Ralph J. Chambers, M.D.; Decision and Order
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Citation: "79 FR 4962"
Document Number: "Docket No. 13-21"
"Notices"
On
FOOTNOTE 1 Notwithstanding this allegation, no evidence was put forward establishing that any such application is pending before the Agency. END FOOTNOTE
The Show Cause Order alleged that, from
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Applicant's Registration and Licensure Status
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FOOTNOTE 2 I have taken official notice of the Agency's registration records which show that Applicant filed a renewal application on
Under an Agency regulation applicable to those applicants who are subject to an Order to Show Cause:
[i]n the event that an applicant for reregistration (who is doing business under a registration previously granted and not revoked or suspended) has applied for reregistration at least 45 days before the date on which the existing registration is due to expire, and the Administrator has issued no order on the application on the date on which the existing registration is due to expire, the existing registration of the applicant shall automatically be extended and continue in effect until the date on which the Administrator so issues his/her order. The Administrator may extend any other existing registration under the circumstances contemplated in this section even though the Applicant failed to apply for reregistration at least 45 days before expiration of the existing registration, with or without request by the Applicant, if the Administrator finds that such extension is not inconsistent with the public health and safety.
21 CFR 1301.36(i). Because Applicant had previously been served with an Order to Show Cause, and he did not apply to renew his registration until twenty-four days before it was due to expire, pursuant to the above regulation, I conclude that his registration expired on
Applicant is also the holder of a
Applicant's first brush with the Board occurred in 2001. GX 2, at 1. That year, the Board filed an administrative complaint against Applicant, alleging, inter alia, that with respect to a patient, who had suffered a stroke, he "fail[ed] to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances," as well as that he "failed to keep written medical records justifying the course of treatment" for that patient. Id. at 9-10 (citing Fla.
In 2010, the Board filed a new complaint, and in 2011, the Board filed two more complaints; these complaints culminated in a single final settlement order in 2012. Id. at 13. The 2010 complaint /3/ alleged that, between
FOOTNOTE 3
The first 2011 /4/ complaint made numerous factual allegations regarding Applicant's treatment of Patient J.D. /5/ Id. at 28-54. Count I of the complaint then alleged, inter alia, that over various periods, Applicant committed malpractice by prescribing controlled substances including Xanax, Lortab (hydrocodone), oxycodone, and Dilaudid (hydromorphone), "in doses which were not medically justified." Id. at 55-56 (citing Fla.
FOOTNOTE 4
FOOTNOTE 5 These included that Applicant failed to document a patient's vital signs, failed to record the quantities of the controlled substances prescribed, and continued to increase the dosage amounts for Lortab and alprazolam for one patient despite continuously noting "no change" in that patient's medical record. See id. at 28-52. In another instance, Applicant prescribed oxycodone, Lortab, and alprazolam to a patient who "reported to Applicant that he had been getting Lortab off the street while waiting for his appointment." Id. at 36. END FOOTNOTE
The second 2011 complaint /6/ made numerous factual allegations regarding Applicant's treatment of patient L.S. Id. at 63-68. Count I of the complaint then alleged that on three occasions, Applicant committed malpractice by: (1) Prescribing Xanax "in doses which were not medically justified," or 2) "[b]y authorizing . . . refills of the prescription of Xanax and Lortab," or 3) "[b]y failing to refer . . . L.S. for a psychiatric consultation." Id. at 69-70 (citing Fla.
FOOTNOTE 6
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Pursuant to the Agreement, Applicant was reprimanded and his medical license was suspended until he submitted to an evaluation by either a state program or Board-approved evaluation and appear before the Board's Probation Committee. Id. at 19. The Board also assessed an administrative fine of
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FOOTNOTE 7 I have taken official notice of the status of Applicant's medical license by accessing the online database of all licensed providers maintained by
The Investigations of Applicant
The 2005-2006 Investigation
In 2005, the
During the operations, the police observed the CSs enter and exit Applicant's office; they also placed a recording device on the CSs. Id. However, during the last operation, the recording device did not work. Id. During each operation, the CSs obtained prescriptions for controlled substances, which they subsequently provided to the police. Id. Copies of these prescriptions were submitted in the record provided by the Government, as were the recordings and transcriptions for the three visits when the recording device functioned properly. See GX 9-12.
Following the buys on
The recordings of the
As for the
FOOTNOTE 8 As explained below, there is a lengthy report of an Expert regarding his review of numerous patient files. However, the Expert did not discuss these visits. END FOOTNOTE
As for the
The recording and transcript do reflect that after Applicant and the CS greeted each other, a lengthy discussion ensued of such matters as Applicant's prior experience treating gunshot wounds as a trauma surgeon and critical care physician, his decision to move to
To this, the CS replied: "Well . . . that . . . what you gave me last time. Made me feel really good. Ah . . . coming to see if I can get something a little stronger this time." Id. Applicant than asked the CS if he wanted something "[s]tronger or just more" of what he had previously gotten; the CS answered: "[m]aybe more stronger." Id. Applicant then stated: "Okay, no problem," and asked the CS if he was getting "any therapy?" Id. The CS replied that he was not. Id. Applicant then asked the CS, "not into it?" Id. The CS answered "[y]eah," and Applicant said "fair enough." Id. Applicant then left the exam room and subsequently provided the CS with prescriptions for 60 Ultram (tramadol, a non-controlled drug) and 120 oxycodone 15mg, a schedule II controlled substance.
CS2 returned to Applicant on
The 2008-2009 Investigation
Several years later, a DEA Diversion Investigator (DI), in conjunction with the
FOOTNOTE 9 DI Stocum's declaration states the date as
According to the DI, after each of the visits, the confidential sources told her that Applicant did not perform a physical examination yet prescribed controlled substances to the CSs. Id. at 2. Subsequently, a search warrant was obtained from the
FOOTNOTE 10 The same day, the Investigators also interviewed Applicant. GX 5. Applicant admitted that his clinic did not accept insurance and was basically a cash clinic. Id. at 9. He also acknowledged that some pharmacies were refusing to fill his prescriptions, but did not follow-up with any of them because of their "attitudes." Id. at 37-38. When asked about the high volume of controlled substances he was prescribing, Applicant stated that he was "not trying to overdose people but most of my chronic patients that I have never run out" of medication. Id. Later, he acknowledged "writ[ing] . . . a fair amount more than most doctors would" and that "every once in a while we have an overdose." Id. at 51. END FOOTNOTE
On
Applicant replied, "[w]ell, now you saw me one time. You saw that other guy, the other guy gets it cheaper than this place." Id. CS3 then denied that she had "see[n] anybody in that office," an apparent reference to Applicant's former practice location, and Applicant noted that it has been "like two (2) years ago." Id. CS3 again stated that she had not gone back to that office because it did not have a therapist and she "didn't really care for his . . . chiropractic procedure." Id. at 9. Applicant said "okay" and asked the CS if she was "tak[ing] something for pain, an anti-inflammatory?" Id. The CS said "yeah," after which CS and Applicant discussed various other matters, none of which related to the CS's medical condition. Id.
Consistent with the DI's statement that the CSs had informed her that Applicant did not perform a physical exam, there is no evidence that Applicant performed a physical exam of CS3. Applicant nonetheless wrote CS3 a prescription for 180 tablets of Percocet 10/325mg. GX 13. CS3 paid
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CS3 then told Applicant that she had a friend who wanted to come in asked if he was seeing new patients. Id. at 11. Applicant said he was but he had rules and the CS's friend would have to bring documentation and that he would let the patient "know beforehand what the rules are gonna be as far as what you get . . . cause somebody walks in here and wants strong pain medication and they've never had anything before, I say, `Let's start out with anti-inflammatories and muscle relaxers, first, and therapy, and let's see how things go.' So . . . I don't know." Id.
CS3 then stated that she had "shared a little bit [of her medications]" with her friend and did not "know if that was the right thing to do." Id. Applicant replied that "it's neither right or wrong, as far as I'm concerned, but you must understand, and, although, I don't think you can get in trouble for it, you both broke the law by doing that." Id. After CS3 replied "I did?" Applicant explained that "[y]ou were dealing drugs and he was taking illegal medication; these are controlled substances." Id. at 12. After CS3 asked if it would "be better now if I just get him an appointment," Applicant stated that "he can call," but that he would have to meet with his colleague and "bring in his documentation." Id.
Applicant asked if the CS's friend "had surgery before," but the CS did not know. Id. Applicant then explained that if "he's had surgery before, then I just need to see some documentation . . . about the surgery." Id. After CS3 stated that she did not "think it was that" and that he may be "going to a chiropractor," Applicant added that "if he can show me that he's had therapy and things like that, that makes a difference." Id. at 12-13. Applicant then explained that "in other words, there are a lot of people who just want to walk in and say, `Give me pain medicine.' And I say, `You don't just get pain medicine without some documentation.'" Id. at 13. Applicant advised that if the CS's friend "gets his medical records together and gets it to us . . . we'll get back to him." Id. Applicant then authorized the dispensing of 210 tablets of Percocet (oxycodone/apap) 10/325mg, for which the CS paid
FOOTNOTE 11 The evidence shows that the drugs were dispensed by Applicant's clinic. GX 14. END FOOTNOTE
On
According to the DI, on
FOOTNOTE 12 However, the transcript lists the date of the visit as
CS4 filled his prescription at Applicant's clinic. As the evidence shows, Applicant dispensed 240 tablets of Oxycodone 15mg. Id.
The Government Expert's Analysis of the Seized Medical Records
As found above, after the execution of the search warrant, the DI provided over 115 medical records to Dr.
Following his review, Dr. Parran offered the following findings. Most significantly, Dr. Parran opined "that there are many cases where the prescribing of controlled drugs appears to have been for other than [a] legitimate medical purpose and appears not to have taken place within the usual course of medical practice." GX 7, at 1.
Dr. Parran then identified several "general characteristics" of Applicant's "prescribing behaviors that are concerning and even alarming." Id. Specifically, he found that: (1) "There [was] virtually always a very scant initial history and typically no documented evidence of a sufficient physical exam done on patients" in the records; (2) there was a remarkable similarity in how Applicant treated each patient, suggesting a lack of individualized treatment; (3) there was typically no note in the patient chart to explain why Applicant started, increased, or changed a drug regimen; (4) there were very few, if any, referrals to alternative treatments (i.e., physical therapy) and specialists (i.e., psychiatry, rheumatology, neurology, orthopedics and neurosurgery); and (5) Applicant routinely "provide[d] on-going supplies of multiple controlled drugs in an escalating pattern, typically culminating in quite high doses, in potentially dangerous combinations." Id. at 1-2. Dr. Parran thus opined that Applicant's "pattern of relentlessly prescribing controlled drugs, with insufficient history and physical . . . and no clinical reasoning evident in progress notes what-so-ever, without initiating a clinical work-up or demonstrating evidence of an effort to obtain prior records, and in the face of non-compliance and often out of control behavior on the part of patients, is not consistent with the usual course of medical practice and constitutes prescribing of controlled drugs for other than [a] legitimate medical purpose." Id. at 2. A more detailed discussion of Dr. Parran's findings with respect to several of the patients follows.
K.B.
At K.B.'s initial visit, she reported that she suffered from head and face trauma and seizures, and was taking undocumented dosages of Xanax, Dilantin and Naproxen. Id. at 4. The file included prior medical records from a neurology pain office several years earlier indicating that she had taken "Oxy 40 BID [twice a day] and Roxi 5 and Xanax 2 TID," three times a day. Id. Dr. Parran found that there was "no evidence of a [physical exam] and little evidence of any history taking." Id.
The next progress note in K.B.'s file is dated 6/6/06, sixteen months after K.B.'s initial visit, and states "Duragesic does not seem to be effective for pain . . . refills." Id. Apparently, no explanation was provided as to when Applicant prescribed Duragesic (fentanyl), a schedule II controlled substance to her. Id.
The next visit documented in K.B.'s record is dated 7/19/06; the progress notes states "former WS pt. with chronic back pain/Lmyalgias/HA/seizures and anxiety." Id. Dr. Parran again noted that there is "no evidence of a PE [physical exam] at all, or health history, or documentation of current RX or labs (to check Dilantin level, etc.) or studies, prior records, etc." Id. Yet Applicant prescribed 120 OC 30 mg (oxycodone), 120 Oxy (also oxycodone) 40mg, 150 Xanax 2mg, Dilantin 300 mg/d, Naprosyn, and 90 Soma.
On 8/16/06, Applicant added 120 Fiorinol to K.B.'s existing medications, without noting why in her record. Id. Dr. Parran opined that "[a]dding a potent barbiturate or an existing barbiturate (soma) and a high dose very potent benzodiazepine and two CII opioids . . . is dangerous to health or even life of a patient and is clinically reckless." Id.
K.B. received the same prescriptions the following month, but the visit note documents only the prescriptions. Id. Thereafter, there were no progress notes until
Dr. Parran then noted that there was no evidence of a physical examination at any time in the past year except for a note regarding "spasm/tenderness in L/SP," and yet Applicant added a prescription for 60 MS XR (morphine sulfate extended release)--"a third CII opioid with no mention in the record at all!" Id. Dr. Parran noted that K.B. received prescriptions that month for Soma 150, 150 OC 30 mg, 150 Xanax 2mg, Dilantin, 120 Oxy 40mg, and had refills that were still active for Naproxen and Fioricet. Id. However, her chart included a note stating that: "
Next, Dr. Parran found that the progress note for
Dr. Parran further found that the
Next, Dr. Parran observed that the
The
As for K.B.'s
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In
The prescribing of four and a half years of markedly escalating opioids and other controlled drugs to this patient with no evaluation, an insufficient H&P, non-existent work-up, lack of studies/consults/evaluation, up to exceedingly high doses of opioids, is inconsistent with the usual course of medical practice and was for other than a legitimate medical purpose.
Id.
D.B.
Regarding D.B., Dr. Parran found that "prior records recommend avoiding long-term narcotic medications." Id. at 5. D.B. reported "spinal and back pain" and yet "mark[ed] off in the patient self report[,] pain in each and every part of the body listed." Id. She also reported being on methadone 40mg, oxycodone 30 mg, Xanax 2mg, and Soma, but another note "explicitly state[d] that the patient was not on any medications currently." Id. Applicant nonetheless prescribed 120 OC 30mg and 60 Valium10mg at the initial office visit. Id. Dr. Parran concluded that "this is clinically reckless and if taken as directed would result in patient harm and even an accidental potentially fatal OD." Id.
At her next appointment (four weeks later), Applicant changed the prescriptions to 120 Percocet 10mg; 120 methadone 40 mg; 90 Xanax 2mg. Id. According to Dr. Parran, this was a "massive increase," which was "even more clinically reckless, and in a patient who was not on any current medications just 4 weeks earlier, could and should have caused harm or even death if taken as directed." Id.
Next, Dr. Parran found that the progress notes showed that the following month, asthma medications were added. Id. Dr. Parran reported that there was "no discussion of asthma (a medical concern in the face of this huge amount of opioid and benzo prescribing), no evidence of a lung exam or evaluation of the severity of pulmonary function." Id.
Over the next three months, D.B.'s patient file documents multiple increases in her prescriptions, such that by December, she was receiving 240 methadone 40mg, 120 Xanax 2mg, 120 Oxycodone 30mg, and 90 Soma, "with no indication in the medical record." Id. Dr. Parran explained that "[t]his bears no resemblance to the usual course of medical practice." Id. Additional increases in Applicant's prescribing of oxycodone, as well as other drugs followed, notwithstanding that Applicant documented in D.B.'s file that the "meds are working good." Id. Regarding the prescriptions, Dr. Parran explained that "[t]he prescribing of three years of markedly escalating opioids and other controlled drugs to this patient with no evaluation, an insufficient [history and physical], non-existent work-up, lack of studies/consults/evaluation, up to exceedingly high doses of opioids, is inconsistent with the usual course of medical practice and was for other than a legitimate medical purpose." Id.
J.H.
Dr. Parran found that J.H.'s patient file indicated that during an initial office visit in
Dr. Parran found that there were "no prior records/studies/referrals/work-up" or significant history and physical documented in her patient file. Id. Yet, at the initial visit, Applicant prescribed to J.H. 180 Percocet 5 mg. and 30 Xanax 2mg. Id. Dr. Parran explained that "[t]his is completely unsupported by the medical record, [and] is inconsistent with the usual course of medical practice and lack [sic] legitimate medical purpose." Id.
Dr. Parran found that at J.H.'s next visit (one month later), Applicant nearly tripled the oxycodone to 120 Oxy 15 mg, but made no mention of this in the progress note. Id. Dr. Parran then explained that if J.H. "had not been on prior opioids . . . and she took it as prescribed . . . it could have resulted in [an] accidental OD [overdose] and even fatal accidental OD." Id.
Dr. Parran observed that at J.H.'s next visit, Applicant added 180 Percocet 5mg to her prescriptions for 120 Oxy 15mg and 30 Xanax 2mg and merely noted that these were refills. Id. Three months later, Applicant documented that the medications "were working fine," even though he noted that she was "doubling up on [her] meds" and had been "out of medications for one week." Id. Yet he did not document any withdrawal symptoms in J.H.'s record and did not change her prescriptions. Id.
Two months later, he again increased her Oxycodone 15mg prescription and doubled her Xanax to 60 tablets. Id. The following month, he noted that J.H. had "been doubling on Oxy 15s . . . would like increase"; Applicant increased the prescription to 120 Oxycodone 30mg. Id. Within no more than a few days, J.H. claimed that she had been "robbed at knife-point in [a] local store" and that her prescriptions were stolen and she "want[ed] more." Id. at 16-17. Applicant documented that he told her "no," and that J.H. later "called back and reported maybe only half the RX was stolen and [that] she could probably make it to the next" visit. Id. at 17. Yet at the next visit, J.H. reported being "better" and that "all is well." Id. Applicant provided new prescriptions and did not document any discussion about J.H.'s claim that half of her medicine had been stolen or whether she actually "only need[ed] half the medication." Id.
By
FOOTNOTE 13 He had previously increased the prescription to 210 tablets in late July. END FOOTNOTE
Dr. Parran also noted that between February and
A.C.
Reviewing the file for Patient A.C., who complained of back pain, Dr. Parran noted that the history forms were "basically blank" except for a notation of "back pain" and "Xanax/Lortab/Oxy." Id. at 10. He further found that there was "no evidence of a significant PE or neuro exam," that there was "no imaging," and that there was "no verification of prior RX." Id. Yet Applicant prescribed to A.C. 120 oxycodone 30mg, 180 Lortab 10mg, and 30 Xanax 2mg. Id. Dr. Parran explained that "[t]his is simply unbelievable and demonstrates reckless disregard for the health and safety of a patient." Id.
Dr. Parran further found that while A.C.'s file indicated that he had suffered a back injury at work and had seen an orthopedist, Applicant never had A.C. sign a release for the records maintained by the orthopedist. Id. Moreover, A.C. missed several visits, showing up several days later, and that during one such late visit, A.C. said that he had been out of medications "for two days." Id. Yet there was "no evidence" that A.C. went through withdrawal, although this "should have been severe." Id. Dr. Parran also noted that Applicant did not perform a urine drug screen on A.C. Id. Finally, A.C.'s medical record showed that he had been simultaneously seeing another physician for six months. Id. Here again, Dr. Parran opined that Applicant acted outside of the usual course of professional practice and lacked a legitimate medical purpose in prescribing controlled substances to A.C.
S.H.
Dr. Parran found that S.H. complained "of coccyx/tail bone pain" which Applicant documented as being "sporadic." Id. at 17. Dr. Parran then found that there was "virtually no HX [history] and no PE [physical exam]" done at S.H.'s initial office visit and that "all patient health history and registration paperwork is blank." Id. Dr. Parran further observed that while S.H. had been a patient at Applicant's previous clinic and there were patient notes for the period of June through September (which immediately preceded) S.H.'s first visit to Applicant's new clinic, there was "basically no clinical information on them what so ever," again with "virtually no" history and "nearly no PE performed." Id.
Dr. Parran found that at the first visit (
For example, two months after the first visit, Applicant noted that S.H. "overtook medications--not strong enough--ran out," yet there was no indication that S.H. had withdrawal symptoms. Id. Moreover, even though this was "contrary to [S.H.'s] Pain Agreement," Applicant increased S.H.'s oxycodone prescription to 240 tablets. Id.
In
In
In
In
Dr. Parran also found that S.H. was seven days late for his March visit (at which he was prescribed a different drug--Morphine Sulfate Immediate Release) and nineteen days late for his April visit (at which Applicant returned to prescribing 400 oxycodone 30mg), and yet there was no mention of why S.H. had been late at either visit. Id. Dr. Parran opined that "[t]his is dangerous and demonstrates clinically reckless disregard for the health and safety of the patient." Id.
Finally, Dr. Parran noted that at S.H.'s last visit, there was "no mention of anxiety/depression/sleep/muscle spasm issues and no mention of [benzodiazepines] at all, yet" Applicant added a prescription for 90 Xanax 2mg. to the prescription for 400 oxycodone 30mg. Id. Dr. Parran opined that this was also "dangerous, and demonstrates clinically reckless disregard for the health and safety of the patient." Id. Dr. Parran then concluded that "the prescribing of controlled drugs to this patient was done in a manner that is inconsistent with the usual course of medical practice, and appears to have been done for other than [a] legitimate medical purpose." Id.
D.F.
Applicant treated D.F. from
The records of the initial office visit showed that D.F. complained of "fibromyalgia and chronic pain endorsing 31 symptoms in the patient self-report sheet and 12 of 15 pain descriptors--and pain everywhere in his body except hips." Id. at 14. The progress note then stated: "spoke with PT . . . he wants to get off methadone and use the Duragesic and other less expensive medications." Id. Regarding this, Dr. Parran opined that "methadone is the least expensive" of these drugs and that "this is inconsistent!" Id.
The file also contained a letter indicating that D.F. had been on a methadone maintenance program at 70 mg/d since 12/07. Id. at 15. Dr. Parran noted that the file included prior records from a pain management specialist dated
Dr. Parran found that there was "[b]asically no H&P [History and Physical]" and yet Applicant started issuing prescriptions for 180 Oxycodone 30mg, Duragesic 75mics, and 50 methadone 10mg. Id. Dr. Parran then found that at D.F.'s last visit (9/28/09) before the search of his clinic, Applicant had increased D.F.'s prescriptions to: 240 Oxycodone 30mg; 150 Dilaudid 8mg; 240 Oxycodone 15mg; 300 Methadone 10mg; and 60 Soma. Id.
Dr. Parran found that throughout D.F.'s file, there were multiple notations that that she was running out early and yet Applicant increased the prescriptions. Id. More specifically, the note for D.F.'s second visit (
Next, Dr. Parran found that the
Dr. Parran found that at D.F.'s
Next, according to the
The following month, Applicant changed D.F. from Dilaudid back to methadone, issuing prescriptions for 240 Methadone 10 mg, 240 Oxycodone 15 mg, 180 Oxycodone 30 mg, and 60 Soma. Id. And in June, Applicant resumed prescribing 120 tablets of Dilaudid 4mg and again increased the methadone to 270 tablets, which he further increased to 300 tablets the next month. Id. Dr. Parran found Applicant's methadone prescribing remarkable given that this was for "a patient who was supposedly being taken off a methadone program and [being given] other medications and patches!" Id.
Next, Dr. Parran found that the
T.T.
Reviewing T.T.'s file, Dr. Parran found that at the initial visit (2/8/06), she complained of chronic lower back pain, but reported taking "no medications." Id. at 36. Dr. Parran observed that T.T. reported no prior doctor and that her file contained no studies, labs, or records and that there was "virtually no" history and physical documented "with no neuro[logical] exam." Id. Applicant nonetheless diagnosed T.T. as having "thoracic and Lumbar Myalgias" and issued her a prescription for 90 tablets of Lortab (hydrocodone/apap) 5mg. Id.
Dr. Parran than observed that at T.T.'s next visit (3/06), Applicant increased her prescription to 120 Lorcet 10mg, and thus nearly tripled the daily dose. Id. Next, Dr. Parran found that in late April, T.T. was provided an "early [prescription] by 10 days." Id. Moreover, in late May, Applicant increased her Lortab prescription to 150 tablets and yet seven days later (
On
Next, Dr. Parran found that while the
While in February, T.T. reported having doubled up on her medications and sought an early refill, Applicant did not grant her request. Id. However, in March, T.T. reported she was "out of Xanax [and] asked for more," and Applicant obliged, increasing her prescription to 120 tablets. Id.
Over the next several months, Applicant changed T.T.'s Lortab prescription to 90 oxycodone 15mg, and increased her Xanax prescription to 150 tablets (and also prescribed to her, both oxycodone 30mg and 15mg, as well as Soma). Id. In
Only two days later, T.T. reported that medications were stolen and Applicant gave her a prescription for 30 Xanax, which was followed only four days later with a prescription for 180 Xanax. Id. Later that month, T.T.'s sister called and asserted that T.T. was stealing her medications; the same day, T.T. called and claimed her medications had been stolen. Id. Moreover, in the middle of December, Applicant received a phone call from an apparent relative of T.T. stating that T.T. was getting addicted. Id. Yet at T.T.'s next visit, he again gave her a prescription for 180 Xanax, as well as increased her Soma prescription to 90 tablets. Id.
Dr. Parran found that in
Dr. Parran further found that notwithstanding that T.T. had been undergoing treatment for addiction and had not seen Applicant for approximately three months, in
Discussion
Section 303(f) of the Controlled Substances Act (CSA) provides that an application for a practitioner's registration may be denied "if the Attorney General determines that the issuance of such registration . . . would be inconsistent with the public interest." 21 U.S.C. 823(f). In making the public interest determination,
(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.
"These factors are . . . considered in the disjunctive."
The Government has the burden of proving, by substantial evidence, that the requirements for a denial of an application, pursuant to 21 U.S.C.
FOOTNOTE 14 The Attorney General has delegated this authority to the Administrator. See 28 CFR 0.100(b). END FOOTNOTE
Factor One: Recommendation of the Appropriate State Licensing Board
At the outset, it should be noted that the Board has not made a formal recommendation as to what action the Agency should take in this matter. However, "DEA precedents have typically taken a broader view as to the scope of this factor."
The Government argues that the
It is well settled that while the possession of state authority to dispense controlled substance is a prerequisite for obtaining (and maintaining a registration), the possession of such authority is not dispositive of the public interest inquiry.
That being said, I do not rely on the findings of the
FOOTNOTE 15
FOOTNOTE 16 Of these clauses, only the latter is contained in Applicant's settlement agreement. END FOOTNOTE
Accordingly, I do not rely on the Board's findings of fact and legal conclusions. Nor is there any need to do so given the extensive evidence which supports the conclusion that Applicant has repeatedly violated the CSA's prescription requirement. /17/
FOOTNOTE 17 I also place no weight on the findings of fact and legal conclusions of the 2001 Board Order. Those findings do not establish that Applicant committed any violations of controlled substance laws and regulations but only that he committed malpractice. As the Administrator has explained, "the CSA and its case law `amply support the conclusion that
Factors Two and Four: Applicant's Experience in Dispensing Controlled Substances and Record of Compliance With Laws Relating to Controlled Substances
To effectuate the dual goals of conquering drug abuse and controlling both the legitimate and illegitimate traffic in controlled substances, "
Fundamental to the CSA's scheme is the Agency's longstanding regulation, which states that "[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
Under the CSA, it is fundamental that a practitioner must establish and maintain a legitimate doctor-patient relationship in order to act "in the usual course of . . . professional practice" and to issue a prescription for a "legitimate medical purpose."
In Florida, a physician is barred from "prescribing, dispensing, administering, mixing, or otherwise preparing . . . any controlled substance, other than in the course of the physician's professional practice." Fla.
Moreover, prior to the conduct at issue here, the
FOOTNOTE 18 The standards were first adopted on
Of particular significance here are the Board's standards pertaining to the "Evaluation of the Patient" and "Medical Records." With respect to the former, the Board's standard provided that:
A complete medical history and physical examination must be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substances.
Id. R.64B8-9.013(3)(a). And with respect to Medical Records, the Board's standard provided that:
The physician is required to keep accurate and complete records to include, but not be limited to:
1. The medical history and physical examination, including history of drug abuse or dependence, as appropriate;
2. Diagnostic, therapeutic, and laboratory results;
3. Evaluations and consultations;
4. Treatment objectives;
5. [D]iscussion of risks and benefits;
6. Treatments;
7. Medications (including date, type, dosage, and quantity prescribed);
8. Instructions and agreements; and
9. Periodic reviews. Records must remain current and be maintained in an accessible manner and readily available for review.
Id. R.64B8-9.013(3)(f).
Here, there is substantial evidence to support the conclusion that on multiple occasions, Applicant acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed controlled substances. 21 CFR 1306.04(a). The evidence shows that notwithstanding that the
FOOTNOTE 19 At the time, carisoprodol was not a controlled substance under federal law. However, in 2011, carisoprodol was placed in schedule IV, based, in part, on its abuse as part of cocktail of other controlled substances which included narcotics such as oxycodone or hydrocodone, and benzodiazepines, such as Valium (diazepam) and Xanax (alprazolam). See Schedules of Controlled Substances, Placement of Carisoprodol Into Schedule IV, 76 FR 77330 (2011). END FOOTNOTE
With respect to CS2, it is acknowledged that the evidence showed that he complained of pain and that Applicant performed a brief physical exam at his first visit. Moreover, there is no evidence establishing that under the standards of professional practice, the examination was inadequate. Nor is there any evidence that under the standards of professional practice, Applicant was required to perform a physical exam at CS2's subsequent visits.
That being said, at CS2's second visit, Applicant made no inquiry into CS2's purported pain condition and CS2 made no mention of being in pain. To the contrary, CS2 made clear that he was seeking the controlled substances to abuse them as he told Applicant that the drug that was prescribed at the previous visit "[m]ade [him] feel really good" and that he had "com[e] to see if [he] could get something a little stronger this time." After Applicant asked the CS if he wanted something "stronger or just more" of what he had gotten at the previous visit, the CS stated that he wanted something "more stronger"; Applicant stated: "Okay, no problem," after which the CS told Applicant that he was not doing "any therapy" and admitted that he was "not into it." Applicant then gave the CS a prescription for 120 oxycodone 15mg. As this conversation demonstrates, this was not a legitimate medical encounter between a doctor and his patient, but rather the negotiation of a drug deal, and thus, I hold that Applicant violated 21 CFR 1306.04(a) when he issued the prescription.
As for CS2's final visit during which the recording device malfunctioned, according to the Sergeant, the CS related in the post-operation debriefing that he told Applicant that he "was no longer in pain," that "he just liked how the pain medication made him feel," and that he wanted something stronger than oxycodone 15mg, which was what he had received at the previous visit. The CS also told the Sergeant that he received a prescription for oxycodone 30mg, which is corroborated by a copy of the prescription.
Notwithstanding that the CS's statements are hearsay and unsworn, I find that they are reliable and entitled to weight given that several other of the CS's hearsay statements were corroborated by other evidence. More specifically, the CS's statement to the Sergeant regarding the scope of the physical exam which was performed by Applicant at the
As for the
FOOTNOTE 20 Nor do we know if Applicant performed at physical exam at the previous visit. That being said, it was the Government's burden to produce evidence that Applicant had not performed a physical exam at that visit. END FOOTNOTE
As for CS3's visit of
As for CS3's final visit, while there is evidence that Applicant further increased her prescription to 240 tablets, the recording device failed. While in her affidavit, the DI stated that during the debriefing, the CS said that Applicant did not perform a physical exam and only took her weight and blood pressure, here again, there is no evidence as to whether, under the standards of medical practice, Applicant was require to perform a physical exam and the scope of an appropriate exam. Nor is there any other evidence as to whether Applicant asked the CS whether she had pain, how the pain affected her ability to function, and how the medication was working. Notwithstanding my conclusion that the prescription issued at CS3's previous visit violated federal law, because the Government has the burden of proof, I conclude that it has not produced substantial evidence to support a finding that Applicant acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he issued this prescription.
As for CS4's
To be sure, the recording establishes that Applicant did not perform a physical exam at the CS's
By contrast, the Government did produce substantial evidence--in the form of the Expert's report--that Applicant acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed controlled substances to numerous patients. As found above, the Government's Expert reviewed the medical records of over one hundred and fifteen of Applicant's patients and found numerous instances in which Applicant acted outside of the usual course of professional practice and lacked a legitimate medical purpose in prescribing controlled substances. GX 6, at 1.
As support for his conclusion, Dr. Parran identified several "general" and "alarming" characteristics of Applicant's "prescribing behaviors." More specifically, he found that: (1) "there [was] virtually always a very scant initial history and typically no documented evidence of a sufficient physical exam done on patients" in the records; (2) there was a remarkable similarity in how Applicant treated each patient, suggesting a lack of individualized treatment; (3) there was typically no note in the patient chart to explain why Applicant started, increased, or changed a drug regimen; (4) there were very few, if any, referrals to alternative treatments (i.e., physical therapy) and specialists (i.e., psychiatry, rheumatology, neurology, orthopedics and neurosurgery); and (5) Applicant routinely "provide[d] on-going supplies of multiple controlled substances in an escalating pattern, typically culminating in quite high doses, in potentially dangerous combinations." GX 7, at 1-2. Dr. Parran thus opined that:
[Applicant's] pattern of relentlessly prescribing controlled drugs, with insufficient history and physical . . . and no clinical reasoning evident in progress notes . . . what-so-ever, without initiating a clinical work-up or demonstrating evidence of an effort to obtain prior records, and in the face of noncompliance and often out of control behavior on the part of patients, is not consistent with the usual course of medical practice and constitutes prescribing of controlled drugs for other than [a] legitimate medical purpose.
Id. at 2.
Dr. Parran's conclusions are fully supported by the more detailed discussion he provided of Applicant's prescribing to various patients including K.B., D.B., J.H., A.C., S.H., D.F., and T.T., as well as others. As these findings show, Applicant repeatedly prescribed highly abused (and multiple) controlled substances including schedule II and III narcotics, as well as benzodiazepines to the patients, without doing a physical exam or doing an inadequate exam and having obtained little to no history; failed to obtain prior records; failed to refer patients to specialists; repeatedly increased both the quantity and strengths of medications or prescribed additional medications without any justification and frequently did so while noting that previous prescriptions were "working good" or the patient was doing "better" or "fine"; prescribed large doses of controlled substances to patients even when presented with evidence that the patients were not currently on medications or had recently been in detoxification programs; prescribed controlled substances even in the face of evidence that the patients were doctor shopping, selling pills, or engaged in various scams (such as claiming that their medications were stolen or had been dropped into the toilet); and ignored evidence that patients did not go through withdrawal even when they reported having been out of drugs for several days.
As these findings (as well as the recordings of several of the undercover visits) demonstrate, Applicant was not engaged in the legitimate practice of medicine with respect to many of his patients, but was engaged in outright drug dealing. See Jack A, Danton, 76 FR 60900, 60917 (2011). I therefore find that the Government's evidence with respect to factors two and four establishes that the issuance of a new registration to Applicant "would be inconsistent with the public interest." /21/ 21 U.S.C. 823(f). See also
FOOTNOTE 21 In its request for Final Agency Action, the Government alleges that Applicant lacked candor during the 2009 interview and that this conduct should be considered under factor five. While the Government cites to three pages of the interview transcript as support for its contention, it does not identify the specific questions posed by the Investigators to which it contends Applicant provided answers that lacked candor. Req. for Final Agency Action, at 9 (citing GX 5, at 38-39, 50). Indeed, many of the remarks of the various law enforcement personnel on these pages are not even properly characterized as questions. Thus, while "[c]andor during DEA investigations properly is considered by the DEA to be an important factor when assessing whether a . . . registration is consistent with the public interest," Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005), because the Government does not identify the specific questions and false answers, I decline to make any findings on the issue.
That being said, such findings are not necessary to support the sanction I have decided to impose, given the unrefuted evidence that Applicant diverted controlled substances and the lack of any evidence that he acknowledges his misconduct. There being no evidence in the record that Applicant has accepted responsibility for his actions, Applicant has failed to rebut the Government's prima facie showing that his registration would be "inconsistent with the public interest."
Under agency precedent, "where a registrant [or applicant] has committed acts inconsistent with the public interest, [he] must accept responsibility for his . . . actions and demonstrate that he . . . will not engage in future misconduct."
There is, however, no evidence that Applicant acknowledges his misconduct, which is egregious, and accepts responsibility for it. Indeed, the Expert's report identifies dozens of patients (beyond the seven specifically discussed above) to whom Applicant diverted controlled substances. Accordingly, Applicant's application will be denied. /22/
FOOTNOTE 22 As found above, because Applicant did not submit his renewal application at least 45 days before the expiration of his registration, and had been served previously with the Order to Show Cause, pursuant to 21 CFR 1301.36(i), his registration expired on
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well as 28 CFR 0.100(b) and 0.104, I order that the pending application of
Dated:
Deputy Administrator.
[FR Doc. 2014-01797 Filed 1-29-14;
BILLING CODE 4410-09-P
| Copyright: | (c) 2014 Federal Information & News Dispatch, Inc. |
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