[Federal Register: May 5, 2009 (Volume 74, Number 85)]
[Notices]
[Page 20727-20736]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05my09-72]
=======================================================================
-----------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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 http://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.
---------------------------------------------------------------------------
[[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 http://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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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'').
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\29\ The Missouri statute contains two other exemptions which
are not remotely applicable to Respondent's conduct. See Mo. Ann.
Stat. Sec. 334.010(3) (providing medical opinion or testimony in
judicial or administrative proceeding) & (4) (performing
``utilization review'').
---------------------------------------------------------------------------
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, Sec. 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 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 Shoppe-
Jonesborough, 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
[[Page 20735]]
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 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]
non-compliance 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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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 doctor-patient relationship under
state laws and medical practice standards is thus 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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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) &
[[Page 20736]]
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. Sec. 841(a)(1)
(``Except as authorized by this subchapter, it shall be unlawful for
any person knowingly or intentionally * * * to * * * distribute, or
dispense * * * a controlled substance''); id. Sec. 843(a)(2) (``It
shall be unlawful for any person knowingly or intentionally * * * to
use in the course of the * * * distribution[] or dispensing of a
controlled substance * * * a registration number which is * * * issued
to another person'').
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 revoked and his pending application will be
denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) &
824(a), as well as 28 CFR 0.100(b) & 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.
---------------------------------------------------------------------------
\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. Sec. 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).
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