the State(s) in which they operate." \77\
(Resp't Ex. 8 at 3.) And the Model Guidelines, offered as Respondent's
Exhibit 9, cautions that "[p]hysicians who treat or prescribe through
Internet Web sites are practicing medicine and must possess appropriate
licensure in all jurisdictions where patients reside." (Resp't Ex. 9
at 12 (emphasis supplied).)
---------------------------------------------------------------------------
\76\ See, e.g., Cal. Bus. & Prof. Code Sec. 2242.1(a); Tenn.
Comp. R. & Regs. Sec. 0880-2.14(7) (2003) ("Prerequisites to
Issuing Prescriptions"); Ohio Admin. Code Sec. 4731-11-09(A)
(2003); Oklahoma State Board of Medical Licensure and Supervision,
Policy on Internet Prescribing (Ratified 01/25/01).
\77\ Although Mr. Carr testified that he interpreted
Respondent's Internet prescribing practices as operating in the
state of Florida (Tr. 160-61), Respondent offered no such testimony.
---------------------------------------------------------------------------
Moreover, Respondent's suggestion that a 2002 letter from the DEA
(see Resp't Ex. 4) gave him permission to prescribe controlled
substances to patients in states where he lacked a medical license (Tr.
60; see also Tr. 89-
[[Page 61174]]
92) is misguided. First, the DEA letter addressed the dispensing
practices of a pharmacy, not the prescribing practices of a physician.
(Tr. 97; see Resp't Ex. 4.) Second, the letter cautioned that DEA's
general expression of approval of the pharmacy came with a number of
caveats: "Management personnel will verify several elements including
* * * professional licensure[,] DEA registration[, l]egitimate patient/
prescriber relationship[, p]rescriptions are issued in the usual course
of professional practice, and [p]rescriptions are issued for a
legitimate medical purpose." (Resp't Ex. 4 at 1.) Respondent therefore
could not reasonably have relied on the DEA's letter as authorizing him
to prescribe controlled substances to patients in states in which he
lacked a medical license.
Nor did Respondent reasonably rely on statements by Mr. Carr, given
Mr. Carr's obvious financial interest in persuading Respondent to issue
prescriptions. (Tr. 151-52.) Indeed, if nothing else, Respondent should
have realized from reading a letter signed by, and another letter
addressed to, "Robert Carr/President/United Prescription Services,
Inc." (Resp't Exs. 3 & 4; Tr. 60, 89-92) that Mr. Carr could not be
counted upon to act as a disinterested advisor to Respondent because as
president he had a stake in the matter. To be certain, there is
substantial evidence that Mr. Carr provided Respondent with incomplete
information, and possibly inaccurate information, concerning the state
of telemedicine law and the legality of Respondent's prescribing
practices at UPR. Even so, ignorance of the law is no excuse,
especially where the proscription of the unlicensed practice of
medicine is hardly unique to California. See generally Hageseth, 59
Cal. Rptr. 3d at 403.
Turning to Alabama, the law of that state has provided since at
least 1975 that "[a]ny person who practices medicine or osteopathy or
offers to do so in this state without a[n Alabama medical license] * *
* shall be guilty of a Class C felony." \78\ Ala. Code Sec. 34-24-51.
Here, although Respondent admitted to prescribing controlled substances
to people located all across the United States (Tr. 27, 39), and
volunteered that the list of states in which his customers resided was
"long" (Tr. 39), there is no testimony or other evidence relating to
Respondent's Alabama prescribing practices, if indeed he had any.\79\
In fact, the word "Alabama" does not appear in the entire hearing
transcript.\80\ I therefore find that substantial evidence does not
support a finding that Respondent violated Ala. Code Sec. 34-24-51.
---------------------------------------------------------------------------
\78\ A 2007 amendment made changes that are not pertinent to
this Recommended Decision.
\79\ In adversarial proceedings such as this one, "it is not
the ALJ's role but rather that of the parties to develop the record;
the ALJ's role is to ensure that the parties do so in accordance
with the Agency's rules of procedure. * * *" East Main Street
Pharmacy, 75 FR 66,149, 66,150 n.2 (DEA 2010).
\80\ In addition, although the opinion in United Prescription
Servs., Inc., 72 FR 50,397 (DEA 2007) indicates that a Dr. Wayne
Starks issued controlled substances prescriptions to a resident of
Alabama in violation of 21 CFR 1306.04(a), see 72 FR at 50,408, that
conclusion is not binding on Respondent in the above-captioned case,
for the reasons discussed above; and in any event, there is no
indication that Dr. Starks acted in conjunction with Respondent or
at his direction.
---------------------------------------------------------------------------
In its post-hearing brief, the Government identifies legal
authority in Tennessee, Illinois and North Carolina that it alleges
Respondent violated. (See Gov't Br. at 5.) Although Respondent did
admit in response to questioning by counsel for the Government that he
issued prescriptions for controlled substances to customers in these
states while holding a medical license only in Florida (Tr. 38-39), I
do not rely on these admissions as a potential basis for recommending
imposition of a sanction because the issue of violations of the laws of
Tennessee, Illinois and North Carolina was not noticed in the OSC,\81\
the Government's prehearing statement \82\ or the Government's
supplemental prehearing statement. Respondent lacked adequate notice
that violations of these states' laws would be at issue where the
Government raised the factual basis of its theory for the first time at
hearing, and raised the legal basis for the first time in its post-
hearing brief. See CBS Wholesale Distribs., 74 FR 36,746, 36,750 (DEA
2009) (finding that Respondent is entitled to a " 'full and fair
opportunity' to litigate both the factual and legal bases of the
Government's theory" (emphasis supplied)).
---------------------------------------------------------------------------
\81\ The OSC alleges: "You violated state laws that prohibit
the unauthorized practice of medicine, including unlicensed, out-of-
state physicians issuing controlled substance prescriptions to state
residents. See e.g. Miss. Code Ann. Sec. 73-25-34; Cal. Bus. &
Prof. Code Sec. 2052; Ala. Code Sec. 34-24-51." (ALJ Ex. 1.) This
language is too vague to notice violations of the laws of Tennessee,
Illinois and North Carolina because the allegation of violations of
"state laws" did not reasonably apprise Respondent of which other
states' laws, if any. To be certain, the three states cited as
exempli gratia (Mississippi, California and Alabama) could
reasonably have apprised Respondent that other states laws might be
in contention, too; but nothing in the OSC or other prehearing
filings reasonably apprised Respondent of which ones.
\82\ While the Government's prehearing statement notices its
intent to offer into evidence controlled substances prescriptions to
individuals in Illinois and Tennessee (Gov't PHS at 3), the
Government withdrew that exhibit (Tr. 6-7). More importantly, the
prehearing statement did not allege violations of Illinois,
Tennessee or North Carolina law.
---------------------------------------------------------------------------
I also decline, for reasons more fully discussed above,\83\ the
Government's invitation to recommend imposition of a sanction on the
basis of "Respondent's violation of numerous state laws [as] explained
in United Prescription Services, Inc., Revocation of Registration, 72
FR 50,397 (August 31, 2007)." (Gov't Br. at 5-6.) The APA, the
doctrine of res judicata and principles of fair play and substantial
justice foreclose the reliance on conclusions as to the legality of
Respondent's conduct reached in a prior hearing where Respondent, a
non-party in that proceeding, lacked both the motive and the
opportunity to fully develop the relevant issues on cross examination
and in fact cooperated with the Government.\84\ See 5 U.S.C. Sec.
551(3) (defining "party") and 556(e) (administrative record); see
also Johnson v. United States, 576 F.2d 606, 614 (5th Cir. 1978)
(cautioning against the use of offensive collateral estoppel). Cf.,
e.g., Fed. R. Evid. 804(b)(1) (former testimony hearsay exception).
---------------------------------------------------------------------------
\83\ See supra Part II(A) (finding that the APA and negative
implications stemming from the doctrine of offensive collateral
estoppel preclude my reliance on conclusions of law regarding
Respondent's conduct in a case in which he was not a named party).
\84\ Tr. 78; see Resp't Br. at 17 ("Respondent's testimony [in
the previous UPS proceeding] was beneficial to and supportive of the
Government's position, and he also provided an affidavit of
assistance to the Government."); see also United Prescription
Servs., Inc., 72 FR 50,397, 50,400 (DEA 2007) (citing affidavit by
Dr. Reppy submitted as Government exhibit in prior proceeding).
---------------------------------------------------------------------------
To summarize, substantial evidence supports the conclusion that
Respondent violated the laws of California by issuing prescriptions to
customers across the country while licensed to practice medicine solely
in the state of Florida, in violation of Cal. Bus. & Prof. Code Sec.
2052(a) and 21 CFR 1306.03 (2010). This finding weighs in favor of a
finding under Factors Two and Four of 21 U.S.C. 823(f) that
Respondent's continued registration would be inconsistent with the
public interest.
(d) Whether Respondent Issued Prescriptions for Controlled Substances
Without a Legitimate Medical Purpose and Outside the Usual Course of
Professional Practice
Another issue concerns whether Respondent conducted his prescribing
practices pursuant to a legitimate medical purpose and within the usual
[[Page 61175]]
course of professional practice, consistent with 21 CFR 1306.04(a) and 21 U.S.C. 841(a)(1).\85\ To be effective, and lawful, a prescription
for a controlled substance "must be issued for a legitimate medical
purpose by an individual practitioner acting in the usual course of his
professional practice * * * An order purporting to be a prescription
issued not in the usual course of professional treatment * * * is not a
prescription * * * and the person knowingly filling such a purported
prescription, as well as the person issuing it, shall be subject to the
penalties provided for violations of the provisions of law relating to
controlled substances." \86\ 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."
Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United States v.
Moore, 423 U.S. 122, 135 (1975)).
---------------------------------------------------------------------------
\85\ The OSC explicitly alleges violations of 21 CFR 1306.04(a)
and 21 U.S.C. 841(a)(1). (ALJ Ex. 1.)
\86\ 21 CFR 1306.04(a) (2010).
---------------------------------------------------------------------------
As an initial matter, "[a] physician who engages in the
unauthorized practice of medicine is not a 'practitioner acting in the
usual course of * * * professional practice" as required by 21 CFR
1306.04(a) (describing requirements for lawful issuance of
prescription). See, e.g., United Prescription Servs., Inc., 72 FR
50,397-01, 50,407 (DEA 2007). As noted above, I find that Respondent
engaged in the unauthorized practice of medicine by issuing
prescriptions for controlled substances to people in California while
he was licensed to practice medicine solely in Florida, in violation of
Cal. Bus. & Prof. Code Sec. 2052(a). I therefore conclude that
Respondent acted outside the usual course of professional practice, in
violation of 21 CFR 1306.04(a).
Federal law further provides that revocation of a registration
under the public interest standard of 21 U.S.C. 823(f) is not limited
to practitioners who intentionally violate the prescription
requirement, but also includes a "practitioner's failure to properly
supervise her patients to prevent them from personally abusing
controlled substances or selling them to others. * * *" Jeri Hassman,
M.D., 75 FR 8194, 8227 (DEA 2010). A practitioner must also "have
established a bona fide doctor-patient relationship with the individual
for whom the prescription is written." Mohammed F. Abdel-Hameed, M.D.,
66 FR 61,366, 61,369 (DEA 2009). At the time of the events at issue
here, the CSA looked to state law to determine whether a physician has
established a valid doctor-patient relationship.\87\ United
Prescription Servs., Inc., 72 FR 50,397, 50,407 (DEA 2007).
---------------------------------------------------------------------------
\87\ On October 15, 2008, the President signed into law the Ryan
Haight Online Pharmacy Consumer Protection Act of 2008, Public Law
110-425, 122 Stat. 4820 (2008). Section 2 of the Act prohibits the
dispensing of a prescription controlled substance "by means of the
Internet without a valid prescription," and defines, in relevant
part, "[t]he term 'valid prescription' [to] mean[ ] a prescription
that is issued for a legitimate medical purpose in the usual course
of professional practice by * * * a practitioner who has conducted
at least 1 in-person medical evaluation of the patient." 122 Stat.
4820. Section 2 further defines "[t]he term 'in-person medical
evaluation' [to] mean[ ] a medical evaluation that is conducted with
the patient in the physical presence of the practitioner, without
regard to whether portions of the evaluation are conducted by other
health professionals." Id. See generally 21 U.S.C. 829 (incorporating amendments). These provisions do not, however, apply
to Respondent's conduct, which predated them.
---------------------------------------------------------------------------
Turning to Florida, a state in which Respondent conducted business
and has been licensed for at least ten years (see, e.g., Tr. 20-23, 51,
56, 68, 107), the law of that state provided for part of the relevant
time period \88\ that "gross or repeated malpractice or the failure to
practice osteopathic medicine with that level of care, skill and
treatment which is recognized by a reasonable prudent similar
osteopathic physician as being accepted under similar conditions and
circumstances, constitutes grounds for discipline." Fla. Stat. Ann.
Sec. 459.015(1)(x) (2001).
---------------------------------------------------------------------------
\88\ The quoted text that follows was the law in Florida from
June 19, 2001, to June 20, 2005. Compare 2001 Fla. Sess. Law Serv.
Ch. 2001-277 (C.S.S.B. 1558) (West) (2001 amendments enacting
language cited), with 2005 Fla. Sess. Law Serv. Ch. 2005-266
(C.S.S.B. 940) (West) (substantially altering Fla. Stat. Ann. Sec.
459.015(1)(x)).
---------------------------------------------------------------------------
In addition, from March 2000 through November 2006,\89\ Florida
required that "complete medical history and physical examination must
be conducted and documented in the medical record." Fla. Admin. Code
Ann. r. 64B15-14.005(3)(a) (2000) ("Standards for the Use of
Controlled Substances for Treatment of Pain"). Osteopathic physicians
have been required continuously since 1997 to "maintain written
legible records on each patient. Such records shall contain * * * (a)
Patient histories; (b) Examination results; (c) Test results; (d)
Records of drugs prescribed, dispensed or administered; (e) Reports of
consultations; and (f) Reports of hospitalizations." Fla. Admin. Code
Ann. r. 64B15-15.004 (Dec. 22, 1997) ("Written Records; Minimum
Content; Retention").\90\ Finally, Florida law has provided
continuously since June 19, 2001,\91\ that prescribing controlled
substances "inappropriately or in excessive or inappropriate
quantities is not in the best interest of the patient and is not in the
course of the physician's professional practice, without regard to his
intent." Fla. Stat. Ann. Sec. 459.015(1)(t).\92\
---------------------------------------------------------------------------
\89\ See Florida Department of State: State Library and Archives
of Florida, Florida Administrative Weekly & Florida Administrative
Code, http://www.flrules.org/gateway/RuleNo.asp?title=PRACTICE.
REQUIREMENTs&ID=64B15-14.005.
\90\ The foregoing provisions of Florida law are prominently
identified in the Florida Administrative Complaint against
Respondent (Gov't Ex. 14), which was provided to Respondent as part
of the Government's document exchange.
\91\ See 2001 Fla. Sess. Law Serv. Ch. 2001-277 (C.S.S.B. 1558)
(West) (adopting quoted language).
\92\ The OSC alleges violations of an identical provision of
Florida law applicable to allopathic doctors, Fla. Stat. Ann. Sec.
458.331(q). See ALJ. Ex. 1. For reasons discussed above, however, I
find the provision applicable to osteopathic doctors was
sufficiently noticed.
---------------------------------------------------------------------------
The evidence at hearing regarding Respondent's prescribing
practices included testimony from Respondent and Ms. Messick. As
discussed above in the Evidence and Incorporated Findings of Fact
section of this Recommended Decision, Respondent prescribed
hydrocodone, a controlled substance, to thousands of patients over a
four-year period from 2002 to 2006 (Tr. 21-23, 43, 51, 53) without
examining as many as ninety percent of his patients (see Tr. 25-26).
Despite his claim that his patients "were not placing their whole care
in my hands" (Tr. 110), Respondent did not consult with the majority
of his patients' primary care physicians. (See, e.g., Tr. 34, 35 (one
or two physician consultations out of 150 patients serviced in given
week); see also Gov't Ex. 10 at 30, 37). In fact, Respondent testified
that he treated patients who had been discharged by their providers,
whether for lack of funding or another reason: "I was continuing the
treatment plan that was first set up by their doctor who might no
longer have been willing to continue that plan. * * *" (Tr. 113; see
also Tr. 116.) While legitimate reasons might have justified continuing
a course of treatment in some instances where the primary care
physician refused to do so,\93\ Respondent's
[[Page 61176]]
conduct in many instances is inconsistent with a continuing course of
treatment.
---------------------------------------------------------------------------
\93\ For instance, read expansively, Respondent's testimony
suggests a doctor might legitimately continue a medically sound
treatment plan under which the previous provider ceased providing
treatment due to a patient's inability to pay. (See Gov't Ex. 10 at
19 (testifying that certain pain management patients could not
afford monthly office visits costing $150); see also Tr. 79.)
Respondent, however, did not offer evidence that most or even many
of his patients were in this situation.
---------------------------------------------------------------------------
The evidence reflects Respondent did not consult with the majority
of his patients' primary care physicians, and he had limited
opportunity, if any, to independently confirm why those physicians
stopped treating Respondent's patients. Florida law required Respondent
to take and record a complete medical history and medical records, see
Fla. Admin. Code Ann. r. 64B15-14.005(3)(a) (2000); Fla. Admin. Code
Ann. r. 64B15-15.004. But the record is silent as to the steps
Respondent took to independently verify most of his patients'
histories. (See Tr. 32 ("not the common practice" for Respondent to
confer with primary care physicians).) Indeed, Respondent testified
that he took no additional steps: "If you have documentation in front
of you that is signed by the primary care doctor * * * that is usually
considered sufficient." (Tr. 32-33.) He added: "the error rate in
records is not particularly high." (Tr. 35.) As for those physicians
he did consult, Respondent provided no details as to the contents of
the conversations.
Respondent therefore had no way to verify, nor is his testimony
consistent with his assertion, that his patients "were not placing
their whole care in [Respondent's] hands." (Tr. 110.) The record
reflects that other doctors referred no more than approximately 300
patients to Respondent over the course of a four-year period (Tr. 35-
36), and that Respondent prescribed hydrocodone to thousands of
individuals without a face-to-face interaction or physical examination.
(Tr. 43; see Tr. 53.) I therefore reject in substantial part
Respondent's argument that he merely acted as a consultant to a primary
care physician and merely extended prescriptions for drugs that had
already been prescribed by another physician. (Tr. 17.) Contrary to
Respondent's claim, Respondent had no affiliation with most of the
physicians whose records he relied on (Tr. 36) and should have
proceeded as if the care of the majority of his patients was solely in
his own hands because, as Respondent's own testimony shows, in a
meaningful number of cases it was. His failure to do so raises the
specter of diversion and improper treatment. It also constitutes a
"failure to practice osteopathic medicine with [a reasonable] level of
care, skill and treatment," which under Florida law from 2001 to 2005
constituted grounds for discipline.\94\ See Fla. Stat. Ann. Sec.
459.015(1)(x) (2001). His conduct was outside the usual course of
professional practice. See 21 CFR 1306.04(a); 21 U.S.C. 841(a)(1).
---------------------------------------------------------------------------
\94\ See supra note 88.
---------------------------------------------------------------------------
In addition to testifying that he did not perform physical
examinations on the majority of his patients (Tr. 25-26), Respondent
also conceded that other physicians did not perform examinations of
patients at Respondent's direction.\95\ (Tr. 36.) And because
Respondent acquired his patients' records directly from patients and
not from medical professionals (see Tr. 34, 79-80), a practice that
could lead to fraud (see generally Tr. 55-56), Respondent had no way to
verify that anyone had ever actually conducted physical examinations on
many of his patients, or that any such physical examinations were
conducted recently enough to warrant a prescription for controlled
substances. In light of Respondent's testimony that he had noticed
fraudulent alterations in some of his patients' records (Tr. 56), there
is insufficient evidence to substantiate Respondent's contention that
"[p]atients did not make [their medical records] up on their own."
(Tr. 34.) Respondent's conduct does not comply with Florida standards,
as follows.
---------------------------------------------------------------------------
\95\ As Respondent explained in his testimony in a prior
proceeding, "the physical examination has to be done by someone
else in the case of telemedicine. [Patients] have to have seen a
local doctor that actually saw them and performed the physical
examination, and gotten those notes to me, so that I know what was
seen and have the information available." (Gov't Ex. 10 at 25-26.)
---------------------------------------------------------------------------
Although there appears to be some ambiguity in Florida law
regarding whether a physical examination must be conducted by the
prescribing physician, as opposed to a referring physician, there are
indications that the prescribing physician must conduct the physical
examination himself. A 2002 decision by the State of Florida Division
of Administrative Hearings interpreting the state telemedicine rule
applicable to osteopathic doctors observed that "assuming that the
physician had complied with the [telemedicine rule, Fla. Admin. Code
Ann. r. 64B15-14.008] by conducting a physical examination when the
drug was prescribed, the requirement [of a documented patient
evaluation, "including history and physical examination, adequate to
establish the diagnosis for which any drug is prescribed"] would
already be satisfied." Levy v. Dep't of Health, No. 02-2308RX, at *45,
2002 Fla. Div. Adm. Hear. LEXIS 1443 (Dec. 3, 2002).
Other Florida decisions interpreting Florida's nearly identical
telemedicine rule (Fla. Admin. Code Ann. r. 64B8-9.014) \96\ applicable
to allopathic doctors are consistent with this conclusion. See, e.g.,
Dep't of Health v. Wise, No. 06-2014PL, at *20, 26, 2006 Fla. Div. Adm.
Hear. LEXIS 530 (Nov. 9, 2006) ("simply relying upon what a patient
reports is their blood pressure does not constitute a physical
examination" and concluding "failure to conduct a physical
examination * * * constituted the failure to practice medicine with
that level of care, skill, and treatment which is recognized by
reasonably prudent physicians as being acceptable under similar
condition and circumstances"). I therefore find that Respondent
violated applicable Florida rules regarding physical examinations.
---------------------------------------------------------------------------
\96\ See supra text at notes 99 to 101.
---------------------------------------------------------------------------
Respondent's conduct also does not comply with standards
acknowledged by Respondent. Respondent testified that to have a valid
doctor-patient relationship, a servicing medical professional must have
conducted a physical examination of the patient. (Gov't Ex. 10 at 79-80
("Someone must have done [a physical examination]).") For follow-up
consultations, Respondent would not require "a new physical exam with
every consult. When it became, in my opinion, too dated, then I would
demand another physical exam." (Gov't Ex. 10 at 79.) Yet there is
substantial evidence, summarized above, that on numerous occasions
Respondent failed to ensure that these requirements were met.
"Respondent thus routinely prescribed without any independent
assessment and verification of his patients' medical complaints."
Ladapo O. Shyngle, M.D., 74 FR 6056, 6057, 6058 (DEA 2009) (holding
that Florida physician failed to establish bona fide doctor-patient
relationship where he "prescribed on the basis of a telephonic
consultation and did not personally conduct a physical exam and take a
medical history from the patients").
Respondent's failure to supervise his PA, John Protheroe, also
bears on the reliability of Respondent's medical records. Respondent
repeatedly suggested that Respondent was part of a process at UPR over
which he lacked control. For instance, Respondent testified that he
could not differentiate between prescriptions issued by Mr. Protheroe
in Respondent's name and prescriptions that Respondent issued
himself.\97\ (E.g., Tr. 41-43.) Asked
[[Page 61177]]
whether Respondent completed the conduct charged in Florida's
Administrative Complaint against him, Respondent stated:
---------------------------------------------------------------------------
\97\ Respondent testified that he did not know the identity of
"[J.N.]," a patient identified in the Florida Administrative
Complaint. (Tr. 42.) Respondent does not know whether he issued any
of the prescriptions alleged in the Complaint, a situation he
attributes to the sheer number of prescriptions his PA wrote without
authorization. (Tr. 41-42.)
---------------------------------------------------------------------------
I actually don't know if I did or not, because as I said, this
PA John Protheroe wrote so many prescriptions without my
authorization using a stamp of my signature that it may well have been done under--under that process.
(Tr. 41.) Yet, in prescribing to his own repeat patients,
Respondent's testimony shows he relied on medical records containing
previous prescriptions bearing his signature without knowing whether he
or Mr. Protheroe issued those prescriptions. Respondent's testimony
that he couldn't distinguish whether he or his PA had treated a
patient, combined with his willingness to nevertheless issue follow-up
prescriptions, is further evidence of Respondent's failure in many
instances to establish and maintain a valid doctor-patient
relationship.
In addition to the problems noted above, Respondent's verification
of patient identity was patently inadequate. Respondent had no face-to-
face interactions with as many as ninety percent of his patients. (Tr.
26, 55.) When ascertaining a patient's identity before issuing a
controlled substance prescription, therefore, Respondent relied almost
exclusively on documents submitted by the patient with no concurrent
verification of identity such as comparing a photo identification with
the person presenting it.
As for how he verified the identity of patients with whom he never
physically interacted, Respondent testified that "I used the same
method of checking their identity as I would if they were present in
front of me." (Tr. 54.) Yet Respondent conceded that he never saw most
of the people to whom he issued prescriptions (Tr. 55), undermining the
basis for his claim.
Respondent explained that "I was rather good at detecting fraud"
by comparing font and language in different parts of patient medical
records. (Tr. 56.) Respondent added: "If the state did not adequately
check their identity before issuing them a driver's license * * * I had
no way of determining that." (Tr. 54.) Respondent's explanation
entirely misses the point. The question Respondent should have cared
about, but apparently did not, was whether the person receiving
treatment was actually the person described in the medical records. A
patient referral provides at least some degree of identity
verification. But given the low rate at which doctors referred patients
to Respondent (Tr. 35-36 (approximately 300 patients over four years))
compared with the total number of Respondent's patients (Tr. 52-53 (150
patients per week, constituting at least 5000 controlled substances
prescriptions per year)), verifying that the patient fit the records
should have been a great concern for Respondent.
Respondent testified that some people misuse and abuse the kinds of
controlled substances that Respondent prescribed at UPR, particularly
hydrocodone, alprazolam, oxycodone and methadone. (Tr. 65.) From time
to time Respondent encountered patients who abused controlled
substances and immediately dismissed them. (Tr. 65.) "I ferreted it
out where I could." (Tr. 65.) Respondent, however, could not state how
many of his patients were addicted to narcotics while he was
prescribing to them. (Tr. 118.)
Without the face-to-face meetings that Respondent conducted in no
more than approximately ten percent of consultations (e.g., Tr. 26,
55)), Respondent could not objectively assess whether a person's
appearance as recited in photo identification and medical records (to
include height, weight, sex, hair color and the like) matched the
person presenting as a patient over the telephone. Because patients
submitted their own medical records to Respondent's clinic (Tr. 34; 79-
80), and thus had both the opportunity and the inclination to
fraudulently modify them (see generally Tr. 56), Respondent's nearly
exclusive reliance on his own ability to detect fraudulent
modifications (see Tr. 56), even if Respondent was quite skilled in
this regard, was unreasonable under the circumstances. Indeed,
Respondent conceded that it was possible that a person posing as a
patient could take the medical records and identification of a deceased
person, and Respondent would have no way of knowing whether the person
on the phone was actually the person whose medical records and
identification Respondent was reviewing. (Tr. 55-56.) Respondent's
testimony suggesting that an unspecified percentage of his patients
could not afford traveling to visit Respondent in person (e.g., Tr. 79,
116) does not substantially mitigate the potential for diversion
inherent to Respondent's Internet prescribing practices.\98\ I find it
more likely than not that Respondent failed "to properly supervise
[his] patients to prevent them from personally abusing controlled
substances or selling them to others. * * *" Jeri Hassman, M.D., 75 FR
8194, 8227 (DEA 2010).
---------------------------------------------------------------------------
\98\ Moreover, the weight given to Respondent's testimony in
this regard is diminished by Respondent's admission that he does not
know how much UPR charged. (Tr. 119.)
---------------------------------------------------------------------------
In sum, Respondent did not verify that the majority of the
individuals to whom he prescribed controlled substances were actually
the patients listed in the medical records associated with their files,
constituting a departure from the usual course of professional
practice. Any quantity of controlled substances Respondent prescribed
to these patients was therefore "inappropriate." See Fla. Stat. Ann.
Sec. 459.015(1)(t). In addition to falling below Florida standards of
professional practice, Respondent's identity verification practices
also raise the specter of the diversion of controlled substances, given
that most or many of the individuals who contacted Respondent at UPR
sought and ultimately received controlled substances. (Tr. 28, 36.)
There are further examples in the record indicating significant
deviations in Respondent's prescribing practices from the usual course
of professional practice, but further elaboration is unnecessary.
Respondent "voluntarily and openly admit[s] that he had issued
prescriptions to individuals via the Internet whom he had not examined
and who were residents of states other than a state in which Respondent
was licensed. * * *" (Resp't Br. at 23.) Respondent concedes, and I so
find by a preponderance of the evidence, that "the Government has
established the fact that the majority of the prescriptions by the
Respondent during his work at [UPR] were not valid." (Resp't Br. at
23.)
In partial mitigation, Respondent recognizes both that his reliance
on Mr. Carr's advice was misplaced and also that Mr. Carr's 2002
correspondence with the DEA does not excuse his prescribing of
controlled substances to patients residing in states where he was not
licensed. (Id.) But even if Respondent's reliance on Mr. Carr's advice
were deemed to be reasonable, and I do not so find, such reliance would
not outweigh the significant weight properly given to his issuance of
thousands of controlled substances prescriptions to patients across the
country while he was licensed to practice medicine solely in Florida;
his
[[Page 61178]]
routine failure to either conduct physical examinations or consult with
a patient's primary care physician to ensure that a physical
examination was conducted recently enough to sustain a diagnosis
justifying controlled substances; his misplaced confidence in his own
ability to detect fraud in medical records, which he obtained directly
from patients, when he could have required the records be sent directly
from other practitioners; and his related failure to acknowledge his
failures to sufficiently verify the identity of most patients.
For the foregoing reasons, I find by substantial evidence that
Respondent issued a substantial number of prescriptions for other than
a legitimate medical purpose or outside the usual course of
professional practice and without establishing a bona fide doctor-
patient relationship, in violation of Florida law, see Fla. Stat. Ann.
Sec. 459.015(1)(x) (2001); Fla. Stat. Ann. Sec. 459.015(1)(t) (2001);
Fla. Admin. Code Ann. rr. 64B15-14.005(3)(a) and 64B15-15.004, and
federal law, see 21 CFR 1306.04(a); 21 U.S.C. 841(a)(1); Mohammed F.
Abdel-Hameed, M.D., 66 FR 61366, 61369 (DEA 2009) and Ladapo O.
Shyngle, M.D., 74 FR 6056, 6057, 6058 (DEA 2009). This finding weighs
heavily in favor of a finding under Factors Two and Four of 21 U.S.C.
823(f) that Respondent's continued registration would be inconsistent
with the public interest.
(e) Adequacy of Notice of Florida Telemedicine Issue
Next at issue is whether the Government adequately noticed its
contention that Respondent violated Florida standards for telemedicine
prescribing practice.\99\
---------------------------------------------------------------------------
\99\ The Government's prehearing statement alleges violations of
Florida telemedicine standards, as discussed below. Before the
Agency may properly impose a sanction on the basis of a given
allegation, Agency precedent requires that a registrant be provided
a " 'full and fair opportunity' to litigate both the factual and
legal bases of the Government's theory." CBS Wholesale Distribs.,
74 FR 36746, 36750 (DEA 2009).
---------------------------------------------------------------------------
Regarding the factual basis of the Government's theory, the
Government's prehearing statement calls into issue "the process by
which [Respondent] authorized Internet requests for drugs" including
the information he collected, the basis of his diagnosis, his
communication with patients and full disclosure, among other things.
(See Gov't PHS, Jun. 18, 2010, at 2-3.) Moreover, the Government's
prehearing statement also notices its intent to introduce as
documentary evidence a copy of Florida Administrative Code Rule 64B8-
9.014 ("Standards for Telemedicine Prescribing Practice"), consistent
with the OSC. (Id. at 3; ALJ Ex. 1.) I therefore find that the factual
issue of Respondent's compliance with applicable Florida telemedicine
practices was adequately noticed.
More complicated is whether the Government adequately noticed its
intent to rely on provisions of Florida law relevant to standards for
telemedicine in seeking the revocation of Respondent's COR. As noted
above, the Government's prehearing statement noticed the issue of
Respondent's compliance with Florida Administrative Code Rule 64B8-
9.014. That provision, which falls under the subtitle of regulations
applicable to allopathic physicians, sets forth standards for
telemedicine prescribing practice in Florida. Fla. Admin. Code Ann. r.
64B8-9.014. But because subtitle 64B8 of the Florida Administrative
Code governs matters pertinent to the Board of [allopathic] Medicine,
and Respondent is a doctor of osteopathy, the relevant Florida
administrative provisions governing Respondent's conduct are located
under subtitle 64B15 ("Board of Osteopathic Medicine"). Rule 64B15-
14.008 in that subtitle contains a telemedicine provision that mirrors
the telemedicine provision applicable to allopathic doctors that was
actually noticed by the Government. A word-by-word comparison of Rule
64B8-9.014 (telemedicine standards for allopathic doctors) and Rule
64B15-14.008 (telemedicine standards for osteopathic doctors), as
codified during the relevant time period of 2004 through 2006 \100\
(see ALJ Ex. 1) reveals that the two provisions are substantially
identical.\101\ Because Respondent thus had actual notice of the legal
standards that the Government alleges that Respondent violated, I find
that the notice provided in this instance was sufficient to apprise
Respondent "that this allegation would be litigated." See CBS, 74 FR
at 36749.
---------------------------------------------------------------------------
\100\ See Gov't Ex. 4 (collecting versions of Fla. Admin. Code
Ann. r. 64B15.4008 from 2004-2006); see also supra note 60.
\101\ The only notable differences are as follows. First, r.
64B15-14.008 inserts the word "osteopathic" at various points to
reflect that the actor contemplated is an osteopathic physician and
not an allopathic physician. Second, r. 64B8-9.014 explicitly
contemplates that PAs may participate in telemedicine practices,
whereas r. 64B15-14.008 does not. Finally, r. 64B8-9.014, but not r.
64B15-14.008, explicitly defines "telemedicine" as including
prescribing via the Internet, telephone or facsimile. Compare Fla.
Admin. Code Ann. r. 64B8-9.014, with id. r. 64B15-14.008.
---------------------------------------------------------------------------
(f) Respondent's Compliance with Florida Telemedicine Standards
On October 16, 2001, Florida enacted a rule applicable to
osteopathic doctors entitled "Standards for Telemedicine Practice."
\102\ Fla. Admin. Code Ann. r. 64B15-14.008. The spirit of the rule is
to prevent physicians from prescribing medications with only minimal
diagnosis and documentation. In addition to constituting grounds for
disciplinary action under Fla. Stat. Ann. Sec. 459.015(1)(x) and (t),
---------------------------------------------------------------------------
\102\ See Florida Department of State: State Library and
Archives of Florida, Florida Administrative Weekly & Florida
Administrative Code, https://www.flrules.org/gateway/ruleNo.asp?id=64B15-14.008 (listing enactment date as October 16,
2001, and identifying sole alteration or variance since that time as
a variance granted to a Virtual Medical Group, Inc. on May 26,
2006).
---------------------------------------------------------------------------
[p]rescribing medications based solely on an electronic medical
questionnaire constitutes the failure to practice osteopathic
medicine with that level of care, skill and treatment which is
recognized by reasonably prudent osteopathic physicians as being acceptable. * * *
Fla. Admin. Code Ann. r. 64B15-14.008. Before an osteopathic physician
may "provide treatment recommendations, including issuing a
prescription, via electronic or other means," the rule requires:
(1) A documented patient evaluation, including history and
physical examination, adequate to establish the diagnosis for which
any drug is prescribed.
(2) Sufficient dialogue between the osteopathic physician and
the patient regarding treatment options and the risks and benefits
of treatment.
(3) Maintenance of contemporaneous medical records meeting the
requirements of Rule 64B15-15.004, F.A.C.
Id. In addition to an emergency services provision not applicable
here, the rule finally states that it "shall not be construed to
prohibit patient care in consultation with another physician who has an
ongoing relationship with the patient, and who has agreed to supervise
the patient's treatment, including the use of any prescribed
medications. * * *" Id.
As discussed supra, Respondent on numerous occasions (Tr. 53 (5000
controlled substances prescriptions per year)) "provide[d] treatment
recommendations, including issuing a prescription, via electronic or
other means" without conducting patient evaluations to include
physical examinations or ensuring that such examinations were reliably
conducted by other qualified medical professionals (see, e.g., supra
text at note 95) and without maintaining medical records meeting the
requirements of Rule 64B15-15.004 (see supra text at notes 93 to 94).
Nor did Respondent in more than approximately 300 cases (see Tr. 35-36)
out of thousands (Tr. 53) ever act in a
[[Page 61179]]
consultative capacity "with another physician who ha[d] an ongoing
relationship with the patient, and who ha[d] agreed to supervise the
patient's treatment, including the use of any prescribed medications,"
Fla. Admin. Code Ann. r. 64B15-14.008. I therefore find that Respondent
failed to comply with Fla. Admin. Code Ann. r. 64B15-14.008
("Standards for Telemedicine Practice"). This finding weighs in favor
of a finding under Factors Two and Four of 21 U.S.C. Sec. 823(f) that
Respondent's continued registration would be contrary to the public
interest.
Factor 5: Such Other Conduct Which May Threaten the Public Health and
Safety
Under Factor Five, the Deputy Administrator is authorized to
consider "other conduct which may threaten the public health and
safety." 5 U.S.C. 823(f)(5). The Agency has accordingly held that
"where a registrant has committed acts inconsistent with the public
interest, the registrant must accept responsibility for his or her
actions and demonstrate that he or she will not engage in future
misconduct. Patrick W. Stodola, 74 FR 20,727, 20,734 (DEA 2009).\103\ A
"[r]espondent's lack of candor and inconsistent explanations" may
serve as a basis for denial of a registration. John Stanford Noell,
M.D., 59 FR 47,359, 47,361 (DEA 1994). Additionally, "[c]onsideration
of the deterrent effect of a potential sanction is supported by the
CSA's purpose of protecting the public interest." Joseph Gaudio, M.D.,
74 FR 10,083, 10,094 (DEA 2009).
---------------------------------------------------------------------------
\103\ See also Hoxie v. DEA, 419 F.3d 477, 484 (6th Cir. 2005)
(decision to revoke registration "consistent with the DEA's view of
the importance of physician candor and cooperation.")
---------------------------------------------------------------------------
As discussed above, the substance of Respondent's conduct between
2004 and 2006 is relatively uncontroverted. Respondent issued,
permitted his PA to issue or failed to prevent his PA from issuing in
Respondent's name thousands of controlled substances prescriptions to
patients around the country while Respondent was licensed to practice
medicine only in Florida. Many of these prescriptions issued without
Respondent or a physician acting at Respondent's direction ever
conducting a physical examination, let alone seeing the patient.
Respondent infrequently consulted with his patients' previous doctors,
and routinely accepted medical records sent in by patients, without
requiring that records be sent by medical professionals. Moreover,
Respondent was aware that some of his patients, or people posing as his
patients, fraudulently altered medical files in order to obtain
controlled substances. Respondent's actions constituted clear
violations of state and federal law.
In light of these essentially uncontroverted facts, a remaining
issue in this case is whether Respondent has adequately accepted
responsibility for his past misconduct such that his continued
registration might nevertheless be consistent with the public interest.
See Patrick W. Stodola, 74 FR 20,727, 20,734 (DEA 2009). Respondent
argues that he has "expressed considerable regret and remorse for his
Internet prescribing and acknowledged its impropriety. * * *" (Resp't
Br. 22.) But across various dimensions, the record reveals that
Respondent has not sustained his burden in this regard.
As an initial matter, I reject Respondent's contention that "no
conduct which might threaten the public health and safety has been
charged and proved." (Resp't Br. at 22.) Indeed, Respondent's failure
to verify the identity of the majority of his patients (see Tr. 26, 54-
56), as detailed above, raises dual specters of diversion and
polypharmacy, both of which threaten the public interest. Respondent
testified that "I used the same method of checking [new patients']
identity as I would if they were present in front of me." (Tr. 54.) To
the contrary, Respondent never saw most of the people to whom he issued
approximately 5000 prescriptions for controlled substances per year.
(Tr. 52-53, 55.) Moreover, patients submitted their own medical records
to Respondent's clinic (Tr. 34; 79-80), and they thus had both the
opportunity and the inclination to fraudulently modify them (see
generally Tr. 56). I find that Respondent's failure to consistently
verify patient identities and secure the integrity of patient records
weighs in favor of a finding that Respondent's continued registration
would be contrary to the public interest.
Respondent has not demonstrated a credible acknowledgment of his
inadequate patient identity verification practices, nor has he
demonstrated that he will not engage in similar future misconduct. For
example, Respondent's sole comment in this regard at hearing offers
valuable insight into his outlook: "If the state did not adequately
check [his patients'] identity before issuing them a driver's license *
* * I had no way of determining that." (Tr. 54.) Respondent's
testimony misses the point and offers no support for a finding that he
has accepted responsibility for his prior misconduct. To the contrary,
Respondent's testimony supports an inference that he would continue the
same unreliable and dangerous identity verification practices if
permitted to maintain his registration in the future. See Alra
Laboratories, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995) (an
"agency rationally may conclude that past performance is the best
predictor of future performance").
Respondent's flagrant failures to supervise his PA also bear upon a
Factor Five analysis. Respondent, who was Medical Director of UPR in
2004 (Resp't Ex. 12 at 2), possessed both actual authority and the
legal duty to exercise "responsible supervision and control" over Mr.
Protheroe. See, e.g., Fla. Stat. Ann. Sec. 459.022(2)(e); see also,
e.g., Dan E. Hale, D.O., 69 FR 69,402, 69,406 (DEA 2004); Robert G.
Hallermeier, M.D., 62 FR 26,818, 26,820 (DEA 1997); Jay Wheeler
Cranston, M.D., 59 FR 36,786, 36,789 (DEA 1994). As chronicled earlier
in this Recommended Decision, Respondent failed to exercise this
supervisory authority, and at times failed to acknowledge that he had
it. He permitted Mr. Protheroe to work under Respondent's license but
did not control Mr. Protheroe's hours; he did not control Mr.
Protheroe's work product; he did not hire him and did not believe he
could fire him. (Tr. 37.) Mr. Protheroe wrote at least 14,000
unauthorized prescriptions in Respondent's name (Tr. 80; see generally
Tr. 132; Gov't Ex. 10 at 84-85), many of which for controlled
substances (e.g., Resp't Ex. 12 at 2), while Respondent was away from
the office for an extended period of time (Tr. 121-22, 132; Gov't Ex.
10 at 85, 96, 101), in violation of Fla. Stat. Ann. Sec. 459.022(4)(e)
(prohibiting PAs from prescribing controlled substances), as well as
other provisions of law.
Respondent fundamentally failed to take responsibility for his
failure to supervise Mr. Protheroe. Respondent conceded at hearing that
he had an obligation to properly supervise Mr. Protheroe (Tr. 101; see
Resp't Ex. 9 at 5 ("physicians should * * * [p]roperly supervise
physician extenders")), and stated that he supervised Mr. Protheroe
during the limited times "when he was in the office. * * * " (Gov't
Ex. 10 at 105) and not working from home. Although these statements
show that Respondent was aware of his unfulfilled supervision
obligation, they reveal no acceptance of responsibility for
Respondent's failure to discharge it. To the contrary, Respondent's
testimony is consistent with blame-shifting:
Q: And so you had an obligation to properly supervis[e] Mr.
Protheroe?
[[Page 61180]]
A: Yes, sir. I freely admit that he was not adequately
supervised. But he was kept away from me and I did not hire or fire
him. I supervised him as much as I could to my ability. But, yes, I
agree that it wasn't enough. (Tr. 101.)
Respondent testified that he regrets his relationship with Mr.
Protheroe. "[I]t's so soured me on the experience that I've never
hired any physician's assistants since and I don't think I ever will."
(Tr. 108-09.) But even viewed in a light most favorable to Respondent,
this statement offers no credible basis to conclude that Respondent
acknowledges and accepts responsibility for his failure to supervise,
nor is there any basis to conclude that if again confronted with the
challenges of supervising a contumacious PA, Respondent would
adequately discharge his supervisory obligations.
Respondent's testimony also consistently downplayed any personal
role that Respondent played in failing to comply, or that he should
have played in complying, with state and federal PA supervision
requirements. Even if Respondent felt he couldn't supervise Mr.
Protheroe, as a last resort Respondent could have withdrawn from his
employment if Mr. Protheroe failed to comply with Respondent's
instructions. Respondent's failure to do so indicates Respondent is
willing to permit the misuse of his DEA registration in order to
maintain his employment, rendering Respondent's registration contrary
to the public interest. See Alra Laboratories, 54 F.3d at 452.
There are additional areas in which Respondent could have accepted
responsibility for his misconduct, but didn't. For instance, rather
than admit that, as concluded above, his telemedicine practices were in
clear violation of contemporaneous standards (see, e.g., supra text at
notes 75-76), Respondent at hearing attempted to cast doubt on the
clarity of the rules. Commenting on his understanding of the patient
evaluation standard of care for Internet prescribing practices in 2002
and 2003, for instance, Respondent opined that today's standard is
different, but that previously "the legal community was struggling in
a gray area to determine what those [standards] would be and now they
have decided." (Tr. 64.) Somewhat contradicting himself, Respondent
also testified that he presently understands that he has an obligation
to prescribe or dispense controlled substances in accordance with all
applicable state laws, and that prescribing across state lines
sometimes includes the application of laws other than the laws in the
State of Florida. (Tr. 63.) That Respondent eventually chose to
discontinue his illegal Internet prescribing practices (Tr. 91; see
also Resp't Br. at 24) does not, without more, show that Respondent's
continued registration would be consistent with the public interest.
Respondent also attempted to shift responsibility for his own
professional misconduct to Mr. Carr. As an initial matter, Respondent's
claim that he reasonably relied on "a letter shown me from the DEA
giving permission to" engage in the controversial telemedicine
practices here at issue (Tr. 59-60, 110; see also Tr. 89-92) is not
credible. The reasonableness of Respondent's reliance on the DEA letter
is undermined by the fact that the letter concerned the dispensing
practices of a pharmacy, not the prescribing practices of a physician.
The letter moreover contained caveats that "[m]anagement personnel
will verify several elements including * * * professional licensure[,]
DEA registration[, l]egitimate patient/prescriber relationship[,
p]rescriptions are issued in the usual course of professional practice,
and [p]rescriptions are issued for a legitimate medical purpose." (Tr.
97; Resp't Ex. 4 at 1.) Additionally, Respondent's unquestioned
reliance on legal advice from Mr. Carr, who Respondent also knew to be
president of UPS, undermines the credibility of Respondent's testimony
on this issue.
Further defending his reliance on Mr. Carr's advice, Respondent
pointed to the Model Guidelines, published by the Federation of State
Medical Boards in 2002. (See Resp't Ex. 9 at 3, 7.) Paraphrasing a
sentence from that document, Respondent stated that "the physician/
patient relationship exists whether or not there has been a personal
encounter between the physician and the patient." (Tr. 76; see Resp't
Ex. 9 at 7.) But the Model Guidelines go on to state that
"[p]hysicians who treat or prescribe through Internet Web sites are
practicing medicine and must possess appropriate licensure in all
jurisdictions where patients reside." (Resp't Ex. 9 at 12.) At
hearing, Respondent conceded that "given hindsight * * * I don't think
I did fully understand" the Model Guidelines when he read them. (Tr.
98.) Respondent, however, contradicted his former testimony and stated
that he could not confirm that he actually reviewed the Model
Guidelines before accepting his position with UPR. (Tr. 100-01.) In any
event, Respondent ultimately conceded that he was mistaken, and that
statements by the Federation of State Medical Boards do not carry legal
weight. (Tr. 45; see also Tr. 164.) Respondent ultimately conceded in
his testimony that Mr. Carr's assurances were inaccurate. (Tr. 110-11;
see Resp't Br. at 25.)
But Respondent's acknowledgements are too little; and because many
of them precede or follow Respondent's own contradictory testimony,
they arrive too late. On the topic of telemedicine standards, for
example, even if Respondent's equivocal statements are read to
acknowledge that Florida had enacted a telemedicine regulation as early
as 2004, Respondent still has not demonstrated that he accepts
responsibility for his failures to comport with those standards. For
instance, Respondent conceded that in hindsight, the prescriptions he
issued at UPR to Internet customers "did not meet the highest standard
* * * and I'm sorry." (Tr. 63-64.) Similarly, when his attorney asked
him whether he now knows that his Internet prescribing at UPR was not
consistent with the law as it was at that time, Respondent answered
"Absolutely." (Tr. 91-92.) But Respondent undercut his own display of
contrition, elaborating that when he engaged in the prescribing
practices that are the subject of the OSC, he wasn't doing anything
wrong. (Tr. 64-65.) "[I]f I thought I was doing anything wrong, I
wouldn't have done it." (Tr. 65.) Based on Respondent's demeanor while
testifying, I find that this statement, along with other similar
statements, undermines the sincerity of Respondent's contrition.
Indeed, Respondent's feelings of regret are best characterized not
as regret that he acted contrary to the public interest, but regret
that his poor choices led to undesirable personal ramifications. Asked
if he was regretful and remorseful for the role he played at UPR in
prescribing controlled substances, Respondent stated: "Yes, very much.
I sincerely wish I had never been duped into being any part of their
operation at all." (Tr. 92.) Moving forward, Respondent promised not
to prescribe for patients in jurisdictions in which he lacks a medical
license. (Tr. 111.) Asked by counsel whether he felt remorse for having
done so, he said "Yes. Not only am I remorseful about it, but I feel
rather foolish and stupid for doing so in retrospect." (Tr. 111.) This
last statement, self-serving though it is, arguably cuts in
Respondent's favor. But it is outweighed by Respondent's subsequent de-
emphasis of his own responsibility. I give significant weight to
Respondent's candid statement that "I was just an hourly employee. I
was just a pawn in the machine." (Tr. 119.) This admission belies
Respondent's belief that actors other than Respondent
[[Page 61181]]
are responsible for Respondent's misconduct. Such a belief is
inconsistent with Agency precedent requiring a registrant to accept
responsibility for his actions and demonstrate that he will not engage
in future misconduct. See Patrick W. Stodola, 74 FR 20,727, 20,734 (DEA
2009).
Respondent contends in mitigation that "no patient for whom Dr.
Reppy prescribed over the Internet suffered any damage or harm and
there were no mortalities or morbidities, and none of them suffered
overdose deaths while he was treating them." (Resp't Br. 6 (citing Tr.
117, 118).) Although Respondent has not stayed in touch with all of his
patients since he left UPR (Tr. 117), no record evidence contradicts
this assertion. Asked whether any patient suffered an overdose death,
Respondent answered that "none of them did while I was prescribing. If
it happened since that time, then it happened because someone else was
prescribing it. I can't be responsible for what some other doctor
did." (Tr. 117.) "I'm sure there would have been a lawsuit if there
was one and I never received any." (Tr. 123.) Respondent ignores the
possibility that his provision of controlled substances to his former
Internet patients could lead to adverse health consequences, for which
Respondent might ultimately share responsibility.
Respondent also downplays the extent to which he could have known
of patient addictions, arguing that "[t]here is no way to know whether
or not patients became addicted" to controlled substances, suggesting
he had only a passive role in the process. (Resp't Br. 6.) Respondent's
testimony reflects a misunderstanding of his affirmative responsibility
as a prescribing practitioner "for the proper prescribing and
dispensing of controlled substances." \104\
---------------------------------------------------------------------------
\104\ 21 CFR 1306.04(a) (2010); see also Fla. Admin. Code Ann.
r. 64B15-14.005(3)(a) (2000) ("complete medical history and
physical examination must be conducted and documented in the medical
record."). See generally Fla. Admin. Code Ann. r. 64B15-15.004
(Dec. 22, 1997) ("Written Records; Minimum Content; Retention").
---------------------------------------------------------------------------
In mitigation, more recent conduct does weigh in Respondent's
favor. First, substantial evidence supports a finding that a
significant period of time has elapsed without incident since the
period of time embracing the unlawful conduct at issue here. Two of
Respondent's employees and two of his patients affirmed that
Respondent: personally sees patients and reviews patient records
(Resp't Ex. 19. at 2 ]] 5-7); requires that new patients produce recent
prior medical records (Resp't Ex. 19. at 3 ] 11); performs physical
examinations (E.g., Resp't Ex. 19. at 2 ] 8; id. at 6 ] 3, 5; id. at 19
] 7); discusses treatment plans and spends between fifteen and thirty
minutes with patients (Resp't Ex. 19. at 2 ] 10; id. at 6 ] 4, 7; id.
at 9 ] 9, 10); reduces patient pain medication levels and suggests
alternate treatment methods (Resp't Ex. 19 at 3 ] 12; id. at 9 ]] 3-4;
see also Tr. 66, 79-80); and dismisses patients who fail to pass drug
screens (Resp't Ex. 19 at 7 ] 9.) Insomuch, therefore, as Respondent's
current practice is relevant, Respondent has painted a generally
positive picture. See Paul J. Caragine, Jr., 63 FR 51,592, 51,601 (DEA
1998) (citing Norman Alpert, M.D., 58 FR 67,420 (DEA 1993)) ("[W]hile
passage of time alone is not dispositive it is a consideration in
assessing whether Respondent's registration would be inconsistent with
the public interest."). Viewed in isolation, Respondent's medical
practice from approximately 2006 to the present weighs somewhat in
favor of a finding that Respondent's continued registration would be
consistent with the public interest. That said, absent acceptance of
responsibility for the misconduct, the passage of time alone precludes
the issuance of even a restricted registration. "DEA has long held
that '[t]he paramount issue is not how much time has elapsed since
[his] unlawful conduct, but rather, whether during that time * * *
Respondent has learned from past mistakes and has demonstrated that he
would handle controlled substances properly if entrusted with a' new
registration." Robert L. Dougherty, M.D., 76 FR 16,823, 16,835 (DEA
2011) (citing Leonardo v. Lopez, M.D., 54 FR 36,915, 36,915 (DEA 1989)
and Robert A. Leslie, M.D., 68 FR 15,227, 15,227 (DEA 2003)).
To be certain, Respondent's voluntary retreat from a telemedicine
pain practice in favor of his current practice provides at least some
indication that Respondent will avoid, or limit, the circumstances
underlying the misconduct alleged in the instant case. But beyond
stating that the prescriptions he issued at UPR to Internet customers
"did not meet the highest standard * * * and I'm sorry" (Tr. 63-64),
Respondent provides limited credible assurance that if given the
opportunity he would not simply repeat the same mistakes he made in the
past.
In light of the foregoing, Respondent's evidence as a whole fails
to sustain his burden to credibly accept responsibility for his
misconduct and demonstrate that he will not engage in future
misconduct. I find that Factor Five weighs in favor of a finding that
Respondent's continued registration would be inconsistent with the
public interest.
VII. Conclusion and Recommendation
After balancing the foregoing public interest factors, I find that
the Government has established by substantial evidence a prima facie
case in support of revoking Respondent's COR, based on Factors Two,
Four and Five of 21 U.S.C. 823(f).
Once DEA has made its prima facie case for revocation or denial,
the burden shifts to the respondent to show that, given the totality of
the facts and circumstances in the record, revoking or denying the
registration would not be appropriate. See Morall v. DEA, 412 F.3d 165,
174 (D.C. Cir. 2005); Humphreys v. DEA, 96 F.3d 658, 661 (3d Cir.
1996); Shatz v. United States Dep't of Justice, 873 F.2d 1089, 1091
(8th Cir. 1989); Thomas E. Johnston, 45 FR 72, 311 (DEA 1980).
Additionally, where a registrant has committed acts inconsistent
with the public interest, he must accept responsibility for his actions
and demonstrate that he will not engage in future misconduct. See
Patrick W. Stodola, 74 FR 20,727, 20,735 (DEA 2009). Also,
"[c]onsideration of the deterrent effect of a potential sanction is
supported by the CSA's purpose of protecting the public interest."
Joseph Gaudio, M.D., 74 FR 10,083, 10,094 (DEA 2009). An agency's
choice of sanction will be upheld unless unwarranted in law or without
justification in fact. A sanction must be rationally related to the
evidence of record and proportionate to the error committed. See Morall
v. DEA, 412 F.3d 165, 181 (D.C. Cir. 2005). Finally, an "agency
rationally may conclude that past performance is the best predictor of
future performance." Alra Laboratories, Inc. v. DEA, 54 F.3d 450, 452
(7th Cir. 1995).
I recommend revocation of Respondent's COR BR5287342 and denial of
any pending applications for renewal or modification, and any
applications for a new COR. I find the evidence as a whole demonstrates
that Respondent has not accepted responsibility, and Respondent's
continued registration would be inconsistent with the public interest.
Dated: March 31, 2011
Timothy D. Wing,
Administrative Law Judge.
[FR Doc. 2011-25229 Filed 9-30-11; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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