On February 2, 2007, I, the Deputy Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration to Dale L. Taylor (Respondent) of Winter Haven, Florida. The Order immediately suspended Respondent's Certificate of Registration, BT8732631, as a practitioner, based on my preliminary finding that Respondent was diverting large quantities of controlled substances through an internet-prescribing scheme. Show Cause Order at 2. I therefore concluded that Respondent's “continued registration during the pendency of these proceedings would constitute an imminent danger to the public health and safety because of the substantial likelihood that [he would] continue to divert controlled substances to drug abusers.” Id. at 3.
The Show Cause Order also alleged that Respondent's “continued registration is inconsistent with the public interest.” Id. at 1. More specifically, the Show Cause Order alleged that beginning in May 2004, Respondent had been issuing prescriptions for controlled substances over the Internet “without the benefit of a legitimate doctor-patient relationship and outside the course of professional practice.” Id. The Show Cause Order alleged that Respondent had admitted to DEA investigators that he had done such prescribing for three different internet entities including Pacific MD, Norco Worldwide, and BestRxCare.com. Id. at 1-2.
The Show Cause Order further alleged that Respondent had admitted that he would log onto a Web site and view a list of customers, review their medical records, and then contact each person by telephone. Id. at 2. The Show Cause Order alleged that Respondent had admitted that his “role was simply to make sure that the type of medication, strength and quantity were consistent with the online customers' alleged medical need,” and he had “never called patients after authorizing their drug orders to provide aftercare.” Id. Relatedly, the Show Cause Order alleged that Respondent told investigators that he took “the on-line patient's word when determining their need for hydrocodone.” Id.
The Show Cause Order alleged that BestRxCare.com's orders were filled by CRJ Pharmacy and that the pharmacy's records for the period from July 3, 2006, to January 22, 2007, showed that it had dispensed “approximately 6,000 [i]nternet drug orders that [Respondent] authorized.” Id. The Show Cause Order alleged that “approximately 85% of these [i]nternet drug orders were for hydrocodone combination products.” Id.
Finally, the Show Cause Order alleged that Respondent had admitted to investigators that he had “authorized controlled substance [prescriptions] for online customers throughout the United States” even though he acknowledged that he was “only licensed to practice medicine in” Florida. Id. The Show Cause Order thus alleged that Respondent had violated various state laws that prohibit “unlicensed, out-of-state physicians issuing controlled substance prescriptions to state residents.” Id.
On February 6, 2007, DEA Investigators served the Show Cause Order and Immediate Suspension, which notified Respondent of his right to a hearing, by leaving it at his residence with his wife. Cf. F.R.C.P. 4(e). Since that time, neither Respondent, nor anyone purporting to represent him, has responded. Because (1) more than thirty days have passed since service of the Show Cause Order, and (2) no request for a hearing has been received, I conclude that Respondent has waived his right to a hearing. See 21 Start Printed Page 30856CFR 1301.43(d). I therefore enter this final order without a hearing based on relevant material in the investigative file and make the following findings.
Respondent is the holder of DEA Certificate of Registration, BT8732631, as a practitioner, with an expiration date of November 30, 2006. On October 11, 2006, Respondent, however, applied for a renewal of his registration via the Internet. Therefore, in accordance with the Administrative Procedure Act, Respondent's registration remains in existence pending the issuance of a final order in this matter. See 5 U.S.C. 558(c).
According to the investigative file, on January 26, 2007, DEA investigators interviewed Respondent regarding his participation in various schemes involving the dispensing of controlled substance over the Internet. Respondent told the investigators that in early to mid 2004, he answered an advertisement placed by an entity known as Pacific MD in a Gainesville, Florida newspaper which sought physicians to perform internet consultations. In May 2004, Pacific MD engaged Respondent to review patient records and if the records were not more than two years old, contact the “patient” and authorize a prescription which was typically for either combination products containing hydrocodone, a schedule III controlled substance, see 21 CFR 1308.13(e), or Xanax (alprazolam), a schedule IV controlled substance. See 21 CFR 1308.14(c). Respondent related that in June 2005, he quit working for Pacific MD because it owed him money.
At some date not specified in the investigative file, Respondent submitted his credentials to a temporary employment service that specialized in medical staffing. Thereafter, Respondent was contacted by another entity, Norco Worldwide, and began working for it. Norco gave Respondent a password which enabled him to review medical records submitted by Norco's customers. According to Respondent, a physician's assistant would contact and talk to the patients and authorize a prescription for a controlled substance using his DEA registration. Respondent further admitted that he wrote prescriptions on a computer program, which were then submitted electronically to a pharmacy which filled them. Respondent stated that he worked for Norco from October 2004 through December 2004 and authorized approximately forty prescriptions per day. Respondent further told investigators that he quit Norco because he wasn't comfortable with the fact that a physician's assistant was authorizing controlled substance prescriptions using his DEA registration.
Shortly thereafter, Respondent was contacted by one Chris Larson. Larson had also formerly worked for Norco and had started two Web sites, BestRx.com, and your painmanagement.com, which allowed persons to order controlled substances over the Internet by completing a questionnaire and submitting their “medical records.” Larson also owned several pharmacies that filled prescriptions for his Web sites.
Respondent told investigators that he would log onto the BestRx.com Web site and obtain a list of “patients” with “appointments.” Respondent would then review the “patient's” medical records before telephoning the person. Respondent asserted that he required the records to be on the previous physician's letterhead and be signed. Respondent further maintained that he reviewed the records to determine whether the drug sought was consistent with the customer's medical condition.
When asked by investigators whether he had ever contacted any of the customer's prior physicians, Respondent claimed that he had but could not recall their names. Respondent further admitted that he was not authorized to require that a customer undergo additional testing and that the customer had to go to their original physician to obtain such tests.
Respondent admitted that he simply trusted that the records submitted by the website's customers were not fraudulent and took the customer's word during the phone consultation. Based on the medical records and the phone conversation, Respondent would prescribe controlled substances. Respondent further admitted that he never called a customer to follow up. Respondent also admitted that on numerous occasions, customers would call him seeking more drugs.
One of the investigators then asked Respondent if he maintained any patient files. Respondent claimed that he kept meticulous record for all of his “patients” at his residence in a plastic storage bin located in his office. Respondent's wife, however, told investigators that the bin did not contain any medical records but merely the names and addresses of persons Respondent had spoken with.
Respondent admitted that he had authorized controlled substances prescriptions for persons located throughout the United States even though he held only a Florida medical license. Respondent further admitted that he authorized as many as twenty to twenty-five prescriptions a day while working for BestRxCare.com.
The investigators asked Respondent to voluntarily surrender his DEA registration. Respondent refused and stated that he intended to continue authorizing prescriptions through the Internet because on-line medicine is the wave of the future. Respondent acknowledged that absent use of a webcam, it was not possible to verify the validity of a “patient” and his or her medical needs. Respondent stated that until then, he would continue to take online patients at their word and accept their records as authentic.
On January 22, 2007, DEA personnel executed an Administrative Inspection Warrant at CRJ Pharmacy and YPM Total Care Pharmacy, two of the businesses owned by Chris Larson. During the search, DEA obtained each pharmacy's dispensing records; the records were then reviewed by a DEA intelligence analyst. According to the records of CRJ Pharmacy, between July 2006 and January 2007, Respondent authorized 6,069 prescriptions for 1,098 persons who resided in forty-six States and the District of Columbia. Of the prescriptions, 5,156 were for hydrocodone-combination products, and 526 were for alprazolam.
The records for YPM showed that from November 27, 2006, through January 17, 2007, Respondent authorized prescriptions for another 171 patients who resided in thirty-six States. More specifically, Respondent authorized 367 orders for hydrocodone-combination products and thirty-three orders for alprazolam. The records also showed that on a single day, Respondent had written as many as fifty-six orders which were filled by YPM.
Section 304(a) of the Controlled Substances Act 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). In making the public interest determination, the Act requires the consideration of the following factors:
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the Start Printed Page 30857manufacture, 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.
- “[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).
Finally, section 304(d) provides that “[t]he Attorney General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this section, in cases where he finds that there is an imminent danger to the public health or safety.” 21 U.S.C. 824(d). In this case I conclude that Factors Two and Four establish that allowing Respondent to continue to dispense controlled substances would be inconsistent with the public interest and therefore will order the revocation of Respondent's registration and the denial of his pending application for renewal.
Factors Two and Four—Respondent's Experience in Dispensing Controlled Substances and Respondent's Compliance With Applicable Laws
The central issue in this case is whether the prescriptions Respondent issued pursuant to his employment with the Web sites BestRx.com and yourpainmanagement.com complied with Federal law. As explained below, the evidence conclusively demonstrates that Respondent used his prescribing authority to act as a drug pusher; the only difference between him and a street dealer was that he did not physically distribute the drugs to the customers of the aforementioned websites.
Under DEA regulations, 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 related 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, 126 S.Ct. 904, 925 (2006) (citing Moore, 423 U.S. 122, 135 (1975)).
It is fundamental that a practitioner must establish a bonafide doctor-patient relationship in order to be acting “in the usual course of * * * professional practice” and to issue a prescription for a “legitimate medical purpose.” Under the State of Florida's regulations, a physician “shall not provide treatment recommendations, including issuing a prescription, via electronic or other means, unless the following elements have been met:
(a) A documented patient evaluation, including history and physical examination to establish the diagnosis for which any legend drug is prescribed.
(b) Discussion between the physician * * * and the patient regarding treatment options and the risks and benefits of treatment.
(c) Maintenance of contemporaneous medical records meeting the requirements of [Florida regulations].
Fla. Admin. Code R. 64B8-9.014.
Relatedly, the American Medical Association's Guidance for Physicians on Internet Prescribing has explained that to establish a bonafide doctor-patient relationship, a “physician shall”:
i. Obtain a reliable medical history and perform a physical examination of the patient, adequate to establish the diagnosis for which the drug is being prescribed and to identify underlying conditions and/or contraindications to the treatment recommended/provided; ii. have sufficient dialogue with the patient regarding treatment options and the risks and benefits of treatment(s); iii. as appropriate, follow up with the patient to assess the therapeutic outcome; iv. maintain a contemporaneous medical record that is readily available to the patient and * * * to his * * * other health care professionals; and v. include the electronic prescription information as part of the patient medical record.
(quoted in William R. Lockridge, 71 FR 77791,77798 (2006)).
To similar effect are the guidelines issued by the Federation of State Medical Boards of the United States, Inc. See Model Guidelines for the Appropriate Use of the Internet in Medical Practice. According to the Guidelines, “[t]reatment and consultation recommendations made in an online setting, including issuing a prescription via electronic means, will be held to the same standards of appropriate practice as those in traditional (face-to-face) settings. Treatment, including issuing a prescription, based solely on an online questionnaire or consultation does not constitute an acceptable standard of care.” Id. at 4 (emphasis added). Cf. DEA, Dispensing and Purchasing Controlled Substances over the Internet, 66 FR 21181, 21183 (2001) (guidance document) (“Completing a questionnaire that is then reviewed by a doctor hired by the Internet pharmacy could not be considered the basis for a doctor/patient relationship.”).
Under the Florida rule and standards of the medical profession, it is clear that Respondent did not prescribe controlled substances pursuant to a bonafide doctor-patient relationship and thus did not comply with federal law. Respondent did not physically examine the “patients.” Nor did he ever act in a consultative capacity “with another physician who ha[d] an ongoing relationship with the patient, and who ha[d] agreed to supervise the patient's treatment, including the use of any prescribed medications.” Fla. Admin. Code R. 64B8-9.014(4).
Moreover, Respondent admitted that he was not authorized by his employer to order that a customer undergo additional testing. Respondent also admitted that he never called a “patient” to follow-up on whether the treatment was successful. Finally, notwithstanding his statement to investigators that he kept meticulous records, the evidence establishes that Respondent did not maintain medical records on his purported patients. Thus, it is clear that under Florida law as well as existing professional standards, Respondent did not establish a bonafide doctor-patient relationship with the persons he prescribed controlled substances for. See, e.g., Fla. Admin. Code R. 64B8-9.014.
Moreover, the investigative file establishes that Respondent issued thousands of prescriptions for controlled substances and did so notwithstanding the potential for fraud that was inherent in the scheme and his admission that on numerous occasions, customers called him requesting more controlled substances. As recognized in Lockridge and other agency orders, “'[le]gally there is absolutely no Start Printed Page 30858difference between the sale of an illicit drug on the street and the illicit dispensing of a licit drug by means of a physician's prescription.”' 71 FR at 77800 (quoting Mario Avello, M.D., 70 FR 11695, 11697 (2005)). See also Floyd A. Santner, M.D., 55 FR 37581 (1990). In short, Respondent was not engaged in the legitimate practice of medicine, but rather, was dealing drugs.
Accordingly, Respondent's experience in dispensing controlled substances and his record of compliance with applicable laws makes plain that his continued registration would “be inconsistent with the public interest.” 21 U.S.C. 824(a)(4). Moreover, for the same reasons which led me to find that Respondent posed “an imminent danger to the public health or safety,” id. section 824(d), I conclude that the public interest requires that his registration be revoked effective immediately and his pending application for renewal be denied. See 21 CFR 1316.67.
Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 824(a), as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA Certificate Registration, BT8732631, issued to Dale L. Taylor, M.D., be, and it hereby is, revoked. I further order that Respondent's pending application for renewal of his registration be, and it hereby is, denied. This order is effective immediately.Start Signature
Dated: May 21, 2007.
Michele M. Leonhart,
[FR Doc. E7-10622 Filed 6-1-07; 8:45 am]
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