Patrick W. Stodola, M.D.; Revocation of Registration, 20727-20736 [E9-10245]
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Hillsdale Circle, El Dorado Hills, CA
95762.
FOR FURTHER INFORMATION CONTACT:
BLM Folsom Field Office at (916) 985–
4474.
Dated: April 3, 2009.
William S. Haigh,
Field Office Manager.
[FR Doc. E9–10301 Filed 5–4–09; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 07–24]
Patrick W. Stodola, M.D.; Revocation of
Registration
On February 7, 2007, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Patrick W. Stodola, M.D.
(Respondent), of Chicago, Illinois. The
Show Cause Order proposed the
revocation of Respondent’s DEA
Certificate of Registration, AS2352653,
as a practitioner, and proposed the
denial of his pending application to
renew his registration, on the ground
that his ‘‘continued registration is
inconsistent with the public interest.’’
Show Cause Order at 1.
The Show Cause Order specifically
alleged that while Respondent is
licensed as a physician only in Illinois,
he prescribed controlled substances, via
the internet, to persons located in
twenty-six other States. Id. The Order
alleged that Respondent’s prescribing
constituted the unauthorized practice of
medicine because he did not possess the
licenses required to practice medicine
(and prescribe) in these States, and that
the prescriptions he authorized ‘‘were
not issued in the usual course of
professional practice as required by 21
CFR 1306.04.’’ Id. at 1–2.
On March 14, 2007, Respondent filed
a request for a hearing and the matter
was placed on the docket of the
Agency’s Administrative Law Judges.
Following pre-hearing procedures, a
hearing was held on October 16, 2007,
in Chicago, Illinois. At the hearing, both
parties elicited testimony and
introduced documentary evidence for
the record. Following the hearing, both
parties submitted briefs containing their
proposed findings of fact, conclusions of
law and argument.
On September 16, 2008, the ALJ
issued her recommended decision (ALJ).
In evaluating Respondent’s experience
in dispensing controlled substances and
record of compliance with applicable
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laws, the ALJ concluded that
Respondent had violated the medical
practice standards adopted by multiple
States which specifically require that a
physician physically examine a patient
before prescribing a drug to him/her.
ALJ at 33–34. The ALJ further
concluded that Respondent had violated
the laws of numerous States by
prescribing to their residents without
holding the requisites licenses to
practice medicine and/or dispense
controlled substances. Id. at 34. While
the ALJ found that Respondent has
retained his Illinois medical license and
has not been convicted of a crime, she
further found that Respondent has
‘‘refus[ed] to acknowledge his
wrongdoing.’’ Id. at 32 & 34. The ALJ
thus ‘‘conclude[d] that Respondent is
unwilling or unable to accept the
responsibilities inherent in a DEA
registration,’’ and recommended that his
registration be revoked and that any
pending applications be denied. Id. at
35.
Respondent did not file exceptions to
the ALJ’s decision.1 Thereafter, the
record was forwarded to me for final
agency action.
Having considered the entire record
in this matter, I adopt the ALJ’s
conclusions of law with respect to the
public interest inquiry. I further adopt
the ALJ’s recommended sanction.
Accordingly, I will revoke Respondent’s
registration and deny his pending
application to renew the registration. I
make the following findings.
Findings
Respondent is the holder of DEA
Certificate of Registration, AS2352653,
which authorizes him to dispensing
controlled substances in schedules II
through V as a practitioner. According
to Respondent’s Certificate of
Registration, the expiration date of his
registration was February 28, 2006. It is
undisputed, however, that Respondent
filed a timely renewal application. I
therefore find that Respondent’s
registration has remained in effect
pending the issuance of this Order. See
5 U.S.C. 558(c).
Respondent holds a medical license
in Illinois. Tr. 85, 190–91. In his
testimony, Respondent acknowledged
that he is not licensed to practice
medicine in any other State, id. at 85 &
191, and that he has never obtained a
license to practice in any other State. Id.
at 85. Moreover, Respondent does not
hold a DEA registration for a location in
any State other than Illinois. Id. at 191.
1 While the Government filed exceptions, the
exceptions do not go to the merits of the
proceeding.
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In early 2006, Respondent read an
advertisement which had been placed
by Just USA Meds 2 in the employment
section of the Chicago Tribune’s Web
site. Id. at 165. Respondent called the
phone number contained in the ad, and
spoke with Challen Sullivan, Just USA’s
owner, who told him that his business
‘‘was to be a provider of medical
services,’’ but not ‘‘a dispenser or a
vending machine of any particular
medications.’’ Id. at 87. Thereafter,
Respondent entered into an agreement
with the entity under which Just USA
Meds would arrange for customers, who
were seeking controlled substances, to
speak with him by telephone. Id. at 14.
Respondent was paid $20 per
consultation and would typically issue
a controlled-substance prescription for
the patient upon the conclusion of the
consultation. Id. The prescriptions were
then sent to pharmacies which had
entered into arrangements with Just
USA Meds to dispense the drugs to its
customers.
According to Respondent, a customer
would contact Just USA Meds, identify
himself, and provide a copy of the credit
card which he intended to use to pay
his bill. Id. at 91. Respondent asserted
that a customer would then be
interviewed by an employee of Just USA
Meds, who would ask him the name of
his doctor, what other drugs he was
taking, and whether he would agree not
to seek drugs from another source if
Respondent (or the other doctors
engaged by Just USA Meds) issued a
prescription for him. Id. at 92. Just USA
would then contact the customer’s
credit card company to verify whether
the card was valid and to request a precharge for the anticipated amount of the
services and drugs being provided. Id.
After Just USA obtained the pre-charge,
the customer would then be scheduled
for a consultation with Respondent or
another physician. Id. at 104.
Respondent admitted that he did not
physically examine any of the persons
who were referred to him by Just USA
Meds. Tr. 18 (testimony of DI); id. at 84
(testimony of Respondent).3 Rather,
Respondent asserted that the customers
were required to send in medical
records including the documentation of
a physical exam which had to be less
than one year old. Id. at 97–98. He also
maintained that persons who claimed
‘‘some sort of structural harm’’ were
2 In this decision, Just USA Meds will also be
referred to as ‘‘Just USA.’’
3 Respondent did not even physically examine
those persons he prescribed to who resided in the
Chicago area. See GX 34 at 24 (resident of Chicago);
GX 39 at 63 (resident of Highland Park, Il.); Id. at
133 (resident of Arlington Heights, Il.); Id. at 171
(resident of Hoffman Estates, Il.).
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required to forward imaging
documentation such as a CT scan, MRI,
or X-Ray, and that if the person did not
have a physical that met the above
requirement, the person was sent an
eleven to twelve-page-long form, which
was to be taken to a doctor in his/her
community to ‘‘have the history and
physical completed.’’ Id. at 98.
Relatedly, Respondent claimed that for
those customers who found it
inconvenient to go to a doctor’s office,
Just USA Meds used a company which
sent a nurse to the customer’s home to
obtain a medical history and perform a
physical. Id. at 100.
Respondent further maintained that
he kept copies of each customer’s
medical records. Id. Respondent did
not, however, produce any of these
records at the hearing.
Respondent also asserted that the
phone consultations he conducted were
probing and would take between twenty
to thirty minutes to complete.4 Id. at 105.
Relatedly, he maintained that Just USA
Meds ‘‘scolded [him] a couple of times
in the beginning’’ because the
consultations took too much time. Id.
According to Respondent, the
consultations were inquiries concerning the
history and physical, which was in front of
me, the nature and extent of the medications
and therapies that they had already received,
their response to any medications that they
had already received, what medications other
than what they were requesting they were
already taking, how their condition affected
them, and I usually used two or three
different tests inquiring from them to find out
the nature of their problem.
Id. at 104. Respondent also maintained
that he asked the customer to rate their
pain ‘‘on a scale of 1 to 10,’’ whether he/
she had previously ‘‘taken
hydrocodone,’’ and if so, how it affected
the customer’s pain level and whether
the drug had caused various adverse
events. Id. at 105. Respondent
maintained that ‘‘those were all
discussed by me each and every time,’’
and that ‘‘[t]here were no exceptions.’’
Id.
Relatedly, Respondent asserted that
the consultations ‘‘were meaningful
interviews that took as long or longer
than is customarily had in a physician’s
4 The prescription records suggest that this
testimony stretches the limits of credulity.
According to GX 35, on February 9, 2006,
Respondent would have performed approximately
thirty consultations, and the following day, he
would have performed approximately thirty-three
consultations. Respondent would thus have spent
between ten and seventeen hours a day consulting.
While this is not out of the realm of possibility, it
seems most unlikely. However, because most (if not
all) of Respondent’s prescribings were illegal
regardless of how long the consultations lasted for,
it is unnecessary to determine whether this
testimony is credible.
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office with the patient physically in
front of them,’’ and ‘‘that the interviews
were comprehensive and medically
appropriate.’’ Id. at 106. According to
Respondent, ‘‘probably about 90 percent
of the patients who were inquiring were
requesting some sort of pain relief.’’ Id.
Respondent also asserted that he would
‘‘sometimes’’ negotiate with the
customers to ‘‘alter their request’’ for
drugs and or ‘‘to use some other
medicine.’’ 5 Id.
According to various prescription
records which were entered into
evidence, Respondent issued in excess
of three hundred controlled-substance
prescriptions for Just USA, the
overwhelming majority (approximately
eighty-five to ninety percent) of which
were for combination drugs containing
hydrocodone, a schedule III controlled
substance, and acetaminophen. See GXs
34, 35, & 39; 21 CFR 1308.13(e).
Invariably, the prescriptions were for
those formulations which contained the
stronger concentrations (7.5 or 10 mg.)
of hydrocodone. See GXs 34, 35, & 39.
As I have noted in numerous other
decisions, these drugs are highly
popular with drug abusers. See
Southwood Pharmaceuticals, Inc., 72 FR
36487, 36503 (2007) (noting 2004 survey
of National Institute of Drug Abuse
found that ‘‘9.3 percent of twelfth
graders reported using Vicodin, a brand
name Schedule III controlled substance
without a prescription in the previous
year’’); William R. Lockridge, 71 FR
77791, 77796 (2006) (noting that in
2002, the abuse of hydrocodone
products resulted in more than 27,000
emergency room visits).6 Respondent
also issued smaller numbers of
prescriptions for Didrex
(benzphetamine, a schedule III
controlled substance), as well as various
schedule IV drugs including alprazolam,
diazepam, Ambien (zolpidem) and
phentermine. See GXs 34, 35, & 39; see
5 The prescriptions records, however, cast doubt
on the credibility of this testimony. As found above,
Respondent invariably issued prescriptions for
combination drugs which contained either 7.5 or 10
mg. of hydrocodone (rather than those drugs which
contain only 5 mg.), and rarely issued prescriptions
for such non-controlled drugs which are used to
treat pain such as Tramadol and Fioricet.
The various prescription records entered into
evidence show that Respondent also wrote a
miniscule number of prescriptions for noncontrolled drugs including Soma (carisoprodol),
Tramadol, and Fioricet (a combination of butalbital,
acetaminophen and caffeine).
6 In his testimony, Respondent asserted that drugs
containing hydrocodone are not addictive or
‘‘dangerous.’’ Tr. 158–59. As found above,
combination hydrocodone drugs are among the
most highly abused controlled substances. I
therefore reject Respondent’s testimony as selfserving.
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also 21 CFR 1308.13(b)(2); Id. 1308.14(c)
& (e).
As the prescriptions records indicate,
the customers were located throughout
the United States, and the
overwhelming majority of them resided
in States other than Illinois. See GXs 34,
35, & 39. More specifically, the records
in evidence show, inter alia, that
Respondent issued hydrocodone
prescriptions in the following amounts:
forty-eight to residents of Texas, forty to
residents of California, nineteen to
residents of North Carolina, thirteen to
residents of both Ohio and of Virginia,
ten to residents of Indiana, nine to
residents of Colorado, eight to residents
of both Massachusetts and Mississippi,
seven to residents of Georgia, six to
residents of Missouri, and four to
residents of Oklahoma.7 See generally
GXs 34, 35, & 39.
As early as March 2006, Respondent
spoke with a DEA Diversion Investigator
to inquire as to why the Agency had not
approved his renewal application. Tr.
87. During the conversation, the DI
asked him ‘‘what [he] was doing to
make a living as a doctor.’’ Id.
Respondent told the DI that he worked
at several clinics and ‘‘had some
telemedicine internet practice going.’’
Id. The DI then told Respondent ‘‘that
there might be a problem with that.’’ Id.
Respondent nonetheless continued his
prescribing for Just USA Meds until
January 2007. Id. at 178.8
Throughout the hearing, Respondent
maintained that his ‘‘prescribing was
appropriate.’’ Id. at 99. Furthermore, on
cross-examination, Respondent
acknowledged that he found evidence
that Just USA Meds had used his name
and registration to back-date several
prescriptions which had been dispensed
before he commenced working for the
7 The Government also introduced into evidence
the sworn declaration of George Van Komen, M.D.
GX 41. Respondent, however, objected to the
admission of the exhibit on the ground that the
declaration was testimonial in nature and that he
was unable to cross-examine Dr. Van Komen. Tr.
58–59. The ALJ overruled Respondent’s objection
and admitted the declaration. Id. at 59.
I do not rely on the exhibit, however, because it
is unclear whether the declaration was properly
admitted. While the Government provided notice of
its intent to use the Declaration in its Supplemental
Prehearing Statement, the Statement does not
disclose the substance of the Declaration. Moreover,
the record does not establish whether a copy of the
Declaration was provided to Respondent in advance
of the hearing. While hearsay is admissible in these
proceedings, a testimonial declaration must be
timely provided to the other party in order to afford
it with the opportunity to determine whether to
request a subpoena of the witness.
8 The record suggests that Respondent had
additional discussions with DEA Investigators in
both May and September 2006 regarding his
practices. The record does not, however, establish
with reasonable specificity the content of these
discussions.
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entity. Id. at 170. Respondent testified
that he did not authorize this use of his
registration which he discovered
‘‘within the first couple of weeks’’ after
he started working for Just USA. Id. at
169.
Respondent failed to report the
incident to the Agency, asserting that
Just USA had told him that ‘‘only one
or two’’ prescriptions had been back
dated. Id. at 170. Respondent admitted,
however, that he ‘‘had no way of
confirming’’ the validity of Just USA’s
representation that the backdating had
occurred in ‘‘only one or two
instances.’’ Id.
Respondent also maintained that on
multiple occasions, he engaged in due
diligence to determine whether his
conduct was legal. Respondent contends
that shortly after he entered into his
arrangement with Just USA, he was sent
a document entitled ‘‘Ordering and
Registration Instructions,’’ which
indicated the procedures which the
‘‘patients’’ were required to complete to
purchase drugs which included
providing a copy of an identification
card, medical records, and physician
reports, etc. RX 7A. Moreover, the
document listed seven States that Just
USA’s pharmacies did not ship to
including Arizona, Kentucky, Missouri,
Nevada, Pennsylvania, South Carolina,
and Tennessee. Id. In his testimony,
Respondent maintained that Just USA
had sent this document to him after he
asked how he would know that he was
permitted to prescribe to residents of
States other than Illinois. Tr. 95.
Respondent further claimed that Just
USA told him that it had ‘‘already done
an examination of the law, and we do
not service’’ the above States, because
they ‘‘required a face-to-face meeting
between the prescribing doctor and the
patient,’’ or the State prohibited an outof-state doctor from prescribing to its
residents, or the State did not permit
telemedicine. Id. at 95–96; see also id.
at 184. According to Respondent, ‘‘it
was good enough for me that they had
ruled out certain states that it was not
appropriate to go to.’’ 9 Id. at 96.
On cross-examination, however, the
Government identified multiple
instances in which Respondent had
issued prescriptions to patients who
lived in these States. See Tr. 186–90.
More specifically, the Government
identified controlled prescriptions
Respondent issued to residents of
Arizona (GX 39 at 6), Kentucky (id. at
21), Missouri (id. at 23), Nevada (id. at
9 Respondent subsequently stated that after he
stopped working for Just USA he learned that there
were two or three other States (in addition to the
seven States listed in RX 7A) where his prescribing
was illegal. Tr. 161.
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75), Pennsylvania (id. at 67), and South
Carolina (id. at 182). When confronted
with this evidence, Respondent did not
‘‘know how that happened’’ and
claimed that he ‘‘wasn’t aware that it
happened.’’ Id. at 194.
Respondent admitted, however, that
the customer’s names and addresses
were in the medical records, which he
claimed he had access to. Id. at 196. He
also admitted that ‘‘in most instances,’’
he did not look at where the customer
lived, id., but instead relied on the
employees of Just USA to screen out the
customers. Id. at 200–01.
Respondent also entered into
evidence an Agency document which
stated that it was clarifying DEA’s
‘‘policies regarding the dispensing and
prescribing of controlled substances as
they pertain to the internet.’’ RX 7C.
This document specifically noted the
prescription requirement of Federal law,
see 21 CFR 1306.04(a), and made
explicit reference to the Agency’s 2001
Guidance Document, Dispensing and
Purchasing Controlled Substances over
the Internet, 66 FR 21181. The
document further stated: ‘‘As noted in
the guidance document, it is unlikely
that such a relationship could be
established through the use of an online
questionnaire completed by a consumer
prior to the purchase of controlled
substances.’’ RX 7C, at 1.
The Agency’s 2001 Guidance
expressly stated 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.’’ 66 FR at
21182. Continuing, the Guidance
observed 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.
Of further relevance, 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
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20729
controlled substances by the State(s) in
which they operate.’’ Id. at 21181
(emphasis added).10
As further support for his contention
that he performed due diligence in
attempting to ascertain whether his
prescribing practices were legal,
Respondent introduced into evidence a
document which appears to be a legal
opinion (dated June 21, 2006) prepared
by a Tampa, Florida-based lawyer.11 See
RX 7D. In stating the issue, the opinion
noted that ‘‘[a]s your Pharmacy and
Prescribing Doctors are located within
the States of Florida, this
Memorandum’s analysis focuses on
Florida law as well as Federal law
concerning appropriate prescribing
standards.’’ Id. at 6. Continuing, the
opinion observed that ‘‘[t]he state laws
and professional standards concerning
telemedicine and prescribing practices
vary from state to state, and because I
am licensed to practice in the State of
Florida, this Memorandum’s analysis is
limited to Florida law as well as Federal
law concerning appropriate prescribing
standards.’’ Id. The opinion further
noted that it ‘‘specifically’’ did not
address such issues as ‘‘physician and
pharmacy licensure.’’ Id.
As for its legal conclusions, the
opinion stated that ‘‘[p]rescribing
standards vary dramatically from state
to state and in some instances vary
within a particular state for the
prescription of specified pharmaceutical
items (e.g., some states have heightened
standards for prescribing controlled
substances and diet drugs).’’ Id. at 1.12
10 Respondent also cites a ‘‘Flow Chart,’’ RX 7B,
which was prepared by Just USA Meds Pharmacy
and which sets forth the purported process by
which customers obtained drugs as evidence of his
having engaged in due diligence. The document
does not set forth any legal advice and is merely
cumulative of Respondent’s testimony as to the
procedures used by Just USA to process customer
orders.
Respondent also submitted a document which
contains several e-mail messages from July 27 and
28, 2006, which discuss an e-prescribing initiative
introduced in Illinois, one of which originated from
Mudri Associates, a DEA Consultancy. RX 7E.
Respondent asserts that this evidence establishes
that he contacted the consultant ‘‘following [its]
inspection of all of the procedures followed by
[J]ust USA * * * [and] the pharmacies with which
[J]ust USA had arrangements.’’ Resp. Br. (Pt. II) at
14. The e-mail does not, however, discuss any issue
other than various proposals that were part of an
Illinois patient safety initiative.
11 The text of the letter appears to have been cut
and inserted into various internet-based text
messages which occurred between Respondent and
Challen Sullivan, the owner of Just USA Meds. See
RX 7–D; Tr. 119 & 125–26. Nor does the text of the
memorandum appear in the exhibit in the order that
is customarily used by lawyers in preparing legal
opinions for their clients. See id.
12 The opinion provides a lengthy discussion of
Florida’s standards, and appears to conclude that
under Florida law and regulations, a physician need
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Moreover, in addition to its discussion
of Florida law, the opinion notes that
‘‘[o]ther states have adopted statutes
specifically relating to prescribing
standards and the business of Internet
pharmacy—often requiring a face to face
physical examination and making noncompliance a crime subject to heavy
penalties. These statutes are usually
more comprehensive in requiring
compliance by all of the website
operators, physicians and pharmacies
involved. Most sophisticated and
established Internet pharmacy operators
avoid conducting business in these
more restrictive states.’’ Id. at 4
(emphasis added).13
The opinion also discussed Federal
prescribing standards. In discussing this
Agency’s 2001 Guidance, the opinion
states that ‘‘[a]lthough the DEA
acknowledges that state law ultimately
controls the issue of whether a
prescription is written in the usual
course of professional practice, the DEA
feels that the weight of legal and
professional authority requires the [four]
elements [set forth in the Guidance] to
be present in order to establish a bona
fide doctor/patient relationship.’’ Id.
The letter then quoted verbatim the four
elements set forth in the Guidance.
Furthermore, the opinion also noted
that ‘‘DEA has in some instances over
the past year informally challenged
some pharmacies and medical
professionals participating in a Medical
Records Based Prescribing pharmacy
business. The DEA has asserted in such
instances that in its opinion Medical
Records Based Prescribing does not
meet applicable local legal standards
which require that an adequate
physician-patient relationship exists for
the prescription.’’ RX 7D at 5.
The opinion, however, rejected the
Agency’s view as to the legality of
Medical Records Based Prescribing,
citing among other things, its author’s
‘‘understanding that the three largest
drug wholesalers * * * have concluded
that the DEA does not have a legal basis
for making these assertions,’’ the 2003
failure of Congress to enact the Ryan
not have personally performed a physical
examination in order to prescribe a drug (other than
a diet drug). Id. at 2–3. However, as found above,
Respondent prescribed to residents of numerous
other States.
13 The opinion also observed that the American
Medical Association’s ‘‘standards suggest that the
physician must personally conduct the physical
examination,’’ RX 7D at 3, and while suggesting that
the AMA’s positions were inconsistent, quoted
another AMA guideline which states in relevant
part: ‘‘Licensure: Physicians who prescribe
medications via the Internet across state lines,
without physically being located in the state(s)
where the patient (clinical) encounter(s) occurs,
must possess appropriate licensure in all
jurisdictions where patients reside.’’ Id. at 4.
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Haight Internet Pharmacy Consumer
Protection Act (which prohibits a
practitioner’s prescribing to a person he/
she has not physically examined),14 and
the December 2005 testimony of Agency
officials to Congress to the effect that the
Controlled Substances Act does not
provide a statutory definition of ‘‘what
constitutes a valid ‘doctor/patient’
relationship.’’ Id. at 5. The opinion thus
concluded that ‘‘the Websites’ Medical
Records Based Prescribing Procedures
appear to comply with the DEA’s
published rules and Federal law.’’ Id.15
Discussion
Section 304(a) of the Controlled
Substances Act (CSA) provides that a
registration to ‘‘dispense a controlled
substance * * * may be suspended or
revoked by the Attorney General upon
a finding that the registrant * * * has
committed such acts as would render
his registration under section 823 of this
title inconsistent with the public
interest as determined under such
section.’’ 21 U.S.C. 824(a)(4). Moreover,
section 303(f) of the CSA provides that
‘‘[t]he Attorney General may deny an
application for [a practitioner’s]
registration if he determines that the
issuance of such registration would be
inconsistent with the public interest.’’
21 U.S.C. 823(f). In making the public
interest determination, the Act requires
the consideration of the following
factors:
(1) The recommendation of the appropriate
State licensing board or professional
disciplinary authority.
(2) The applicant’s experience in
dispensing * * * controlled substances.
14 On October 15, 2008, the President signed into
law the Ryan Haight Online Pharmacy Consumer
Protection Act of 2008, Public Law No. 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, the
‘‘[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 ‘inperson 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. These
provisions do not, however, apply to Respondent’s
conduct.
15 Respondent also cites a December 1, 2006
rulemaking which amended DEA regulations to
require that a practitioner obtain a separate
registration for each State in which he practices,
and a December 22, 2006, memo written by the
same Tampa-based attorney regarding the
applicability of the new rule to internet prescribers.
See RX 7G. In light of the fact that almost (if not)
all of the actual prescriptions which are in evidence
in this matter were issued by Respondent prior to
his having reviewed either of these documents, I
find it unnecessary to make any findings based on
them.
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(3) The applicant’s conviction record under
Federal or State laws relating to the
manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State,
Federal, or local laws relating to controlled
substances.
(5) Such other conduct which may threaten
the public health and safety.
Id.
‘‘[T]hese factors are * * * considered
in the disjunctive.’’ Robert A. Leslie,
M.D., 68 FR 15227, 15230 (2003). I may
rely on any one or a combination of
factors, and may give each factor the
weight I deem appropriate in
determining whether to revoke an
existing registration or to deny an
application to renew a registration. Id.
Moreover, I am ‘‘not required to make
findings as to all of the factors.’’ Hoxie
v. DEA, 419 F.3d 477, 482 (6th Cir.
2005); see also Morall v. DEA, 412 F.3d
165, 173–74 (D.C. Cir. 2005).
Having considered all of the factors, I
acknowledge that the record contains no
evidence that the State of Illinois has
taken action against Respondent’s
medical license (factor one) or that
Respondent has been convicted of an
offense related to controlled substances
(factor two).16 The record contains,
however, an abundance of evidence that
Respondent’s experience in dispensing
controlled substances (factor two) and
record of compliance with applicable
Federal and State laws (factor four) is
characterized by his repeated violation
of the CSA’s prescription requirement,
as well as numerous state laws and
regulations prohibiting the unlicensed
practice of medicine and setting the
standards for prescribing a drug.
Moreover, I reject Respondent’s
contention that his conduct should be
excused because he engaged in due
diligence in attempting to ascertain the
legal requirement for his prescribing.
Even if I was to recognize such a
defense in the context of a prescribing
practitioner, the record establishes that
Respondent’s efforts were half-baked at
best, and that when he did receive
information that his activities were
likely illegal, he ignored it. Finally,
while Respondent eventually ceased his
internet-related prescribing activities,
his testimony manifests that he has not
accepted responsibility for his
misconduct, but rather blames others.
16 This Agency has long held that a State’s failure
to take action against a practitioner’s authority to
dispense controlled substances is not dispositive in
determining whether the granting of an application
for registration would be consistent with the public
interest. See Mortimer B. Levin, 55 FR 8209, 8210
(1990). I further note that the absence of a criminal
conviction is not dispositive of the public interest
inquiry. See, e.g., Edmund Chein, 72 FR 6580, 6593
n.22 (2007).
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I therefore conclude that
Respondent’s continued registration
would be ‘‘inconsistent with the public
interest.’’ 21 U.S.C. 823(f). Accordingly,
Respondent’s registration will be
revoked and his application to renew
his registration will be denied.
Factor Two and Four—Respondent’s
Experience in Dispensing Controlled
Substances and Record of Compliance
With Applicable Controlled Substance
Laws
The primary issue in this case is
whether the prescriptions Respondent
issued pursuant to his agreement with
Just USA Meds were lawful
prescriptions under the CSA. Under a
longstanding DEA regulation, a
prescription for a controlled substance
is not ‘‘effective’’ unless it is ‘‘issued for
a legitimate medical purpose by an
individual practitioner acting in the
usual course of his professional
practice.’’ 21 CFR 1306.04(a). This
regulation further provides that ‘‘an
order purporting to be a prescription
issued not in the usual course of
professional treatment * * * is not a
prescription within the meaning and
intent of [21 U.S.C. 829] and * * * the
person issuing it, shall be subject to the
penalties provided for violations of the
provisions of law relating to controlled
substances.’’ Id. As the Supreme Court
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, 143 (1975)).
Under the CSA, it is fundamental that
a practitioner must establish a bona fide
doctor-patient relationship in order to
act ‘‘in the usual course of * * *
professional practice’’ and to issue a
prescription for a ‘‘legitimate medical
purpose.’’ Moore, 423 U.S. at 141–43. At
the time of the events at issue here, the
CSA generally looked to state law to
determine whether a doctor and patient
have established a bona fide doctorpatient relationship. See Kamir GarcesMejias, 72 FR 54931, 54935 (2007);
United Prescription Services, Inc., 72 FR
50397, 50407 (2007); Dispensing and
Purchasing Controlled Substances Over
the Internet, 66 FR at 21182–83; but see
n.14, supra (discussing the Ryan Haight
Act).
Moreover, shortly after the CSA’s
enactment, the Supreme Court
explained that ‘‘[i]n the case of a
physician [the Act] contemplates that he
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is authorized by the State to practice
medicine and to dispense drugs in
connection with his professional
practice.’’ Moore, 423 U.S. at 140–41
(emphasis added). Accordingly, ‘‘[a]
physician who engages in the
unauthorized practice of medicine’’
under state laws ‘‘is not a ‘practitioner
acting in the usual course of * * *
professional practice’ ’’ under the CSA.
United Prescription Services, 72 FR at
50407 (quoting 21 CFR 1306.04(a)). This
rule is supported by the plain meaning
of the Act, which defines the ‘‘[t]he term
‘practitioner’ [to] mean [ ] a physician
* * * licensed, registered, or otherwise
permitted, by the United States or the
jurisdiction in which he practices * * *
to * * * dispense * * * a controlled
substance,’’ 21 U.S.C. 802(21), and
‘‘[t]he term ‘dispense’ [to] mean [ ] to
deliver a controlled substance to an
ultimate user * * * by, or pursuant to
the lawful order of, a practitioner.’’ Id.
§ 802(10). See also id. § 823(f) (‘‘The
Attorney General shall register
practitioners * * * to dispense * * * if
the applicant is authorized to dispense
* * * controlled substances under the
laws of the State in which he
practices.’’).
A controlled-substance prescription
issued by a physician who lacks the
license or other authority required to
practice medicine within a State is
therefore unlawful under the CSA. See
21 CFR 1306.04(a) (‘‘An order
purporting to be a prescription issued
not in the usual course of professional
treatment * * * is not a prescription
within the meaning an intent of’’ the
CSA); cf. 21 CFR 1306.03(a)(1) (‘‘A
prescription for a controlled substance
may be issued only by an individual
practitioner who is * * * [a]uthorized
to prescribe controlled substances by
the jurisdiction in which he is licensed
to practice his profession[.]’’).
The record establishes that in issuing
the prescriptions for Just USA’s
customers, Respondent repeatedly
violated the CSA’s prescription
requirement. 21 CFR 1306.04(a). This is
so for two reasons: (1) Respondent
prescribed without establishing a valid
doctor-patient relationship in violation
of the medical practice standards of
numerous States because he failed to
physically examine the patients, and (2)
Respondent’s prescribing typically
constituted the unauthorized practice of
medicine in the States where the
patients were located because he was
licensed to practice medicine (and
authorized to prescribe) only in Illinois.
Furthermore, Respondent issued
unlawful prescriptions even where
various States had either enacted laws
and regulations, rendered decisions in
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adjudications, or issued policy
statements making clear that his
prescribing practices were illegal.
For example, as found above,
Respondent issued forty hydrocodone
prescriptions to residents of California.
In 2000, California enacted Cal. Bus. &
Prof. Code § 2242.1,17 which
specifically 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, except as authorized by
Section 2242.’’ Moreover, the statute,
which provides for a fine or civil
penalty of twenty-five thousand dollars
for a violation, further directs that ‘‘[i]f
the person or entity that is the subject
of an action brought pursuant to this
section is not a resident of this state, a
violation of this section shall, if
applicable, be reported to the person’s
or entity’s appropriate professional
licensing authority.’’ Id. at (e).
Relatedly, in 2003, the Medical Board
of California revoked a physician’s
medical license for engaging in the same
type of prescribing practices as
Respondent did here. See In re John
Steven Opsahl, M.D., Decision and
Order, at 3 (Med. Bd. Cal. 2003)
(available by query at https://
publicdocs.medbd.ca.gov/pdl/
mbc.aspx). In Opsahl, the Medical
Board expressly found that ‘‘[b]efore
prescribing a dangerous drug, a physical
examination must be performed.’’ Id.
Continuing, the Board found 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.
Finally, the Board found that:
Medical indication means having a
condition that warrants specific treatment. It
is determined after the physician takes a
history, performs a physical examination and
makes an assessment about the patient’s
condition. * * * A physician cannot
determine whether there is a medical
indication for prescription of a dangerous
drug without performing a physical
examination.
Id.18
17 This
statute was effective January 1, 2001.
Opsahl’s prescribing practices involved
‘‘verifying patient identity,’’ ‘‘obtaining and
reviewing medical records,’’ ‘‘having direct contact
with the patient, though personal contact was not
required,’’ and ‘‘having an opportunity for followup.’’ Decision at 4. Opsahl prescribed both noncontrolled and controlled drugs including
combination drugs containing hydrocodone,
benzodiazepines, schedule three drugs containing
codeine, as well as Ambien, phentermine, and
phendimetrazine. Id. at 6.
18 Dr.
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Moreover, prior to Respondent’s
engaging in internet-based prescribing,
the Medical Board of California had
issued numerous Citation Orders to outof-state physicians for internet
prescribing to California residents.
These Orders invariably cited not only
the physicians’ failure to perform ‘‘a
good faith prior examination,’’ but also
their lack of ‘‘a valid California
Physician and Surgeon’s License to
practice medicine in California.’’
Citation Order, Martin P. Feldman (Aug.
15, 2003); see also Citation Order, Harry
Hoff (Jun. 17, 2003); Citation Order,
Carlos Gustavo Levy (Jan. 28, 2003);
Citation Order, Carlos Gustavo Levy
(Nov. 30, 2001). Moreover, the Board
had issued several press releases setting
forth its position that internet
prescribing is unlawful. See GX 11 at 9
(Feb. 2004 Action Report) (‘‘The Board
has taken action against California
physicians and licensees from other
states for prescribing over the Internet
without a good faith prior exam, and
continues to investigate cases as it
becomes aware of the practice.’’);
Record Fines Issued by Medical Board
to Physicians in Internet Prescribing
Cases (News Release Feb. 10, 2003)
(available at
https://www.mbc.ca.gov/board/media/
releases_2003_0210_internet_drugs.html). Respondent
thus clearly violated both California law
and the CSA in issuing these
prescriptions.
Respondent issued forty-eight
prescriptions for hydrocodone drugs to
residents of Texas. Respondent did not,
however, hold a Texas medical license.
See Tex. Occ. Code § 155.001; see also
id. § 151.056(a) (‘‘A person who is
physically located in another
jurisdiction but who, through the use of
any medium, including an electronic
medium, performs an act that is part of
a patient care service initiated in this
state, * * * and that would affect the
diagnosis or treatment of the patient, is
considered to be engaged in the practice
of medicine in this state and is subject
to appropriate regulation by the
board.’’); 22 Tex. Admin. Code
§ 174.4(c) (‘‘Physicians who treat and
prescribe through the Internet are
practicing medicine and must possess
appropriate licensure in all jurisdictions
where patients reside.’’).
Respondent also lacked the state
registration required to prescribe a
controlled substance. See Tex. Health &
Safety Code § 481.061(a) (requiring state
registration to dispense); id.
§ 481.063(d) (requiring as a condition
for registration that ‘‘a practitioner [be]
licensed under the laws of this state’’).
Respondent thus also violated Texas
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law, and the CSA, in prescribing
controlled substances to that State’s
residents. See Moore, 423 U.S. at 140–
41 (‘‘In the case of a physician [the CSA]
contemplates that he is authorized by
the State to practice medicine and to
dispense drugs in connection with his
professional practice.’’) (emphasis
added); United Prescription Services, 72
FR at 50407 (‘‘A controlled-substance
prescription issued by a physician who
lacks the license [or other authority
required] to practice medicine within a
State is * * * unlawful under the
CSA.’’); 21 U.S.C. 802(10) (defining
‘‘ ‘dispense’ [to] mean[ ] to deliver a
controlled substance to an ultimate user
* * * by, or pursuant to the lawful
order of, a practitioner’’).
Respondent issued nineteen
prescriptions for drugs containing
hydrocodone to North Carolina
residents. Respondent did so
notwithstanding that under North
Carolina law, ‘‘prescribing medication
by use of the Internet or a toll-free
telephone number, shall be regarded as
practicing medicine’’ in the State and
subjects the practitioner to North
Carolina law ‘‘and appropriate
regulation by the North Carolina
Medical Board.’’ N.C. Gen. Stat. Ann.
§ 90–18(b). North Carolina law further
provides that ‘‘[n]o person shall practice
medicine * * * nor in any case
prescribe for the cure of diseases unless
the person shall have been first licensed
and registered to do so.’’ Id. § 90–18(a).
Moreover, if ‘‘the person so practicing
without a license is an out-of-state
practitioner who has not been licensed
and registered to practice medicine and
surgery in this State, the person shall be
guilty of a Class I felony.’’ Id.19
In addition, in February 2001, the
North Carolina Medical Board issued a
Position Statement entitled: Contact
With Patients Before Prescribing. GX 25
at 11. Therein, the Board stated ‘‘that
prescribing drugs to an individual the
prescriber has not personally examined
is inappropriate except as noted * * *
below.’’ Id. The Board further explained
that ‘‘[b]efore prescribing a drug, a
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 personally perform an
appropriate history and physical
examination, make a diagnosis, and
19 While North Carolina exempts from these
requirements an out-of-state practitioner who ‘‘on
an irregular basis, consults with a resident
registered physician,’’ Respondent does not
maintain that he was consulting with a North
Carolina physician. N.C. Gen. Stat. Ann. § 90–
18(c)(11).
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formulate a therapeutic plan, a part of
which might be a prescription.’’ Id.
While the North Carolina Board
recognized that it may be appropriate to
prescribe to a patient without having
performed a physical exam ‘‘under
certain circumstances,’’ none of these
apply to Respondent.20 I thus conclude
that Respondent violated both North
Carolina law and the CSA in prescribing
to the State’s residents.
Respondent issued thirteen
prescriptions for hydrocodone to Ohio
residents. Ohio law defines ‘‘ ‘the
practice of telemedicine’ [to] mean[ ]
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 authorizes ‘‘[t]he holder
of a telemedicine certificate [to] engage
in the practice of telemedicine in this
state.’’ Ohio Rev. Code Ann.
§ 4731.296(A) & (C). See also id.
§ 4731.41 (‘‘No person shall practice
medicine and surgery, or any of its
branches, without the appropriate
certificate from the state medical board
to engage in the practice.’’). Moreover,
under the regulations of the State
Medical Board of Ohio, ‘‘a physician
shall not prescribe, dispense, or
otherwise provide, or cause to be
provided, any controlled substances to a
person who the physician has never
personally examined and diagnosed’’
except for in limited situations not
applicable here.21 Ohio Admin. Code
§ 4731–11–09(A). I thus conclude that
Respondent violated both Ohio law and
the CSA in issuing prescriptions to Ohio
residents.
Respondent issued thirteen
prescriptions for hydrocodone to
Virginia residents. Under Virginia law,
it is ‘‘unlawful for any person to
practice medicine * * * in the
Commonwealth without a valid
unrevoked licensed issued by the Board
of Medicine,’’ Va. Code Ann. § 54.1–
2902; and ‘‘[a]ny person shall be
20 These circumstances ‘‘may include admission
orders for a newly hospitalized patient, prescribing
for a patient of another physician for whom the
prescriber is taking call, or continuing medication
on a short-term basis for a new patient prior to the
patient’s first appointment.’’ GX 25 at 11. The Board
also noted that ‘‘[e]stablished patients may not
require a new history and physical examination for
each new prescription, depending on good medical
practice.’’ Id.
21 The exceptions are for ‘‘institutional settings,
on call situations, cross coverage situations,
situations involving new patients,’’ (but limited to
where ‘‘the physician has scheduled or is in the
process of scheduling an appointment to examine
the patient and the drugs are intended to be used
pending that appointment’’), ‘‘protocol situations,’’
‘‘nurses practicing in accordance with standard care
arrangements, and hospice settings.’’ Ohio Admin.
Code § 4731–11–09.
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regarded as practicing the healing arts
who actually engages in such practice as
defined in this chapter.’’ Id. § 54.1–
2903; see also id. § 54.1–2900 (the
‘‘[p]ractice of medicine’’ * * * means
the prevention, diagnosis and treatment
of human physical or mental ailments,
conditions, diseases, pain or infirmities
by any means or method’’); id. § 54.1–
2929 (‘‘No person shall practice * * *
medicine * * * without obtaining a
license from the Board of Medicine’’).22
Furthermore, ‘‘[a] prescription for a
controlled substance may be issued only
by a practitioner of medicine * * * who
is authorized to prescribe controlled
substances.’’ Va. Code § 54.1–3303(A).
Moreover, ‘‘[t]he prescription shall be
issued for a medicinal or therapeutic
purpose and may be issued only to
persons * * * with whom the
practitioner has a bona fide practitionerpatient relationship.’’ Id.
The Virginia statute also provides that
‘‘a bona fide practitioner-patient
relationship means that the practitioner
shall * * * perform or have performed
an appropriate examination of the
patient, either physically or by the use
of instrumentation and diagnostic
equipment through which images and
medical records may be transmitted
electronically; except for medical
emergencies, the examination of the
patient shall have been performed by
the practitioner himself, within the
group in which he practices, or by a
consulting practitioner prior to issuing a
prescription.’’ Id. (emphasis added). I
thus conclude that Respondent violated
Virginia law and the CSA in prescribing
to Virginia’s residents.
Respondent issued ten prescriptions
for hydrocodone to Indiana residents.
Under Indiana law, ‘‘[i]t is unlawful for
any person to practice medicine * * *
in this state without holding a license or
permit to do so.’’ Ind. Code § 25–22.5–
8–1. Moreover, the practice of medicine
includes the ‘‘prescription * * * of any
form of treatment, without limitation.’’
Id. § 25–22.5–1–1.1(a)(1)((B); see also
id.§ (a)(4).
The Medical Licensing Board of
Indiana has also adopted a regulation
(similar to Ohio’s), which provides that
except for in limited situations, ‘‘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.’’ 844 Ind. Admin. Code 5–4–
1(a).23 This rule has been effect since
October 2003. I thus conclude that
Respondent violated Indiana law and
the CSA in prescribing to Indiana
residents.
Respondent issued nine prescriptions
for hydrocodone to Colorado residents.
In November 2000, the Colorado State
Board of Medical Examiners issued a
policy statement entitled ‘‘Guidelines
Regarding Prescribing for Unknown
Patients.’’ In this statement, the
Colorado Board declared that:
22 Respondent does not claim that his prescribing
came within one of the limited exceptions for outof-state practitioners recognized by Virginia law.
See Va. Code Ann. § 54.1–2901(A)(7) (authorizing
‘‘[t]he rendering of medical advice * * * through
telecommunications from a physician licensed to
practice medicine in * * * an adjoining state to
emergency medical personnel acting in an
emergency situation’’).
23 The exceptions are for ‘‘institutional settings,
on-call situations, cross-coverage situations, and
situations involving advanced practice nurses with
prescriptive authority.’’ 844 Ind. Admin. Code 5–4–
1(a). Respondent does not claim that his prescribing
falls within any of these exceptions.
24 The Colorado Board has also recognized
limited exceptions similar to those adopted by Ohio
and Indiana.
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It is unprofessional conduct for a physician
to provide treatment and consultation
recommendations, including issuing a
prescription via electronic or other means,
unless the physician has obtained a history
and physical evaluation of the patient
adequate to establish diagnoses and identify
underlying conditions and/or contraindications to the treatment recommended/
provided. Issuing a prescription on the basis
of a questionnaire, Internet-based
consultation, or a telephonic consultation, all
without a valid pre-existing patient/
practitioner relationship does not constitute
an acceptable standard of care.
Before prescribing a drug, a physician
should make an informed medical judgment
based on the circumstances of the situation
and on his/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.24
GX 12 at 14. I thus conclude that
Respondent acted outside of the course
of professional practice in issuing the
prescriptions to Colorado residents and
violated the CSA.
Respondent issued eight prescriptions
for hydrocodone to Mississippi
residents. In May 2000, the Mississippi
State Board of Medical Licensure issued
a policy statement on Internet
Prescribing. See GX 21 at 6. The
Mississippi Board advised that the
‘‘[e]ssential components of proper
prescribing and legitimate medical
practice requires [sic] that the physician
obtains a thorough medical history and
conducts an appropriate physical
examination before prescribing any
medication for the first time.’’ Id.
Moreover, since 1997, Mississippi law
has provided that ‘‘no person shall
engage in the practice of medicine
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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 and has met all
education and licensure requirements as
determined by the State Board * * *. ’’
Miss. Code Ann. § 73–25–34(2). The
statute specifically defines the terms
‘‘telemedicine, or the practice of
medicine across state lines,’’ as
including ‘‘[t]he rendering of treatment
to a patient within this state by a
physician located outside this state as a
result of transmission of individual
patient data by electronic or other
means from within this state to such
physician or his agent.’’ Id. § 73–25–
34(1)(b).25 I thus conclude that
Respondent violated Mississippi law
and the CSA when he prescribed to the
State’s residents.
Respondent also issued eight
prescriptions for hydrocodone to
residents of Massachusetts, whose law
follows nearly verbatim the CSA’s
prescription requirement. Compare
Mass. Gen. Laws ch. 94C, § 19(a), with
21 CFR 1306.04(a). In December 2003,
the Massachusetts Board of Registration
in Medicine issued the following
interpretation of the State’s prescription
law:
[t]o satisfy the requirement that a
prescription be issued by a practitioner in the
usual course of his professional practice,
there must be a physician-patient
relationship that is for the purpose of
maintaining the patient’s well-being and the
physician must conform to certain minimum
norms and standards for the care of patients,
such as taking an adequate medical history
and conducting an appropriate physical and/
or mental status examination and recording
the results. Issuance of a prescription, by any
means, including the Internet or other
electronic process, that does not meet these
requirements is therefore unlawful.
Commonwealth of Massachusetts,
Board of Registration in Medicine,
Policy 03–06 INTERNET PRESCRIBING
(Adopted Dec. 17, 2003).26 As the
25 Mississippi exempts an out-of-state physician
from the licensure requirement when the physician
provides an evaluation, treatment recommendation,
or medical opinion at the request of ‘‘a physician
duly licensed to practice medicine in th[e] state,’’
and the requesting physician ‘‘has already
established a doctor/patient relationship with the
patient to be evaluated and/or treated.’’ Miss. Code
Ann. § 73–25–34(3). Respondent, however,
produced no evidence that any physician had ever
requested that he evaluate a Just USA patient.
26 The ALJ also concluded that Respondent was
required to be licensed to practice medicine in
Massachusetts and violated its law by prescribing
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Board’s interpretation makes plain,
Respondent acted outside of the usual
course of professional practice when he
prescribed controlled substances to
residents of Massachusetts, and
therefore violated both Massachusetts
law and the CSA.
Respondent issued seven
prescriptions for hydrocodone for
residents of Georgia. Under the rules of
the Georgia Composite State Board of
Medical Examiners, it is
‘‘unprofessional conduct’’ to
‘‘[p]rovid[e] 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(6).27
Moreover, Respondent violated Georgia
law because he engaged in the
unlicensed practice of medicine. See Ga.
Code Ann. § 43–34–31.1.28 I thus
conclude that Respondent violated the
CSA in prescribing to Georgia residents.
Respondent issued six prescriptions
for hydrocodone to Missouri residents.
Under Missouri law—which was last
amended in 1998—it is ‘‘unlawful for
any person not now a registered
physician within the meaning of the law
to practice medicine [or] * * * to
engage in the practice of medicine
to residents of that State. ALJ at 34. In light of the
Massachusetts’ Board clear interpretation as set
forth in its policy on Internet Prescribing, I
conclude that it is unnecessary to address whether
Respondent also violated the State’s provisions
requiring a license and controlled substance
registration which appear to allow an out-of-state
practitioner to issue a prescription to a state
resident in some instances. Id. Mass. Gen. Laws ch.
94C, 18(c).
27 It is noted that the rule does ‘‘not prohibit a
licensee who is on call or covering for another
licensee from treating and/or consulting a patient of
such other licensee.’’ Ga. Comp. R. & Regs. 360–3–
.02(6). Respondent did not maintain that he was
covering for, or consulting with, other physicians
who were treating the Georgia residents he
prescribed to.
28 This statute provides:
(a) A person who is physically located in another
state * * * and who, through the use of any means,
including electronic * * * or other means of
telecommunication, through which medical
information or data is transmitted, performs an act
that is part of a patient care service located in this
state * * * that would affect the diagnosis or
treatment of the patient is engaged in the practice
of medicine in this state. Any person who performs
such acts through such means shall be required to
have a license to practice medicine in this state and
shall be subject to regulation by the board.
Ga. Code Ann. § 43–34–31.1(a). While the statute
includes exceptions when, inter alia, the physician
‘‘[p]rovides consultation services at the request of
a physician licensed in this state,’’ or ‘‘[p]rovides
consultation services in the case of an emergency,’’
id. § 43–34–31.1(b)(1) & (2), neither exception
applies to Respondent.
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23:12 May 04, 2009
Jkt 217001
across state lines * * * except as herein
provided.’’ Mo. Ann. Stat. § 334.010(1).
The statute defines ‘‘the practice of
medicine across state lines’’ to mean in
relevant part, ‘‘[t]he rendering of
treatment to a patient within this state
by a physician located outside this state
as a result of transmission of individual
patient data by electronic or other
means from within this state to such
physician or physician’s agent.’’ Id.
§ 334.010(2)(2). While the statute
exempts from the licensure requirement
an out-of-state physician who consults
with a Missouri-licensed physician
when the latter ‘‘retains ultimate
authority and responsibility for the
* * * diagnoses and treatment * * * of
the patient located within th[e] state,’’
id. § 334.010(3), Respondent makes no
claim that his prescribing falls within
this exemption.29 Respondent thus
violated both Missouri law and the CSA
when he prescribed to the State’s
residents.
Finally, Respondent issued four
prescriptions for hydrocodone to
Oklahoma residents. In January 2001,
the Oklahoma State Board of Medical
Licensure and Supervision issued its
Policy on Internet Prescribing. GX 27, at
19. Therein, the Oklahoma Board
explained that ‘‘[u]nprofessional
conduct includes ‘prescribing * * * a
drug * * * without sufficient
examination and the establishment of a
valid physician/patient
relationship’* * * . The members of the
Oklahoma Medical Board have
interpreted that a ‘sufficient
examination’ and ‘establishment of a
valid physician/patient relationship’
can NOT take place without an initial
face to face encounter with the patient.’’
Id. (emphasis in original and quoting
Okla. Stat. tit. 59, § 509–13). I thus
conclude that Respondent acted outside
of the usual course of professional
practice when he prescribed to
Oklahoma residents and thus violated
the CSA.
As the forgoing demonstrates,
Respondent, in issuing the prescriptions
for Just USA, repeatedly violated both
state laws prohibiting the unlicensed
practice of medicine and those
establishing standards of medical
practice. As the California Court of
Appeal has noted, ‘‘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
29 The Missouri statute contains two other
exemptions which are not remotely applicable to
Respondent’s conduct. See Mo. Ann. Stat.
§ 334.010(3) (providing medical opinion or
testimony in judicial or administrative proceeding)
& (4) (performing ‘‘utilization review’’).
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Fmt 4703
Sfmt 4703
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). The same is true of
the standards for establishing a valid
doctor-patient relationship.
I thus hold that Respondent acted
outside of ‘‘the usual course of * * *
professional practice,’’ and lacked ‘‘a
legitimate medical purpose,’’ 21 CFR
1306.04(a), in issuing numerous
prescriptions for the customers of Just
USA. I further conclude that
Respondent has committed acts which
render his continued registration
‘‘inconsistent with the public interest.’’
21 U.S.C. 824(a)(4).
Sanction
Under Agency precedent, where, as
here, ‘‘the Government has proved that
a registrant has committed acts
inconsistent with the public interest, a
registrant must ‘present sufficient
mitigating evidence to assure the
Administrator that [he] can be entrusted
with the responsibility carried by such
a registration.’ ’’ Medicine ShoppeJonesborough, 73 FR 364, 387 (2008)
(quoting Samuel S. Jackson, 72 FR
23848, 23853 (2007) (quoting Leo R.
Miller, 53 FR 21931, 21932 (1988))).
‘‘Moreover, because ‘past performance is
the best predictor of future
performance,’ ALRA Labs, Inc. v. DEA,
54 F.3d 450, 452 (7th Cir.1995), [DEA]
has repeatedly held that where a
registrant has committed acts
inconsistent with the public interest, the
registrant must accept responsibility for
[his] actions and demonstrate that [he]
will not engage in future misconduct.’’
Medicine Shoppe, 73 FR at 387; see also
Jackson, 72 FR at 23853; John H.
Kennedy, 71 FR 35705, 35709 (2006);
Prince George Daniels, 60 FR 62884,
62887 (1995). See also Hoxie v. DEA,
419 F.3d at 483 (‘‘admitting fault’’ is
‘‘properly consider[ed]’’ by DEA to be
an ‘‘important factor’’ in the public
interest determination).
Respondent contends that his conduct
should be excused because he
‘‘exercised due diligence to ensure that
his medical behavior was within the
law.’’ Resp. Br. (Pt. II) at 11. In
Respondent’s words, ‘‘[d]ue diligence,
of course, does not mean that all
mistakes were avoided. What it means,
is that every effort is being made to
search out whether or not any mistakes
were being made.’’ Id. Respondent
further contends that ‘‘his due diligence
was not a one time, flash-in-the pan’’
effort, and that he ‘‘pursu[ed] and
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persist[ed] in his efforts to assure
compliance with the law.’’ Id.
Even were I to recognize a due
diligence defense in the context of a
practitioner’s obligation to know the
law, Respondent’s contention is wholly
unpersuasive. First, while Respondent
testified that he relied on Just USA’s
representation that it did not ship to
seven States because it had examined
their laws and determined that these
States either required a face-to-face
meeting between the patient and doctor,
or prohibited an out-of-state doctor from
prescribing to State residents, Tr. 95,
Respondent nonetheless issued multiple
prescriptions to persons who resided in
those States.
Respondent attempted to justify his
issuance of these prescriptions,
explaining that he relied on the
employees of Just USA to screen out
such customers. Respondent’s
explanation ignores that he is the
physician and is thus ultimately
responsible for his prescribing. In short,
his explanation is nothing more than
excuse-making.
More broadly, Respondent is a
licensed physician, and is thus properly
charged with the obligation to
determine what the law required with
respect to his prescribing activities. See,
e.g., Hageseth, 59 Cal. Rptr. 3d at 403
(licensed health care provider cannot
‘‘reasonably claim ignorance’’ of state
provisions regulating medical practice).
Moreover, those who voluntarily engage
in commerce by dispensing controlled
substances to persons located in other
States are properly charged with
knowledge of the legal requirements
applicable to the practice of medicine in
those States. United, 72 FR at 50407.
In this regard, Respondent offered no
evidence that he contacted any of the
Medical Boards of the various States
where the recipients of his prescriptions
resided, to determine what their laws
required with respect to both obtaining
a license and establishing a legitimate
doctor-patient relationship. Indeed, for
all of his professed interest in the
internet, Respondent does not maintain
that he ever visited the Web site of any
state board to research what the legal
requirements were to prescribe.
In his brief, Respondent also claims
that the legal opinion prepared by a
Florida-based lawyer (RX 7D)
‘‘expresses * * * the idea that
Respondent * * * behave[d] within the
law.’’ Resp. Br. (Pt. II) at 14. According
to Respondent, this document was
offered ‘‘purely and exclusively to show
that [he] had exercised due diligence,
regardless of what the letter said in its
content.’’ Id. Moreover, it shows that ‘‘in
the middle of the year 2006, [he] was
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23:12 May 04, 2009
Jkt 217001
continuing to persist in the due
diligence investigation of his * * *
practice.’’ Id.
It is clear why Respondent does not
rely on the content of the opinion. The
opinion expressly stated that it was
limited to Florida law, that it was not
addressing issues such as physician
licensure, warned that ‘‘[p]rescribing
standards vary dramatically from state
to state,’’ noted that other States had
adopted prescribing standards which
‘‘often require[] a face to face physical
examination and mak[e] noncompliance a crime subject to heavy
penalties.’’ RX 7D at 4 & 6. Respondent
nonetheless prescribed to persons in
States whose prescribing standards did
require face-to-face examinations, and
did so even after he received the
opinion—in June 2006 according to his
brief and testimony. See generally GX
39. It is thus clear that even when
Respondent was provided information
as to the potential illegality of his
activities, he ignored it.30
In his brief, Respondent also
maintains that as part of his efforts he
reviewed various DEA pronouncements,
and that in them, ‘‘there is not one word
regarding face-to-face physical
examinations being required by federal
rules or instructions.’’ Resp. Br. (Pt. II)
at 12–13. Respondent further contends
that ‘‘[a]ny requirements for face-to-face
physical examinations are to be found
exclusively in State laws.’’ Id. at 13.
That much is true—at least for the
prescriptions at issue here which were
written before the enactment of the
Ryan Haight Act—but it provides no
comfort to Respondent. As I have
previously explained, ‘‘in enacting the
CSA, Congress did not adopt a federal
standard for determining whether a
valid doctor-patient relationship exists,’’
and that ‘‘on this issue, the CSA
recognizes the traditional role of the
States in regulating the practice of
medicine.’’ Paul H. Volkman, 73 FR
30630, 30643 (2008) (citing Gonzales,
546 U.S. at 270). Taking the steps
necessary to establish a valid doctorpatient relationship under state laws
and medical practice standards is thus
30 While the opinion letter concluded that ‘‘the
Websites’ Medical Records Based Prescribing
Procedures appear to comply with the DEA’s
published rules and Federal law,’’ the opinion was
based on its analysis of Florida’s telemedicine rule
and did not purport to analyze whether these
practices were legal in any other State. Nor did it
address whether under Florida law, a physician
who is not licensed in the State, can prescribe a
controlled substance to a Florida resident. Rather,
in its conclusion the opinion states only that
‘‘Florida’s laws and professional standards * * *
indicate * * * that a prescribing physician located
in Florida can prescribe using Medical Records
Based Prescribing procedures.’’ RX 7D at 1
(emphasis added).
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
20735
fundamental to a practitioner’s
establishing that he acted in ‘‘the usual
course of professional practice’’ and
issued a prescription for ‘‘a legitimate
medical purpose’’ as required by
Federal law. Most significantly, nothing
in the 2001 Guidance Document or any
other Agency pronouncement can
reasonably be construed as stating that
Respondent’s prescribing practices were
legal under Federal law.31
As the forgoing demonstrates, when
Respondent did obtain legal advice that
his practices were likely unlawful, he
ignored it and continued to prescribe in
violation of the laws of numerous States
and the CSA. Moreover, when
Respondent was confronted at the
hearing with the evidence that he had
prescribed to residents of States
where—according to his testimony—it
was illegal to do so, he denied that he
was responsible and instead blamed
others.
The record thus amply demonstrates
the absurdity of Respondent’s
contentions that he made ‘‘heroic’’ and
‘‘serious efforts to assure himself that he
was behaving correctly * * * relative to
the law,’’ that any ‘‘mistakes and errors
* * * would have been readily
corrected had they been brought to his
attention,’’ and that ‘‘[i]t would be rare
to find someone who is attempting so
studiously to abide by the law.’’ Resp.
Br. (Pt. II) at 15. In short, Respondent’s
contentions are disingenuous.
Moreover, the record establishes that
Respondent was aware of the fact that
Just USA had used his registration to
issue several backdated prescriptions.
These too were violations of the CSA,
because a prescription ‘‘may be issued
only by an individual practitioner who
is: (1) [a]uthorized to prescribe * * * by
the jurisdiction in which he is licensed
to practice * * * and (2) [e]ither
registered or exempted from
registration,’’ see 21 CFR 1306.03(a) &
31 Respondent also contends that ‘‘there was zero
testimony regarding any complaints or inquiries
directed toward [him] by any State.’’ Resp. Br. (Pt.
II) at 13. The contention is beside the point as there
is no evidence in the record that any of the States
whose laws Respondent violated were aware of his
misconduct. Moreover, even if a State was aware of
Respondent’s misconduct and declined to take
action, DEA would not be precluded from acting
because Congress vested authority to enforce the
CSA in the Attorney General and not state officials.
See Edmund Chein, 72 FR 6580, 6590 (2007).
Respondent also contends that the DI ‘‘never
suggested what it is that [he] might have been doing
wrong.’’ Resp. Br. (Pt. II) at 15. The testimony
establishes, however, that when Respondent told
the DI that he ‘‘had some telemedicine internet
practice going,’’ the DI responded ‘‘that there might
be a problem with that.’’ Tr. 87. Even if it is the
case that the DI did not specifically identify why
Respondent’s telemedicine prescribing was
unlawful, it is not as if the DI told him it was
lawful.
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1306.04, and obviously lacked a
legitimate medical purpose. See also 21
U.S.C. 822(a)(2) (‘‘Every person who
dispenses * * * shall obtain from the
Attorney General a registration. * * *’’);
id. § 841(a)(1) (‘‘Except as authorized by
this subchapter, it shall be unlawful for
any person knowingly or intentionally
* * * to * * * distribute, or dispense
* * * a controlled substance’’); id.
§ 843(a)(2) (‘‘It shall be unlawful for any
person knowingly or intentionally
* * * to use in the course of the * * *
distribution[] or dispensing of a
controlled substance * * * a
registration number which is * * *
issued to another person’’).
Respondent did not report the
violations, Tr. 170, and in his brief he
trivialized the violations as just
‘‘mistakes’’ of the sort that ‘‘[c]lerks, and
other people who work for doctors,
make.’’ Resp. Br. (Pt. II) at 22.
Notwithstanding the illegal nature of
these acts (which had happened shortly
after Respondent began his arrangement
with Just USA), and that Respondent
had no way of confirming the validity
of Just USA’s representation that its
employees had used his name and
registration to backdate prescriptions
only once or twice, Respondent
continued to work for them.
As the record demonstrates,
Respondent issued hundreds of illegal
prescriptions for highly abused and
dangerous controlled substances.32
While Respondent ceased his illegal
activity—after engaging in it for
approximately one year—he maintained
throughout the hearing that his
‘‘prescribing was appropriate,’’ Tr. 99,
and that it was illegal in only about two
or three other States in addition to the
seven States identified by Just USA and
where he prescribed to anyway. Id. at
161. Moreover, when confronted with
the evidence showing that that he had
prescribed to persons in those seven
States, Respondent’s did not accept
responsibility for having done so, but
rather blamed others.
I thus conclude that Respondent has
not accepted responsibility for his
misconduct and that he has failed to
rebut the Government’s prima facie
showing that his continued registration
‘‘would be inconsistent with the public
interest.’’ 21 U.S.C. 823(f). Accordingly,
Respondent’s registration will be
32 As found above, Respondent maintained at the
hearing that hydrocodone is not addictive or
dangerous. Yet in 2002, the abuse of hydrocodone
drugs resulted in more than 27,000 emergency room
visits. Moreover, the drug is also highly abused by
teenagers, among others. Respondent’s testimony
buttresses my conclusion that Respondent cannot
be trusted to acted responsibly.
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23:12 May 04, 2009
Jkt 217001
revoked and his pending application
will be denied.
DEPARTMENT OF LABOR
Order
Employment and Training
Administration
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) & 824(a), as well as
28 CFR 0.100(b) & 0.104, I hereby order
that DEA Certificate of Registration,
AS2352653,33 issued to Patrick W.
Stodola, M.D., be, and it hereby is,
revoked. I further order that any
pending application to renew or modify
the registration be, and it hereby is,
denied. This Order is effective June 4,
2009.
Dated: April 24, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9–10245 Filed 5–4–09; 8:45 am]
BILLING CODE 4410–09–P
[TA–W–65,162]
Dana Holding Corporation, Humboldt,
TN; Notice of Termination of
Investigation
Pursuant to Section 221 of the Trade
Act of 1974, as amended, an
investigation was initiated on February
6, 2009 in response to a worker petition
filed by the American Federation of
Labor and Congress of Industrial
Organizations (AFL–CIO) on behalf of
workers of Dana Holding Corporation,
Humboldt, Tennessee.
The petitioner has requested that the
petition be withdrawn. Consequently,
the investigation has been terminated.
Signed at Washington, DC, this 31st day of
March 2009.
Elliott S. Kushner,
Certifying Officer, Division of Trade
Adjustment Assistance.
[FR Doc. E9–10212 Filed 5–4–09; 8:45 am]
DEPARTMENT OF LABOR
Employment and Training
Administration
[TA–W–65,680]
BILLING CODE 4510–FN–P
SMTC Enclosure Systems Division
Franklin, MA; Notice of Termination of
Investigation
Pursuant to Section 221 of the Trade
Act of 1974, as amended, an
investigation was initiated on March 26,
2009 in response to a petition filed by
a company official on behalf of workers
of SMTC, Enclosure Systems Division,
Franklin, Massachusetts.
The petitioner has requested that the
petition be withdrawn. Consequently,
the investigation has been terminated.
Signed at Washington, DC, this 31st day of
March 2009.
Linda G. Poole,
Certifying Officer, Division of Trade
Adjustment Assistance.
[FR Doc. E9–10210 Filed 5–4–09; 8:45 am]
BILLING CODE 4510–FN–P
33 While the Show Cause Order did not expressly
reference Respondent’s registration number
XS2352653, which authorizes him to dispense
narcotic drugs for the purposes of maintenance or
detoxification treatment, the holding of a
practitioner’s registration under 21 U.S.C. 823(f) is
a prerequisite for obtaining the separate registration
required to conduct narcotic treatment under 21
U.S.C. 823(g). See id. § 823(g)(2)(D)(i). Accordingly,
the revocation of Respondent practitioner’s
registration requires the revocation of his
registration under 21 U.S.C. 823(g).
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DEPARTMENT OF LABOR
Employment and Training
Administration
[TA–W–65,231]
Rawlings Sporting Goods,
Washington, MO; Notice of
Termination of Investigation
Pursuant to Section 221 of the Trade
Act of 1974, as amended, an
investigation was initiated on February
12, 2009 in response to a petition filed
by a company official on behalf of
workers of Rawlings Sporting Goods,
Washington, Missouri.
The petitioner has requested that the
petition be withdrawn. Consequently,
the investigation has been terminated.
Signed at Washington, DC, this 26th day of
March 2009.
Linda G. Poole,
Certifying Officer, Division of Trade
Adjustment Assistance.
[FR Doc. E9–10215 Filed 5–4–09; 8:45 am]
BILLING CODE 4510–FN–P
E:\FR\FM\05MYN1.SGM
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Agencies
[Federal Register Volume 74, Number 85 (Tuesday, May 5, 2009)]
[Notices]
[Pages 20727-20736]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10245]
=======================================================================
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 07-24]
Patrick W. Stodola, M.D.; Revocation of Registration
On February 7, 2007, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Patrick W. Stodola, M.D. (Respondent), of Chicago,
Illinois. The Show Cause Order proposed the revocation of Respondent's
DEA Certificate of Registration, AS2352653, as a practitioner, and
proposed the denial of his pending application to renew his
registration, on the ground that his ``continued registration is
inconsistent with the public interest.'' Show Cause Order at 1.
The Show Cause Order specifically alleged that while Respondent is
licensed as a physician only in Illinois, he prescribed controlled
substances, via the internet, to persons located in twenty-six other
States. Id. The Order alleged that Respondent's prescribing constituted
the unauthorized practice of medicine because he did not possess the
licenses required to practice medicine (and prescribe) in these States,
and that the prescriptions he authorized ``were not issued in the usual
course of professional practice as required by 21 CFR 1306.04.'' Id. at
1-2.
On March 14, 2007, Respondent filed a request for a hearing and the
matter was placed on the docket of the Agency's Administrative Law
Judges. Following pre-hearing procedures, a hearing was held on October
16, 2007, in Chicago, Illinois. At the hearing, both parties elicited
testimony and introduced documentary evidence for the record. Following
the hearing, both parties submitted briefs containing their proposed
findings of fact, conclusions of law and argument.
On September 16, 2008, the ALJ issued her recommended decision
(ALJ). In evaluating Respondent's experience in dispensing controlled
substances and record of compliance with applicable laws, the ALJ
concluded that Respondent had violated the medical practice standards
adopted by multiple States which specifically require that a physician
physically examine a patient before prescribing a drug to him/her. ALJ
at 33-34. The ALJ further concluded that Respondent had violated the
laws of numerous States by prescribing to their residents without
holding the requisites licenses to practice medicine and/or dispense
controlled substances. Id. at 34. While the ALJ found that Respondent
has retained his Illinois medical license and has not been convicted of
a crime, she further found that Respondent has ``refus[ed] to
acknowledge his wrongdoing.'' Id. at 32 & 34. The ALJ thus
``conclude[d] that Respondent is unwilling or unable to accept the
responsibilities inherent in a DEA registration,'' and recommended that
his registration be revoked and that any pending applications be
denied. Id. at 35.
Respondent did not file exceptions to the ALJ's decision.\1\
Thereafter, the record was forwarded to me for final agency action.
---------------------------------------------------------------------------
\1\ While the Government filed exceptions, the exceptions do not
go to the merits of the proceeding.
---------------------------------------------------------------------------
Having considered the entire record in this matter, I adopt the
ALJ's conclusions of law with respect to the public interest inquiry. I
further adopt the ALJ's recommended sanction. Accordingly, I will
revoke Respondent's registration and deny his pending application to
renew the registration. I make the following findings.
Findings
Respondent is the holder of DEA Certificate of Registration,
AS2352653, which authorizes him to dispensing controlled substances in
schedules II through V as a practitioner. According to Respondent's
Certificate of Registration, the expiration date of his registration
was February 28, 2006. It is undisputed, however, that Respondent filed
a timely renewal application. I therefore find that Respondent's
registration has remained in effect pending the issuance of this Order.
See 5 U.S.C. 558(c).
Respondent holds a medical license in Illinois. Tr. 85, 190-91. In
his testimony, Respondent acknowledged that he is not licensed to
practice medicine in any other State, id. at 85 & 191, and that he has
never obtained a license to practice in any other State. Id. at 85.
Moreover, Respondent does not hold a DEA registration for a location in
any State other than Illinois. Id. at 191.
In early 2006, Respondent read an advertisement which had been
placed by Just USA Meds \2\ in the employment section of the Chicago
Tribune's Web site. Id. at 165. Respondent called the phone number
contained in the ad, and spoke with Challen Sullivan, Just USA's owner,
who told him that his business ``was to be a provider of medical
services,'' but not ``a dispenser or a vending machine of any
particular medications.'' Id. at 87. Thereafter, Respondent entered
into an agreement with the entity under which Just USA Meds would
arrange for customers, who were seeking controlled substances, to speak
with him by telephone. Id. at 14. Respondent was paid $20 per
consultation and would typically issue a controlled-substance
prescription for the patient upon the conclusion of the consultation.
Id. The prescriptions were then sent to pharmacies which had entered
into arrangements with Just USA Meds to dispense the drugs to its
customers.
---------------------------------------------------------------------------
\2\ In this decision, Just USA Meds will also be referred to as
``Just USA.''
---------------------------------------------------------------------------
According to Respondent, a customer would contact Just USA Meds,
identify himself, and provide a copy of the credit card which he
intended to use to pay his bill. Id. at 91. Respondent asserted that a
customer would then be interviewed by an employee of Just USA Meds, who
would ask him the name of his doctor, what other drugs he was taking,
and whether he would agree not to seek drugs from another source if
Respondent (or the other doctors engaged by Just USA Meds) issued a
prescription for him. Id. at 92. Just USA would then contact the
customer's credit card company to verify whether the card was valid and
to request a pre-charge for the anticipated amount of the services and
drugs being provided. Id. After Just USA obtained the pre-charge, the
customer would then be scheduled for a consultation with Respondent or
another physician. Id. at 104.
Respondent admitted that he did not physically examine any of the
persons who were referred to him by Just USA Meds. Tr. 18 (testimony of
DI); id. at 84 (testimony of Respondent).\3\ Rather, Respondent
asserted that the customers were required to send in medical records
including the documentation of a physical exam which had to be less
than one year old. Id. at 97-98. He also maintained that persons who
claimed ``some sort of structural harm'' were
[[Page 20728]]
required to forward imaging documentation such as a CT scan, MRI, or X-
Ray, and that if the person did not have a physical that met the above
requirement, the person was sent an eleven to twelve-page-long form,
which was to be taken to a doctor in his/her community to ``have the
history and physical completed.'' Id. at 98. Relatedly, Respondent
claimed that for those customers who found it inconvenient to go to a
doctor's office, Just USA Meds used a company which sent a nurse to the
customer's home to obtain a medical history and perform a physical. Id.
at 100.
---------------------------------------------------------------------------
\3\ Respondent did not even physically examine those persons he
prescribed to who resided in the Chicago area. See GX 34 at 24
(resident of Chicago); GX 39 at 63 (resident of Highland Park, Il.);
Id. at 133 (resident of Arlington Heights, Il.); Id. at 171
(resident of Hoffman Estates, Il.).
---------------------------------------------------------------------------
Respondent further maintained that he kept copies of each
customer's medical records. Id. Respondent did not, however, produce
any of these records at the hearing.
Respondent also asserted that the phone consultations he conducted
were probing and would take between twenty to thirty minutes to
complete.\4\ Id. at 105. Relatedly, he maintained that Just USA Meds
``scolded [him] a couple of times in the beginning'' because the
consultations took too much time. Id. According to Respondent, the
---------------------------------------------------------------------------
\4\ The prescription records suggest that this testimony
stretches the limits of credulity. According to GX 35, on February
9, 2006, Respondent would have performed approximately thirty
consultations, and the following day, he would have performed
approximately thirty-three consultations. Respondent would thus have
spent between ten and seventeen hours a day consulting. While this
is not out of the realm of possibility, it seems most unlikely.
However, because most (if not all) of Respondent's prescribings were
illegal regardless of how long the consultations lasted for, it is
unnecessary to determine whether this testimony is credible.
consultations were inquiries concerning the history and physical,
which was in front of me, the nature and extent of the medications
and therapies that they had already received, their response to any
medications that they had already received, what medications other
than what they were requesting they were already taking, how their
condition affected them, and I usually used two or three different
---------------------------------------------------------------------------
tests inquiring from them to find out the nature of their problem.
Id. at 104. Respondent also maintained that he asked the customer to
rate their pain ``on a scale of 1 to 10,'' whether he/she had
previously ``taken hydrocodone,'' and if so, how it affected the
customer's pain level and whether the drug had caused various adverse
events. Id. at 105. Respondent maintained that ``those were all
discussed by me each and every time,'' and that ``[t]here were no
exceptions.'' Id.
Relatedly, Respondent asserted that the consultations ``were
meaningful interviews that took as long or longer than is customarily
had in a physician's office with the patient physically in front of
them,'' and ``that the interviews were comprehensive and medically
appropriate.'' Id. at 106. According to Respondent, ``probably about 90
percent of the patients who were inquiring were requesting some sort of
pain relief.'' Id. Respondent also asserted that he would ``sometimes''
negotiate with the customers to ``alter their request'' for drugs and
or ``to use some other medicine.'' \5\ Id.
According to various prescription records which were entered into
evidence, Respondent issued in excess of three hundred controlled-
substance prescriptions for Just USA, the overwhelming majority
(approximately eighty-five to ninety percent) of which were for
combination drugs containing hydrocodone, a schedule III controlled
substance, and acetaminophen. See GXs 34, 35, & 39; 21 CFR 1308.13(e).
Invariably, the prescriptions were for those formulations which
contained the stronger concentrations (7.5 or 10 mg.) of hydrocodone.
See GXs 34, 35, & 39.
As I have noted in numerous other decisions, these drugs are highly
popular with drug abusers. See Southwood Pharmaceuticals, Inc., 72 FR
36487, 36503 (2007) (noting 2004 survey of National Institute of Drug
Abuse found that ``9.3 percent of twelfth graders reported using
Vicodin, a brand name Schedule III controlled substance without a
prescription in the previous year''); William R. Lockridge, 71 FR
77791, 77796 (2006) (noting that in 2002, the abuse of hydrocodone
products resulted in more than 27,000 emergency room visits).\6\
Respondent also issued smaller numbers of prescriptions for Didrex
(benzphetamine, a schedule III controlled substance), as well as
various schedule IV drugs including alprazolam, diazepam, Ambien
(zolpidem) and phentermine. See GXs 34, 35, & 39; see also 21 CFR
1308.13(b)(2); Id. 1308.14(c) & (e).
---------------------------------------------------------------------------
\5\ The prescriptions records, however, cast doubt on the
credibility of this testimony. As found above, Respondent invariably
issued prescriptions for combination drugs which contained either
7.5 or 10 mg. of hydrocodone (rather than those drugs which contain
only 5 mg.), and rarely issued prescriptions for such non-controlled
drugs which are used to treat pain such as Tramadol and Fioricet.
The various prescription records entered into evidence show that
Respondent also wrote a miniscule number of prescriptions for non-
controlled drugs including Soma (carisoprodol), Tramadol, and
Fioricet (a combination of butalbital, acetaminophen and caffeine).
\6\ In his testimony, Respondent asserted that drugs containing
hydrocodone are not addictive or ``dangerous.'' Tr. 158-59. As found
above, combination hydrocodone drugs are among the most highly
abused controlled substances. I therefore reject Respondent's
testimony as self-serving.
---------------------------------------------------------------------------
As the prescriptions records indicate, the customers were located
throughout the United States, and the overwhelming majority of them
resided in States other than Illinois. See GXs 34, 35, & 39. More
specifically, the records in evidence show, inter alia, that Respondent
issued hydrocodone prescriptions in the following amounts: forty-eight
to residents of Texas, forty to residents of California, nineteen to
residents of North Carolina, thirteen to residents of both Ohio and of
Virginia, ten to residents of Indiana, nine to residents of Colorado,
eight to residents of both Massachusetts and Mississippi, seven to
residents of Georgia, six to residents of Missouri, and four to
residents of Oklahoma.\7\ See generally GXs 34, 35, & 39.
---------------------------------------------------------------------------
\7\ The Government also introduced into evidence the sworn
declaration of George Van Komen, M.D. GX 41. Respondent, however,
objected to the admission of the exhibit on the ground that the
declaration was testimonial in nature and that he was unable to
cross-examine Dr. Van Komen. Tr. 58-59. The ALJ overruled
Respondent's objection and admitted the declaration. Id. at 59.
I do not rely on the exhibit, however, because it is unclear
whether the declaration was properly admitted. While the Government
provided notice of its intent to use the Declaration in its
Supplemental Prehearing Statement, the Statement does not disclose
the substance of the Declaration. Moreover, the record does not
establish whether a copy of the Declaration was provided to
Respondent in advance of the hearing. While hearsay is admissible in
these proceedings, a testimonial declaration must be timely provided
to the other party in order to afford it with the opportunity to
determine whether to request a subpoena of the witness.
---------------------------------------------------------------------------
As early as March 2006, Respondent spoke with a DEA Diversion
Investigator to inquire as to why the Agency had not approved his
renewal application. Tr. 87. During the conversation, the DI asked him
``what [he] was doing to make a living as a doctor.'' Id. Respondent
told the DI that he worked at several clinics and ``had some
telemedicine internet practice going.'' Id. The DI then told Respondent
``that there might be a problem with that.'' Id. Respondent nonetheless
continued his prescribing for Just USA Meds until January 2007. Id. at
178.\8\
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\8\ The record suggests that Respondent had additional
discussions with DEA Investigators in both May and September 2006
regarding his practices. The record does not, however, establish
with reasonable specificity the content of these discussions.
---------------------------------------------------------------------------
Throughout the hearing, Respondent maintained that his
``prescribing was appropriate.'' Id. at 99. Furthermore, on cross-
examination, Respondent acknowledged that he found evidence that Just
USA Meds had used his name and registration to back-date several
prescriptions which had been dispensed before he commenced working for
the
[[Page 20729]]
entity. Id. at 170. Respondent testified that he did not authorize this
use of his registration which he discovered ``within the first couple
of weeks'' after he started working for Just USA. Id. at 169.
Respondent failed to report the incident to the Agency, asserting
that Just USA had told him that ``only one or two'' prescriptions had
been back dated. Id. at 170. Respondent admitted, however, that he
``had no way of confirming'' the validity of Just USA's representation
that the backdating had occurred in ``only one or two instances.'' Id.
Respondent also maintained that on multiple occasions, he engaged
in due diligence to determine whether his conduct was legal. Respondent
contends that shortly after he entered into his arrangement with Just
USA, he was sent a document entitled ``Ordering and Registration
Instructions,'' which indicated the procedures which the ``patients''
were required to complete to purchase drugs which included providing a
copy of an identification card, medical records, and physician reports,
etc. RX 7A. Moreover, the document listed seven States that Just USA's
pharmacies did not ship to including Arizona, Kentucky, Missouri,
Nevada, Pennsylvania, South Carolina, and Tennessee. Id. In his
testimony, Respondent maintained that Just USA had sent this document
to him after he asked how he would know that he was permitted to
prescribe to residents of States other than Illinois. Tr. 95.
Respondent further claimed that Just USA told him that it had ``already
done an examination of the law, and we do not service'' the above
States, because they ``required a face-to-face meeting between the
prescribing doctor and the patient,'' or the State prohibited an out-
of-state doctor from prescribing to its residents, or the State did not
permit telemedicine. Id. at 95-96; see also id. at 184. According to
Respondent, ``it was good enough for me that they had ruled out certain
states that it was not appropriate to go to.'' \9\ Id. at 96.
---------------------------------------------------------------------------
\9\ Respondent subsequently stated that after he stopped working
for Just USA he learned that there were two or three other States
(in addition to the seven States listed in RX 7A) where his
prescribing was illegal. Tr. 161.
---------------------------------------------------------------------------
On cross-examination, however, the Government identified multiple
instances in which Respondent had issued prescriptions to patients who
lived in these States. See Tr. 186-90. More specifically, the
Government identified controlled prescriptions Respondent issued to
residents of Arizona (GX 39 at 6), Kentucky (id. at 21), Missouri (id.
at 23), Nevada (id. at 75), Pennsylvania (id. at 67), and South
Carolina (id. at 182). When confronted with this evidence, Respondent
did not ``know how that happened'' and claimed that he ``wasn't aware
that it happened.'' Id. at 194.
Respondent admitted, however, that the customer's names and
addresses were in the medical records, which he claimed he had access
to. Id. at 196. He also admitted that ``in most instances,'' he did not
look at where the customer lived, id., but instead relied on the
employees of Just USA to screen out the customers. Id. at 200-01.
Respondent also entered into evidence an Agency document which
stated that it was clarifying DEA's ``policies regarding the dispensing
and prescribing of controlled substances as they pertain to the
internet.'' RX 7C. This document specifically noted the prescription
requirement of Federal law, see 21 CFR 1306.04(a), and made explicit
reference to the Agency's 2001 Guidance Document, Dispensing and
Purchasing Controlled Substances over the Internet, 66 FR 21181. The
document further stated: ``As noted in the guidance document, it is
unlikely that such a relationship could be established through the use
of an online questionnaire completed by a consumer prior to the
purchase of controlled substances.'' RX 7C, at 1.
The Agency's 2001 Guidance expressly stated 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.'' 66 FR at 21182. Continuing, the Guidance observed 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.
Of further relevance, 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).\10\
---------------------------------------------------------------------------
\10\ Respondent also cites a ``Flow Chart,'' RX 7B, which was
prepared by Just USA Meds Pharmacy and which sets forth the
purported process by which customers obtained drugs as evidence of
his having engaged in due diligence. The document does not set forth
any legal advice and is merely cumulative of Respondent's testimony
as to the procedures used by Just USA to process customer orders.
Respondent also submitted a document which contains several e-
mail messages from July 27 and 28, 2006, which discuss an e-
prescribing initiative introduced in Illinois, one of which
originated from Mudri Associates, a DEA Consultancy. RX 7E.
Respondent asserts that this evidence establishes that he contacted
the consultant ``following [its] inspection of all of the procedures
followed by [J]ust USA * * * [and] the pharmacies with which [J]ust
USA had arrangements.'' Resp. Br. (Pt. II) at 14. The e-mail does
not, however, discuss any issue other than various proposals that
were part of an Illinois patient safety initiative.
---------------------------------------------------------------------------
As further support for his contention that he performed due
diligence in attempting to ascertain whether his prescribing practices
were legal, Respondent introduced into evidence a document which
appears to be a legal opinion (dated June 21, 2006) prepared by a
Tampa, Florida-based lawyer.\11\ See RX 7D. In stating the issue, the
opinion noted that ``[a]s your Pharmacy and Prescribing Doctors are
located within the States of Florida, this Memorandum's analysis
focuses on Florida law as well as Federal law concerning appropriate
prescribing standards.'' Id. at 6. Continuing, the opinion observed
that ``[t]he state laws and professional standards concerning
telemedicine and prescribing practices vary from state to state, and
because I am licensed to practice in the State of Florida, this
Memorandum's analysis is limited to Florida law as well as Federal law
concerning appropriate prescribing standards.'' Id. The opinion further
noted that it ``specifically'' did not address such issues as
``physician and pharmacy licensure.'' Id.
---------------------------------------------------------------------------
\11\ The text of the letter appears to have been cut and
inserted into various internet-based text messages which occurred
between Respondent and Challen Sullivan, the owner of Just USA Meds.
See RX 7-D; Tr. 119 & 125-26. Nor does the text of the memorandum
appear in the exhibit in the order that is customarily used by
lawyers in preparing legal opinions for their clients. See id.
---------------------------------------------------------------------------
As for its legal conclusions, the opinion stated that
``[p]rescribing standards vary dramatically from state to state and in
some instances vary within a particular state for the prescription of
specified pharmaceutical items (e.g., some states have heightened
standards for prescribing controlled substances and diet drugs).'' Id.
at 1.\12\
[[Page 20730]]
Moreover, in addition to its discussion of Florida law, the opinion
notes that ``[o]ther states have adopted statutes specifically relating
to prescribing standards and the business of Internet pharmacy--often
requiring a face to face physical examination and making non-compliance
a crime subject to heavy penalties. These statutes are usually more
comprehensive in requiring compliance by all of the website operators,
physicians and pharmacies involved. Most sophisticated and established
Internet pharmacy operators avoid conducting business in these more
restrictive states.'' Id. at 4 (emphasis added).\13\
---------------------------------------------------------------------------
\12\ The opinion provides a lengthy discussion of Florida's
standards, and appears to conclude that under Florida law and
regulations, a physician need not have personally performed a
physical examination in order to prescribe a drug (other than a diet
drug). Id. at 2-3. However, as found above, Respondent prescribed to
residents of numerous other States.
\13\ The opinion also observed that the American Medical
Association's ``standards suggest that the physician must personally
conduct the physical examination,'' RX 7D at 3, and while suggesting
that the AMA's positions were inconsistent, quoted another AMA
guideline which states in relevant part: ``Licensure: Physicians who
prescribe medications via the Internet across state lines, without
physically being located in the state(s) where the patient
(clinical) encounter(s) occurs, must possess appropriate licensure
in all jurisdictions where patients reside.'' Id. at 4.
---------------------------------------------------------------------------
The opinion also discussed Federal prescribing standards. In
discussing this Agency's 2001 Guidance, the opinion states that
``[a]lthough the DEA acknowledges that state law ultimately controls
the issue of whether a prescription is written in the usual course of
professional practice, the DEA feels that the weight of legal and
professional authority requires the [four] elements [set forth in the
Guidance] to be present in order to establish a bona fide doctor/
patient relationship.'' Id. The letter then quoted verbatim the four
elements set forth in the Guidance.
Furthermore, the opinion also noted that ``DEA has in some
instances over the past year informally challenged some pharmacies and
medical professionals participating in a Medical Records Based
Prescribing pharmacy business. The DEA has asserted in such instances
that in its opinion Medical Records Based Prescribing does not meet
applicable local legal standards which require that an adequate
physician-patient relationship exists for the prescription.'' RX 7D at
5.
The opinion, however, rejected the Agency's view as to the legality
of Medical Records Based Prescribing, citing among other things, its
author's ``understanding that the three largest drug wholesalers * * *
have concluded that the DEA does not have a legal basis for making
these assertions,'' the 2003 failure of Congress to enact the Ryan
Haight Internet Pharmacy Consumer Protection Act (which prohibits a
practitioner's prescribing to a person he/she has not physically
examined),\14\ and the December 2005 testimony of Agency officials to
Congress to the effect that the Controlled Substances Act does not
provide a statutory definition of ``what constitutes a valid `doctor/
patient' relationship.'' Id. at 5. The opinion thus concluded that
``the Websites' Medical Records Based Prescribing Procedures appear to
comply with the DEA's published rules and Federal law.'' Id.\15\
---------------------------------------------------------------------------
\14\ On October 15, 2008, the President signed into law the Ryan
Haight Online Pharmacy Consumer Protection Act of 2008, Public Law
No. 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, the ``[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. These provisions
do not, however, apply to Respondent's conduct.
\15\ Respondent also cites a December 1, 2006 rulemaking which
amended DEA regulations to require that a practitioner obtain a
separate registration for each State in which he practices, and a
December 22, 2006, memo written by the same Tampa-based attorney
regarding the applicability of the new rule to internet prescribers.
See RX 7G. In light of the fact that almost (if not) all of the
actual prescriptions which are in evidence in this matter were
issued by Respondent prior to his having reviewed either of these
documents, I find it unnecessary to make any findings based on them.
---------------------------------------------------------------------------
Discussion
Section 304(a) of the Controlled Substances Act (CSA) provides that
a registration to ``dispense a controlled substance * * * may be
suspended or revoked by the Attorney General upon a finding that the
registrant * * * has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined under such section.'' 21 U.S.C.
824(a)(4). Moreover, section 303(f) of the CSA provides that ``[t]he
Attorney General may deny an application for [a practitioner's]
registration if he determines that the issuance of such registration
would be inconsistent with the public interest.'' 21 U.S.C. 823(f). In
making the public interest determination, the Act requires the
consideration of the following factors:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id.
``[T]hese factors are * * * considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). I may rely on any one or a
combination of factors, and may give each factor the weight I deem
appropriate in determining whether to revoke an existing registration
or to deny an application to renew a registration. Id. Moreover, I am
``not required to make findings as to all of the factors.'' Hoxie v.
DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also Morall v. DEA, 412
F.3d 165, 173-74 (D.C. Cir. 2005).
Having considered all of the factors, I acknowledge that the record
contains no evidence that the State of Illinois has taken action
against Respondent's medical license (factor one) or that Respondent
has been convicted of an offense related to controlled substances
(factor two).\16\ The record contains, however, an abundance of
evidence that Respondent's experience in dispensing controlled
substances (factor two) and record of compliance with applicable
Federal and State laws (factor four) is characterized by his repeated
violation of the CSA's prescription requirement, as well as numerous
state laws and regulations prohibiting the unlicensed practice of
medicine and setting the standards for prescribing a drug.
---------------------------------------------------------------------------
\16\ This Agency has long held that a State's failure to take
action against a practitioner's authority to dispense controlled
substances is not dispositive in determining whether the granting of
an application for registration would be consistent with the public
interest. See Mortimer B. Levin, 55 FR 8209, 8210 (1990). I further
note that the absence of a criminal conviction is not dispositive of
the public interest inquiry. See, e.g., Edmund Chein, 72 FR 6580,
6593 n.22 (2007).
---------------------------------------------------------------------------
Moreover, I reject Respondent's contention that his conduct should
be excused because he engaged in due diligence in attempting to
ascertain the legal requirement for his prescribing. Even if I was to
recognize such a defense in the context of a prescribing practitioner,
the record establishes that Respondent's efforts were half-baked at
best, and that when he did receive information that his activities were
likely illegal, he ignored it. Finally, while Respondent eventually
ceased his internet-related prescribing activities, his testimony
manifests that he has not accepted responsibility for his misconduct,
but rather blames others.
[[Page 20731]]
I therefore conclude that Respondent's continued registration would
be ``inconsistent with the public interest.'' 21 U.S.C. 823(f).
Accordingly, Respondent's registration will be revoked and his
application to renew his registration will be denied.
Factor Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Record of Compliance With Applicable Controlled
Substance Laws
The primary issue in this case is whether the prescriptions
Respondent issued pursuant to his agreement with Just USA Meds were
lawful prescriptions under the CSA. Under a longstanding DEA
regulation, a prescription for a controlled substance is not
``effective'' unless it is ``issued for a legitimate medical purpose by
an individual practitioner acting in the usual course of his
professional practice.'' 21 CFR 1306.04(a). This regulation further
provides that ``an order purporting to be a prescription issued not in
the usual course of professional treatment * * * is not a prescription
within the meaning and intent of [21 U.S.C. 829] and * * * the person
issuing it, shall be subject to the penalties provided for violations
of the provisions of law relating to controlled substances.'' Id. As
the Supreme Court 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, 143
(1975)).
Under the CSA, it is fundamental that a practitioner must establish
a bona fide doctor-patient relationship in order to act ``in the usual
course of * * * professional practice'' and to issue a prescription for
a ``legitimate medical purpose.'' Moore, 423 U.S. at 141-43. At the
time of the events at issue here, the CSA generally looked to state law
to determine whether a doctor and patient have established a bona fide
doctor-patient relationship. See Kamir Garces-Mejias, 72 FR 54931,
54935 (2007); United Prescription Services, Inc., 72 FR 50397, 50407
(2007); Dispensing and Purchasing Controlled Substances Over the
Internet, 66 FR at 21182-83; but see n.14, supra (discussing the Ryan
Haight Act).
Moreover, shortly after the CSA's enactment, the Supreme Court
explained that ``[i]n the case of a physician [the Act] contemplates
that he is authorized by the State to practice medicine and to dispense
drugs in connection with his professional practice.'' Moore, 423 U.S.
at 140-41 (emphasis added). Accordingly, ``[a] physician who engages in
the unauthorized practice of medicine'' under state laws ``is not a
`practitioner acting in the usual course of * * * professional
practice' '' under the CSA. United Prescription Services, 72 FR at
50407 (quoting 21 CFR 1306.04(a)). This rule is supported by the plain
meaning of the Act, which defines the ``[t]he term `practitioner' [to]
mean [ ] a physician * * * licensed, registered, or otherwise
permitted, by the United States or the jurisdiction in which he
practices * * * to * * * dispense * * * a controlled substance,'' 21
U.S.C. 802(21), and ``[t]he term `dispense' [to] mean [ ] to deliver a
controlled substance to an ultimate user * * * by, or pursuant to the
lawful order of, a practitioner.'' Id. Sec. 802(10). See also id.
Sec. 823(f) (``The Attorney General shall register practitioners * * *
to dispense * * * if the applicant is authorized to dispense * * *
controlled substances under the laws of the State in which he
practices.'').
A controlled-substance prescription issued by a physician who lacks
the license or other authority required to practice medicine within a
State is therefore unlawful under the CSA. See 21 CFR 1306.04(a) (``An
order purporting to be a prescription issued not in the usual course of
professional treatment * * * is not a prescription within the meaning
an intent of'' the CSA); cf. 21 CFR 1306.03(a)(1) (``A prescription for
a controlled substance may be issued only by an individual practitioner
who is * * * [a]uthorized to prescribe controlled substances by the
jurisdiction in which he is licensed to practice his profession[.]'').
The record establishes that in issuing the prescriptions for Just
USA's customers, Respondent repeatedly violated the CSA's prescription
requirement. 21 CFR 1306.04(a). This is so for two reasons: (1)
Respondent prescribed without establishing a valid doctor-patient
relationship in violation of the medical practice standards of numerous
States because he failed to physically examine the patients, and (2)
Respondent's prescribing typically constituted the unauthorized
practice of medicine in the States where the patients were located
because he was licensed to practice medicine (and authorized to
prescribe) only in Illinois. Furthermore, Respondent issued unlawful
prescriptions even where various States had either enacted laws and
regulations, rendered decisions in adjudications, or issued policy
statements making clear that his prescribing practices were illegal.
For example, as found above, Respondent issued forty hydrocodone
prescriptions to residents of California. In 2000, California enacted
Cal. Bus. & Prof. Code Sec. 2242.1,\17\ which specifically 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, except as authorized by
Section 2242.'' Moreover, the statute, which provides for a fine or
civil penalty of twenty-five thousand dollars for a violation, further
directs that ``[i]f the person or entity that is the subject of an
action brought pursuant to this section is not a resident of this
state, a violation of this section shall, if applicable, be reported to
the person's or entity's appropriate professional licensing
authority.'' Id. at (e).
---------------------------------------------------------------------------
\17\ This statute was effective January 1, 2001.
---------------------------------------------------------------------------
Relatedly, in 2003, the Medical Board of California revoked a
physician's medical license for engaging in the same type of
prescribing practices as Respondent did here. See In re John Steven
Opsahl, M.D., Decision and Order, at 3 (Med. Bd. Cal. 2003) (available
by query at https://publicdocs.medbd.ca.gov/pdl/mbc.aspx). In Opsahl,
the Medical Board expressly found that ``[b]efore prescribing a
dangerous drug, a physical examination must be performed.'' Id.
Continuing, the Board found 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. Finally,
the Board found that:
Medical indication means having a condition that warrants
specific treatment. It is determined after the physician takes a
history, performs a physical examination and makes an assessment
about the patient's condition. * * * A physician cannot determine
whether there is a medical indication for prescription of a
dangerous drug without performing a physical examination.
Id.\18\
---------------------------------------------------------------------------
\18\ Dr. Opsahl's prescribing practices involved ``verifying
patient identity,'' ``obtaining and reviewing medical records,''
``having direct contact with the patient, though personal contact
was not required,'' and ``having an opportunity for follow-up.''
Decision at 4. Opsahl prescribed both non-controlled and controlled
drugs including combination drugs containing hydrocodone,
benzodiazepines, schedule three drugs containing codeine, as well as
Ambien, phentermine, and phendimetrazine. Id. at 6.
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[[Page 20732]]
Moreover, prior to Respondent's engaging in internet-based
prescribing, the Medical Board of California had issued numerous
Citation Orders to out-of-state physicians for internet prescribing to
California residents. These Orders invariably cited not only the
physicians' failure to perform ``a good faith prior examination,'' but
also their lack of ``a valid California Physician and Surgeon's License
to practice medicine in California.'' Citation Order, Martin P. Feldman
(Aug. 15, 2003); see also Citation Order, Harry Hoff (Jun. 17, 2003);
Citation Order, Carlos Gustavo Levy (Jan. 28, 2003); Citation Order,
Carlos Gustavo Levy (Nov. 30, 2001). Moreover, the Board had issued
several press releases setting forth its position that internet
prescribing is unlawful. See GX 11 at 9 (Feb. 2004 Action Report)
(``The Board has taken action against California physicians and
licensees from other states for prescribing over the Internet without a
good faith prior exam, and continues to investigate cases as it becomes
aware of the practice.''); Record Fines Issued by Medical Board to
Physicians in Internet Prescribing Cases (News Release Feb. 10, 2003)
(available at https://www.mbc.ca.gov/board/media/releases_2003_02-10_internet_drugs.html). Respondent thus clearly violated both California
law and the CSA in issuing these prescriptions.
Respondent issued forty-eight prescriptions for hydrocodone drugs
to residents of Texas. Respondent did not, however, hold a Texas
medical license. See Tex. Occ. Code Sec. 155.001; see also id. Sec.
151.056(a) (``A person who is physically located in another
jurisdiction but who, through the use of any medium, including an
electronic medium, performs an act that is part of a patient care
service initiated in this state, * * * and that would affect the
diagnosis or treatment of the patient, is considered to be engaged in
the practice of medicine in this state and is subject to appropriate
regulation by the board.''); 22 Tex. Admin. Code Sec. 174.4(c)
(``Physicians who treat and prescribe through the Internet are
practicing medicine and must possess appropriate licensure in all
jurisdictions where patients reside.'').
Respondent also lacked the state registration required to prescribe
a controlled substance. See Tex. Health & Safety Code Sec. 481.061(a)
(requiring state registration to dispense); id. Sec. 481.063(d)
(requiring as a condition for registration that ``a practitioner [be]
licensed under the laws of this state''). Respondent thus also violated
Texas law, and the CSA, in prescribing controlled substances to that
State's residents. See Moore, 423 U.S. at 140-41 (``In the case of a
physician [the CSA] contemplates that he is authorized by the State to
practice medicine and to dispense drugs in connection with his
professional practice.'') (emphasis added); United Prescription
Services, 72 FR at 50407 (``A controlled-substance prescription issued
by a physician who lacks the license [or other authority required] to
practice medicine within a State is * * * unlawful under the CSA.'');
21 U.S.C. 802(10) (defining `` `dispense' [to] mean[ ] to deliver a
controlled substance to an ultimate user * * * by, or pursuant to the
lawful order of, a practitioner'').
Respondent issued nineteen prescriptions for drugs containing
hydrocodone to North Carolina residents. Respondent did so
notwithstanding that under North Carolina law, ``prescribing medication
by use of the Internet or a toll-free telephone number, shall be
regarded as practicing medicine'' in the State and subjects the
practitioner to North Carolina law ``and appropriate regulation by the
North Carolina Medical Board.'' N.C. Gen. Stat. Ann. Sec. 90-18(b).
North Carolina law further provides that ``[n]o person shall practice
medicine * * * nor in any case prescribe for the cure of diseases
unless the person shall have been first licensed and registered to do
so.'' Id. Sec. 90-18(a). Moreover, if ``the person so practicing
without a license is an out-of-state practitioner who has not been
licensed and registered to practice medicine and surgery in this State,
the person shall be guilty of a Class I felony.'' Id.\19\
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\19\ While North Carolina exempts from these requirements an
out-of-state practitioner who ``on an irregular basis, consults with
a resident registered physician,'' Respondent does not maintain that
he was consulting with a North Carolina physician. N.C. Gen. Stat.
Ann. Sec. 90-18(c)(11).
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In addition, in February 2001, the North Carolina Medical Board
issued a Position Statement entitled: Contact With Patients Before
Prescribing. GX 25 at 11. Therein, the Board stated ``that prescribing
drugs to an individual the prescriber has not personally examined is
inappropriate except as noted * * * below.'' Id. The Board further
explained that ``[b]efore prescribing a drug, a 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 personally perform an appropriate
history and physical examination, make a diagnosis, and formulate a
therapeutic plan, a part of which might be a prescription.'' Id. While
the North Carolina Board recognized that it may be appropriate to
prescribe to a patient without having performed a physical exam ``under
certain circumstances,'' none of these apply to Respondent.\20\ I thus
conclude that Respondent violated both North Carolina law and the CSA
in prescribing to the State's residents.
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\20\ These circumstances ``may include admission orders for a
newly hospitalized patient, prescribing for a patient of another
physician for whom the prescriber is taking call, or continuing
medication on a short-term basis for a new patient prior to the
patient's first appointment.'' GX 25 at 11. The Board also noted
that ``[e]stablished patients may not require a new history and
physical examination for each new prescription, depending on good
medical practice.'' Id.
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Respondent issued thirteen prescriptions for hydrocodone to Ohio
residents. Ohio law defines `` `the practice of telemedicine' [to]
mean[ ] 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 authorizes ``[t]he holder of a
telemedicine certificate [to] engage in the practice of telemedicine in
this state.'' Ohio Rev. Code Ann. Sec. 4731.296(A) & (C). See also id.
Sec. 4731.41 (``No person shall practice medicine and surgery, or any
of its branches, without the appropriate certificate from the state
medical board to engage in the practice.''). Moreover, under the
regulations of the State Medical Board of Ohio, ``a physician shall not
prescribe, dispense, or otherwise provide, or cause to be provided, any
controlled substances to a person who the physician has never
personally examined and diagnosed'' except for in limited situations
not applicable here.\21\ Ohio Admin. Code Sec. 4731-11-09(A). I thus
conclude that Respondent violated both Ohio law and the CSA in issuing
prescriptions to Ohio residents.
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\21\ The exceptions are for ``institutional settings, on call
situations, cross coverage situations, situations involving new
patients,'' (but limited to where ``the physician has scheduled or
is in the process of scheduling an appointment to examine the
patient and the drugs are intended to be used pending that
appointment''), ``protocol situations,'' ``nurses practicing in
accordance with standard care arrangements, and hospice settings.''
Ohio Admin. Code Sec. 4731-11-09.
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Respondent issued thirteen prescriptions for hydrocodone to
Virginia residents. Under Virginia law, it is ``unlawful for any person
to practice medicine * * * in the Commonwealth without a valid
unrevoked licensed issued by the Board of Medicine,'' Va. Code Ann.
Sec. 54.1-2902; and ``[a]ny person shall be
[[Page 20733]]
regarded as practicing the healing arts who actually engages in such
practice as defined in this chapter.'' Id. Sec. 54.1-2903; see also
id. Sec. 54.1-2900 (the ``[p]ractice of medicine'' * * * means the
prevention, diagnosis and treatment of human physical or mental
ailments, conditions, diseases, pain or infirmities by any means or
method''); id. Sec. 54.1-2929 (``No person shall practice * * *
medicine * * * without obtaining a license from the Board of
Medicine'').\22\ Furthermore, ``[a] prescription for a controlled
substance may be issued only by a practitioner of medicine * * * who is
authorized to prescribe controlled substances.'' Va. Code Sec. 54.1-
3303(A). Moreover, ``[t]he prescription shall be issued for a medicinal
or therapeutic purpose and may be issued only to persons * * * with
whom the practitioner has a bona fide practitioner-patient
relationship.'' Id.
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\22\ Respondent does not claim that his prescribing came within
one of the limited exceptions for out-of-state practitioners
recognized by Virginia law. See Va. Code Ann. Sec. 54.1-2901(A)(7)
(authorizing ``[t]he rendering of medical advice * * * through
telecommunications from a physician licensed to practice medicine in
* * * an adjoining state to emergency medical personnel acting in an
emergency situation'').
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The Virginia statute also provides that ``a bona fide practitioner-
patient relationship means that the practitioner shall * * * perform or
have performed an appropriate examination of the patient, either
physically or by the use of instrumentation and diagnostic equipment
through which images and medical records may be transmitted
electronically; except for medical emergencies, the examination of the
patient shall have been performed by the practitioner himself, within
the group in which he practices, or by a consulting practitioner prior
to issuing a prescription.'' Id. (emphasis added). I thus conclude that
Respondent violated Virginia law and the CSA in prescribing to
Virginia's residents.
Respondent issued ten prescriptions for hydrocodone to Indiana
residents. Under Indiana law, ``[i]t is unlawful for any person to
practice medicine * * * in this state without holding a license or
permit to do so.'' Ind. Code Sec. 25-22.5-8-1. Moreover, the practice
of medicine includes the ``prescription * * * of any form of treatment,
without limitation.'' Id. Sec. 25-22.5-1-1.1(a)(1)((B); see also
id.Sec. (a)(4).
The Medical Licensing Board of Indiana has also adopted a
regulation (similar to Ohio's), which provides that except for in
limited situations, ``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.'' 844 Ind. Admin. Code 5-4-1(a).\23\ This rule has been
effect since October 2003. I thus conclude that Respondent violated
Indiana law and the CSA in prescribing to Indiana residents.
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\23\ The exceptions are for ``institutional settings, on-call
situations, cross-coverage situations, and situations involving
advanced practice nurses with prescriptive authority.'' 844 Ind.
Admin. Code 5-4-1(a). Respondent does not claim that his prescribing
falls within any of these exceptions.
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Respondent issued nine prescriptions for hydrocodone to Colorado
residents. In November 2000, the Colorado State Board of Medical
Examiners issued a policy statement entitled ``Guidelines Regarding
Prescribing for Unknown Patients.'' In this statement, the Colorado
Board declared that:
It is unprofessional conduct for a physician to provide
treatment and consultation recommendations, including issuing a
prescription via electronic or other means, unless the physician has
obtained a history and physical evaluation of the patient adequate
to establish diagnoses and identify underlying conditions and/or
contra-indications to the treatment recommended/provided. Issuing a
prescription on the basis of a questionnaire, Internet-based
consultation, or a telephonic consultation, all without a valid pre-
existing patient/practitioner relationship does not constitute an
acceptable standard of care.
Before prescribing a drug, a physician should make an informed
medical judgment based on the circumstances of the situation and on
his/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.\24\
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\24\ The Colorado Board has also recognized limited exceptions
similar to those adopted by Ohio and Indiana.
GX 12 at 14. I thus conclude that Respondent acted outside of the
course of professional practice in issuing the prescriptions to
Colorado residents and violated the CSA.
Respondent issued eight prescriptions for hydrocodone to
Mississippi residents. In May 2000, the Mississippi State Board of
Medical Licensure issued a policy statement on Internet Prescribing.
See GX 21 at 6. The Mississippi Board advised that the ``[e]ssential
components of proper prescribing and legitimate medical practice
requires [sic] that the physician obtains a thorough medical history
and conducts an appropriate physical examination before prescribing any
medication for the first time.'' Id.
Moreover, since 1997, Mississippi law has provided 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 and has met all education
and licensure requirements as determined by the State Board * * *. ''
Miss. Code Ann. Sec. 73-25-34(2). The statute specifically defines the
terms ``telemedicine, or the practice of medicine across state lines,''
as including ``[t]he rendering of treatment to a patient within this
state by a physician located outside this state as a result of
transmission of individual patient data by electronic or other means
from within this state to such physician or his agent.'' Id. Sec. 73-
25-34(1)(b).\25\ I thus conclude that Respondent violated Mississippi
law and the CSA when he prescribed to the State's residents.
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\25\ Mississippi exempts an out-of-state physician from the
licensure requirement when the physician provides an evaluation,
treatment recommendation, or medical opinion at the request of ``a
physician duly licensed to practice medicine in th[e] state,'' and
the requesting physician ``has already established a doctor/patient
relationship with the patient to be evaluated and/or treated.''
Miss. Code Ann. Sec. 73-25-34(3). Respondent, however, produced no
evidence that any physician had ever requested that he evaluate a
Just USA patient.
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Respondent also issued eight prescriptions for hydrocodone to
residents of Massachusetts, whose law follows nearly verbatim the CSA's
prescription requirement. Compare Mass. Gen. Laws ch. 94C, Sec. 19(a),
with 21 CFR 1306.04(a). In December 2003, the Massachusetts Board of
Registration in Medicine issued the following interpretation of the
State's prescription law:
[t]o satisfy the requirement that a prescription be issued by a
practitioner in the usual course of his professional practice, there
must be a physician-patient relationship that is for the purpose of
maintaining the patient's well-being and the physician must conform
to certain minimum norms and standards for the care of patients,
such as taking an adequate medical history and conducting an
appropriate physical and/or mental status examination and recording
the results. Issuance of a prescription, by any means, including the
Internet or other electronic process, that does not meet these
requirements is therefore unlawful.
Commonwealth of Massachusetts, Board of Registration in Medicine,
Policy 03-06 INTERNET PRESCRIBING (Adopted Dec. 17, 2003).\26\ As the
[[Page 20734]]
Board's interpretation makes plain, Respondent acted outside of the
usual course of professional practice when he prescribed controlled
substances to residents of Massachusetts, and therefore violated both
Massachusetts law and the CSA.
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\26\ The ALJ also concluded that Respondent was required to be
licensed to practice medicine in Massachusetts and violated its law
by prescribing to residents of that State. ALJ at 34. In light of
the Massachusetts' Board clear interpretation as set forth in its
policy on Internet Prescribing, I conclude that it is unnecessary to
address whether Respondent also violated the State's provisions
requiring a license and controlled substance registration which
appear to allow an out-of-state practitioner to issue a prescription
to a state resident in some instances. Id. Mass. Gen. Laws ch. 94C,
18(c).
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Respondent issued seven prescriptions for hydrocodone for residents
of Georgia. Under the rules of the Georgia Composite State Board of
Medical Examiners, it is ``unprofessional conduct'' to ``[p]rovid[e]
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(6).\27\
Moreover, Respondent violated Georgia law because he engaged in the
unlicensed practice of medicine. See Ga. Code Ann. Sec. 43-34-
31.1.\28\ I thus conclude that Respondent violated the CSA in
prescribing to Georgia residents.
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\27\ It is noted that the rule does ``not prohibit a licensee
who is on call or covering for another licensee from treating and/or
consulting a patient of such other licensee.'' Ga. Comp. R. & Regs.
360-3-.02(6). Respondent did not maintain that he was covering for,
or consulting with, other physicians who were treating the Georgia
residents he prescribed to.
\28\ This statute provides:
(a) A person who is physically located in another state * * *
and who, through the use of any means, including electronic * * * or
other means of telecommunication, through which medical information
or data is transmitted, performs an act that is part of a patient
care service located in this state * * * that would affect the
diagnosis or treatment of the patient is engaged in the practice of
medicine in this state. Any person who performs such acts through
such means shall be required to have a license to practice medicine
in this state and shall be subject to regulation by the board.
Ga. Code Ann. Sec. 43-34-31.1(a). While the statute includes
exceptions when, inter alia, the physician ``[p]rovides consultation
services at the request of a physician licensed in this state,'' or
``[p]rovides consultation services in the case of an emergency,''
id. Sec. 43-34-31.1(b)(1) & (2), neither exception applies to
Respondent.
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Respondent issued six prescriptions for hydrocodone to Missouri
residents. Under Missouri law--which was last amended in 1998--it is
``unlawful for any person not now a registered physician within the
meaning of the law to practice medicine [or] * * * to engage in the
practice of medicine across state lines * * * except as herein
provided.'' Mo. Ann. Stat. Sec. 334.010(1). The statute defines ``the
practice of medicine across state lines'' to mean in relevant part,
``[t]he rendering of treatment to a patient within this state by a
physician located outside this state as a result of transmission of
individual patient data by electronic or other means from within this
state to such physician or physician's agent.'' Id. Sec.
334.010(2)(2). While the statute exempts from the licensure requirement
an out-of-state physician who consults with a Missouri-licensed
physician when the latter ``retains ultimate authority and
responsibility for the * * * diagnoses and treatment * * * of the
patient located within th[e] state,'' id. Sec. 334.010(3), Respondent
makes no claim that his prescribing falls within this exemption.\29\
Respondent thus violated both Missouri law and the CSA when he
prescribed to the State's residents.
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\29\ The Missouri statute contains two