[Federal Register Volume 62, Number 81 (Monday, April 28, 1997)] [Notices] [Pages 22968-22972] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-10781] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 95-26] Leonel Tano, M.D.; Revocation of Registration On March 7, 1995, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, (DEA), issued an Order to Show Cause to Leonel Tano, M.D., (Respondent) of San Antonio, Texas, notifying him of an opportunity to show cause as to why DEA should not revoke his DEA Certificate of Registration, AT7513282, and deny any pending applications for renewal of such registration as a practitioner under 21 U.S.C. 823(f), for reason that his continued registration would be inconsistent with the pubic interest pursuant to 21 U.S.C. 824(a)(4). The Order to Show Cause also asserted as a basis for the proposed action pursuant to 21 USC 824(a)(1), Respondent's material falsification of an application for registration. By letter dated May 3, 1995, Respondent, through counsel, filed a request for a hearing, and following prehearing procedures, a hearing was held in Austin, Texas on December 12 and 13, 1995, before Administrative Law Judge Mary Ellen Bittner. At the hearing, both parties called witnesses to testify and introduced documentary evidence. Ultimately, the alleged falsification was not pursued as an independent basis for revocation and instead was considered as part of the overall public interest issue. After the hearing, counsel for both parties submitted proposed findings of fact, conclusions of law and argument. On September 17, 1996, Judge Bittner issued her Opinion and Recommended Ruling, Findings of Fact, Conclusions of Law and Decision, recommending that Respondent's DEA Certificate of Registration be revoked. Neither party filed exceptions to her decision, and on October 18, 1996, Judge Bittner transmitted the record of these proceedings to the Acting Deputy Administrator. The Acting Deputy administrator has considered the record in its entirety, and pursuant to 21 CFR 1316.67, hereby issues his final order based upon findings of fact and conclusions of law as hereinafter set forth. The Acting Deputy Administrator adopts, in full, the Findings of Fact, Conclusions of Law, and Recommended Ruling of the Administrative Law Judge, and his adoption is in no manner diminished by any recitation of facts, issues and conclusions herein, or of any failure to mention a matter of fact or law. The Acting Deputy Administrator finds that Respondent is a physician who has maintained a general practice in San Antonio, Texas since 1978. Respondent testified that he practices in a low income neighborhood and that ninety percent of his patients has been seeing him for sixteen or seventeen years. In 1987, DEA conducted a routine inspection of a local narcotic treatment program. During that inspection, it was learned that some of the clients in the program had tested positive for controlled substances, other than methadone, including Valium, Darvon, Xanax, and Phenephan with codeine, and that they admitted receiving the prescriptions for those substances from Respondent. Subsequently, in August 1990, the Texas State Board of Medical Examiners (Board) entered an Order, which was agreed to by Respondent, that found that Respondent prescribed controlled substances, including Xanax, Halcion, Darvocet N-100, Restoril and Valium to two individuals who were in a methadone treatment program. The Board found that as a result, Respondent was subject to disciplinary action pursuant to Texas Health & Safety Code Art. 4495b, section 3.08(4)(C) for ``writing prescriptions for a dispensing to a person known to be a habitual user of narcotic drugs, controlled substances, or dangerous drugs or to a person who the physician should have known was a habitual user of the narcotic drugs, controlled substances or dangerous drugs.'' It should be noted that the statute also provides that the section ``does not apply to those persons being treated by the physician for their narcotic use after the physician notifies the board in writing of the name and address of the person so treated.'' Respondent apparently did not provide such notice to the Board. Therefore, the Board ordered, among other things, that Respondent ``shall not prescribe or dispense controlled substances to any known drug abuser, including methadone patients.'' At the hearing in this matter, Respondent testified that his problems with the Board began when ``somebody'' came to his office and asked if he was treating any patients who were taking methadone. According to Respondent, he told the person that for the last two or three years he had been treating two patients he knew were on methadone. Respondent testified that he did not believe that his actions warranted restrictions being placed on his medical license by the Board, but instead, he should have been reprimanded or advised about the limitations on prescribing to methadone patients. In September 1990, DEA conducted a routine inspection of a local narcotic treatment program. During the course of the inspection, the program's director noted that several of the program's patients had tested positive for controlled substances other than methadone, and that some of the [[Page 22969]] patients stated that they had received the prescriptions for the controlled substances from Respondent. Thereafter, in January 1992, DEA initiated an undercover investigation of Respondent's controlled substance handling practices. On January 9, 1992, a cooperating individual introduced an undercover DEA task force officer to K.B. who had obtained controlled substances from Respondent in the past. The officer's true identity was not revealed to K.B. The officer and K.B. then went to Respondent's office. K.B. filled out a form, telling the officer that she knew what to put down on the form in order to get Xanax, however that form is not in evidence in this proceeding. When he saw Respondent, the officer asked for Xanax, but it is unclear from the officer's testimony what reason, if any, was given for wanting the drug. Respondent asked the officer whether he was an alcoholic or drug abuser, and whether he knew that Xanax was addictive. Respondent performed a cursory physical examination and then issued the officer a prescription for 30 dosage units of Xanax. The Government does not contend that this prescription, in and of itself, was improper. The officer returned to Respondent's office on February 7, 1992, this time accompanied by another undercover DEA task force officer. On this occasion, the undercover officers represented that they were truck drivers. The first officer asked Respondent for a prescription for 60 dosage units of Xanax, but Respondent gave him a prescription for forty dosage units instead, saying that it would be too risky to prescribe a larger quantity. After writing the prescription, Respondent then performed a cursory physical examination, not asking the officer any questions about his medical history or current problems. A nurse took the second officer's weight and blood pressure. The officer told Respondent that he was having trouble meeting his work deadlines because he frequently had to stop to eat and rest, so he asked for something that could keep him awake and something that could bring him back down when he finished driving. The officer also told Respondent that he was constantly hungry and needed to stop too frequently to eat. He told Respondent that he had been buying drugs at truck stops. At the hearing in this matter the second officer testified that he always needed to lose weight, but that he and Respondent did not discuss any weight problems. Respondent issued the officer prescriptions for 30 dosage units of Zantryl (brand name for a product containing phentermine) and 25 dosage units of Xanax, both Scheduled IV controlled substances. Respondent testified at the hearing that he prescribed the Zantryl to the officer because it is an appetite suppressant and the officer had stated that he was a compulsive eater and was overweight, and that he prescribed the Xanax to calm him down at the end of the day. On February 26, 1993, a third undercover DEA task force officer went to Respondent's office. On the patient history form, the officer listed her complaints as headache, back pain, and weight gain. She indicated to Respondent that she was tired and that she had gained five pounds. When Respondent asked her what was wrong with her, she replied, ``I am tired, bored, no energy to do anything. I was falling asleep outside while waiting.'' At some point during the visit, the undercover officer began crying. Respondent issued the officer a prescription for a non-controlled antidepressant. As to her headaches, the officer told Respondent that Tylenol did not help her. Respondent then issued a prescription for Fiorinal, a Schedule III controlled substance. The Government does not contend that these prescriptions were illegitimate. The officer returned to Respondent's office on March 26, 1993. During this visit she asked Respondent for phentermine, which Respondent refused stating that she was not overweight. Respondent issued the officer another prescription for the non-controlled antidepressant, since according to Respondent, the officer appeared ``anxious or down.'' The officer next went to Respondent's office on April 15, 1993. She told Respondent that the drugs that he had previously prescribed for her were not strong enough. Respondent advised the officer not to purchase drugs on the street, because she would not know what she was buying. Respondent then prescribed the officer a non-controlled substance and 20 dosage units of Xanax. Respondent told the officer to take one Xanax per day and if that did not help to take two, but to try not to take it at all. Respondent also told the officer to take the Xanax only if she needed it to sleep, not to relax. The officer's fourth undercover visit was on April 28, 1993. The day before, the officer, while acting in an undercover capacity, attempted to purchase Xanax from an individual on the street. The individual stated that he did not have any Xanax, but that he could get some from Respondent. The officer and the individual went to Respondent's office together on April 28, 1993. The officer saw Respondent first. She asked Respondent for more Xanax, and Respondent asked her if she wanted it to help her sleep. The officer responded affirmatively, and then Respondent said he would give her ``something else,'' because ``they don't want us to write Xanax.'' There was then some discussion about giving the officer Valium or Restoril, both Schedule IV controlled substances, but instead Respondent gave the officer three sample packages each containing two tablets of Halcion, also a Schedule IV controlled substance. Before leaving the examination room, the officer asked Respondent if she could buy some Xanax from him since she could not buy it on the streets. Respondent stated. ``I don't know how much they charge,'' but refused to sell it to her. The individual who had accompanied the officer then went into the examination room. The officer stood outside the room listening to the individual's conversation with Respondent. Respondent told the individual that he could not write any prescriptions for Xanax because he was being investigated. After some discussion, it was decided that Respondent could issue the individual a prescription since Respondent had not seen him in a while. The individual offered Respondent $25.00 and Respondent then wrote a prescription which turned out to be for 30 dosage units of diazepam 10 mg. (the generic form of Valium), not Xanax. Respondent testified at the hearing in this matter that he confronted the officer about not seeing a psychiatrist as he had recommended and was confused by the officer's requests for different drugs at different visits. Respondent did not offer any explanation for the diazepam prescription issued for the individual on this occasion. This officer made her final undercover visit on June 30, 1993. The officer indicated that nothing was wrong with her, that she had not gone to see a psychiatrist, and that she had finished the drugs he had given her a long time ago. The officer offered to buy Xanax from Respondent, but Respondent told her that he could not write a prescription, and that she would have to see a psychiatrist. Nonetheless, Respondent wrote the officer a prescription for 25 tablets of Xanax. Finally, a fourth undercover DEA task force officer made two visits to Respondent's office. The officer testified that when he first went to Respondent's office on October 15, 1993, the nurse would not let him see Respondent unless he indicated that something was wrong with him, so he put down on the medical history form that he had bad headaches. However, when he saw Respondent, he indicated that he had [[Page 22970]] headaches a long time ago, but was now trying to get off Vicodin (a Schedule III controlled substance containing hydrocodone). The officer also told Respondent that he used to use marijuana, but not anymore. Respondent testified that he was suspicious that the officer had Medicaid coverage since ``he looked a healthy person to me.'' Respondent wrote a prescription for the officer for 20 dosage units of hydrocodone with APAP, and told him ``don't take it if you don't need it,'' and ``don't give this to anybody.'' Respondent testified at the hearing in this matter that he prescribed the hydrocodone to the officer in case he had headaches in the future, and that he did not think that the officer was addicted to Vicodin. Respondent also testified that ``I wouldn't call Vicodin a narcotic.'' The officer returned to Respondent's office on October 21, 1993. During this visit, the officer indicated that was not having headaches, but that he was going out of town and did not want to be ``short of pills.'' Respondent continued to be suspicious of the officer's Medicaid coverage. Respondent issued the officer a prescription for 25 tablets of Vicodin and told him to ``[t]ry not to take these things if you don't need them.'' The officer then asked Respondent for some Xanax. Respondent refused, offering to give him something else. Respondent stated that, ``[t]here are a lot of problems with Xanax.'' The officer next offered to buy some Xanax from Respondent, but again Respondent refused, saying, ``they check on everything.'' Respondent testified at the hearing that the officer's insistence on obtaining Xanax caused him to suspect that the officer was seeking the drug for other than medical purposes. In addition to the undercover visits, DEA's investigation of Respondent included a review of the records of three local narcotic treatment programs to determine whether Respondent had continued to treat methadone patients with controlled substances after the Board's 1990 order precluding him from doing so. The records of one program showed that Respondent issued a total of 29 controlled substance prescriptions to 21 different patients between February 1991 and January 1994. The records from the second program indicated that Respondent prescribed controlled substances a total of 52 times to six different patients between September 1990 and January 1994. Finally, the third program's records showed that Respondent prescribed controlled substances a total of 50 times to 18 patients between January 1991 and February 1994. Except for five of these patients, it is unclear whether Respondent knew that he was prescribing controlled substances to individuals undergoing methadone treatment. Respondent testified at the hearing that while he had never received notification from the Board that the order restricting his medical license had expired or been modified, he had received copies of a form letter from the program director of one of the narcotic treatment programs which he believed justified his prescribing of controlled substances to individuals undergoing methadone treatment. This letter, dated September 30, 1992, and addressed to ``Dear Colleague'', was to be provided by a client of the program to a physician who prescribed the client controlled substances, if the client tested positive for drugs other than methadone. The letter states that the bearer is in a methadone maintenance treatment program and explains the effect of methadone maintenance treatment and considerations in treating methadone patients with drugs for other conditions.The letter advises the prescribing physician that state law requires that methadone patients provide documentation to the narcotic treatment program from the prescribing physician as to the necessity of the prescription and that the prescribing physician is aware that the patient is receiving methadone treatment. The letter specifically states that, ``[t]he intention of the regulation is not to restrict physicians in the exercise of their professional judgment in the practice of medicine but to require [methadone maintenance] patients to inform other physicians of this information which is vital to the prescribing physician.'' Respondent testified that approximately 15 of his patients presented him with a copy of this letter, and that he continued treating four of them because they had been longtime patients. Respondent admitted that he signed notes for these four patients saying that he knew that they were on methadone. Respondent further testified that he did not think that his prescribing of controlled substances to the patients on methadone in any way violated the standard of care, because he did not increase the dosages and some of the patients ``got into trouble with the law.'' Notwithstanding the Board's order precluding Respondent's prescribing of controlled substances to methadone patients, as discussed above, Texas law precludes such prescribing unless the physician notifies the Board in writing of the name and address of the patient that the physician is treating for narcotic use. The Government introduced into evidence an affidavit dated November 28, 1995, from the Board's Assistant Custodian of Records stating that the Board had no records indicating that Respondent had notified the Board of the name and address of any person he was treating for his or her narcotic use. Respondent testified at the hearing that he never knowingly violated any standards of care with respect to prescribing for patients who were in methadone treatment programs; that he has never caused a patient to become addicted to any medication; that he was never a ``heavy writer'' of prescriptions, but that he has nonetheless become more cautious; and that in the past five years, he has refused to treat patients he thought were abusing drugs unless they agreed to a urinalysis. On November 30, 1994, Respondent executed an application for renewal of his DEA Certificate of Registration. On this application, he answered ``No'' to a question asking, among other things, if he ``ever had a State professional license or controlled substance registration revoked, suspended, denied, restricted or placed on probation?'' During a discussion on March 22, 1995, a DEA investigator asked Respondent whether his medical license had ever been suspended or had any other action taken against it. Respondent answered that no such action had been taken. At the hearing in this matter, Respondent did not offer any explanation for the response on his 1994 renewal application or his representations to the DEA investigator. The Government contends that Respondent's registration should be revoked based upon his prescribing of controlled substances to the undercover officers; his violation of the Board's 1990 order not to prescribe controlled substances to methadone treatment patients; and his falsification of his 1994 renewal application for DEA registration. Respondent contends that his registration should not be revoked because he did not engage in any misconduct serious enough to warrant restricting his authority to handle controlled substances; that questions of medical judgment are not within the purview of this forum and should be decided by the state medical board; and that he does the best he can practicing in a ``war zone'' of drug activity. Pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy Administrator may revoke a DEA Certificate of Registration and deny any pending applications, if he determines that the continued registration would be inconsistent with the public interest. Section 823(f) [[Page 22971]] requires that the following factors be considered: (1) The recommendation of the appropriate State licensing board or professional disciplinary authority. (2) The applicant's experience in dispensing, or conducting research with respect to 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 or safety. These factors are to be considered in the disjunctive; the Deputy Administrator may rely on any one or a combination of factors and may give each factor the weight he deems appropriate in determining whether a registration should be revoked or an application for registration be denied. See Henry J. Schwarz, Jr., M.D., Docket No. 88- 42, 54 FR 16422 (1989). Regarding factor one, in August 1990, the Board restricted Respondent's license to practice medicine by prohibiting him from prescribing or dispensing controlled substances to any known drug abuser, including methadone patients. There is no evidence in the record that the Board's order has been terminated or modified, and in fact, Respondent testified that as far as he knew, it was still in effect. The recommendation of the appropriate state licensing board is just one of the factors to be considered and is not dispositive of whether Respondent's continued registration is inconsistent with the public interest. Therefore, the Acting Deputy Administrator rejects Respondent's argument that consideration of the undercover visits should be left to the state medical board. As to Respondent's experience in dispensing controlled substances, Judge Bittner concluded that, excluding the prescriptions issued on January 9, 1992, February 26, 1993, and March 26, 1993, the prescriptions that Respondent issued to the undercover officers were not for a legitimate medical purpose. Respondent issued prescriptions to the undercover officers with little, if any, discussion regarding the medical need for the drug, and with little or no physical examination. On one occasion the officer asked for 60 dosage units of Xanax, however Respondent only prescribed 40 dosage units noting that it would be ``too risky'' to prescribe more. On several occasions, Respondent issued the prescriptions even after the officers indicated that there was nothing wrong with them. Specifically, one officer, while noting on the patient history form that he suffered from headaches, told Respondent during his first visit that had suffered from headaches in the past, but was now trying to get off Vicodin. On his second visit, the officer stated that he was not having headaches. The only reason given by the officer for wanting Vicodin was that he was going out of town and he was ``short of pills.'' Nonetheless, Respondent issued the officer a prescription for 20 hydrocodone with APAP and six days later issued another prescription for 25 dosage units. Not only did Respondent issue prescriptions to the undercover officers, but he also issued a prescription to another individual for no legitimate medical reason. Of particular note regarding this prescription is that Respondent at first refused to issue the individual a prescription stating that he (Respondent) was under investigation. Nevertheless, Respondent issued the individual a prescription for Xanax after the individual pointed out that he had not seen Respondent in a while. Respondent asserts that he practices in a virtual ``war zone'' of drug activity. The Acting Deputy Administrator concludes that in light of this assertion, Respondent should have been all the more vigilant in ensuring that controlled substances were prescribed only for legitimate medical purposes. Instead, Respondent prescribed controlled substances to the officers even though he admitted that he was confused by their repeated requests for different drugs. Two of the officers asked to purchase Xanax from Respondent after he refused to prescribe it for them. Although Respondent refused to sell the officers Xanax, he nonetheless issued them prescriptions for other controlled substances. Respondent admitted during his testimony that he was suspicious of one of the officer's Medicaid coverage, since the officer appeared healthy. Respondent also admitted that he refused to issue this officer a prescription for Xanax because he was suspicious of the officer's request. Yet Respondent issued this officer prescriptions for hydrocodone, in case the officer had headaches in the future, even though the officer denied suffering from headaches. The Acting Deputy Administrator concludes that these are not actions of a DEA registrant who is trying to prevent controlled substances from being diverted. Instead, Respondent's prescribing during the undercover investigation demonstrates a disregard for his responsibilities as a DEA registrant. Of equal concern to the Acting Deputy Administrator is Respondent's continued prescribing of controlled substances to methadone patients after the Board entered an order in 1990, specifically prohibiting such prescribing. As Judge Bittner noted, it is undisputed that ``between February 1991 and January 1994, Respondent prescribed controlled substances a total of 131 times to a total of forty-five patients who were clients of various methadone treatment programs.'' While Judge Bittner found it unclear whether Respondent knew or should have known that all of these individuals were in narcotic treatment, she did find the evidence clear that ``Respondent was aware of five such patients. * * *'' Respondent asserted that a form letter, presented to him by some of his patients, that was addressed to ``Dear Colleague'' from the program director of a local narcotic treatment program, constituted permission for Respondent to issue prescriptions for controlled substances to methadone treatment patients. Like Judge Bittner, the Acting Deputy Administrator finds no merit to this assertion. This letter was a form letter from a narcotic treatment program, not from the Board that had restricted his medical license. There is no evidence in the record that Respondent sought to ascertain from the Board whether he was permitted to issue such prescriptions. The Acting Deputy Administrator is extremely troubled by the number of prescriptions that Respondent issued to narcotic treatment patients after the Board issued its order prohibiting such prescribing. The Acting Deputy Administrator agrees with Judge Bittner that the evidence in the record shows that Respondent only actually knew that five of these individuals were undergoing narcotic treatment. However, as Judge Bittner stated in her opinion, ``one would expect that after the Medical Board disciplined Respondent and restricted his medical license for prescribing controlled substances to addicts and habitual users, Respondent would have been especially careful to avoid engaging in that conduct again.'' Regarding factors three and four, the Acting Deputy Administrator finds that Respondent has no convictions under Federal or state law relating to controlled substances. However, between 1987 and 1990, Respondent violated the Texas Medical Practice Act by prescribing controlled substances to patients who were in methadone maintenance treatment. Respondent continued to prescribe controlled substances to such patients after the Board prohibited him from doing so in 1990. In addition, Respondent issued [[Page 22972]] prescriptions during the undercover investigation for no legitimate medical purpose in violation of 21 CFR 1306.04. Finally, as to factor five, the Acting Deputy Administrator finds relevant Respondent's representation on his 1994 application for renewal of his DEA registration that his state medical license had not been restricted, when in fact the Board had restricted his license in 1990. As stated previously, ``[s]ince DEA must rely on the truthfulness of information supplied by applicants in registering them to handle controlled substances, falsification cannot be tolerated.'' Bobby Watts, M.D. 58 FR 46995 (1993). In addition, the Acting Deputy Administrator finds it significant that in 1995, when specifically asked by a DEA investigator whether any action had been taken against his state medical license, Respondent replied that no such action had been taken. Respondent has not offered any explanation for these misstatements. Judge Bittner concluded that Respondent's continued registration would be inconsistent with the public interest at this time in light of his prescribing of controlled substances during the undercover investigation for no legitimate medical purpose; his prescribing of controlled substances to patients enrolled in methadone treatment programs that resulted in the Board's 1990 order restricting his medical license; his continued prescribing of controlled substances to at least several patients he knew were in methadone treatment programs after the Board prohibited such prescribing; and his false statements on his renewal application and to the DEA investigator regarding the Board's action against his medical license. Judge Bittner concluded that ``Respondent is not fully capable and/or willing to accept and carry out the responsibilities inherent in DEA registration. * * *'' The Acting Deputy Administrator concurs with Judge Bittner's findings and conclusions. Accordingly, the Acting Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in him by 21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that DEA Certificate of Registration AT7513282, issued to Leonel Tano, M.D., be, and it hereby is, revoked. The Acting Deputy Administrator further orders that any pending applications for renewal of such registration, be, and they hereby are, denied. This order is effective May 28, 1997. Dated: April 16, 1997. James S. Milford, Acting Deputy Administrator. [FR Doc. 97-10781 Filed 4-25-97; 8:45 am] BILLING CODE 4410-09-M