[Federal Register: March 9, 2009 (Volume 74, Number 44)]
[Notices]
[Page 10083-10095]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09mr09-81]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 06-28]
Joseph Gaudio, M.D.; Suspension of Registration
On September 16, 2005, the Deputy Assistant Administrator, Office
of Diversion Control, Drug Enforcement Administration, issued an Order
to Show Cause to Joseph Gaudio, M.D. (Respondent) of Alpine, New
Jersey. The Show Cause Order sought the revocation of Respondent's DEA
Certificate of Registration, which authorizes him to handle controlled
substances as a practitioner, and the denial of any pending
applications to renew or modify his registration, on the ground that he
had committed acts which rendered his continued registration
``inconsistent with the public interest.'' Show Cause Order at 1
(citing 21 U.S.C. 823(f) & 824(a)(4)).
The Show Cause Order alleged that Respondent had issued
prescriptions for controlled substances which lacked a legitimate
medical purpose, and that in doing so, he had acted outside of the
usual course of professional practice. Id. at 1 & 6. The Show Cause
Order specifically alleged that Respondent had ``prescrib[ed]
controlled substances to Internet customers despite never establishing
a genuine doctor-patient relationship with the Internet customer.'' Id.
at 5. Relatedly, the Show Cause Order alleged that Respondent ``did not
see customers, had no prior doctor-patient relationships with the
Internet customers, did not conduct physical exams, * * * did [not]
create or maintain patient records,'' and that ``[t]he only information
usually reviewed prior to issuing drug orders was the customer's online
questionnaire.'' Id. at 6.
The Show Cause Order also alleged that ``[a] review of
prescriptions filled by [Carrington Healthcare System/Infiniti Services
Group] revealed that [Respondent] ha[d] issued drug orders for
controlled substances to Internet customers throughout the United
States, including Georgia, Texas, Pennsylvania, Alabama, Louisiana, and
Kentucky.'' Id. The Show Cause Order further alleged that ``[a] review
of prescriptions filled by [Carrington/Infiniti] for the period October
13, 2004 to January 21, 2005, revealed that [Respondent] ha[d] issued
16 drug orders to Internet customers in at least nine different
states.'' Id.
On October 21, 2005, Respondent, through his counsel, requested a
hearing on the allegations. The matter was assigned to Administrative
Law Judge (ALJ) Gail Randall, who conducted a hearing on May 2-5, 2006,
in New York, NY. At the hearing, both parties put on testimony and
introduced documentary evidence. Thereafter, both parties submitted
briefs containing their proposed findings of fact, conclusions of law,
and arguments.
On November 2, 2007, the ALJ issued her recommended decision. In
her decision, the ALJ concluded that ``[t]he Government has clearly
demonstrated that the Respondent's Internet practice and his resulting
issuance of controlled substance prescriptions * * * violated the
Controlled Substances Act.'' ALJ at 43. Applying the totality of the
circumstances test, the ALJ concluded, however, that the revocation of
Respondent's registration was not warranted. Id. at 43-44.
The ALJ specifically noted that ``Respondent's conduct encompassed
a one year period,'' that Respondent had ``voluntarily cease[d]'' his
conduct, but that he had not done so until three months after he was
served with the Show Cause Order. Id. at 43. While the ALJ deemed
Respondent's cessation of his conduct as ``commendable because of its
voluntary nature,'' she further explained that he ``demonstrated a lack
of sound judgment'' in ``continuing to'' prescribe after being served
with the Show Cause Order. Id. at 44. The ALJ also found of concern
``Respondent's failure to be totally truthful during his testimony.''
Id.
The ALJ reasoned, however, that Respondent was ``a very educated,
dedicated and talented physician practicing in a sometimes difficult
specialty, pain management,'' and that the revocation of his
registration would render him ``being unable to handle controlled
substances'' in his specialty. Id. Because the record demonstrated that
Respondent had practiced medicine for eleven years, and that ``the only
instances of [his] improper handling of controlled substances were
related to his'' Internet prescribing, the ALJ recommended that
Respondent's registration be continued subject to the condition that he
``not engage in any activity involving prescribing controlled
substances and the Internet.'' Id.
Having considered the entire record in this matter, I hereby issued
this Decision and Final Order. I adopt the ALJ's conclusions that
Respondent violated both the Controlled Substances Act (CSA) and
various state standards of medical practice in issuing prescriptions to
persons who ordered drugs through an Internet site. For reasons
explained below, I reject the ALJ's recommended sanction as
inconsistent with agency precedent and will order the suspension of
Respondent's registration for a period of one year. I make the
following findings.
Findings
Respondent is a medical doctor who is board certified in both
anesthesiology and pain management and is licensed to practice medicine
in the States of New York and New Jersey. Tr. 488. Respondent is also
the holder of a DEA Certificate of Registration, which authorizes him
to dispense controlled substances in schedules II through V as a
practitioner. GX 1, at 2. While the expiration date of Respondent's
registration was September 30, 2006, Respondent submitted a renewal
application on August 4, 2006. See Reply to Respondent's Status Report,
at 1. I therefore find that Respondent's prior registration has
remained in effect pending the issuance of this Final Order and that
Respondent also has an application pending before the Agency. See 5
U.S.C. 558(c).
Respondent attended medical school at The Autonomous University of
Guadalajara, and the New York Medical College. RX 1, at 2.
Subsequently, Respondent did his residency in anesthesiology at St.
Luke's/Roosevelt Hospital, an institution which is affiliated with the
Columbia University College of Physicians and Surgeons, where he
received an award given to the Outstanding Graduate Resident in
Anesthesiology. Id. Respondent also did a fellowship in Pain Management
at the Memorial Sloan Kettering Cancer Center, where he was elected
Chief Fellow. Id. at 1.
Upon completion of his fellowship, Respondent joined New Jersey
Anesthesia Associates (NJAA), a group of physicians which provides
anesthesia services at St. Barnabas Medical Center. Tr. 345-47.
Respondent is a partner in NJAA. Id. at 347. In addition to providing
anesthesia, Respondent also treats both acute and chronic pain
patients. Id. at 555-56. Respondent is also an attending physician and
clinical professor at St. Barnabas, where he trains residents in
anesthesia. Id. at 360.
Respondent came to the attention of the Agency during its
investigation of a
[[Page 10084]]
large criminal conspiracy which was run by Johar Saran, and which used
the Internet to unlawfully distribute controlled substances. Id. at
156-159; see also GX 16 (Indictment, United States v. Saran, et al.,
No. 305-CR-0240P (N.D. Tex. 2005). As part of the investigation, DEA
Investigators conducted trash runs at the premises of Carrington Health
Care System, an entity owned by Saran which was located at 301 E.
Stephens, Suite 100, Arlington, Texas. Tr. 159, 185. During the trash
runs, investigators found various documents including ``Drug
Prescription'' sheets and copies of some prescription labels which are
placed on pill vials. See GXs 17-29.
The ``Drug Prescription'' sheets listed a patient's name, address,
birth date, age, sex, phone number, medication history, and allergies.
See GXs 17-24. In the block titled ``Physician,'' the sheets listed
Respondent's name, address, phone numbers, and DEA number. Id. In the
block titled ``Rx,'' the sheets gave the date, drug name (which in each
instance was a schedule III controlled substance containing
hydrocodone), quantity, number of refills, instructions for taking the
drug, instructions to the pharmacist as to whether substitution was
permitted or the drug was to be dispensed as written, and bore the
electronic signature of Respondent. See id. In a block entitled
``Pharmacy Services Use Only,'' each of the sheets listed a number, as
well as the date and time of a consultation, and included the notation
``LBRTY.'' Id. \1\ Finally, each of the sheets included shipping
information. Id.
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\1\ At the top of all but one of the sheets was the notation:
``From: Dr. Joseph Gaudio, M.D.,'' and a date and time which was
typically only a short period after the date and time listed for the
consultation. See GXs 17, 18, 20, 21, 22, 23.
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The prescription labels listed ``Triphasic Pharmacy,'' with an
address of ``301 E. Stephens St. Ste 100'' in Arlington as the
dispensing pharmacy. GXs 25-31. The labels also listed the patient's
name, the drug, a date, the quantity dispensed, a prescription number,
instructions for taking the drug, number of refills, and a physician's
name. Id. Respondent was listed as the prescribing physician on eight
of the prescription labels, each of which indicated that the customer
had received a schedule III controlled substance containing
hydrocodone. See id.
Several months later, Respondent was served with the Show Cause
Order. Tr. 51-52. When asked by a DI whether he had prescribed over the
Internet, Respondent admitted that ``he had a contract with a company
called Liberty Med,'' that ``he reviewed on-line patient applications
of Liberty Med,'' and that he ``was paid $20 per on-line patient
consultation.'' Id. at 52. Respondent also told the DI that he reviewed
MRIs and X-rays. When asked if he maintained patient records,
Respondent told the DI that Liberty Med ``kept them.'' Id. at 53.
In his testimony, Respondent explained that in October 2004, one of
his partners in NJAA introduced him to Liberty Medical and Mr. Craig
Boswell, whose mother ran the company. Tr. 371-72. Respondent's partner
told him that ``he understood [that Liberty] was a legitimate company
that practices Internet-based medicine and that I might be interested
in talking to Craig Boswell concerning possibly doing work for them.''
Id. at 371.
Respondent met with Boswell, who told him that the company ``was
not one of these companies opening and shutting in a week or month,
[that it] was a legitimate company, [and that] they wanted to set up
consultation services doing this internet website.'' Id. at 373.
Boswell further advised Respondent that Liberty ``deal[t] with patients
who have medical records, who have been seen by other physicians, who
have radiological evidence of pain.'' Id. Boswell also told Respondent
that Liberty would carefully screen the patients, that ``they would
make sure that the patient wasn't sourcing meds from another
facility,'' and that ``they would also obtain'' the address and phone
number of the patient's primary physician ``so that we could call them
if there is any question as to whether'' the person was ``a legitimate
patient.'' Id. at 374.
Boswell subsequently asked Respondent if he would perform on-line
consultations for Liberty. Id. The consultations were to involve
``interview[ing] the patients'' and ``mak[ing] a recommendation'' to
prescribe drugs based ``on all the information.'' Id.
In his testimony, Respondent maintained that he asked Boswell
whether this was permissible. Id. at 375. Respondent stated that
Boswell ``assured [him] that everything was legitimate,'' that Boswell
told him that ``he was in the Armed Forces,'' and that ``he had two men
in his squad [who] were in the DEA and [that] he constantly bounced
questions off of them * * * always to make sure that he was within the
limits of the law.'' Id. Boswell also told Respondent that ``there were
certain states that did not allow internet prescribing'' and that
persons from these states would be excluded. Id. at 376.
Respondent did not, however, seek legal advice regarding the
lawfulness of Boswell's proposal. Id. at 375. Moreover, even though he
understood that he would be prescribing to patients throughout the
country, he did not undertake any inquiry on his own into the laws of
any State pertaining to the propriety of the proposed activity. Id. at
512. Instead, he concluded that Liberty was engaged in legitimate
activity because Boswell had been referred to him by his partner and
Boswell was ``concerned about making sure that everything was done
correctly,'' id. at 375, and had told him that ``he had reviewed all
the laws pertaining to this.'' Id. at 512.\2\
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\2\ Respondent also maintained that ``to find out more'' he had
talked with another physician who performed online consultations for
Liberty. Id. at 509. Respondent did not, however, testify as to the
specifics of this conversation. Id. Respondent did not meet any of
the medical professionals who worked for Liberty and did not know
where the business was located. Id.
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In November 2004, Respondent entered into a written contract with
Liberty; Respondent performed online consultations and prescribings for
it from approximately December 2004 through December 2005. Id. at 507.
Respondent was paid $20 per consultation and received the same fee
regardless of whether he prescribed a drug.\3\ Id. at 382-83, 508, 601.
Respondent did consultations for Liberty five days a week, and did so
every week between December 2004 and December 2005, except for three
weeks during which he took vacation. Id. at 516. Respondent performed
twenty to fifty consultations a week; he also testified that while he
was ``not exactly sure,'' he issued twenty to thirty prescriptions a
week. Id. The record is, however, unclear as to how many of the
prescriptions were for controlled substances. Id. at 568.\4\ According
to
[[Page 10085]]
Respondent, he prescribed hydrocodone, Vicodin (a schedule III
controlled substance which contains hydrocodone), and oxycodone, a
schedule II controlled substance. Id. at 547. See Physicians' Desk
Reference 526 (59th ed. 2005); see also 21 CFR 1308.12(b)(1) &
1308.13(e).
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\3\ Respondent maintained that his compensation from Liberty was
only ``a very small part of [his] income'' and that ``it was more of
my interest in telemedicine that drove me to do it.'' Tr. 383.
Respondent testified that he was involved in a start-up company,
Technology Integrated for Medical Application (TIMA), which
conducted academic research with major institutions, and that TIMA
was developing systems to engage in medical monitoring of people
from remote locations. Id. at 505. Respondent explained that ``[w]e
can speculate that some day we'll be able to diagnose patients from
a distance where you can have a doctor in a remote location who
doesn't have the expertise in a certain area that can receive
expertise from * * * physicians in another area based on giving real
time information back to those physicians.'' Id. at 506.
\4\ Respondent testified that he prescribed both narcotics and
non-narcotics and that the estimated number of prescriptions
referred to ``all in total.'' Tr. 568. Notably, the Government
introduced no evidence showing the number of controlled-substance
prescriptions he issued during the course of his contract with
Liberty; nor did it introduce evidence showing the number of
controlled prescription he issued during a defined period of time.
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Liberty gave Respondent a user name and password, which he used to
access PSDOCTOR, a Web-based software program which listed his
appointments; according to Respondent, he ``would call the patient and
obtain a detailed history.'' Id. at 377. Respondent testified that
through PSDOCTOR, he could retrieve patient records including a
patient's history (including the patient's complaint, what drugs the
patient was taking, what surgeries the patient had undergone, and the
patient's name and address), charts, and exams including radiological
reports. Id. at 377-78. Respondent also testified that ``sometimes [the
patients] would * * * also submit physical exams.'' \5\ Id. at 378.
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\5\ Respondent testified that ``on the average,'' the physical
exam had to be no more than ``approximately six months'' old, but
that ``sometimes we required records more recent than six months and
sometimes patient[s] could have records up to eight months [old] or
more.'' Tr. 571. Respondent maintained, however, that in each
instance, he would have a conversation with a patient before
prescribing and that this provided ``an independent basis'' to
determine whether the patient's symptoms were continuing.'' Id. at
572.
Moreover, the ``Consent for Treatment'' forms that are in
several patient files indicate that a patient could receive the
``first prescription with an agreement that I will fax my medical
records and a photo ID * * * within 27 days and before my next
prescription is due for refill.'' RX 11, at G0156 (signed on ``12/8/
04''); RX 10, at G0151 (signed on ``12/5/05''). This suggests that
in some instances, Respondent may have issued prescriptions without
even reviewing a patient's records.
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Respondent maintained that he would ``call the patients because
[he] want[ed] to actually talk to the patients before [he] made any
decisions on the patient,'' that ``[t]he history was very important,''
id. at 378-79, and that the calls would last an average of twenty
minutes. Id. at 615. He also testified that he performed a telephonic
consultation with every patient he prescribed to. Id. at 614-15.
Relatedly, Respondent maintained that based on his experience as a
pain doctor, he could ``get a sense of whether the patient was telling
me the truth because certain pains in certain areas elicit certain
responses.'' Id. at 379. He also testified that most patients did not
``have the savvy'' to dupe him and that ``sometimes [he] would lead
patients down the wrong path to see if they were telling the truth * *
* because there are a lot of drug seekers out there.'' Id. at 381-82.
He also stated that if a patient told him something that did not match
what was in their medical record, ``we would either call their primary
doctor'' or ``deny them.'' Id. at 382. Respondent also testified that
he ``denied a lot of patients and some of the records will show that.''
Id.
The ALJ found that some of Respondent's testimony was contradicted
in several material respects by other evidence. See ALJ at 12 (] 36).
While Respondent testified that he never prescribed without conducting
a telephone consultation with the patient, and that the consultations
lasted twenty minutes on average, Ms. A.B., who received hydrocodone
pursuant to a prescription issued by Respondent on December 8, 2004,
see GX 17, stated to a DI that within a couple of hours after she faxed
medical records to Liberty,\6\ she received a telephone call from a
doctor which lasted approximately ``one minute.'' GX 35, at 1-2. The
doctor, whose name she did not recall, asked her what her pain was. Id.
at 2. Ms. A.B. told the doctor that she had previously been treated by
a doctor in North Carolina for headaches caused by nerve damage
incurred in an automobile accident; the doctor then agreed to prescribe
for her, ninety tablets of hydrocodone/apap.\7\ Id. Ms. A.B. further
stated that the doctor did not discuss with her how her progress would
be monitored, what to do if she experienced side effects, and how to
contact him in an emergency. Id.
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\6\ Those records included a progress note dated September 16,
2004, which indicated that A.B.'s physician had prescribed ninety
Lorcet (10/650 mg.), with no refills. RX 6, at G0050. Lorcet is a
schedule III controlled substance which combines hydrocodone with
acetaminophen. See PDR, at 1287.
\7\ Apap is an abbreviation for acetaminophen.
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Another DI interviewed K.B., who had also obtained a combination
drug containing hydrocodone through the Liberty Web site. See GX 21;
Tr. 116-151. K.B. told the DI that she had become aware of Liberty
through a pop-up ad and that she went to the Web site and filled out a
questionnaire. Tr. 117. On August 4, 2004, K.B. sent Liberty an MRI
report showing that she had a herniated disk. Id. at 118; RX 15, at
G0190-91. ``A couple of days later,'' Tr. 118, K.B. was contacted by a
woman who stated that she was a representative of Liberty. Id.
According to K.B., the woman performed a consultation and told K.B.
that a prescription had been approved by Respondent.\8\ Id. at 118 &
131.
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\8\ Having found that K.B. faxed a copy of the MRI report on
August 4, 2004, four months before Respondent began his contract
with Liberty, I find that Respondent did not issue the initial
prescription which K.B. received from Liberty. I do find, however,
that Respondent issued a prescription to K.B. on December 15, 2004.
See GX 21.
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On or about December 15, 2004, K.B. received ninety tablets of
Lortab (hydrocodone/apap (10/500)), a schedule III controlled
substance, pursuant to a prescription issued by Respondent. Id. at 119-
20, GX 21; see also PDR at 3240. K.B. received approximately twenty-
five prescriptions through Liberty, the majority of which were
authorized by Respondent. Tr. 132, 141, 148, 150. K.B. never had a
conversation with Respondent, id. at 140, and had no contact with
Liberty with respect to any of the subsequent orders she placed other
than when she contacted the Web site to determine the status of an
order. Id. at 121. K.B. further told the DI that she became addicted to
hydrocodone. Id. at 122. K.B. also obtained drugs from another Web site
during a portion of the period in which she obtained drugs through
Liberty; her primary care physician did not know that she was acquiring
drugs through the internet. Id. at 120-22.\9\
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\9\ Investigators also attempted to interview several other
persons whose names were listed on the prescription sheets found
during the trash runs. Some of the individuals could not be located,
Tr. 162 & 165, others were uncooperative. Id. at 163. Investigators
were unable to contact the persons named on the prescription labels
because the labels did not contain addresses. Id. at 169.
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DEA Investigators also attempted to contact the persons identified
in Respondent's Exhibits 19-45, as patients who were denied
prescriptions. Tr. 470. The DIs could not contact most of the
individuals and were able to speak with only eight of them. See id. at
634-44. Of these eight persons, the record establishes that Respondent
prescribed to only one of them, Ms. S.A. See GX 26.\10\ More
specifically, on
[[Page 10086]]
December 7, 2004, Respondent prescribed to S.A. ninety tablets of
hydrocodone/apap (7.5/750 mg.).
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\10\ For example, while a DI spoke to L.L.'s daughter (RX 20),
she did not know whether her mother ever spoke with Respondent. Tr.
635. R.T. (RX 24) stated that he never received drugs from Liberty,
Tr. 637, and there is no evidence to the contrary. While M.A. stated
that he did not speak with Respondent, id. at 637-38, documentary
evidence indicated that Respondent did not issue a prescription
because he felt that M.A. ``IS WANTING MEDS FOR SOMEONE ELSE.'' RX
26. Again, there is no evidence establishing that Respondent issued
a prescription to M.A.
A.F. (RX 27) acknowledged taking Vicodin and sending medical
records somewhere. Tr. 638. He did not, however, remember where,
id.; and in any event, there is no evidence that Respondent
prescribed to him. M.K. (RX 31) acknowledged receiving hydrocodone
from Liberty ten times, that he received his first order without a
consultation, and that his ``subsequent orders usually did involve a
two to three minute conversation with someone claiming to be a
physician or a physician's assistant.'' Tr. 640. Again, there is no
evidence establishing that Respondent (as opposed to other doctors
who worked for Liberty) prescribed to him. RX 31.
M.B. (RX 33) acknowledged that he received hydrocodone from
Liberty four times and ``recalled talking to someone at the Liberty
Meds Web site but [did not] remember who.'' Tr. 641. K.K. (RX 36)
acknowledged ordering hydrocodone ``four or five'' times, but
identified a different doctor as the prescriber. Tr. 641-42.
Similarly, T.A. (RX 37) stated that he had ordered hydrocodone from
Liberty ``two or three'' times, and that he had conversations with
either a doctor or physician's assistant lasting ``two to three
minutes,'' but could only identify a different doctor as the person
he spoke to. Id. at 642. As above, there is no evidence establishing
that Respondent prescribed to either M.B. or T.A.
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Ms. S.A. stated that she ordered hydrocodone from Liberty ``at
least ten times and that she did not speak to any physician on the
first two occasions.'' \11\ Tr. 643. S.A. further stated that on
subsequent orders, she had ``very short conversations lasting
approximately one minute or less,'' but could not recall the name of
any person she had talked to. Id. at 643-44.
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\11\ Here again, the evidence shows that S.A. faxed her records
to Liberty on August 25, 2004, four months before Respondent began
his contract with Liberty. RX 7, at G0113-14.
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Respondent testified that S.A.'s medical record supported the
prescription he issued and that the drug and dosage he prescribed was
appropriate for her condition. Tr. 451. Yet the evidence suggests that
the most recent medical report available to Respondent was an
``Operative Report'' for a procedure which had been performed nearly
eight months earlier. See RX 7, at G0112. Moreover, Respondent offered
no explanation as to why S.A.'s condition was of such a nature as to
justify prescribing based on an eight-month-old report.
A DI also interviewed R.Z., to whom Respondent prescribed 90
tablets of Vicodin ES (7.5/750 mg.), on January 5, 2005. GX 18. R.Z.
told the DI that she had become aware of Liberty in approximately
November 2004; someone at Liberty put R.Z. in contact with a man ``who
claimed to be a doctor.'' Tr. 72. R.Z. could not, however, remember the
name of the doctor, but did recall having a phone conversation of
``approximately ten minutes'' duration with him in which she was asked
questions about her condition, what type of pain she had, what type of
pain medication she needed, how she tolerated pain medications, and her
blood pressure. Id. at 73. The doctor then told R.Z. that he would
prescribe to her ninety tablets of Vicodin. Id. at 74. R.Z. also told
the DI that she had faxed to Liberty an x-ray report which showed that
she had a bulging disk.\12\ Id. R.Z. further told the DI that she had
received from Liberty monthly prescriptions for ninety tablets of
Vicodin over ``a thirteen to fourteen-month period.'' \13\ Id. at 77-
78.
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\12\ R.Z. stated that she had sent in only the x-ray report and
filled out an online questionnaire. Tr. 89. R.Z. was never directed
to obtain further tests (such as a new x-ray), and stated that she
did not believe that Liberty ever contacted her primary doctor. Id.
at 79, 89-90.
\13\ R.Z. also stated that she had conversations every three to
four months regarding her condition with a woman from Liberty who
claimed to be a physician. Tr. 76, 87. R.Z. testified that she had a
single conversation with a male caller. Id. at 96.
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Respondent testified that the prescription he issued was consistent
with the findings contained in the x-ray report. Id. at 459; RX 10, at
G0154. The x-ray report contains the notations: ``Record Received on 1/
31/05,'' and ``Verified on 1/31/05 By MW.'' Id. In addition, the record
includes a handwritten note dated ``1/31/05,'' which states in relevant
part: ``Attention Leisha, Here are the results of the xray I had on my
back. * * * I would like my refill sent when it becomes time to do
so.'' Id. at G0153. Respondent further testified that ``I don't see a
physical exam here but it would be something that we would require.''
Tr. 459. He also maintained that in order for R.Z. to get an x-ray,
``she had to have some history,'' because ``you can't refer yourself
for an x-ray.'' Id.
Even so, that a patient needs a referral to obtain an x-ray, does
not establish that Respondent reviewed R.Z.'s history and a physical
exam report before he prescribed to her. Indeed, the absence of a
physical exam report in R.Z.'s file is consistent with her statement
that she sent in only the x-ray report. See Tr. 89. I therefore find
that contrary to Respondent's testimony, he did not review a physical
exam report before prescribing to R.Z.\14\
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\14\ The ALJ noted that it ``is unclear * * * whether or not the
Respondent had access to, or actually reviewed medical records prior
to prescribing controlled substances to any of Liberty's customers
discussed at the hearing.'' ALJ at 19 n.10. While this is correct
with respect to some patients, with respect to R.Z., it is clear
that Respondent prescribed without having any medical records that
supported the prescription.
In the context of discussing his prescribing through Liberty,
Respondent also testified that ``I will always'' have some ``data''
and ``I won't just place them on a prescription.'' Tr. 442. Perhaps
Respondent was testifying about his prescribing practices at the
time of the hearing. Or perhaps he considered the answers Liberty's
customers gave to the questionnaires to be ``data.'' In any event,
the evidence establishes that he prescribed to R.Z. without either
reviewing a physical exam report or the x-ray report.
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As for Respondent's statement that the Vicodin prescription he
issued to R.Z. was consistent with the findings of the x-ray report,
the evidence shows that he issued the prescription on January 5, 2005,
nearly four weeks before Liberty received the x-ray report. Respondent
therefore could not have issued the prescription on the basis of the
report.
With respect to K.B. (whose interview with a DI is described
above), Respondent also maintained that a report for an MRI which had
been done ten months earlier, see RX 15, at G0190; established that the
hydrocodone prescription he issued was appropriate. Tr. 467. Respondent
then testified that Respondent ``had been on Toradol and Ultram and had
not received results.'' Id. Continuing, Respondent stated that ``[s]he
also had gotten Lortab it seems. If you look at G0195, in the middle
where it says 2/19/04, it says renewed her Lortab and Flexeril.'' Id.
at 467-68.
Notably, both pages G0194 and G0195, which appear to contain
progress notes of various visits K.B. made to an orthopedic clinic
between January 15, 2003, and November 29, 2004, have the notations:
``Record Received on 1/31/05,'' and ``Verified on 1/31/05 By MW.'' RX
15, at G0194-95. Moreover, each page has a header indicating that it
was faxed on January 31, 2005. See id. As found above, Respondent
issued the prescription to K.B. on December 15, 2004, approximately six
weeks before these documents were faxed to Liberty. GX 21. Here again,
Respondent could not have relied on the documents when he issued the
prescription to K.B., notwithstanding his testimony that ``we would
require'' a physical exam. Tr. 459.\15\
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\15\ As found above, Respondent never spoke with K.B. Tr. 140.
During the period she was obtaining controlled substances from
Liberty, K.B. was under the care of another physician; K.B.,
however, never told the latter physician that she was receiving
drugs from Liberty. Id. at 122, 142-43.
Respondent maintained that Liberty was ``unable to provide all
the records'' because of problems it was having with its ``IT
person.'' Tr. 410. However, the files for some of the patients
appear extensive, see RXs 3 (22 pages), 5 (18 pages), 6 (64 pages),
7 (17 pages), & 14 (23 pages), thus prompting the question of why
Liberty was able to provide so much documentation for these patients
but not for some of the others. Moreover, the patient files indicate
that the patients almost always faxed or mailed their records to
Liberty. Thus, even if the records were scanned into Liberty's
computer system, Respondent offered no evidence to establish what
happened to the original records. Finally, there is no evidence that
Respondent requested a subpoena for the records. While the ALJ
apparently found that Respondent credibly testified that he did not
receive all of the information he requested, ALJ Dec. at 13 n.3., I
conclude that the patient files Respondent introduced into evidence
fairly reflect the patient files as obtained by Liberty.
The ALJ further reasoned that Respondent's testimony supported
``the requirement that [he] maintain his own patient records.'' Id.
It is further noted that under the New Jersey Board of Medical
Examiners' regulation which governs the prescribing of controlled
substances, ``[t]he practitioner shall keep accurate and complete
records.'' N.J. Adm. Code 13:35-7.6(g) (emphasis added). There is,
however, no requirement under federal law that an ``individual
practitioner * * * keep records of controlled substances in
Schedules II, III, IV, and V which are prescribed in the lawful
course of professional practice, unless such substances are
prescribed in the course of maintenance or detoxification treatment
of an individual.'' 21 CFR 1304.03. I do not decide whether it was
permissible under the New Jersey regulation for Respondent to
maintain medical records through the Liberty Web site.
---------------------------------------------------------------------------
[[Page 10087]]
Other Patients
On January 5, 2005, Respondent issued a prescription to K.A., a
Texas resident, for ninety tablets of hydrocodone/apap (10/500mg). GX
27. The record contains extensive progress notes showing that K.A. was
being treated by a San Antonio, Texas pain management specialist during
2004 and 2005 for neck pain.\16\ See RX 3. Respondent testified that
K.A. ``has various different problems * * * that would cause one to
have a ton of severe pain.'' Tr. 426. Respondent testified that based
on his review of the record, the medication and dosage he prescribed
was appropriate. Id. at 432. Respondent offered no testimony, however,
as to whether he contacted the pain management specialist who was
treating K.A. See generally id. at 426-32.
---------------------------------------------------------------------------
\16\ Based on the progress notes as well as K.A.'s Texas
driver's license, I find that K.A. was a resident of Texas. See RX
3, at G0001.
---------------------------------------------------------------------------
On December 20, 2004, Respondent prescribed to P.G., a Minnesota
resident, ninety tablets of hydrocodone/apap (10/500 mg.) with one
refill. GX 19. Although the most recent progress note in P.G.'s record,
which was dated April 13, 2004, indicated that he had ``[c]hronic low
back with right lower extremity radicular pain,'' and that his local
physician had issued him a prescription for twenty tablets of Percocet
p.r.n., P.G.'s physician further observed that ``[l]ong-term use of
narcotics for back pain is not in his best interest and therefore he is
given only 20 tablets at this time.'' RX 4, at G0024. While Respondent
testified that his prescription was appropriate, Tr. 435, when asked on
cross-examination whether the eight-month-old progress note was of
sufficient recency to make a diagnosis, he testified: ``It really
depended also on the patients and the physical findings but this does
seem like it was two months later than we usually accept. * * *'' Id.
at 525.
On January 5, 2005, Respondent prescribed to D.C., a resident of
Georgia, ninety tablets of hydrocodone/apap (10/325 mg.). GX 24. The
most recent progress note in her file prior to this prescribing was
dated June 24, 2004, and indicated that the physician's impression was:
``Probable right C7 radiculopathy.'' RX 5, at G0035. When asked by his
counsel whether this would ``indicate that pain should be in a
particular area?,'' Respondent answered: ``Yes, she should have the
pain in the right upper extremity. If I had spoken with this person
about giving her a treatment, I would have first tried to elicit where
her pain was coming from.'' Tr. 437 (emphasis added). Respondent then
discussed the findings of a physical exam which occurred on April 21,
2005, and which he obviously could not have relied on when he issued
the prescription three months earlier. See id. at 437-38.
Next, Respondent maintained that he would try to confirm with the
patient whether their reported pain matched with ``what it should be.''
Id. at 439. He also maintained that his prescribing was consistent with
the drug (Vicodin 7.5) that the physician, who physically examined her
three months later, had prescribed. Id. at 440; RX 5, at G0032.
On cross-examination, Respondent acknowledged that while the
medical records showed that D.C. had been by an orthopedist and
neurologist, neither had referred her to him. Tr. 527. When asked what
his treatment plan was for D.C., Respondent could not recall. Id. He
also did not refer her to a pain clinic near where she lived. Id. at
528.
On December 15, 2004, Respondent prescribed to S.K., a resident of
Texas, ninety tablets of hydrocodone/apap (10/325mg.), with one refill.
GX 22. Again, Respondent testified that the prescription he wrote
``would be consistent with what she's experiencing on physical exam
here.'' Tr. 454. While Respondent testified that S.K.'s records ``were
accessed through PSDoctor,'' id. at 455; the only medical exam report
in S.K.'s file is dated ``6/1/05,'' and was faxed on June 10, 2005. See
RX 8, at G0129-31. Respondent therefore could not have relied on the
report in issuing the prescription.
On January 6, 2005, Respondent prescribed to S.B., a South Carolina
resident, ninety tablets of Lortab (10/500mg.). GX 27. SB's patient
file contains only three documents: a copy of her driver's license, a
``consent for treatment'' form dated ``12/8/04,'' and the results of a
blood test taken on October 28, 2003. See RX 11. Respondent maintained
that S.B.'s file was ``incomplete,'' and that ``she would'' have been
asked to provide other data. Tr. 460. The ALJ did not, however, make
any findings regarding the credibility of Respondent's testimony
pertaining to S.B. In light of the other instances in which Respondent
prescribed even though a patient's file was missing information, I find
that it is more likely than not that he prescribed to S.B. without
obtaining any additional medical documentation.
On January 5, 2005, Respondent prescribed to K.S., a resident of
Texas, ninety tablets of hydrocodone/apap (10/500) with one refill. GX
29. K.S.'s records include extensive progress notes which show that she
had last been seen by a physician on September 28, 2004, and had last
been prescribed a controlled substance (codeine/apap) on December 20,
2004. RX 14, at G0182.
Respondent testified that ``[i]t seemed like she had really good
follow-up here according to these progress notes,'' Tr. 462-63, and
that the prescription he wrote ``would be appropriate for'' the
condition documented in the record. Id. at 465. Respondent offered no
explanation as to why he was prescribing to a patient who had received
a controlled substance prescription from another physician only two
weeks earlier. Moreover, given his acknowledgment that K.S.'s records
showed that she was receiving good follow-up care, he offered no
testimony that he had contacted K.S.'s physician to coordinate her care
and ensure that she was not engaged in doctor shopping.\17\
---------------------------------------------------------------------------
\17\ K.S.'s file includes a letter which forwarded some records
to Liberty. On the letter, there is a handwritten notation that the
records had been reviewed, but that the clinic, which treated K.S.,
was ``closed for lunch.'' RX 14, at G0170.
---------------------------------------------------------------------------
On January 3, 2005, Respondent prescribed ninety tablets of
hydrocodone/apap (10/325 mg.) to E.M., a New Hampshire resident.\18\
Beside two copies of E.M.'s driver's license, her patient file contains
two forms: (1) A Family and Medical Leave Act certification that E.M.
had a serious illness, and (2) an Office of Workers Compensation
Programs' form documenting a medical examination (performed on October
1, 2004) and diagnosis and supporting the need for certain restrictions
on E.M.'s work-related duties. See RX 16 at G0200-01. The latter form
indicates that E.M. had low back pain and tendonitis in her hand and
shoulder. Id. at G0201. The form, however, contains no
[[Page 10088]]
documentation of her vital signs. See id. Moreover, when asked by his
counsel whether the prescription he issued to E.M. was appropriate,
Respondent answered that ``we do prescribe medicine for'' tendonitis
and carpal tunnel, but that ``it seems like this chart is incomplete,''
Tr. 469, and that ``[i]t might have been missing EMGs or other
things.'' Id. at 536. He again testified that it was his practice to
look for other data before prescribing such as ``radiographic or
EMGs.'' Id. at 537. While Respondent acknowledged that E.M.'s record
did not have any such data, he then maintained that ``this might be an
incomplete record.'' Id.
---------------------------------------------------------------------------
\18\ While the ALJ found that E.M. was a Texas resident, ALJ at
27 (FOF 90), RX 16 includes copies of E.M.'s driver's license which
appears to indicate that she was a New Hampshire resident. Moreover,
the fax header indicted that the documents were faxed to Liberty
from a phone number with a 603 area code, which is an area code for
New Hampshire.
The ALJ also noted that the prescription label (GX 29) was dated
``1/3/04.'' ALJ at 27 n.18. Based on the undisputed evidence that
Respondent did not commence working for Liberty until December 2004,
the ALJ found that the actual date of the prescription was January
3, 2005. Id.; see also Tr. 535. I adopt this finding.
---------------------------------------------------------------------------
Yet several of the documents contained in E.M.'s patient file
indicate that they were faxed to Liberty on December 31, 2004. Id. at
G0202-03.\19\ Again, Respondent offered no credible explanation as to
why E.M's file as turned over to him had these documents (which Liberty
obtained shortly before he issued the prescription to her) but not the
others which ``might have been missing.'' Id. at 536. I therefore find
that there were no such additional documents in E.M.'s patient file
when he prescribed to her.
---------------------------------------------------------------------------
\19\ Again, while Respondent testified that the records that he
requested from Liberty were incomplete, he offered no explanation as
to why Liberty was able to provide some records for a patient but
not the missing ones. Moreover, the evidence indicates that many of
the patients faxed their records to Liberty. Even if these records
were scanned into a database, Respondent offered no evidence as to
what became of the original documents.
---------------------------------------------------------------------------
On December 15, 2004, Respondent issued to L.F., a resident of New
Jersey, a prescription for ninety tablets of hydrocodone/apap (7.5/
750mg.) with one refill. GX 23. Respondent testified that L.F.'s
records showed that his physician ``did a physical exam,'' and that
``[t]here is also one on 10/8/04 by the same physician which was
consistent with what was found on 10/8/03, * * * you can see the same
vertebral bodies marked off, so it's very consistent with what the
patient is having.'' Tr. 456. Respondent maintained that L.F. had a
condition which ``merit[ed] intervention for pain,'' id., and that the
dosage he prescribed was consistent with his condition. Id. at 457.
On cross-examination, the Government asked Respondent to compare
the handwriting of the two reports of ``Examination Findings,'' which
were dated ``10/8/03'' and ``10/8/04'' respectively. Id. at 530; see
also RX 9, at G0142 & G0145. Respondent acknowledged that ``[a]ll the
handwriting [on the two reports] is in exactly the same position.'' Tr.
530. Respondent testified, however, that when he prescribed to L.F., he
``did not'' recognize that one of the documents had probably been
falsified. Id. Moreover, none of the documents in L.F's file contained
his vital signs. See RX 9. And as with the other Liberty patients,
Respondent did not physically examine L.F., even though he lived in
northern New Jersey, and near where he practiced.\20\ See id. at G0147,
GX 23.
---------------------------------------------------------------------------
\20\ Respondent practiced pain management at a clinic in
Livingston, New Jersey. RX 1; ALJ at 5. L.F. lived in Wallington,
and L.W. lived in Warren, New Jersey. RXs 20 & 23. In accordance
with 5 U.S.C. Sec. 556(e), I take official notice of the fact that
all three of these cities are located in northern New Jersey. See 5
Rand McNally, Business Traveler's Road Atlas 62, 68-69 (1994).
Notwithstanding the proximity of his clinic to L.F.'s and L.W.'s
residences, Respondent did not require them to appear for a physical
examination.
An agency ``may take official notice of facts at any stage in a
proceeding--even in the final decision.'' U.S. Dept. of Justice,
Attorney General's Manual on the Administrative Procedure Act 80
(1947). In accordance with the Administrative Procedure Act and
DEA's regulation, Respondent is ``entitled on timely request to an
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21
CFR 1316.59(e). Accordingly, Respondent may file a motion for
reconsideration within fifteen days of service of this order which
shall commence with the mailing of the order.
---------------------------------------------------------------------------
On December 7, 2004, Respondent prescribed to L.W., another New
Jersey resident, ninety tablets of hydrocodone/apap (10/325 mg.) with
one refill. GX 20. L.W.'s patient file consisted of three pages: a
progress note dated June 17, 2004, a sheet indicating that L.W. was
faxing her driver's license, and a blurred copy of a driver's license.
See RX 12. The progress note lists several diagnostic codes and under
the handwritten notation of ``CODES,'' states: ``polycystic ovaries,''
``adhesions,'' and ``pelvic pain.'' RX 12, at G0158. Next to the column
for history, the document includes a notation of ``Percocet
120.'' Id.
With respect to L.W., Respondent maintained that ``[t]hese patients
have pelvic pain generally to the lower abdomen.'' Tr. 461. Respondent
then testified that ``[t]here is no radiological exam that you would do
to tell you anything differently[,] [b]ut obviously they know she has
polycystic ovaries according to this physician's history and
physical.'' Id. Respondent testified that the prescription was
appropriate for a patient with this condition, and that he believed
someone had verified L.W.'s identity with her physician because ``her
license was blurred.'' Id. Respondent did not, however, testify that he
called Respondent's physician.
Respondent's Other Evidence
Respondent also testified that he had proposed that Liberty use a
narcotic contract under which a patient was required to agree not to
give or sell his drugs to others, as well as not to seek drugs from
other physicians. Tr. 384; see also RX 11, at G0156. According to the
contract, a patient would be dismissed for failing to comply. Tr. 384.
Yet Respondent was not ``sure how'' Liberty determined whether a
patient was obtaining drugs from other sources such as another Web
site. Id. at 385.
Respondent gave conflicting testimony as to whether he had
prescribed oxycodone to Liberty's patients. First, he testified that he
did so at a frequency that was ``pretty much equal'' to that of his
hydrocodone prescribing. Id. at 585. Later, however, when Respondent
was asked by the ALJ as to whether he ever recalled prescribing
schedule II controlled substances to a Liberty patient, he appeared to
backtrack from this testimony answering: ``Yes, there was a patient in
our system you mean.'' Id. at 605.\21\
---------------------------------------------------------------------------
\21\ The ALJ also found that Respondent authorized refills of
schedule II controlled substances and that he ``was unaware of the
forms needed to actually prescribe a schedule II controlled
substance.'' ALJ 14 (citing Tr. 604-05). Respondent testified,
however, that he was not ``aware of'' ``a requirement for a Schedule
II substance to be prescribed on a specifically identified form.''
Tr. 605.
Except for in an emergency situation, the dispensing of a
schedule II controlled substance requires ``a written prescription
signed by the practitioner,'' and the ``original written, signed
prescription [must be] presented to the pharmacist for review prior
to the actual dispensing of the controlled substance.'' 21 CFR
1306.11(a). However, no special form is required to prescribe a
schedule II drug and Respondent's testimony was correct. Federal law
does, however, prohibit the refilling of a schedule II controlled
substance. 21 U.S.C. 829(a).
---------------------------------------------------------------------------
Respondent further testified that he believed that his prescribing
practices complied with New Jersey's regulations and were consistent
with a 2001 DEA Guidance Document. With respect to the New Jersey
regulation, which provides that ``a practitioner shall not dispense
drugs or issue prescriptions to an individual, * * * without first
having conducted an examination, which shall be appropriately
documented in the patient record,'' except for in six defined
circumstances, N.J. Admin Code Sec. 13:35-7.1A, Respondent testified
that exceptions three (``[f]or continuation medications on a short term
basis for a new patient prior to the patient's first appointment'') and
four (``[f]or an established patient who, based on sound medical
practice, the physician believes does not require a new examination
before issuing a new prescription''), ``could apply.'' Tr. 589; see
also N.J. Admin. Code Sec. 13:35-7.1A(b)(3) & (4). Respondent did not,
however, identify any patient he prescribed to over the
[[Page 10089]]
Internet who later came in for an appointment. Nor did he testify that
any of the persons whose names were found on the prescription sheets
and labels was an established patient.
Respondent also maintained that his Internet prescribing was
consistent with the statements in this Agency's Guidance Document,
Dispensing and Purchasing Controlled Substances Over the Internet, 66
FR 21181 (2001). More specifically, Respondent maintained that his
practices were consistent with the Guidance Document because ``[w]e
always had the patient's chief complaint, history was taken, a physical
examination was done by another physician, and we collected all the
evidence together and then I made my decision based on all the evidence
including the radiographical evidence.'' Tr. 417. Respondent further
maintained that ``it was not'' his practice to prescribe based solely
on Internet correspondence. Id.
Finally, Respondent's counsel read to him the following question
and answer from the Guidance Document:
I am a Physician. Does the need for a Physical Exam Mean that I
Cannot Engage in Telemedicine and Prescribe Controlled Substances?
No, DEA does not intend to limit the ability of doctors to
engage in telemedicine. If the patient cannot travel to your office,
but you supervise an exam given by a nurse or other professional,
you can then prescribe the needed medications based on the results,
to the extent that State law allows. In this case, your decision on
the appropriateness of the medication is based on facts (symptoms,
blood pressure, etc.) that have been verified by a qualified third
party and observed by you electronically.
GX 6, at 5; Tr. 418.\22\
---------------------------------------------------------------------------
\22\ At the hearing, Respondent's counsel slightly altered the
text of the answer published in the Guidance Document. The
alteration did not, however, materially change the meaning of the
answer.
---------------------------------------------------------------------------
Respondent was then asked by his counsel whether his Internet
practice was consistent with this statement. Tr. 418-19. Respondent
answered: ``Yes. In fact, we've exceeded those, also communicating with
the physicians, not just electronically but via telephone.'' Id. at
419. Respondent then explained that ``the radiographical reports were
read by a physician radiologist, the physical exams were done by
another physician, so sometimes we have a couple of physicians involved
in the process. Id.\23\
---------------------------------------------------------------------------
\23\ Respondent also testified that the first time he saw the
2001 Guidance Document was at the hearing. Tr. 522.
---------------------------------------------------------------------------
Respondent did not, however, identify a single instance in which he
supervised and observed a physical exam as it was being performed by
another qualified medical professional. Moreover, Respondent did not
have any recollection as to having spoken to any of the physicians who
were identified in the patient records that were introduced into
evidence in this proceeding. Id. at 573. Finally, he was unaware as to
whether any of the patient notes he made were ever sent by Liberty to
the primary care physicians of those he prescribed to. Id. at 614. He
also never gave written referrals for Liberty patients to see local
doctors. Id. at 512.
Respondent testified that he had stopped performing telemedicine
consultations for Liberty in late December of 2005. Id. at 487. He also
represented that it was not his ``present intention'' to resume
internet based prescribing. Id.
As noted above, Respondent introduced into evidence a number of
printouts from Liberty's software with the heading ``Patient
Information for Appointment.'' See RXs 19-45. These printouts establish
that in several instances, patients were denied drugs because they were
receiving them from other sources. See RXs 19, 21, 27, 32, 33, 39.
Moreover, in other instances Respondent did not approve a prescription,
see RX 23, 34, 43; and in at least one case, Respondent denied a
prescription because he felt the person ``was wanting meds for someone
else.'' RX 26. Moreover, the printouts suggest that in other instances,
either Liberty or Respondent denied requests because the person was
seeking the drugs too soon, RX 22, 35, 36; the patient's records had
not been verified, RX 28; or the patient needed to be evaluated and
send in records before Respondent approved a refill. RX 42 & 44. Only
one of these printouts, however, corresponds with a patient (S.A.) who
was identified above as having received a prescription which was issued
by Respondent.\24\ Compare RX 44 with GX 26.
---------------------------------------------------------------------------
\24\ The National Center on Addiction and Substance Abuse (CASA)
has reported that ``[t]he number of people who admit abusing
controlled prescription drugs increased from 7.8 million in 1992 to
15.1 million in 2003.'' National Center on Addiction and Substance
Abuse, Under the Counter: The Diversion and Abuse of Controlled
Prescription Drugs in the U.S. 3 (2005) (GX 3). Moreover,
``[a]pproximately six percent of the U.S. population (15.1 million
people) admitted abusing controlled prescription drugs in 2003, 23
percent more than the combined number abusing cocaine (5.9 million),
hallucinogens (4.0 million), inhalants (2.1 million) and heroin
(328,000).'' Id. Relatedly, ``[b]etween 1992 and 2003, there has
been a * * * 140.5 percent increase in the self-reported abuse of
prescription opioids''; in the same period, the ``abuse of
controlled prescription drugs has been growing at a rate twice that
of marijuana abuse, five times greater than cocaine abuse and 60
times greater than heroin abuse.'' Id. at 4.
CASA has further reported that teenagers ``represent an
especially vulnerable group,'' because ``[t]eens may view
prescription drugs as relatively safe either when abused alone or in
combination with alcohol or other drugs.'' Id. According to CASA,
``[i]n 2003, 2.3 million teens ages 12 to 17 (9.3 percent) reported
abusing a controlled prescription drug in the past year; 83 percent
of them reported abusing opioids.'' Id. Moreover, ``[b]etween 1992
and 2002, the number of [first time] teenage prescription opioid
abusers increased by 542 percent.'' Id. at 35.
Finally, CASA noted that ``[i]nternet sites not adhering to
state licensing requirements, medical board standards or federal law
have enabled consumers to obtain controlled prescription drugs
without a valid prescription or physician supervision and without
regard to age.'' Id. at 63. CASA also noted that ``illegal
[i]nternet pharmacies have introduced a new avenue through which
unscrupulous buyers and users can purchase controlled substances for
unlawful purposes.'' Id. Moreover, ``[t]he age of the customers
appears not to be an issue for Internet pharmacies,'' and that there
are ``no mechanisms in place to block children from purchasing
controlled drugs over the Internet.'' Id. at 66.
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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). With respect to a practitioner, the Act requires the
consideration of the following factors in making the public interest
determination:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id. section 823(f).
``[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 a registration should be
revoked.'' 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).
In this matter, it is undisputed that neither the State of New York
nor the
[[Page 10090]]
State of New Jersey has taken action against Respondent's medical
license (factor one). It is also undisputed that Respondent has not
been convicted of an offense related to controlled substances under
federal or state law (factor three).\25\ This proceeding focused,
however, on Respondent's experience in dispensing controlled substances
and his record of compliance with applicable laws. As discussed below,
the evidence pertaining to these factors is disturbing and
establishes--at a minimum--that Respondent committed numerous
violations of both Federal and state laws.
---------------------------------------------------------------------------
\25\ Under settled precedent, neither of these factors is
dispositive. See Edmund Chein, 72 FR 6580, 6590 n.22 (2007);
Mortimer B. Levin, 55 FR 8209, 8210 (1990).
---------------------------------------------------------------------------
Factor Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Record of Compliance With Applicable Controlled
Substance Laws
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 (1975)).
Under the CSA, it is fundamental that a practitioner must establish
a bonafide doctor-patient relationship in order to act ``in the usual
course of * * * professional practice'' and to issue a prescription for
a ``legitimate medical purpose.'' Moore, 423 U.S. at 141-43. The CSA,
however, generally looks to state law to determine whether a doctor and
patient have established a bonafide 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.\26\
---------------------------------------------------------------------------
\26\ On October 15, 2008, the President signed into law, the
Ryan Haight Online Pharmacy Consumer Protection Act of 2008, Pub. L.
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.
---------------------------------------------------------------------------
Moreover, ``[a] physician who engages in the unauthorized practice
of medicine'' under state laws ``is not a `practitioner acting in the
usual course of * * * professional practice''' under the CSA. United
Prescription Services, 72 FR at 50407 (quoting 21 CFR 1306.04(a)). As
explained therein, 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. section 802(10). See also id. section 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.'').
As I noted in United Prescription Services, 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)
(quoted at 72 FR 50407). 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[.]'').\27\
---------------------------------------------------------------------------
\27\ 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).
---------------------------------------------------------------------------
Under the regulation of the New Jersey Board of Medical Examiners,
``a practitioner shall not dispense drugs or issue prescriptions to an
individual * * * without first having conducted an examination, which
shall be appropriately documented in the patient record.'' N.J. Admin
Code Sec. 13:35-7.1A(a). This rule further requires that ``[a]s part
of the patient examination, the practitioner shall'':
1. Perform an appropriate history and physical examination;
2. Make a diagnosis based upon the examination and all
diagnostic and laboratory tests consistent with good medical care;
3. Formulate a therapeutic plan and discuss such plan, along
with the basis for the plan and the risks and benefits of various
treatment options, with the patient; and
4. Ensure the availability of the physician or coverage for
appropriate follow-up care.
Id.
It is undisputed that Respondent did not perform a physical
examination on any of the Liberty patients he prescribed to, including
those who were New Jersey residents. Instead, Respondent asserted that
two exceptions provided in the New Jersey rule ``could apply'' to his
internet prescribing. Tr. 589. The first of these authorizes the
prescribing of ``continuation medications on a short term basis for a
new patient prior to the patient's first appointment''; the second
authorizes prescribing ``[f]or an established patient who, based on
sound medical practice, the physician believes does not require a new
examination before issuing a new prescription.'' N.J. Admin Code 13:35-
7.1A(b)(3) & (4).
As the record establishes, none of Respondent's Liberty patients
were ever expected to see him for a ``first appointment,'' and none
did. Moreover, Respondent offered no evidence that any of his Liberty
patients were his ``established patients.'' \28\
---------------------------------------------------------------------------
\28\ I acknowledge that in Gonzales, the Supreme Court stated
that ``[a]s for the federal law factor, though it does require the
Attorney General to decide `[c]ompliance' with the law, it does not
suggest he may decide what the law says. Were it otherwise, the
Attorney General could authoritatively interpret `State' and `local
laws,' which are also included in 21 U.S.C. 823(f), despite the
obvious constitutional problems in his doing so.'' 546 U.S. at 264.
In determining whether Respondent established a legitimate
doctor-patient relationship with the Liberty patients, this Agency
must necessarily examine state law. Moreover, the requirement that a
practitioner must generally perform a physical exam in order to
properly diagnose a patient is one which is universally accepted
throughout the medical community and by state medical boards. See
American Medical Association, Guidance for Physicians on Internet
Prescribing (GX 8); see also Federation of State Medical Boards,
Internet Prescribing Language By State (available at http://
www.fsmb.org/ncip_resources.html/).
Notably, Respondent cites no decision of either the New Jersey
Board of Medical Examiners or the New Jersey courts holding that
conduct similar to his internet prescribing was lawful under the
exceptions which he contended ``could apply.'' Tr. 589. If
Respondent had, this Agency would, of course, respect that decision.
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[[Page 10091]]
In his brief, Respondent also contends that New Jersey's exception
``[f]or a patient examined by a healthcare professional who is in
collaborative practice with the practitioner'' also applies. Id. Sec.
13:35-7.1A(b)(5); see Resp. Prop. Findings 52. However, with respect to
this exception, Respondent testified that ``I don't know what
collaborative means there,'' Tr. 589, and in any event, there is no
credible evidence that Respondent collaborated with any of the
practitioners who may have previously examined the Liberty patients.
Id. at 573 & 614.
Respondent thus failed to establish a legitimate doctor-patient
relationship under the New Jersey regulation. I therefore further hold
that Respondent's prescriptions to the Liberty patients were not
``issued for a legitimate medical purpose by an individual practitioner
acting in the usual course of his professional practice,'' 21 CFR
1306.04(a) and thus violated the CSA as well.
Respondent's prescriptions also violated numerous laws of the
States where the patients were located. Respondent prescribed
controlled substances to two residents of Georgia, A.B. and D.C. 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).\29\ Moreover,
Respondent violated Georgia law because he engaged in the unlicensed
practice of medicine. See Ga. Code Ann. Sec. 43-34-31.1.\30\
---------------------------------------------------------------------------
\29\ 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 either A.B.
or D.C.
\30\ 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 also prescribed controlled substances to four residents
of Texas, S.A., K.A., S.K., and K.S. Respondent did not hold a Texas
medical license. See Tex. Occup. 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
regulations 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 prescribed a controlled substance to R.Z., a
Massachusetts resident. Massachusetts 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).\31\ As the
Board's interpretation makes plain, Respondent acted outside of the
usual course of professional practice when he prescribed a controlled
substance to R.Z., and therefore violated both Massachusetts law and
the CSA.\32\
\31\ The ALJ also noted that Respondent was required to be
licensed to practice medicine in Massachusetts and that ``[o]nly a
practitioner who is authorized to prescribe controlled substances
may do so.'' ALJ at 39 (citing Mass. Gen. Laws. ch. 94C, Sec.
18(a)). 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.
Sec. 18(c).
\32\ The ALJ also found that Respondent violated Minnesota law
when he prescribed to P.G. because he lacked either a state medical
license or a telemedicine registration. ALJ at 39-40 (citing Minn.
Stat. Sec. 147.081). The ALJ observed that Minnesota allows a
physician to provide telemedicine services if four conditions are
met including that the physician register with the State. ALJ at 40
(citing Minn. Stat. Sec. 147.032 Subd. 1(a)). The Minnesota
statute, however, exempts a physician who holds a valid license to
practice in another state ``if * * * the services are provided on an
irregular or infrequent basis,'' which is defined as ``if the person
provides the services less than once a month or provides the
services to fewer than ten patients annually.'' Id. Subd. 2(2).
The Government's evidence established that Respondent issued
only a single prescription to P.G.; there is no evidence that he
prescribed to any other Minnesota residents. While it may well be
the case that Respondent issued additional prescriptions to P.G. or
other Minnesota residents, the Government has not proved that he
engaged in the unauthorized practice of medicine within Minnesota.
---------------------------------------------------------------------------
[[Page 10092]]
Respondent also issued a prescription for controlled substance to
E.M., a New Hampshire resident. In April 2004, the New Hampshire Board
of Medicine issued Guidelines on internet prescribing. In pertinent
---------------------------------------------------------------------------
part, the Board stated:
The members of the NH Board of Medicine have interpreted that a
sufficient examination in the establishment of a valid physician-
patient relationship cannot take place without an initial face-to-
face encounter with the patient. It requires at a minimum: (1)
Verifying the person requesting the medication is who they claim to
be; (2) establishing a diagnosis through the use of acceptable
medical practices, such as patient history, mental status exam,
physical exam, and appropriate diagnostic and laboratory testing by
the prescribing physician; (3) discussing with the patient the
diagnosis and the evidence for it, and the risks and benefits of
various treatment options; and (4) ensuring availability of the
physician or coverage for the patient for appropriate follow-up
care; (which usually includes a face-to-face encounter at least once
a year and as often as is necessary to assure safe continuation of
medication). Complete management of a patient by Internet, e-mail,
or other forms of electronic communication is inappropriate.
New Hampshire Board of Medicine, Guidelines for Physician Internet and
Telephone Prescribing (April 7, 2004).
Moreover, under New Hampshire law, ``[a]ny person shall be regarded
as practicing medicine * * * who shall diagnose, treat * * * or
prescribe any treatment of medicine for any disease or human ailment.''
N.H. Rev. Stat. Sec. 329:1. Moreover, practicing medicine without a
license or as ``otherwise authorized according to the law of'' the
State constitutes the ``unlawful practice'' of medicine.\33\ Id. Sec.
329:24. I thus conclude that Respondent acted outside of the usual
course of professional practice in prescribing a controlled substance
to E.M. and violated both New Hampshire law and the CSA.
---------------------------------------------------------------------------
\33\ Respondent produced no evidence that his internet practice
came within any of the exceptions to New Hampshire's licensing
requirement. See N.H. Rev. Stat. Sec. 329:21.
---------------------------------------------------------------------------
Respondent also prescribed a controlled substance to S.B., a South
Carolina resident. In May 2001, the South Carolina Board of Medical
Examiners promulgated its regulation on ``Contact with Patients before
Prescribing.'' S.C. Code Regs. 81-28. This regulation declares that
``[i]t is unprofessional conduct for a physician to initially prescribe
drugs to an individual without first establishing a proper physician-
patient relationship.'' Id. Continuing, the regulation states that
forming ``a proper relationship'' requires that a physician:
(1) Personally perform an appropriate history and physical
examination, make a diagnosis, and formulate a therapeutic plan.
This process must be documented appropriately; and
(2) Discuss with the patient the diagnosis and evidence for it,
and the risks and benefits of various treatment options; and
(3) Insure the availability of the physician or coverage for
appropriate follow-up care.
Id.\34\ Here too, Respondent failed to establish a valid doctor-patient
relationship with S.B. under South Carolina law and thus violated the
CSA when he prescribed a controlled substance to her. 21 CFR
1306.04(a).
\34\ Similar to other State's regulations (such as New
Jersey's), the South Carolina rules recognizes several circumstances
in which a physician can lawfully prescribe to a patient he had not
personally examined. See S.C. Code of Regs. R. 81-28(B). Respondent
has not, however, demonstrated that his prescribing to S.B. came
within any of the exceptions that excuse a physician from personally
examining his patient before prescribing.
---------------------------------------------------------------------------
Respondent also issued a prescription to K.B., a resident of
Alabama. Under Alabama law, ``[t]he practice of medicine * * * across
state lines means the practice of medicine * * * as defined in Section
34-24-50(1), as it applies to * * * [t]he rendering of treatment to a
patient located 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 this state to such physician or his or
her agent.'' Ala. Code Sec. 34-24-501(a); see also id. Sec. 34-24-50
(defining the ``practice of medicine'' as meaning ``[t]o diagnose,
treat, correct, advise or prescribe for any human disease, ailment,
injury, infirmity, deformity, pain or other condition, physical or
mental, real or imaginary, by any means or instrumentality'').
Moreover, under Alabama law, ``[n]o person shall engage in the practice
of medicine * * * across state lines in this state * * * unless he * *
* has been issued a special purpose license to practice medicine * * *
across state lines.'' Id. Sec. 34-24-502(a).
Respondent did not hold either a medical license or a special
purpose license to practice medicine across state lines as required by
Alabama law. In issuing the prescription to K.B., Respondent not only
violated Alabama law, he acted outside of the usual course of
professional practice and thereby violated the CSA as well.
As the foregoing demonstrates, Respondent repeatedly violated both
the CSA and various State laws in prescribing to Liberty's customers.
Respondent nonetheless contends that the Supreme Court's decision in
Gonzales ``indicates that the continuation of his registration should
not turn on [this Agency's] determination of whether in fact he had
satisfied the relevant standards for establishing a doctor-patient
relationship.'' Resp. Br. at 51; see also id. at 52 (arguing that
Gonzales ``militates against a determination by the agency, for
purposes of determining whether [Respondent's] registration should be
revoked, as to whether [his] practices with internet patients satisfied
state * * * standards for effective medical practice'').
Contrary to Respondent's view, Gonzales expressly recognized that
one of the core purposes of the prescription requirement was to
``ensure[] [that] patients use controlled substances under the
supervision of a doctor so as to prevent addiction and recreational
abuse.'' 546 U.S. at 274. Respondent's internet prescribing practices
beg the question of how he was supervising the persons to whom he
prescribed, to prevent them from becoming addicted to, or engaging in
recreational abuse of, the drugs.\35\ Examining whether Respondent
established legitimate doctor-patient relationships under state law
with those to whom he prescribed, is thus a necessary incident of
determining whether he violated the CSA.
---------------------------------------------------------------------------
\35\ Respondent contends that his internet practice ``was not
substantially different from the evaluation process he would perform
when he was contacted by a nurse from [the hospital] while he was on
call,'' in that ``without examining the patient directly, [he] would
draw upon his substantial experience and expertise to get the
information he needed * * * to determine what care the patient
required.'' Response to Gov.'s Exceptions at 5. It does not require
a degree in medicine, however, to recognize that there is a critical
difference between the two situations. In the on-call situation, a
nurse is personally observing the patient and likely relating the
patient's vital signs and other information regarding the patient's
symptoms/condition to the physician. In contrast, even when
Respondent, in the course of his internet prescribing, reviewed the
results of physical examinations, he had no current information
available as to the patient's vital signs and other symptoms.
---------------------------------------------------------------------------
Respondent further argues that the DEA 2001 Guidance ``does not
require the doctor personally to take the history or perform the
[physical] examination.'' Resp. Br. at 50. Relatedly, Respondent
contends that ``in terms of the indicia'' of a legitimate doctor-
patient relationship as stated in the Guidance, ``there is clearly room
for a physician to issue a prescription premised in part upon an
examination or history conducted by another professional.'' Id.
At the hearing, however, Respondent testified that he had not seen
the Guidance prior to this proceeding, Tr.
[[Page 10093]]
414-15; Respondent therefore could not have been induced into believing
that his conduct was legal by the Guidance. Moreover, the Guidance made
clear that its discussion of the criteria for establishing a legitimate
doctor-patient relationship was based on a summary of the standards
adopted by the various States. See 66 FR at 21182 (GX 6, at 4).\36\
---------------------------------------------------------------------------
\36\ The Guidance is not a regulation and thus does not have the
force and effect of law. Rather, it is a Notice which simply
provides guidance.
---------------------------------------------------------------------------
As Respondent acknowledged, he did not conduct his own review of
state laws or seek legal advice concerning the legality of prescribing
through the Liberty website. At the time he commenced his contract with
Liberty, numerous state medical boards had already issued either policy
statements or regulations (including those States discussed above)
which addressed the legality of a physician's prescribing to patients
he had not personally examined. Moreover, at the time Respondent
commenced his contract with Liberty, this Agency had published several
final orders revoking practitioners' registrations based on their
prescribing over the internet and without performing a physical
examination.\37\ See, e.g., Marvin L. Gibbs, Jr., M.D., 69 FR 11658,
11661 (issued Mar. 11, 2004); Mark Wade, M.D., 69 FR 7018, 7021-22
(issued Feb. 12, 2004); Rick Joe Nelson, M.D., 66 FR 30752, 30753
(2001) (noting immediate suspension of practitioner's registration
based on internet prescribing).
---------------------------------------------------------------------------
\37\ Respondent also contends that his shortfalls were of one
``seeking to practice in an area where the technical requirements
are both widely dispersed and in flux.'' Resp. Br. 46; see also id.
at 52. However, at the time he commenced his contract with Liberty,
each of the States discussed above had already either enacted laws,
or issued regulations or policy statements, addressing the propriety
of this activity. And in any event, Respondent cannot credibly argue
that his conduct should be excused because the legal requirements
were in flux when he made no inquiry as to what the requirements
were.
---------------------------------------------------------------------------
In his response to the Government's Exceptions, Respondent contends
that because of Boswell's ``attentiveness to regulatory and compliance
issues,'' he was ``led * * * to believe that his internet practice
would be proper.'' Response to Gov.'s Exceptions 7. This is not a
persuasive argument. Indeed, one would think that a licensed
professional and the holder of an appointment as a clinical professor
would be well aware of such state laws and regulations as those
prohibiting the unauthorized practice medicine and those defining
something as fundamental to the practice of medicine as the steps
necessary to establish a legitimate doctor-patient relationship. As the
California Court of Appeal has explained:
[the] proscription of the unlicensed practice of medicine is neither
an obscure nor an unusual state prohibition of which ignorance can
reasonably be claimed, and certainly not by persons * * * who are
licensed health care providers. Nor can such persons reasonably
claim ignorance of the fact that authorization of a prescription
pharmaceutical constitutes the practice of medicine.
Hageseth v. Superior Court, 59 Cal. Rptr.3d 385, 403 (Ct. App. 2007).
Respondent further contends that his case is distinguishable from
other Agency cases involving internet prescribers. See Resp. Br. at 43-
46. More specifically, Respondent contends that in contrast to other
internet prescribers, he ``issued no more than a handful of
prescriptions a day,'' that he prescribed ``only after reviewing the
patient's medical record and conducting a searching personal
interview,'' that he ``only prescribed medications that were pertinent
to his area of medical expertise,'' and that he ``rejected many
requests for medication that he deemed inappropriate.'' Id. at 43.
Relatedly, Respondent contends that Liberty attempted to identify
persons who were obtaining drugs from multiple sources and that it
verified medical records. Id. at 45. He also contends that ``[h]e
genuinely made a good faith effort'' to practice ``medicine properly
and effectively.'' Resp. to Gov.'s Exceptions at 10.
As to these contentions, the evidence is mixed. While there is no
evidence rebutting his contention that he issued only a small number of
prescriptions each day, by his own admission he consulted for Liberty
for approximately one year during which he issued between 800 and 1200
prescriptions. However, the record does not establish the extent to
which these prescriptions were for controlled substances. Moreover, he
continued to prescribe for three months after being served with the
Order to Show Cause.\38\ While it seems likely that he prescribed
controlled substances during this period, the Government did not
establish the scope of his controlled substance prescribing activity
after he was served with the Order.
---------------------------------------------------------------------------
\38\ With respect to his prescribing following the service of
the Show Cause Order, Respondent does not maintain that he did not
prescribe controlled substances in this period. Rather, he argues
that I should consider the fact that the Order alleged that he
``improperly prescribed drugs [phentermine and phendimetrazine] that
he never in fact prescribed.'' Response to Gov.'s Exceptions at 11.
Respondent ignores, however, that the Show Cause Order also quoted
the prescription requirement of 21 CFR 1306.04(a), and the New
Jersey regulation setting forth the requirements for prescribing a
drug including that a ``practitioner shall * * * perform an
appropriate history and physical examination.'' Show Cause Order at
1 & 3. Moreover, the Show Cause Order alleged that Respondent was
prescribing to persons that he was not physically examining and had
no prior doctor-patient relationship with, and was thus violating 21
CFR 1306.04. Id. at 6. The Show Cause Order thus provided Respondent
with fair warning as to the illegality of his conduct.
---------------------------------------------------------------------------
Moreover, notwithstanding his contention that he prescribed only
after reviewing a patient's medical record and ``conducting a
searching'' interview, the evidence establishes that in some instances
(R.Z. and S.K.) he prescribed before Liberty even obtained the records,
and that in other instances he relied on records that--according to his
own testimony--were outdated (P.G) and even indicated that narcotics
were not in the patient's best interest. Relatedly, as the ALJ noted,
other evidence casts serious doubt as to his assertions that he always
conducted a consultation with the patients, let alone a searching
interview of them. ALJ at 12. (FoF 36).
On the other hand, there is some evidence that Liberty rejected
patients who were seeking drugs from multiple sources, or who were
seeking drugs to give to others. There is also evidence that in some
instances, Liberty verified a patient's records with the patient's
original physicians although it is unclear what this process involved
and how often it was undertaken.\39\ Relatedly, even though the patient
files typically included photocopies of a driver's license, there is no
guarantee that the drugs were actually going to these persons.
---------------------------------------------------------------------------
\39\ For example, did Liberty's employees simply ask whether a
person had been a patient? Did they ask whether the patient was
still being treated by the physician? Did they ask what the
physician's diagnosis was? And did they ask if there was any
evidence that the patient had engaged in drug seeking behavior?
Moreover, in some instances, Respondent prescribed before the
records were even sent to Liberty. Finally, in at least one case
(patient L.F.), it appeared that some of the records were
fraudulent.
---------------------------------------------------------------------------
Moreover, the ALJ found that Respondent ``declined to prescribe
medications in many instances where Liberty customers were directed to
him.'' ALJ at 17 (FoF 52). The Government produced no evidence to rebut
Respondent's contention as to the frequency of his refusals to
prescribe. Relatedly, there is also evidence that Respondent rejected a
request for drugs when he thought the person would divert or was
seeking drugs from multiple sources. Moreover, there is evidence that
Respondent refused to prescribe because a person's complaint (and the
supporting records) had not been verified.
[[Page 10094]]
While the record as a whole may not conclusively show that
Respondent knowingly diverted, at the very least it establishes that
Respondent acted with reckless disregard for his obligations as a
practitioner under both the CSA and numerous state laws. Moreover,
Respondent acknowledged that he prescribed schedule II drugs and
authorized refills of these prescriptions, in violation of federal law.
See 21 U.S.C. 829(a).\40\ The Government has therefore proved that
Respondent has committed acts that render his registration
``inconsistent with the public interest.'' Id. Sec. 824(a)(4).
---------------------------------------------------------------------------
\40\ Respondent also provided Liberty with an electronic copy of
his signature. Tr. 511 & 570. While Respondent credibly testified
that he had no reason to suspect that Liberty was using his
signature to authorize prescriptions which he had not approved, he
acknowledged that he had no way of determining whether Liberty was
misusing his signature. Id. at 570. This Agency has previously held
that failing to safeguard one's signature constitutes conduct
inconsistent with the public interest. See Robert G. Hallermeier,
M.D., 62 FR 26818, 26820 (1997).
---------------------------------------------------------------------------
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).
The ALJ acknowledged that the Government had ``clearly
demonstrated'' that Respondent's internet prescribing practices
violated the CSA. ALJ at 43. While the ALJ recognized that Respondent's
internet prescribing was ``egregious conduct,'' id., that he ``fail[ed]
to be totally truthful during his testimony,'' id. at 44, and that he
``demonstrated a lack of sound judgment'' in continuing his internet
prescribing for three months following the service of the Show Cause
Order, id., she also noted that he ``is clearly a very educated,
dedicated and talented physician,'' id.; that he had been practicing
medicine for eleven years, and that ``the only instances of [his]
improper handling of controlled substances were related to his''
internet prescribing. Id. Balancing Respondent's misconduct against his
overall practice, the ALJ recommended that I continue his registration,
subject only to the condition that he not prescribe over the internet.
Id.
As explained above, this Agency has repeatedly held that accepting
responsibility for one's misconduct is an ``important factor'' in the
public interest determination. See Hoxie, 419 F.3d at 483 (upholding
Agency's consideration of whether registrant/applicant has admitted
fault); Jackson, 72 FR at 23853; Kennedy, 71 FR at 35709; Daniels, 60
FR at 62887. The ALJ, however, made no finding as to whether Respondent
had accepted responsibility for his misconduct.
While Respondent testified that it was not his ``present
intention'' to resume internet prescribing,\41\ the record as a whole
does not establish that he has accepted responsibility for his
misconduct. I acknowledge that the DI who served Respondent with the
Show Cause Order described him as cooperative, and that Respondent
admitted that his internet prescribing was even more extensive than
that shown by the Government. In his testimony, however, Respondent
continued to maintain that his prescribing without performing a
physical exam was lawful under New Jersey's regulation. Moreover,
Respondent did not acknowledge that he violated either the CSA, or any
other state laws and regulations, whether they related to the standards
for establishing a legitimate doctor-patient relationship or addressed
the unauthorized practice of medicine. Respondent's failure to
acknowledge the illegality of his conduct does not inspire confidence
that he will refrain from engaging in similar acts in the future.
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\41\ Notably, while the ALJ credited this testimony, she was
less than impressed with Respondent's testimony that he did not
intend to resume internet prescribing. See ALJ 15 n.4 (``Although
[Respondent] appeared to be credible when he testified here to his
intent, I do question how he resolves this intent with his continued
interest in telemedicine.''). Indeed, intentions can change, and
Respondent's statement is hardly an unequivocal statement that he
will not resume such conduct in the future.
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Moreover, while a registrant must accept responsibility and
demonstrate that he will not engage in future misconduct in order to
establish that his/her continued registration is consistent with the
public interest, these are not the only factors that are relevant in
determining the appropriate sanction. As I have previously noted,
``[n]either Jackson nor any other agency decision holds * * * that the
Agency cannot consider the deterrent value of a sanction in deciding
whether a registration should be [suspended or] revoked.'' Southwood
Pharmaceuticals, Inc., 72 FR 36487, 36504 (2007).\42\
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\42\ Southwood was decided before the ALJ issued her recommended
decision in this matter. The ALJ did not, however, even acknowledge
the decision.
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In Southwood, I explained that ``even when a proceeding serves a
remedial purpose, an administrative agency can properly consider the
need to deter others from engaging in similar acts.'' Id. (citing Butz
v. Glover Livestock Commission Co., Inc., 411 U.S. 182, 187-88 (1973)).
I further noted that the ``[c]onsideration of the deterrent effect of a
potential sanction is supported by the CSA's purpose of protecting the
public interest, see 21 U.S.C. 801, and the broad grant of authority
conveyed in the statutory text, which authorizes the [suspension or]
revocation of a registration when a registrant `has committed such acts
as would render [his] registration * * * inconsistent with the public
interest,' id. section 824(a)(4), and [which] specifically directs the
Attorney General to consider [`such other conduct which may threaten
public health and safety,' id. section 823(f)].'' Southwood, 72 FR at
36504.
I acknowledge that Respondent has impressive credentials, and that
except for his internet prescribing, there is no evidence that he
violated the CSA or state laws in his years of practice as an
anesthesiologist and pain management specialist. However, under any
circumstance, Respondent's conduct as an internet prescriber would be
disturbing. That he holds an appointment as a clinical professor
renders his conduct even more so. Relatedly, Respondent's testimony as
to why he believed that his Internet prescribing was lawful and failed
to perform his own inquiries into the legality of this practice is
especially unpersuasive and does not excuse his failure to obey the
law.
Moreover, Respondent's Internet prescribing was not a brief sojourn
into illegality. Rather, he engaged in his
[[Page 10095]]
misconduct for a year, during which time he likely issued between 800
to 1,200 prescriptions. Yet the record does not establish the extent to
which these prescriptions were for controlled substances.\43\
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\43\ It is also noted that Respondent continued his internet
prescribing for three months after he received the Show Cause Order,
even though the Order put him on notice as to the requirements for a
lawful prescription under both the CSA and state law. While
Respondent did not dispute that he prescribed controlled substances
during this period, I do not rely on this conduct in setting the
sanction because the Government did not identify a single controlled
substance prescription that he issued following the service of the
Show Cause Order. If the Government had shown specific instances of
Respondent's prescribing of controlled substances following service
of the Order, I would have found that he knowingly diverted
controlled substances and revoked his registration.
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I acknowledge that proceedings under Section 304 are non-punitive.
But even were I to ignore that Respondent has not accepted
responsibility for his misconduct, and credit his testimony that he did
not intend to resume his internet practice, I would still conclude that
a lengthy suspension of his registration is warranted.
As found above, the diversion and abuse of prescription drugs has
increased dramatically, with the number of people admitting to such
abuse (approximately 15.1 million) exceeding by twenty-three percent,
the number who abuse cocaine, hallucinogens, inhalants and heroin
combined. Moreover, the growth rate of prescription drug abuse is twice
the growth rate of marijuana abuse and five times the growth rate of
cocaine abuse; between 1992 and 2002, the growth in prescription opioid
abuse among teenagers grew by 542 percent.
The use of the internet and telephone to prescribe to individuals
with whom a physician has not established a bona fide doctor-patient
relationship is one of the primary means by which controlled substances
are being diverted and obtained for recreational abuse. The growth of
this means of diversion represents a grave threat to public health and
safety. Accordingly, this Agency has repeatedly revoked the
registrations of numerous practitioners who have committed similar acts
by prescribing over the internet without establishing legitimate
doctor-patient relationships. See, e.g., Kamir Garces-Mejias, 72 FR
54931 (2007); William Lockridge, 71 FR 77791 (2006); Mario Diaz, 71 FR
70788 (2006). The ALJ did not, however, even acknowledge any of the
numerous Agency decisions to this effect.
Respondent maintains that his case is distinguishable from these
and other reported decisions involving internet prescribers because he
``genuinely believed * * * that he was practicing medicine properly and
effectively[,]'' and ``genuinely made a good faith effort to do so.''
Response to Gov.'s Exceptions at 10. He also contends that he ``is an
extraordinarily dedicated and tireless physician who saw the internet
as a way to care for more patients,'' and that while he ``can be
faulted'' for ``having trusted colleagues and new business associates
when he should have been more skeptical,'' ``the price should not be
his career.'' Id. at 14.
It is true that in other Agency decisions revoking the
registrations of internet prescribers, the evidence strongly supported
the conclusion that the physicians were engaged in intentional acts of
diversion. Here, by contrast, the evidence does not establish that he
knowingly distributed controlled substances to those who were seeking
the drugs to abuse them or to sell them to abusers. His conduct--which
is extraordinary for its recklessness--nonetheless violated the CSA.
Continuing Respondent's registration, subject only to the condition
that he refrain from prescribing over the Internet, is no sanction at
all given the numerous state laws and new Federal law which prohibit
this practice in the manner Respondent engaged in it. Adopting the
ALJ's recommendation would not only ``ignore how irresponsibly
[Respondent] acted,'' Southwood, 71 FR at 36503; it would also signal
to others that one can ignore the law (and his obligation to determine
what the law is) and yet incur no consequence for having done so. Given
the extraordinary harm to public health and safety caused by internet
prescribing, this is not the message that should be sent to those who
contemplate prescribing controlled substances in this manner. Rather,
such persons should understand that they are responsible for knowing
the law and acting in conformity therewith, and that there will be
serious consequences for those who fail to do so.
Accordingly, I conclude that Respondent's registration should be
suspended for a period of one year. Moreover, Respondent's pending
application for renewal of his registration will be held in abeyance
during the course of the suspension. Upon completion of the suspension,
his application will be approved provided that he fulfills the
following condition. Because Respondent has not acknowledged that his
internet prescribing practices violated the CSA, he must provide a
sworn statement to this effect. If Respondent complies with this
condition (and he commits no other acts which would warrant the denial
of his application), the Agency will expeditiously grant his renewal
application. If, however, if he fails to do so, his 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 the DEA
Certificate of Registration issued to Joseph Gaudio, M.D., be, and it
hereby is, suspended for a period of one year. I further order that
Respondent's pending application to renew his registration be, and it
hereby will be, held in abeyance pending the completion of the period
of suspension and Respondent's providing to this Agency a sworn
statement acknowledging that his internet prescribing activities
violated the Controlled Substances Act and DEA regulations. This Order
is effective April 8, 2009.\44\
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\44\ Respondent can choose to commence serving his suspension
earlier by tendering his Certificate of Registration and any order
forms he has been issued to the nearest DEA office.
Dated: February 26, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-4903 Filed 3-6-09; 8:45 am]
BILLING CODE 4410-09-P